Jury awards $3M in Topamax cleft palate case

A Philadelphia jury has awarded $3 million to the family of a 5-year-old girl born in 2009 with bilateral cleft palate and lip after her mother took Topamax (topiramate) for headaches during her pregnancy.

The March 7 verdict concluded that Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, failed to include warning labels about Topamax's risk for birth defect injuries such as cleft palate on the drug's label, according to Simmons Firm, the law firm that represented the family.

Topamax is prescribed for seizures and migraine headaches in adults. Kelly Anderson was prescribed Topamax throughout her pregnancy to treat chronic migraines. Her daughter has had 14 procedures, including four surgeries, to treat the condition.

In 2011, the U.S. Food and Drug Administration (FDA) required Janssen to update Topamax's label, and officially classified Topamax as a pregnancy category D medication, indicating there is evidence of fetal risk with the drug use. Data from the North American Antiepileptic Drug Pregnancy Registry indicate an increased risk of oral clefts in infants exposed to topiramate during the first trimester of pregnancy, according to the FDA.

Janssen previously agreed to pay more than $80 million to settle an investigation by the U.S. Department of Justice (DOJ) over the drug's marketing. The DOJ responded to reports that Janssen improperly marketed Topamax for psychiatric use, which was never approved by the FDA, according to drugrecallattorneysblog.com.

The federal government got involved when physicians started billing Medicare and Medicaid for Topamax prescriptions to treat psychiatric disorders such as binge eating, bipolar, and bulimia disorders.

This is the third Topamax case to go to trial, all of which have ruled against Janssen. The highest award was in November 2013, when another Philadelphia jury awarded $11 million to the family of a boy born with a cleft lip. Attorneys argued that Janssen knew about the risks of birth defects with the drug use and intentionally hid or minimized them.

More than 130 Topamax lawsuits are pending against Janssen.