The case, entitled Powell v. Janssen Pharmaceuticals, Philadelphia No. 110502251, is only the second of 132 Topamax mass torts currently underway to render a verdict, according to Stanley Thompson, director of the Philadelphia Court of Common Pleas' Complex Litigation Center. The verdict was handed down on November 20.
In their lawsuit the parents alleged that Janssen had failed to warn of the risk for birth defects associated with the anticonvulsant medication. The US Food and Drug Administration (FDA) has issued a warning about the risk of Topamax side effects including a risk of Topamax birth defects in children exposed to Topamax prior to birth. These Topamax oral birth defects include a risk of cleft lip and cleft palate. Because of the risk of Topamax cleft palate or cleft lip, the FDA has requested that Topamax carry a stronger warning and announced it will change Topamax from Pregnancy Category C to Pregnancy Category D.
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Topamax, known generically as topiramate, is approved by the FDA to treat certain types of seizures and to prevent migraine headaches. Based on new research, the FDA suggests that health care professionals strongly weigh the benefits and risks of topiramate when prescribing it to women who are of childbearing age, and Topamax will now be classified as a Pregnancy Category D drug. Part of the problem is that oral clefts occur when parts of the lip or palate do not completely fuse in the first trimester of pregnancy??"before some women even know they are pregnant.
The first lawsuit against Janssen for Topamax birth defects that produced a verdict was Czimmer v. Ortho-McNeil-Janssen Pharmaceuticals, which rendered a $4 million verdict October 31, according to Thompson.