Can generic drug maker be sued over labels?

By Jesse J. Holland Associated Press WASHINGTON (AP) -- The Supreme Court seemed split on Wednesday on whether to allow generic drug makers to be sued in state court for not trying to get federal regulators to add warnings about potentially dangerous side effects to their drug labels. Federal laws require generic drugs to have the same labels as their brand name equivalents. "I don't see how you can hold them liable, so long as they continued to give the warnings that they had to give," Justice Antonin Scalia said of the companies that make the generic drugs. But Justice Sonia Sotomayor argued that it didn't seem likely that Congress wanted to completely immunize generic companies against these types of lawsuits. "Do you think Congress really intended to create a market in which consumers can only sue brand-named products?" she said. "Because if that's the case, why would anybody ever take a" generic? PLIVA Inc. and other generic drug manufacturers argue that it's not their legal responsibility to request label changes, and lawsuits filed in state courts over the content of labels improperly infringe on the Food and Drug Administration's enforcement area. "When a company doesn't make appropriate disclosures to the FDA, even if people are hurt by that, even if it causes people to be injured and states might otherwise want to compensate them for them, those disclosure obligations are up to the FDA with its discretion to enforce," said lawyer Jay P. Lefkowitz. But lawyers for victims say their lawsuits complement federal safety laws, instead of conflicting with them. "This case is about the duty that the company owes to my clients and their doctors to provide them with adequate warnings," lawyer Louis M. Bograd said. 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 in state court in Minnesota, 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 Food and Drug Administration ordered warnings about tardive dyskinesia to be added to Reglan and metoclopramide in February 2009. The court will make a decision by the end of summer. The cases are PLIVA Inc. v Mensing, 09-993, Actavis Elizabeth LLC v. Mensing, 09-1039 and Activis, Inc., v. Demahy, 09-1501. Published: Fri, Apr 1, 2011