WASHINGTON (AP) — The Supreme Court last Friday agreed to decide whether generic drug makers can be sued for not warning about potentially dangerous side effects on their drug labels even when they follow federal rules that only require their labels to match those of their brand-name equivalents.
The high court agreed to hear an appeal from PLIVA Inc. and other drug manufacturers.
Gladys Mensing took metoclopramide for four years to help fight diabetic gastroparesis. She alleges that taking the drug gave her a severe neurological movement disorder, tardive dyskinesia, but none of the generic drug’s manufacturers and distributors made any effort to include warnings on the label.
She sued, and the generic drug’s manufacturers and distributors asked for the lawsuit to be thrown out. They said government regulations require them to have the same label on metoclopramide as is on its brand-name equivalent, Reglan. Reglan did not have a warning about tardive dyskinesia while Mensing was taking metoclopramide.
A federal judge agreed, saying the lawsuit was pre-empted by the federal regulations requiring the two labels to match.
But the 8th U.S. Circuit Court of Appeals in St. Louis overturned that ruling, saying more should have been done to warn consumers about possible risks.
“The generic defendants were not compelled to market metoclopramide,” the appeals court said. “If they realized their label was insufficient but did not believe they could even propose a label change, they could have simply stopped selling the product. Instead, they are alleged to have placed a drug with inadequate labeling on the market and profited from its sale.”
The Food and Drug Administration ordered warnings about tardive dyskinesia to be added to Reglan and metoclopramide in February 2009.
The high court accepted two other appeals last Friday.
One involves a division among federal appeals courts over how much local telephone companies may charge new competitors for access to their existing networks. The other case asks whether federal judges may impose a longer prison sentence so that an inmate can take part in a treatment or other rehabilitation program.
The cases will be argued in the spring.
The generic labeling case is PLIVA Inc. v Mensing, 09-993.
