Heartburn and the Constitution: The Case for a Compensatory Scheme in the Hatch-Waxman Amendments

Author:Claudiu Handaric
Position:Nova Southeastern University-Shepard Broad College of Law
Pages:109-150
SUMMARY

Although the decision of the Supreme Court in Pliva, Inc. v. Mensing preempted and thus, invalidated common law claims against generic drug manufacturers, the lower courts and the FDA proposed several solutions to compensate the victims affected by the side-effects caused by generic drugs. This paper uses competing public policies to evaluate the efficiency and the justness of the solutions... (see full summary)

 
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e Indonesian Journal of International & Comparative Law
ISSN: 2338-7602; E-ISSN: 2338-770X
http://www.ijil.org
© 2019 e Institute for Migrant Rights Press
hEartBurn and thE Constitution:
the CASe for A CompenSAtory SCheme In the
hAtCh-WAxmAn AmendmentS
Claudiu E. Handaric
Nova Southeastern University—Shepard Broad College of Law
E-mail: ch1713@mynsu.nova.edu
Although the decision of the Supreme Court in Pliva, Inc. v. Mensing preempted
and thus, invalidated common law claims against generic drug manufactur-
ers, the lower courts and the FDA proposed several solutions to compensate
the victims aected by the side-eects caused by generic drugs. is paper uses
competing public policies to evaluate the eciency and the justness of the solu-
tions proposed. An in-depth analysis of the litigation surrounding the gener-
ic drug metoclopramide reveals that the current scheme le thousands of vic-
tims with no adequate remedy to compensate for their injuries. It thus appears
that the federal statutes and most notably, the Hatch-Waxman Amendments,
turned out to deprive the consumers of generic drugs of any judicial redress for
their grievances. is paper concludes with an appeal to Congress to amend the
Hatch-Waxman Amendments with a compensatory scheme providing restitu-
tion to the victims of generic drugs. Such a reform is the only option that can
preserve the benets of the Hatch-Waxman Amendments while restoring justice
amid the regulations controlling the pharmaceutical drugs.
Keywords: Law & Medicine, e Right to Health, Jurisprudence, Constitutional Law.
VI Indonesian Journal of International & Comparative Law 109-150 (January 2019)
110
Handaric
INTRODUCTION
In 2001 and 2002, Gladys Mensing and Julie Demahy were diagnosed
with a common condition among American population.1 e women
suered from heartburn also known as “acid reux.2 eir doctors de-
ned the medical condition as “gastroesophageal reux disease” and
prescribed Reglan©, a common medicine to treat digestive disorders.3
e pharmacists substituted Reglan© with a cheaper, identical version
of the medicine, namely generic metoclopramide.4
Aer taking the drug for several months, both women developed
tardive dyskinesia—a severe neurological disorder manifesting in
involuntary and uncontrollable body movements.5 Both patients sued
the manufacturer of metoclopramide for failure to warn about the
side–eects associated with the drug.6 In defense, the manufacturers
asserted that the lawsuits were preempted by federal law.7 Aer the
Circuit Courts rejected the manufacturer’s argument, the Supreme
Court of the United States heard Mensing’s and Demahy’s cases.8 But the
Supreme Court ruled against the patients and held that both lawsuits
were preempted by federal law.9 As a result, the consumers were le with
no remedy to compensate for their irreversible neurological condition.
Gladys Mensing’s and Julie Demahy’s examples are not unique.
More than 40 million people in the United States suer from acid
1. See PLIVA, Inc. v. Mensing, 564 U.S. 604, 609 (2011); see also How Many People
Have Acid Reux? (June 14 2017), VWH, https://www.verywell.
com/how-many-people-have-acid-reux-1743035 (last visited April 8, 2018)
(stating that heartburn aects between 18% and 28% of the adult U.S. popula-
tion, which translates into a number between 42 million and 64 million adults
in the U.S. suering from acid reux).
2. See Mensing, 564 U.S. at 609.
3. Id.
4. Id.
5. Id. at 610.
6. Id.
7. Id.
8. Id. at 610–11.
9. Id. at 609.
111
Heartburn and the Constitution
Handaric
reux.10 e doctors prescribe Reglan© to two million people
annually and the pharmacists commonly substitute Reglan© with
generic metoclopramide.11 When taken for more than twelve weeks,
the treatment can cause tardive dyskinesia, an oen–irreversible
neurological disorder.12 Symptoms include: “’grotesque facial grimacing
and open–mouthed, uncontrollable tongue movements, tongue
thrusting, [and] tongue chewing.13 Arguably, this is a too high price to
pay for taking a medicine to treat heartburn.
As a result, thousands of lawsuits are led in the American
courts. A Pennsylvania–based watchdog group referred to Reglan©
and metoclopramide as being the most litigated drug during 2011
and mentioned more than 11,0000 litigation–related adverse reports
received by the Federal Food and Drug Administration (FDA).14
e present research focuses on Reglan©/metoclopramide litigation
from two competing public policy considerations. Hence, this paper
acknowledges both the need for an eective pharmaceutical market
and the need for a tolerable administration of justice.15 e underlying
premise of this study is that numbers and statistics fail to accurately
depict the reality of individuals suering from the side–eects associated
with generic drugs. Statistically, the current regulatory framework may
have brought “more drugs more quickly and cheaply to the public.16
But the search for eciency has ignored thousands of victims who
are deprived from any remedy to compensate and to prevent the side
eects produced by the pharmaceutical drugs. When considered from
the point of view of individual suering, the current scheme cannot
10. See How Many People Have Acid Reux?, supra note 1.
11. Reglan & Tardive Dyskinesia, DW, https://www.drugwatch.com/
reglan/ (last visited Apr. 4, 2018).
12. Id.
13. Huck v. Wyeth, Inc., 850 N.W. 2d 353, 359 (Iowa 2014).
14. Reglan & Tardive Dyskinesia Litigation, DW, https://www.drugwatch.
com/reglan/litigation/ (last visited Apr. 4, 2018).
15. If the eighteenth-century Scottish economist and philosopher, Adam Smith,
was correct, both economic ineciency and intolerable administration of jus-
tice hinder the progress of a society. See generally A S, T T
 M S (2002).
16. Mensing, 564 U.S. at 626.

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