A recent decision by the U.S. Supreme Court may mean that consumers are unable to bring state law personal injury claims against generic pharmaceutical manufacturers. In Pliva, Inc. v. Mensing, the Court decided 5-4 that federal statutes and Food and Drug Administration (FDA) regulations preempt state laws allowing consumers to sue generic pharmaceutical manufacturers who failed to provide adequate warning labels on their drugs. While the full impact of the Pliva decision has yet to be realized, it appears to be a major loss for consumers who are injured by negligently labeled drugs.
Reglan Can Be Dangerous
In Pliva, the court considered respondents' claims that they had suffered serious injuries from the drug metoclopramide, also known by the brand name Reglan. Recent studies of metoclopramide - which is commonly prescribed to treat digestive tract disorders - indicate that use of the drug can cause tardive diskenesia, a serious neurological disorder. As a result of these studies, drug manufacturers have strengthened the warnings that accompany the drug.
The respondents in Pliva initially sued generic drug manufacturers in state court, claiming that metoclopramide caused their tardive diskenesia and that the manufacturers failed to provide adequate warning labels on their drugs.
The manufacturers argued that the state-law claims were barred by both federal statutes and FDA regulations that required generic drugs to carry the same warning labels as name-brand drugs.
The Court Rules in Favor of Manufacturers
Although the Fifth and Eighth Circuits rejected the manufacturers' arguments, the Supreme Court held that respondents' state-law claims were, in fact, preempted.
The Court held that the state law claims were barred because it would impossible for generic drug manufacturers to comply with both state and federal law. While state law requires drug manufacturers to label their drugs in a way that makes them reasonably safe for use, federal law requires drug manufacturers to prove their products are safe, effective, and that their labels provide adequate warnings before the products may be marketed to the public.
Prior to 1984's Hatch-Waxman Amendments, these federal rules applied to all drug manufacturers, including generic manufacturers. Hatch-Waxman, however, allows generic drug manufacturers to prove the adequacy of their labels by demonstrating that they are the same as those provided by name-brand manufacturers. Although the respondents in Pliva argued that generic manufacturers could unilaterally strengthen their labels, the Court disagreed.
Bad News for Consumers
The Court's decision may lead to absurd results. Justice Sotomayor, for example, argued in dissent that the decision leaves consumers injured by generic drugs without a legal remedy, while those who are injured by brand-name drugs are able to pursue claims in state court. Furthermore, Pliva seems to run counter to the Court's decision in Wyeth v. Levine, which holds that federal law does not, in fact, preempt state law failure to warn claims against brand-name drug manufacturers.
An Attorney Can Help
If you or someone you love has suffered injury due to metoclopramide or any other prescription medication, contact an experienced personal injury attorney. A knowledgeable personal injury lawyer can assess your case and help you get the compensation for medical bills, lost wages, and pain and suffering you deserve. For more information, contact an attorney today.
