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Topamax Maker Failed To Adequately Warn Of Birth Defect Risk

There are several drugs on the market that when ingested by a pregnant woman exposes the fetus to great risk of birth defects.  A jury in Philadelphia  found that Janssen Pharmaceuticals, the manufacturer of Topamax, failed to adequately warn consumers and their doctors of the risk of birth defects associated with use of the migraine medication. The jury awarded $3 million to the parents of a child born with a cleft palate and bilateral cleft lip.

The mother took Topamax for migraine headaches throughout her pregnancy. The child, now five years old, had undergone multiple surgeries to reconstruct her palate and will require additional reconstructive surgery at age eight and eighteen. She continues to suffer from facial deformities that affect her speech.

The plaintiffs in this case presented a draft informed consent form that had been circulated at Janssen that would have required pregnant women to sign acknowledging the risks to unborn babies if exposed to the Topamax during the first trimester. This draft consent form was never finalized but is evidence that Janssen knew as early as 2001 that Topamax could cause birth defects in the babies whose mothers took the drug during pregnancy. The company did not warn of the risk of cleft defects until 10 years later in 2011. There are also reports that some company officials testified that the company was aware of these risks but failed to take action to notify physicians and their patients.

This jury verdict is a great result. Pharmaceutical companies must adequately warn physicians and consumers of the risks of their medications, particularly risks to unborn children.

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