Court Rejects Acne Drug Manufacturer's Preemption Argument

GREENSBORO, N.C. - A failure-to-warn claim in a pharmaceutical product liability case may not be preempted absent evidence that a warning submitted by the manufacturer was rejected by the FDA and, as a result, not included on the drug's approved label, a federal judge has ruled. Sarli v. Mylan Bertek Pharmaceuticals Inc., No. 07-43 (M.D. N.C.).

Judge N. Carlton Tilly of the U.S. District Court for the Middle District of North Carolina ruled July 19 that Taimaz Sarli's state law failure-to-warn claim based on injuries he suffered as a result of taking the acne drug Amnesteem does not conflict with …