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UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF FLORIDA
IN RE: ZANTAC (RANITIDINE)
PRODUCTS LIABILITY
LITIGATION
_______________________________/
MDL NO. 2924
20-MD-2924
JUDGE ROBIN L. ROSENBERG
MAGISTRATE JUDGE BRUCE E. REINHART
THIS DOCUMENT RELATES TO:
Ralph Dudley v. GlaxoSmithKline, et al. 9:20-cv-81056-RLR
Kalmeta Salvatore v. GlaxoSmithKline, et al. 9:20-cv-81059-RLR
Allen Brittner v. GlaxoSmithKline, et al. 9:20-cv-81061-RLR
John Cash v. GlaxoSmithKline, et al. 9:20-cv-81065-RLR
Jose Flores v. GlaxoSmithKline, et al. 9:20-cv-81068-RLR
Joseph Gregory Jr. v. GlaxoSmithKline, et al. 9:20-cv-81072-RLR
Roy Williams v. GlaxoSmithKline, et al. 9:20-cv-81073-RLR
Mark Hernandez v. GlaxoSmithKline, et al. 9:20-cv-81074-RLR
Michael White v. GlaxoSmithKline, et al. 9:20-cv-81075-RLR
Ryan Ortega v. GlaxoSmithKline, et al. 9:20-cv-81077-RLR
Oliver Reynolds v. GlaxoSmithKline, et al. 9:20-cv-81078-RLR
Grag Amelino v. GlaxoSmithKline, et al. 9:20-cv-81087-RLR
Matthew Yedlin v. GlaxoSmithKline, et al. 9:20-cv-81089-RLR
Armando Becerril v. GlaxoSmithKline, et al. 9:20-cv-81090-RLR
Lynn Smith v. GlaxoSmithKline, et al. 9:20-cv-81092-RLR
Chris Ives v. GlaxoSmithKline, et al. 9:20-cv-81093-RLR
James Newton v. GlaxoSmithKline, et al. 9:20-cv-81094-RLR
Michael Jerde v. GlaxoSmithKline, et al. 9:20-cv-81096-RLR
Albert Muesse v. GlaxoSmithKline, et al. 9:20-cv-81097-RLR
Reha Ray Karaoz v. GlaxoSmithKline, et al. 9:20-cv-81098-RLR
Greg Knell v. GlaxoSmithKline, et al. 9:20-cv-81099-RLR
Austin Barnes v. GlaxoSmithKline, et al. 9:20-cv-81104-RLR
Michael Caratti v. GlaxoSmithKline, et al. 9:20-cv-81105-RLR
Brian Elias v. GlaxoSmithKline, et al. 9:20-cv-81106-RLR
Marc Friedland v. GlaxoSmithKline, et al. 9:20-cv-81107-RLR
Marc Mitchell v. GlaxoSmithKline, et al. 9:20-cv-81109-RLR
Mark Morrison v. GlaxoSmithKline, et al. 9:20-cv-81110-RLR
Dwight Norman v. GlaxoSmithKline, et al. 9:20-cv-81112-RLR
Brian Wilbur v. GlaxoSmithKline, et al. 9:20-cv-81118-RLR
Velo Wright Jr. v. GlaxoSmithKline, et al. 9:20-cv-81119-RLR
Case 9:20-md-02924-RLR Document 2569 Entered on FLSD Docket 01/15/2021 Page 1 of 30
Claudia Masouredis v. GlaxoSmithKline, et al. 9:20-cv-81121-RLR
Lolita Mills v. GlaxoSmithKline, et al. 9:20-cv-81122-RLR
Gary Campbell v. GlaxoSmithKline, et al. 9:20-cv-81142-RLR
John Geurin v. GlaxoSmithKline, et al. 9:20-cv-81143-RLR
Carbajal, et al. v. GlaxoSmithKline, et al. 9:20-cv-81144-RLR
Joseph Gigliello v. GlaxoSmithKline, et al. 9:20-cv-81145-RLR
James Goetz v. GlaxoSmithKline, et al. 9:20-cv-81152-RLR
Steven Brodie v. GlaxoSmithKline, et al. 9:20-cv-81153-RLR
Henry D. Harbaugh v. GlaxoSmithKline, et al. 9:20-cv-81154-RLR
John Russell v. GlaxoSmithKline, et al. 9:20-cv-81157-RLR
Gilbert Astruc v. GlaxoSmithKline, et al. 9:20-cv-81216-RLR
MOTION TO REMAND CASES TO CALIFORNIA STATE COURT
The above-captioned Plaintiffs, by and through undersigned counsel, move this Court to
remand forty-one cases removed from California state court pursuant to 28 U.S.C. § 1447(c).
This Motion is filed with leave of Court pursuant to the Court’s January 11, 2021 Order (Doc.
2535).
Case 9:20-md-02924-RLR Document 2569 Entered on FLSD Docket 01/15/2021 Page 2 of 30
i
TABLE OF CONTENTS
Page
TABLE OF CONTENTS ................................................................................................................. i
TABLE OF AUTHORITIES .......................................................................................................... ii
INTRODUCTION .......................................................................................................................... 1
BACKGROUND ............................................................................................................................ 4
LEGAL STANDARD ..................................................................................................................... 4
ARGUMENT .................................................................................................................................. 6
I. The Drug Company Defendants Have Not Proven, with Clear and Convincing
Evidence, that Plaintiffs’ Negligence Claims Against the California Retailers Are
Impossible ......................................................................................................................... 6
A. Plaintiffs State a Colorable, if Not Plausible, Claim of Negligence Against the
California Retailer Defendants .................................................................................. 6
B. This Court Recently Held that Pleading a Negligence Claim Against a Retailer
Would Be Possible .................................................................................................... 9
C. Defendants’ Attempt to Reconstitute Plaintiffs’ Claims Solely Around Testing for a
Latent Defect Fails Because Plaintiffs Allege Actual and Constructive Knowledge
of the Defect ............................................................................................................ 10
II. The Drug Company Defendants Have Not Established that Plaintiffs’ Strict Liability
Claims Are, by Clear and Convincing Evidence, Impossible Based on a Defense of
Preemption ...................................................................................................................... 13
A. The Drug Company Defendants Cannot Establish Fraudulent Joinder of Plaintiffs’
Strict Liability Claims Based on a Preemption Defense Because the Court Lacks
Independent Jurisdiction to Consider the Merits of the Defense ............................ 14
B. The Drug Company Defendants Have Not Demonstrated, with Clear and
Convincing Evidence, that Plaintiffs’ Strict Liability Manufacturing Defect Claims
Are Impossible ........................................................................................................ 18
CONCLUSION ............................................................................................................................. 20
REQUEST FOR HEARING ......................................................................................................... 21
CERTIFICATION PURSUANT TO LOCAL RULE 7.1(A)(3) .................................................. 21
Case 9:20-md-02924-RLR Document 2569 Entered on FLSD Docket 01/15/2021 Page 3 of 30
ii
TABLE OF AUTHORITIES
Page(s)
Cases
A.S. v. Pfizer, Inc.,
No. 1:13-CV-00524-LJO, 2013 WL 2384320 (E.D. Cal. May 30, 2013) .......................... 16, 17
Ambriz v. CVS Pharmacy, Inc.,
No. 19-CV-1391, 2020 WL 1660018 (E.D. Cal. Apr. 3, 2020) ........................................... 7, 12
Armstrong v. McKesson Corp.,
No. C, 13-03113 WHA, 2013 WL 4516668 (N.D. Cal. Aug. 23, 2013) ............................ 16, 17
Arriaga v. CitiCapital Commercial Corp.,
85 Cal. Rptr. 3d 143 (Ct. App. 2008) ....................................................................................... 19
Barker v. Lull Eng’g Co.,
573 P.2d 443 (Cal. 1978) .......................................................................................................... 19
Brush v. Bayside Orthopaedics, Inc.,
No. 8:14-CV-2163-T-36EAJ, 2014 WL 5426643 (M.D. Fla. Oct. 22, 2014) .......................... 18
Buck v. McKesson Corp.,
No. 13CV2541 JLS (RBB), 2014 WL 12514793
(S.D. Cal. July 29, 2014)..................................................................................................... 15, 17
Cabral v. Ralphs Grocery Co.,
248 P.3d 1170 (Cal. 2011) .......................................................................................................... 8
Caouette v. Bristol-Myers Squibb Co.,
No. C-12-1814 EMC, 2012 WL 3283858 (N.D. Cal. Aug. 10, 2012)...................................... 16
Catlett v. McKesson Corp.,
No. C, 13-03067 WHA, 2013 WL 4516732 (N.D. Cal. Aug. 23, 2013) ............................ 16, 17
Celeste v. Merck, Sharp & Dohme Corp.,
No. 14CV360 AJB MDD, 2014 WL 2739025 (S.D. Cal. June 17, 2014) ................................ 15
Chicago, Rock Island & Pacific Ry. Co. v. Schwyhart,
227 U.S. 184 (1913) .................................................................................................................... 5
Cotton v. Mass. Mut. Life Ins. Co.,
402 F.3d 1267 (11th Cir. 2005) .......................................................................................... 15, 18
Coyle v. Historic Mission Inn Corp.,
234 Cal. Rptr. 3d 330 (Ct. App. 2018) ..................................................................................... 12
Case 9:20-md-02924-RLR Document 2569 Entered on FLSD Docket 01/15/2021 Page 4 of 30
iii
Crowe v. Coleman,
113 F.3d 1536 (11th Cir. 1997) ........................................................................................ 5, 6, 12
D.A. ex rel. Wilson v. McKesson Corp.,
No. 1:13-CV-01700-LJO, 2014 WL 202738 (E.D. Cal. Jan. 17, 2014) ............................. 15, 17
Dodich v. Pfizer Inc.,
No. C 18-02764 WHA, 2018 WL 3584484 (N.D. Cal. July 26, 2018) .............................. 15, 17
Eddy v. Stowe,
185 P. 1024 (Cal. Ct. App. 1919) ....................................................................................... 12, 13
Emana v. McKesson Corp.,
No. C, 13-03157 WHA, 2013 WL 4426257 (N.D. Cal. Aug. 14, 2013) ............................ 16, 17
Ferrari v. Nat. Partners, Inc.,
No. 15-CV-04787, 2016 WL 4440242 (N.D. Cal. Aug. 23, 2016) ............................................ 7
Florence v. Crescent Res., LLC,
484 F.3d 1293 (11th Cir. 2007) ................................................................................................ 17
Franchise Tax Bd. of State of Cal. v. Constr. Laborers Vacation Tr. for S. California,
463 U.S. 1 (1983) ...................................................................................................................... 14
Fransas v. Brenntag N. Am. Inc.,
No. 9:17-CV-80058, 2017 WL 9292098 (S.D. Fla. Mar. 10, 2017)..................................... 6, 11
Garrett v. Howmedica Osteonics Corp.,
153 Cal. Rptr. 3d 693 (Ct. App. 2013) ..................................................................................... 19
Garza v. Endo Pharm.,
No. CV 12-1585-CAS OPX, 2012 WL 5267897 (C.D. Cal. Oct. 24, 2012) .............................. 8
Geisse v. Bayer HealthCare Pharm. Inc.,
No. 17-CV-07026-JD, 2019 WL 1239854 (N.D. Cal. Mar. 18, 2019) ............................... 15, 18
Grancare, LLC v. Thrower by & through Mills,
889 F.3d 543 (9th Cir. 2018) .................................................................................................... 15
Hatherley v. Pfizer, Inc.,
No. CIV. 2:13-00719 WBS, 2013 WL 3354458 (E.D. Cal. July 3, 2013) ......................... 16, 17
Henderson v. Washington Nat. Ins. Co.,
454 F.3d 1278 (11th Cir. 2006) ............................................................................................ 5, 17
Hensley-Maclean v. Safeway, Inc.,
No. CV 11-01230 RS, 2014 WL 1364906 (N.D. Cal. Apr. 7, 2014) ................................... 8, 12
Case 9:20-md-02924-RLR Document 2569 Entered on FLSD Docket 01/15/2021 Page 5 of 30
iv
Hermosillo v. McKesson Corp.,
No. C, 13-03169 WHA, 2013 WL 4427828 (N.D. Cal. Aug. 14, 2013) ............................ 16, 17
Hughes v. Mylan Inc.,
No. CIV.A. 11-5543, 2011 WL 5075133 (E.D. Pa. Oct. 25, 2011).......................................... 16
Hunter v. Philip Morris USA,
582 F.3d 1039 (9th Cir. 2009) .................................................................................................. 15
In re Abilify (Aripiprazole) Prod. Liab. Litig.,
No. 3:16MD2734, 2018 WL 6258903, at *6 (N.D. Fla. Nov. 8, 2018) ................ 3, 5, 14, 15, 18
In re Avandia Mktg., Sales Practices & Prod. Liab. Litig.,
624 F. Supp. 2d 396 (E.D. Pa. 2009) .................................................................................. 16, 17
In re Darvocet, Darvon & Propoxyphene Prod. Liab. Litig. (“Darvocet I”),
889 F. Supp. 2d 931 (E.D. Ky. 2012) ................................................................................. 16, 17
In re Darvocet, Darvon & Propoxyphene Prod. Liab. Litig. (“Darvocet II”),
106 F. Supp. 3d 849 (E.D. Ky. 2015) ................................................................................. 16, 17
In re Diet Drugs (Phentermine, Fenfluramine, Dexfenfluramine) Prod. Liab. Litig.,
905 F. Supp. 2d 644 (E.D. Pa. 2012) .................................................................................. 16, 17
In re Lipitor (Atorvastatin Calcium) Mktg. Sales Practices & Prod. Liab. Litig.,
No. 2:14-MN-2502-RMG, 2016 WL 7373887 (D.S.C. July 14, 2016) .............................. 16, 17
In Re Plavix Prod. Liab. & Mktg. Litig.,
No. 3:13-CV-03610-FLW, 2014 WL 4954654 (D.N.J. Oct. 1, 2014)................................ 16, 17
In re Zoloft (Sertraline Hydrochloride) Prod. Liab. Litig.,
No. 12-MD-2342, 2013 WL 6050627 (E.D. Pa. Nov. 14, 2013) ....................................... 16, 17
In re: Zantac (Ranitidine) Prods. Liab. Litig.,
No. 20-MD-2924, 2020 WL 7864213 (S.D. Fla. Dec. 31, 2020) ............................................... 9
In re: Zantac (Ranitidine) Prods. Liab. Litig.,
No. 20-MD-2924, 2020 WL 7864585 (S.D. Fla. Dec. 31, 2020) ............................................... 9
J.E. v. Smithkline Beecham Corp.,
No. CV 13-04897-KAW, 2014 WL 11369807 (N.D. Cal. Jan. 27, 2014) ......................... 15, 17
J.F. ex rel. Moore v. McKesson Corp.,
No. 1:13-CV-01699-LJO, 2014 WL 202737 (E.D. Cal. Jan. 17, 2014) ............................. 15, 17
J.K.B. by Bennett v. Pfizer, Inc.,
No. CV1305043MMMJCGX, 2013 WL 12129385 (C.D. Cal. Nov. 4, 2013)................... 16, 17
Case 9:20-md-02924-RLR Document 2569 Entered on FLSD Docket 01/15/2021 Page 6 of 30
v
J.P. ex rel. Plummer v. McKesson Corp.,
No. 2:13-CV-02207-TLN, 2014 WL 3890326 (E.D. Cal. Aug. 7, 2014)........................... 15, 17
Kemp v. Int’l Bus. Machines Corp.,
109 F.3d 708 (11th Cir. 1997) .................................................................................................. 14
LAOSD Asbestos Cases,
248 Cal. Rptr. 3d 219 (Ct. App. 2019) ................................................................................. 7, 10
Lueck v. McKesson Corp.,
No. C, 13-03167 WHA, 2013 WL 4427111 (N.D. Cal. Aug. 14, 2013) ............................ 16, 17
Mathis v. Pfizer Inc.,
No. SACV1801256AGAFMX, 2018 WL 5291933 (C.D. Cal. Oct. 22, 2018) .................. 15, 17
Pacheco de Perez v. AT&T Co.,
139 F.3d 1368 (11th Cir. 1998) .................................................................................................. 6
Parks v. The New York Times Co.,
308 F.2d 474 (5th Cir. 1962) ...................................................................................................... 5
Pike v. Frank G. Hough Co.,
467 P.2d 229 (Cal. 1970) ............................................................................................................ 7
Rentz v. McKesson Corp.,
No. CV 12-4399 PSG (EX), 2012 WL 12888362 (C.D. Cal. Aug. 7, 2012) ............................ 16
Robinson v. Pfizer Inc.,
No. 4:16-CV-439 (CEJ), 2016 WL 1721143 (E.D. Mo. Apr. 29, 2016) .................................. 17
Rodriguez v. Inglewood Unified Sch. Dist.,
230 Cal. Rptr. 823 (Ct. App. 1986)............................................................................................. 7
Romo v. McKesson Corp.,
No. CV 12-2036 PSG (EX), 2013 WL 12131188 (C.D. Cal. Feb. 20, 2013) .......................... 16
Scimone v. Carnival Corp.,
720 F.3d 876 (11th Cir. 2013) .................................................................................................... 5
Seo v. All-Makes Overhead Doors,
119 Cal. Rptr. 2d 160 (Ct. App. 2002) ....................................................................................... 7
Smith v. Amylin Pharm., LLC,
No. 13CV1236 AJB MDD, 2013 WL 3467442 (S.D. Cal. July 10, 2013) .............................. 16
Spiers v. McKesson Corp.,
No. C, 13-03046 WHA, 2013 WL 4671231 (N.D. Cal. Aug. 29, 2013) ............................ 16, 17
Case 9:20-md-02924-RLR Document 2569 Entered on FLSD Docket 01/15/2021 Page 7 of 30
vi
Steel Co. v. Citizens for a Better Env’t,
523 U.S. 83 (1998) ...................................................................................................................... 6
Stillwell v. Allstate Ins. Co.,
663 F.3d 1329 (11th Cir. 2011) .......................................................................................... 4, 5, 6
Strawbridge v. Curtiss,
7 U.S. 267 (1806) ........................................................................................................................ 4
Taha v. Pfizer, Inc.,
No. CV1302577MWFFFMX, 2013 WL 12142560 (C.D. Cal. July 1, 2013) .................... 16, 17
Travis v. McKesson Corp.,
No. C, 13-03099 WHA, 2013 WL 5737946 (N.D. Cal. Aug. 26, 2013) ............................ 16, 17
Trees v. Pfizer Inc.,
No. CV 2:16-0334-RMG, 2016 WL 11540619 (D.S.C. Aug. 18, 2016) ............................ 15, 17
Triggs v. John Crump Toyota, Inc.,
154 F.3d 1284 (11th Cir. 1998) .................................................................................................. 5
Univ. of S. Alabama v. Am. Tobacco Co.,
168 F.3d 405 (11th Cir. 1999) .................................................................................................... 6
Vandermark v. Ford Motor Co.,
391 P.2d 168 (Cal. 1964) .......................................................................................................... 19
W.W. v. McKesson Corp.,
No. SACV131649AGDFMX, 2014 WL 12577143 (C.D. Cal. Jan. 31, 2014) .................. 15, 17
Zachman v. Johnson & Johnson,
No. 15-CV-04285-RS, 2015 WL 7717190 (N.D. Cal. Nov. 30, 2015) .................................... 15
Zaremba v. Orthopedics, Inc.,
No. 8:14-CV-1016-T-33TGW, 2014 WL 3057400 (M.D. Fla. July 7, 2014) .................... 13, 18
Statutes
28 U.S.C. § 1441 ............................................................................................................................. 4
28 U.S.C. § 1447 ..................................................................................................................... 2, 1, 3
Cal. Civ. Code § 1714 ................................................................................................................... 12
Other Authorities
Judicial Council of California Civil Jury Instruction 1221 ....................................................... 7, 11
Fla. Std. Jury Instr. (Civ.) 601.4 ................................................................................................... 11
Case 9:20-md-02924-RLR Document 2569 Entered on FLSD Docket 01/15/2021 Page 8 of 30
1
INTRODUCTION
In June 2020, the Drug Company Defendants1 improperly removed the above-captioned
cases from California state court, claiming federal subject matter jurisdiction when none existed.
Pursuant to 28 U.S.C. § 1447(c), Plaintiffs request that these cases be remanded back to
California state court before any further prejudice attends these Plaintiffs.
As set forth in their complaints, Plaintiffs are California citizens and originally filed their
cases in California state court, naming at least one California Retailer Defendant2 and at least one
Drug Company Defendant, thus complete diversity does not exist between the parties.
Notwithstanding this lack of complete diversity, the Drug Company Defendants removed the
cases to federal court, claiming that the citizenship of the California Retailer Defendants should
be ignored for jurisdictional purposes because of the heavily disfavored doctrine of fraudulent
joinder. Under the doctrine, the Court can ignore the citizenship of the diversity-destroying
California Retailer Defendants only if Drug Company Defendants prove, with clear and
convincing evidence and all factual and legal uncertainties going against them, that it would be
impossible to bring any claim against the California Retailer Defendants. If even a single claim
is colorable, remand must occur.
Plaintiffs allege three causes of action against the California Retailer Defendants: (1)
negligence, (2) strict liability - failure to warn, and (3) strict liability - manufacturing defect. The
Drug Company Defendants have failed to meet—and cannot meet—their heavy burden of
proving that each and every cause of action is, by clear and convincing evidence, impossible.
Regarding negligence, Plaintiffs specifically allege that the California Retailer Defendants
were negligent by failing to limit ranitidine’s exposure to heat during the transport, storage, and
stocking of ranitidine products. These failures, in turn, led to the accumulation of N-nitroso-
dimethylamine (“NDMA”) in the ranitidine products that substantially contributed to each
1 “Drug Company Defendants” collectively refers to Defendants GlaxoSmithKline, LLC, Boehringer Ingelheim
Pharmaceuticals, Inc., Boehringer Ingelheim USA Corp., Pfizer, Inc., Sanofi US Services Inc., and Sanofi-Aventis
U.S. LLC. 2 “California Retailer Defendants” collectively refers to Defendants Safeway, Inc., Safeway Health, Inc., The Vons
Companies, Inc., Kaiser Permanente International, and Grocery Outlet.
Case 9:20-md-02924-RLR Document 2569 Entered on FLSD Docket 01/15/2021 Page 9 of 30
2
Plaintiff’s development of cancer. California law has long recognized that the seller of a good
must take reasonable precautions to ensure the products they sell do not pose an unreasonable
risk to the consumer. This is settled law that is enshrined in California’s model jury instructions
and significant caselaw. Indeed, the possibility of this type of negligence claim was recently
acknowledged by this Court in its recent motions to dismiss rulings. This finding of possibility,
in and of itself, demands remand.
Notwithstanding, the Drug Company Defendants argue that this negligence claim is
impossible because the only way the California Retailer Defendants could have known about the
need to avoid exposure to heat would have been to conduct extensive drug testing. This
argument, however, misrepresents the allegations and confuses the law. Factually, the
complaints allege that California Retailer Defendants knew or should have known that exposing
ranitidine to heat could cause NDMA formation because this fact had been well documented for
decades. Thus, the premise of the Drug Company Defendants’ argument is, factually, false.
Legally, whether the California Retailer Defendants were “negligent” will turn on whether the
defendant acted as a reasonably prudent person would under like circumstances. This inquiry
looks at what the California Retailer Defendants knew or should have known and balances that
against the burden of protecting against the risk. If, as Plaintiffs allege, the California Retailer
Defendants knew or should have known that exposing ranitidine to heat would lead to NDMA
formation, then they could be negligent by failing to prevent their ranitidine products from being
exposed to heat. Under California law, such a claim is not only possible, it is plausible.
Therefore, because the Drug Company Defendants fail to prove impossibility for the negligence
claim, the Court need not reach the strict liability claims; there would be a least one possible
claim against the California Retailer Defendants in each lawsuit, requiring remand.
For Plaintiffs’ strict liability claims, the Drug Company Defendants argue that they are
“impossible” pursuant to federal preemption. However, as discussed below, in the context of a
motion to remand, this Court cannot address the merits of a preemption defense. There is a
jurisdictional bar—an impossibility preemption affirmative defense cannot, itself, establish
Case 9:20-md-02924-RLR Document 2569 Entered on FLSD Docket 01/15/2021 Page 10 of 30
3
fraudulent joinder because the Court must have independent jurisdiction, in the first place, to
adjudicate preemption. This was recently observed by the Hon. M. Casey Rodgers in the
neighboring In re Abilify (Aripiprazole) Prod. Liab. Litig. MDL in the Northern District of
Florida. No. 3:16MD2734, 2018 WL 6258903, at *6 (N.D. Fla. Nov. 8, 2018). There, Judge
Rodgers held, in the context of a remand motion for cases removed from California state court,
“that, without any independent grounds for federal jurisdiction over Plaintiffs’ claims, [the court]
lacks subject matter jurisdiction to assess the merits of [a] potential conflict preemption defense.”
Id. This holding is supported by a mountain of unanimous authority from thirty-five different
federal courts across the United States, including seven other MDLs. The Drug Company
Defendants cannot, as a matter of law, establish fraudulent joinder of Plaintiffs’ strict liability
claims by arguing that the state claim is preempted.
Finally, with regard to Plaintiffs’ manufacturing defect claim, the Drug Company
Defendants argue that Plaintiffs’ claim against the California Retailer Defendants is impossible
because they did not manufacture the ranitidine at issue. This is a misstatement of California
law. In California, a manufacturing defect is not limited to errors in the manufacturing process,
but refers to any defect in the product that renders it different from its intended design. Here,
Plaintiffs allege that the California Retailer Defendants caused their ranitidine products to
develop a “manufacturing defect” by letting their products accumulate unsafe levels of NDMA
during transport and storage. Under this theory, California law recognizes a strict liability
manufacturing defect claim. That the California Retailer Defendants did not literally
“manufacture” the pills is irrelevant.
The Drug Company Defendants have failed to prove, with clear and convincing evidence
and all factual and legal uncertainties going against them, that it would be impossible for the
Plaintiffs to bring any claim against a California Retailer Defendant. Accordingly, there is no
fraudulent joinder and, thus, no subject matter jurisdiction over these cases. Pursuant to 28
U.S.C. § 1447(c), Plaintiffs respectfully request this Court remand these cases.
Case 9:20-md-02924-RLR Document 2569 Entered on FLSD Docket 01/15/2021 Page 11 of 30
4
BACKGROUND
These forty-one cases were originally filed over eight months ago in California state court.
Specifically, on May 11, 2020, thirty-nine of the underlying lawsuits were filed in California
Superior Court, Alameda County (the “Alameda Cases”) and on June 10, 2020, Plaintiffs Mills
(9:20-cv-81122-RLR) and Masouredis (9:20-cv-81121-RLR) filed lawsuits in California
Superior Court, San Francisco County (“San Francisco Cases”). On June 15, 2020, the Drug
Company Defendants removed the Alameda Cases to the Northern District of California and
they removed the San Francisco cases on June 23, 2020.
While these cases were pending before the Northern District of California, Plaintiffs filed
motions to remand. However, after the cases were transferred to the MDL, those motions were
denied without prejudice on July 22, 2020 pursuant to Pretrial Order # 24.
On July 27, 2020, Plaintiffs moved for leave to refile a motion to remand. (Doc. 1205.)
The motion was denied, without prejudice, on August 7, 2020. (Doc. 1394). After denying two
more requests for leave to file a motion to remand without prejudice, (Docs. 1607 & 2229), on
January 11, 2021, this Court gave leave to Plaintiffs to file a motion to remand by January 15,
2021. (Doc. 2535).
While these removed cases were waiting for their opportunity to seek remand, the Parties
met and conferred and agreed that these California Plaintiffs would not need to adopt the Master
Pleadings, submit short form complaints, or provide any Census Plus Forms unless this Court
denied Plaintiffs’ anticipated motion to remand. Exh. 1 at 1.3
LEGAL STANDARD
An action filed in state court may be removed to federal court based upon diversity or
federal question jurisdiction. 28 U.S.C. § 1441(a). “When a case is removed based on diversity
jurisdiction,” like here, “the case must be remanded to state court if there is not complete
diversity between the parties[.]” Stillwell v. Allstate Ins. Co., 663 F.3d 1329, 1332 (11th Cir.
2011) (emphasis added) (citing Strawbridge v. Curtiss, 7 U.S. 267, 267 (1806)). This is because,
3 All cited exhibits are attached to the Declaration of R. Brent Wisner filed concurrently with this motion.
Case 9:20-md-02924-RLR Document 2569 Entered on FLSD Docket 01/15/2021 Page 12 of 30
5
without complete diversity, the Court lacks subject matter jurisdiction over the lawsuit.
“As a general proposition, a plaintiff, as ‘master of the complaint,’ is free to structure his
case in a manner that falls short of the requirements for diversity jurisdiction, including by
properly joining a diversity-destroying defendant.” In re Abilify (Aripiprazole) Prod. Liab.
Litig., No. 3:16MD2734, 2018 WL 6258903, at *1 (N.D. Fla. Nov. 8, 2018) (citing Scimone v.
Carnival Corp., 720 F.3d 876, 882 (11th Cir. 2013)). Indeed, a plaintiff’s motive in naming a
non-diverse defendant is irrelevant. Triggs v. John Crump Toyota, Inc., 154 F.3d 1284, 1291
(11th Cir. 1998) (quoting Chicago, Rock Island & Pacific Ry. Co. v. Schwyhart, 227 U.S. 184
(1913)). The “plaintiff has the right to select the forum, to elect whether to sue joint tortfeasors
and to prosecute his own suit in his own way to a final determination.” Crowe v. Coleman, 113
F.3d 1536, 1538 (11th Cir. 1997) (quoting Parks v. The New York Times Co., 308 F.2d 474, 478
(5th Cir. 1962)). Here, the Drug Company Defendants concede, as they must, that there is not
complete diversity between the Plaintiffs and the California Retailer Defendants because they are
all citizens of the State of California. Instead, the Drug Company Defendants invoke the
doctrine of fraudulent joinder. Notice of Removal, ¶¶ 4-7.4 Under the doctrine, the Court can
“ignore the presence of the non-diverse defendant” and retain subject matter jurisdiction,
provided the removing party proves that the non-diverse defendant was fraudulently joined.
Henderson v. Washington Nat. Ins. Co., 454 F.3d 1278, 1281 (11th Cir. 2006). The removing
parties here, i.e., the Drug Company Defendants, have not met this heavy burden.
To establish fraudulent joinder, “the removing party has the burden of proving by clear and
convincing evidence that … there is no possibility the plaintiff can establish a cause of action
against the resident defendant[.]” Stillwell, 663 F.3d at 1332 (emphasis added) (quoting Crowe,
113 F.3d at 1538).5 The Court must “construe removal statutes strictly” and resolve “all doubts
4 To facilitate ease of reference, all citations to a “complaint” or “notice of removal” will be to the complaint and
notice of removal filed in Ralph Dudley v. GlaxoSmithKline, et al., 9:20-cv-81056-RLR, found at docket number 1.
A copy of those documents are attached as Exhibits 1 and 2 to the Declaration of R. Brent Wisner. 5 Fraudulent joinder can also be established if the removing party can prove that the plaintiff “has fraudulently pled
jurisdictional facts to bring the resident defendant into state court.” Stillwell, 663 F.3d at 1332. However, there is
no claim of actual fraud raised in any Notice of Removal and, thus, it does not form the basis for any removal.
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about jurisdiction … in favor of remand to state court.” Univ. of S. Alabama v. Am. Tobacco
Co., 168 F.3d 405, 411 (11th Cir. 1999) (emphasis added, citations omitted). This burden is,
intentionally, “a heavy one.” Fransas v. Brenntag N. Am. Inc., No. 9:17-CV-80058, 2017 WL
9292098, at *2 (S.D. Fla. Mar. 10, 2017) (J. Rosenberg). “A presumption in favor of remand is
necessary because if a federal court reaches the merits of a pending motion in a removed case
where subject matter jurisdiction may be lacking it deprives a state court of its right under the
Constitution to resolve controversies in its own courts” and “‘offends fundamental principles of
separation of powers[.]”” Univ. of S. Alabama, 168 F.3d at 411 (quoting Steel Co. v. Citizens for
a Better Env’t, 523 U.S. 83, 94 (1998)). Moreover, “strict construction of removal statutes also
prevents ‘exposing the plaintiff to the possibility that he will win a final judgment in federal
court, only to have it determined that the court lacked jurisdiction on removal[.]” Crowe, 113
F.3d at 1538 (quotation omitted).
And, in assessing whether a claim is “possible,” the Court cannot use federal pleading
standards. Stillwell, 663 F.3d at 1334. Unlike the plausibility standard in federal
court,“[n]othing in [Eleventh Circuit] precedents concerning fraudulent joinder requires anything
more than conclusory allegations[.]” Id. In considering the allegations and legal theories, “[t]he
district court must evaluate factual allegations in the light most favorable to the plaintiff and
resolve any uncertainties about the applicable law in the plaintiff’s favor.” Id. (emphasis
added). “Where a plaintiff states even a colorable claim against the resident defendant, joinder is
proper and the case should be remanded” for lack of subject matter jurisdiction. Pacheco de
Perez v. AT&T Co., 139 F.3d 1368, 1380 (11th Cir. 1998).
ARGUMENT
I. The Drug Company Defendants Have Not Proven, with Clear and Convincing
Evidence, that Plaintiffs’ Negligence Claims Against the California Retailers Are
Impossible
A. Plaintiffs State a Colorable, if Not Plausible, Claim of Negligence Against the
California Retailer Defendants
In each underlying complaint, the Plaintiffs allege negligence against the California
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Retailer Defendants under California law. Thus, to keep these cases in federal court, the Drug
Company Defendants bear the burden of proving, with clear and convincing evidence—and with
all factual and legal doubts resolved in Plaintiffs’ favor—that a negligence claim against the
California Retailer Defendants is impossible. The Drug Company Defendants have not even
come close to meeting this heavy burden.
In California, a “seller is negligent if it fails to use the amount of care in … selling the
products that a reasonably careful … seller would use in similar circumstances to avoid exposing
others to a foreseeable risk of harm.” LAOSD Asbestos Cases, 248 Cal. Rptr. 3d 219, 223 (Ct.
App. 2019), review denied (Cal. Aug. 21, 2019) (citing Judicial Council of California Civil Jury
Instruction 1221 regarding negligence under products lability). To state a negligence claim
against the seller of a good under California law, a plaintiff must prove:
1. That [the Supplier] … supplied …. the [product];
2. That [the Supplier] was negligent in …supplying… the [product];
3. That [the plaintiff] was harmed; and
4. That [the Supplier]’s negligence was a substantial factor in causing [the
plaintiff]’s harm.
Judicial Council of California Jury Instruction 1221 (Negligence – Essential Factual Elements).
“[I]n determining whether [the defendant] used reasonable care, [the factfinder] should balance
what [defendant] knew or should have known about the likelihood and severity of potential harm
from the product against the burden of taking safety measures to reduce or avoid harm.” Id.; see
Pike v. Frank G. Hough Co., 467 P.2d 229, 232 (Cal. 1970).
This duty to exercise reasonable care for the welfare of customers while selling products
stems from a long-recognized “special relationship” between the “supplier of good and buyer or
user” enshrined in California common law. Seo v. All-Makes Overhead Doors, 119 Cal. Rptr. 2d
160, 167 (Ct. App. 2002) (quoting Rodriguez v. Inglewood Unified Sch. Dist., 230 Cal. Rptr.
823, 825 (Ct. App. 1986)). Negligence against a retailer is a well-established theory of liability
under California law. See Ambriz v. CVS Pharmacy, Inc., No. 19-CV-1391, 2020 WL 1660018,
at *4 (E.D. Cal. Apr. 3, 2020); Ferrari v. Nat. Partners, Inc., No. 15-CV-04787, 2016 WL
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4440242, at *9 (N.D. Cal. Aug. 23, 2016); Hensley-Maclean v. Safeway, Inc., No. CV 11-01230
RS, 2014 WL 1364906, at *3 (N.D. Cal. Apr. 7, 2014) (“Safeway has not pointed to any
statutory provision limiting its general duty of care[.]”); see Cabral v. Ralphs Grocery Co., 248
P.3d 1170, 1175 (Cal. 2011); see also Garza v. Endo Pharm., No. CV 12-1585-CAS OPX, 2012
WL 5267897, at *2 (C.D. Cal. Oct. 24, 2012) (noting that plaintiff “could potentially state a
claim against defendant CVS for negligence[.]”).
Here, Plaintiffs allege each element of a negligence claim. Specifically, Plaintiffs allege
that the California Retailer Defendants “had a duty to ensure that the Ranitidine-Containing
Drugs supplied to Plaintiff were stored, handled, and dispensed in a safe manner[.]” Complaint, ¶
283. Plaintiffs allege that the California Retailer Defendants “breached their duty to Plaintiff by
failing to properly store the Ranitidine-Containing Drugs supplied to Plaintiff, leading to
dangerous levels of NDMA accumulating in the drugs that harmed Plaintiff.” Complaint, ¶ 287.
The underlying complaints explain:
Defendants acted below the standard of care by storing and dispensing Ranitidine-
Containing Drugs to Plaintiff without first undertaking efforts to ensure that the drugs
were safe for human use by, for example, consulting the available medical literature
evidencing the potential human health dangers associated with the storage of
Ranitidine-Containing Drugs and the formation of NDMA within Ranitidine-
Containing drugs when the drugs are stored at particular temperatures.
Complaint, ¶ 287. Indeed, the underlying complaints state that “[b]ased on the public scientific
information available starting in 1982 (or earlier), the Defendants knew or should have known
that NDMA could form in ranitidine by exposure to heat and/or over time in storage” and that
“[e]arly studies, including the one conducted by GSK in the early 1980s, demonstrated that
NDMA formed when ranitidine was exposed to heat.” Complaint, ¶¶ 180, 144. Because of this
“[e]xtensive data” showing “that exposure to heat in storage conditions leads to the systematic
breakdown of the ranitidine molecule into NDMA, accumulating over time in the finished
product[,]” the underlying complaints assert that “[n]othing prevented any Defendant from, on its
own, taking action to prevent accumulation of NDMA in ranitidine drugs by ensuring cold
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storage and transport.” Complaint, ¶¶ 286, 171 see also Complaint, ¶ 288 (“Defendants knew or
should have known that storage of Ranitidine-Containing Drug can lead to the formation of
dangerous levels of carcinogenic NDMA in the drugs.”). And, in fact, the underlying complaints
specifically allege that the California Retailer Defendants “failed to adhere to and/or follow its
established practices and procedures in storing the Ranitidine-Containing Drugs” that were
ingested by the Plaintiffs. Complaint, ¶ 289. Thus, “[a]s a direct and proximate result of
Defendants’ improper storage practices of the Ranitidine-Containing Drugs, Plaintiff was
exposed to dangerous levels of NDMA which caused Plaintiff’s cancer.” Complaint, ¶ 290.
These allegations, with all factual or legal uncertainties read in a light most favorable to the
Plaintiffs, state a colorable claim for negligence against the California Retailer Defendants. The
risk of NDMA accumulation is alleged to have been known or knowable and a jury could
conclude that a “reasonably careful” seller should have used more care in the storage, transport,
and stocking of the ranitidine products they sold.
B. This Court Recently Held that Pleading a Negligence Claim Against a Retailer
Would Be Possible
Recently, this Court confirmed that bringing a negligence claim against a retailer for
negligent storage and transport could be possible:
With respect to the “heating” theory—that the [Retailer] Defendants should be
held liable for storing ranitidine at an elevated temperature prohibited by both
federal law and state law—the Plaintiffs have leave in an amended complaint to
plead this theory because, at this juncture, the Court is not prepared to conclude it
would be futile for the Plaintiffs to so plead[.]
In re: Zantac (Ranitidine) Prods. Liab. Litig., No. 20-MD-2924, 2020 WL 7864585, at *18 (S.D.
Fla. Dec. 31, 2020). This ruling was focused on the MDL’s Master Pleadings, where the MDL
Plaintiffs did not allege a heating theory of negligence. See In re: Zantac (Ranitidine) Prods.
Liab. Litig., No. 20-MD-2924, 2020 WL 7864213, at *19 (S.D. Fla. Dec. 31, 2020) (“[T]o the
extent that it is Plaintiffs’ intent to hold Defendants liable for storing ranitidine products under
the wrong conditions, such a theory is not pled.”). This contrasts with the complaints here,
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which specifically allege negligence regarding heating against the California Retailer
Defendants.6 See Complaint, ¶¶ 283-91. And, while the Court delineated various issues that
needed to be addressed in an amended pleading to satisfy the plausibility standard in federal
court, the issue here, i.e., impossibility, was decided. Defendants argued that amendment would
be futile, i.e., impossible, and the Court rejected that argument; holding, instead, that pleading a
negligence claim against a retailer might be possible. Thus, for the purposes of a fraudulent
joinder analysis, the Drug Company Defendants have not met their heavy burden of proving
impossibility. In fact, they have already lost this argument in this Court.
C. Defendants’ Attempt to Reconstitute Plaintiffs’ Claims Solely Around Testing
for a Latent Defect Fails Because Plaintiffs Allege Actual and Constructive
Knowledge of the Defect
Retailers in California, like any other seller of a good, must take reasonable care in selling
their products to avoid foreseeable harm to their customers. LAOSD Asbestos Cases, 248 Cal.
Rptr. at 223 (A “seller is negligent if it fails to use the amount of care in … selling the products
that a reasonably careful … seller would use in similar circumstances to avoid exposing others to
a foreseeable risk of harm.”). The Drug Company Defendants try to reconstitute Plaintiffs’
negligence claim around testing for “unforeseeable risks” or “latent defects,” arguing that “a
seller of a product does not have a duty to investigate or test products stocked on its shelves for
unforeseen risks[.]” Notice of Removal, ¶ 36 (emphasis added). But, the premise of this
argument, i.e., that the risk of NDMA formation was unforeseen or unforeseeable, is false. The
underlying complaints clearly allege that “[b]ased on the public scientific information available
starting in 1983 (or earlier), the Defendants knew or should have known that NDMA could form
in ranitidine by exposure to heat [.]” Complaint, ¶ 180. In other words, the complaints
specifically allege that the risk was foreseen and/or foreseeable. Nowhere do the complaints
suggest that testing was the only way the California Retailer Defendants could know NDMA
would form. When such allegations are considered in a light most favorable to Plaintiffs—as
6 These forty-one cases are not subject to the master pleadings, nor have they adopted the master pleadings.
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they must—the Defendant Drug Company Defendants’ argument falls apart.
In fact, alleging that a retailer should have known of the risk is generally sufficient to state
a possible negligence claim for the purposes of defeating fraudulent joinder. In Fransas v.
Brenntag N. Am. Inc., this Court directly addressed this issue. 2017 WL 9292098, at *2. There,
a plaintiff asserted a negligence claim under Florida law—negligence law that is almost identical
to California7—against a well-known Florida retailer, Publix, and several other manufacturers
and distributors of talcum powder. Id. Like here, the Fransas plaintiff alleged that the talcum
powder was contaminated (asbestos) and that the contamination substantially contributed to the
development of cancer (mesothelioma). Id. The defendants removed the case from Florida state
court to the Southern District of Florida, arguing that the negligence claim against Publix was
impossible and, thus, fraudulently joined. Id. To support this claim, Publix submitted a
declaration indicating that it had no knowledge of the asbestos contamination, did not test the
product, and simply sold the product in the exact way it was received. Id., at *3. The plaintiff
did not refute this fact, but pointed to allegations that Publix should have known of the risk. 8 Id.
Thus, this Court ruled that, “[v]iewed in the light most favorable to Plaintiffs … combined with
the remaining unrefuted allegations in Plaintiffs’ Complaint are sufficient to establish a
possibility that Plaintiffs may state a claim for negligence against Publix under Florida law[.]”
Id., at *4. This Court then remanded the case. Id.
The same analysis applies here. Plaintiffs allege that the California Retailer Defendants
knew or should have known that exposing ranitidine products to heat could cause NDMA
formation, and they allege facts about that information as being publicly available. See, e.g.,
Complaint 1, ¶ 288. Assuming those allegations are true—as this Court must—if the California
Retailer Defendants allowed their ranitidine products to be exposed to heat and then sold that
7 Compare Fla. Std. Jury Instr. (Civ.) 601.4 with Jud. Council of Cal. Civil Jury Inst. 1221. 8 Incidentally, on these facts, Plaintiffs’ claims against the California Retailer Defendants in these cases present an
even stronger case for negligence than the plaintiff in Fransas against Publix. In Fransas, Publix claimed (and the
plaintiff did not refute) that the talcum powder “products were not altered by Publix prior to sale of the products to
consumers[.]” 2017 WL 9292098, at *3. Here, Plaintiffs allege that the California Retailer Defendants, through
negligent storage and transport, contributed to ranitidine breaking down into NDMA and thus caused the
contamination. See Complaint, ¶¶ 286-89.
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ranitidine to the Plaintiffs, there is a possible, if not plausible, claim of negligence. And, if
negligence is possible, then there is no fraudulent joinder. Remand must issue.
To the extent the Drug Company Defendants are arguing that it would be unreasonable for
the California Retailer Defendants to have known about the risk of exposing ranitidine to heat,
such an argument is factually and legally insufficient. Legally, this argument goes to the merits
of Plaintiffs’ claim and, thus, cannot form the basis for removal. Crowe, 113 F.3d at 1542.
There is no dispute, under California law, that a retailer owes a duty of care to their customers to
exercise reasonable care in storing and transporting the products they sell. Cal. Civ. Code §
1714(a) (“Everyone is responsible, not only for the result of his or her willful acts, but also for an
injury occasioned to another by his or her want of ordinary care or skill in the management of his
or her property or person[.]”); see CVS Pharmacy, Inc., 2020 WL 1660018, at *4; Safeway, Inc.,
2014 WL 1364906, at *3. And, “whether [the defendant] used reasonable care,” involves
balancing “what [the defendant] knew or should have known about the likelihood and severity of
potential harm from the product against the burden of taking safety measures to reduce or avoid
harm.” Judicial Council of California Jury Instruction 1221. These questions are, by their
nature, fact- and case-specific. “This is because ‘[e]ach case presents different conditions and
situations. What would be ordinary care in one case might be negligence in another.’” Coyle v.
Historic Mission Inn Corp., 234 Cal. Rptr. 3d 330, 340 (Ct. App. 2018), reh’g denied (July 9,
2018), review denied (Sept. 19, 2018) (quoting Eddy v. Stowe, 185 P. 1024, 1027 (Cal. Ct. App.
1919)). More importantly, they are questions for a jury. And, in the context of a fraudulent
joinder analysis, they are questions that must be answered in favor of remand.
Factually, this argument fails as well. The premise of the Drug Company Defendants’
argument—that testing was the only way the California Retailer Defendants could have known
to avoid exposing the ranitidine to heat during transport and storage—is contrary to the
underlying complaints. For example, Plaintiffs allege that “[t]he risk of creating NDMA by
exposing ranitidine to heat has been well-known and documented.” Complaint, ¶ 144; see also
Complaint, ¶¶ 180, 286 (alleging that ranitidine breaking down into NDMA after exposure to
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heat was well known for decades). In fact, the ranitidine warning label directly cautions against
exposure to heat. The over-the-counter box for Zantac states “avoid excessive heat” and to store
the drug below 77⸰F. Exh. 4 at 1. This has been on the box since, at least, 1998. Id. Similar
warnings exist on the prescription Zantac label, requiring storage below 86⸰F. Exh. 5 at 2. It is
entirely possible—indeed, likely—that in transporting and storing ranitidine throughout
California, where temperatures routinely exceed 90⸰F, excessive heat exposure occurred; heat
exposure that could have been avoided had the California Retailer Defendants used temperature-
controlled transport systems. Any argument that the California Retailer Defendants needed to
conduct exhaustive testing is nothing more than a red herring. They just needed to read the label
of the product they sold.
The Drug Company Defendants’ attempt to reconstitute and narrow Plaintiffs’ alleged
negligence regarding transport and storage into one about extensive testing for unknown risks is
unavailing. It contradicts the allegations in the complaints and impermissibly delves into the
merits of Plaintiffs’ claims. It surely does not satisfy the Drug Company Defendants’ heavy
burden of proving impossibility.
II. The Drug Company Defendants Have Not Established that Plaintiffs’ Strict Liability
Claims Are, by Clear and Convincing Evidence, Impossible Based on a Defense of
Preemption
The Court only needs to consider Plaintiffs’ strict liability claims if the Drug Company
Defendants have proven, with clear and convincing evidence, that negligence against the
California Retailer Defendants is impossible. E.g., Zaremba v. Orthopedics, Inc., No. 8:14-CV-
1016-T-33TGW, 2014 WL 3057400, at *3 (M.D. Fla. July 7, 2014) (refusing to consider
preemption defense as basis for fraudulent joinder because other claims were possible). If the
Court concludes that the Drug Company Defendants have met this heavy burden regarding the
negligence claim, then the Court will still need to determine if the Drug Company Defendants
have also proven that the strict liability claims alleged in twenty-seven complaints are also
impossible under California law.
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The Drug Company Defendants make one argument as to why Plaintiffs’ strict lability
claims are impossible: they argue the claims are preempted by federal law. Notice of Removal,
¶¶ 23-35. This defense is based on a supposed “conflict” between state and federal law, i.e., that
it is impossible for the California Retailer Defendants’ to comply with California law without
also violating federal law. Mensing, 564 U.S. at 624. This Court has analyzed the merits of a
similar preemption challenge—to the extent claims are premised on labeling or design defects—
in ruling on the first round of the Retailers’ Motions to Dismiss based on preemption. Plaintiffs
will not repeat any argument raised in that briefing. Instead, Plaintiffs focus on two issues.
A. The Drug Company Defendants Cannot Establish Fraudulent Joinder of
Plaintiffs’ Strict Liability Claims Based on a Preemption Defense Because the
Court Lacks Independent Jurisdiction to Consider the Merits of the Defense
A preemption defense cannot, as a matter of law, form the basis for fraudulent joinder
because the Court must have federal jurisdiction before deciding the merits of a preemption
defense. See Kemp v. Int’l Bus. Machines Corp., 109 F.3d 708, 714 (11th Cir. 1997) (“Without
any basis for federal jurisdiction over a case, a federal court cannot decide a preemption
defense.”); see also Franchise Tax Bd. of State of Cal. v. Constr. Laborers Vacation Tr. for S.
California, 463 U.S. 1, 2 (1983) (A case “may not be removed on the basis of a federal defense,
including the defense of pre-emption, even if the defense is anticipated in the complaint and both
parties admit that the defense is the only question truly at issue.”).
The Hon. M. Casey Rodgers in the Northern District of Florida9 recently confirmed this
jurisdictional rule in the Eleventh Circuit. In re Abilify, 2018 WL 6258903, at *5-6. There, like
here, the drug company defendants10 argued, in the context of fraudulent joinder, that the
California defendant’s claims were preempted because they had “no authority ‘to initiate a
design, manufacturing, or label change’ for the brand name drugs they distribute.” Id., at *5-6.
9 Judge Rodgers currently presides over two MDLs, In re: Abilify (Aripiprazole) Products Liability Litigation, 3:16-
md-2734 (N.D. Fla.) and In re: 3M Combat Arms Earplug Products Liability Litigation, 3:19-md-2885 (N.D. Fla.),
where over 210,000 cases are pending. 10 Defense Co-Lead Anand Agneshwar was in leadership in the Abilify MDL and was responsible for the removal of
the Abilify cases from California state court. He also filed the opposition to remand in the Abilify MDL. It is worth
noting that despite losing this exact issue two years ago, Mr. Agneshwar repeated these arguments here.
Case 9:20-md-02924-RLR Document 2569 Entered on FLSD Docket 01/15/2021 Page 22 of 30
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Judge Rodgers, however, could not address the merits of the defense (no matter how
compelling11) because “in conflict preemption cases where a federal court otherwise lacks
subject matter jurisdiction over the dispute, the case must be remanded and the preemption
argument must be decided by the state court.” Id., at *5. She explained that even though the
preemption defense “is framed within the context of fraudulent joinder, it nonetheless remains a
substantive defense that goes to the merits of Plaintiffs’ state law claims” and, thus, “must be
decided by a court with competent jurisdiction.” Id., at *6 (quoting Cotton v. Mass. Mut. Life
Ins. Co., 402 F.3d 1267, 1292 (11th Cir. 2005). And, because impossibility preemption was the
only basis for arguing fraudulent joinder of the strict lability claims, just like here, Judge Rodgers
“lack[ed] subject matter jurisdiction to assess the merits of [the California defendant]’s potential
conflict preemption defense … which means the issue cannot provide a basis for a finding that
[the California defendant] was fraudulently joined.” Id.
Judge Rodgers’ jurisdictional holding is supported by a deluge of unanimous case law.
Thirty-five federal courts (including the Ninth Circuit Court of Appeals, where this case was
removed) have looked at this exact issue and each court concluded that a Mensing preemption
defense does not provide a basis for removal due to fraudulent joinder.12 This case law includes
11 See, e.g., In re Abilify, 2018 WL 6258903, at *5 (“This argument [preemption] is not without conceptual and,
frankly, practical appeal. … If the preemption issue were properly before the Court for a determination on the
merits, these authorities might well be considered persuasive.”). 12 See, e.g., Hunter v. Philip Morris USA, 582 F.3d 1039, 1045 (9th Cir. 2009); Grancare, LLC v. Thrower by &
through Mills, 889 F.3d 543, 549 (9th Cir. 2018) (Interpreting Hunter as holding that “an
implied preemption affirmative defense was not a permissible ground for finding fraudulent joinder[.]”); Geisse v.
Bayer HealthCare Pharm. Inc., No. 17-CV-07026-JD, 2019 WL 1239854, at *3 (N.D. Cal. Mar. 18, 2019)
(“[P]reemption goes to the merits of the plaintiff’s case and entails a degree of analysis that does not render a state
law claim obviously barred or frivolous for fraudulent joinder purposes.”); Mathis v. Pfizer Inc., No.
SACV1801256AGAFMX, 2018 WL 5291933, at *3 (C.D. Cal. Oct. 22, 2018); Dodich v. Pfizer Inc., No. C 18-
02764 WHA, 2018 WL 3584484, at *3 (N.D. Cal. July 26, 2018); Trees v. Pfizer Inc., No. CV 2:16-0334-RMG,
2016 WL 11540619, at *9 (D.S.C. Aug. 18, 2016); Zachman v. Johnson & Johnson, No. 15-CV-04285-RS, 2015
WL 7717190, at *3 (N.D. Cal. Nov. 30, 2015); J.P. ex rel. Plummer v. McKesson Corp., No. 2:13-CV-02207-TLN,
2014 WL 3890326, at *5 (E.D. Cal. Aug. 7, 2014); Buck v. McKesson Corp., No. 13CV2541 JLS (RBB), 2014 WL
12514793, at *4 (S.D. Cal. July 29, 2014); Celeste v. Merck, Sharp & Dohme Corp., No. 14CV360 AJB MDD, 2014
WL 2739025, at *6 (S.D. Cal. June 17, 2014); W.W. v. McKesson Corp., No. SACV131649AGDFMX, 2014 WL
12577143, at *3 (C.D. Cal. Jan. 31, 2014); J.E. v. Smithkline Beecham Corp., No. CV 13-04897-KAW, 2014 WL
11369807, at *3 (N.D. Cal. Jan. 27, 2014); J.F. ex rel. Moore v. McKesson Corp., No. 1:13-CV-01699-LJO, 2014
WL 202737, at *10 (E.D. Cal. Jan. 17, 2014) (“[I]t is inappropriate to determine whether Plaintiffs' claims against
McKesson are preempted by federal law.”); D.A. ex rel. Wilson v. McKesson Corp., No. 1:13-CV-01700-LJO, 2014
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seven decisions (including Judge Rodgers’) from MDL courts throughout the country. See In re
Darvocet, Darvon & Propoxyphene Prod. Liab. Litig. (“Darvocet I”), 889 F. Supp. 2d 931, 934
(E.D. Ky. 2012) (“Preemption is a federal defense that goes to the merits of a claim. As such, it
does not support a finding of fraudulent joinder.”); In re Darvocet, Darvon & Propoxyphene
Prod. Liab. Litig. (“Darvocet II”), 106 F. Supp. 3d 849, 855 (E.D. Ky. 2015) (“[I]t would be
inappropriate for the Court to analyze whether the claims against McKesson are preempted by
federal law at this stage in the proceedings.”); In re Diet Drugs (Phentermine, Fenfluramine,
Dexfenfluramine) Prod. Liab. Litig., 905 F. Supp. 2d 644, 647 (E.D. Pa. 2012) (“[A] federal
preemption defense to support their assertion that McKesson has been fraudulently joined
fails.”); In re Lipitor (Atorvastatin Calcium) Mktg. Sales Practices & Prod. Liab. Litig., No.
2:14-MN-2502-RMG, 2016 WL 7373887, at *6 (D.S.C. July 14, 2016); In re Zoloft (Sertraline
Hydrochloride) Prod. Liab. Litig., No. 12-MD-2342, 2013 WL 6050627, at *2 (E.D. Pa. Nov.
14, 2013) (“A preemption defense goes to the merits of a plaintiff’s case and does not overcome
the strong presumption against removal jurisdiction[.]”); In Re Plavix Prod. Liab. & Mktg. Litig.,
No. 3:13-CV-03610-FLW, 2014 WL 4954654, at *8 (D.N.J. Oct. 1, 2014); In re Avandia Mktg.,
Sales Practices & Prod. Liab. Litig., 624 F. Supp. 2d 396, 420 (E.D. Pa. 2009) (rejecting
preemption as a ground for fraudulent joinder).
Importantly, no court has ever found fraudulent joinder because a Mensing preemption
WL 202738, at *10 (E.D. Cal. Jan. 17, 2014); J.K.B. by Bennett v. Pfizer, Inc., No. CV1305043MMMJCGX, 2013
WL 12129385, at *6 (C.D. Cal. Nov. 4, 2013); Spiers v. McKesson Corp., No. C 13-03046 WHA, 2013 WL
4671231, at *2 (N.D. Cal. Aug. 29, 2013); Travis v. McKesson Corp., No. C 13-03099 WHA, 2013 WL 5737946, at
*2 (N.D. Cal. Aug. 26, 2013); Armstrong v. McKesson Corp., No. C 13-03113 WHA, 2013 WL 4516668, at *2
(N.D. Cal. Aug. 23, 2013); Catlett v. McKesson Corp., No. C 13-03067 WHA, 2013 WL 4516732, at *2 (N.D. Cal.
Aug. 23, 2013); Emana v. McKesson Corp., No. C 13-03157 WHA, 2013 WL 4426257, at *2 (N.D. Cal. Aug. 14,
2013); Lueck v. McKesson Corp., No. C 13-03167 WHA, 2013 WL 4427111, at *2 (N.D. Cal. Aug. 14, 2013);
Hermosillo v. McKesson Corp., No. C 13-03169 WHA, 2013 WL 4427828, at *2 (N.D. Cal. Aug. 14, 2013); Smith
v. Amylin Pharm., LLC, No. 13CV1236 AJB MDD, 2013 WL 3467442, at *4 (S.D. Cal. July 10, 2013); Hatherley v.
Pfizer, Inc., No. CIV. 2:13-00719 WBS, 2013 WL 3354458, at *6 (E.D. Cal. July 3, 2013); Taha v. Pfizer, Inc., No.
CV1302577MWFFFMX, 2013 WL 12142560, at *3 (C.D. Cal. July 1, 2013); A.S. v. Pfizer, Inc., No. 1:13-CV-
00524-LJO, 2013 WL 2384320, at *9 (E.D. Cal. May 30, 2013); Romo v. McKesson Corp., No. CV 12-2036 PSG
(EX), 2013 WL 12131188, at *9 (C.D. Cal. Feb. 20, 2013); Caouette v. Bristol-Myers Squibb Co., No. C-12-1814
EMC, 2012 WL 3283858, at *4 (N.D. Cal. Aug. 10, 2012); Rentz v. McKesson Corp., No. CV 12-4399 PSG (EX),
2012 WL 12888362, at *4 (C.D. Cal. Aug. 7, 2012); Hughes v. Mylan Inc., No. CIV.A. 11-5543, 2011 WL 5075133,
at *6 (E.D. Pa. Oct. 25, 2011) (“Mensing merely provides a framework for the state court to adjudicate Plaintiffs’
claim; it is not a hook that lands these cases in federal court.”).
Case 9:20-md-02924-RLR Document 2569 Entered on FLSD Docket 01/15/2021 Page 24 of 30
17
defense rendered a claim impossible. Indeed, these Drug Company Defendants, represented by
these same attorneys, have specifically litigated and lost this exact issue over twenty-five times
and, each time, lost.13 Pfizer, in particular, has a history of recycling lost arguments. E.g.,
Robinson v. Pfizer Inc., No. 4:16-CV-439 (CEJ), 2016 WL 1721143, at *4 (E.D. Mo. Apr. 29,
2016) (“In light of these repeated admonishments and remands to state court for six years,
defendant can no longer argue that its asserted basis for seeking removal to federal court in these
circumstances is objectively reasonable … plaintiffs are entitled to just costs and actual expenses
because defendant lacked an objectively reasonable basis for seeking removal.”).14
The Eleventh Circuit has, in rare circumstances, pondered the merits of an affirmative
defense (never preemption) in consideration of fraudulent joinder; but, even there, the Eleventh
Circuit expressly refused to rule on the merits of the defense and, instead, ordered remand so the
state court could decide the issue. See, e.g., Florence v. Crescent Res., LLC, 484 F.3d 1293,
1298 (11th Cir. 2007) (considering whether state statute barred claims and concluding the issue
should be remanded and decided by the state court); Henderson v. Washington Nat. Ins. Co., 454
13 GSK: W.W., 2014 WL 12577143, at *3; J.E, 2014 WL 11369807, at *3; J.F., 2014 WL 202737, at *10; D.A.,
2014 WL 202738, at *10; Spiers, 2013 WL 4671231, at *2; Travis, 2013 WL 5737946, at *2; Armstrong, 2013 WL
4516668, at *2; Emana, 2013 WL 4426257, at *2; Lueck, 2013 WL 4427111, at *2; Catlett, 2013 WL 4516732, at
*2; Hermosillo, 2013 WL 4427828, at *2; D.A., 2014 WL 202738, at *10; J.P., 2014 WL 3890326, at *5; Buck,
2014 WL 12514793, at *4; see also In re Avandia, 624 F. Supp. 2d at 420. Pfizer: Mathis, 2018 WL 5291933, at
*3; Dodich, 2018 WL 3584484, at *3; Trees, 2016 WL 11540619, at *9; In re Lipitor, 2016 WL 7373887, at *6; In
re Zoloft, 2013 WL 6050627, at *2; J.K.B. 2013 WL 12129385, at *6; Hatherley, 2013 WL 3354458, at *6; Taha,
2013 WL 12142560, at *3; A.S., 2013 WL 2384320, at *9; In re Diet Drugs, 905 F. Supp. 2d at 648. Sanofi: In Re
Plavix, 2014 WL 4954654, at *8. 14 Co-lead defense counsel, Mark S. Cheffo, was involved with the Robinson case. Mr. Cheffo has a well-
documented history of repeatedly using preemption to assert fraudulent joinder of a California defendant to avoid
state court jurisdiction and, each time, losing. In 2012, he removed cases from California state court and had them
transferred to the Darvocet MDL, arguing that the California defendants were fraudulently joined. The court
rejected that argument, holding that “[p]reemption is a federal defense that goes to the merits of a claim. As such, it
does not support a finding of fraudulent joinder.” In re Darvocet I, 889 F. Supp. 2d at 934. Six months later, he
removed even more cases from California state court into the Zoloft MDL using the same arguments. Again, he lost.
In re Zoloft, 2013 WL 6050627, at *2. Undeterred, he attempted to make this argument again, in the Darvocet MDL
and the Court rejected it: “it would be inappropriate for the Court to analyze whether the claims against McKesson
are preempted by federal law at this stage in the proceedings, and the Court reiterates its previous conclusion that the
defendants’ preemption argument does not support a finding of fraudulent joinder. The Court has previously
addressed and rejected the defendants’ fraudulent joinder arguments … and will not reconsider them here.”
Darvocet II, 106 F. Supp. 3d at 855. Then, in 2016, in the Lipitor litigation, Mr. Cheffo removed cases from
California and, again an MDL court rejected it: In re Lipitor, 2016 WL 7373887, at *6. Considering Mr. Cheffo’s
repeated use of an argument that he has lost multiple times in other MDLs, it raises the question of whether this
removal, using the same failed argument, was made in good faith.
Case 9:20-md-02924-RLR Document 2569 Entered on FLSD Docket 01/15/2021 Page 25 of 30
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F.3d 1278, 1284 (11th Cir. 2006) (considering whether plaintiff pleaded fraudulent concealment
in a case where parties agreed the statue of limitations had expired and concluding that the
district court erred for not remanding the case because allowing “a federal court to interpose its
judgment would fall short of the scrupulous respect for the institutional equilibrium between the
federal and state judiciaries that our federal system demands.”); see also Brush v. Bayside
Orthopaedics, Inc., No. 8:14-CV-2163-T-36EAJ, 2014 WL 5426643, at *4 (M.D. Fla. Oct. 22,
2014) (discussing the merits of a Mensing preemption and concluding it “is a determination best
left to State Court.” (quoting Zaremba, 2014 WL 3057400, at *3 n.2)). Indeed, Plaintiffs have
not found, and the Drug Company Defendants have not cited, a single case in which the Eleventh
Circuit (or any Circuit) allowed consideration of a preemption defense in the context of
fraudulent joinder. “To the contrary, the Eleventh Circuit has emphasized that conflict
preemption ‘is a substantive issue that must be decided by a court with competent jurisdiction.’”
In re Abilify, 2018 WL 6258903, at *6 (quoting Cotton, 402 F.3d at 1292).
The law is overwhelming and unanimous15—asserting a preemption defense does not
render a claim impossible for fraudulent joinder purposes, specifically in the context of a motion
to remand. Absent independent jurisdiction over the case, the Court cannot consider the merits
of the Defendant Drug Company’s preemption defense and therefore remand is required.
B. The Drug Company Defendants Have Not Demonstrated, with Clear and
Convincing Evidence, that Plaintiffs’ Strict Liability Manufacturing Defect
Claims Are Impossible
In the context of Plaintiffs’ manufacturing defect claim, even if the Court entertained
Defendant’s “preemption” argument, it still fails. The Drug Company Defendants argue that
Plaintiffs’ manufacturing defect claims against the California Retailer Defendants are
15 In their Notice of Removal, the Drug Company Defendants argue that this jurisdictional bar is unsettled, citing an
appeal to the Ninth Circuit in Geisse v. Bayer HealthCare Pharm. Inc., No. 17-CV-07026-JD, 2019 WL 1239854, at
*2-3 (N.D. Cal. Mar. 18, 2019). Notice of Removal, ¶ 32. In Geisse, the district court ruled, consistent with the
unanimous authority, that “preemption goes to the merits of the plaintiff's case and entails a degree of analysis that
does not render a state law claim obviously barred or frivolous for fraudulent joinder purposes.” Id., at *3. And,
while the defendant appealed this ruling, as noted by the Drug Company Defendants, the defendant ultimately
abandoned the appeal. See No. 19-15783, at Docs. 57-59 (9th Cir.).
Case 9:20-md-02924-RLR Document 2569 Entered on FLSD Docket 01/15/2021 Page 26 of 30
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“preempted” because “the Retailer Defendants could not have altered the manufacturing of
Zantac.” Notice of Removal, ¶ 29. But, the California Retailer Defendants are not being sued
for the literal manufacturing process of the ranitidine product; they are being sued for their role
in creating a “manufacturing defect” through their “[f]ailure to implement procedures that would
reduce or eliminate NDMA levels in Ranitidine-Containing Drugs” and “[f]ailure to implement
appropriate handling instructions and storage conditions for the drug.” Complaint, ¶¶ 217(c)-(d).
In California, “retailers engaged in the business of distributing goods to the public are
strictly liable in tort for personal injuries caused by defects in those goods.” Arriaga v.
CitiCapital Commercial Corp., 85 Cal. Rptr. 3d 143, 149 (Ct. App. 2008) (citing Vandermark v.
Ford Motor Co., 391 P.2d 168, 171 (Cal. 1964)). To bring a manufacturing defect claim against
a retailer, a plaintiff must prove: (1) that the defendant sold the product, (2) that the product
contained a manufacturing defect when it left defendants’ possession, (3) that the plaintiff was
harmed, and (4) that the product was a substantial factor in causing plaintiff’s harm. Judicial
Council of California Civil Jury Instruction 1201 (Strict Liability—Manufacturing Defect—
Essential Factual Elements). The term “manufacturing defect” is not limited to defects caused in
the manufacturing process. Rather, “[a] product has a manufacturing defect if it differs from the
manufacturer’s intended result or from other ostensibly identical units of the same product line.”
Garrett v. Howmedica Osteonics Corp., 153 Cal. Rptr. 3d 693, 706 (Ct. App. 2013) (citing
Barker v. Lull Eng’g Co., 573 P.2d 443, 454 (Cal. 1978)).
Here, Plaintiffs allege the California Retailer Defendants failed “to implement procedures
that would reduce or eliminate NDMA levels in Ranitidine-Containing Drugs” and “implement
appropriate handling instructions and storage conditions for the drug” which resulted in the
ranitidine products being “defective with respect to their manufacture,” because “Defendants
deviated materially from their … handling, and storage specifications[.]” Complaint, ¶¶ 215,
217(c), 217(d). And, Plaintiffs allege this improper “storage, and handling posed an
unreasonable risk of harm to Plaintiff.” Complaint, ¶ 215. These allegations, when combined
with other allegations explaining that NDMA forms during “transport and storage, and especially
Case 9:20-md-02924-RLR Document 2569 Entered on FLSD Docket 01/15/2021 Page 27 of 30
20
when exposed to heat … accumulating over time in the finished product,” Complaint, ¶ 149, and
that “[n]othing prevented any Defendant from, on its own, taking actions to prevent
accumulation of NDMA in ranitidine drugs by ensuring cooled storage and transport[,]”
Complaint, ¶ 171, state a possible manufacturing defect claim against the California Retailer
Defendants. These allegations outline a theory of “manufacturing defect” liability whereby the
California Retailer Defendants failed to properly store and transport the ranitidine products
which, in turn, led to the accumulation of NDMA in the finished product—a manufacturing
defect—that contributed to each Plaintiffs’ cancer.
Under this theory, the Drug Company Defendants’ preemption argument, i.e., that “the
Retailer Defendants could not have altered the manufacturing of Zantac[,]” is irrelevant. This
claim is not based on whether the California Retailer Defendants actually manufactured the
product, it is based on whether the California Retailer Defendants created a manufacturing defect
in improperly transporting and storing the ranitidine products. And, nothing in the Drug
Company Defendants’ notices of removal suggests or otherwise challenges the ability of the
California Retailer Defendants, under federal law, to take precautions consistent with the
labeling to reduce NDMA accumulation. Thus, the Drug Company Defendants cannot prove by
clear and convincing evidence that a manufacturing defect claim under California law is
impossible based upon a preemption defense.
CONCLUSION
The Drug Company Defendants have failed to meet their heavy burden of demonstrating,
by clear and convincing evidence—with all factual and legal uncertainties resolving in Plaintiffs’
favor—that Plaintiffs’ claims against the California Retailer Defendants are impossible under
California law. As this Court lacks subject matter jurisdiction, Plaintiffs respectfully request the
Court enter an order remanding these cases to their respective California state courts.16
16 The Mills (9:20-cv-81122-RLR) and Masouredis (9:20-cv-81121-RLR) cases should be remanded to California
Superior Court, County of San Francisco. All other cases should be remanded to California Superior Court, County
of Alameda.
Case 9:20-md-02924-RLR Document 2569 Entered on FLSD Docket 01/15/2021 Page 28 of 30
21
REQUEST FOR HEARING
Pursuant to Local Rule 7.1(b)(2), Plaintiffs respectfully request oral argument on this
motion to respond to any questions or concerns the Court may regarding the legal and factual
issues underpinning this Motion. A hearing would also give any the Court an opportunity to
organize and discuss this Motion’s effect on the overall MDL, if any, and provide a platform for
the Parties to address any issues that may arise between now and the Court’s ruling.
CERTIFICATION PURSUANT TO LOCAL RULE 7.1(A)(3)
Pursuant to Local Rule 7.1(a)(3), undersigned Counsel on behalf of Plaintiffs, conferred with
all parties or non-parties who may be affected by the relief sought in this motion in a good faith effort
to resolve the issues raised in the motion and has been unable to do so.
DATED: January 15, 2021 Respectfully submitted,
/s/ R. Brent Wisner
R. Brent Wisner, Esq.
BAUM, HEDLUND, ARISTEI, &
GOLDMAN, P.C.
10940 Wilshire Blvd., 17th Floor
Los Angeles, CA 90024
Telephone: (310) 207-3233
Facsimile: (310) 820-7444
/s/ Jennifer A. Moore
Jennifer A. Moore, Esq.
MOORE LAW GROUP, PLLC
1473 South 4th Street
Louisville, KY 40208
Telephone: (502) 717-4080
Facsimile: (502) 717-4086
Attorneys for Plaintiffs
Case 9:20-md-02924-RLR Document 2569 Entered on FLSD Docket 01/15/2021 Page 29 of 30
22
CERTIFICATE OF SERVICE
I hereby certify that on this 15th day of January, 2021, I filed the foregoing MOTION
TO REMAND CASES TO CALIFORNIA STATE COURT electronically through the
CM/ECF system, which will send notice of filing to all CM/ECF participants.
Dated: January 15, 2021 BAUM, HEDLUND, ARISTEI & GOLDMAN, P.C.
/s/ R. Brent Wisner
R. Brent Wisner, Esq.
10940 Wilshire Blvd., 17th Floor
Los Angeles, CA 90024
Telephone: (310) 207-3233
Facsimile: (310) 820-7444
Counsel for Plaintiffs
Case 9:20-md-02924-RLR Document 2569 Entered on FLSD Docket 01/15/2021 Page 30 of 30
1
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF FLORIDA
IN RE: ZANTAC (RANITIDINE)
PRODUCTS LIABILITY
LITIGATION
_______________________________/
MDL NO. 2924
20-MD-2924
JUDGE ROBIN L. ROSENBERG
MAGISTRATE JUDGE BRUCE E. REINHART
THIS DOCUMENT RELATES TO:
Ralph Dudley v. GlaxoSmithKline, et al. 9:20-cv-81056-RLR
Kalmeta Salvatore v. GlaxoSmithKline, et al. 9:20-cv-81059-RLR
Allen Brittner v. GlaxoSmithKline, et al. 9:20-cv-81061-RLR
John Cash v. GlaxoSmithKline, et al. 9:20-cv-81065-RLR
Jose Flores v. GlaxoSmithKline, et al. 9:20-cv-81068-RLR
Joseph Gregory Jr. v. GlaxoSmithKline, et al. 9:20-cv-81072-RLR
Roy Williams v. GlaxoSmithKline, et al. 9:20-cv-81073-RLR
Mark Hernandez v. GlaxoSmithKline, et al. 9:20-cv-81074-RLR
Michael White v. GlaxoSmithKline, et al. 9:20-cv-81075-RLR
Ryan Ortega v. GlaxoSmithKline, et al. 9:20-cv-81077-RLR
Oliver Reynolds v. GlaxoSmithKline, et al. 9:20-cv-81078-RLR
Grag Amelino v. GlaxoSmithKline, et al. 9:20-cv-81087-RLR
Matthew Yedlin v. GlaxoSmithKline, et al. 9:20-cv-81089-RLR
Armando Becerril v. GlaxoSmithKline, et al. 9:20-cv-81090-RLR
Lynn Smith v. GlaxoSmithKline, et al. 9:20-cv-81092-RLR
Chris Ives v. GlaxoSmithKline, et al. 9:20-cv-81093-RLR
James Newton v. GlaxoSmithKline, et al. 9:20-cv-81094-RLR
Michael Jerde v. GlaxoSmithKline, et al. 9:20-cv-81096-RLR
Albert Muesse v. GlaxoSmithKline, et al. 9:20-cv-81097-RLR
Reha Ray Karaoz v. GlaxoSmithKline, et al. 9:20-cv-81098-RLR
Greg Knell v. GlaxoSmithKline, et al. 9:20-cv-81099-RLR
Austin Barnes v. GlaxoSmithKline, et al. 9:20-cv-81104-RLR
Michael Caratti v. GlaxoSmithKline, et al. 9:20-cv-81105-RLR
Brian Elias v. GlaxoSmithKline, et al. 9:20-cv-81106-RLR
Marc Friedland v. GlaxoSmithKline, et al. 9:20-cv-81107-RLR
Marc Mitchell v. GlaxoSmithKline, et al. 9:20-cv-81109-RLR
Mark Morrison v. GlaxoSmithKline, et al. 9:20-cv-81110-RLR
Dwight Norman v. GlaxoSmithKline, et al. 9:20-cv-81112-RLR
Brian Wilbur v. GlaxoSmithKline, et al. 9:20-cv-81118-RLR
Velo Wright Jr. v. GlaxoSmithKline, et al. 9:20-cv-81119-RLR
Case 9:20-md-02924-RLR Document 2569-1 Entered on FLSD Docket 01/15/2021 Page 1 of 5
2
Claudia Masouredis v. GlaxoSmithKline, et al. 9:20-cv-81121-RLR
Lolita Mills v. GlaxoSmithKline, et al. 9:20-cv-81122-RLR
Gary Campbell v. GlaxoSmithKline, et al. 9:20-cv-81142-RLR
John Geurin v. GlaxoSmithKline, et al. 9:20-cv-81143-RLR
Carbajal, et al. v. GlaxoSmithKline, et al. 9:20-cv-81144-RLR
Joseph Gigliello v. GlaxoSmithKline, et al. 9:20-cv-81145-RLR
James Goetz v. GlaxoSmithKline, et al. 9:20-cv-81152-RLR
Steven Brodie v. GlaxoSmithKline, et al. 9:20-cv-81153-RLR
Henry D. Harbaugh v. GlaxoSmithKline, et al. 9:20-cv-81154-RLR
John Russell v. GlaxoSmithKline, et al. 9:20-cv-81157-RLR
Gilbert Astruc v. GlaxoSmithKline, et al. 9:20-cv-81216-RLR
DECLARATION OF R. BRENT WISNER IN SUPPORT OF MOTION TO REMAND
I, R. Brent Wisner, do hereby declare and state:
1. I am an attorney licensed to practice in the State of California and District of
Columbia. I am admitted to practice before this Court pro hac vice and pursuant to Pretrial
Order # 1. I am a Shareholder with the law firm of Baum, Hedlund, Aristei & Goldman, P.C.,
and counsel of record for several Plaintiffs in the above-captioned actions. I make this
declaration based on my personal knowledge and, if called as a witness, I could and would testify
competently to these matters.
2. In each of the above-captioned complaints, a negligence claim is alleged against one
or more of the following defendants, collectively referred to as the California Retailer
Defendants in the accompanying motion and memorandum of law: Safeway, Inc., Safeway
Health, Inc., The Vons Companies, Inc., Kaiser Permanente International, and Grocery Outlet.
3. In the following lawsuits, a strict liability claim is alleged against one of more of the
California Retailer Defendants:
Ralph Dudley v. GlaxoSmithKline, et al. 9:20-cv-81056-RLR
Kalmeta Salvatore v. GlaxoSmithKline, et al. 9:20-cv-81059-RLR
John Cash v. GlaxoSmithKline, et al. 9:20-cv-81065-RLR
Jose Flores v. GlaxoSmithKline, et al. 9:20-cv-81068-RLR
Joseph Gregory Jr. v. GlaxoSmithKline, et al. 9:20-cv-81072-RLR
Roy Williams v. GlaxoSmithKline, et al. 9:20-cv-81073-RLR
Case 9:20-md-02924-RLR Document 2569-1 Entered on FLSD Docket 01/15/2021 Page 2 of 5
3
Mark Hernandez v. GlaxoSmithKline, et al. 9:20-cv-81074-RLR
Michael White v. GlaxoSmithKline, et al. 9:20-cv-81075-RLR
Ryan Ortega v. GlaxoSmithKline, et al. 9:20-cv-81077-RLR
Oliver Reynolds v. GlaxoSmithKline, et al. 9:20-cv-81078-RLR
Grag Amelino v. GlaxoSmithKline, et al. 9:20-cv-81087-RLR
Matthew Yedlin v. GlaxoSmithKline, et al. 9:20-cv-81089-RLR
Chris Ives v. GlaxoSmithKline, et al. 9:20-cv-81093-RLR
James Newton v. GlaxoSmithKline, et al. 9:20-cv-81094-RLR
Reha Ray Karaoz v. GlaxoSmithKline, et al. 9:20-cv-81098-RLR
Brian Wilbur v. GlaxoSmithKline, et al. 9:20-cv-81118-RLR
Velo Wright Jr. v. GlaxoSmithKline, et al. 9:20-cv-81119-RLR
Claudia Masouredis v. GlaxoSmithKline, et al. 9:20-cv-81121-RLR
Lolita Mills v. GlaxoSmithKline, et al. 9:20-cv-81122-RLR
Gary Campbell v. GlaxoSmithKline, et al. 9:20-cv-81142-RLR
John Geurin v. GlaxoSmithKline, et al. 9:20-cv-81143-RLR
Carbajal, et al. v. GlaxoSmithKline, et al. 9:20-cv-81144-RLR
Joseph Gigliello v. GlaxoSmithKline, et al. 9:20-cv-81145-RLR
James Goetz v. GlaxoSmithKline, et al. 9:20-cv-81152-RLR
Henry D. Harbaugh v. GlaxoSmithKline, et al. 9:20-cv-81154-RLR
John Russell v. GlaxoSmithKline, et al. 9:20-cv-81157-RLR
Gilbert Astruc v. GlaxoSmithKline, et al. 9:20-cv-81216-RLR
4. Attached as Exhibit 1 is a fair and accurate copy of the complaint filed in California
Superior Court, Alameda County on May 11, 2020 in Ralph Dudley v. GlaxoSmithKline, et al.,
9:20-cv-81056-RLR. To the best of my knowledge, this Complaint contains exemplar
allegations of all forty-one Plaintiffs’ negligence and strict liability claims against the California
Retailer Defendants.
5. Attached as Exhibit 2 is a fair and accurate copy of the Notice of Removal filed in
Ralph Dudley v. GlaxoSmithKline, et al, 9:20-cv-81056-RLR. To the best of my knowledge, this
Notice contains exemplar arguments concerning the grounds for the removal of the above-
captioned cases from California State Court.
6. Attached as Exhibit 3 is a fair and accurate copy of an email exchange between
myself, Jennifer Moore, and Joseph Petrosinelli memorializing an agreement regarding whether
the Plaintiffs would need to file short form complaints and census plus forms prior to a ruling on
a motion to remand.
Case 9:20-md-02924-RLR Document 2569-1 Entered on FLSD Docket 01/15/2021 Page 3 of 5
4
7. Attached as Exhibit 4 is a fair and accurate copy of the over-the-counter packaging
from a Zantac product approved by the U.S. Food and Drug Administration (“FDA”) in 1998.
This document was obtained from the FDA’s website. Please note, the document has been
highlighted to note identify the portion relevant to this Motion.
8. Attached as Exhibit 5 is a fair and accurate copy of the prescription drug label for
Zantac, approved by the FDA in 1985. This document was obtained from the FDA’s website.
Please note, the document has been highlighted to identify the portion relevant to this Motion.
I declare under penalty of perjury that the foregoing is true and correct.
Executed on the 15th of January, 2021 at Tiburon, California.
/s/ R. Brent Wisner
R. Brent Wisner, Esq.
Case 9:20-md-02924-RLR Document 2569-1 Entered on FLSD Docket 01/15/2021 Page 4 of 5
5
CERTIFICATE OF SERVICE
I hereby certify that on this 15th day of January, 2021, I filed the foregoing
DECLARATION OF R. BRENT WISNER IN SUPPORT OF MOTION TO REMAND
electronically through the CM/ECF system, which will send notice of filing to all CM/ECF
participants.
Dated: January 15, 2021 BAUM, HEDLUND, ARISTEI & GOLDMAN, P.C.
/s/ R. Brent Wisner
R. Brent Wisner, Esq.
10940 Wilshire Blvd., 17th Floor
Los Angeles, CA 90024
Telephone: (310) 207-3233
Facsimile: (310) 820-7444
Counsel for Plaintiffs
Case 9:20-md-02924-RLR Document 2569-1 Entered on FLSD Docket 01/15/2021 Page 5 of 5
EXHIBIT 1
Case 9:20-md-02924-RLR Document 2569-2 Entered on FLSD Docket 01/15/2021 Page 1 of61
005
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• r Jennifer A. Moore (SBN 206779)
[email protected] 2 MOORE LAW GROUP, PLLC
1473 South 4th Street 3 Louisville, KY 40208
4 Tel: (502) 717-4080 Fax: (502) 717-4086
5
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RALPH DUDLEY
Plaintiff,
V.
GlaxoSmithKline, LLC; GlaxoSmithKline, plc; Boehringer lngelheim Pharmaceuticals, Inc.; Boehringer Ingelheim USA Corporation; Boehringer lngelheim Corporation; Pfizer, Inc.; Sanofi US Services, Inc.; Sanofi S.A.; Sanofi-Aventis U.S. LLC; The Vons Companies, Inc.; and DOES 1 through 100 inclusive,
Defendants.
Case No.
RG2006167 152 COMPLAINT .
DEMAND :FOR JURY TRIAL
1 COMPLAINT
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TABLE OF CONTENTS
Page
TABLE OF CONTENTS ........................................................................................................................ 2
INTRODUCTION .................................................................................................................................. 4
PARTIES ................................................................................................................................................ 5
I. Plaintiff ........................................................................................................................... 5
II. Defendants ...................................................................................................................... 7
A. Manufacturer Defendants .................................................................................... 7
B. Retailer Defendants ........................................................................................... 10
C. Doe Defendants ................................................................................................. 11
JURISDICTION AND VENUE ........................................................................................................... 12
FACTUAL ALLEGATIONS ............................................................................................................... 13
I. Regulatory History of Ranitidine-Containing Drugs .................................................... 13
II. Recalls and the FDA’s Ban ........................................................................................... 16
III. Dangers of NDMA ........................................................................................................ 20
IV. How Ranitidine Transforms into NDMA Within the Human Body ............................. 25
A. Formation of NDMA in the Environment of the Human Stomach .................. 26
B. Formation of NDMA in the Other Organs of Human Body ............................. 32
C. Formation of NDMA by Exposure to Heat and/or Time .................................. 34
D. Evidence Also Directly Links Ranitidine Exposure to Cancer ......................... 36
V. Defendants Made False Statements in the Labeling of Their Ranitidine-Containing Drugs. ............................................................................................................................ 37
VI. Defendants Knew or Should Have Known of the NDMA Risk ................................... 38
VII. Exemplary / Punitive Damages Allegations (Against Manufacturer Defendants) ....... 42
VIII. Equitable Tolling/Estoppel ........................................................................................... 43
CAUSES OF ACTION ......................................................................................................................... 44
COUNT I: STRICT PRODUCTS LIABILITY – FAILURE TO WARN .............................. 44
COUNT II: STRICT PRODUCTS LIABILITY – MANUFACTURING DEFECT ............... 47
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COUNT III: NEGLIGENCE – FAILURE TO WARN ............................................................ 49
COUNT IV: NEGLIGENT PRODUCT DESIGN ................................................................... 52
COUNT V: NEGLIGENT MANUFACTURING .................................................................... 55
COUNT VI: NEGLIGENT MISREPRESENTATION ............................................................ 56
COUNT VII: NEGLIGENCE ................................................................................................... 58
JURY TRIAL DEMAND ..................................................................................................................... 59
PRAYER FOR RELIEF ....................................................................................................................... 59
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INTRODUCTION
1. This is a personal injury action for damages relating to Defendants’ design,
manufacture, sale, marketing, advertising, promotion, testing, labeling, packaging, handling,
distribution, and storage of ranitidine-containing drugs including the brand name, Zantac, and its
various generic forms (“Ranitidine-Containing Drugs,” unless specifically identified).
2. Plaintiff brings this action for personal injuries suffered as a result of ingesting the
defective and unreasonably dangerous Ranitidine-Containing Drugs and developing various cancers
and their sequelae as a result of this ingestion.
3. As more particularly set forth herein, Plaintiff maintains that the Ranitidine-
Containing Drugs he ingested are defective, dangerous to human health, unfit and unsuitable to be
advertised, marketed, and sold in the United States, were manufactured improperly, and lacked
proper warnings of the dangers associated with their use.
4. N-Nitrosodimethylamine (“NDMA”) is a potent carcinogen. Discovered as a
byproduct in manufacturing rocket fuel in the early 1900s, today, its only use is to induce tumors in
animals as part of laboratory experiments. Its only function is to cause cancer. It has no business
being in a human body.
5. Zantac, the popular antacid medication that was used by millions of people every day,
leads to the production of staggering amounts of NDMA. The U.S. Food and Drug Administration’s
(“FDA”) allowable daily limit of NDMA is 96 ng (nanograms) and yet, in a single dose of Zantac,
researchers are discovering over 3 million ng.
6. These recent revelations by independent researchers have caused widespread recalls of
Zantac and its generic forms both domestically and internationally, including the domestic recall by
the current owner and controller of Zantac new drug applications (“NDA”). Recently, on April 1,
2020, the FDA ordered the immediate recall of all Ranitidine-Containing Drugs sold in the United
States citing unacceptable and unpreventable levels of NDMA accumulation.
7. The high levels of NDMA observed in Ranitidine-Containing Drugs is a function of
the ranitidine molecule: (1) the way it breaks down in the human digestive system; (2) the way it
interacts with various enzymes in the human body; (3) the way it breaks down when exposed to heat,
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in particular, during transport and storage; and (4) the way the molecule naturally degrades, over
time, into NDMA. As it stands, ingestion of Ranitidine-Containing Drugs leads to real-world levels
NDMA exposure that are proven to cause cancer.
8. This lawsuit seeks to hold Defendants responsible for defective design, manufacturing,
sale, marketing, advertising, promotion, testing, labeling, packaging, handling, distribution, and
storage that caused Plaintiff’s severe injuries.
PARTIES
I. Plaintiff
9. Plaintiff resides in California and is a citizen of California and no other state.
10. Plaintiff started consuming brand name over-the-counter Ranitidine-Containing Drugs
in approximately 1995 until approximately 2020.
11. As a direct and proximate result of consuming carcinogenic Ranitidine-Containing
Drugs, Plaintiff was diagnosed with prostate cancer.
12. Based on prevailing scientific evidence, exposure to Ranitidine-Containing Drugs (and
the attendant NDMA) can cause prostate cancer in humans.
13. Had any Defendant warned Plaintiff that Ranitidine-Containing Drugs could lead to
exposure to NDMA or, in turn, cancer, Plaintiff would not have taken Ranitidine-Containing Drugs.
14. Plaintiff is informed and believes and based thereon alleges that as a direct and
proximate result of Plaintiff’s use of and/or exposure to Ranitidine-Containing Drugs supplied and
distributed by Defendants herein, Plaintiff suffered significant harm, conscious pain and suffering,
physical injury and bodily impairment including, but not limited to cancer, other permanent physical
deficits, permanent bodily impairment and other sequelae. Plaintiff’s injuries required
hospitalizations, in-patient surgeries, medication treatments, and other therapies to address the
adverse physical effects and damage caused by Plaintiff’s use of and/or exposure to Ranitidine-
Containing Drugs.
15. As a direct and proximate result of the wrongful conduct, acts, omissions, fraudulent
concealments, fraudulent misrepresentations, and fraudulent business practices by Defendants and
DOES 1 through 100, inclusive, Plaintiff used and/or was exposed to Ranitidine-Containing Drugs
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and were diagnosed with serious health injuries including prostate cancer.
16. As a result of using and/or being exposed to Defendants’ Ranitidine-Containing
Drugs, Plaintiff has been permanently and severely injured, having suffered serious consequences
from Ranitidine-Containing Drugs.
17. As a further direct and proximate result of defects in Ranitidine-Containing Drugs and
the wrongful conduct, acts, omissions, and fraudulent misrepresentations of Defendants, Plaintiff
suffered severe mental and physical pain and have and will sustain permanent injuries and emotional
distress, along with economic loss due to medical expenses and living-related expenses as a result of
lifestyle changes.
18. As a further direct and proximate result of defects in Ranitidine-Containing Drugs and
the wrongful conduct, acts, omissions, and fraudulent misrepresentations of Defendants, Plaintiff
required extensive emergency medical treatment, health care, attention and services, thereby
incurring medical, incidental, and service expenses pertaining to emergency medical treatments and
procedures undertaken in efforts to maintain and/or save Plaintiff.
19. Plaintiff is an individual who suffered damages as a result of injuries resulting from
Plaintiff’s use and/or exposure to Ranitidine-Containing Drugs and is authorized to bring an action
for the causes of actions alleged herein including, but not limited to, injuries and damages sustained
by Plaintiff, resulting from Plaintiff’s use and/or exposure to Ranitidine-Containing Drugs. Said
injuries and damages sustained by Plaintiff were caused or substantially contributed to by the
wrongful conduct of Defendants and DOES 1 through 100, inclusive.
20. The product warnings for Ranitidine-Containing Drugs in effect during the time period
Plaintiff used and/or were exposed to Ranitidine-Containing Drugs were vague, incomplete or
otherwise inadequate, both substantively and graphically, to alert consumers to the severe health risks
associated with Ranitidine-Containing Drugs use and/or exposure.
21. The Defendants and DOES 1 through 100, and each of them, inclusive, did not
provide adequate warnings to consumers including Plaintiff and the general public about the
increased risk of serious adverse events that are described herein.
22. Had Plaintiff been adequately warned of the potential life-threatening side effects of
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the Defendants’ and DOES 1 through 100, and each of them, inclusive, Ranitidine-Containing Drugs,
Plaintiff would not have purchased, used or been exposed to Ranitidine-Containing Drugs.
23. By reason of the foregoing, Plaintiff developed serious and dangerous side effects
including prostate cancer and other cancers, related sequelae, physical pain and suffering, mental
anguish, and loss of enjoyment of life. By reason of the foregoing, Plaintiff suffered economic losses
and special damages including, but not limited to, loss of earning and medical expenses. Plaintiff’s
general and special damages are in excess of the jurisdictional limits of the Court.
24. Plaintiff has reviewed his potential legal claims and causes of action against the
Defendants and have intentionally chosen only to pursue claims based on state law. Any reference to
any federal agency, regulation or rule is stated solely as background information and does not raise a
federal question. Plaintiff has chosen to only pursue claims based on state law and are not making
any claims which raise federal questions. Accordingly, Plaintiff contends that California State
jurisdiction and venue is proper.
II. Defendants
A. Manufacturer Defendants
25. Defendant, Boehringer Ingelheim Pharmaceuticals, Inc., is a Delaware corporation
with its principal place of business located at 900 Ridgebury Road, Ridgefield, Connecticut 06877.
Boehringer Ingelheim Pharmaceuticals, Inc. is a citizen of Connecticut and Delaware, and not of any
other state. Boehringer Ingelheim Pharmaceuticals, Inc. is a subsidiary of the German company
Boehringer Ingelheim Corporation. Boehringer Ingelheim Pharmaceuticals, Inc. owned and
controlled the NDAs for over-the-counter (“OTC”) Zantac between December 2006 and January
2017, and manufactured and distributed the drug in the United States during that period. At all
relevant times, Boehringer Ingelheim Pharmaceuticals, Inc. has conducted business and derived
substantial revenue from its manufacturing, advertising, distributing, selling, and marketing of Zantac
within the State of California and Alameda County.
26. Defendant, Boehringer Ingelheim USA Corporation, is a Delaware corporation with
its principal place of business located in at 900 Ridgebury Rd., Ridgebury, Connecticut 06877.
Boehringer Ingelheim USA Corporation is a citizen of Delaware and Connecticut and is not a citizen
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of any other state. At all relevant times, Boehringer Ingelheim USA Corporation has conducted
business and derived substantial revenue from its manufacturing, advertising, distributing, selling,
and marketing of Zantac within the State of California and Alameda County.
27. Defendant, Boehringer Ingelheim Corporation, is a German multinational
pharmaceutical corporation with its principal place of business located at Matthias Reinig 55216,
Ingelheim, Germany. Boehringer Ingelheim Corporation is the parent company of Defendants,
Boehringer Ingelheim Pharmaceuticals, Inc. and Boehringer Ingelheim USA Corporation. At all
relevant times, Boehringer Ingelheim Corporation has conducted business and derived substantial
revenue from its manufacturing, advertising, distributing, selling, and marketing of Zantac within the
State of California and Alameda County.
28. Collectively, Defendants, Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer
Ingelheim USA Corporation, and Boehringer Ingelheim Corporation, shall be referred to as
“Boehringer.”
29. Defendant, GlaxoSmithKline, LLC, is a Delaware limited liability company with its
principal place of business located at 5 Crescent Drive, Philadelphia, Pennsylvania, 19112 and Five
Moore Drive, Research Triangle, North Carolina, 27709. GSK is a citizen of Delaware. GSK is a
wholly owned subsidiary of GlaxoSmithKline, plc, which is its sole member. At all relevant times,
GSK has conducted business and derived substantial revenue from its manufacturing, advertising,
distributing, selling, and marketing of Zantac within the State of California and Alameda County.
30. Defendant, GlaxoSmithKline, plc, is a foreign entity and a citizen of the United
Kingdom, and is not a citizen of any state in the United States. GlaxoSmithKline, plc is the
successor-in-interest to the companies that initially developed, patented, and commercialized the
molecule known as ranitidine. Ranitidine was initially developed by Allen & Hanburys Ltd., which
was a subsidiary of Glaxo Labs Ltd. Allen & Hanburys Ltd. was awarded Patent No. 4,128,658 by
the U.S. Patent and Trademark Office in December 1978, which covered the ranitidine molecule. In
1983, the FDA granted approval to Glaxo Holdings, Ltd. to sell Zantac in the United States. Glaxo
Holdings, Ltd. was later absorbed into Glaxo Wellcome, PLC. And then, in 2000, GlaxoSmithKline,
plc and GSK were created by the merger of Glaxo Wellcome and SmithKline Beecham. At all
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relevant times, GlaxoSmithKline, plc has conducted business and derived substantial revenue from its
manufacturing, advertising, distributing, selling, and marketing of Zantac within the State of
California and Alameda County.
31. Collectively, Defendants GlaxoSmithKline, LLC and GlaxoSmithKline, plc, shall be
referred to as “GSK.” GSK, and its predecessors, have controlled the prescription Zantac NDAs
since 1983.
32. Defendant, Pfizer, Inc. (“Pfizer”), is a Delaware corporation with its principal place of
business located at 235 East 42nd Street, New York, New York 10017. Pfizer is a citizen of
Delaware and New York and is not a citizen of any other state. In 1993, Glaxo Wellcome, plc
formed a joint venture with Warner-Lambert, Inc. to develop and obtain OTC approval for Zantac. In
1995, NDA 20-520 Zantac OTC 75 mg tablets were approved. In 1998, NDA 20-745 OTC Zantac
75 mg effervescent tablets were approved. Also, in 1998, Warner-Lambert and Glaxo Wellcome
ended their joint venture, with Warner-Lambert retaining control over the OTC NDA for Zantac and
the Zantac trademark in the United States and Glaxo Wellcome retaining control over the Zantac
trademark internationally.1 In 2000, Pfizer acquired Warner-Lambert and maintained control over
the Zantac OTC NDA until December 2006. At all relevant times, Pfizer has conducted business and
derived substantial revenue from its manufacturing, advertising, distributing, selling, and marketing
of Zantac within the State of California and Alameda County.
33. Defendant, Sanofi US Services, Inc., is a Delaware corporation with its principal place
of business located at 55 Corporate Drive, Bridgewater, New Jersey 08807, and is a wholly owned
subsidiary of Sanofi S.A. Sanofi is a citizen of Delaware and New Jersey and is not a citizen of any
other state. Sanofi controlled the NDA for OTC Zantac starting in January 2017 through the present
and manufactured and distributed the drug in the United States during that period. Sanofi voluntarily
recalled all brand name OTC Zantac on October 18, 2019. At all relevant times, Sanofi has conducted
1 See Warner-Lambert and Glaxo End A Venture on Ulcer Drug Zantac, WALL STREET JOURNAL (Aug. 4, 1998), available at https://www.wsj.com/articles/SB902188417685803000.
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business and derived substantial revenue from its manufacturing, advertising, distributing, selling,
and marketing of Zantac within the State of California and Alameda County.
34. Defendant, Sanofi S.A., is a French multinational pharmaceutical company
headquartered in Paris, France, with its principal place of business located at 54, Rue La Boetie, in
the 8th arrondissement. Defendant, Sanofi S.A., changed its name to Sanofi in May 2011. As of 2013,
Sanofi S.A. was the world’s fifth largest pharmaceutical company by prescription sales. At all
relevant times, Sanofi S.A. has conducted business and derived substantial revenue from its
manufacturing, advertising, distributing, selling, and marketing of Zantac within the State of
California and Alameda County.
35. Defendant, Sanofi-Aventis U.S. LLC, was and is a Delaware limited liability company
with its principal place of business located at 55 Corporate Drive, Bridgewater, New Jersey 08807.
Sanofi-Aventis U.S. LLC is a citizen of Delaware and New Jersey and is not a citizen of any other
state. Sanofi-Aventis US LLC is a wholly owned subsidiary of Sanofi S.A. At all relevant times,
Sanofi-Aventis U.S. LLC has conducted business and derived substantial revenue from its
manufacturing, advertising, distributing, selling, and marketing of Zantac within the State of
California and Alameda County.
36. Collectively, Defendants Sanofi US Services, Inc., Sanofi S.A., and Sanofi-Aventis
U.S. LLC, shall be referred to as “Sanofi.”
37. Defendants, Boehringer, GSK, Pfizer, and Sanofi, shall be referred to collectively as
the “Manufacturer Defendants.”
B. Retailer Defendants
38. The Vons Companies, Inc. (“Vons”) is a Michigan Corporation with its headquarters
and principal place of business located at 11555 Dublin Canyon Rd., Pleasanton, California 94588.
Vons is a wholly owned subsidiary of Albertsons Companies, Inc. Vons is a citizen of California and
Delaware and is not a citizen of any other state. At all relevant times, Vons has conducted business
and derived substantial revenue from its advertising, selling, and marketing of Ranitidine-Containing
Drugs within the State of California and Alameda County. Specifically, Vons supplied Plaintiff with
the Ranitidine-Containing Drugs which caused Plaintiff’s injuries.
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C. Doe Defendants
39. The true names and/or capacities, whether individual, corporate, partnership,
associate, governmental, or otherwise, of Defendants DOES 1 through 100, inclusive, and each of
them, are unknown to Plaintiff at this time, who therefore sues said Defendants by such fictitious
names. Plaintiff is informed and believes, and thereon alleges, that each Defendant designated herein
as a DOE caused injuries and damages proximately thereby to Plaintiff as hereinafter alleged; and
that each DOE Defendant is liable to the Plaintiff for the acts and omissions alleged herein below,
and the resulting injuries to Plaintiff, and damages sustained by Plaintiff. Plaintiff will amend this
Complaint to allege the true names and capacities of said DOE Defendants when that same is
ascertained.
40. Plaintiff is informed and believes, and thereon alleges, that at all times herein
mentioned, each of the Defendants and each of the DOE Defendants was the agent, servant,
employee and/or joint venturer of the other co-Defendants and other DOE Defendants, and each of
them, and at all said times, each Defendants and each DOE Defendant was acting in the full course,
scope and authority of said agency, service, employment and/or joint venture.
41. Plaintiff is informed and believes and alleges that at all times mentioned herein,
Defendants and DOES 1 through 100, inclusive, and each of them, were also known as, formerly
known as and/or were the successors and/or predecessors in interest/business/product line/or a
portion thereof, assigns, a parent, a subsidiary (wholly or partially owned by, or the whole or partial
owner), affiliate, partner, co-venturer, merged company, alter egos, agents, equitable trustees and/or
fiduciaries of and/or were members in an entity or entities engaged in the funding, researching,
studying, manufacturing, fabricating, designing, developing, labeling, assembling, distributing,
supplying, leasing, buying, offering for sale, selling, inspecting, servicing, contracting others for
marketing, warranting, rebranding, manufacturing for others, packaging and advertising of
Ranitidine-Containing Drugs. Defendants and DOES 1 through 100, inclusive, and each of them, are
liable for the acts, omissions and tortious conduct of its successors and/or predecessors in
interest/business/product line/or a portion thereof, assigns, parent, subsidiary, affiliate, partner, co-
venturer, merged company, alter ego, agent, equitable trustee, fiduciary and/or its alternate entities in
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that Defendants and DOES 1 through 100, inclusive, and each of them, enjoy the goodwill originally
attached to each such alternate entity, acquired the assets or product line (or portion thereof), and in
that there has been a virtual destruction of Plaintiff’s remedy against each such alternate entity, and
that each such Defendants has the ability to assume the risk spreading role of each such alternate
entity.
42. Plaintiff is informed and believes, and thereon alleges, that at all times herein
mentioned, that Defendants and DOES 1 through 100, inclusive, and each of them, were and are
corporations organized and existing under the laws of the State of California or the laws of some state
or foreign jurisdiction; that each of the said Defendants and DOE Defendants were and are authorized
to do and are doing business in the States of California and Missouri and regularly conducted
business in these States and in Alameda County.
43. Upon information and belief, at relevant times, Defendants and DOES 1 through 100,
and each of them, inclusive, were engaged in the business of researching, developing, designing,
licensing, manufacturing, distributing, selling, marketing, and/or introducing into interstate
commerce and into the State of California, including in Alameda County, either directly or indirectly
through third parties or related entities, Ranitidine-Containing Drugs.
44. At relevant times, Defendants and DOES 1 through 100, inclusive, and each of them,
conducted regular and sustained business and engaged in substantial commerce and business activity
in the State of California, which included but was not limited to selling, marketing and distributing
Ranitidine-Containing Drugs in the State of California and Alameda County.
45. At all relevant times, Defendants and DOES 1 through 100, inclusive, and each of
them, expected or should have expected that their acts would have consequences within the United
States of America including the State of California and including Alameda County, said Defendants
derived and derive substantial revenue therefrom.
JURISDICTION AND VENUE
46. This Court has jurisdiction over this action pursuant to the California Constitution
Article VI, Section 10, which grants the Superior Court “original jurisdiction in all causes except
those given by statute to other trial courts.” The Statutes under which this action is brought do not
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specify any other basis for jurisdiction.
47. This Court has personal jurisdiction over each Defendant insofar as each Defendant is
authorized and licensed to conduct business in the State of California, a resident of the State of
California, maintains and carries on systematic and continuous contacts in the State of California,
regularly transacts business within the State of California, and regularly avails itself of the benefits of
the State of California.
48. Additionally, Defendants caused tortious injury by acts and omissions in this judicial
jurisdiction and caused tortious injury in this jurisdiction by acts and omissions outside this
jurisdiction while regularly doing and soliciting business, engaging in a persistent course of conduct,
and deriving substantial revenue from goods used or consumed and services rendered in this
jurisdiction.
49. Venue is proper in this Court pursuant to California Code of Civil Procedure Section
395(a) in that the headquarters and principal place of business of Defendant The Vons Companies,
Inc. is in Alameda County, California.
50. Plaintiff seeks relief that is within the jurisdictional limits of the Court.
FACTUAL ALLEGATIONS
I. Regulatory History of Ranitidine-Containing Drugs
51. Defendants marketed and sold Ranitidine-Containing Drugs under the brand name
“Zantac” or its generic version by either prescription or OTC. Defendants sold Ranitidine-
Containing Drugs in the following forms: injection, syrup, and/or tablets and capsules.
52. Zantac (ranitidine) was originally discovered and developed by scientist John
Bradshaw on behalf of GSK2 in 1976.
53. The drug belongs to a class of medications called histamine H2-receptor antagonists
(or H2 blockers), which decrease the amount of acid produced by cells in the lining of the stomach.
2 Dr. Bradshaw was working for Glaxo Inc. at the time. Glaxo Inc. later merged with the Wellcome Foundation in 1995 to become Glaxo Wellcome plc. Then, in 2000, Glaxo Wellcome plc merged with SmithKline Beecham plc to form GlaxoSmithKline plc one of the defendants in this MDL. For the purposes of this PIMC, these entities will be referred to as GSK.
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Other drugs within this class include cimetidine (Tagamet), famotidine (Pepcid), and nizatidine
(Tazac).
54. Cimetidine (Tagamet), discovered and developed by Smith, Kline and French3, was
the first H2 blocker to be developed and is the prototypical histamine H2 receptor antagonist from
which the later members of the class were developed. Indeed, Zantac was specifically developed by
GSK in response to the success of cimetidine.
55. Zantac was approved by the FDA, pursuant to the New Drug Application (“NDA”)
process in 1983 (NDA 18-703) and, quickly, became one of GSK’s most successful products, being
the first prescription drug in history to reach $1 billion in sales, which in the pharmaceutical industry
is referred to as a “Blockbuster.”
56. In 1993, GSK entered into a joint venture with Pfizer4 to develop an OTC version of
Zantac. That joint venture led to FDA approval of an OTC version of Zantac in 1995. Zantac OTC
was approved through an NDA process (NDA 20-520).
57. In 1997, GSK’s patent on the original prescription Zantac drug expired, and generic
Ranitidine-Containing Drugs entered the market. Despite generic entry, however, brand name
prescription and OTC Zantac continued to be sold. Although sales of brand-name Zantac declined as
a result of generic and alternative products, Ranitidine-Containing Drug sales remained strong over
time. As recently as 2018, Zantac was one of the top 10 antacid tablet brands in the United States,
with sales of Zantac 150 totaling $128.9 million—a 3.1% increase from the previous year.
58. In 1998, the joint venture between GSK and Pfizer dissolved. As part of the
separation, GSK retained the rights to sell all forms of Zantac internationally and prescription Zantac
in the U.S., while Pfizer retained the rights to sell OTC Zantac domestically and retained ownership
over the Zantac trademark under a trademark licensing agreement. Under this agreement, GSK
3 Smith, Kline and French later merged with the Beecham Group in 1989 to form SmithKline Beecham plc. And, as discussed above, SmithKline Beecham plc was merged into GSK in 2000. 4 The joint venture was between Glaxo Wellcome plc and Warner–Lambert, Inc. Warner-Lambert was later acquired by Pfizer, Inc. in 2000. For the purposes of this PIMC, Warner-Lambert will be referred to as Pfizer.
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retained control and responsibility over the prescription Zantac NDAs and Pfizer retained control and
responsibility over the OTC Zantac NDAs; however, Pfizer was required to obtain approval from
GSK prior to making any product or trademark improvements or changes.
59. In October 2000, Pfizer obtained full rights to OTC Zantac in the United States and
Canada from GSK pursuant to a divestiture and transfer agreement. As part of this agreement, GSK
divested all domestic Zantac OTC assets to Pfizer including all trademark rights and removed the
restrictions on Pfizer’s ability to seek product line extensions or the approval for higher doses of OTC
Zantac. GSK retained the right to exclusive use of the Zantac name for any prescription ranitidine-
containing product in the US.
60. In October 2003, Pfizer submitted NDA 21-698 for approval to market OTC Zantac
150 mg. The FDA approved NDA 21-698 OTC Zantac 150 mg on August 31, 2004.
61. In 2006, Pfizer through a divestiture agreement, transferred all assets pertaining to its
Zantac OTC line of products, including the rights to sell and market all formulations of OTC Zantac
in the United States and Canada, as well as all intellectual property, research and development, and
customer and supply contracts to Boehringer Ingelheim Pharmaceuticals, Inc. As part of this deal,
Boehringer obtained control and responsibility over all of the Zantac OTC NDAs.
62. In 2009, GSK ceased marketing prescription Zantac in the U.S. and abandoned the
Zantac prescription NDA. Although, according to GSK’s recent annual report (2019), GSK claims to
have “discontinued making and selling prescription Zantac tablets in 2017 … in the U.S.”5
63. In 2016, Boehringer sold the rights of OTC Zantac to Sanofi US Services, Inc.
pursuant to an asset swap agreement As part of this deal, Sanofi obtained control and responsibility
over the OTC NDAs and currently retains that control and responsibility.
64. To date, the FDA has approved numerous generic manufacturers for the sale of
prescription and OTC Ranitidine-Containing Drugs through an Abbreviated New Drug Application
(“ANDA”) process.
5 GlaxoSmithKline, plc, Annual Report at 37 (2019), available at https://www.gsk.com/media/5894/annual-report.pdf
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II. Recalls and the FDA’s Ban
65. On September 9, 2019, pharmacy and testing laboratory Valisure LLC and
ValisureRX LLC (collectively, “Valisure”) filed a Citizen Petition calling for the recall of all
ranitidine-containing drugs due to exceedingly high levels of NDMA found in ranitidine pills. FDA
and European regulators started reviewing the safety of ranitidine with specific focus on the presence
of NDMA.6 This triggered a cascade of recalls by the makers and retailers of Ranitidine-Containing
Drugs.
66. On September 13, 2019, the FDA’s Director for Drug Evaluation and Research, Dr.
Janet Woodcock, issued a statement that some ranitidine medicines may contain NDMA.
67. On September 24, 2019, generic manufacturer Sandoz Inc. voluntarily recalled all of
its ranitidine-containing drugs due to concerns of a “nitrosamine impurity, N-nitrosodimethylamine
(NDMA), which was found in the recalled medicine.”7
68. On September 26, 2019, Walgreens, Walmart, and Rite-Aid and Apotex Corp.—
makers of generic OTC ranitidine—voluntarily recalled all ranitidine-containing drugs and removed
the drugs from the shelves.8 Apotex issued a statement, noting that “Apotex has learned from the
U.S. Food and Drug Administration and other Global regulators that some ranitidine medicines
including brand and generic formulations of ranitidine regardless of the manufacturer, contain a
nitrosamine impurity called N-nitrosodimethylamine (NDMA)[.]”9
69. On September 28, 2019, CVS Health Corp. stated that it would stop selling Zantac and
its own generic ranitidine-containing drugs out of concern that it might contain a carcinogen.
6 https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine; https://www.ema.europa.eu/en/news/ema-review-ranitidine-medicines-following-detection-ndma. 7 https://www.fda.gov/news-events/press-announcements/fda-announces-voluntary-recall-sandoz-ranitidine-capsules-following-detection-impurity. 8 https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine. 9 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-ranitidine-tablets-75mg-and-150mg-all-pack-sizes-and.
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70. On October 2, 2019, the FDA ordered testing on Zantac and specified a protocol to be
used that did not involve the use of heat.10
71. On October 8, 2019, GSK voluntarily recalled all Zantac and ranitidine-containing
drugs internationally.11 As part of the recall, GSK publicly acknowledged that unacceptable levels of
NDMA were discovered in Zantac and noted that “GSK is continuing with investigations into the
potential source of the NDMA.”12
72. On October 23, 2019, Dr. Reddy’s Laboratories Ltd and Sanofi voluntarily recalled all
of their ranitidine-containing drugs.13
73. On October 28, 2019, Perrigo Company plc, Novitium Pharma LLC, and Lannet
Company Inc., voluntarily recalled all their ranitidine-containing drugs from the market.14
74. On November 1, 2019, the FDA announced the results of recent testing, finding
“unacceptable levels” of NDMA in ranitidine-containing drugs, and requested that drug makers begin
to voluntarily recall their ranitidine-containing drugs.15
75. Between November 1, 2019 and February 27, 2020, the following ranitidine makers
recalled their drugs from the market, citing NDMA concerns: Aurobindo Pharma USA, Amneal
Pharmaceuticals, LLC, American Health Packaging, Golden State Medical Supply, Precision Dose
Inc., Glenmark Pharmaceutical Inc., Appco Pharma LLC, and Northwind Pharmaceuticals.16
10 https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine 11 https://www.gov.uk/government/news/zantac-mhra-drug-alert-issued-as-glaxosmithkline-recalls-all-unexpired-stock 12 Justin George Varghese, GSK recalls popular heartburn drug Zantac globally after cancer scare, Reuters (Oct. 8, 2019), available at https://www.reuters.com/article/us-gsk-heartburn-zantac/gsk-recalls-popular-heartburn-drug-zantac-globally-after-cancer-scare-idUSKBN1WN1SL. 13 https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine. 14 Id. 15 https://www.fda.gov/drugs/drug-safety-and-availability/laboratory-tests-ranitidine. 16 https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine.
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76. On January 2, 2020, research laboratory, Emery Pharma, submitted a Citizen Petition
to the FDA, showing that NDMA accumulates in ranitidine at unsafe rates when exposed to heat
levels that would occur during transport and storage.
77. Emery’s Citizen Petition outlined its substantial concern that Ranitidine is a time- and
temperature-sensitive pharmaceutical product that develops a known carcinogen, NDMA, when
exposed to heat, a common occurrence during shipping, handling, and storage. In addition to
warning about this condition, Emery requested agency directives to manufacturers and distributors to
ship Ranitidine-Containing Drugs in temperature-controlled vehicles.
78. In response,17 on April 1, 2020, the FDA recounted that a recall is an “effective
methods [sic.] of removing or correcting defective FDA-regulated products . . . particularly when
those products present a danger to health.”18 The FDA sought the voluntary consent of
manufacturers to accept the recall “to protect the public health from products that present a risk of
injury.”19 The FDA found that the recall of all Ranitidine-Containing Drugs and public warning of
the recall was necessary because the “product being recalled presents a serious health risk.”20 The
FDA therefore sent Information Requests to all applicants and pending applicants of Ranitidine-
Containing Drugs “requesting a market withdrawal.”21
79. The FDA found its stability testing raised concerns that NDMA levels in some
ranitidine drugs stored at room temperature can increase with time to unacceptable levels. Other
testing conducted by FDA revealed a correlation between NDMA levels and expiration date. The
FDA’s testing eroded the agency’s confidence that any ranitidine product could remain stable through
its labeled expiration date. Consequently, the FDA was compelled to order the drugs off the market.
17 Letter of Janet Woodcock, Docket No. FDA-2020-P-0042 (April 1, 2020), available at https://emerypharma.com/wp-content/uploads/2020/04/FDA-2020-P-0042-CP-Response-4-1-2020.pdf. 18 Id., citing 21 CFR 7.40(a). 19 Id. 20 Id. 21 Id., fn. 43.
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The FDA’s decision to ban the drug rendered moot Emery’s request for temperature-controlled sales
conditions.
80. The FDA therefore issued a public statement requesting the immediate removal of all
Ranitidine-Containing Drugs from the market due to the risk to public health.22 “The agency has
determined that the impurity in some ranitidine drugs increases over time and when stored at higher
than room temperatures and may result in consumer exposure to unacceptable levels of this
impurity.” Based upon its own testing and evaluation, the FDA concluded that “NDMA levels
increase in ranitidine even under normal storage conditions and NDMA has been found to increase
significantly in samples stored at higher temperatures, including temperatures the product may be
exposed to during distribution and handling by consumers.”
81. The FDA’s reaction to the NDMA crisis involving ranitidine has come under attack.
Over 43 different countries and jurisdictions took action to restrict or ban ranitidine-containing drugs
before the FDA took any action.23 Indeed, despite being notified of the problem by Valisure in June
2019, the FDA left the drug on the market for nearly an entire year, during which time countless
more individuals were exposed to a carcinogen against their will.
82. The FDA’s reaction to the NDMA crisis involving ranitidine has come under attack.
Over 43 different countries and jurisdictions took action to restrict or ban ranitidine-containing drugs
before the FDA took any action.24
22 Press Release, FDA Requests Removal of All Ranitidine Products (Zantac) from the Market, U.S. Food and Drug Administration (April 1, 2020), available at https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market 23 Margaret Newkirk and Susan Berfield, FDA recalls are always voluntary and sometimes haphazard—and the agency doesn’t want more authority to protect consumers, Bloomberg Businessweek (Dec. 3, 2019), available at https://www.bloomberg.com/graphics/2019-voluntary-drug-recalls-zantac/. 24 Margaret Newkirk and Susan Berfield, FDA recalls are always voluntary and sometimes haphazard—and the agency doesn’t want more authority to protect consumers, Bloomberg Businessweek (Dec. 3, 2019), available at https://www.bloomberg.com/graphics/2019-voluntary-drug-recalls-zantac/.
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III. Dangers of NDMA
83. According to the U.S. Environmental Protection Agency (“EPA”), “NDMA is a
semivolatile organic chemical that forms in both industrial and natural processes.”25 It is one of the
simplest members of a class of N-nitrosamines, a family of potent carcinogens. The dangers that
NDMA poses to human health have long been recognized. A news article published in 1979 noted
that “NDMA has caused cancer in nearly every laboratory animal tested so far.”26 NDMA is no
longer produced or commercially used in the United States, except for research, such as a tumor
initiator in animal bioassays. In other words, the only use for NDMA today is to cause cancer in
laboratory animals.
84. Both the EPA and the International Agency for Research on Cancer (“IARC”) have
classified NDMA as a probable human carcinogen.27
85. The American Conference of Governmental Industrial Hygienists classifies NDMA as
a confirmed animal carcinogen.28
86. The U.S. Department of Health and Human Services (“DHHS”) states that NDMA is
reasonably anticipated to be a human carcinogen.29 This classification is based upon DHHS’s
25 United States Environmental Protection Agency, Technical Fact Sheet – N-Nitroso-dimethylamine (NDMA) (Nov. 2017), https://www.epa.gov/sites/production/files/2017-10/documents/ndma_fact_sheet_update_9-15-17_508.pdf (last visited Apr. 15, 2020). 26 Jane Brody, Bottoms Up: Alcohol in moderation can extend life, The Globe and Mail (CANADA) (Oct. 11, 1979); see Rudy Platiel, Anger grows as officials unable to trace poison in reserve’s water, The Globe and Mail (CANADA) (Jan. 6, 1990) (reporting that residents of Six Nations Indian Reserve “have been advised not to drink, cook or wash in the water because testing has found high levels of N-nitrosodimethylamine (NDMA), an industrial byproduct chemical that has been linked to cancer”); Kyrtopoulos et al, DNA adducts in humans after exposure to methylating agents, 405 MUT. RES. 135 (1998) (noting that “chronic exposure of rats to very low doses of NDMA gives rise predominantly to liver tumors, including tumors of the liver cells (hepatocellular carcinomas), bile ducts, blood vessels and Kupffer cells”). 27 See EPA Technical Fact Sheet, supra; International Agency for Research on Cancer (IARC) - Summaries & Evaluations, N-NITROSODIMETHYLAMINE (1978), http://www.inchem.org/documents/iarc/vol17/n-nitrosodimethylamine.html (last visited Apr. 15, 2020). 28 https://www.epa.gov/sites/production/files/2017-10/documents/ndma_fact_sheet_update_9-15-17_508.pdf. 29 Id. at 3.
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findings that NDMA caused tumors in numerous species of experimental animals, at several different
tissue sites, and by several routes of exposure, with tumors occurring primarily in the liver,
respiratory tract, kidney, and blood vessels.30
87. The FDA considers NDMA a chemical that “could cause cancer” in humans.31
88. The World Health Organization (“WHO”) states that there is “conclusive evidence
that NDMA is a potent carcinogen” and that there is “clear evidence of carcinogenicity.”32
89. As early as 1980, consumer products containing unsafe levels of NDMA and other
nitrosamines have been recalled by manufacturers, either voluntarily or at the direction of the FDA.
90. Most recently, beginning in the summer of 2018, there have been recalls of several
generic drugs used to treat high blood pressure and heart failure—Valsartan, Losartan, and
Irbesartan—because the medications contained nitrosamine impurities that do not meet the FDA’s
safety standards.
91. The no-observed-adverse-effect level (“NOAEL”) is the level of exposure at which
there is no biologically or significant increase in the frequency or severity of any adverse effects of
the chemical. Due to NDMA’s ability to affect DNA at a microscopic level, there is no NOAEL for
NDMA. This means any amount of NDMA exposure increases risk.
92. That said, the FDA has set an acceptable daily intake (“ADI”) level for NDMA at 96
nanograms. This means, according to the FDA, consumption of 96 nanograms of NDMA a day
would increase the risk of developing cancer by 0.001% over the course of a lifetime. That risk
increases as the level of NDMA exposure increases. However, any level above 96 nanograms is
30 https://www.epa.gov/sites/production/files/2017-10/documents/ndma_fact_sheet_update_9-15-17_508.pdf. 31 https://www.fda.gov/news-events/press-announcements/statement-alerting-patients-and-health-care-professionals-ndma-found-samples-ranitidine 32 World Health Organization, Guidelines for Drinking Water Quality, N-Nitrosodimethylamine (NDMA) (3rd ed. 2008), available at https://www.who.int/water_sanitation_health/dwq/ chemicals/ndmasummary_2ndadd.pdf.
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considered unacceptable.33 For example, tobacco smoke also contains NDMA. One filtered cigarette
contains between 5 to 43 nanograms of NDMA.
93. In mouse studies examining the carcinogenicity of NDMA through oral
administration, animals exposed to NDMA developed cancer in the kidney, bladder, liver, and lung.
In comparable rat studies, similar cancers were observed in the liver, kidney, pancreas, and lung. In
comparable hamster studies, similar cancers were observed in the liver, pancreas, and stomach. In
comparable Guinea-pig studies, similar cancers were observed in the liver and lung. In comparable
rabbit studies, similar cancers were observed in the liver and lung.
94. In other long-term animal studies in mice and rats utilizing different routes of
exposures—inhalation, subcutaneous injection, and intraperitoneal (abdomen injection)—cancer was
observed in the lung, liver, kidney, nasal cavity, and stomach.
95. Prior to the agency’s ban on Ranitidine-Containing Drugs, the FDA considered the
drug as category B for birth defects, meaning it was considered safe to take during pregnancy.
However, in animal experiments, for those animals exposed to NDMA during pregnancy, the
offspring had elevated rates of cancer in the liver and kidneys.
96. NDMA is, itself, a very small molecule. This allows it to freely pass through all areas
of the body, including the blood-brain and placental barrier. This is particularly concerning as
ranitidine has been marketed for pregnant women and young children for years.
97. In addition, NDMA breaks down into various derivative molecules that, themselves,
are associated with causing cancer. In animal studies, derivatives of NDMA induced cancer in the
stomach and intestine (including colon).
98. Research shows that lower levels of NDMA, i.e., 40 ng, are fully metabolized in the
liver, but high doses enter the body’s general circulation.
99. Numerous in vitro studies confirm that NDMA is a mutagen—causing mutations in
human and animal cells.
33 https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-angiotensin-ii-receptor-blocker-arb-recalls-valsartan-losartan.
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100. Overall, the animal data demonstrates that NDMA is carcinogenic in all animal
species tested: mice, rats, Syrian golden, Chinese and European hamsters, guinea-pigs, rabbits,
ducks, mastomys, fish, newts, and frogs.
101. Pursuant to the EPA cancer guidelines, “tumors observed in animals are generally
assumed to indicate that an agent may produce tumors in humans.”34
102. In addition to the overwhelming animal data linking NDMA to cancer, there are
numerous human epidemiological studies exploring the effects of dietary exposure to various cancers.
And, while these studies (several discussed below) consistently show increased risks of various
cancers, the exposure levels considered in these studies are a very small fraction—as little as 1
millionth—the exposures noted in a single Zantac capsule, i.e., 0.191 ng/day (dietary) v. 304,500
ng/day (Zantac).
103. In a 1995 epidemiological case-control study looking at NDMA dietary exposure with
220 cases, researchers observed a statistically significant 700% increased risk of gastric cancer in
persons exposed to more than 0.51 ng/day.35
104. In a 1995 epidemiological case-control study looking at NDMA dietary exposure with
746 cases, researchers observed statistically significant elevated rates of gastric cancer in persons
exposed to more than 0.191 ng/day.36
105. In another 1995 epidemiological case-control study looking at, in part, the effects of
dietary consumption on cancer, researchers observed a statistically significant elevated risk of
developing aerodigestive cancer after being exposed to NDMA at .179 ng/day.37
106. In a 1999 epidemiological cohort study looking at NDMA dietary exposure with 189
cases and a follow up of 24 years, researchers noted that “N-nitroso compounds are potent
34 See https://www3.epa.gov/airtoxics/cancer_guidelines_final_3-25-05.pdf. 35 Pobel, et al., Nitrosamine, nitrate and nitrite in relation to gastric cancer: a case-control study in Marseille, France, 11 EUROP. J. EPIDEMIOL. 67–73 (1995). 36 La Vecchia, et al., Nitrosamine intake and gastric cancer risk, 4 EUROP. J. CANCER. PREV. 469–474 (1995). 37 Rogers, et al., Consumption of nitrate, nitrite, and nitrosodimethylamine and the risk of upper aerodigestive tract cancer, 5 CANCER EPIDEMIOL. BIOMARKERS PREV. 29–36 (1995).
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carcinogens” and that dietary exposure to NDMA more than doubled the risk of developing
colorectal cancer.38
107. In a 2000 epidemiological cohort study looking at occupational exposure of workers in
the rubber industry, researchers observed significant increased risks for NDMA exposure for
esophagus, oral cavity, pharynx, prostate, and brain cancer.39
108. In a 2011 epidemiological cohort study looking at NDMA dietary exposure with 3,268
cases and a follow up of 11.4 years, researchers concluded that “[d]ietary NDMA intake was
significantly associated with increased cancer risk in men and women” for all cancers, and that
“NDMA was associated with increased risk of gastrointestinal cancers” including rectal cancers.40
109. In a 2014 epidemiological case-control study looking at NDMA dietary exposure with
2,481 cases, researchers found a statistically significant elevated association between NDMA
exposure and colorectal cancer.41
110. In addition to studies demonstrating that NDMA directly causes cancer, research
shows that exposure to NDMA (1) can exacerbate existing but dormant cancers (i.e., not malignant),
(2) promote otherwise “initiated cancer cells” to develop into cancerous tumors; and (3) reduce the
ability of the body to combat cancer. Thus, in addition to NDMA being a direct cause of cancer
itself, NDMA can also be a contributing factor to a cancer injury caused by some other source.
111. NDMA is also known to be genotoxic—meaning, it can cause DNA damage in human
cells. Indeed, multiple studies demonstrate that NDMA is genotoxic both in vivo and in vitro.
However, recent studies have shown that the ability of NDMA to cause mutations in cells is affected
38 Knekt, et al., Risk of Colorectal and Other Gastro-Intestinal Cancers after Exposure to Nitrate, Nitrite and N-nitroso Compounds: A Follow-Up Study, 80 INT. J. CANCER 852–856 (1999) 39 Straif, et al., Exposure to high concentrations of nitrosamines and cancer mortality among a cohort of rubber workers, 57 OCCUP ENVIRON MED 180–187 (2000). 40 Loh, et al., N-nitroso compounds and cancer incidence: the European Prospective Investigation into Cancer and Nutrition (EPIC)–Norfolk Study, 93 AM J CLIN NUTR. 1053–61 (2011). 41 Zhu, et al., Dietary N-nitroso compounds and risk of colorectal cancer: a case-control study in Newfoundland and Labrador and Ontario, Canada, 111 BR J NUTR. 6, 1109–1117 (2014).
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by the presence of enzymes typically found in living humans, suggesting that “humans may be
especially sensitive to the carcinogenicity of NDMA.”42
IV. How Ranitidine Transforms into NDMA Within the Human Body
112. The ranitidine molecule, itself, contains the constituent molecules to form NDMA.
See Figure 1.
113. Specifically, the O=N (Nitroso) on one side of the ranitidine molecule can combine
with the H3C-N-CH3 (DMA) on the other side to form NDMA. The NDMA forms out of the
ranitidine molecule itself.
114. The formation of NDMA by the reaction of DMA and a nitroso source (such as a
nitrite) is well characterized in the scientific literature and has been identified as a concern for
contamination of the American water supply.43 Indeed, in 2003, alarming levels of NDMA in
drinking water processed by wastewater treatment plants was specifically linked to the presence of
ranitidine.44
42 World Health Organization, Guidelines for Drinking Water Quality, N-Nitrosodimethylamine (NDMA) (3rd ed. 2008), available at https://www.who.int/water_sanitation_health/dwq/ chemicals/ndmasummary_2ndadd.pdf. 43 Ogawa, et al., Purification and properties of a new enzyme, NG, NG-dimethylarginine dimethylaminohydrolase, from rat kidney, 264 J. BIO. CHEM. 17, 10205-10209 (1989). 44 Mitch, et al., N-Nitrosodimethylamine (NDMA) as a Drinking Water Contaminant: A Review, 20 ENV. ENG. SCI. 5, 389-404 (2003).
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115. Ranitidine leads to NDMA exposure by: (1) formation of NDMA in the human
stomach; (2) formation of NDMA due to an enzymatic reaction throughout the human body; and (3)
formation of NDMA due to heat and/or time.
A. Formation of NDMA in the Environment of the Human Stomach
116. When the ranitidine molecule is exposed to the acidic environment of the stomach,
particularly when accompanied by nitrites (a chemical commonly found in heartburn-inducing
foods), the Nitroso molecule (0=N) and the DMA molecule (H3C-N-CH3) break off and reform as
NDMA.
117. In 1981, Dr. Silvio de Flora, an Italian researcher from the University of Genoa,
published the results of experiments he conducted on ranitidine in the well-known journal, The
Lancet. When ranitidine was exposed to human gastric fluid in combination with nitrites, his
experiment showed “toxic and mutagenic effects[.]”45 Dr. de Flora hypothesized that these
mutagenic effects could have been caused by the “formation of more than one nitroso derivative
[which includes NDMA] under our experimental conditions.” Id. Dr. de Flora cautioned that, in the
context of ranitidine ingestion, “it would seem prudent to … suggest[] a diet low in nitrates and
nitrites, by asking patients not to take these at times close to (or with) meals[.]”46 Id.
118. GSK knew of Dr. de Flora’s publication because, two weeks later, GSK responded in
The Lancet, claiming that the levels of nitrite needed to induce the production of nitroso derivatives
(i.e., NDMA) were not likely to be experienced by people in the real world.47
45 De Flora, Cimetidine, Ranitidine and Their Mutagenic Nitroso Derivatives, THE LANCET 993-994 (Oct. 31, 1981). 46 This admonition came two years before the FDA’s approved Zantac in 1983. Notwithstanding, in 1998 GSK applied for and obtained an indication for OTC Zantac “[f]or the prevention of meal-induced heartburn at a dose of 75 mg taken 30 to 60 minutes prior to a meal.” See https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/ 20520s1_Zantac.pdf. So, GSK specifically invited patients to take Zantac shortly before eating heartburn-inducing food. 47 R. T., Brittain, et al, Safety of Ranitidine, THE LANCET (Nov. 14, 1981).
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119. In its submission to the FDA, GSK explained that the level of nitrite present would be
unrealistic and, thus, these results had no “practical clinical significance”48:
120. Around this same time—before Zantac was approved by the FDA—GSK conducted
another study to examine, among other things, how long-term use of ranitidine could affect the levels
of nitrite in the human stomach.49 Remarkably, in the study that was presented to the FDA, GSK
admitted that ranitidine use caused the proliferation of bacteria in the human stomach that are known
to convert nitrates to nitrites, which leads to elevated levels of nitrite in the stomach environment.
GSK acknowledged this could increase the risk of developing NDMA and, in turn, cancer, but then
dismissed this risk because people were only expected to use ranitidine-containing drugs for a short-
term period:
48 Excerpted from the Summary Basis of Approval submitted to the FDA to obtain approval of Zantac in the early 1980s. This document was obtained through a Freedom of Information Act request to the FDA. 49 The results of this study are discussed in the Summary Basis of Approval, obtained from the FDA.
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121. GSK knew—and indeed specifically admitted—that ranitidine could react with nitrite
in the human stomach to form NDMA and, at the same time, that long-term use of ranitidine could
lead to elevated levels of nitrite in the human stomach.
122. In response to Dr. de Flora’s findings, in 1982, GSK conducted a clinical study
specifically investigating gastric contents in human patients.50 The study, in part, specifically
measured the levels of N-Nitroso compounds in human gastric fluid. GSK indicated that there were
no elevated levels, and even published the results of this study five years later, in 1987. The study,
however, was rigged. It did not use gold-standard mass spectrometry to test for NDMA, but instead,
used a process that could not measure N-nitrosamines efficiently. And worse, in the testing it did do,
GSK refused to test gastric samples that contained ranitidine in them out of concern that samples with
ranitidine would contain “high concentrations of N-nitroso compounds being recorded.” Id. So, GSK
did not test for NDMA in any gastric fluid that contained ranitidine.
123. In 1983, the same year Zantac obtained approval from the FDA, seven researchers
from the University of Genoa published a study discussing ranitidine and its genotoxic effects (ability
to harm DNA).51 The researchers concluded “it appears that reaction of ranitidine with excess
sodium nitrite under acid conditions gives rise to a nitroso-derivative (or derivatives) [like NDMA]
capable of inducing DNA damage in mammalian cells.” Id.
124. Then, again in 1983, Dr. de Flora, along with four other researchers, published their
complete findings.52 The results “confirm our preliminary findings on the formation of genotoxic
derivatives from nitrite and ranitidine[.]” Id. Again, the authors noted that, “the widespread clinical
use [of ranitidine] and the possibility of a long-term maintenance therapy suggest the prudent
adoption of some simple measures, such as a diet low in nitrates and nitrites or the prescription of
these anti-ulcer drugs at a suitable interval from meals.” Id. This admonition carries weight
50 Thomas, et al., Effects of one year’s treatment with ranitidine and of truncal vagotomy on gastric contents, 6 GUT. Vol. 28, 726-738 (1987). 51 Maura, et al., DNA Damage Induced by Nitrosated Ranitidine in Cultured Mammalian Cells, 18 TOX. LTTRS. 97-102 (1983). 52 De Flora, et al., Genotoxicity of nitrosated ranitidine, 4 CARCINOGENESIS 3, 255-260 (1983).
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considering GSK’s studies indicate that long-term ranitidine consumption, itself, leads to elevated
levels of nitrites in the human gut.
125. The high instability of the ranitidine molecule was elucidated in scientific studies
investigating ranitidine as a source of NDMA in drinking water and specific mechanisms for the
breakdown of ranitidine were proposed.53 These studies underscore the instability of the NDMA
group on the ranitidine molecule and its ability to form NDMA in the environment of water treatment
plants which supply many American cities with water.
126. In 2016, researchers at Stanford University conducted an experiment on healthy
volunteers (Stanford Study).54 They measured the NDMA in urine of healthy individuals over the
course of 24 hours, administered one dose of ranitidine, and then measured the NDMA in the urine of
the same individuals for another 24 hours. On average, the level of NDMA increased by 400 times,
to approximately 47,000 nanograms. The only change during that 24-hour period was the
consumption of ranitidine. This study directly demonstrated that unsafe levels of NDMA are formed
in the human body as a result of ranitidine ingestion. The scientists further explained that humans do
not typically excrete NDMA in their urine, so that the observed 47,000 nanograms likely only
captured 1/100 of the actual NDMA levels in the human body.
127. These studies did not appreciate the full extent of NDMA formation risk from
ranitidine; specifically, the added danger of this drug having not only a labile DMA group but also a
readily available nitroso source in its nitrite group on the opposite terminus of the molecule. Recent
testing reveals that NDMA levels in ranitidine batches are so high that the nitroso for NDMA likely
comes from no other source than the ranitidine molecule itself.
128. Valisure is an online pharmacy that also runs an analytical laboratory that is ISO
17025 accredited by the International Organization for Standardization (“ISO”) – an accreditation
recognizing the laboratories technical competence for regulatory. Valisure’s mission is to help
53 Le Roux, et al., NDMA Formation by Chloramination of Ranitidine: Kinetics and Mechanism, 46 Environ. Sci. Technol. 20, 11095-11103 (2012). 54 Zeng, et al., Oral intake of ranitidine increases urinary excretion of N-nitrosodimethylamine, 37 CARCINOGENESIS 625-634 (2016).
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ensure the safety, quality, and consistency of medications and supplements in the market. In
response to rising concerns about counterfeit medications, generics, and overseas manufacturing,
Valisure developed proprietary analytical technologies that it uses in addition to FDA standard assays
to test every batch of every medication it dispenses.
129. In its September 9, 2019 Citizen’s Petition to the FDA, Valisure disclosed as part of
its testing of Zantac, and other ranitidine-containing drugs that in every lot tested there were
exceedingly high levels of NDMA discovered. Valisure’s ISO 17025 accredited laboratory used FDA
recommended GC/MS headspace analysis method FY19-005-DPA8 for the determination of NDMA
levels. As per the FDA protocol, this method was validated to a lower limit of detection of 25 ng.55
The results of Valisure’s testing show levels of NDMA well above 2 million ng per 150 mg Zantac
tablet, shown below in Table 1.
Table 1 – Ranitidine Samples Tested by Valisure Laboratory Using GC/MS Protocol
150 mg Tablets or equivalent Lot # NDMA per tablet (ng)
Reference Powder* 125619 2,472,531
Zantac, Brand OTC 18M498M 2,511,469
Zantac (mint), Brand OTC 18H546 2,834,798
Wal-Zan, Walgreens 79L800819A 2,444,046
Wal-Zan (mint), Walgreens 8ME2640 2,635,006
Ranitidine, CVS 9BE2773 2,520,311
Zantac (mint), CVS 9AE2864 3,267,968
Ranitidine, Equate 9BE2772 2,479,872
Ranitidine (mint), Equate 8ME2642 2,805,259
Ranitidine, Strides 77024060A 2,951,649
55 US Food and Drug Administration. (updated 01/25/2019). Combined N-Nitrosodimethlyamine (NDMA) and N-Nitrosodiethylamine (NDEA) Impurity Assay, FY19-005-DPA-S.
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130. Valisure’s testing shows, on average, 2,692,291 ng of NDMA in a 150 mg Zantac
tablet. Considering the FDA’s permissible limit is 96 ng, this would put the level of NDMA at
28,000 times the legal limit. By way of comparison, a person would need to smoke at least 6,200
cigarettes to achieve the same levels of NDMA found in one 150 mg dose of Zantac.
131. Valisure, however, was concerned that the extremely high levels of NDMA observed
in its testing were a product of the modest oven heating parameter of 130 °C in the FDA
recommended GC/MS protocol. So, Valisure developed a low temperature GC/MS method that
could still detect NDMA but would only subject samples to 37 °C, the average temperature of the
human body. This method was validated to a lower limit of detection of 100 ng.
132. Valisure tested ranitidine tablets by themselves and in conditions simulating the
human stomach. Industry standard “Simulated Gastric Fluid” (“SGF” 50 mM potassium chloride, 85
mM hydrochloric acid adjusted to pH 1.2 with 1.25 g pepsin per liter) and “Simulated Intestinal
Fluid” (“SIF” 50 mM potassium chloride, 50 mM potassium phosphate monobasic adjusted to pH 6.8
with hydrochloric acid and sodium hydroxide) were used alone and in combination with various
concentrations of nitrite, which is commonly ingested in foods like processed meats and is elevated in
the stomach by antacid drugs. The inclusion of nitrite in gastric fluid testing is commonplace and
helps simulate the environment of a human stomach.
133. Indeed, Zantac was specifically advertised to be used when consuming foods
containing high levels of nitrates, like tacos, pizza, etc.56
134. The results of Valisure’s tests on ranitidine tablets in biologically relevant conditions
demonstrate significant NDMA formation under simulated gastric conditions with nitrite present (see
Table 2).
Table 2 – Valisure Biologically Relevant Tests for NDMA Formation
Ranitidine Tablet Studies NDMA (ng/mL) NDMA per tablet (ng)
Tablet without Solvent Not Detected Not Detected
56 See, e.g., https://www.ispot.tv/ad/dY7n/zantac-family-taco-night; https://youtu.be/jzS2kuB5_wg; https://youtu.be/Z3QMwkSUlEg; https://youtu.be/qvh9gyWqQns.
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Table 2 – Valisure Biologically Relevant Tests for NDMA Formation
Tablet Not Detected Not Detected
Simulated Gastric Fluid (“SGF”) Not Detected Not Detected
Simulated Intestinal Fluid Not Detected Not Detected
SGF with 10 mM Sodium Nitrite Not Detected Not Detected
SGF with 25 mM Sodium Nitrite 236 23,600
SGF with 50 mM Sodium Nitrite 3,045 304,500
135. Under biologically relevant conditions, when nitrites are present, high levels of
NDMA are found in one dose of 150 mg Zantac, ranging between 245 and 3,100 times above the
FDA-allowable limit. One would need to smoke over 500 cigarettes to achieve the same levels of
NDMA found in one dose of 150 mg Zantac at the 25 nanogram level (over 7,000 for the 50
nanogram level).
136. When the scientific data is assessed overall, the literature demonstrates that the
ingestion of ranitidine in the presence of human-relevant levels of nitrite in the stomach—a substance
that is commonly found in foods that induce heartburn and that is known to be elevated in people
taking ranitidine for longer than a month—the ranitidine molecule breaks down into levels of NDMA
that would dramatically increase a person’s risk of developing cancer.
B. Formation of NDMA in the Other Organs of Human Body
137. In addition to the gastric fluid mechanisms investigated in the scientific literature,
Valisure identified a possible enzymatic mechanism for the liberation of ranitidine’s DMA group via
the human enzyme dimethylarginine dimethylaminohydrolase (“DDAH”), which can occur in other
tissues and organs separate from the stomach.
138. Liberated DMA can lead to the formation of NDMA when exposed to nitrite present
on the ranitidine molecule, nitrite freely circulating in the body, or other potential pathways,
particularly in weak acidic conditions such as that in the kidney or bladder. The original scientific
paper detailing the discovery of the DDAH enzyme in 1989 specifically comments on the propensity
of DMA to form NDMA: “This report also provides a useful knowledge for an understanding of the
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endogenous source of dimethylamine as a precursor of a potent carcinogen, dimethylnitrosamine
[NDMA].”57
139. In Figure 2, below, computational modelling demonstrates that ranitidine (shown in
green) can readily bind to the DDAH-1 enzyme (shown as a cross-section in grey) in a manner
similar to the natural substrate of DDAH-1 known as asymmetric dimethylarginine (“ADMA,”
shown in blue).
140. These results indicate that the enzyme DDAH-1 increases formation of NDMA in the
human body when ranitidine is present; therefore, the expression of the DDAH-1 gene is useful for
identifying organs most susceptible to this action.
141. Figure 3 below, derived from the National Center for Biotechnology Information,
illustrates the expression of the DDAH-1 gene in various tissues in the human body.
57 Ogawa, et al., Purification and properties of a new enzyme, NG, NG-dimethylarginine dimethylaminohydrolase, from rat kidney, 264 J. BIO. CHEM. 17, 10205-10209 (1989).
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142. DDAH-1 is most strongly expressed in the kidneys but also broadly distributed
throughout the body, such as in the liver, prostate, stomach, bladder, brain, colon, and prostate. This
offers both a general mechanism for NDMA formation in the human body from ranitidine and
specifically raises concern for the effects of NDMA on numerous organs, including the bladder.
143. The possible enzymatic reaction of ranitidine to DDAH-1, or other enzymes, suggests
that high levels of NDMA can form throughout the human body. Indeed, ranitidine metabolizes and
circulates throughout the human body, crossing the placental and blood-brain barrier, within 1-2
hours. When the ranitidine interacts with the DDAH-1 enzyme in various organs throughout the
body, it breaks down into NDMA. This observation is validated by the Stanford study.
C. Formation of NDMA by Exposure to Heat and/or Time
144. The risk of creating NDMA by exposing ranitidine to heat has been well-known and
documented. Early studies, including the one conducted by GSK in the early 1980s, demonstrated
that NDMA formed when ranitidine was exposed to heat. This point was underscored in the Valisure
petition, which specifically developed a detection protocol that did not use heat.
145. In response to Valisure, on October 2, 2019, the FDA recommended that researchers
use the LC-HRMS protocol for detecting NDMA in ranitidine because the “testing method does not
use elevated temperatures” and has been proven capable of detecting NDMA.
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146. On January 2, 2020, Emery Pharma, an FDA-certified pharmaceutical testing
laboratory, conducted a series of tests on ranitidine using the FDA-recommended LC-HRMS
protocol. The researchers exposed ranitidine to 70 ⸰C for varying periods of time. The results
showed that increasing levels of NDMA formed based on exposure to heat. The following diagram
reveals how NDMA accumulates over time when exposed to 70 ⸰C:
147. The researchers cautioned:
NDMA accumulates in ranitidine-containing drug products on exposure to elevated temperatures, which would be routinely reached during shipment and during storage. More importantly, these conditions occur post-lot release by the manufacturer. Hence, while NDMA levels in ranitidine may be acceptable at the source, they may not be so when the drug is purchased and subsequently at the time of consumption by the consumer.
148. Indeed, the FDA’s recent testing confirms that NDMA levels increase in ranitidine
even under normal storage conditions, and NDMA has been found to increase significantly in
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samples stored at higher temperatures, including temperatures to which ranitidine may be exposed
during distribution and handling by consumers.58
149. The results of this data demonstrate that in normal transport and storage, and
especially when exposed to heat, the ranitidine molecule systematically breaks down into NDMA,
accumulating over time in the finished product. Considering ranitidine-containing drugs have an
approved shelf life of 36 months, the possibility of the drug accumulating dangerously high levels of
NDMA prior to consumption is very real—a point underscored by the FDA’s swift removal of the
product from the market.
D. Evidence Also Directly Links Ranitidine Exposure to Cancer
150. In addition to numerous epidemiology studies examining how NDMA causes cancer
in humans, researchers have also specifically looked at ranitidine and found an association with
cancer.
151. One epidemiology study, published in 2004, showed that men taking either ranitidine
or cimetidine (Tagamet) had increased risks of bladder cancer.59
152. In one epidemiology study specifically designed to look at breast cancer, ranitidine
was shown to more than double the risk of breast cancer, an effect that was even more pronounced in
those with specific gene mutations.60
153. In another comprehensive epidemiological study looking at various cancer risks and
H2 blockers, including ranitidine, the data showed that ranitidine consumption increased the risk of
prostate, lung, esophageal, pancreatic, and kidney cancer. Of particular note, the study indicated that
people under the age of 60 that took ranitidine were five times more likely to contract prostate cancer.
58 Press Release, FDA Requests Removal of All Ranitidine Products (Zantac) from the Market, U.S. Food and Drug Administration (April 1, 2020), available at https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market 59 D. Michaud, et al, Peptic Ulcer Disease and the Risk of Bladder Cancer in a Prospective Study of Male Health Professionals, 13 CANCER EPI. BIOMARK. & PREV. 250–254, 252 (Feb. 2004). 60 Robert W. Mathes, et al, Relationship between histamine2-receptor antagonist medications and
risk of invasive breast cancer, 17 CANCER EPI. BIOMARKERS & PREVENTION 1, 67-72 (2008).
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154. A study published in 2018, demonstrated an increased risk of liver cancer associated
with use of ranitidine in comparison with other histamine type 2 receptor antagonists (H2RAs) in the
class. The purpose of the study was to determine whether there was an increased risk of liver cancer
associated with proton pump inhibitors, a different class of medications indicated for the treatment of
GERD. This finding is particularly notable as the authors adjusted for variables and, more
significantly, did not study or consider long term use of H2RAs or the possibility of a dose dependent
increase in risk.61
155. In 2018, a study found an increased risk in hepatocellular carcinoma associated with
use of H2RAs.62 The authors were evaluating the risk of cancer in association with proton pump
inhibitors and looked at H2RAs as a confounder. The study only considered use of H2RAs within one
year of cancer diagnosis and still found an increased odds ratio associated with use of H2RAs and
hepatocellular carcinoma, a type of liver cancer.
156. A number of other studies have been published over the years showing an increased
risk of various cancers associated with use of ranitidine and/or H2RAs.63 However it is especially
noteworthy that Memorial Sloan Kettering, in conjunction with various researchers, plan to publish a
study specifically looking at ranitidine users and cancer risks in the Journal of the American Medical
Association (“JAMA”). The article was accepted and is set for publication.
V. Defendants Made False Statements in the Labeling of Their Ranitidine-Containing Drugs.
157. A manufacturer is required to give adequate directions for the use of a pharmaceutical
61 Kim Tu Tran,, et al., Proton pump inhibitor and histamine‐2 receptor antagonist use and risk of liver cancer in two population‐based studies, 48 ALIMENTARY PHARMA & THERAP 1, 55-64 (2018). 62 Shao, Y‐HJ, et al., Association between proton pump inhibitors and the risk of hepatocellular carcinoma, 48 ALIMENTARY PHARMA & THERAP 4, 460-468 (2018). 63 Robert W. Mathes, et al., Relationship between histamine2-receptor antagonist medications and risk of invasive breast cancer, 17 CANCER EPID. & PREV BIOMARKERS 1, 67-72 (2008); see also Ahn, Jeong Soo, et al., Acid suppressive drugs and gastric cancer: a meta-analysis of observational studies, 19 WORLD J. GASTROENTEROLOGY 16, 2560 (2013); Lai, Shih-Wei, et al., Use of proton pump inhibitors correlates with increased risk of pancreatic cancer: a case-control study in Taiwan, 46 KUWAIT MED J. 1, 44-48 (2014); Poulsen et al., Proton Pump Inhibitors and risk of gastric cancer – a population based cohort study, 100 BRITISH J CANCER 1503-1507 (2009); E Wennerström, Acid-suppressing therapies and subsite-specific risk of stomach cancer, 116 BRITISH J CANCER 9, 1234-1238 (2017).
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drug such that a “layman can use a drug safely and for the purposes for which it is intended,”64 and
conform to requirements governing the appearance of the label.65
158. “Labeling” encompasses all written, printed or graphic material accompanying the
drug or device,66 and therefore broadly encompasses nearly every form of promotional activity,
including not only “package inserts” but also advertising.
159. “Most, if not all, labeling is advertising. The term “labeling” is defined in the FDCA
as including all printed matter accompanying any article. Congress did not, and we cannot, exclude
from the definition printed matter which constitutes advertising.”67
160. If a manufacturer labels a drug but omits ingredients, that renders the drug
misbranded.68
161. Because Defendants did not disclose NDMA as an ingredient in the Ranitidine-
Containing Drugs ingested by Plaintiff, the subject drugs were misbranded.
162. It is unlawful to introduce a misbranded drug into interstate commerce.69 Thus, the
Ranitidine-Containing Drugs ingested by Plaintiff were unlawfully distributed and sold.
VI. Defendants Knew or Should Have Known of the NDMA Risk
163. During the time that Defendants manufactured and sold Ranitidine-Containing Drugs
in the United States, the weight of scientific evidence showed that Ranitidine-Containing Drugs
exposed users to unsafe levels of NDMA. Defendants failed to disclose this risk to consumers on the
drug’s label—or through any other means—and Defendants failed to report these risks to the FDA.
164. Going back as far as 1981, two years before Zantac entered the market, research
showed elevated rates of NDMA, when properly tested. This was known or should have been known
by the Defendants or any other maker or distributor of ranitidine-containing drugs.
64 21 C.F.R. § 201.5. 65 21 C.F.R. § 801.15. 66 Id. 65 Fed. Reg. 14286 (March 16, 2000). 67 U.S. v. Research Labs., 126 F.2d 42, 45 (9th Cir. 1942). 68 21 C.F.R. § 201.6; 201.10. 69 21 U.S.C. § 331(a).
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165. Defendants concealed the Zantac–NDMA link from consumers in part by not
reporting it to the FDA, which relies on drug manufacturers (or others, such as those who submit
citizen petitions) to bring new information about an approved drug like Ranitidine-Containing Drugs
to the agency’s attention.
166. Manufacturers of an approved drug are required by regulation to submit an annual
report to the FDA containing, among other things, new information regarding the drug’s safety
pursuant to 21 C.F.R. § 314.81(b)(2):
The report is required to contain . . . [a] brief summary of significant new information from the previous year that might affect the safety, effectiveness, or labeling of the drug product. The report is also required to contain a brief description of actions the applicant has taken or intends to take as a result of this new information, for example, submit a labeling supplement, add a warning to the labeling, or initiate a new study.
167. 21 C.F.R. § 314.81(b)(2)(v) provides:
The manufacturer’s annual report also must contain copies of unpublished reports and summaries of published reports of new toxicological findings in animal studies and in vitro studies (e.g., mutagenicity) conducted by, or otherwise obtained by, the [manufacturer] concerning the ingredients in the drug product.
168. Defendants ignored these regulations and, disregarding the scientific evidence
available to them, did not report to the FDA significant new information affecting the safety or
labeling of Ranitidine-Containing Drugs.
169. Knowledge regarding the risk of NDMA in ranitidine was sufficiently available in the
publicly available scientific literature that any maker or distributor, consistent with their heightened
obligations to ensure the safety of their products, should have known about the potential NDMA risks
associated with ranitidine consumption.
170. Defendants never conducted or provided the relevant studies to the FDA, nor did they
present to the FDA with a proposed disclosure noting the link between ranitidine and NDMA.
Accordingly, because the Defendants never properly disclosed the risk to the FDA, they never
proposed any labeling or storage / transportation guidelines that would have addressed this risk.
Thus, the FDA was never able to reject any proposed warning or proposal for transport / storage.
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171. Nothing prevented any Defendant from, on its own, taking actions to prevent
accumulation of NDMA in ranitidine drugs by ensuring cooled storage and transport. Such actions
would not have required FDA approval, nor would they have violated any regulatory decisions or
laws.
172. Defendants also knew federal law requires pharmaceutical drugs to be stored,
warehoused, and distributed in accordance with current “Good Manufacturing Practices” (“GMPs”)
to ensure they meet safety, quality, purity, identity, and strength standards. See 21 U.S.C. §
351(a)(2)(B).
173. 21 C.F.R. § 211.142(b) states that the GMPs required that warehousing of drug
products shall be performed to provide for “[s]torage of drug products under appropriate conditions
of temperature, humidity, and light so that the identity, strength, quality, and purity of the drug
products are not affected.” In other words, Defendants had a duty and were obligated to properly
store, handle, and warehouse Ranitidine-Containing Drugs.
174. Testing conducted by the FDA, which led to the agency’s ban on Ranitidine-
Containing Drugs, confirms that improper storage of Ranitidine-Containing Drugs has resulted in
extremely high levels of NDMA. FDA has also concluded that NDMA can increase in Ranitidine-
Containing Drugs even under normal storage conditions. and NDMA has been found to increase
significantly in samples stored at higher temperatures, including temperatures the product may be
exposed to during distribution and handling by consumers. FDA’s testing also showed that as
Ranitidine-Containing Drugs age the level of NDMA in the product increases.
175. FDA concluded that these defects raised the level of NDMA in Ranitidine-Containing
Drugs above the acceptable daily intake limit to the point that the drugs had to be banned.
176. In a 1981 study published by GSK, the originator of the ranitidine molecule, the
metabolites of ranitidine in urine were studied using liquid chromatography.70 Many metabolites were
listed, though there is no indication that NDMA was looked for. Plaintiff believes this was
70 Carey, et al., Determination of ranitidine and its metabolites in human urine by reversed-phase ion-pair high-performance liquid chromatography, 255 J. CHROMATOGRAPHY B: BIOMEDICAL SCI. & APPL. 1, 161-168 (1981).
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intentional—a gambit by the manufacturer to avoid detecting a carcinogen in their product. All
Defendants knew or should have known about this study and, therefore, were obligated to investigate
this issue properly. None did.
177. Indeed, in that same year, Dr. de Flora published a note in The Lancet discussing the
results of his experiments showing that ranitidine was turning into mutagenic N-nitroso compounds,
of which NDMA is one, in human gastric fluid when accompanied by nitrites – a substance
commonly found in food and in the body. GSK was aware of this as GSK specifically responded to
the note and attempted to discredit it. Defendants knew or should have known about this scientific
exchange as it was in a popular scientific journal, The Lancet. Therefore, the Defendants were
obligated to investigate this issue properly, and none did.
178. By 1987, after numerous studies raised concerns over ranitidine and cancerous nitroso
compounds (discussed previously), GSK published a clinical study specifically investigating gastric
contents in human patients and N-nitroso compounds.71 This study specifically indicated that there
were no elevated levels of N-nitroso compounds (of which NDMA is one). However, the study was
rigged to fail. It used an analytical system called a “nitrogen oxide assay” for the determination of N-
nitrosamines, which was developed for analyzing food and is a detection method that indirectly and
non-specifically measures N-nitrosamines. Furthermore, in addition to this approach being less
accurate, GSK also removed all gastric samples that contained ranitidine out of concern that samples
with ranitidine would contain “high concentrations of N-nitroso compounds being recorded.” So,
without the chemical being present in any sample, any degradation into NDMA could not, by design,
be observed. Again, this spurious test was intentional and designed to mask any potential cancer risk.
The inadequacy of this test was knowable in light of its scientific publication in 1987. All
Defendants either knew or should have known about the inadequacy of this study and should have
investigated the issue properly and/or took action to protect consumers from the NDMA risks in their
drugs. None did.
71 Thomas, et al., Effects of one year’s treatment with ranitidine and of truncal vagotomy on gastric contents, 6 GUT. Vol. 28, 726-738 (1987).
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179. In fact, upon information and belief, none of the Defendants ever used a mass
spectrometry assay to test for the presence of nitrosamines in any of the studies and trials they did in
connection with their trials associated with the ranitidine NDA. That is because when using mass
spectrometry, it requires heating of up to 130 degrees Celsius, which can result in excessive amounts
of nitrosamines being formed. Had the Defendants used a mass spectrometry assay, it would have
revealed in the finding of large amounts of NDMA, and the FDA would never have approved Zantac
as being safe.
180. Based on the public scientific information available starting in 1983 (or earlier), the
Defendants knew or should have known that NDMA could form in ranitidine by exposure to heat
and/or over time in storage. No Defendants, upon information and belief, took action to reduce this
risk through altering supply-chain conduct or warning consumers. Additionally, no Defendants took
any action to further investigate this issue notwithstanding the signal that existed in the scientific
literature.
181. There are multiple alternatives to Zantac that do not pose the same risk, such as
Cimetidine (Tagamet), Famotidine (Pepcid), Omeprazole (Prilosec), Esomeprazole (Nexium), and
Lansoprazole (Prevacid).
VII. Exemplary / Punitive Damages Allegations (Against Manufacturer Defendants)
182. Defendants’ conduct as alleged herein was done with reckless disregard for human
life, oppression, and malice. Defendants were fully aware of the safety risks of Ranitidine-
Containing Drugs, particularly the carcinogenic potential of Ranitidine-Containing Drugs as it
transforms into NDMA within the chemical environment of the human body and/or during transport
and/or storage. Nonetheless, Defendants deliberately crafted their label, marketing, and promotion to
mislead consumers.
183. This was not done by accident or through some justifiable negligence. Rather,
Defendants knew they could profit by convincing consumers that Ranitidine-Containing Drugs was
harmless to humans, and that full disclosure of the true risks of Ranitidine-Containing Drugs would
limit the amount of money Defendants would make selling the drugs. Defendants’ object was
accomplished not only through a misleading label, but through a comprehensive scheme of selective
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misleading research and testing, false advertising, and deceptive omissions as more fully alleged
throughout this pleading. Plaintiff was denied the right to make an informed decision about whether
to purchase and use Ranitidine-Containing Drugs, knowing the full risks attendant to that use. Such
conduct was done with conscious disregard of Plaintiff’s rights.
184. Accordingly, Plaintiff requests punitive damages against the Manufacturer Defendants
for the harms caused to Plaintiff.
VIII. Equitable Tolling/Estoppel
185. Plaintiff asserts all applicable statutory and common law rights and theories related to
the tolling or extension of any applicable statute of limitations, including equitable tolling, delayed
discovery, discovery rule and/or fraudulent concealment.
186. The discovery rule applies to toll the running of the statute of limitations until Plaintiff
knew, or through the exercise of reasonable care and diligence should have known, of facts that
Plaintiff had been injured, the cause of the injury, and the tortious nature of the wrongdoing that
caused the injury.
187. The nature of Plaintiff’s injuries, damages, or their causal relationship to Defendants’
conduct was not discovered, and through reasonable care and due diligence could not have been
discovered until a date within the applicable statute of limitations for filing Plaintiff’s claims.
188. The running of the statute of limitations is tolled due to equitable tolling. Defendants
are estopped from relying on any statutes of limitation or repose by virtue of their acts of fraudulent
concealment, through affirmative misrepresentations and omissions to Plaintiff and defects associated
with Ranitidine-Containing Drugs including the severity, duration, and frequency of risks and
complications. Defendants affirmatively withheld and/or misrepresented facts concerning the safety
of Ranitidine-Containing Drugs. As a result of Defendants’ misrepresentations and concealment,
Plaintiff could not have known or have learned through reasonable diligence that Plaintiff had been
exposed to the risks alleged herein and that those risks were the direct and proximate result of the
wrongful acts and/or omissions of the Defendants.
189. Given Defendants’ affirmative actions of concealment by failing to disclose this
known but non-public information about the defects – information over which the Defendants had
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exclusive control – and because Plaintiff could not reasonably have known that Ranitidine-
Containing Drugs were and are defective, Defendants are estopped from relying on any statutes of
limitations or repose that might otherwise be applicable to the claims asserted herein.
CAUSES OF ACTION
COUNT I: STRICT PRODUCTS LIABILITY – FAILURE TO WARN
(Against Manufacturer Defendants and the Retailer Defendant)
190. Plaintiff incorporates by reference each allegation set forth in preceding paragraphs as
if fully stated herein.
191. At all relevant times, Defendants engaged in the business of researching, testing,
developing, designing, manufacturing, labeling, marketing, selling, inspecting, handling, storing,
distributing, and promoting Ranitidine-Containing Drugs, which are defective and unreasonably
dangerous to consumers, including Plaintiff, because they do not contain adequate warnings or
instructions concerning the dangerous characteristics of Ranitidine-Containing Drugs and NDMA.
These actions were under the ultimate control and supervision of Defendants. At all relevant times,
Defendants registered, researched, manufactured, distributed, marketed, and sold Ranitidine-
Containing Drugs and aimed at a consumer market.
192. Defendants researched, tested, developed, designed, manufactured, labeled, marketed,
sold, inspected, handled, stored, distributed, and promoted, and otherwise released into the stream of
commerce their Ranitidine-Containing Drugs, and in the course of same, directly advertised or
marketed the products to consumers and end users, including Plaintiff, and therefore had a duty to
warn of the risks associated with the use of Ranitidine-Containing Drugs.
193. At all relevant times, Defendants had a duty to properly test, develop, design,
manufacture, inspect, package, label, market, promote, sell, handle, store, distribute, maintain,
supply, provide proper warnings, and take such steps as necessary to ensure their Ranitidine-
Containing Drugs did not cause users and consumers to suffer from unreasonable and dangerous
risks. Defendants had a continuing duty to warn Plaintiff of dangers associated with Ranitidine-
Containing Drugs. Defendants, as a manufacturer, seller, or distributor of pharmaceutical
medication, are held to the knowledge of an expert in the field.
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194. Defendants had a continuing duty to provide appropriate and accurate instructions
regarding the proper storage and handling of Ranitidine-Containing Drugs.
195. At the time of manufacture, Defendants could have provided the warnings or
instructions regarding the full and complete risks of Ranitidine-Containing Drugs because they knew
or should have known of the unreasonable risks of harm associated with the use of and/or exposure to
such products.
196. At all relevant times, Defendants failed and deliberately refused to investigate, study,
test, or promote the safety or to minimize the dangers to users and consumers of their product and to
those who would foreseeably use or be harmed by Defendants’ Ranitidine-Containing Drugs.
197. Even though Defendants knew or should have known that Ranitidine-Containing
Drugs posed a grave risk of harm, they failed to exercise reasonable care to warn of the dangerous
risks associated with use and exposure to the drugs. The dangerous propensities of their products and
the carcinogenic characteristics of NDMA as produced within the human body as a result of ingesting
Ranitidine-Containing Drugs, as described above, were known to Defendants, or scientifically
knowable to Defendants through appropriate research and testing by known methods, at the time they
distributed, supplied or sold the product, and were not known to end users and consumers, such as the
Plaintiff.
198. Defendants knew or should have known that their products created significant risks of
serious bodily harm to consumers, as alleged herein, and Defendants failed to adequately warn or
instruct consumers, i.e., the reasonably foreseeable users, of the risks of exposure to their products.
Defendants failed to warn and have wrongfully concealed information concerning the dangerous
level of NDMA in their Ranitidine-Containing Drugs and the potential for ingested Ranitidine-
Containing Drugs to transform into the carcinogenic NDMA compound, and further, have made false
and/or misleading statements concerning the safety of Ranitidine-Containing Drugs.
199. At all relevant times, Defendants’ Ranitidine-Containing Drugs reached the intended
consumers, handlers, and users or other persons coming into contact with these products, including
Plaintiff, without substantial change in their condition as designed, manufactured, sold, distributed,
labeled, and marketed by Defendants.
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200. Plaintiff was exposed to Defendants’ Ranitidine-Containing Drugs without knowledge
of their dangerous characteristics.
201. At all relevant times, Plaintiff used and/or was exposed to the use of Defendants’
Ranitidine-Containing Drugs while using them for their intended or reasonably foreseeable purposes,
without knowledge of their dangerous characteristics.
202. Plaintiff could not have reasonably discovered the defects and risks associated with
Ranitidine-Containing Drugs prior to or at the time of Plaintiff consuming Zantac. Plaintiff relied
upon the skill, superior knowledge, and judgment of Defendants to know about and disclose serious
health risks associated with using Defendants’ products.
203. Defendants knew or should have known that the minimal warnings disseminated with
their Ranitidine-Containing Drugs were inadequate, failed to communicate adequate information on
the dangers and safe use/exposure, and failed to communicate warnings and instructions that were
appropriate and adequate to render the products safe for their ordinary, intended and reasonably
foreseeable uses.
204. The information that Defendants did provide or communicate failed to contain
relevant warnings, hazards, and precautions that would have enabled consumers such as Plaintiff to
avoid using the drug. Instead, Defendants disseminated information that was inaccurate, false, and
misleading, and which failed to communicate accurately or adequately the comparative severity,
duration, and extent of the risk of injuries with use of and/or exposure to Ranitidine-Containing
Drugs; continued to aggressively promote the efficacy of their products, even after they knew or
should have known of the unreasonable risks from use or exposure; and concealed, downplayed, or
otherwise suppressed, through aggressive marketing and promotion, any information or research
about the risks and dangers of ingesting Ranitidine-Containing Drugs.
205. This alleged failure to warn is not limited to the information contained on Ranitidine-
Containing Drugs’ labeling. The Defendants were able, in accord with federal law, to comply with
relevant state law by disclosing the known risks associated with Ranitidine-Containing Drugs through
other non-labeling mediums, i.e., promotion, advertisements, public service announcements, and/or
public information sources. But the Defendants did not disclose these known risks through any
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medium.
206. Had Defendants provided adequate warnings and instructions and properly disclosed
and disseminated the risks associated with their Ranitidine-Containing Drugs, Plaintiff could have
avoided the risk of developing injuries and could have obtained or used alternative medication.
However, as a result of Defendants’ concealment of the dangers posed by their Ranitidine-Containing
Drugs, Plaintiff could not have averted their injuries.
207. Defendants’ conduct, as described above, was reckless. Defendants risked the lives of
consumers and users of their products, including Plaintiff, with knowledge of the safety problems
associated with Ranitidine-Containing Drugs, and suppressed this knowledge from the general public.
Defendants made conscious decisions not to redesign, warn or inform the unsuspecting public.
Defendants’ reckless conduct warrants an award of punitive damages.
208. The Defendants’ lack of adequate warnings and instructions accompanying their
Ranitidine-Containing Drugs were a substantial factor in causing Plaintiff’s injuries.
209. As a direct and proximate result of the Defendants’ failure to provide an adequate
warning of the risks of Ranitidine-Containing Drugs, Plaintiff has been injured, sustained severe and
permanent pain, suffering, disability, impairment, loss of enjoyment of life, economic loss and
damages including, but not limited to past and future medical expenses, lost income, and other
damages.
210. WHEREFORE, Plaintiff respectfully requests this Court to enter judgment in
Plaintiff’s favor for damages, together with interest, costs herein incurred, attorneys’ fees and all such
other and further relief as this Court deems just and proper.
COUNT II: STRICT PRODUCTS LIABILITY – MANUFACTURING DEFECT
(Against Manufacturer Defendants and the Retailer Defendant)
211. Plaintiff incorporates by reference each allegation set forth in preceding paragraphs as
if fully stated herein.
212. At all times herein mentioned, Defendants designed, manufactured, tested, marketed,
sold, handled, distributed, and stored the Ranitidine-Containing Drugs ingested by Plaintiff to
patients and physicians.
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213. At all relevant times, the medication ingested by Plaintiff were expected to and did
reach Plaintiff without a substantial change in its condition as manufactured, handled, distributed,
stored, and sold by Defendants.
214. At all relevant times, the medications ingested by Plaintiff were used in a manner that
was foreseeable and intended by Defendants.
215. The Ranitidine-Containing Drugs ingested by Plaintiff were not reasonably safe for
their intended use and were defective with respect to their manufacture, as described herein, in that
Defendants deviated materially from their design, manufacturing, handling, and storage specifications
and/or such design, manufacture, storage, and handling posed an unreasonable risk of harm to
Plaintiff.
216. The Defendants’ Ranitidine-Containing Drugs are inherently dangerous and defective,
unfit and unsafe for its intended and reasonably foreseeable uses, and do not meet or perform to the
expectations of patients and their health care providers.
217. The Ranitidine-Containing Drugs create risks to the health and safety of the patients
that are far more significant and devastating than the risks posed by other products and treatments
available to treat the corresponding medical conditions, and which far outweigh the utility of the
ranitidine-containing drugs because of Defendants’ manufacturing defects, which included but were
not limited to:
a. Failure to follow Good Manufacturing Practices;
b. Failure to adequately inspect/test the drugs during the manufacturing process;
c. Failure to implement procedures that would reduce or eliminate NDMA levels in
Ranitidine-Containing Drugs;
d. Failure to implement appropriate handling instructions and storage conditions for the
drug.
218. Defendants have intentionally and recklessly manufactured the Ranitidine-Containing
Drugs with wanton and willful disregard for the rights and health of the Plaintiff, and with malice,
placing their economic interests above the health and safety of the Plaintiff.
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219. The manufacturing defects in Defendants’ Ranitidine-Containing Drugs were
substantial factors in causing Plaintiff’s injuries
220. As a direct and proximate result of the Defendants’ defective manufacture of the
Ranitidine-Containing Drugs, Plaintiff has been injured, sustained severe and permanent pain,
suffering, disability, impairment, loss of enjoyment of life, economic loss and damages including, but
not limited to medical expenses, lost income, and other damages.
WHEREFORE, Plaintiff respectfully requests this Court to enter judgment in Plaintiff’s favor
for damages, together with interest, costs herein incurred, attorneys’ fees and all such other and further
relief as this Court deems just and proper.
COUNT III: NEGLIGENCE – FAILURE TO WARN
(Against Manufacturer Defendants)
221. Plaintiff incorporates by reference each allegation set forth in preceding paragraphs as
if fully stated herein.
222. At all relevant times, Defendants engaged in the business of testing, developing,
designing, manufacturing, marketing, selling, handling, storing, distributing, and promoting
Ranitidine-Containing Drugs. Defendants knew or by the exercise of reasonable care should have
known that their Ranitidine-Containing Drugs are not accompanied with adequate warnings or
instructions concerning the dangerous characteristics of Ranitidine-Containing Drugs and NDMA.
These actions were under the ultimate control and supervision of Defendants.
223. Defendants researched, developed, designed, tested, manufactured, inspected, labeled,
handled, stored, distributed, marketed, promoted, sold, and otherwise released into the stream of
commerce their Ranitidine-Containing Drugs, and in the course of same, directly advertised or
marketed the products to consumers and end users, including Plaintiff, and therefore had a duty to
warn of the risks associated with the use of Ranitidine-Containing Drugs.
224. At all relevant times, Defendants had a duty to properly test, develop, design,
manufacture, inspect, package, label, market, promote, sell, handle, store, distribute, maintain,
supply, provide proper warnings, and take such steps as necessary to ensure their Ranitidine-
Containing Drugs did not cause users and consumers to suffer from unreasonable and dangerous
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risks. Defendants had a continuing duty to warn Plaintiff of dangers associated with Ranitidine-
Containing Drugs. Defendants, as a manufacturer, seller, or distributor of pharmaceutical
medication, are held to the knowledge of an expert in the field.
225. Defendants had a continuing duty to provide appropriate and accurate instructions
regarding the proper storage and handling of Ranitidine-Containing Drugs.
226. At the time of manufacture, Defendants could have provided warnings or instructions
regarding the full and complete risks of Ranitidine-Containing Drugs because they knew or should
have known use of Ranitidine-Containing Drugs was dangerous, harmful and injurious when used by
Plaintiff in a reasonably foreseeable manner.
227. At all relevant times, Defendants failed and deliberately refused to investigate, study,
test, or promote the safety or to minimize the dangers to users and consumers of their product and to
those who would foreseeably use or be harmed by Defendants’ Ranitidine-Containing Drugs.
228. Defendants knew or should have known that Ranitidine-Containing Drugs posed a
grave risk of harm, but failed to exercise reasonable care to warn of the dangerous risks associated
with use and exposure to the products. The dangerous propensities of their products and the
carcinogenic characteristics of NDMA as produced within the human body as a result of ingesting
Ranitidine-Containing Drugs, as described above, were known to Defendants, or scientifically
knowable to Defendants through appropriate research and testing by known methods, at the time they
distributed, supplied or sold the product, and were not known to end users and consumers, such as the
Plaintiff.
229. Defendants further breached their duty by failing to use reasonable care to adequately
warn or instruct consumers (i.e., the reasonably foreseeable users) of the risks of exposure to their
products. Defendants failed to warn and have wrongfully concealed information concerning the
dangerous level of NDMA in their Ranitidine-Containing Drugs and the potential for ingested
Ranitidine-Containing Drugs to transform into the carcinogenic NDMA compound, and further, have
made false and/or misleading statements concerning the safety of Ranitidine-Containing Drugs.
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230. At all relevant times, Plaintiff used and/or was exposed to excessive levels of NDMA
through the use of Defendants’ Ranitidine-Containing Drugs while using them for their intended or
reasonably foreseeable purposes, without knowledge of their dangerous characteristics.
231. Defendants knew or should have known that the minimal warnings disseminated with
their Ranitidine-Containing Drugs were inadequate, failed to communicate adequate information on
the dangers and safe use/exposure, and failed to communicate warnings and instructions that were
appropriate and adequate to render the products safe for their ordinary, intended and reasonably
foreseeable uses.
232. The information that Defendants did provide or communicate failed to contain
relevant warnings, hazards, and precautions that would have enabled consumers such as Plaintiff to
avoid using the product. Instead, Defendants disseminated information that was inaccurate, false, and
misleading, and which failed to communicate accurately or adequately the comparative severity,
duration, and extent of the risk of injuries with use of and/or exposure to Ranitidine-Containing
Drugs; continued to aggressively promote the efficacy of their products, even after they knew or
should have known of the unreasonable risks from use or exposure; and concealed, downplayed, or
otherwise suppressed, through aggressive marketing and promotion, any information or research
about the risks and dangers of ingesting Ranitidine-Containing Drugs.
233. A reasonable company under the same or similar circumstance would have warned
and instructed of the dangers of Ranitidine-Containing Drugs.
234. This alleged failure to warn is not limited to the information contained on Ranitidine-
Containing Drugs’ labeling. The Defendants were able, in accord with federal law, to comply with
relevant state law by disclosing the known risks associated with Ranitidine-Containing Drugs through
other non-labeling mediums, i.e., promotion, advertisements, public service announcements, and/or
public information sources. But the Defendants did not disclose these known risks through any
medium.
235. Had Defendants provided adequate warnings and instructions and properly disclosed
and disseminated the risks associated with their Ranitidine-Containing Drugs, Plaintiff could have
avoided the risk of developing injuries and could have obtained or used alternative medication.
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However, as a result of Defendants’ concealment of the dangers posed by their Ranitidine-Containing
Drugs, Plaintiff could not have averted their injuries.
236. Defendants’ conduct, as described above, was reckless. Defendants risked the lives of
consumers and users of their products, including Plaintiff, with knowledge of the safety problems
associated with Ranitidine-Containing Drugs, and suppressed this knowledge from the general public.
Defendants made conscious decisions not to redesign, warn or inform the unsuspecting public.
Defendants’ reckless conduct warrants an award of punitive damages.
237. The Defendants’ lack of adequate warnings and instructions accompanying their
Ranitidine-Containing Drugs were a substantial factor in causing Plaintiff’s injuries.
238. As a direct and proximate result of the Defendants’ failure to provide an adequate
warning of the risks of Ranitidine-Containing Drugs, Plaintiff has been injured, sustained severe and
permanent pain, suffering, disability, impairment, loss of enjoyment of life, economic loss and
damages including, but not limited to past and future medical expenses, lost income, and other
damages.
239. WHEREFORE, Plaintiff respectfully requests this Court to enter judgment in
Plaintiff’s favor for damages, together with interest, costs herein incurred, attorneys’ fees and all such
other and further relief as this Court deems just and proper.
COUNT IV: NEGLIGENT PRODUCT DESIGN
(Against Manufacturer Defendants)
240. Plaintiff incorporates by reference each allegation set forth in preceding paragraphs as
if fully stated herein.
241. The Defendants knew or, by the exercise of reasonable care, should have known,
ordinary consumers such as Plaintiff would not have realized the potential risks and dangers of
Ranitidine-Containing Drugs.
242. The Defendants owed a duty to all reasonably foreseeable users to design a safe
product.
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243. The Defendants breached their duty by failing to use reasonable care in the design of
Ranitidine-Containing Drugs because the drug exposed users to unsafe levels of the carcinogen
NDMA.
244. The Defendants breached their duty by failing to use reasonable care in the design of
Ranitidine-Containing Drugs by negligently designing the drug with an inherent susceptibility to
form NDMA.
245. The Defendants breached their duty by failing to use reasonable care in the design of
Ranitidine-Containing Drugs by negligently designing in design and formulation, in one or more of
the following ways:
a. When placed in the stream of commerce, Defendants’ Ranitidine-Containing
Drugs were defective in design and formulation, and, consequently, dangerous
to an extent beyond that which an ordinary consumer would contemplate;
b. When placed in the stream of commerce, Defendants’ Ranitidine-Containing
Drugs were unreasonably dangerous in that they were hazardous and posed a
grave risk of cancer and other serious illnesses when used in a reasonably
anticipated manner;
c. When placed in the stream of commerce, Defendants’ Ranitidine-Containing
Drugs contained unreasonably dangerous design defects and were not
reasonably safe when used in a reasonably anticipated or intended manner;
d. Defendants did not sufficiently test, investigate, or study their Ranitidine-
Containing Drugs and, specifically, the ability for Ranitidine-Containing Drugs
to transform into the carcinogenic compound NDMA within the human body;
e. Defendants did not sufficiently test, investigate, or study their Ranitidine-
Containing Drugs and, specifically, the ability for Ranitidine-Containing Drugs
to develop increasing levels of NDMA over time under anticipated and
expected storage and handling conditions;
f. Exposure to Ranitidine-Containing Drugs presents a risk of harmful side
effects that outweigh any potential utility stemming from the use of the drug;
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g. Defendants knew or should have known at the time of marketing Ranitidine-
Containing Drugs that exposure to Ranitidine-Containing Drugs could result in
cancer and other severe illnesses and injuries;
h. Defendants did not conduct adequate post-marketing surveillance of their
Ranitidine-Containing Drugs; and
i. Defendants could have employed safer alternative designs and formulations.
For example, the Defendants could have added ascorbic acid (Vitamin C) to
each dose of Ranitidine-Containing Drugs, which is known to scavenge nitrites
and reduce the ability of the body to recombine ranitidine into NDMA.
246. The Defendants breached their duty by failing to use reasonable care by failing to use
cost effective, reasonably feasible alternative designs. there was a practical, technically feasible, and
safer alternative design that would have prevented the harm without substantially impairing the
reasonably anticipated or intended function of Defendants’ Ranitidine-Containing Drugs.
247. A reasonable company under the same or similar circumstances would have designed
a safer product.
248. Plaintiff was harmed directly and proximately by the Defendants’ failure to use
reasonable care in the design of their Ranitidine-Containing Drugs. Such harm includes significant
exposure to a known carcinogen, NDMA, which can cause or contribute the development of cancers.
249. Defendants’ defective design of Ranitidine-Containing Drugs was willful, wanton,
malicious, and conducted with reckless disregard for the health and safety of users of the Ranitidine-
Containing Drugs, including Plaintiff.
250. The defects in Defendants’ Ranitidine-Containing Drugs were substantial factors in
causing Plaintiff’s injuries.
251. As a direct and proximate result of the Defendants’ defective design of the Ranitidine-
Containing Drugs, Plaintiff has been injured, sustained severe and permanent pain, suffering,
disability, impairment, loss of enjoyment of life, economic loss and damages including, but not
limited to past and future medical expenses, lost income, and other damages.
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252. WHEREFORE, Plaintiff respectfully requests this Court to enter judgment in
Plaintiff’s favor for damages, together with interest, costs herein incurred, attorneys’ fees and all such
other and further relief as this Court deems just and proper.
COUNT V: NEGLIGENT MANUFACTURING
(Against Manufacturer Defendants)
253. Plaintiff incorporates by reference each allegation set forth in preceding paragraphs as
if fully stated herein.
254. At all relevant times, the Defendants manufactured, tested, marketed, sold, handled,
distributed and stored the Ranitidine-Containing Drugs that Plaintiff consumed.
255. The Defendants had a duty to exercise reasonable care, in the manufacturing, testing,
marketing, sale, handling, storing, packaging, and distribution of Ranitidine-Containing Drugs.
256. The Defendants knew or, by the exercise of reasonable care, should have known, use
of Ranitidine-Containing Drugs were carelessly manufactured, packaged was dangerous, harmful and
injurious when used by Plaintiff in a reasonably foreseeable manner.
257. The Defendants knew or, by the exercise of reasonable care, should have known,
ordinary consumers such as Plaintiff would not have realized the potential risks and dangers of
Ranitidine-Containing Drugs improperly manufactured, tested, marketed, sold, handled, distributed,
and stored.
258. Without limitation, examples of the manner in which Defendants breached their duty
to exercise reasonable care in manufacturing Ranitidine-Containing Drugs, included:
a. Failure to follow Good Manufacturing Practices;
b. Failure to adequately inspect/test the drugs during the manufacturing process;
c. Failure to implement procedures that would reduce or eliminate NDMA levels
in Ranitidine-Containing Drugs; and
d. Failure to implement appropriate handling instructions and storage conditions
for the drug.
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259. A reasonable manufacturer under the same or similar circumstances would have
implemented appropriate manufacturing procedures to better ensure the quality and safety of their
product.
260. Plaintiff was harmed directly and proximately by the Defendants’ failure to use
reasonable care in the manufacture of their Ranitidine-Containing Drugs. Such harm includes
significant exposure to a known carcinogen, NDMA, which can cause or contribute the development
of cancers.
261. Defendants’ improper manufacturing of Ranitidine-Containing Drugs was willful,
wanton, malicious, and conducted with reckless disregard for the health and safety of users of the
Ranitidine-Containing Drugs, including Plaintiff.
262. The defects in Defendants’ Ranitidine-Containing Drugs were substantial factors in
causing Plaintiff’s injuries.
263. As a direct and proximate result of the Defendants’ improper manufacturing of
Ranitidine-Containing Drugs, Plaintiff has been injured, sustained severe and permanent pain,
suffering, disability, impairment, loss of enjoyment of life, economic loss and damages including, but
not limited to past and future medical expenses, lost income, and other damages.
264. WHEREFORE, Plaintiff respectfully requests this Court to enter judgment in
Plaintiff’s favor for damages, together with interest, costs herein incurred, attorneys’ fees and all such
other and further relief as this Court deems just and proper.
COUNT VI: NEGLIGENT MISREPRESENTATION
(Against Manufacturer Defendants)
265. Plaintiff incorporates by reference each allegation set forth in preceding paragraphs as
if fully stated herein.
266. At all relevant times, Defendants designed, manufactured, tested (or not), packaged,
labeled, marketed, advertised, promoted, supplied, stored, handled, warehoused, distributed, sold
and/or otherwise placed Ranitidine Containing Drugs into the stream of commerce, and therefore
owed a duty of reasonable care to avoid causing harm to those that consumed Ranitidine-Containing
Drugs, such as Plaintiff.
Case 9:20-md-02924-RLR Document 2569-2 Entered on FLSD Docket 01/15/2021 Page 57 of61
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267. Defendants were negligent, reckless, and careless and owed a duty to Plaintiff to make
accurate and truthful representations regarding Ranitidine Containing Drugs, Defendants breached
their duty, thereby causing Plaintiff to suffer harm.
268. Defendants represented to Plaintiff via the media, advertising, website, social media,
packaging, and promotions, among other misrepresentations described herein that:
269. Ranitidine-Containing Drugs were both safe and effective for the lifetime of the
product, when in fact, the drug contains unsafe levels of NDMA far in excess of the 96 ng limit that
increases as the product ages;
270. Consumption of Ranitidine-Containing Drugs would not result in excessive amounts
of NDMA being formed in their bodies; and
271. The levels of NDMA in Ranitidine-Containing Drugs have no practical clinical
significance; and
272. Ranitidine-Containing Drugs were safe for their intended use when, in fact,
Defendants knew or should have known the products were not safe for their intended purpose.
273. These representations were false. Because of the unsafe levels of NDMA in
Ranitidine-Containing Drugs, the drug presented an unacceptable risk of causing cancer. Ranitidine-
Containing Drugs are so unsafe that the FDA was compelled to order the immediate ban of all
Ranitidine-Containing Drugs on April 1, 2020.
274. Defendants knew or should have known these representations were false and
negligently made them without regard for their truth.
275. Defendants had a duty to accurately provide this information to Plaintiff. In concealing
this information from Plaintiff, Defendants breached their duty. Defendants also gained financially
from, and as a result of their breach.
276. Defendants intended for Plaintiff to rely on these representations.
277. Each of these misrepresentations were material at the time they were made. In
particular, each of the misrepresentations concerned material facts that were essential to the analysis
undertaken by Plaintiff as to whether to purchase or consume Ranitidine Containing Drugs.
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58 COMPLAINT
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278. Defendants have yet to correct these misrepresentations about Ranitidine-Containing
Drugs.
279. Plaintiff reasonably relied on these representations and were harmed as described
herein. Plaintiff’s reliance on Defendants’ representation was a substantial factor in causing
Plaintiff’s harms. Had Defendants told Plaintiff the truth about the safety and composition of
Ranitidine-Containing Drugs, Plaintiff would not have consumed or purchased them.
280. Defendants’ acts and omissions as described herein were committed in reckless
disregard of Plaintiff’s rights, interests, and well-being to enrich Defendants.
281. Plaintiff was injured as a direct and proximate result of Defendants’ negligent
misrepresentations regarding Ranitidine-Containing Drugs as described herein.
282. WHEREFORE, Plaintiff respectfully requests this Court to enter judgment in
Plaintiff’s favor for damages, together with interest, costs herein incurred, attorneys’ fees and all such
other and further relief as this Court deems just and proper.
COUNT VII: NEGLIGENCE
(Against Retailer Defendant)
283. Plaintiff incorporates by reference every allegation set forth in preceding paragraphs
as if fully stated herein.
284. At all times relevant to this Complaint, Defendants had a duty to ensure that the
Ranitidine-Containing Drugs supplied to Plaintiff were stored, handled, and dispensed in a safe
manner.
285. In particular, Defendants had a duty to ensure that the Ranitidine-Containing Drugs
prescribed to Plaintiff were safely stored on Defendants’ premises by conducting diligent
surveillance, monitoring and inspection of storage practices.
286. As described throughout this Complaint, storage of Ranitidine-Containing Drugs can
lead to the formation of dangerous levels of NDMA within the drugs. Extensive data exists to
demonstrate that exposure to heat in storage conditions leads to the systematic breakdown of the
ranitidine molecule into NDMA, accumulating over time in the finished product. Considering
Ranitidine-Containing drugs have an approved shelf life of 36 months, the possibility of the drug
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accumulating dangerously high levels of NDMA prior to consumption is very real—a point
underscored by the FDA’s swift removal of the product from the market.
287. Defendants breached their duty to Plaintiff by failing to properly store the Ranitidine-
Containing Drugs supplied to Plaintiff, leading to dangerous levels of NDMA accumulating in the
drugs that harmed Plaintiff. Defendants acted below the standard of care by storing and dispensing
Ranitidine-Containing Drugs to Plaintiff without first undertaking efforts to ensure that the drugs
were safe for human use by, for example, consulting the available medical literature evidencing the
potential human health dangers associated with the storage of Ranitidine-Containing Drugs and the
formation of NDMA within Ranitidine-Containing drugs when the drugs are stored at particular
temperatures.
288. Defendants knew or should have known that storage of Ranitidine-Containing Drugs
can lead to the formation of dangerous levels of carcinogenic NDMA in the drugs.
289. Defendants failed to adhere to and/or follow its established practices and procedures in
storing the Ranitidine-Containing Drugs supplied to Plaintiff.
290. As a direct and proximate result of Defendants’ improper storage practices of the
Ranitidine-Containing Drugs, Plaintiff was exposed to dangerous levels of NDMA which caused
Plaintiff’s cancer.
291. As a direct and proximate result of Defendants’ storage, handling and dispensing of
Ranitidine-Containing Drugs, Plaintiff has been injured, sustained severe and permanent pain,
suffering, disability, impairment, loss of enjoyment of life, economic loss and damages including, but
not limited to past and future medical expenses, and other damages.
JURY TRIAL DEMAND
292. Plaintiff demands a trial by jury on all the triable issues within this pleading.
PRAYER FOR RELIEF
293. WHEREFORE, Plaintiff requests the Court to enter judgment in Plaintiff’s favor and
against the Defendants for:
a. actual or compensatory damages in such amount to be determined at trial and as
provided by applicable law;
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b. exemplary and punitive damages sufficient to punish and deter the Defendants and
others from future wrongful practices;
c. pre-judgment and post-judgment interest;
d. costs including reasonable attorneys’ fees, court costs, and other litigation expenses;
and
e. any other relief the Court may deem just and proper.
Dated: May 11, 2020
Jennifer A. Moore, Esq. (State Bar No. 206779) [email protected] MOORE LAW GROUP, PLLC 1473 South 4th Street Louisville, KY 40208 Tel: (502) 717-4080 Fax: (502) 717-4086
Counsel for Plaintiff
Case 9:20-md-02924-RLR Document 2569-2 Entered on FLSD Docket 01/15/2021 Page 61 of61
EXHIBIT 2
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NOTICE OF REMOVAL
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UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF CALIFORNIA
DEFENDANTS’ GLAXOSMITHKLINE, LLC; BOEHRINGER INGELHEIM
PHARMACEUTICALS, INC.; BOEHRINGER INGELHEIM USA CORPORATION; PFIZER, INC.; SANOFI US SERVICES INC; AND SANOFI-AVENTIS U.S. LLC
NOTICE OF REMOVAL
Pursuant to 28 U.S.C. §§ 1332, 1441, and 1446, Defendants GlaxoSmithKline, LLC;
Boehringer Ingelheim Pharmaceuticals, Inc.; Boehringer Ingelheim USA Corporation; Pfizer, Inc.;
Sanofi US Services Inc.; Sanofi-Aventis U.S. LLC; (collectively, “Removing Defendants”) hereby
give notice of removal of this action, Ralph Dudley v. GlaxoSmithKline, LLC et al., Case No.
RG20061652 from the Superior Court of the State of California in and for Alameda County to the
United States District Court for the Northern District of California.
Andrew T. Bayman (pro hac vice forthcoming) Matthew J. Blaschke (SBN 281938) KING & SPALDING LLP 101 Second Street, Suite 2300 San Francisco, CA 94105 Tel: (415) 318-1212 Fax: (415) 318-1300 [email protected] [email protected] Attorneys for Defendant Boehringer Ingelheim Pharmaceuticals, Inc. and Boehringer Ingelheim USA Corporation [Additional Counsel on Signature Page]
Ralph Dudley
Plaintiff,
v.
GlaxoSmithKline, LLC; Boehringer Ingelheim Pharmaceuticals, Inc.; Boehringer Ingelheim USA Corporation; Pfizer, Inc.; Sanofi US Services Inc.; Sanofi-Aventis U.S. LLC; The Vons Companies, Inc.; and DOES 1 through 100, inclusive,
Defendants.
Case No. 3:20-cv-3913 NOTICE OF REMOVAL OF ACTION DEMAND FOR JURY TRIAL
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INTRODUCTION
1. This action is one of hundreds of related lawsuits filed against manufacturers and
sellers of Zantac (ranitidine), an antacid medication, alleging that the medication causes various
cancers. On February 6, 2020, the Judicial Panel on Multidistrict Litigation (“JPML”) created a
Multidistrict Litigation (“MDL”) in the Southern District of Florida before Judge Robin Rosenberg
for pretrial coordination of cases like this one “in which plaintiffs allege that they developed cancer
as a result of NDMA formed from Zantac.” In re Zantac (Ranitidine) Prods. Liab. Litig., 2020 WL
582134, at *2 (J.P.M.L. 2020). To date, over 300 actions have been transferred to the Zantac MDL.
2. On May 11, 2020, Plaintiff filed this Complaint in the Superior Court of the State of
California in and for Alameda County against the Removing Defendants, which had manufactured
or sold Zantac over various time periods. The thrust of this Complaint—like those already pending
in the MDL—is that Plaintiff ingested over-the-counter (“OTC”) “Ranitidine-Containing Drugs,”
and as a result, developed cancer, in this case prostate cancer. Compl. ¶¶ 10-11. The Removing
Defendants are not citizens of California for diversity purposes. See id. ¶¶ 25, 26, 29, 32-33, 35. A
copy of the Complaint is attached as Exhibit A.
3. Unlike the cases in the MDL—including cases filed by these same plaintiffs’
lawyers—this Complaint also names a California-based retailer as a Defendant in an effort to
destroy diversity jurisdiction. Specifically, the Complaint includes The Vons Companies, Inc. (the
“Retailer Defendant”) as a named defendant. Id. ¶ 38. The Retailer Defendant is alleged to be a
citizen of California for diversity purposes. Id. ¶ 38.
4. As further explained below, the Retailer Defendant is fraudulently joined in this action
because—on its face—Plaintiff’s complaint fails to allege any viable cause of action against it, and
therefore its citizenship must be ignored for purposes of diversity jurisdiction.
5. First, Plaintiff cannot state any viable strict products liability claim against the
Retailer Defendant because those claims are preempted by federal law. The Retailer Defendant
lacks the legal authority under U.S. Food and Drug Administration (“FDA”) regulations to
unilaterally alter Zantac’s government-approved labeling or to manufacture the product differently.
See, e.g., Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011) (“If the Manufacturers had independently
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changed their labels to satisfy their state-law duty [to attach a safer label], they would have violated
federal law.”); In re Fosamax (Alendronate Sodium) Prods. Liab. Litig. (No. II), MDL No. 2243,
2012 WL 181411, at *3 (D.N.J. Jan. 17, 2012) (“As a distributor of Fosamax, Watson has no power
to change Fosamax labeling. That power lies with the applicant who filed the New Drug Application
. . . seeking approval to market Fosamax.”).
6. Second, Plaintiff does not state a viable negligence claim against the Retailer
Defendant. The basis for Plaintiff’s claim is that the Retailer Defendant allegedly failed to ascertain
that the products at issue can degrade under certain conditions to form a compound called N-
nitrosodiethylamine (“NDMA”) and failed to properly store Zantac to avoid such degradation.
Compl. ¶¶ 285, 287. It is black-letter law that retailers do not have a duty to inspect or test products
in common use for defects unknown to them. See Sears, Roebuck & Co. v. Marhenke, 121 F.2d
598, 600 (9th Cir. 1941) (applying California law) (a retailer “who purchases and sells an article in
common and general use, in the usual course of trade, without knowledge of its dangerous qualities
is not under duty to exercise ordinary care to discover whether it is dangerous or not”); Valentine v.
Baxter Healthcare Corp., 68 Cal. App. 4th 1467, 1485–86 (1999) (“[I]mposition of liability for
breach of an independent duty to conduct long-term testing, where the causal link to the known
harm to plaintiff is the unknown outcome of testing that was not done, would be beyond the pale
of any California tort doctrine we can identify.”) (emphasis in original). Otherwise, every retailer
in California would have the responsibility to conduct a battery of scientific testing on all
pharmaceuticals stocked on its shelves, despite their FDA approval, in order to independently
ascertain their safety. That is not the law.
7. Because the Retailer Defendant is fraudulently joined, federal jurisdiction over this
action is proper based on complete diversity between Plaintiff and all properly joined defendants.
JURISDICTION
8. The Removing Defendants remove this action on the basis of diversity jurisdiction
pursuant to 28 U.S.C. §§ 1332, 1441, and 1446 and the doctrine of fraudulent joinder.
9. This Court has subject matter jurisdiction under 28 U.S.C. § 1332(a) because:
(1) there is complete diversity between Plaintiff and the properly joined Defendants; (2) the amount
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in controversy exceeds $75,000, exclusive of interest and costs; and (3) all other requirements for
removal have been satisfied.
BASIS FOR REMOVAL
I. There Is Complete Diversity Between Plaintiff and the Properly Joined Parties.
10. Plaintiff is a citizen of California. Id. ¶ 9.
11. The properly joined defendants are all citizens of states other than California. See id.
¶¶ 25, 26, 29, 32-33, 35.1
12. Defendant Boehringer Ingelheim Pharmaceuticals, Inc. is a corporation organized
under the laws of Delaware with its principal place of business in Ridgefield, Connecticut. Id. ¶ 25.
Boehringer Ingelheim Pharmaceuticals, Inc. is, therefore, a citizen of Delaware and Connecticut.
13. Defendant Boehringer Ingelheim USA Corporation is a corporation organized under
the laws of Delaware with its principal place of business in Ridgefield, Connecticut. Id. ¶ 26.
Boehringer Ingelheim USA Corporation is, therefore, a citizen of Delaware and Connecticut.
14. Defendant GlaxoSmithKline LLC is a limited liability company organized under the
laws of Delaware with its principal place of business in Wilmington, Delaware. Its sole member is
GlaxoSmithKline Holdings (America) Inc., a corporation organized under the laws of Delaware
with its principal place of business in Wilmington, Delaware. See Attachment to Corp. Disclosure
Statement, In re Zantac (Ranitidine) Prods. Liab. Litig., MDL No. 2924, Dkt. 43-1.
GlaxoSmithKline LLC is, therefore, a citizen of Delaware.
15. Defendant Pfizer Inc. is a corporation organized and existing under the laws of the
State of Delaware, with its principal place of business in New York, New York. Id. ¶ 32. Pfizer
Inc. is, therefore, a citizen of Delaware and New York.
16. Defendant Sanofi US Services Inc. is a corporation organized under the laws of
Delaware with its principal place of business in Bridgewater, New Jersey. Id. ¶ 33. Sanofi US
Services Inc. is, therefore, a citizen of Delaware and New Jersey.
1 Plaintiff dismissed Defendants Boehringer Ingelheim Corporation, GlaxoSmithKline, plc, and Sanofi S.A., and thus this Court need not consider their citizenship for purposes of removal. Exhibit A, at 001. In any event, Boehringer Ingelheim Corporation, GlaxoSmithKline, plc, and Sanofi S.A. are foreign entities and are not citizens of California. See Compl. ¶¶ 27, 30, 34.
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17. Defendant Sanofi-Aventis U.S. LLC is a limited liability company organized under
the laws of Delaware with its principal place of business in Bridgewater, New Jersey. Id. ¶ 35. The
sole member of Sanofi-Aventis U.S. LLC is Sanofi US Services Inc., a Delaware corporation with
its principal place of business in New Jersey. Defendant Sanofi-Aventis U.S. LLC is, is therefore,
a citizen of Delaware and New Jersey.
18. Defendants Does 1 through 100 are sued under “fictitious names.” Id. ¶ 39-45.
Therefore, their citizenship must be ignored for purposes of determining the propriety of removal.
See 28 U.S.C. § 1441(b)(1) (“In determining whether a civil action is removable on the basis of the
jurisdiction under section 1332(a) of this title, the citizenship of defendants sued under fictitious
names shall be disregarded.”).
19. Because Plaintiff is a citizen of California and the properly joined defendants are
citizens of states other than California, complete diversity exists between Plaintiff and the properly
joined defendants. See 28 U.S.C. §§ 1332, 1441.
II. The Retailer Defendant Is Fraudulently Joined
20. The Retailer Defendant is fraudulently joined, and its California citizenship should
therefore be disregarded for purposes of removal.
21. A defendant is fraudulently joined and its presence in the lawsuit is ignored for
purposes of determining diversity where there is no “possibility that a state court would find that
the complaint states a cause of action” against it. Grancare, LLC v. Thrower by & through Mills,
889 F.3d 543, 549 (9th Cir. 2018). See also Morris v. Princess Cruises, Inc., 236 F.3d 1061, 1067
(9th Cir. 2001) (a defendant is fraudulently joined “if the plaintiff fails to state a cause of action
against the resident defendant, and the failure is obvious according to the settled rules of the state”)
(citing McCabe v. Gen. Foods Corp., 811 F.2d 1336, 1339 (9th Cir. 1987)); Ritchey v. Upjohn Drug
Co., 139 F.3d 1313, 1318 (9th Cir. 1998) (same).
22. Here, the Retailer Defendant is fraudulently joined because: (1) retailers cannot
unilaterally change an FDA-approved label or alter the highly regulated manufacturing processes as
mere sellers of Ranitidine-Containing Drugs, and the claims against them are accordingly
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preempted; and (2) Plaintiff does not plead a cognizable negligence action against the Retailer
Defendant.
A. Plaintiff’s Strict Liability Claims Against the Retailer Defendant Are Preempted.
23. Plaintiff’s claims for strict products liability, under failure-to-warn and
manufacturing-defect theories, against the Retailer Defendant is preempted by federal law. As a
result, there is no “possibility that a state court would find that the complaint states a cause of action”
against the retailer. Grancare, LLC v. Thrower by & through Mills, 889 F.3d 543, 549 (9th Cir.
2018).
24. In Pliva, Inc. v. Mensing, 564 U.S. 604 (2011), the Supreme Court held that claims
involving an FDA-approved product are preempted under federal law when a defendant cannot
unilaterally satisfy state-law duties without FDA’s prior approval. Id. at 623–24 (“[W]hen a party
cannot satisfy its state duties without the Federal Government’s special permission and assistance,
which in turn is dependent on the exercise of judgment by a federal agency, that party cannot
independently satisfy those state duties for pre-emption purposes.” Id. at 623–24 (emphasis added);
see also Mutual Pharm. Co. v. Bartlett, 570 U.S. 472, 475 (2013). In Mensing, the Supreme Court
announced this preemption principle in the context of product liability actions against manufacturers
of generic drugs. Mensing, 564 U.S. at 610. The manufacturers argued that, under federal drug
regulations, they are “prevented . . . from independently changing their generic drugs’ safety labels.”
Id. at 617. Consequently, they asserted, holding them liable under state law for failure to
“adequately and safely label their products,” would directly conflict with labeling requirements
under federal law. Id. The Supreme Court agreed: Because generic manufacturers are unable to
comply with both state and federal law, state failure-to-warn claims against generic drug
manufacturers must be preempted. Id. at 618–620, 614 (“If the Manufacturers had independently
changed their labels to satisfy their state-law duty [to attach a safer label], they would have violated
federal law.”).
25. The same preemption analysis that the Supreme Court articulated in Mensing bars
claims against pharmaceutical distributors or retailers that stand even further removed than generic
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manufacturers from the ability to change drug labeling that the FDA has approved. Only the party
that submits the New Drug Application (the “NDA”) to obtain FDA approval to market a drug can
seek to change the drug’s labeling after initial approval. 21 C.F.R. § 314.71(a); id. § 314.70(a)(4)
(“The applicant must promptly revise all promotional labeling and advertising to make it consistent
with any labeling change implemented . . . .”). Here, the Retailer Defendant is not, and never was,
the holder of the Zantac NDA. Rather, it is named solely in its capacity as a retailer that sold FDA-
approved products manufactured by other parties. Therefore, the Retailer Defendant, had no
authority to unilaterally change the product’s labeling.
26. In fact, had the Retailer Defendant provided warnings about risks not included in
Zantac’s approved product labeling, it would have been breaking federal law, and would be subject
to potential civil and/or criminal penalties for “misbranding.” 21 U.S.C. §§ 333, 334. FDA
regulations on misbranding prohibit any person, including a pharmaceutical distributor, from
issuing any warning that is not consistent with the drug’s FDA-approved labeling. 21 C.F.R.
§ 201.100(d)(1). Under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq. (the
“FDCA”), when FDA approves a drug for marketing, it also approves the drug’s labeling, including
information about the drug’s potential risks and benefits. 21 U.S.C. § 355(d).
27. The FDCA and its implementing regulations provide that a drug is misbranded if its
labeling is “false and misleading in any particular.” 21 U.S.C. § 352(a); id. § 321(n); id. § 331(a),
(b), (k); 21 C.F.R § 201.6(a). A statement about a drug’s risks would be considered “false and
misleading” if FDA has not found it to be properly substantiated. 40 Fed. Reg. 28,584 (1975) (“In
short, a drug is misbranded if its labeling makes claims that have not been properly substantiated.”).
By definition, an unapproved warning by a distributor or retailer that is inconsistent with the
approved drug labeling would not have been found to be substantiated by FDA and, thus, would
constitute misbranding.2
2 Plaintiff’s allegation that the alleged failure to warn was not limited to the Ranitidine-Containing Drugs’ labeling does not save this claim. Compl. ¶ 205. The term “labeling” under FDA regulations is broad and includes “all labels and other written, printed, or graphic matter.” 21 U.S.C. § 321(m); see also 21 C.F.R. § 1.3 (same). Thus, all materials disseminated by pharmaceutical distributors about a drug’s risks and benefits, including promotional and other materials, must be “consistent with and not contrary to . . . the approved or permitted labeling.” 21 C.F.R. § 201.100(d)(1); 73
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28. Applying this Supreme Court precedent, numerous federal courts have accordingly
held that failure-to-warn claims asserted against pharmaceutical distributors are preempted because
the distributors cannot change approved product labeling. See, e.g., In re Fosamax (Alendronate
Sodium) Prods. Liab. Litig. (No. II), MDL No. 2243, 2012 WL 181411, at *3 (D.N.J. Jan. 17, 2012)
(“As a distributor of Fosamax, Watson has no power to change Fosamax labeling. That power lies
with the applicant who filed the New Drug Application . . . seeking approval to market Fosamax.”);
Pierik v. GE Healthcare Inc., No. 1:18-cv-07733, 2019 WL 4686551, at *1 (N.D. Ill. June 18, 2019)
(“As McKesson is alleged to be a distributor rather than a manufacturer of Omniscan and
MultiHance, I cannot draw a reasonable inference that McKesson had the ability to modify the
warning labels of those drugs. Plaintiffs’ claims against McKesson are preempted . . . .”); Smith v.
GE Healthcare, Inc., No. 3:19-cv-00492, 2019 WL 4565246 (W.D. La. Sept. 4, 2019) (finding
failure-to-warn claims preempted because “McKesson has no authority to unilaterally change or
add to the Omniscan labeling” as a pharmaceutical distributor); Brazil v. Janssen Research & Dev.
LLC, 196 F. Supp. 3d 1351, 1364–65 (N.D. Ga. 2016) (“A distributor, even of a brand name drug,
has no power to change . . . labeling. That power lies with the applicant who filed the New Drug
Application.”) (citations and quotation marks omitted); In re Yasmin & Yaz Prods. Liab. Litig.,
MDL No. 2100, 2014 WL 1632149, at *6 (S.D. Ill. Apr. 24, 2014) (“Under applicable federal
regulations, generic distributors have no more authority than generic manufacturers to alter a drug’s
composition, label, or design. Accordingly, the principles announced in Mensing . . . are equally
applicable to generic distributors.”). Supreme Court precedent mandates the same result here.
29. Plaintiff’s manufacturing-defect claim against the Retailer Defendant is preempted
for the same reason as Plaintiff’s failure-to-warn claim: under federal law, the Retailer Defendant
could not have altered the manufacturing of Zantac. If the Retailer Defendant manufactured Zantac
in a different manner, it would be liable under the FDCA for the introduction into interstate
commerce of an unapproved and misbranded new drug. See 21 U.S.C. § 331(a) and (d).
Fed. Reg. 2848, 2850 n.3 (2008) (“Federal law governs not only what information must appear in labeling, but also what information may not appear.”).
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30. FDA highly regulates the manufacturing of drugs and associated processes. See
FDCA § 505; 21 U.S.C. § 355. As a result, the NDA holder must describe and disclose to FDA all
manufacturers of its products. See 21 U.S.C. § 355(b)(1)(D) (NDA must contain “a full description
of the methods used in, and the facilities and controls used for, the manufacture, processing, and
packing of such drug.”); 21 C.F.R. § 314.50(d)(i) (NDA must contain “a detailed technical
chemistry, manufacturing, and controls section,” detailing, among other things “the name and
address of the drug substance’s manufacturer” as well as “the name and address of each
manufacturer of the drug product; [and] a description of the manufacturing and packaging
procedures and in-process controls for the drug product.”). To add or change a manufacturer, the
NDA holder must accordingly submit a supplement to its NDA. See 21 C.F.R. § 314.70(a). Just as
only the NDA holder can change drug labeling, only the NDA holder has authority to submit a
supplement to its NDA to add or change a manufacturer. See 21 C.F.R. § 314.71(a) (“Only the
applicant may submit a supplement to an application.”). Manufacturing a drug out of compliance
with an approved NDA causes the product to be an unapproved new drug in violation of the FDCA.
21 U.S.C. § 331(d) (“The following acts are prohibited: . . . The introduction or delivery for
introduction into interstate commerce of any article in violation of section . . . 505 (21 U.S.C. §
355)”).
31. The Retailer Defendant was not identified in the Zantac NDA as an authorized
manufacturer of Zantac or listed and registered with FDA to manufacture Zantac. Nor did the
Retailer Defendant have the authority to designate itself as a manufacturer pursuant to an approved
NDA because none is an NDA holder. Had the Retailer Defendant nevertheless manufactured and
sold Zantac in a different manner to avoid alleged state-law liability, that would have violated the
FDCA by introducing an unapproved new drug into interstate commerce. See 21 U.S.C. § 331(d)
(“The following acts are prohibited: . . . The introduction or delivery for introduction into interstate
commerce of any article in violation of section . . . 505”). In addition, manufacturing Zantac without
appropriately registering and listing with FDA would cause the resulting product to be misbranded.
21 U.S.C. § 352(o) (A drug or device shall be deemed misbranded “[i]f it was manufactured,
prepared, propagated, compounded, or processed in an establishment not duly registered”). Both
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actions would subject retailers to civil and/or criminal penalties. See 21 U.S.C. § 333(a); 21 U.S.C.
§ 303(a)(1) (“Any person who violates a provision section 301 shall be imprisoned for not more
than one year or fined not more than $1,000, or both.”). Thus, under the settled preemption
principles articulated in Mensing, there is no “possibility that a state court would find that the
complaint states a cause of action” against the Retailer Defendant. Grancare, LLC, 889 F.3d at 549
(internal quotation marks omitted).
32. Some district courts have remanded cases where removals were based on preemption
of similar claims against distributors, though acknowledging the logic of the argument.3 These
cases are not binding, and the Court need not follow them. Indeed, this very issue is currently
pending before the United States Court of Appeals for the Ninth Circuit. See Geisse v. Bayer
HealthCare Pharm. Inc., No. 17-CV-07026-JD, 2019 WL 1239854, at *2–*3 (N.D. Cal. Mar. 18,
2019), appeal docketed, No. 19-15783 (9th Cir. Apr. 17, 2019).
33. Nor is the reasoning of those cases persuasive. Most invoked Hunter v. Philip Morris
USA, 582 F.3d 1039, 1044 (9th Cir. 2009), for the proposition that it is inappropriate to examine the
affirmative defense of preemption in the context of a motion to remand. But Hunter involved a
common defense that would “effectively decide[] the entire case” by barring claims against all
defendants. Id. at 1045 (internal quotation marks omitted). Not so here. Although the Removing
Defendants have a variety of dispositive defenses (including some based on different federal
preemption arguments), the claims against the Retailer Defendant is barred here for a different
3 See Geisse v. Bayer HealthCare Pharm. Inc., No. 17-CV-07026-JD, 2019 WL 1239854, at *3 (N.D. Cal. Mar. 18, 2019), appeal docketed, No. 19-15783 (9th Cir. Apr. 17, 2019) (“[P]reemption goes to the merits of the plaintiff’s case and entails a degree of analysis that does not render a state law claim obviously barred or frivolous for fraudulent joinder purposes.”); Dodich v. Pfizer Inc., No. C 18-02764 WHA, 2018 WL 3584484, at *3 (N.D. Cal. July 26, 2018) (“Although logical, neither Mensing nor Bartlett specifically dealt with distributors and defendants do not identify binding authority extending the decisions. As such, it is not manifest that plaintiff has no possible claim against McKesson under California law.”); Hatherley v. Pfizer, Inc., No. CIV 2:13-00719 WBS, 2013 WL 3354458, at *6 (E.D. Cal. July 3, 2013) (“Thus, while the argument that distributors of brand name drugs are the same as generic manufacturers may be persuasive, unless and until this rational is extended, it is not obvious that plaintiffs have no claim against McKesson under California law because of a preemption defense.”) (emphasis in original) (citations and quotation marks omitted); In re Abilify (aripiprazole) Prods. Liab. Litig., 3:16-MD-2734, 2018 WL 6258903, at *5 (N.D. Fla. Nov. 8, 2018) (noting the “conceptual, and frankly, practical appeal” of the argument).
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reason that does not apply to the Removing Defendants: the Retailer Defendant never had labeling
or manufacturing responsibility for the product, making it impossible for them to unilaterally change
the label or manufacturing of the product. Cf. id. at 1044.
34. In addition, no searching inquiry into the merits of the case is required to find that the
claims against the Retailer Defendant are preempted. Hunter, 582 F.3d at 1044 (explaining that
only a “summary inquiry [was] appropriate” to determine whether an in-state defendant was
fraudulently joined) (citations and quotation marks omitted). Here, preemption is a legal defense
that applies because of the simple and undisputed fact that the Retailer Defendant never held
regulatory authority to alter the labeling or manufacture of the product. The Court need not review
or determine any facts concerning the Retailer Defendant’s conduct or the scientific issues involved
in the litigation to assess preemption.
35. Indeed, Defendants have already successfully urged this basis for removal in the
Zantac litigation. An action was filed in Florida state court against some of the instant defendants
and a non-diverse retailer, Publix. As here, the plaintiff brought claims against all defendants for
strict products liability, and the defendants removed the case to federal court on the basis of
fraudulent joinder. Following removal, the plaintiff did not oppose defendants’ removal and,
instead, voluntarily dismissed Publix from the case. That case is now coordinated in the MDL. See
Notice of Removal, Galimidi v. Sanofi US Servs. Inc., No. 1:10-cv-24395-BB, ECF 1 (S.D. Fla.
Oct. 23, 2019); see also Notice of Voluntary Dismissal Without Prejudice as to Publix Super
Markets, Inc., In re: Zantac (Ranitidine) Prods. Liab. Litig., No. 9:20-md-2924, ECF 259 (S.D. Fla.
Mar. 6, 2020).
B. Plaintiff Fails to Plead a Cognizable Negligence Claim against the Retailer Defendant under California Law.
36. There is no possibility that Plaintiff could prevail on his negligence claim against the
Retailer Defendant under California law because a seller of a product does not have a duty to
investigate or test products stocked on its shelves for unforeseen risks.
37. The Complaint asserts that in January 2020, an FDA-certified pharmaceutical testing
laboratory called Emery Pharma conducted tests revealing that NDMA accumulates in Ranitidine-
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Containing Drugs exposed to elevated temperatures. See Compl. ¶ 147. It further alleges that
subsequent FDA testing revealed that NDMA levels could increase even under normal storage
conditions. Compl. ¶ 148.
38. The thrust of the Complaint is that the Retailer Defendant was negligent for not itself
earlier investigating and testing Ranitidine-Containing Drugs to uncover these alleged facts, and
accordingly for storing the product in conditions that allegedly led to NDMA formation. See, e.g.,
Compl. ¶ 287 (“Defendants acted below the standard of care by storing and dispensing Ranitidine-
Containing Drugs to Plaintiff without first undertaking efforts to ensure that the drugs were safe for
human use by, for example, consulting the available medical literature evidencing the potential
human health dangers associated with the storage of Ranitidine-Containing Drugs and the formation
of NDMA within Ranitidine-Containing Drugs when the drugs are stored at particular
temperatures.”).
39. Plaintiff’s claim that the Retailer Defendant should have determined that Ranitidine-
Containing Drugs degrade and form NDMA when stored at particular temperatures or lengths of
time seeks to impose a duty to investigate and test that California law does not recognize. California
law is clear that “a dealer who purchases and sells an article in common and general use, in the usual
course of trade, without knowledge of its dangerous qualities is not under duty to exercise ordinary
care to discover whether it is dangerous or not.” See Sears, Roebuck & Co. v. Marhenke, 121 F.2d
598, 600 (9th Cir. 1941) (applying California law) (emphasis added and citations omitted); see also
Tourte v. Horton Mfg. Co., 108 Cal. App. 22, 24 (1930) (affirming the holding of the Superior Court
of Alameda County that the seller of a washing machine had no duty to examine the product where
there was a latent defect unknown to the seller). Cf. Burgess v. Montgomery Ward & Co., 264 F.2d
495, 497 (10th Cir. 1959) (holding that it would be “completely unreasonable to expect the
shopkeeper to perform the inspection or test which would have revealed to an expert the defect in
the ladder rail”); Ziglar v. E. I. Du Pont De Nemours & Co., 152, 280 S.E.2d 510, 514 (N.C. App.
1981) (holding that retailer of inherently dangerous toxic substance was under no duty to detect or
remedy hidden defect); Odum v. Gulf Tire & Supply Co., 196 F. Supp. 35, 36 (N.D. Fla. 1961)
(holding that “a retailer or wholesaler is not under a duty to inspect manufactured articles of a
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complex nature for defects which are latent”); Meyer v. Rich’s Inc., 12 S.E.2d 123, 123 (Ga. App.
1940) (a seller of men’s suits had no duty to analyze the suit chemically and was therefore not liable
for buyer’s injuries caused by poisonous dye and chemicals in suit).4
40. In Sears, for example, after suffering burns from hot water leaking from a rubber hot
water bag, plaintiff sued the retailer from whom he purchased the product. 121 F.2d at 599. An
expert testified that the defect in the bag was in the faulty method of construction of the stopper and
the socket so that there was a slight leakage of water around the stopper. Id. The Ninth Circuit
explained that the question of whether or not the retailer “should have known of such defects
depends upon whether or not the vendor who sells goods manufactured by another is obligated to
inspect the goods to determine whether or not they are defective.” Id. at 600. It squarely held that
the retailer had no such duty. See id. Thus, the retailer was under no obligation to inspect the
product whether the defects “could only be discovered by such investigations as were made by the
experts, or could have been ascertained by the simple test of filling the bag with water and inverting
it after the stopper had been screwed into its socket.” Id.
41. Plaintiff’s claim here seeks to impose an even more obviously untenable duty than in
Sears. The alleged defect in the hot water bottle in Sears could have been discovered by a “simple
test.” 121 F.2d at 600. Yet here, Plaintiff’s theory would impose upon every California pharmacist
and/or retailer who sells prescription and/or over-the counter medications the obligation to conduct
their own independent, specialized testing to determine the safety of every lot of every prescription
and/or over-the-counter medication stocked on its shelves.
42. This would be a wholly unprecedented undertaking to require of every retailer in
California at pains of negligence liability. Stability testing of pharmaceutical products involves a
complex set of procedures that require considerable cost, time, and scientific expertise. Under
federal regulations, for instance, a manufacturer must submit a written protocol that includes, inter
4 Plaintiff’s conclusory and unsupported allegation that the Retailer Defendant failed to follow its own “established practices and procedures” to store the products presupposes that the Retailer owed a duty to investigate and test the products to learn that it could potentially form NDMA through certain storage conditions. Only if it had conducted such testing and investigation could formation of NDMA be a foreseeable risk of deviating from established storage practices.
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alia, sample size and test intervals based on statistical criteria for each attribute examined; storage
conditions for samples retained for testing; specific test models; testing of the drug product in the
same container-closure system as that in which the drug product is marketed; and testing of the drug
product at the time of dispensing as directed in the labeling. 21 C.F.R. § 211.166(a)(1)-(5). Such
testing must include an adequate number of batches at various storage conditions as defined in the
protocol. 21 C.F.R. § 211.166(b). Pharmaceutical companies often contract with a Contract
Manufacturing Organization (“CMO”) to conduct the stability testing. Such testing can cost
anywhere from $40,000-$60,000 per product. See PCI Synthesis, How to Know When to Toss Your
Prescription Drug or Refrigerate It (June 28, 2017), available at
https://www.pcisynthesis.com/how-to-know-when-to-toss-your-prescription-drug-or-refrigerate-
it/.
43. Yet under Plaintiff’s theory, not just the specific Retailer Defendant here but “mom
and pop” grocery or convenience stores throughout the State would be required to conduct such
detailed scientific investigations of the pharmaceutical products they sell to guarantee their safety.
Nor would Plaintiff’s novel theory be limited to storage conditions for pharmaceuticals; retailers
would have to conduct extensive testing of all of their products to discover any latent dangers and
warn against them. See, e.g., Burgess v. Montgomery Ward & Co., 264 F.2d 495, 497 (10th Cir.
1959) (“Montgomery Ward is operating a retail store, not a testing laboratory. If Montgomery Ward
were obliged to test this [allegedly defective] ladder for structural strength, so is the operator of
every retail store in the villages which dot the Kansas prairies.”). This is not the “ordinary care”
that the law demands of retailers who sell over-the-counter pharmaceuticals, or any other common
product for that matter.
44. The Complaint therefore states no cognizable claim against the Retailer Defendant
under California negligence law. The Retailer Defendant is, therefore, fraudulently joined and its
California citizenship should be disregarded for purposes of removal.
III. The Amount-in-Controversy Requirement Is Satisfied
45. Plaintiff’s claims also satisfy the amount in controversy requirement set forth in 28
U.S.C. § 1332(a).
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46. “[A] defendant’s notice of removal need include only a plausible allegation that the
amount in controversy exceeds the jurisdictional threshold.” Dart Cherokee Basin Operating Co.,
LLC v. Owens, 135 S. Ct. 547, 554 (2014). “[T]he defendant’s amount-in-controversy allegation
should be accepted when not contested by the plaintiff or questioned by the court,” and “[e]vidence
establishing the amount is required by § 1446(c)(2)(B) only when the plaintiff contests, or the court
questions, the defendant’s allegation.” Id. at 553–54.
47. Plaintiff seeks several categories of damages, including compensatory damages,
exemplary damages, and punitive damages. See Compl., Prayer for Relief ¶ 293(a)-(b).
48. The Complaint includes seven causes of action and alleges that Plaintiff’s use of
Zantac caused Plaintiff to suffer “significant harm, conscious pain and suffering, physical injury
and bodily impairment including, but not limited to cancer, other permanent physical deficits,
permanent bodily impairment and other sequelae.” Id. ¶ 14. It further asserts that Plaintiff’s injuries
required hospitalizations, in-patient surgeries, medication treatments, and other therapies to address
the adverse physical effects and damage” caused by Zantac. Id.
49. Recently, in denying remand, a court of this Circuit found that the amount in
controversy was met in a Zantac-related case similarly alleging a cancer injury and seeking
compensatory and punitive damages. There, the Court held that even applying a “conservative
estimate” the allegations “on their face” established that the amount in controversy was met. Order,
Brooks v. Sanofi, No. 2:20-cv-565, ECF 13, at 6-7 (D. Nev. Apr. 13, 2018).
50. Courts have similarly found that allegations of serious injury in products liability
actions, such as those Plaintiff makes here, support an inference that the amount-in-controversy
requirement has been met. See Mullaney v. Endogastric Sols. Inc., No. 11-62056-CIV, 2011 WL
4975904, at *2 (S.D. Fla. Oct. 19, 2011) (inferring that amount in controversy requirement was met
where plaintiff alleged that he underwent “surgical intervention that required additional life saving
medical treatment” and suffered “serious, permanent and disabling injuries”); see also Geographic
Expeditions, Inc. v. Estate of Lhotka, 599 F.3d 1102, 1107–08 (9th Cir. 2010) (“even though the
state court complaint does not specify an amount” it satisfied amount in controversy requirement
by requesting damages for, among other things, wrongful death, loss of consortium, and negligence,
Case 4:20-cv-03913-DMR Document 1 Filed 06/15/20 Page 15 of 19
Case 9:20-md-02924-RLR Document 2569-3 Entered on FLSD Docket 01/15/2021 Page 16 of20
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as well as funeral, medical and burial expenses); Campbell v. Bridgestone/Firestone, Inc., No.
CIVF051499-FVSDLB, 2006 WL 707291, at *2 (E.D. Cal. Mar. 17, 2006) (apparent from
complaint that amount in controversy met where plaintiffs asserted strict products liability,
negligence, and breach of warranty claims against multiple defendants and sought compensatory
damages, hospital and medical expenses, general damages, and loss of earning capacity).
51. Based on Plaintiff’s allegations, the amount in controversy exceeds $75,000,
exclusive of interest and costs.
IV. Procedural Requirements of Removal Are Satisfied
52. This Notice of Removal is timely filed pursuant to 28 U.S.C. § 1446(b). The
Removing Defendants have received a copy of, but have not yet been served with, the Complaint.
53. The Northern District of California is the federal judicial district encompassing the
Superior Court of the State of California in and for Alameda County, where this suit was originally
filed. Venue is therefore proper in this district under 28 U.S.C. §§ 84(a) and 1441(a).
54. Intradistrict Assignment. Pursuant to Civil Local Rule 3-2(c) and (d), this action
should be assigned to the Oakland or San Francisco Division, because the action arose in Alameda
County.
55. Removal pursuant to 28 U.S.C. § 1441(a) requires that “all defendants who have been
properly joined and served must join in or consent to the removal of the action.” 28 U.S.C.
§ 1446(b)(2)(A).
56. All of the Removing Defendants join in and consent to this removal.
57. No other Defendant is required to consent to this removal. On information and belief,
as of the time of filing this Notice, the Retailer Defendant has not been served with the Complaint.
Therefore, the Retailer Defendant is not required to join in or consent to the removal of this action.
See Destfino v. Reiswig, 630 F.3d 952, 957 (9th Cir. 2011) (finding an exception to the consent rules
where a defendant had not been properly served at the time of removal). Moreover, the Retailer
Defendant is fraudulently joined and therefore not required to join in the removal. See United
Computer Sys. Inc. v. AT&T Corp., 298 F.3d 756, 762 (9th Cir. 2002). The unidentified defendants
Case 4:20-cv-03913-DMR Document 1 Filed 06/15/20 Page 16 of 19
Case 9:20-md-02924-RLR Document 2569-3 Entered on FLSD Docket 01/15/2021 Page 17 of20
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Does 1-100 are not required to consent to removal. See Hafiz v. Greenpoint Mortg. Funding, 409
F. App’x 70, 72 (9th Cir. 2010) (nominal parties are not required to consent to removal).
58. The Removing Defendants are providing Plaintiff with written notice of the filing of
this Notice of Removal as required by 28 U.S.C. § 1446(d).
59. Pursuant to 28 U.S.C. § 1446(d), the Removing Defendants are filing a copy of this
Notice of Removal with the Clerk of the Superior Court of the State of California in and for Alameda
County.
60. Pursuant to 28 U.S.C. § 1446(a), copies of all process, pleadings, orders and other
papers filed in the state court action—as available from the state court docket or otherwise made
available to the Removing Defendants at the time of filing this Notice—are attached hereto as
Exhibit A.
61. If any question arises regarding the propriety of the removal of this action, the
Removing Defendants respectfully request the opportunity to present a brief and be heard at oral
argument in support of removal.
62. No previous application has been made for the relief requested herein.
63. This Court has subject matter jurisdiction pursuant to 28 U.S.C. § 1332 because this
is a civil action in which the amount in controversy exceeds $75,000, exclusive of interest and costs,
and is an action between citizens of different states.
V. Demand for Jury Trial
64. The Removing Defendants hereby demand a separate jury trial on all claims and issues
so triable.
WHEREFORE, the Removing Defendants give notice that the matter bearing Case No.
RG20061652 pending in the Superior Court of the State of California in and for Alameda County
is removed to the United States District Court for the Northern District of California, and requests
that this Court retain jurisdiction for all further proceedings in this matter.
Case 4:20-cv-03913-DMR Document 1 Filed 06/15/20 Page 17 of 19
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Dated: June 15, 2020 KING & SPALDING LLP
By: /s/ Matthew J. Blaschke________ Andrew T. Bayman (pro hac vice forthcoming) KING & SPALDING LLP 1180 Peachtree Street, Suite 1600 Atlanta, GA 30309 Tel: (404) 572-4600 Fax: (404) 572-5100 [email protected] Matthew J. Blaschke (SBN 281938) KING & SPALDING LLP 101 Second Street, Suite 2300 San Francisco, CA 94105 Tel: (415) 318-1212 Fax: (415) 318-1300 [email protected] Attorneys for Defendants Boehringer Ingelheim Pharmaceuticals, Inc. and Boehringer Ingelheim USA Corporation
By: /s/ Sharon D. Mayo___________
(as authorized on June 12, 2020)
Sharon D. Mayo (SBN 150469) Tommy Huynh (SBN 306222) ARNOLD & PORTER KAYE SCHOLER LLP Three Embarcadero Center, 10th Floor San Francisco, CA 94111-4024 Tel: (415) 471-3100 Fax: (415) 471-3400 [email protected] [email protected] Attorneys for Defendants Sanofi US Services Inc. and Sanofi-Aventis U.S. LLC
By: /s/ Jessica B. Rydstrom_________ (as authorized on June 12, 2020) Jessica B. Rydstrom (SBN 256600) WILLIAMS & CONNOLLY LLP
Case 4:20-cv-03913-DMR Document 1 Filed 06/15/20 Page 18 of 19
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725 12th Street NW Washington, DC 20005 Tel: (202) 434-5000 Fax: (202) 434-5029 [email protected] Attorney for Defendant Pfizer Inc.
By: /s/ Jonathan Tam______________ (as authorized on June 12, 2020) Mark S. Cheffo (pro hac vice forthcoming) DECHERT LLP 1095 Avenue of the Americas New York, NY 10036 Tel: (212) 698-3500 Fax: (212) 698-3599 [email protected] Will W. Sachse (pro hac vice forthcoming) DECHERT LLP Cira Centre, 2929 Arch Street Philadelphia, PA 19104 Tel: (215) 994-4000 Fax: (215) 994-2222 [email protected] Jonathan Tam (SBN 304143) DECHERT LLP One Bush Street, Suite 1600 San Francisco, CA 94104-4446 Tel: (415) 262-4500 Fax: (415) 262-4555 [email protected] Attorneys for Defendant GlaxoSmithKline LLC
Case 4:20-cv-03913-DMR Document 1 Filed 06/15/20 Page 19 of 19
Case 9:20-md-02924-RLR Document 2569-3 Entered on FLSD Docket 01/15/2021 Page 20 of20
EXHIBIT 3
Case 9:20-md-02924-RLR Document 2569-4 Entered on FLSD Docket 01/15/2021 Page 1 of 4
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Wisner, R. Brent
From: Petrosinelli, Joe <[email protected]>Sent: Wednesday, November 11, 2020 3:43 PMTo: Jennifer Moore; Wisner, R. BrentCc: [email protected]: RE: 42 California Plaintiffs Challenging MDL Jurisdiction
Jennifer – I have spoken with our side and we are agreeable with your suggestion that these 42 clients not be required to submit CPFs or file Short Form Complaints at this time, pending the outcome of their anticipated motions to remand. I assume you agree that if their remand motions are denied, they will promptly submit CPFs and file SFCs (we can discuss an exact timetable if that occurs). Please confirm. Thanks. Joe
From: Jennifer Moore <[email protected]> Sent: Tuesday, November 10, 2020 2:41 PM To: Petrosinelli, Joe <[email protected]>; Wisner, R. Brent <[email protected]> Cc: [email protected] Subject: FW: 42 California Plaintiffs Challenging MDL Jurisdiction Joe, Thanks for returning my call yesterday. Below is the email Brent sent to LMI on 11/3/20 addressing the alleged deficiencies regarding the 42 cases we filed in California state court and stating our objections. I understand that you will discuss with your side and get back to us prior to taking any further action by the end of the week. Thanks.
Jennifer A. Moore Moore Law Group, PLLC T: (502) 717‐4080 F: (502) 717‐4086 http://www.moorelawgroup.com @MooreLawGroupKY
From: "Wisner, R. Brent" <[email protected]> Date: Tuesday, November 3, 2020 at 10:04 PM To: "Stakes, David P." <[email protected]> Cc: "Adlivankina, Valeriya" <[email protected]>, Jennifer Moore <[email protected]> Subject: 42 California Plaintiffs Challenging MDL Jurisdiction
Dear Mr. Stakes, I am writing to you on behalf of the clients listed below, represented by Baum Hedlund and Moore Law Group. LMI recently notified Baum Hedlund that these cases were allegedly delinquent in submitting Census Plus Forms pursuant to Pretrial Order # 24. It is our understanding that this notice of delinquency was prompted by the Defendants. Please note that we did not file these cases in the
Case 9:20-md-02924-RLR Document 2569-4 Entered on FLSD Docket 01/15/2021 Page 2 of 4
2
MDL, but instead the Defendants improperly removed them to federal court. We have been waiting for leave from the Court to challenge it’s lack of jurisdiction over these cases for nearly five months. This attempt by the Defendants to impose the requirements of Pretrial Order # 24 is unfair and improper, reflecting a continued effort by these Defendants to use this federal forum to harass these Plaintiffs despite this Court lacking jurisdiction. We formally object to the Defendants’ attempt to impose PTO # 24 on these Plaintiffs. Clients: Amelino, Grag Astruc, Gilbert Barnes, Austin Becerril, Armando Brittner, Allen Brodie, Steven Campbell, Gary Caratti, Michael Carbajal, Hanna Cash, John Dudley, Ralph Elias, Brian Flores, Joes Friedland, Marc Geurin, John Gibbons, Nathan Gigliello, Joseph Goetz, James Gregory, Joseph, Jr. Harbaugh, Henry D. Hernandez, Mark Ives, Chris Jerde, Michael Karaoz, Reha Ray Knell, Greg Masouredis, Claudia Mills, Lolita Mitchell, Marc Morrison, Mark Muesse, Albert Newton, James Norman, Dwight Ortega, Ryan Reynolds, Oliver Russell, John Salvatore, Kalmeta
Case 9:20-md-02924-RLR Document 2569-4 Entered on FLSD Docket 01/15/2021 Page 3 of 4
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Smith, Lynn White, Michael Wilbur, Brian Williams, Roy Wright, Jr., Velo Yedlin, Matthew
Thank you for all your hard work in this MDL (Val tells me you have been a great resource). Best,
R. Brent Wisner
Vice President | Senior Partner
(310) 207-3233 baumhedlund.com 10940 Wilshire Blvd, 17th Floor Los Angeles, CA 90024
CONFIDENTIALITY NOTICE -- This electronic mail message may contain confidential information belonging to the sender which is protected by the attorney-client and/or work product privilege. The information is intended only for the use of the individual(s) or entity(ies) named above. If you are not the intended recipient, you are notified that any disclosure, copying, distribution, or the taking of any action in reliance on the contents of this information is strictly prohibited. If you have received this transmission in error, please purge the received information from your system and immediately notify the sender by telephone and by return e-mail. Thank you. IRS DISCLAIMER: Communications from our firm may contain or incorporate federal tax advice. Under recently promulgated US Internal Revenue Service standards (Circular 230), we are required to inform you that only formal, written tax opinions meeting the requirements of Circular 230 may be relied upon by taxpayers for the purpose of avoiding tax-related penalties. Accordingly, this communication is not intended or written to be used, and it cannot be used, for the purpose of avoiding tax-related penalties under the Internal Revenue Code.
This message and any attachments are intended only for the addressee and may contain information that is privileged and confidential. If you have received this message in error, please do not read, use, copy, distribute, or disclose the contents of the message and any attachments. Instead, please delete the message and any attachments and notify the sender immediately. Thank you.
Case 9:20-md-02924-RLR Document 2569-4 Entered on FLSD Docket 01/15/2021 Page 4 of 4
EXHIBIT 4
Case 9:20-md-02924-RLR Document 2569-5 Entered on FLSD Docket 01/15/2021 Page 1 of 3
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EXHIBIT 5
Case 9:20-md-02924-RLR Document 2569-6 Entered on FLSD Docket 01/15/2021 Page 1 of 3
Case 9:20-md-02924-RLR Document 2569-6 Entered on FLSD Docket 01/15/2021 Page 2 of 3
Case 9:20-md-02924-RLR Document 2569-6 Entered on FLSD Docket 01/15/2021 Page 3 of 3
1
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF FLORIDA
IN RE: ZANTAC (RANITIDINE)
PRODUCTS LIABILITY
LITIGATION
_______________________________/
MDL NO. 2924
20-MD-2924
JUDGE ROBIN L. ROSENBERG
MAGISTRATE JUDGE BRUCE E. REINHART
THIS DOCUMENT RELATES TO:
Ralph Dudley v. GlaxoSmithKline, et al. 9:20-cv-81056-RLR
Kalmeta Salvatore v. GlaxoSmithKline, et al. 9:20-cv-81059-RLR
Allen Brittner v. GlaxoSmithKline, et al. 9:20-cv-81061-RLR
John Cash v. GlaxoSmithKline, et al. 9:20-cv-81065-RLR
Jose Flores v. GlaxoSmithKline, et al. 9:20-cv-81068-RLR
Joseph Gregory Jr. v. GlaxoSmithKline, et al. 9:20-cv-81072-RLR
Roy Williams v. GlaxoSmithKline, et al. 9:20-cv-81073-RLR
Mark Hernandez v. GlaxoSmithKline, et al. 9:20-cv-81074-RLR
Michael White v. GlaxoSmithKline, et al. 9:20-cv-81075-RLR
Ryan Ortega v. GlaxoSmithKline, et al. 9:20-cv-81077-RLR
Oliver Reynolds v. GlaxoSmithKline, et al. 9:20-cv-81078-RLR
Grag Amelino v. GlaxoSmithKline, et al. 9:20-cv-81087-RLR
Matthew Yedlin v. GlaxoSmithKline, et al. 9:20-cv-81089-RLR
Armando Becerril v. GlaxoSmithKline, et al. 9:20-cv-81090-RLR
Lynn Smith v. GlaxoSmithKline, et al. 9:20-cv-81092-RLR
Chris Ives v. GlaxoSmithKline, et al. 9:20-cv-81093-RLR
James Newton v. GlaxoSmithKline, et al. 9:20-cv-81094-RLR
Michael Jerde v. GlaxoSmithKline, et al. 9:20-cv-81096-RLR
Albert Muesse v. GlaxoSmithKline, et al. 9:20-cv-81097-RLR
Reha Ray Karaoz v. GlaxoSmithKline, et al. 9:20-cv-81098-RLR
Greg Knell v. GlaxoSmithKline, et al. 9:20-cv-81099-RLR
Austin Barnes v. GlaxoSmithKline, et al. 9:20-cv-81104-RLR
Michael Caratti v. GlaxoSmithKline, et al. 9:20-cv-81105-RLR
Brian Elias v. GlaxoSmithKline, et al. 9:20-cv-81106-RLR
Marc Friedland v. GlaxoSmithKline, et al. 9:20-cv-81107-RLR
Marc Mitchell v. GlaxoSmithKline, et al. 9:20-cv-81109-RLR
Mark Morrison v. GlaxoSmithKline, et al. 9:20-cv-81110-RLR
Dwight Norman v. GlaxoSmithKline, et al. 9:20-cv-81112-RLR
Brian Wilbur v. GlaxoSmithKline, et al. 9:20-cv-81118-RLR
Velo Wright Jr. v. GlaxoSmithKline, et al. 9:20-cv-81119-RLR
Case 9:20-md-02924-RLR Document 2569-7 Entered on FLSD Docket 01/15/2021 Page 1 of 3
2
Claudia Masouredis v. GlaxoSmithKline, et al. 9:20-cv-81121-RLR
Lolita Mills v. GlaxoSmithKline, et al. 9:20-cv-81122-RLR
Gary Campbell v. GlaxoSmithKline, et al. 9:20-cv-81142-RLR
John Geurin v. GlaxoSmithKline, et al. 9:20-cv-81143-RLR
Carbajal, et al. v. GlaxoSmithKline, et al. 9:20-cv-81144-RLR
Joseph Gigliello v. GlaxoSmithKline, et al. 9:20-cv-81145-RLR
James Goetz v. GlaxoSmithKline, et al. 9:20-cv-81152-RLR
Steven Brodie v. GlaxoSmithKline, et al. 9:20-cv-81153-RLR
Henry D. Harbaugh v. GlaxoSmithKline, et al. 9:20-cv-81154-RLR
John Russell v. GlaxoSmithKline, et al. 9:20-cv-81157-RLR
Gilbert Astruc v. GlaxoSmithKline, et al. 9:20-cv-81216-RLR
[PROPOSED] ORDER GRANTING PLAINTIFFS’ MOTION TO REMAND CASES TO
CALIFORNIA STATE COURT
Having reviewed the Parties’ submissions, the Court finds good cause to GRANT
Plaintiffs’ Motion. The following cases are hereby immediately remanded to the Superior Court
of California for the County of Alameda:
Ralph Dudley v. GlaxoSmithKline, et al. 9:20-cv-81056-RLR
Kalmeta Salvatore v. GlaxoSmithKline, et al. 9:20-cv-81059-RLR
Allen Brittner v. GlaxoSmithKline, et al. 9:20-cv-81061-RLR
John Cash v. GlaxoSmithKline, et al. 9:20-cv-81065-RLR
Jose Flores v. GlaxoSmithKline, et al. 9:20-cv-81068-RLR
Joseph Gregory Jr. v. GlaxoSmithKline, et al. 9:20-cv-81072-RLR
Roy Williams v. GlaxoSmithKline, et al. 9:20-cv-81073-RLR
Mark Hernandez v. GlaxoSmithKline, et al. 9:20-cv-81074-RLR
Michael White v. GlaxoSmithKline, et al. 9:20-cv-81075-RLR
Ryan Ortega v. GlaxoSmithKline, et al. 9:20-cv-81077-RLR
Oliver Reynolds v. GlaxoSmithKline, et al. 9:20-cv-81078-RLR
Grag Amelino v. GlaxoSmithKline, et al. 9:20-cv-81087-RLR
Matthew Yedlin v. GlaxoSmithKline, et al. 9:20-cv-81089-RLR
Armando Becerril v. GlaxoSmithKline, et al. 9:20-cv-81090-RLR
Lynn Smith v. GlaxoSmithKline, et al. 9:20-cv-81092-RLR
Chris Ives v. GlaxoSmithKline, et al. 9:20-cv-81093-RLR
James Newton v. GlaxoSmithKline, et al. 9:20-cv-81094-RLR
Michael Jerde v. GlaxoSmithKline, et al. 9:20-cv-81096-RLR
Case 9:20-md-02924-RLR Document 2569-7 Entered on FLSD Docket 01/15/2021 Page 2 of 3
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Albert Muesse v. GlaxoSmithKline, et al. 9:20-cv-81097-RLR
Reha Ray Karaoz v. GlaxoSmithKline, et al. 9:20-cv-81098-RLR
Greg Knell v. GlaxoSmithKline, et al. 9:20-cv-81099-RLR
Austin Barnes v. GlaxoSmithKline, et al. 9:20-cv-81104-RLR
Michael Caratti v. GlaxoSmithKline, et al. 9:20-cv-81105-RLR
Brian Elias v. GlaxoSmithKline, et al. 9:20-cv-81106-RLR
Marc Friedland v. GlaxoSmithKline, et al. 9:20-cv-81107-RLR
Marc Mitchell v. GlaxoSmithKline, et al. 9:20-cv-81109-RLR
Mark Morrison v. GlaxoSmithKline, et al. 9:20-cv-81110-RLR
Dwight Norman v. GlaxoSmithKline, et al. 9:20-cv-81112-RLR
Brian Wilbur v. GlaxoSmithKline, et al. 9:20-cv-81118-RLR
Velo Wright Jr. v. GlaxoSmithKline, et al. 9:20-cv-81119-RLR
Gary Campbell v. GlaxoSmithKline, et al. 9:20-cv-81142-RLR
John Geurin v. GlaxoSmithKline, et al. 9:20-cv-81143-RLR
Carbajal, et al. v. GlaxoSmithKline, et al. 9:20-cv-81144-RLR
Joseph Gigliello v. GlaxoSmithKline, et al. 9:20-cv-81145-RLR
James Goetz v. GlaxoSmithKline, et al. 9:20-cv-81152-RLR
Steven Brodie v. GlaxoSmithKline, et al. 9:20-cv-81153-RLR
Henry D. Harbaugh v. GlaxoSmithKline, et al. 9:20-cv-81154-RLR
John Russell v. GlaxoSmithKline, et al. 9:20-cv-81157-RLR
Gilbert Astruc v. GlaxoSmithKline, et al. 9:20-cv-81216-RLR
Additionally, the following cases are hereby immediately remanded to the Superior
Court of California for the County of San Francisco:
Claudia Masouredis v. GlaxoSmithKline, et al. 9:20-cv-81121-RLR
Lolita Mills v. GlaxoSmithKline, et al. 9:20-cv-81122-RLR
DONE and ORDERED in Chambers, West Palm Beach, Florida, this ______ day of
________, 2021.
___________________________
ROBIN L. ROSENBERG
UNITED STATES DISTRICT JUDGE
Copies furnished to Counsel of Record
Case 9:20-md-02924-RLR Document 2569-7 Entered on FLSD Docket 01/15/2021 Page 3 of 3