No. 09 - 993

Supreme CourL U.S~~I..ED

APR 2 1 2010OFFICE OF "rile CLERK...j

IN THE

~upreme q~ourt of tl)e ~nit¢l~ ~tate~

PLIVA, INC.; TEVA PHARMACEUTICALS USA,INC.; UDL LABORATORIES, INC.,

Vo

GLADYS MENSING,

Petitioners,

Respondent.

On Petition for a Writ of Certiorarito the United States Court of Appeals

for the Eighth Circuit

RESPONDENT’S BRIEF IN OPPOSITION

MICHAEL K. JOHNSONLUCL4 J. W. MCLARENGOLDENBERG & JOHNSON,

P.L.L.C.33 South Sixth StreetSuite 4530Minneapolis, MN 55402(612) 335-9961

Louis M. BOGRAD*CENTER FOR CONSTITUTIONAL

LITIGATION, P.C.777 6th Street, N.W.Suite 520Washington, DC 20001(202) 944-2803lou.bograd@cclfirm.com

Counsel for Respondent

*Counsel of Record

(additional counsel on inside cover)

DANIEL J. MCGLYNNMCGLYNN, GLISSON & MOUTON340 Florida StreetPost Office Box 1909Baton Rouge, LA 70801(225) 344-3555

CLAIRE PRESTELPUBLIC JUSTICE1825 K Street, N.W.Suite 200Washington, DC 20006(202) 797-8600

QUESTION PRESENTED

Whether state law products liability claimsbrought by injured patients against manufacturers ofgeneric drugs are impliedly preempted by the Food,Drug and Cosmetic Act?

ii

TABLE OF CONTENTS

QUESTION PRESENTED ................................: ........i

TABLE OF CONTENTS ............................................ii

RESPONDENT’S BRIEF IN OPPOSITION ..............1

COUNTERSTATEMENT OF THE CASE .................2

Federal Regulation of Generic Drugs ..............3

REASONS FOR DENYING THE PETITION ............6

I. There Is No Conflict Among the UnitedStates Courts of Appeals and/or StateCourts of Last Resort ........................................7

II. The Lower Courts Are Not ConfusedAbout the Application of Wyeth v.Levine to Claims Against Generic DrugCompanies .........................................................9

III. Petitioners Seek Special ProtectionFrom Tort Liability That Is NotAvailable to Other Manufacturers andThat Finds No Support in the Hatch-Waxman Amendments ...................................11

CONCLUSION ..........................................................14

TABLE OF APPENDICES

APPENDIX A: 21 U.S.C. § 352(f)(2) .....................la

APPENDIX B: 21 C.F.R. § 201.57(e) (2005)- excerpt ........................................................2a

APPENDIX C: 21 C.F.R. § 314.70(b) (2005)

111

- excerpt ........................................................8a

APPENDIX D: 21 C.F.R. § 314.70(c)(6)(iii) (2005)

iv

TABLE OF AUTHORITIES

Cases

Bartlett v. Mutual Pharmaceutical Co., 659 F.Supp. 2d 279 (D.N.H. 2009) ...........................10

Bates v. Dow Agrosciences LLC, 544 U.S. 431(2005) ...............................................................11

Bonito Boats, Inc. v. Thunder Craft Boats, Inc.,489 U.S. 141(1989) ........................................13

Couick v. Wyeth, Inc., No. 3:09-CV-210-RJC-DSC, 2009 WL 4644394 (W.D.N.C. Sept.30, 2009) ..........................................................10

Demahy v. Actavis, Inc., 593 F.3d 428 (5th Cir.2010) ........................................................ passim

Dorsett v. Sandoz, Inc., No. CV06-7821, 2010WL 1174204 (C.D. Cal. Mar. 26, 2010) ............9

Foster v. American Home Products Corp., 29F.3d 165 (4th Cir. 1994) ...............................8, 9

Fulgenzi v. Wyeth, Inc., No. 5:09CV1767, 2010WL 649349 (N.D. Ohio Feb. 19, 2010) ...........10

Gaeta v. Perrigo Pharmaceuticals Co., No. 09-15001 (9th Cir. filed Jan. 6, 2009) ...................7

Gaetav. Perrigo Pharmaceuticals Co., No.C05-04115JW, 2009 WL 4250690 (N.D.Cal. Nov. 24, 2009) .........................................10

Kellogg v. Wyeth, 612 F. Supp. 2d 437 (D. Vt.2009) ................................................................10

V

Morris v. Wyeth, Inc., 582 F. Supp. 2d 861(W.D. Ky. Oct. 24, 2008) .................................10

Morris v. Wyeth, Inc., No. 09-5460 (6th Cir.filed Apr. 27, 2009) ...........................................7

Munroe v. Barr Laboratories, 670 F. Supp. 2d1299 (N.D. Fla. 2009) .....................................10

Pustejovsky v. Wyeth, No. 4:07-CV-103-Y, 2009WL 3336032 (N.D. Tex. Sept. 4, 2009) ...........10

Schrock v. Wyeth, 601 F. Supp. 2d 1262 (W.D.Okla. 2009) ......................................................10

Smith v. Wyeth, Inc., No. 09-5460 (6th Cir.filed Apr. 16, 2009) ...........................................7

Stacel v. Teva Pharmaceuticals, USA, 620 F.Supp. 2d 899 (N.D. Ill. 2009) ..........................10

Swicegood v. Pliva, Inc., No. 1:07-cv-1671,2010 WL 1138455 (N.D. Ga. Mar. 22,2010) ................................................................10

Thomas v. Winchester, 6 N.Y. 397 (1852) .................12

Vitatoe v. Mylan Pharmaceuticals, Inc., No.1:08cv85, 2010 WL 1008788 (N.D.W.Va. Mar. 5, 2010) ............................................10

Weilbrenner v. Teva Pharmaceuticals USA,Inc., No. 7:08-CV-23, 2010 WL 924915(M.D. Ga. Mar. 10, 2010) ................................10

Wilson v. Pliva, Inc., No. 09-5466 (6th Cir.filed Apr. 20, 2009) ...........................................7

vi

Wyeth v. Levine, --- U.S. ----, 129 S. Ct. 1187(2009) .......................................................passim

Statutes

21 U.S.C. § 352(f)(2) ................................................3, 6

Pub. L. No. 110-85, 121 Stat. 823 (2007) ....................2

Other Authorities

Buehler, Gary, Center for Drug Evaluationand Research, Letter to Health CareProfessionals (Feb. 26, 2009) ............................5

Korvick, Joyce, Center for Drug Evaluationand Research, Letter to Health CareProfessionals (Feb. 26, 2009) ............................5

Lesser, Karen E., et al., Timing of New BlackBox Warnings and Withdrawals forPrescription Medications, 287 J.A.M.Ao2215 (May 1, 2002) ...........................................6

Okie, Susan, Multinational Medicines--Ensuring Drug Quality in an Era ofGlobal Manufacturing, 361 New Eng. J.Med. 737 (2009) ..............................................11

Regulations

21 C.F.R. § 201.57(c)(6)(i) (2010) ............................4, 6

21 C.F.R. § 201.57(e) (2005) ........................................4

21 C.F.R. § 201.80(e) (2010) ..............................4, 6, 12

21 C.F.R. § 314.70 (2005) ............................................5

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21 ¢.F.R. § ~14.70(b) (200~) ........................................~

21 ¢.F.R. § 314.70(c) (200~) ........................................~

21 ¢.F.R. § 314.70(c)(~)(iii)(A) (200~) .........................~

21 ¢.F.R. § 314.80 (9,010) ............................................4

21 ¢.F.R. § 314.97 (2OO8) ............................................5

21 C.F.R. § 314.98 (2010) ............................................4

44 Fed. Reg. 37,434 (June 26, 1979) ...........................6

57 Fed. Reg. 17,950 (Apr. 28, 1992) ............................4

71 Fed. Reg. 3,922 (Jan. 24, 2006) ..............................4

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RESPONDENT’S BRIEF IN OPPOSITION

Respondent Gladys Mensing respectfullyrequests that this Court deny the petition for reviewof the decision of the United States Court of Appealsfor the Eighth Circuit, which held that Ms.Mensing’s state products liability claims against themanufacturers of the generic drugs that injured herare not impliedly preempted by the Food, Drug andCosmetic Act (FDCA), or the Hatch-WaxmanAmendments thereto.

The decision below does not conflict with anydecision of another federal court of appeals or of astate court of last resort, and it is consistent withrelevant decisions of this Court. In fact, it is astraightforward application of the reasoning in thisCourt’s decision last term in Wyeth v. Levine, --- U.S..... , 129 S. Ct. 1187 (2009), to a state failure-to-warnsuit brought against manufacturers of a genericdrug. Every court to take up the question since theLevine decision has concluded that state failure-to-warn claims against generic drug companies are notpreempted.

Petitioners seek a special immunity fromliability for generic drug companies, an immunitythat is not available to name-brand drug companiesor other manufacturers. Given that seventy percentof all prescriptions are now filled with generic drugs,preemption of state tort claims against suchcompanies would leave most persons injured byinadequately labeled drugs, including Ms. Mensing,remediless. Congress’s silence regarding preemptionof these cases is "powerful evidence that Congressdid not intend" such a draconian result. Id. at 1200.

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COUNTERSTATEMENT OF THE CASE

Gladys Mensing developed tardive dyskinesia,a severe and irreversible neurological disorder, as aresult of her long-term use of the prescription drugmetoclopramide, which was prescribed to treat herdiabetic gastroparesis. At the time,1 themetoclopramide label indicated that the risk of any"extrapyramidal symptom" from metoclopramideuse, including tardive dyskinesia, was"approximately 1 in 500 patients." In fact, the actualincidence of tardive dyskinesia in patients usingmetoclopramide long-term was many times higher,perhaps as high as 1 in 5 patients.

Despite mounting evidence that the risks oftardive dyskinesia were much greater than reflectedin the product label, no manufacturer ofmetoclopramide ever proposed to the Food and DrugAdministration (FDA) that the warnings on themetoclopramide label should be changed to reflectthat greater risk. In February 2009, too late for Ms.Mensing, the FDA--acting on its own initiativepursuant to powers granted to the agency in theFood and Drug Administration Amendments Act of2007, Pub. L. No. 110-85, 121 Stat. 823 (2007)(FDAAA)~rdered manufacturers of metoclopramideto add a "Boxed Warning" to their labels. Thatwarning stated, in relevant part: "Prolongedtreatment (greater than 12 weeks) withmetoclopramide should be avoided in all but rarecases where therapeutic benefit is thought tooutweigh the risks to the patient of developingtardive dyskinesia."

~ Ms. Mensing took metoclopramide from March 2001through March 2005.

Ms. Mensing sued the manufacturers of thegeneric metoclopramide she had used, includingpetitioners, for failure to adequately warn her of therisks of long-term metoclopramide use.2 The districtcourt, ruling before Wyeth v. Levine was decided,granted the generic-drug-company defendants’dispositive motions on the grounds that Ms.Mensing’s state failure-to-warn claims werepreempted by the Hatch-Waxman Amendments tothe FDCA and the federal regulatory schemegoverning generic drugs. The Eighth Circuit,following Levine, unanimously reversed, ruling thatCongress had not intended to preempt such state tortclaims against generic drug companies.

Federal Regulation of Generic Drugs

As this Court recognized in Levine, "it hasremained a central premise of federal drugregulation that the manufacturer bearsresponsibility for the content of its label at all times.It is charged both with crafting an adequate labeland with ensuring that its warnings remainadequate." 129 S. Ct. at 1197-98.

This principle applies with equal force to bothname-brand and generic drug companies. All drugcompanies are under a statutory obligation tomaintain adequate warnings on their labels.21 U.S.C. § 352(f)(2) (App. la) ("A drug.., shall bedeemed to be misbranded unless its labelingbears . . . such adequate warnings against use . . .where its use may be dangerous.., as are necessary

2 She also sued the manufacturers of the name-brand

version of metoclopramide, Reglan, for misrepresention. Thedistrict court dismissed those claims on state law grounds andthe Eighth Circuit affirmed.

for the protection of users"). Both name-brand andgeneric drug manufacturers have an obligation torevise their labels "to include a warning as soon asthere is reasonable evidence of an association of aserious hazard with a drug; a causal relationshipneed not have been proved." 21 C.F.R. § 201.57(e)(2005) (App. 2a).3 As the FDA has specificallyinstructed manufacturers of generic drugs, "[a]fterapproval of an [Abbreviated New Drug Application],if an ANDA holder believes that new safetyinformation should be added, it should providedadequate supporting information to FDA, and FDAwill determine whether the labeling for the genericand listed drugs should be revised"). 57 Fed. Reg.17,950, 17,961 cmt. 40 (Apr. 28, 1992).

It is not necessary for a drug company toconduct new clinical studies in order to conclude that"reasonable evidence" supports an additionalwarning. As this Court recognized in Levine, a newwarning may be justified by adverse drug experiencereports, 129 S. Ct. at 1197; all drug manufacturersare required to collect information on adverse drugexperiences and to report them to the FDA.21 C.F.R. §§ 314.80 (NDA holders) & 314.98 (2010)

3 In 2006, the FDA issued amended labeling regulations

for prescription drugs. 71 Fed. Reg. 3,922 (Jan. 24, 2006). Thatrulemaking, which became effective on June 30, 2006,redesignated § 201.57(e) as 21 C.F.R. § 201.80(e) and it remainsthe regulatory standard for drugs labeled under the old labelingrules, such as metoclopramide. 71 Fed. Reg. at 3,988, 3,996. Avirtually identical requirement applies to drugs labeled underthe new regulation. 21 C.F.R. § 201.57(c)(6)(i) (2010) ("Inaccordance with §§ 314.70 and 601.12 of this chapter, thelabeling must be revised to include a warning about a clinicallysignificant hazard as soon as there is reasonable evidence of acausal association with a drug; a causal relationship need nothave been definitively established."). 71 Fed. Reg. at 3,990.

(ANDA holders). Reports in the medical literaturecan also provide evidence to support a labelingchange; indeed, the FDA letters orderingmanufacturers of metoclopramide to add a boxedwarning justified the change by referencingpublished studies. See Letter from Joyce Korvick,Center for Drug Evaluation and Research ("CDER"),to Health Care Professionals 1 & nn.l-3 (Feb. 26,2009) to Health Care Professionals, available athttp ://www.fda. gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM111376.pdf; Letter from Gary Buehler,CDER, to Health Care Professionals 1-2 & nn.l-3(Feb. 26, 2009), available at http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM 111378.pdf.

There are two procedures by which bothbrand-name and generic drug companies may changetheir labels: (1) a Prior Approval Supplement,required for "Major Changes," 21 C.F.R. § 314.70(b)(2005) (App. 3a), or (2) a Changes Being Effected(CBE) Supplement for "Moderate Changes," 21C.F.R. § 314.70(c) (2005) (App. 5a), under which amanufacturer may proceed with the change uponnotification to the agency, unless the FDAdisapproves. Labeling changes to "add or strengthena contra-indication, warning, precaution, or adversereaction," may be made through the CBE process. 21C.F.R. § 314.70(c)(6)(iii)(A) (2005).4 21 C.F.R. §314.97 (2010) instructs generic drug companies tofollow these procedures "regarding the submission of

4 Petitioners inadvertently included the current version

of § 314.70 in the appendix to their petition, rather than theversion in effect during the time at issue in this litigation.

supplemental applications and other changes to anapproved abbreviated application."

Even before a product label can be revised,drug companies may warn health care professionalsby other means, such as a "Dear Doctor" letter,whenever possibly harmful adverse effects associatedwith use of the drug are discovered. 44 Fed. Reg.37,434, 37,447 (June 26, 1979).

Thus, drug labels are not fixed as of the dateof FDA approval. Nor should they be: name-branddrugs receive initial approval based upon verylimited clinical trials and there is a substantiallikelihood that new risks, complications, andcontraindications will only be identified or confirmedafter the drug--and its generic equivalents---havebeen prescribed more widely. See Karen E. Lesser, etal., Timing of New Black Box Warnings andWithdrawals for Prescription Medications, 287J.A.M.A. 2215, 2218 (May 1, 2002) ("Only half ofnewly discovered serious ADRs are detected anddocumented in the Physicians’ Desk Referencewithin 7 years after drug approval."). For thisreason, a drug company’s obligation to providephysicians and patients with up-to-date warningsand precautions continues as long as the product isbeing marketed and prescribed to patients. 21U.S.C. § 352(f)(2); 21 C.F.R. §§ 201.57(c)(6)(i),201.80(e) (2010).

REASONS FOR DENYING THE PETITION

There Is No Conflict Among the UnitedStates Courts of Appeals and/or StateCourts of Last Resort.

Review is unwarranted because there is noconflict among the lower courts with regard towhether federal law preempts failure-to-warn claimsinvolving generic drugs. The ruling below was thefirst appellate decision to apply the reasoning ofWyeth v. Levine to state tort claims against genericdrug companies, but it is far from the only courtruling on preemption of such claims. To date, threefederal courts of appeals--the Fourth, Fifth, andEighth Circuits--have addressed the issue of genericdrug companies’ potential liability for failure to warnof the risks posed by their products; each hasconcluded, without dissent, that the federalregulatory scheme permits generic drug companiesto strengthen label warnings and that suchcompanies may be held liable under state law forinadequate warnings.5

Shortly after the decision below, the FifthCircuit joined the Eighth Circuit in rejecting ageneric drug company’s preemption defense. InDemahy v. Actavis, Inc., 593 F.3d 428 (5th Cir. 2010),the court of appeals applied the reasoning of Levineand concluded that the plaintiffs failure-to-warnclaims were not preempted because the generic-drug-

~ As Petitioners note, the issue of preemption of stateclaims against generic drug manufacturers is pending beforeboth the Sixth and Ninth Circuits. Morris v. Wyeth, Inc., et al.,No. 09-5460 (6th Cir. filed Apr. 27, 2009); Smith v. Wyeth, Inc.,et al., No. 09-5460 (6th Cir. filed Apr. 16, 2009); Wilson v. Pliva,Inc., et al., No. 09-5466 (6th Cir. filed Apr. 20, 2009); Gaeta v.Perrigo Pharm. Co., No. 09-15001 (9th Cir. filed Jan. 6, 2009).To Respondent’s knowledge, no case raising the issue hasreached the highest court of any state.

company defendant could have sought to strengthenits warnings through the CBE process or the priorapproval process or by sending warnings directly tohealth care providers. Id. at 439-445. The courtrejected the argument that the responsibility forstrengthening label warnings rested solely on thename-brand drug company:

The federal interest is in maintainingsafe and effective labeling that isconsistent across name brand andgeneric bioequivalent versions of thesame drug. Who prompts the FDA toconsider necessary changes to thatshared label is immaterial.

Id. at 445 (emphasis in original).

The Fifth Circuit viewed its decision asfollowing naturally from this Court’s ruling in Wyethv. Levine: "While not directing our result, it shadowsour conclusion that the federal regulatory regimegoverning generics is also without preemptive effect."Id. at 430.

Even before Levine, the U.S. Court of Appealsfor the Fourth Circuit had reached a similarconclusion regarding a generic drug company’spotential liability for inadequate warnings. In Fosterv. American Home Products Corp., 29 F.3d 165(4th Cir. 1994), that court opined:

When a generic manufacturer adopts aname brand manufacturer’s warningsand representations withoutindependent investigation, it does so atthe risk that such warnings andrepresentations may be flawed .... The

9

statutory scheme governingpremarketing approval for drugs simplydoes not evidence Congressional intentto insulate generic drug manufacturersfrom liability for misrepresentationsmade regarding their products, or tootherwise alter state products liabilitylaw. Manufacturers of generic drugs,like all other manufacturers, areresponsible for the representations theymake regarding their products.

Id. at 169-70.

Every court of appeals to address this questionhas reached the same conclusion. The absence ofconflict in the lower courts strongly supports denialof the petition for certiorari in this case.

II. The Lower Courts Are Not ConfusedAbout the Application of Wyeth v. Levineto Claims Against Generic DrugCompanies.

As the foregoing discussion demonstrates, theFifth and Eighth Circuits have had no problemapplying the lessons of Levine to preemptiondefenses asserted by generic drug companies: bothcourts recognized that that decision carried"important implications" for generic drug companiesas well. Pet. App. 9a. But they are not alone infinding the application of preemption doctrine clearin this context. At least a dozen courts have takenup the issue of preemption of state tort claimsagainst generic drug manufacturers since Wyeth v.Levine was decided. Every one of them hasconcluded, in light of Levine, that the plaintiffs’

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claims are not preempted. See, e.g., Demahy, 593F.3d 428; Mensing v. Wyeth, Pet. App. la; Dorsett v.Sandoz, Inc., No. CV06-7821, 2010 WL 1174204(C.D. Cal. Mar. 26, 2010); Swicegood v. Pliva, Inc.,No. 1:07-cv-1671, 2010 WL 1138455 (N.D. Ga. Mar.22, 2010); Weilbrenner v. Teva Pharm. USA, Inc., No.7:08-CV-23, 2010 WL 924915 (M.D. Ga. Mar. 10,2010); Vitatoe v. Mylan Pharm., Inc., No. 1:08cv85,2010 WL 1008788 (N.D.W. Va. Mar. 5, 2010);Fulgenzi v. Wyeth, Inc., No. 5:09CV1767, 2010 WL649349 (N.D. Ohio Feb. 19, 2010); Munroe v. BarrLabs., 670 F. Supp. 2d 1299, 1303 (N.D. Fla. 2009);Bartlett v. Mutual Pharm. Co., 659 F. Supp. 2d 279(D.N.H. 2009); Stacel v. Teva Pharrn., USA, 620 F.Supp. 2d 899, 907 (N.D. Ill. 2009); Schrock v. Wyeth,601 F. Supp. 2d 1262, 1265 (W.D. Okla. 2009);Couick v. Wyeth, Inc., No. 3:09-CV-210-RJC-DSC,2009 WL 4644394 (W.D.N.C. Sept. 30, 2009);Pustejovsky v. Wyeth, No. 4:07-CV-103-Y, 2009 WL3336032, at "1 n.4 (N.D. Tex. Sept. 4, 2009); see alsoKellogg v. Wyeth, 612 F. Supp. 2d 437, 442 (D. Vt.2009) (post-Levine decision rejecting generic drugcompany defendant’s request to certify pre-Levineruling denying preemption for interlocutory appeal).6

In short, the lower courts have had nodifficulty applying Levine’s teachings. There isaccordingly no need for this Court to grant a petitionfor certiorari to provide guidance to the lower courts.

6 The two cases cited by Petitioner, Pet. 24, n.5, Gaeta v.

Perrigo Pharmaceuticals Co., No. C05-04115JW, 2009 WL4250690 (N.D. Cal. Nov. 24, 2009), and Morris v. Wyeth, Inc.,582 F. Supp. 2d 861 (W.D. Ky. Oct. 24, 2008), both involved pre-Levine rulings in favor of preemption that the district courtsdeclined to reconsider following Levine. Both rulings arecurrently pending on appeal.

11

III. Petitioners Seek Special Protection FromTort Liability That Is Not Available toOther Manufacturers and That Finds NoSupport in the Hatch-WaxmanAmendments.

It should not be surprising, especially in thewake of Levine, that the lower courts have had littledifficulty rejecting preemption claims by genericdrug companies. Petitioners seek a special shieldagainst tort liability that is not available to othermanufacturers, including the manufacturers ofname-brand drugs. Seventy percent of prescriptionsin this country are today filled with generics. SusanOkie, Multinational Medicines--Ensuring DrugQuality in an Era of Global Manufacturing, 361 NewEng. J. Med. 737, 738 (2009).A finding ofpreemption would leave all consumers ofinadequately labeled generic drugs,including Ms.Mensing, without legal remedy. As the Fifth Circuitobserved in Demahy, it would be a "bizarreconclusion that Congress intended to implicitlydeprive a plaintiff whose doctor prescribes a genericdrug of any remedy, while under Levine, that sameplaintiff would have a state-law claim had she onlydemanded a name brand drug instead." 593 F.3d at449. "If Congress had intended to deprive injuredparties of a long available form of compensation, itsurely would have expressed that intent moreclearly." Bates v. Dow Agrosciences LLC, 544 U.S.431, 449 (2005).

Despite the alarmist tone of the petition, theEighth Circuit’s decision does not threaten to drivegeneric drugs off the market or to endanger theviability of the generic drug industry. Suits againstdrug manufacturers for inadequate warnings have

12

existed since long before there was an FDA, see, e.g.,Thomas v. Winchester, 6 N.Y. 397 (1852), and thegeneric drug industry has thrived despite the risk oftort liability.

As both the Fifth and Eighth Circuits haverecognized, generic drug companies need notundertake expensive clinical trials in order to protectthemselves from liability. All they need do is reviewthe adverse drug experience reports they alreadyreceive, and monitor the medical literature forstudies identifying new risks associated with theproducts they sell. Pet. App. 18a; Demahy, 593 F.3dat 447. If the name-brand company is properlystrengthening its label warnings "as soon as there isreasonable evidence of an association of a serioushazard with a drug," 21 C.F.R. § 201.80(e), itsgeneric competitors can simply tag along with thoselabel changes; but where the name-brandmanufacturer fails to propose necessary warnings,generic drug companies cannot just rely upon thatinaction: "In these circumstances, § 201.57(e) [now21 C.F.R. § 201.80(e)] does not permit genericmanufacturers passively to accept the inadequacy oftheir drug’s label as they market and profit from it."Pet. App. 12a.

There is not a hint anywhere in the Hatch-Waxman Amendments or their legislative historythat Congress intended to shield generic drugcompanies from state tort liability. As this Courtsaid in Levine:

If Congress thought state-law suitsposed an obstacle to its objectives, itsurely would have enacted an expresspre-emption provision at some point

13

during the FDCA’s 70-year history. Butdespite its 1976 enactment of anexpress pre-emption provisionformedical devices, Congress hasnotenacted such a provision forprescription drugs. Its silence onthisissue, coupled with its certainawareness of the prevalence of state tortlitigation, is powerful evidence thatCongress did not intend FDA oversightto be the exclusive means of ensuringdrug safety and effectiveness.AsJustice O’Connor explained inheropinion for a unanimous Court:"Thecase for federal pre-emption isparticularly weak where Congresshasindicated its awareness of the operationof state law in a field of federal interest,and has nonetheless decided to stand byboth concepts and to tolerate whatevertension there [is] between them."

Wyeth v. Levine, 129 S. Ct. at 1200 (quoting BonitoBoats, Inc. v. Thunder Craft Boats, Inc., 489 U.S.141, 166-67 (1989)) (other citations omitted).

This analysis applies with full force toPetitioners’ preemption argument. As the court ofappeals observed:

The Hatch-Waxman Amendments arepart of this 70 year history and they donot explicitly preempt suits againstgeneric manufacturers. Congress couldhave crafted a preemption provision forgeneric drugs in its 1984 amendments,having done so for medical devices less

14

than 10 years earlier.that.

It chose not to do

Pet. App. 8a.

CONCLUSION

The petition for a writ of certiorari should bedenied.

April 21, 2010 Respectfully submitted,

LOUIS M. BOGRAD*CENTER FOR CONSTITUTIONAL

LITIGATION, P.C.

777 6th Street, N.W.Suite 520Washington, DC 20001(202) 944-2803lou.bograd@cclfirm.com

MICHAEL K. JOHNSON

LUCIA J. W. MCLARENGOLDENBERG 8~ JOHNSON,

P.L.L.C.33 South Sixth StreetSuite 4530Minneapolis, MN 55402(612) 335-9961

DANIEL J. MCGLYNNMCGLYNN, GLISSON & MOUTON340 Florida StreetPost Office Box 1909Baton Rouge, LA 70801(225) 344-3555

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CLAIRE PRESTEL

PUBLIC JUSTICE

1825 K Street, N.W.Suite 200Washington, DC 20006(202) 797-8600

*Counsel of RecordCounsel for Respondent

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