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Spangenberg Shibley & Liber, LLP | Jun 9, 2012

Supreme Court Rejects Liability For Generic Drug Makers In Labeling Suits

Categories: Articles

In June 2011, the U.S. Supreme Court decided PLIVA, Inc. v. Mensing, in which the Court considered generic pharmaceutical manufacturers' liability under state tort law to warn users of potential side effects. In a 5-4 decision, the Court held that federal statutes and FDA regulations directly conflict with, and therefore preempt, state tort claims alleging that generic pharmaceutical manufacturers failed to provide adequate warning labels.


At issue in PLIVA were respondents' claims for injuries suffered as a result of taking the drug metoclopramide, also known by the brand name Reglan, which is commonly prescribed to treat digestive tract disorders. In recent years, warning labels on the drug have been strengthened after studies proved that use of Reglan can cause tardive dyskinesia, a severe neurological disorder. In state-court suits, respondents sued the generic drug manufacturers that produced the metoclopramide they took, claiming that the drug caused their tardive dyskinesia and that the generic drug manufacturers did not provide adequate warning labels on their products.

The generic drug manufacturers claimed that the respondents' state law claims were preempted, and therefore barred, by federal statutes and FDA regulations that required the same warning labels on generic metoclopramide as brand-name Reglan.


Both the Fifth and Eighth Circuits rejected manufacturers' arguments and held that respondents' state-law claims were not, in fact, preempted. The Supreme Court disagreed.

The Court held that it would be impossible for generic drug manufacturers to comply with both state and federal law and, therefore, the state law must give way. State tort law requires a drug manufacturer who is, or should reasonably be aware of the dangers posed by its drug to label it in a way that makes its use reasonably safe. Under federal law, a drug manufacturer must prove to the FDA both that its drug is safe and effective and that its label is accurate and adequate before it may begin marketing the drug. Although these federal rules once applied to all drug manufacturers, 1984's Hatch-Waxman Amendments allow a generic drug manufacturer to prove the accuracy and adequacy of its label by showing it is the same as the already approved label for the brand-name drug. Despite respondents' arguments to the contrary, the Court held that the generic drug manufacturers could not have unilaterally strengthened their labels.


In dissent, Justice Sotomayor suggested that the Court's decision leaves consumers who are injured as a result of taking generic drugs without legal recourse, while consumers who are injured from taking name brand drugs are allowed to pursue state-law tort claims. Indeed, just two years ago, the Court held in Wyeth v. Levinethat similar state-law claims against name-brand drug manufacturers are not preempted by federal law because name-brand drug manufacturers are allowed to add to or strengthen a warning label in response to newly discovered evidence of adverse effects.


The full impact of PLIVA has yet to be realized, but it appears that the ruling is a major loss for those who suffer injury due to negligently labeled prescription drugs. If you or someone you love has been injured after taking Reglan or any other prescription pharmaceutical, contact an experienced personal injury attorney. A knowledgeable lawyer can assess your case and help you get the compensation you deserve.