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

AuthorFabian Nehrbass
Pages1155-1182
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.

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