The U.S. Supreme Court reinforced its bar on lawsuits by patients against generic-drug makers, overturning a $21 million award to a woman who suffered debilitating injuries after taking a generic painkiller.
The justices, voting 5-4, said the federal drug-approval regime prevented Karen L. Bartlett from claiming the medication's design was unreasonably dangerous in violation of New Hampshire product-liability law. Bartlett sued Mutual Pharmaceutical Co., a drugmaker sold earlier this year by Takeda Pharmaceutical Co. to Sun Pharmaceutical Industries Ltd.
The decision extends a 2011 Supreme Court ruling that barred patients from suing generic-drug companies using a different legal theory — failure to warn about dangerous side effects.
The court in the earlier case said those suits are "pre- empted" because federal law requires generic-drug companies to copy the packaging inserts used by brand-name manufacturers. The court said it would be impossible for drug companies to comply with both federal labeling requirements and state-imposed duties to supply even stronger warnings.
In the latest case, a federal appeals court had said it wasn't impossible for Mutual to comply with both state and federal law. The appeals court said Mutual "certainly can choose not to make the drug at all."
The Supreme Court majority today disagreed with that reasoning.
"Our pre-emption cases presume that an actor seeking to satisfy both his federal- and state-law obligations is not required to cease acting altogether in order to avoid liability," Justice Samuel Alito wrote for the majority.
Alito said Bartlett’s lawsuit implicitly claimed that Mutual should have changed the warnings on its packaging inserts — something it is barred from doing under federal law.
Justices Stephen Breyer, Elena Kagan, Ruth Bader Ginsburg, and Sonia Sotomayor dissented.
Sotomayor said the majority had misread federal drug-approval law.
"The court has left a seriously injured consumer without any remedy despite Congress’s explicit efforts to preserve state common-law liability," Sotomayor wrote.
People who take generic drugs ultimately might win the right to sue through a regulatory change. The Food and Drug Administration is considering giving generic-drug makers the power to change their package inserts and include new or stronger warnings. That shift could open generic-drug companies to suits for inadequate warnings, the Justice Department said in court papers.
The Generic Pharmaceutical Association, an industry trade group, backed Mutual in the case, as did generic-drug makers Ranbaxy Laboratories Ltd., Teva Pharmaceutical Industries Ltd. and Mylan Inc.
The Obama administration supported Mutual, urging the court to throw out the award.
Bartlett suffered what the appeals court called "truly horrific" injuries after taking sulindac, a generic painkiller made by Mutual, for shoulder pain. The anti-inflammatory medicine triggered an allergic reaction that caused Bartlett to lose more than 60 percent of her outer skin layer.
Bartlett spent months in a medically induced coma, spent a year being tube-fed, and endured 12 eye surgeries. She is almost blind, can't eat normally because of esophageal burns, and can’t engage in aerobic activities because of lung injuries. A federal jury in New Hampshire issued the award in 2009.
Takeda is based in Osaka, Japan, while Sun is based in Mumbai.
The case is Mutual Pharmaceutical Co. v. Bartlett, 12-142.
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