Trial Underway in Topamax Lawsuit Over Cleft Lip, Cleft Palate Birth Defects

Trial began this week in Philadelphia for a Topamax birth defect lawsuit brought by a Virginia mother, who alleges that Johnson & Johnson’s Janssen Pharmaceuticals subsidiary failed to adequately warn pregnant women that side effects of the epilepsy drug may put their unborn children at risk of suffering a cleft lip or cleft palate.  

The case involves a product liability lawsuit filed by April Czimmer, whose six-year-old son was born with facial malformations that she blames on pregnancy side effects of Topamax. Czimmer used the medication during the first six months she was pregnant with her son to prevent epileptic seizures.

Czimmer’s case is the first of dozens of Topamax lawsuits pending nationwide to reach a jury over the drug maker’s warnings provided to pregnant women. At least 63 of the complaints are currently pending in Philadelphia Court of Common Pleas, where the state court Topamax litigation was centralized in September 2011.

All of the lawsuits raise similar allegations that Johnson & Johnson failed to properly research the impact of the medication on pregnant women or provide adequate warnings to consumers or the medical community about the risk of women giving birth to children with birth defects from Topamax, such as cleft lip, cleft palate, genital malformations and other problems.

Topamax (generic topiramate) was approved by the FDA in 1997, and it has been available as a generic since 2006. It is approved for the treatment of epilepsy, migraines and to promote weight loss.

Johnson & Johnson has maintained that adequate Topamax warnings were provided. However, in March 2011, the FDA issued a warning about the Topamax oral cleft birth defect risk among babies born to mothers who took the drug during the first trimester of pregnancy. The FDA has urged doctors to avoid giving Topamax to pregnant women or women who are of child-bearing age and at a high risk of pregnancy.

Cleft palate and cleft lip occur when parts of the lip or palate fail to completely fuse together. The defect results in the child being born with defects as small as a notched lip to extreme as an open groove that goes from the roof of the mouth to the nose. Cleft palate and cleft lip can cause problems eating and talking and can increase the risk of ear infections, resulting in the need for corrective surgery.