$10M Verdict Against Janssen in Topamax LawsuitNov 19, 2013
On Monday, a Philadelphia state jury decided that Janssen Pharmaceuticals Inc. must pay more than $10 million to the parents of a child who allegedly suffered birth defects from prenatal exposure to the company's epilepsy drug Topamax.
The jury determined that Janssen, a Johnson & Johnson unit, did not sufficiently warn doctors about the drug’s birth defect risks, plaintiffs' counsel said, according to Law360. The suit alleged the company knew about the risks years before the drug was prescribed to patients.
The plaintiffs’ five-year-old son allegedly developed a cleft palate and other defects after being exposed to Topamax during his mother's pregnancy. This verdict came less than three weeks after another Philadelphia jury returned a $4 million verdict in a related suit, alleging Topamax caused similar injuries in another child, Law360 reports.
The U.S. Food and Drug Administration (FDA) approved Topamax as an anti-epileptic drug and to prevent migraine headaches. According to Law360, in 2010, Janssen agreed to pay more than $81 million to settle a Justice Department inquiry into off-label marketing of Topamax, and in 2011 the FDA issued a warning that Topamax increased the risk of certain congenital defects, particularly oral clefts, in babies born to women who took Topamax during pregnancy.
Data from the North American Antiepileptic Drug Pregnancy Registry linked an increased risk of cleft lips and cleft palates for infants exposed to Topamax and its generic versions during the first trimester of pregnancy, the FDA said. Cleft lips and cleft can cause a variety of problems, including ear infections and problems with eating and talking.
The agency said that Topamax would be reclassified Pregnancy Category D, meaning there is "positive evidence of human fetal risk based on human data," but that the potential benefits of the drug in pregnant women may outweigh the risks in certain situations.
Plaintiffs in the Pennsylvania suits alleged that Janssen did not fully, truthfully, or accurately disclose Topamax data to the FDA, to them, and to their doctors. They say Janssen intentionally and fraudulently misled the medical community and the public about the risks to a fetus associated with the use of Topamax during pregnancy, according to Law360.