First Topamax Trial Goes to Jury

A jury has begun deliberation in the first trial of more than 130 Topamax lawsuits pending in Philadelphia over claims the drug caused birth defects such as cleft palate and lip.

The plaintiff is a Virginia woman who alleges she wouldn’t have taken Topamax for six months if the company had warned her about the risks to her unborn baby. Her son suffered physical deformities that have required four surgeries since he was born in 2007.

A verdict requires agreement by at least 10 jurors regarding whether Johnson & Johnson’s Janssen Pharmaceutical unit negligently failed to warn of the risks, and that the company’s negligence was a substantial factor in the boy’s injuries, according to Judge Victor J. DiNubile.

Cleft palate is a birth defect in which the two plates of a person’s skull that form the roof of their mouth do not join during fetal development. Cleft lip does not affect the palate structure of a person’s mouth, but it can range from a small notch that forms on the lip to a complete split that extends from the lip to the base of the nose.

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