A Philadelphia jury ordered Johnson & Johnson (J&J)’s Janssen Pharmeceuticals unit to pay $11 million in a lawsuit alleging the company failed to warn doctors and patients that its drug Topamax can cause birth defects when taken during pregnancy.
The Topamax lawsuit, brought on behalf of a woman who gave birth to a son with a cleft lip, is the second loss for Janssen in less than a month. The company lost a $4.02 million verdict in October in a lawsuit on behalf of a Virginia woman whose son suffered similar injuries. Janssen said it will appeal both verdicts.
This case was selected by the drug manufacturer to go to trial.
The second plaintiff became pregnant after more than a year of taking Topamax and another anti-epileptic drug. Her five-year-old son faces at least five surgeries before age 21 to repair the cleft lip defect, which also caused nasal deformities.
Cleft lip and palate range from a small notch in the lip to a groove that runs into the roof of the mouth and nose. The U.S. Food and Drug Administration (FDA) asked Janssen to change the Topamax label in March 2011 after studies suggested the drug might contribute to cleft lip and palate in infants born to mothers who used the drug during pregnancy. The FDA also reclassified Topamax to a Pregnancy Category D drug, which means there is evidence of a risk to unborn babies based on human studies, but the benefits may warrant use of the drug in some pregnant women despite risks.
About 134 more Topamax lawsuits are pending in Philadelphia.