Jury in Topamax birth defects lawsuit awards $11 million verdict against Johnson & Johnson’s Janssen Pharmaceuticals

by Eric Pearson

A Pennsylvania jury has ordered Johnson & Johnson’s Janssen Pharmaceuticals unit to pay $11 million in a lawsuit claiming the company’s anti-seizure drug Topamax caused birth defects. Haley Powell became pregnant in October of 2007, more than a year after she began taking Topamax and another anti-epileptic drug.

Powell alleged—and the jury agreed—that Janssen failed to adequately warn her doctors of the risks of Topamax before she gave birth to a son with a cleft lip. Her son now faces at least five surgeries before age 21 to repair the defect, which also caused nasal deformities.

Powell’s case was the second of more than 130 such lawsuits pending in Philadelphia over the epilepsy drug Topamax. The lawsuits allege that Janssen knew that the drug could cause debilitating birth defects yet intentionally kept the information from physicians and patients. The first trial resulted in $4.02 million verdict against Jannsen in October. Additional trials are scheduled for February and March

Topamax was approved by the FDA in 1996 and was one of Johnson & Johnson’s top sellers before it lost patent protection in 2009. Lawyers for the plaintiffs contend that Janssen knew as early as 1997 that animal studies showed an increased risk for birth defects, especially oral clefts.

The FDA asked the company to change the label in March 4, 2011, when it said preliminary studies suggested Topamax might contribute to cleft lips and cleft palates in infants born to women who used the medication during pregnancy. The government asked that the label be updated to reflect a stronger classification and warning for the drug.

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