Bloomberg Anywhere Remote Login Bloomberg Terminal Demo Request


Connecting decision makers to a dynamic network of information, people and ideas, Bloomberg quickly and accurately delivers business and financial information, news and insight around the world.


Financial Products

Enterprise Products


Customer Support

  • Americas

    +1 212 318 2000

  • Europe, Middle East, & Africa

    +44 20 7330 7500

  • Asia Pacific

    +65 6212 1000


Industry Products

Media Services

Follow Us

Bloomberg Customers

Bloomberg News

Patient Generic-Drug Lawsuits Curbed by U.S. Supreme Court (2)

June 24, 2013

(Corrects to reflect Takeda sold Mutual after court agreed to hear case, and that Obama administration supported Mutual.)

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. (4502) to Sun Pharmaceutical Industries Ltd. (SUNP)

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.

Alito Opinion

“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.

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.

Pharmaceutical Association

The Generic Pharmaceutical Association, an industry trade group, backed Mutual in the case, as did generic-drug makers Ranbaxy Laboratories Ltd. (RBXY), Teva Pharmaceutical Industries Ltd. (TEVA:US) and Mylan Inc. (MYL:US)

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, can’t have sex because of vaginal injuries 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.

To contact the reporter on this story: Greg Stohr in Washington at

To contact the editor responsible for this story: Steven Komarow at

blog comments powered by Disqus