A verdict of $3 million has been returned against Janssen Pharmaceuticals, Inc., a Johnson & Johnson unit, in a case alleging the company failed to warn about side effects associated with its epilepsy drug Topamax during pregnancy. The lawsuit was filed by the Wisconsin family of 5-year-old Payton Anderson, who was born with a cleft lip after her mother, Kelly, took Topamax to treat chronic migraines while she was pregnant. Philadelphia County Court of Common Pleas heard on Tuesday that Janssen allegedly didn’t update the label on Topamax to warn about recent research showing that it can increase the risk of cleft lips and cleft palates in newborns.
According to Law360, the lawsuit was first filed in December 2011. It is the third case of its kind filed in Philadelphia to go to trial, and court records show that more are on the way; over 130 additional lawsuits are pending as part of the a mass tort litigation. The previous two cases to go to trial returned verdicts in favor of the plaintiffs. A $4 million was returned in October and a family won $10 million after a verdict returned in their favor in December. A fourth Topamax lawsuit in Philadelphia went to trial late last month.
In 2010, Janssen agreed to pay over $81 million in response to an inquiry by the U.S. Department of Justice over its off-label marketing of Topamax.
In closing arguments on Tuesday, plaintiffs’ parties argued that Janssen had been receiving reports of craniofacial defects such as cleft lips and cleft palates since 2000. Despite this, they argued, they did not ask the U.S. Food and Drug Administration (FDA) to re-categorize the medication as a “Pregnancy Category D drug”, which warns consumers that human studies or adverse reaction data show there is evidence of fetal risk. At the time, Topamax was a Category C drug, which warns that risk of fetal complications have been shown in animal studies. The FDA re-categorized Topamax as Class D in March 2011.
