U.S. Supreme Court ruling on generic drugs

By Dr. Ananya Mandal, MDJun 23 2011

According to the new ruling from the U.S. Supreme Court, people harmed by generic drugs may find it harder to get restitution. The court ruled on Thursday that generic drug makers cannot be sued for failing to warn consumers of their products' side effects if they copy the exact warnings on the drugs' brand-name equivalents.

The decision was 5-4 and the court ruled that the federal law requiring generics to have the same warnings as their brand-name equivalents trumps state laws that allow people to sue drug companies that fail to provide proper warnings for their products.

Justice Sonia Sotomayor said in a dissent, “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.”

Justice Clarence Thomas added that it was impossible for generic drug makers to comply both with federal laws requiring them to have the same label as the brand-name drugs and state laws that require them to add additional warnings. So the federal law prevails. Thomas acknowledged the “unfortunate hand” dealt to people who are harmed by inadequate labels on generic drugs. They would be able to sue the companies who make brand name drugs for the same offense but are barred from suing the generic manufacturers.

This decision could affect millions of Americans, given that generics make up 75 percent of the prescription drugs dispensed in the U.S., justices said.

In the first case, Pliva v. Mensing, No. 09-993, the court split 5 to 4 along ideological lines in ruling that the makers of generic drugs may not be sued under state law for failing to warn customers about the risks associated with their products. Gladys Mensing and Julie Demahy had sued PLIVA Inc. and other generic drug manufacturers in state courts in Minnesota and Louisiana over the labels for metoclopramide, the generic version of Reglan. The two women alleged that metoclopramide gave them a severe neurological movement disorder called tardive dyskinesia, but none of the generic drug's manufacturers and distributors made any effort to include warnings on the label. PLIVA Inc. and other generic drug manufacturers argue that it's not their legal responsibility to request label changes, and that lawsuits filed in state courts over the content of labels improperly infringe on the Food and Drug Administration's enforcement area.