The U.S. Supreme Court has agreed to hear argument over whether generic drug makers can be sued for the failure to warn about dangerous side effects on their drug label even when they follow federal rules.
In PLIVA, Inc. v. Mensing a woman took metoclopramide – the generic equivalent of Reglan – for four years to fight diabetic gastroparesis. She claims that the drug caused a severe neurological movement disorder – tardive dyskinesia – not warned about by the drug’s manufacturers and distributors.
The 8th U.S. Circuit Court of Appeals found in favor of the woman, noting that more should have been done to warn consumers about possible risks. The court reasoned, “If they realized their label was insufficient but did not believe they could propose a label change, they could have simply stopped selling the product. Instead they …placed a drug with inadequate labeling on the market and profited from its sale.”
The FDA has now required Reglan to add warnings about tardive dyskinesia in February 2009.
The Supreme Court will hear argument in the spring.