According to a February 28, 2013 lawsuit filed in Philadelphia, Pennsylvania, an Indiana woman has alleged that her child was born with a cleft palate as a result of her ingestion of Topamax during pregnancy. Topamax, manufactured by New Jersey based Ortho-McNeil-Janssen Pharmaceuticals, is prescribed to treat epilepsy in adults and children.

The lawsuit alleges multiple counts including design defect, failure to warn, negligence, negligent design, fraud, misrepresentation and breach of express and implied warranties. The lawsuit is part of the consolidated mass tort action currently underway in Philadelphia.  To date, the manufacturer has paid $75 million to the United States Department of Justice and other plaintiffs for violations of the federal False Claims Act for improper marketing, promotion and sale of Topamax.

Trials are currently set for some of the Philadelphia Topamax cases starting in July 2013.