Supreme Court blocks suits on generic-drug warning labels

Federal law requires generic drugs to maintain the same labeling as the brand-name products they reproduce, including warnings of potential side effects. In a 5-4 decision, the court said patients therefore can’t sue the maker of a generic drug over the fact that a particular warning wasn’t on its label. 

Allowing those suits to proceed would require the drug companies to violate federal law, the majority said.

{mosads}The case was filed by patients who were injured by a generic version of the drug Reglan. They sued the manufacturers, saying the companies should have known about the safety risks and updated their labels to include a warning.

Federal drug regulations provide a process for drug companies to update their labels without waiting for approval from the Food and Drug Administration in some instances — including to add new safety information.

But that process is only relevant to brand-name drugs, because of the legal requirement that generics have identical labeling, the court ruled.

{mosads}”If the Manufacturers had independently changed their labels to satisfy their state-law duty, they would have violated federal law,” Justice Clarence Thomas wrote in the majority opinion.

Justices Stephen Breyer, Ruth Bader Ginsburg, Sonia Sotomayor and Elana Kagan dissented.

The Generic Pharmaceutical Association said the Supreme Court recognized that letting patients sue over generics’ labeling “places the generic manufacturer in the impossible position of defending the content of a label that they are required by law to use but prevented by law from changing.”

The Supreme Court ruled in 2008 that federal law does not provide the same protection to brand-name drugs. They can unilaterally change their labels and can be sued for failing to do so, the court said then.