Supreme Court ruling protects makers of generic drugs

WASHINGTON  Makers of generic drugs cannot be sued for failing to warn people of dangerous side effects as long as their labels follow the brand-name counterpart, the Supreme Court ruled Thursday. The 5-4 decision would affect the vast majority of prescriptions nationwide.

Justice Clarence Thomas, writing for the majority, said federal regulations, which require generic drugs to have the same warning labels as the brand-name prescription, override state personal injury law that lets people sue manufacturers for allegedly inadequate labels. The state laws at issue dictated that drug manufacturers strengthen their labels as they became aware of new risks.

Thomas said the court was bound by the principle that federal law trumps the states and by relevant U.S. regulations. Yet he acknowledged it "makes little sense" that, based on court interpretation of varying U.S. regulations, people who are injured by generic drugs have no state failure-to-warn claim but those injured by brand-name drugs do.

In the 2009 Wyeth v. Levine case, the high court allowed such a state law claim to go forward against a brand-name manufacturer.

Thomas was joined Thursday by the more conservative justices. The liberal dissenters said the majority misconstrued principles regarding the intersection of federal and state law and asserted the decision would lead to "absurd consequences."

Justice Sonia Sotomayor, writing for dissenters, said, "As a result of today's decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug. The court gets one thing right: This outcome makes 'little sense.'"

She noted that about 75% of all prescription drugs dispensed in the USA are generics.

Thursday's ruling in Pliva v. Mensing marked one of two major victories for the pharmaceutical industry. In a separate case, the justices by a 6-3 vote struck down, as a First Amendment free-speech violation, a Vermont law that prevented pharmacies from selling prescription information for marketing purposes.

The dispute over safety labels traced to the early 2000s when Gladys Mensing in Minnesota and Julie Demahy in Louisiana took generic versions of Reglan, prescribed for digestive tract problems and containing the active ingredient metoclopramide.

The women developed a severe neurological disorder. They sued Pliva and other generic manufacturers under their respective state laws, alleging that the manufacturers had a duty to strengthen their warning labels as problems related to the long-term use of metoclopramide became evident.

Lower U.S. courts of appeals said the claims could go forward, rejecting manufacturers' arguments that they were pre-empted by federal law.

Reversing those decisions Thursday and providing a legal shield for generic drugs, Thomas said it is impossible for makers of generics to meet the requirements of state laws — demanding tougher warning labels as safety problems surface — and follow federal law, which Thomas said requires merely that the generic label be the same as the brand-name equivalent.

He was joined by Chief Justice John Roberts and Justices Antonin Scalia, Anthony Kennedy and Samuel Alito.

Sotomayor criticized the decision's reasoning and its consequences for consumers. She said generic manufacturers, who dominate the drug market, have a duty under federal law to monitor their products' safety and approach the Food and Drug Administration to propose label changes.