Save Now, Pay Later: The Unfortunate Reality of PLIVA v. Mensing

• Author: Fabian Nehrbass
• Pages: 1155-1182

Save Now, Pay Later: The Unfortunate Reality of

PLIVA v. Mensing

INTRODUCTION

In 2001 and 2002, Gladys Mensing and Julie Demahy were

prescribed Reglan,1 a drug often utilized for treating acid reflux.2

Their pharmacists gave them generic metoclopramide, which they

took, as prescribed, for several years.3 Both women developed

tardive dyskinesia, a severe neurological disorder characterized b y

involuntary movements of the face, torso, and extremities.4 Demah y

experienced violent shaking, blinked excessively, and often

struggled to speak and write.5 The disorder was so damaging that

Demahy was forced to stay at home due to her inability to work

effectively or drive safely.6 Mensing’s situation was not any better.

Extremely limited in control of her movement, Gladys Mensing was

forced to rely on her granddaughter to help her bathe.7 Also plagued

with an inability to control the movement of her tongue and facial

muscles,8 Gladys struggled to be understood by others.9

In separate lawsuits, both Mensing and Demahy alleged that the

generic drug manufacturers of metoclopramide were liable under

state tort law for failure to provide adequate warning labels.10 At the

Copyright 2013, by FABIAN NEHRBASS.

1. PLIVA, Inc. v. Mensing¸131 S. Ct. 2567, 2573 (2011).

2. Gastroesophageal reflux disease is the medical term for acid reflux.

Demahy v. Wyeth Inc., 586 F. Supp. 2d 642, 643 (E.D. La. 2008), aff’d sub nom.

Demahy v. Actavis, Inc., 593 F.3d 428 (5th Cir. 2010), rev’d sub nom. PLIVA,

Inc. v. Mensing, 131 S. Ct. 2567 (2011).

3. PLIVA, 131 S. Ct. at 2573.

4. Demahy, 586 F. Supp. 2d at 644.

5. Ramon Antonio Vargas, Slidell Woman’s Case Against Generic Drug

Manufacturer Has Attention of U.S. Supreme Court, THE TIMES-PICAYUNE (Mar.

28, 2011, 4:15 PM), http://www.nola.com/health/index.ssf/2011/03/slidell_

womans_case_against_ge.html.

6. Id.

7. Am. Ass’n for Justice, The Story of PLIVA v. Mensing, http://vimeo

.com/20439521 (last visited Apr. 8, 2013).

8. Brad Allen, Important Generic-drug Case Has Minnesota Roots,

MINNPOST (Mar. 25, 2011), http://www.minnpost.com/business/2011/03/import

ant-generic-drug-case-has-minnesota-roots.

9. Am. Ass’n for Justice, supra note 7.

10. PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2573 (2011). Although

Mensing asserted a number of claims, inherent in each claim was the allegation

that the generic companies “failed to adequately warn about the association

between long-term ingestion of [metoclopramide] and movement disorders.”

Mensing v. Wyeth, Inc., 562 F. Supp. 2d 1056, 1058 (D. Minn. 2008), rev’d, 588

F.3d 603 (8th Cir. 2009), rev’d sub nom. PLIVA, Inc. v. Mensing, 131 S. Ct. 2567

(2011). Mensing had also initially sued the brand-name drug manufacturer for

1156 LOUISIANA LAW REVIEW [Vol. 73

district court level, Mensing’s failure-to-warn claims were held to

conflict with and to be preempted by federal law.11 The Eighth

Circuit Court of Appeals reversed, stating that the Food, Drug, and

Cosmetic Act (FDCA) did not preempt Mensing’s failure-to-warn

claims against the generic manufacturers.12 Demahy’s failure-to-

warn claims were not held at either the district court level or at the

Fifth Circuit Court of Appeals to be preempted.13 Mensing’s and

Demahy’s cases were eventuall y consolidated and brought before

the Supreme Court, which rejected the failure-to-warn claims that

each plaintiff asserted due to preemption by federal law.14

The Court stated that even assuming that the failure-to-warn

allegations were valid, the claims were preempted due to the

impossibility of the manufacturers being able to comply with both

federal and state drug law.15 Specifically, the Court relied on the

Food and Drug Administration’s (FDA) belief that the generic drug

manufacturers, unlike their brand-name counterparts, could not

unilaterally have utilized the Changes-Being-Effected (CBE)

process that allows a drug manufacturer to enhance a warning label

without prior FDA approval.16 The PLIVA decision came just two

years after the Court reached the opposite conclusion regarding

brand name drugs in Wyeth v. Levine.17 In Wyeth, the Supreme

Court held that failure-to-warn claims against brand-name drug

manufacturers were not preempted by federal law. Noting the

“unfortunate hand that federal drug regulation ha[d] dealt”18

Mensing and Demahy, the PLIVA Court admitted that

finding pre-emption here but not in Wyeth makes little sense.

Had Mensing and Demahy taken Reglan, the brand-name

drug prescribed by their doctors, Wyet h would control and

fraud and negligent misrepresentation, but that issue was not brought before the

Supreme Court. Mensing v. Wyeth, Inc. 588 F.3d 603, 605 (8th Cir. 2009), rev’d

sub nom. PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011). Demahy sued

specifically under the Louisiana Products Liability Act for “failure to warn of the

risks of neurological disorder after long-term use of metoclopramide.” Demahy v.

Actavis, Inc., 593 F.3d 428, 431 (5th Cir. 2010) (citation omitted), rev’d sub nom.

PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011).

11. Mensing, 562 F. Supp. 2d at 1056.

12. Mensing, 588 F.3d at 614.

13. Demahy, 593 F.3d at 428; Demahy v. Wyeth Inc., 586 F. Supp. 2d 642,

642 (E.D. La. 2008), aff’d sub nom. Demahy v. Actavis, Inc., 593 F.3d 428 (5th

Cir. 2010), rev’d sub nom. PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011).

14. PLIVA, 131 S. Ct. at 2572.

15. Id. at 2578.

16. Id. at 2575. See infra Part I.B.1 (regarding the CBE process).

17. Wyeth v. Levine, 555 U.S. 555, 581 (2009).

18. PLIVA, 131 S. Ct. at 2581.