Court: Generic drug makers not liable for warnings
WASHINGTON (AP) — The Supreme Court says makers of generic drugs cannot be held responsible for warning consumers of the dangers of their drugs on the package's label when the brand-name equivalent doesn't.
The high court on Thursday ruled in a 5-4 decision against Gladys Mensing, who had sued PLIVA Inc. and other generic drug manufacturers.
She alleges that taking metoclopramide gave her a severe neurological movement disorder, but none of the generic drug's manufacturers and distributors made any effort to include warnings on the label.
Generic drug makers say 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. The drug is often taken for heartburn.
The high court said federal law trumped Mensing's complaint.