48
No. 1101397 IN THE SUPREME COURT OF ALABAMA WYETH, INC., ET AL., Appellants, V. DANNY WEEKS, ET AL., Appellees. Certified Question from the United States District Court for the Middle District of Alabama, Southern Division: Case No. 1:10-cv-602 APPELLANTS’ APPLICATION FOR REHEARING Frederick George Helmsing, Jr. MCDOWELL, KNIGHT, ROEDDER & SLEDGE, L.L.C. Post Office Box 350 Mobile, AL 36601-0350 251.431.8818 [email protected] Henninger S. Bullock Andrew J. Calica Admitted Pro Hac Vice MAYER BROWN LLP 1675 Broadway New York, NY 10019 212.506.2500 [email protected] [email protected] Attorneys for Appellant Schwarz Pharma, Inc. Kevin C. Newsom Marc James Ayers Lindsey C Boney IV BRADLEY ARANT BOULT CUMMINGS LLP One Federal Place 1819 Fifth Avenue North Birmingham, AL 35203-2119 205.521.8000 [email protected] [email protected] Philip H. Butler George R. Parker BRADLEY ARANT BOULT CUMMINGS LLP Alabama Center for Commerce 401 Adams Avenue, Suite 780 Montgomery, AL 36104 334.956.7700 [email protected] [email protected] Attorneys for Appellants Wyeth LLC and Pfizer Inc. E-Filed 01/25/2013 @ 05:38:56 PM Honorable Robert Esdale Clerk Of The Court

No. 1101397 IN THE SUPREME COURT OF …No. 1101397 IN THE SUPREME COURT OF ALABAMA WYETH, INC., ET AL., Appellants, V. DANNY WEEKS, ET AL., Appellees. Certified Question from the United

  • Upload
    others

  • View
    2

  • Download
    0

Embed Size (px)

Citation preview

No. 1101397

IN THE SUPREME COURT OF ALABAMA

WYETH, INC., ET AL.,

Appellants,

V.

DANNY WEEKS, ET AL.,

Appellees.

Certified Question from the United States District Court for the Middle District of Alabama, Southern Division:

Case No. 1:10-cv-602

APPELLANTS’ APPLICATION FOR REHEARING

Frederick George Helmsing, Jr. MCDOWELL, KNIGHT, ROEDDER & SLEDGE, L.L.C. Post Office Box 350 Mobile, AL 36601-0350 251.431.8818 [email protected] Henninger S. Bullock Andrew J. Calica Admitted Pro Hac Vice MAYER BROWN LLP 1675 Broadway New York, NY 10019 212.506.2500 [email protected] [email protected] Attorneys for Appellant Schwarz Pharma, Inc.

Kevin C. Newsom Marc James Ayers Lindsey C Boney IV BRADLEY ARANT BOULT CUMMINGS LLP One Federal Place 1819 Fifth Avenue North Birmingham, AL 35203-2119 205.521.8000 [email protected] [email protected] Philip H. Butler George R. Parker BRADLEY ARANT BOULT CUMMINGS LLP Alabama Center for Commerce 401 Adams Avenue, Suite 780 Montgomery, AL 36104 334.956.7700 [email protected] [email protected]

Attorneys for Appellants Wyeth LLC and Pfizer Inc.

E-Filed 01/25/2013 @ 05:38:56 PM Honorable Robert Esdale Clerk Of The Court

i

TABLE OF CONTENTS

TABLE OF AUTHORITIES ..................................... ii

INTRODUCTION .............................................. 1

ARGUMENT .................................................. 4

I. This Court’s Opinion “Overlook[s]” — Indeed, Entirely Ignores — Several Bedrock Principles of Alabama Tort Law. ..................................... 4

II. This Court “Misapprehended” The Meaning Of The Supreme Court’s Recent Mensing Decision And “Overlooked” Unanimous Post-Mensing Precedent. ........ 7

CONCLUSION ............................................... 11

CERTIFICATE OF SERVICE ................................... 13

ii

TABLE OF AUTHORITIES

Cases

Bailey v. Faulkner 940 So. 2d 247 (Ala. 2007) ............................ 5

Brasley-Thrash v. Teva Pharm. USA, Inc. No. 10-cv-00031, 2011 WL 4025734 (S.D. Ala. Sept. 12, 2011) ............................................ 10

Coundouris v. Wyeth No. ATL-L-1940-10, 2012 WL 2401776 (N.J. Super. Ct. Law Div. June 26, 2012) ........................... 9

Demahy v. Schwarz Pharma, Inc. 702 F.3d 177, 2012 WL 6698692 (5th Cir. 2012), pet. for reh’g denied (Dec. 7, 2012) .................. 8

DiBiasi v. Joe Wheeler Elec. Membership Corp. 988 So. 2d 454 (Ala. 2008) ............................ 5

Dietrich v. Wyeth, Inc. No. 50-2009-CA-021586, slip op. (Fla. Cir. Ct. Sept. 4, 2012) ........................................ 9

Fullington v. Pfizer, Inc. 4:10-cv-00236-JLH, 2011 WL 6153608 (E.D. Ark. Dec. 12, 2011) ............................................. 9

Gardley-Starks v. Pfizer, Inc. No. 4:10-cv-00099, 2013 WL 139900 (N.D. Miss. Jan. 10, 2013) ............................................. 8

Gross v. Pfizer, Inc. No. 8:10-cv-00110-AW, 2011 WL 4005266 (D. Md. Sept. 7, 2011) ........................................ 9

Guarino v. Wyeth LLC No. 8:10-cv-2885-T-30TGW, 2012 WL 1138631 (M.D. Fla. Apr. 3, 2012) .................................... 9

Hogue v. Pfizer, Inc. __ F. Supp. 2d __, 2012 WL 4466609 (S.D. Ohio Sept. 27, 2012) ....................................... 8

iii

Huck v. Trimark Physicians Grp. No. LACV018947, slip op. (Iowa Dist. Ct. Jan. 6, 2012) ................................................. 9

Keck v. Dryvit Sys., Inc. 830 So. 2d 1 (Ala. 2002) .............................. 6

Mensing v. Wyeth, Inc. No. 08-3850 (8th Cir. Sept. 29, 2011), ECF No. 3834382 ............................................... 8

Metz v. Wyeth LLC 830 F. Supp. 2d 1291 (M.D. Fla. 2011) ................. 9

Morris v. Wyeth, Inc. No. 3:09-CV-854, 2011 WL 4975317 (W.D. La. Oct. 19, 2011) ............................................. 9

Pfizer, Inc. v. Farsian 682 So. 2d 405 (Ala. 1996) ............................ 5

Phares v. Actavis-Elizabeth LLC __ F. Supp. 2d __, 2012 WL 3779227 (S.D. Tex. Aug. 30, 2012) ............................................. 8

Phelps v. Wyeth, Inc. 857 F. Supp. 2d 1114 (D. Or. 2012) .................... 8

PLIVA, Inc. v. Mensing 564 U.S. __, 131 S. Ct. 2567 (2011) .............. passim

Smith v. Wyeth, Inc. 657 F.3d 420 (6th Cir. 2011) .......................... 8

State Farm Fire & Cas. Co. v. Owen 729 So. 2d 834 (Ala. 1998) ............................ 5

Thompson-Hayward Chem. Co. v. Childress 169 So. 2d 305 (Ala. 1964) ............................ 5

Rules

Ala. R. App. P. 40 ........................................ 1

iv

Other Authorities

Bernstein Liebhard LLP, Generic Drug Lawsuits: Alabama Supreme Court Rules Brand Name Drug Makers Can Be Sued for Generic Drug Injuries, S.F. Chron. (online edition) (Jan. 16, 2013), http://www.sfgate.com ................................. 3

First Outrageous State Supreme Court Ruling of 2013, Judicial Hellholes (Jan. 15, 2013), http://www.judicialhellholes.org ...................... 3

Man Taking Generic Drug Can Sue Branded Maker, N.Y. Times, Jan. 12, 2013 .................................. 3

Meghan A. McCaffrey, Alabama Supreme Court Stretches Foreseeability in Wyeth v. Weeks, Product Liability Monitor (Jan. 14, 2013), http://product-liability.weil.com .................................... 3

Greg Ryan, Brand-Name Makers Can Face Generic-Drug Suits: Ala. Court, Law360, Jan. 11, 2013 .............. 3

1

APPLICATION FOR REHEARING

Pursuant to Rule 40, Ala. R. App. P., Appellants Wyeth

LLC, Pfizer Inc., and Schwarz Pharma, Inc. (“the brand-name

defendants”) respectfully submit this application for re-

hearing.1 The brand-name defendants seek reconsideration of

this Court’s January 11, 2013 decision primarily on two

grounds, as described below.

INTRODUCTION

The certified question before the Court asks, as a mat-

ter of first impression in this State — though hardly so

nationwide — whether a brand-name drug manufacturer can be

held liable, on a fraud-based theory, for physical injuries

allegedly caused by its competitors’ generic products.

This Court answered “yes” and — for the first time — “ex-

tended third-party fraud beyond the economic realm to

claims alleging physical harm.” Slip op. at 45. The Court

held that “it is not fundamentally unfair” to hold brand-

name drug manufacturers liable for harm allegedly caused by

1 The Court’s majority opinion noted that Justice Murdock dissented and would be publishing his dissent in a “writing to follow.” Slip op. at 52. Because the ability to review Justice Murdock’s dissent is essential to preparation of a brief in support of this application, the brand-name de-fendants obtained additional time — until February 8, 2013 — to prepare the accompanying brief.

2

generic drug manufacturers’ failure to warn because, the

Court said, after the U.S. Supreme Court’s recent decision

in PLIVA, Inc. v. Mensing, 564 U.S. __, 131 S. Ct. 2567

(2011), it is “foreseeabl[e]” that the labeling for brand-

name drugs will be repeated in generic drugs. Id. at 41,

52.

This Court’s decision is breathtakingly broad. In one

fell swoop, the Court implicitly overturned decades of set-

tled Alabama law concerning pleading requirements, product-

liability limitations, and tort duties. Although the

brand-name defendants briefed the leading Alabama prece-

dents at length and in detail, the Court’s opinion never

even mentions them, let alone distinguishes them. Nor does

the opinion acknowledge that courts nationwide (1) have

overwhelmingly (by a 76-2 margin) rejected the “innovator

liability” theory that underlies the Weekses’ claims and

(2) have unanimously rejected this Court’s aggressive read-

ing of Mensing.

Reaction to the Court’s decision has been swift — and

severe. Some have proclaimed that the decision puts Ala-

3

bama back on the road to “tort hell.”2 Others have observed

that the decision has “national implications,” particularly

because the Court “def[ied] other courts across the coun-

try,” which have decisively repudiated the aberrant innova-

tor-liability theory.3 The plaintiffs’ bar, as expected,

has hailed the decision as “pav[ing] the way for similar

rulings in other states.”4 The defense bar, for its part,

has expressed “surpris[e]” that the Court would spurn so

clear a national consensus and instead align itself with

lower court decisions in California and Vermont, the “only

two other courts” that have embraced innovator liability.5

2 See First Outrageous State Supreme Court Ruling of 2013, Judicial Hellholes (Jan. 15, 2013), http://www.judicialhellholes.org (attached as Exhibit A).

3 See Katie Thomas, Man Taking Generic Drug Can Sue Branded Maker, N.Y. Times, Jan. 12, 2013, at B3 (attached as Exhib-it B); Greg Ryan, Brand-Name Makers Can Face Generic-Drug Suits: Ala. Court, Law360, Jan. 11, 2013 (attached as Ex-hibit C).

4 See Bernstein Liebhard LLP, Generic Drug Lawsuits: Alabama Supreme Court Rules Brand Name Drug Makers Can Be Sued for Generic Drug Injuries, S.F. Chron. (online edition) (Jan. 16, 2013), http://www.sfgate.com (attached as Exhibit D).

5 See Meghan A. McCaffrey, Alabama Supreme Court Stretches Foreseeability in Wyeth v. Weeks, Product Liability Monitor (Jan. 14, 2013), http://product-liability.weil.com (at-tached as Exhibit E).

4

The Court should grant rehearing and hold, consistent

with the national consensus and existing Alabama tort law,

that a brand-name drug manufacturer cannot be held liable

for injuries caused by its competitors’ generic drug prod-

ucts.

At the very least, before undertaking such a radical

expansion of Alabama tort law — and once again making this

State a magnet for novel personal-injury lawsuits — the

Court should hold oral argument.

ARGUMENT

As will be explained more fully in the brand-name de-

fendants’ brief in support of this application, this Court

made two fundamental errors of law in holding that brand-

name drug manufacturers may be held liable for harm caused

by other companies’ generic products.

I. This Court’s Opinion “Overlook[s]” — Indeed, Entirely Ignores — Several Bedrock Principles of Alabama Tort Law.

Inexplicably, despite the brand-name defendants’ (and

their amici’s) focus on these principles and the settled

Alabama precedents that underlie them, the Court’s opinion

never even mentions them, let alone distinguishes them.

For instance —

5

! A plaintiff, like Mr. Weeks, who in substance al-leges physical injury caused by a product has only a product-liability claim — subject to traditional product-liability limitations — “‘[r]egardless of how [he] pleads his claim.’” Blue Br. 32–36 (quoting Pfizer, Inc. v. Farsian, 682 So. 2d 405, 407 (Ala. 1996), and citing Bailey v. Faulkner, 940 So. 2d 247 (Ala. 2007)). The Court’s opinion never engages Alabama’s “anti-circumvention” rule or, for that matter, even mentions any of the de-cisions cited by the brand-name defendants as rec-ognizing it.

! Similarly, even under pre-AEMLD jurisprudence, a plaintiff, like Mr. Weeks, who has (in substance) a failure-to-warn “product-liability” claim must prove that the defendant actually manufactured or sold the product that he claims injured him. See Blue Br. 36–38 (citing Thompson-Hayward Chem. Co. v. Childress, 169 So. 2d 305 (Ala. 1964)). The Court’s opinion wrongly assumes that the brand-name defendants’ argument somehow implicates the AEMLD, see slip op. at 7–8, and that, in any event, the product-identification requirement does not apply in failure-to-warn cases, see id. at 40– 41, 52. Both assumptions ignore the clear holding of Thompson-Hayward, a pre-AEMLD decision applying the product-identification requirement in a fail-ure-to-warn context. See Blue Br. 36–38; Gray Br. 18–19 & n.14.

! Finally, even setting product-liability limita-tions aside, settled precedent establishes (1) that a “relationship” between plaintiff and de-fendant is an indispensible prerequisite to the “duty” element of a common law fraud or negligence claim and, by contrast, (2) that simple “foreseea-bility” alone is insufficient to establish a duty. See Blue Br. 40–47 (citing, e.g., Thompson-Hayward, State Farm Fire & Cas. Co. v. Owen, 729 So. 2d 834 (Ala. 1998), DiBiasi v. Joe Wheeler Elec. Membership Corp., 988 So. 2d 454 (Ala. 2008), and Keck v. Dryvit Sys., Inc., 830 So. 2d 1

6

(Ala. 2002)). The Court’s opinion never mentions the “relationship” limitation and proceeds as if foreseeability alone were enough.

The Court’s opinion implicitly overturns each of these

foundational tort rules without even acknowledging them.

To make matters worse, in jettisoning settled tort lim-

itations in favor of an unprecedented extension of the

rarely invoked “third-party-fraud” rule, the Court misap-

plied the learned intermediary doctrine, a product-

liability doctrine that has never been understood to create

an independent duty to physicians.

Finally, this Court overlooked the dramatic implica-

tions of its decision, which makes brand-name drug manufac-

turers the insurers of the entire prescription-drug market

— liable for injuries caused by products they did not make.

If allowed to stand, the Court’s decision will radically

alter the financial realities of drug innovation, forcing

brand-name manufacturers to anticipate that, after their

period of exclusivity has expired, they will nonetheless be

responsible for an ever-growing generic market over which

they have no control and from which they derive no profit.

And to be clear, the Court’s reasoning — in particular, its

implicit rejection of the “anti-circumvention” principle

7

and the “relationship” prerequisite — will undoubtedly ex-

tend to other industries, as well. At a minimum, imposing

such potentially limitless liability retroactively on an

entire industry, and potentially on other industries, rais-

es profound concerns under the U.S. Constitution, as a mat-

ter of due process and fundamental fairness.

II. This Court “Misapprehended” The Meaning Of The Supreme Court’s Recent Mensing Decision And “Overlooked” Unani-mous Post-Mensing Precedent.

In addition to ignoring settled Alabama law, this Court

both “misapprehended” the meaning of the U.S. Supreme

Court’s recent decision in PLIVA, Inc. v. Mensing, 564 U.S.

__, 131 S. Ct. 2567 (2011), and “overlooked” the fact that

every court to have considered the question has held that

Mensing has absolutely no bearing on brand-name drug manu-

facturers’ state-law duties and liabilities.

As an initial matter, Mensing emphatically does not —

indeed, could not — mean that because federal law preempts

some claims against generic drug manufacturers, state law

must be manipulated to provide a cause of action against

brand-name drug manufacturers. Indeed, in Mensing, both

the majority and the dissent assumed that no such cause of

action exists against brand-name manufacturers. See 131 S.

8

Ct. at 2581–82 (majority op.); id. at 2592 (Sotomayor, J.,

dissenting). Not surprisingly, since Mensing, every court

that has confronted plaintiffs’ innovator-liability theory

has rejected it. And even more to the point, except for

this Court, all 15 courts to have addressed the issue — in-

cluding the U.S. Courts of Appeals for the Fifth, Sixth,

and Eighth Circuits — have held that Mensing is irrelevant

to the question of brand-name liability.6 On that key

point, then, this Court stands absolutely alone.

6 See Demahy v. Schwarz Pharma, Inc., 702 F.3d 177, 2012 WL 6698692, at *4 (5th Cir. 2012), pet. for reh’g denied (Dec. 7, 2012) (“[T]he Supreme Court’s decision in Mensing had no effect on Louisiana state law[] ... [and] does not impose on name-brand manufacturers a duty of care to customers us-ing generic products.”); Smith v. Wyeth, Inc., 657 F.3d 420, 424 (6th Cir. 2011) (rejecting the argument that Mensing changed state law as to the brand-name defendants); Order Reinstating Opinion in Part, Mensing v. Wyeth, Inc., No. 08-3850 (8th Cir. Sept. 29, 2011), ECF No. 3834382 (re-instating judgment in favor of the brand-name defendants after mistakenly vacating the court’s earlier judgment in its entirety following remand from the Supreme Court) (at-tached as Exhibit F); Gardley-Starks v. Pfizer, Inc., No. 4:10-cv-00099, 2013 WL 139900 (N.D. Miss. Jan. 10, 2013); Hogue v. Pfizer, Inc., __ F. Supp. 2d __, 2012 WL 4466609, at *5 (S.D. Ohio Sept. 27, 2012) (holding that Mensing “has no bearing whatsoever on the issue whether the Brand De-fendants may be held liable under Ohio Product liability law”); Phares v. Actavis-Elizabeth LLC, __ F. Supp. 2d __, 2012 WL 3779227, at *10 (S.D. Tex. Aug. 30, 2012) (“Mensing does not affect the principles underlying Texas products liability law ....”); Phelps v. Wyeth, Inc., 857 F. Supp. 2d 1114, 1119 (D. Or. 2012); Guarino v. Wyeth LLC, No. 8:10-cv-2885-T-30TGW, 2012 WL 1138631, at *2 (M.D. Fla.

9

Moreover, the U.S. Supreme Court did not hold (as this

Court’s opinion suggests, see slip op. at 30) that generic

drug manufacturers bear no responsibility for the labeling

of their products. Mensing itself recognizes that generic

manufacturers retain certain duties with regard to their

products’ labeling, including to ensure that it matches the

brand-name drug labeling. See Mensing, 131 S. Ct. at 2574.

Apr. 3, 2012) (rejecting the argument that Mensing somehow changed Florida law as to brand-name drug manufacturers); Fullington v. Pfizer, Inc., 4:10-cv-00236-JLH, 2011 WL 6153608, at *6 (E.D. Ark. Dec. 12, 2011) (“Nothing in Mensing purported to overrule [the governing] principle of state law, nor would the United States Supreme Court have the authority to overrule such a principle of state law in the absence of a conflict between state law and federal law.”); Metz v. Wyeth LLC, 830 F. Supp. 2d 1291, 1293 (M.D. Fla. 2011); Morris v. Wyeth, Inc., No. 3:09-CV-854, 2011 WL 4975317, at *1 (W.D. La. Oct. 19, 2011); Gross v. Pfizer, Inc., No. 8:10-cv-00110-AW, 2011 WL 4005266, at *2 (D. Md. Sept. 7, 2011) (“The Supreme Court’s holding in Mensing neither created nor abrogated any duty under Maryland law with regard to brand-name-manufacturers ....”); Dietrich v. Wyeth, Inc., No. 50-2009-CA-021586, slip op. at 3–4 (Fla. Cir. Ct. Sept. 4, 2012) (attached as Exhibit G); Huck v. Trimark Physicians Grp., No. LACV018947, slip op. at 2 (Io-wa Dist. Ct. Jan. 6, 2012) (“The Mensing case does nothing to expressly expand liability to the manufacturer of a branded drug that did not manufacture or supply the actual drug ingested.”) (attached as Exhibit H); Coundouris v. Wy-eth, No. ATL-L-1940-10, 2012 WL 2401776, at 4 (N.J. Super. Ct. Law Div. June 26, 2012) (holding that Mensing “does not change New Jersey law” because the decision “did not ad-dress or impact the issue ... whether a brand-name manufac-turer owes a duty to a patient who ingested a drug that the brand-name manufacturer did not make or sell”).

10

Relatedly, this Court seems to have assumed that Mensing

necessarily forecloses all claims against generic drug man-

ufacturers. See slip op. at 25 (concluding that after

Mensing “any state-law claims against a generic manufactur-

er were preempted”). That is a particularly odd assumption

to make in this case: To this day, the Weekses continue to

pursue their claims against the manufacturers of the gener-

ic metoclopramide that Mr. Weeks used, arguing that those

claims survive Mensing. See also, e.g., Brasley-Thrash v.

Teva Pharm. USA, Inc., No. 10-cv-00031, 2011 WL 4025734, at

*3 (S.D. Ala. Sept. 12, 2011) (holding that a generic manu-

facturer can be held liable for failing to “reiterate[]

warnings contained in the approved label”).

Finally, and in any event, the Court’s decision ignores

the fact that Mensing rejected the then-prevailing view

about generic preemption. The fair-notice principles em-

bodied in the Due Process Clause foreclose this Court’s

suggestion that Mensing’s recognition of generic preemption

could somehow retroactively render Mr. Weeks’s harm “fore-

seeable” to the brand-name defendants. See slip op. at 41–

42.

11

CONCLUSION

For these reasons, the brand-name defendants respect-

fully submit that this Court should grant this application

for rehearing, withdraw its opinion, and answer the certi-

fied question in the negative. At the very least, the

Court should hold oral argument before so fundamentally al-

tering longstanding Alabama law.

Respectfully submitted,

s/ Kevin C. Newsom

Kevin C. Newsom

One of the Attorneys for Defendants Wyeth LLC and

Pfizer Inc. OF COUNSEL: Marc James Ayers Lindsey C Boney IV BRADLEY ARANT BOULT CUMMINGS LLP One Federal Place 1819 Fifth Avenue North Birmingham, AL 35203-2119 205.521.8000 [email protected] [email protected] Philip H. Butler George R. Parker BRADLEY ARANT BOULT CUMMINGS LLP Alabama Center for Commerce 401 Adams Avenue, Suite 780 Montgomery, AL 36104 334.956.7700

12

[email protected] [email protected] s/ Frederick G. Helmsing, Jr.

Frederick George Helmsing, Jr. One of the Attorneys for Defend-

ant Schwarz Pharma, Inc. OF COUNSEL: MCDOWELL, KNIGHT, ROEDDER & SLEDGE, L.L.C. Post Office Box 350 Mobile, AL 36601-0350 251.431.8818 [email protected] Henninger S. Bullock Andrew J. Calica Admitted Pro Hac Vice MAYER BROWN LLP 1675 Broadway New York, NY 10019 212.506.2500 [email protected] [email protected]

13

CERTIFICATE OF SERVICE

I hereby certify I have this the 25th day of January, 2012, served a copy of the above and foregoing document by United States Mail and/or electronic mail on the following: Christopher Boyce Hood [email protected] Christopher Gadsden Hume, III [email protected] David Alan Lester [email protected] Edward Simmons Sledge, III [email protected] Hugh M. Stanley [email protected] Richard Dean [email protected]

Richard A. Oetheimer [email protected] Steven Frank Casey [email protected] William L Bross, IV [email protected] William Lewis Garrison, Jr [email protected] Jonathan I Price [email protected]

s/ Kevin C. Newsom

OF COUNSEL

EXHIBIT A

1 California

2 West Virginia

3 Madison County, Illinois

4 New York City and Albany, New York

5 Baltimore, Maryland

Download the full report (2.5MB PDF) >

CONNECT

To receive new posts automatically via e-mail, enter your address:

Delivered by FeedBurner

RECENT POSTS

Louisiana AG’s ‘Pay-to-Play’ Party Rolls on in 2013

First Outrageous State Supreme Court Ruling of 2013

Illinois High Court Limits Forum Shopping with Case from Former Judicial Hellhole

Madison County Shatters Asbestos Lawsuits Record

Small Business Advocate Makes Case for Venue Reform in Pennsylvania

Case Gives SCOTUS Chance to Rein in Class-Action Extortionists in Once and Future Judicial Hellhole

Asbestos Racketeers Suffer Huge Loss, Plaintiffs’ Bar PR Campaign Devastated

California Replaces Reforming Philly atop ‘Judicial Hellholes®’ List, Is Joined by Jurisdictions in West Virginia, Illinois, New York and Maryland

Ohio Lawmakers Pass First of Its Kind Asbestos Transparency Legislation

ATRA ‘Disappointed’ by Jindal’s Endorsement of Hughes for High Court

TELL ON A HELLHOLE

Contribute to our project by letting us know about additional Judicial

Subscribe

JANUARY 15TH, 2013

First Outrageous State Supreme Court Ruling of 2013

JUDICIAL HELLHOLES ALABAMA, CONTE, INNOVATOR LIABILITY

It only took eleven days for a state supreme court to issue the first outrageous liability-expanding ruling of 2013. The ruling abandons a core principle of law– that manufacturers are liable only for injuries caused by their own products, not the products of others — and replaces it with, what is known in strict legal terms as, the ”someone has to pay” approach.

The ruling, a product of the Alabama Supreme Court, came in the context of drug liability. The court ruled that companies that make brand-name prescription drugs are on the hook for injuries of people who take a competing generic drug.

The reason: the brand-name drug manufacturer in consultation with, and with the approval of, the U.S. Food and Drug Administration, originally developed the warning language, which, by virtue of federal law, is “merely repeated” by generic drug makers on their products.

About 80 courts across the country have rejected this theory, according to this scorecard, finding that such lawsuits violate the basic principle that manufacturers are liable only for injuries caused by their own products. Just two outlier courts — a mid-level appellate court in California and a federal district court in Vermont – allowed claims to proceed against a brand-name manufacturer for injuries to those who took generic products. In fact, three federal courts in Alabama had held that such liability, commonly known as “innovator liability,” was impermissible.

That changed with the Alabama Supreme Court’s decision in Wyeth, Inc. v. Weeks. The Alabama Supreme Court decided to abandon fundamental principles of law in order to provide plaintiffs with a deep pocket to sue.

By way of background, in PLIVA v. Mensing, the U.S. Supreme Court in 2011 ruled that generic drug makers could not be held liable for inadequately warning of the risks of their products because federal law requires them to use the same warnings as those approved by the FDA for the equivalent brand-name product and does not allow the generic manufacturer to unilaterally alter the labeling. That’s called “federal preemption.”

That preemption decision, the Alabama Supreme Court found, opened the door for it to take the state’s tort law on a wild new ride. Since plaintiffs can no longer sue the generic manufacturer for inadequate warnings, the court decided to shift the liability to the manufacturer of the brand-name drug, even though the plaintiff did not use its product.

But that is not law. When there is a defect in a product, product liability law distributes the burden of paying for injuries on each company in the chain of distribution. In other words, if you made money from selling the product, you are responsible for paying for resulting injuries resulting from that product.

But when a court holds a brand-name drug manufacturer liable when an individual took a competing generic product, it turns product liability law on its head. The brand-name drug manufacturer did not make money from the sale of the generic product. In fact, manufacturers often stop selling brand-name drugs when a generic version becomes available. According to one study, the generic version of a drug, on average, seizes 80 percent of brand-name drug sales within six months of the loss of patent protection. Many states, including Alabama, have substitution laws that require pharmacies to dispense the generic version of a drug, even if a doctor wrote the brand-name product on his or her prescription pad.

Yet under the “innovator liability approach,” the company that invested millions of dollars on research and development of a drug, and shepherded the product through the lengthy FDA approval process, remains indefinitely subject to liability for injuries allegedly cause by a competitor’s lower-cost product.

The public policy implications of this ruling, if accepted by other courts, could be disastrous. Will this new liability discourage innovating companies that already take an extraordinary gamble by seeking to develop life-improving or -saving medications, many of which do not make it to market, from doing so? Will the price of new drugs rise significantly because companies will now need to account for unpredictable future liability stemming from generic products that it does not sell?

Share/Bookmark

Page 1 of 4First Outrageous State Supreme Court Ruling of 2013 « Judicial Hellholes

1/16/2013http://www.judicialhellholes.org/2013/01/15/first-outrageous-state-supreme-court-ruling-o...

Hellholes.

BLOGROLL

WSJ Law BlogCopyright Claim Against 50 Cent Doesn’t ‘Cut the Dope’ just recently

The BLTLeahy Says Immigration Reform Top Priority for Senate Judiciary Committee just recently

ShopfloorManufacturing Production Continues to Improve Post-Sandy in the last hour

Lowering the BarBad News for Dog-Flinging Mascots 3 hrs ago

OverlawyeredThe family that crashes together 5 hrs ago

Torts Prof BlogIndiana Governor Seeks Tort Reform 6 hrs ago

SCOTUS BlogArgument recap: An ever-shrinking “takings” claim 19 hrs ago

The Legal PulseAlabama Justices Court Litigation Inc.’s Business with Drug Liability Ruling yesterday

Point of LawBranded manufacturer liable for failure to warn, when consumer uses generic drug 2 days ago

WCJC BlogArticle Highlights Recently Enacted Civil Liability Reforms throughout the Country 5 days ago

California Civil Justice BlogCalifornia Named Worst “Judicial Hellhole” in the Nation 34 days ago

AmLaw DailyThe Am Law Daily Has a New Home 256 days ago

On the Docket‘E’ In SEC Doesn’t Stand For Environment — Why Is It Probing Fracking? 509 days ago

NATIONAL ORGANIZATIONS

American Justice Partnership

Page 2 of 4First Outrageous State Supreme Court Ruling of 2013 « Judicial Hellholes

1/16/2013http://www.judicialhellholes.org/2013/01/15/first-outrageous-state-supreme-court-ruling-o...

American Legislative Exchange Council

American Tort Reform Association

FightingDocs

Foundation for Fair Civil Justice

Heartland Institute

Lawyers for Civil Justice

Manhattan Institute Center for Legal Policy

NFIB Small Business Legal Center

Product Liability Advisory Council

Rand Institute for Civil Justice

Sick of Lawsuits

U.S. Chamber Institute for Legal Reform

Washington Legal Foundation

STATE TORT REFORM COALITIONS

Civil Justice Association of California

Colorado Civil Justice League

Florida Justice Reform Institute

Illinois Civil Justice League

Lawsuit Reform Alliance of NY

Mississippians for Economic Progress

New Jersey Lawsuit Reform Alliance

Texans for Lawsuit Reform

Texas Civil Justice League

Washington State Liability Reform Coalition

Wisconsin Civil Justice Council

CITIZENS AGAINST LAWSUIT ABUSE

Bay Area CALA

California CALA

Central Texas CALA

East Texans Against Lawsuit Abuse

Houston CALA

Illinois Lawsuit Abuse Watch

Maryland CALA

Michigan Lawsuit Abuse Watch

Texans Against Lawsuit Abuse

West Virginia CALA

SORT POSTS BY TAG

ADA Alabama Asbestos Claims ATRA atrazine

California Charlie Sheen

Clark County class-action

Consumer lawsuit abuse Dishonorable Mention

Eastern District of Texas Florida

fraudulent claims Illinois

Judge Barbara Crowder legacy lawsuits Los Angeles

Page 3 of 4First Outrageous State Supreme Court Ruling of 2013 « Judicial Hellholes

1/16/2013http://www.judicialhellholes.org/2013/01/15/first-outrageous-state-supreme-court-ruling-o...

Louisiana Madison County Medical Liability Mississippi

Nevada New Jersey New York New York City

noneconomic damages Obesity

Lawsuits pain and suffering Pay-

to-Play Pennsylvania

Personal Responsibility

Phantom Damages

Philadelphia PIP fraud

Rogues' Gallery Sheldon Silver Smith

County South Florida Tiger Joyce Unbalanced Court Procedures

Wacky Lawsuits Wall Street Journal Watch List West Virginia

ARCHIVES

!Select Month

Page 4 of 4First Outrageous State Supreme Court Ruling of 2013 « Judicial Hellholes

1/16/2013http://www.judicialhellholes.org/2013/01/15/first-outrageous-state-supreme-court-ruling-o...

EXHIBIT B

Search All NYTimes.com

Global DealBook Markets Economy Energy Media Personal Tech Small Business Your Money

Man Taking Generic Drug Can Sue Branded MakerBy KATIE THOMASPublished: January 11, 2013

The Alabama Supreme Court ruled on Friday that a patient could sue

a brand-name company for failing to warn about a drug’s risks even

though he had taken a generic version of the product that the

company did not make.

Although the decision applies only to Alabama, it is likely to be closely

read by lawyers with similar cases pending around the country whose

clients have been barred from suing generic companies because of a

recent United States Supreme Court ruling.

“It has national implications,” said Bill Curtis, a Dallas lawyer who

has filed hundreds of similar cases in several states. “I suspect that

now, like most folks, if a client comes into my office, I’d be suing both

the generic they took and the brand who’s responsible for the label.”

In the Alabama case, the plaintiff, Danny Weeks, claimed that he had developed a

movement disorder known as tardive dyskinesia after taking generic versions of Reglan to

treat his acid reflux. Mr. Weeks sued Actavis and Teva, the generic companies that made

the drugs he took, as well as Wyeth, which developed the drug, for failing to adequately

warn about Reglan’s risks.

In 2009, the Food and Drug Administration required all manufacturers of

metoclopramide, the generic name for Reglan, to place stronger warnings on their labels

detailing a link between long-term use of the drug and tardive dyskinesia. Hundreds of

lawsuits have been filed by patients who claim that Wyeth failed to properly warn about

Reglan’s risks.

The chances of those claims against the generic companies succeeding are unclear after a

2011 Supreme Court decision, Pliva v. Mensing, which ruled that generic drug companies

had no control over what their labels said and so could not be sued for failing to alert

patients about the risks of taking their drugs. With few exceptions, generic manufacturers

are required to use the same labels as the brand names.

The suit was filed in a federal court in Alabama because Mr. Weeks lives in Alabama and

the drug companies are based elsewhere. The federal court asked the Alabama Supreme

Court whether a branded company could be sued in such a case.

In its decision on Friday, the Alabama Supreme Court ruled that “an omission or defect in

the labeling for the brand-name drug would necessarily be repeated in the generic labeling,

foreseeably causing harm to a patient who ingested the generic product.”

Kevin Newsom, a lawyer for Pfizer, which acquired Wyeth in 2009, described the decision

as an outlier. He said more than 70 court decisions, including four from federal appeals

courts, had taken the opposite view. Representatives for brand-name companies have

argued that they cannot be held liable for injuries caused by products they did not

manufacture. “It comes as something of a surprise because it is contrary to the

Log In With Facebook

Aaron Swartz, Internet Activist, Dies at 26

Hypochondria: An Inside Look

MOST E-MAILED RECOMMENDED FOR YOU

Log in to see what your friends are sharing on nytimes.com. Privacy Policy | What’s This?

What’s Popular Now

Sign up for the latest financial news delivered before the opening bell and after the market close.

See Sample | Privacy Policy

Get DealBook by E-Mail

HOME PAGE TODAY'S PAPER VIDEO MOST POPULAR

Business Day WORLD U.S. N.Y. / REGION BUSINESS TECHNOLOGY SCIENCE HEALTH SPORTS OPINION ARTS STYLE TRAVEL JOBS REAL ESTATE AUTOS

FACEBOOK

TWITTER

GOOGLE+

SAVE

E-MAIL

SHARE

PRINT

REPRINTS

Subscribe: Digital / Home Delivery Log In Register Now HelpU.S. Edition

Page 1 of 3Court Says Pfizer Can Be Sued by Man Who Took Generic - NYTimes.com

1/14/2013http://www.nytimes.com/2013/01/12/business/court-says-pfizer-can-be-sued-by-man-who-...

A version of this article appeared in print on January 12, 2013, on page B3 of the New York edition with the headline: Man Taking Generic Drug Can Sue Branded Maker.

SAVE E-MAIL SHARE

Drugs (Pharmaceuticals)

Decisions and Verdicts

Get Free E-mail Alerts on These Topics

Generic Brands and Products

Suits and Litigation

overwhelming weight of authority on this issue nationwide,” he said. He said two other

decisions have held similar views as the Alabama court.

The court ruled that Mr. Weeks could go ahead with his lawsuit based on what Mr.

Newsom described as a “unique wrinkle” in Alabama state law: that third parties like

Wyeth can be held liable for a person’s injury if that third party provided false or

misleading information that led to the injury. Mr. Weeks is arguing that Wyeth

misinformed his doctor, not Mr. Weeks himself.

Sheldon Gilbert, a lawyer with the National Chamber Litigation Center, which advocates

for the Chamber of Commerce and filed a brief in the case, said plaintiffs’ lawyers were

likely to see the Alabama decision as a lucrative opening. “What we’ve seen again and again

and again is that the trial lawyers get a decision that they think is good and they all flock to

that jurisdiction,” he said.

Chris Hood, a lawyer for Mr. Weeks, said, “When someone’s hurt by a generic tablet and

that injury can be laid at the feet of misinformation about the drug, then there’s only one

party who can be held responsible,” he said, “the branded company.”

Get 50% Off The New York Times & Free All Digital Access.

Ads by Google what's this?

Yasmin Lawsuit Lawyers

Suffered a Yaz Related Illness?

Learn Your Rights. Contact Us Now!

YazLawsuitLawyer.net/YazLawsuit

Log in to discover more articles based on what you‘ve read.

PRESENTED BY

What’s This? | Don’t Show

1. Heat, Flood or Icy Cold, Extreme Weather Rages Worldwide

2. On Scale of 0 to 500, Beijing’s Air Quality Tops ‘Crazy Bad’ at 755

3. When Markets Rise Above Politics

4. ECONOMIC VIEWAbove the Debt Ceiling, Boehner Might Find a Blue Sky

5. IT’S THE ECONOMYShould We Tax People for Being Annoying?

6. PAUL KRUGMANCoins Against Crazies

7. NEWS ANALYSISThe Low Politics of Low Growth

8. EDITORIALAmerica’s Health Disadvantage

9. RECIPES FOR HEALTHSicilian Cauliflower and Black Olive Gratin

10. In Second Look, Few Savings From Digital Health Records

© 2013 The New York Times Company Site Map Privacy Your Ad Choices Advertise Terms of Sale Terms of Service Work With Us RSS Help Contact UsSite Feedback

THEATER »

Kansas Heat That Has Little to Do With Weather

OPINION »

Op-Ed: The Myth of Nuclear NecessityAtomic weapons are aging, dangerous and no longer useful.

WORLD »

Greece Sees Gold Boom, but at a Price

U.S. »

Private Pain, Played Out on Public Stage

OPINION »

A Guide to Breaking the Debt CeilingRoom for Debate asks: How could the government avoid default even if Congress won’t raise the borrowing limit?

SPORTS »

They Left Their Hearts at Coogan’s Bluff

INSIDE NYTIMES.COM

Page 2 of 3Court Says Pfizer Can Be Sued by Man Who Took Generic - NYTimes.com

1/14/2013http://www.nytimes.com/2013/01/12/business/court-says-pfizer-can-be-sued-by-man-who-...

Page 3 of 3Court Says Pfizer Can Be Sued by Man Who Took Generic - NYTimes.com

1/14/2013http://www.nytimes.com/2013/01/12/business/court-says-pfizer-can-be-sued-by-man-who-...

EXHIBIT C

Portfolio Media. Inc. | 860 Broadway, 6th Floor | New York, NY 10003 | www.law360.com Phone: +1 646 783 7100 | Fax: +1 646 783 7161 | [email protected]

Brand-Name Makers Can Face Generic-Drug Suits: Ala. CourtBy Greg Ryan

Law360, New York (January 11, 2013, 5:08 PM ET) -- The Alabama Supreme Court ruled Friday that makers of brand-name drugs can be held liable for injuries caused by their generic counterparts in some circumstances, defying other courts across the country that have held otherwise. Under Alabama law, consumers allegedly injured by a generic drug can bring suit against the corresponding brand-name manufacturer for fraud or misrepresentation based on statements it made about the brand-name drug, such as those on a warning label, the high court held. "Because a warning label is not a part of the manufacturing process, we do not agree that the fact that a brand-name manufacturer that did not produce the version of the drug ingested by the plaintiff bars the plaintiff's tort action when the plaintiff is arguing that he or she was injured by a failure to warn," the opinion said. The ruling was the Supreme Court's response to a question certified to it by an Alabama federal court in August 2011 in a lawsuit brought by Danny Weeks, who allegedly developed the involuntary movement disorder tardive dyskinesia as a result of taking generic versions of the heartburn medication Reglan. Pfizer Inc., Wyeth Ltd. and Schwarz Pharma Inc., the brand-name manufacturers of Reglan sued by Weeks, asked the federal court to petition the Supreme Court for its view on brand-name makers' liability for generic-drug injuries, in response to the federal court's rejection of their dismissal motion. When faced with claims against brand-name makers similar to those of Weeks, nearly all courts nationwide — including in Alabama — have dismissed the allegations. Until the decision Friday, the two notable exceptions had been a California state appeals court's decision in Conte v. Wyeth in 2008 and a Vermont federal court's decision in Kellogg v. Wyeth in 2010. In joining those two courts, the Alabama Supreme Court held that a brand-name manufacturer could reasonably foresee that a generic version of its drug would eventually be made and that a physician prescribing a drug would rely on the brand-name drug warning. The brand-name manufacturers argued that the Supreme Court had never extended liability for an alleged fraud to a third party that did not manufacture the product at issue, but the court responded that "prescription medication is unlike other consumer products." Under the learned intermediary doctrine, drugmakers are not required to warn consumers

Page 1 of 2Brand-Name Makers Can Face Generic-Drug Suits: Ala. Court - Law360

1/22/2013http://www.law360.com/articles/406673/print?section=productliability

themselves about a drug's risks, but they must warn consumers' physicians, the high court said. In turning aside several previous Alabama federal court decisions finding brand-name manufacturers could not be liable for generic-drug injuries, the Supreme Court pointed out that the rulings had come before the U.S. Supreme Court's landmark Mensing decision in 2011. That ruling held that because federal law requires generic-drug warning labels to match those of their brand-name counterparts, state-law failure-to-warns claims against generics manufacturers are preempted. "Overton was issued before the Supreme Court decided [Mensing]," the high court said of one such case. "Accordingly, the federal court's conclusion in Overton that a generic manufacturer becomes responsible for its own warning label after the [abbreviated new drug application] process is incorrect." Eight of the high court's judges joined the majority opinion, with only one judge, Justice Glenn Murdock, dissenting. The dissent did not appear to be published as of Friday afternoon. Pfizer said in a statement that it was considering its appellate options. “We are disappointed with the Supreme Court of Alabama’s decision, which is not a decision on the merits of the case and is at odds with the vast majority of courts across the country that have held brand-name pharmaceutical manufacturers may not be held liable, on any theory, for injuries caused by products they did not manufacture," the company said. An attorney for Weeks declined comment Friday. Attorneys for Schwarz did not immediately return requests for comment. Weeks and his wife are represented by Christopher Hood, W. Lewis Garrison Jr. and William Bross of Heninger Garrison Davis LLC. Pfizer and Wyeth, which was purchased by Pfizer in October 2009, are represented by Kevin Newsom, Lindsey Boney, Philip Butler and George Parker of Bradley Arant Boult Cummings LLP. Schwarz is represented by Andrew Calica and Henninger Bullock of Mayer Brown LLP and Frederick Helmsing of McDowell Knight Roedder & Sledge LLC. The Supreme Court case is Wyeth Inc. et al. v. Weeks et al., case number 1101397, in the Alabama Supreme Court. The federal case is Weeks et al. Wyeth Inc. et al., case number 1:10-cv-00602, in the U.S. District Court for the Middle District of Alabama. --Editing by Elizabeth Bowen.

All Content © 2003-2013, Portfolio Media, Inc.

Page 2 of 2Brand-Name Makers Can Face Generic-Drug Suits: Ala. Court - Law360

1/22/2013http://www.law360.com/articles/406673/print?section=productliability

EXHIBIT D

Generic Drug Lawsuits: Alabama Supreme Court Rules Brand Name Drug Makers Can Be Sued for Generic Drug Injuries, Bernstein Liebhard LLP Reports

Published 1:00 am, Wednesday, January 16, 2013

0 0

Bernstein Liebhard LLP investigating lawsuits on

behalf of individuals injured as a result of drug

side effects.

New York, New York (PRWEB) January 15, 2013

An Alabama Supreme Court ruling could pave the

way for individuals allegedly injured by generic

versions of popular medications such as Fosamax,

Accutane, Darvocet and others to pursue generic drugs lawsuits against brand name drug

makers, Bernstein Liebhard LLP reports. According to The New York Times, in a decision

issued on July 11, 2013, the Court ruled that patients taking a generic medication can bring

failure to warn claims against the brand name drug manufacturer responsible for the

medication’s label. While the Alabama decision involved a generic version of the drug

Reglan, Bernstein Liebhard LLP believes it could have nationwide implications, and pave

the way for victims of generic drugs to obtain compensation for their injuries.* (U.S.

District Court, Middle District of Alabama,Case No. 1:10-cv-602)

“Generic versions of medications pose the same risks as their name-brand counterparts.

Yet, under the current state of the law, the millions of people who take these medications

have had no legal recourse for serious injuries allegedly caused by the drugs,” says

Bernstein Liebhard LLP, a nationwide law firm representing the victims of defective drugs

and medical devices.

Generic Drug Lawsuits

Generic drugs are required to carry the very same label warnings as name-brand versions.

In 2011, the U.S. Supreme Court ruled in Pliva vs. Mensing that victims of generic drug

injuries could not be sued for failing to warn patients about their risks since they have no

control over the content of the drug’s labels. According to a report published by the New

York Times in the wake of the Mensing decision, lawsuits involving generic versions of

Accutane and other medications have since faced dismissal in courts throughout the

country.** In July 2012, for example, the Judge overseeing federal Fosamax femur

fracture lawsuits in the U.S. District Court, District of New Jersey, granted a motion filed

by generic manufacturers to dismiss all claims against them that were based on failure to

warn. (In re: Fosamax (Aledronate Sodium) Products Liability Litigation (No. II) – MDL

2243). Last March, the judge overseeing the federal Darvon/Darvocet litigation in the U.S.

District Court, Eastern District of Kentucky, also cited Mensing when he dismissed claims

Photo Galleries Displaying 1-3 of 40

Herring

World in Focus

Nation in Focus

How Penny Stocks Are Creating Millionaires Every Day

How to Improve Memory with Scientifically Designed Brain Exercises

How Cruise Lines Fill All Those Unsold Cruise Cabins

From Around the Web

Are interest rates likely to rise? See our outlook for 2013. (Merrill Lynch)

Kobe Bryant, Dwight Howard reportedly confront issues in tense Lakers meeting (SI.com)

Review of Bathroom Tile Ideas for Small Bathrooms (Interior Decor Experts)

[?]

Most Read | Most Commented | Most Emailed

F

"#$%&' "#$%& "#$%&

Comments (0)

Larger | Smaller

Printable Version

Email This

Font

sfgate.com Web Search by YAHOO! Businesses

Technology Markets Real Estate Mortgage Rates Home Guides Public Notices Press Releases Sponsored Content

San Francisco, CA(change) Mostly Cloudy

Today46/64

Sat. 46/57

Friday Jan 25, 2013 10:03 AM PT

59 ° 5 Day Forecast Traffic

Home News Sports Business Entertainment Food Living Travel Columns Shopping Index !Cars Jobs Real Estate

Sign In | Register

Page 1 of 4Generic Drug Lawsuits: Alabama Supreme Court Rules Brand Name Drug Makers Can Be Sued for G...

1/25/2013http://www.sfgate.com/business/prweb/article/Generic-Drug-Lawsuits-Alabama-Supreme-Court-41969...

involving generic versions. (In Re: Darvocet, Darvon and Propoxyphene Products Liability

Litigation MDL 2226)

According to The New York Times, the generic Reglan lawsuit at the center of the Alabama

decision was filed in federal court. The federal court then asked the Alabama Supreme

Court to determine whether a brand name drug maker could be sued in such a case. In

allowing the lawsuit to move forward, the Alabama Supreme Court ruled that “an omission

or defect in the labeling for the brand-name drug would necessarily be repeated in the

generic labeling, foreseeably causing harm to a patient who ingested the generic product.”

The Alabama decision only applies to failure to warn lawsuits filed in that state.

Nonetheless, Bernstein Liebhard LLP believes it may pave the way for similar rulings in

other states.

Victims of defective drugs may be entitled to compensation for medical bills, lost wages,

pain and suffering and other damages. Bernstein Liebhard LLP offers free legal

consultations to individuals injured as a result of drug side effects, including those

allegedly caused by Fosamax, Actos and Pradaxa.Learn more by visiting Bernstein

Liebhard LLP’s website, http://www.consumerinjurylawyers.com/. For additional

information, contact a lawyer at Bernstein Liebhard LLP today at (877) 779-1414.

*nytimes.com/2013/01/12/business/court-says-pfizer-can-be-sued-by-man-who-took-

generic.html?_r=0

**nytimes.com/2012/03/21/business/drug-lawsuits-hinge-on-the-detail-of-a-label.html?

pagewanted=all&_r=0

About Bernstein Liebhard LLP

Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured

persons in complex individual and class action lawsuits nationwide since 1993, including

those who have been harmed by dangerous drugs, defective medical devices and consumer

products. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot

List,” recognizing the top plaintiffs’ firms in the country, for the past 10 consecutive years.

Bernstein Liebhard LLP

10 East 40th Street

New York, New York 10016

(877) 779-1414

ATTORNEY ADVERTISING. © 2013 Bernstein Liebhard LLP. The law firm responsible

for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New

York 10016, (212) 779-1414. The lawyer responsible for this advertisement in the State of

Connecticut is Amy L. Abate. Prior results do not guarantee or predict a similar outcome

with respect to any future matter.

###

Contact Information:

Felecia L. Stern, Esq.

Bernstein Liebhard LLP

info(at)consumerinjurylawyers(dot)com

http://www.consumerinjurylawyers.com

For the original version on PRWeb visit: http://www.prweb.com/releases/prwebgeneric-

drug-lawsuits/generic-drug-side-effects/prweb10328020.htm

1. Harbaughs marked by family loyalty

2. Eddie D. may return to scene of crime

3. Woodside estate becomes 2nd most expensive property ever sold in the U.S.

4. SF Ballet's 80th season gala opening

5. SF restaurants pocketed health care fees

6. Damon 'hijacks' Kimmel's ABC show

7. Prosecutor: Murder suspect was growing pot

Today's Deal

$39 - Unicorn: Pan-Asian Dinner for 2 in FiDi, Reg. $80

SALE ENDS IN

6d:14h:04m

PRICE

$39

Page 2 of 4Generic Drug Lawsuits: Alabama Supreme Court Rules Brand Name Drug Makers Can Be Sued for G...

1/25/2013http://www.sfgate.com/business/prweb/article/Generic-Drug-Lawsuits-Alabama-Supreme-Court-41969...

Ads by Yahoo!

The Death of the PC The days of paying for costly software upgrades are numbered. The PC will soon be obsolete. And BusinessWeek reports 70% of Americans are already using the technology that will replace it. Merrill Lynch calls it "a $160 billion tsunami." Computing giants including IBM, Yahoo!, and Amazon are racing to be the first to cash in on this PC-killing revolution. Yet, a small group of little-known companies have a huge head start. Get the full details on these companies, and the technology that is destroying the PC, in a free video from The Motley Fool. Enter your email address below to view this stunning video.

Privacy / Legal Information

Enter email address... Click here for details

We Recommend

From Around the Web

Calif prison escapee caught after 17 years

2 gray wolves illegally killed near Jackson

Olympic medalist Michelle Kwan marries in RI

Tiger reportedly wants to remarry ex

Prosecutor: DC cop left child to die in hot car

Jindal: GOP must stop being 'stupid party'

How Much You Should Tip a Taxi or Shuttle (DexKnows)

Wes Welker wife Anna Burns rips Ray Lewis (SI.com)

What Disorder Do J.K. Rowling, Mark Twain, and

Van Gogh Have… (Health Guru)

Don’t Touch that Ketchup: Keep Healthy by

Avoiding these 8 Germ Havens (AARP.org)

Tom Cruise And Katie Holmes' Unusual Marriage

Revealed (Zimbio)

Thinking About Early Retirement? A Few Things to

Consider: (Allstate Blog)

[What's this?]

Subscribe to the San Francisco Chronicle and receive access to the Chronicle for iPad App and a gift:

"#$%& Sunday + a $15 gift card

"#$%& Fri-Sun + a $15 gift card

"#$%& Mon-Sun + a $25 gift card

Select an offer

Inside SFGate Displaying 1-4 of 15

Drummer's life in 'Beware of Mr. Baker'

Hopeful notes on aging in 'Quartet'

'4000 Miles': Grandma's a commie

Sam Jordan's Bar gets landmark status

Printable Version Email This 0 0

Add Your Comment

New to the site?

To use commenting, you need to sign up.

Register

Already a member?

Please log in. (Forgot Password?)

Remember Me Sign In

Username

Password

()*+,

Page 3 of 4Generic Drug Lawsuits: Alabama Supreme Court Rules Brand Name Drug Makers Can Be Sued for G...

1/25/2013http://www.sfgate.com/business/prweb/article/Generic-Drug-Lawsuits-Alabama-Supreme-Court-41969...

Mortgage Rates Hit 2.50% White House Program Cuts Up to $1k off Monthly Payments! (2.90% APR) www.SeeRefinanceRates.com

Hot Stock Pick ASCC Find Out Why This Play Could Lead to Rapid Profitability--Free Info! www.OTCStockPick.com

1 Tip to Lose Stomach Fat This interesting article shows 1 fruit that fights stomach fat. www.ConsumerSavingToday.com

Home News Sports Business Entertainment Food Living Travel Shopping Find Bay Area Jobs Real Estate Cars Site Index

Company Info: Contact Us Hearst Privacy Policy Your California Privacy Rights Terms & Conditions Work for Us Chron in Education Events & Promotions Submissions Advertising Services: Advertise with us Place a Classified About Our Ads Public Notices Local Businesses: Business Directory Reader Services: Home Delivery Subscribers iPad E-Edition Mobile RSS Feeds Newsletters Feedback FAQ Corrections Get Us Local Services: Air Conditioning Contractors Car Dealerships Cleaning Services Family Doctors Furniture Stores Injury Attorneys Local Restaurants New Car Dealers Real

Estate Agents Real Estate Attorneys

© 2013 Hearst Communications Inc.

Page 4 of 4Generic Drug Lawsuits: Alabama Supreme Court Rules Brand Name Drug Makers Can Be Sued for G...

1/25/2013http://www.sfgate.com/business/prweb/article/Generic-Drug-Lawsuits-Alabama-Supreme-Court-41969...

EXHIBIT E

Alabama Supreme Court Stretches Foreseeability in Wyeth v. WeeksPosted By Meghan A. McCaffrey Category: Uncategorized

In a significant decision [1], the Supreme Court of Alabama ruled Friday that “it is not fundamentally unfair to hold the brand-name manufacturer liable for warnings on a product it did not produce[.]“ Rejecting the majority approach, Alabama now joins only two other courts — California and Vermont — in holding branded manufacturers liable for claims based on a generic drug.

The question certified by an Alabama federal court in August 2001 was “Under Alabama law, may a drug company be held liable for fraud or misrepresentation (by misstatement or omission), based on statements it made in connection with the manufacture or distribution of a brand-name drug, by a plaintiff claiming physical injury from a generic drug manufactured and distributed by a different company?” With its 8-1 decision, Alabama answered with a resounding yes, finding that a branded drug manufacturer “could reasonably foresee that a physician prescribing a brand-name drug (or a generic drug) to a patient would rely on the warning drafted by the brand-name manufacturer even if the patient ultimately consumed the generic version of the drug.”

The ruling seems to stretch the bounds of foreseeability well beyond its limit, holding that foreseeability exists just because there is a patient — somewhere down the line — whose doctor may rely on the labeling of a branded drug to prescribe medication; branded medication that the patient may not actually take, instead taking — by virtue of a patient’s choice, a pharmacist’s choice, or an insurance company’s choice — the generic version. By doing so, the court expands a branded manufacturers duty of care well beyond fundamental and well-established principles of tort and product liability law. In O’Neil v. Crane Co. [2], a California court rejected the same pure foreseeability doctrine that Alabama adopted on Friday, stating that “duty is not an immutable fact of nature but only an expression of the sum total of those considerations of policy which lead the law to say that the particular plaintiff is entitled to protection.” O’Neil v. Crane Co., S177401, *30-31(Cal. Jan. 12, 2011). Indeed, the O’Neil court went on to hold that “foreseeability alone is not sufficient to create an independent tort duty. Instead, the recognition of a legal duty of care depends upon the foreseeability of the risk and a weighing of policy considerations for and against imposition of liability.” Id. at 31.

How did the Alabama Supreme Court get to its ruling? Surprisingly, it did so relying on the Supreme Court’s decisions in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) and Wyeth v. Levine, 555 U.S. 555 (2009), as well as the only other two lower court cases supporting its ruling, California’s Conte v. Wyeth, Inc., 168 Cal. App. 4th 89 (2008) and Vermont’s Kellogg v. Wyeth, 762 F. Supp. 2d 694 (D. Vt. 2010). Using the Supreme Court’s opinions in Levine and PLIVA, Alabama reasoned that state-law claims against a manufacturer were not preempted and plaintiffs could hold a branded manufacturer liable for warnings on a generic product it did not produce because PLIVA had found that federal regulations prohibited generic manufacturers from changing warning labels on their generic drugs. Because a generic drug’s label must be the same as the brand-name drug, the court argued, “it is not fundamentally unfair to hold the brand-name manufacturer liable for warnings on a product it did not produce because the manufacturing process is irrelevant to misrepresentation theories based, not on manufacturing defects in the product itself, but on information and warning deficiencies, when those alleged misrepresentations were drafted by the brand-name manufacturer and merely repeated by the generic manufacturer.”

While Alabama’s decision still appears to be an outlier [3], its extension of the foreseeability doctrine could have potentially vast implications not only for the pharmaceutical industry, but the larger products industry as a whole. For Wyeth and the Weekses, the battle will continue – the Alabama Supreme Court’s ruling was not on the merits, so the Weekses will still have to prove that their prescribing physician received and relied upon the branded manufacturer’s label and warnings and that those labels and warnings were inadequate or fraudulent. Nonetheless, it is clear that this was a results-driven analysis; PLIVA unequivocally proscribes recovery against generic manufacturers, but the Alabama Supreme Court still wanted to hold someone liable. It remains to be seen whether other courts will follow suit, but we’ll continue to follow these developments here at the Product-Liability Monitor.

Article printed from Product-Liability Monitor – Weil: liability.weil.com-http://product

URL to article: -v-wyeth-in-foreseeability-stretches-court-supreme-liability.weil.com/uncategorized/alabama-http://productweeks/

Copyright © 2010 Weil - Product-Liability Monitor. All rights reserved.

Page 1 of 1Product-Liability Monitor – Weil » Alabama Supreme Court Stretches Foreseeability in ...

1/17/2013http://product-liability.weil.com/uncategorized/alabama-supreme-court-stretches-foreseeab...

EXHIBIT F

UNITED STATES COURT OF APPEALS FOR THE EIGHTH CIRCUIT

No: 08-3850

Gladys Mensing

Appellant

v.

Wyeth, Inc., et al.

Appellees ______________________________________________________________________________

Appeal from U.S. District Court for the District of Minnesota - Minneapolis (0:07-cv-03919-DWF)

______________________________________________________________________________

ORDER

The Supreme Court having reversed the judgment of this court and remanded this action for further proceedings in light of its opinion in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), we now vacate Sections I, II, and IV of our opinion in Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009), reinstate Section III of that opinion, and deny Mensing's motion for leave to file a supplemental brief

September 29, 2011

Order Entered at the Direction of the Court: Clerk, U.S. Court of Appeals, Eighth Circuit. ____________________________________ /s/ Michael E. Gans

Appellate Case: 08-3850 Page: 1 Date Filed: 09/29/2011 Entry ID: 3834382

EXHIBIT G

EXHIBIT H

el/1S/2e12 12:es 17126627978 SAC COUNTY CLERK PAGE 04/06

IN THE IOWA DISTRICT COURT FOR SAC COUNTY

THERESA HUCK, ) )

Plaintiff, ) No. LACV018947 )

,....., "' ···•( ;-:;;; :::tl

Vs. ) ORDER ;j·,t:; .): .. __ : ) I

\,0

TRIMARK PHYSICIANS GROUP, ) -nc f;;o('.

"" BERNADETTE GYANO, M.C., ) :::io: KENNETH ADAMS, M.D., WYETH ) .. INC., 0/B/A WYETH, SCHWARZ ) .t.-PHARMA, INC., I"LIVA, INC., AND ) BARR LABORATORIES, )

) Defendants. )

Motion for Relief from Judgment as to Defendants Wyeth Inc. & Schwarz Pharma, Inc. was submitted without oral argument. The pending motion seeks In substance to have this Court reconsider its March 2, 2009 order dismissing all claims against Defendants Wyeth Inc., and Schwarz Pharma, Inc. in light of the Supreme Court's subsequent opinion In Pliva Inc. v. Mensing, 564 U.S. _, 131 S. Ct. 567 (2011), holding that fecleral regulations applicable to generic drug manufacturers pre-empt state law failure-to-warn claims against generic drug manufacturers. The pending Motion should be overruled.

Insofar as relevant here, this Court's February 27, 2009 order was based upon the rule in Iowa "that a Plaintiff in a products liability action bears the burden of proving the Defendant manufactured or supplied the product that caused the injury." Mulcahy v. Ell Lilly & Co., 386 N.W.2d 67, 69 (Iowa 1986). "The term 'product liability' relates to liability arising from injury or damages resulting from the use of a product." Bingham v. Marshall & Huschart Machinery, 45 N.W.2d 78, 79 (Iowa 1992); see Smith v. Wyeth, 657 F,3d 420, 423 (61h Cir. 2011) ("The Kentucky Products Liability Act, a codification of preexisting common- law principles, defines a 'product liability action' as 'any action brought for or 01'1 account of personal Injury, death or property damage caused by or resulting from the manufacture, construction, design, formulation. . . warning,

-c· -<,, c;s

01/18/2012 12:08 17126&27978 SAC COUNTY CLERK PAGE 135/136

Instructing, marketing, advertising, packaging or labeling of any product' Ky. Rev. State. Sec. 411.300(1)(2010). As the Kentucky Supreme Court has held, '[t]he Products Liability Act] applies to all damage claims arising frarn the use of products, regardless of the legal theory advanced.' Monsanto Co. v. Reed, 950 s.W. 2d 811, 814 (Ky. 1997)."). Consistent with the foregoing, this court dismissed Wyeth and Schwarz from this case in its March 2, 2009 Order because they had not manufactured or supplied the drug ingested by the plaintiff; the plaintiff ingested only a generic form of the brand drug Reglan, whereas the Defendants Wyeth and Schwarz manufactured and distributed only the brand drug Raglan.

The Mensing case does nothing to expressly expand lfablllty to the manufacturer of a branded drug that did not manufacture or supply the actual drug Ingested. Nonetheless, the Plaintiff argues that by preempting state law claims against generic manufacturers, the Supreme Court has eliminated one of the underpinnings of the cases holding that manufacturers/suppliers of the branded drug, who did not manufacture or supply the generic drug ingested, are not liable. (Many of the prior cases had opined that· the injured party had a cause of action against .the manufact:urer/provider of the actual generic drug Ingested. See, e.g., Foster v. American Home Products Corp., 29 F.3d 165 (41h Cir. 1994)). The Courts that have considered this precise question since Mensing have all rejected the Plalnttff's argument. See, e.g., Order, Mensing v. Wyeth, Inc., No. 08"3850, (Sept. ·29, 2011), ECF No. 3834382 (8th Clr.); Smith. v. Wyeth, 657 F.3d 420 (61h Cir. 2011); Gross v.Pflzer, Inc, 2011 WL 4005266 (D. Md.)

Nothing has been cited, and this court's own research, has revealed nothing that would suggest that Iowa would part ways with the jurisdictions that have already considered this issue. Accordingly, the· Motion should be overruled.

ORDER IT IS THEREFORE ORDERED that Plaintiffs Motion for Relief from

Judgment as to Defendant Wyeth, Inc. and Schwarz Pharma, Inc. Is overruled. Dated this 5th day of January, 2012.

01/18/2012 12:08

\_ ... ·

Clerk to provide copies 1 _ 1 James Van Dyke l,-t"f'(U t.etJif

Lederer Richard Sapp .• kcJ

SAC COUNTY CLERK PAGE 06/06

·-·· \