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A Philadelphia jury has ordered Johnson & Johnson to pay more than $4 million in damages for birth defects from Topamax, an antiseizure medication that allegedly caused a child to develop cleft lip and other malformations as a result exposure before birth.
The Topamax lawsuit was filed by April Czimmer, whose son, Blake, was born in 2007 with numerous birth defects that required surgery to correct. According to allegations raised at trial, the child developed a cleft lip and other injuries as a result of side effects of Topamax, which Czimmer took for six months during pregnancy.
The trial was the first of about 134 product liability lawsuits involving Topamax birth defects that are currently pending against Johnson & Johnson and their Janssen Pharmaceutical subsidiary. The complaints all involve similar allegations that the drug makers failed to adequately research the medications or provide adequate warnings for women or the medical community about the Topamax pregnancy risks.
At least 63 of the cases filed nationwide are pending in the Philadelphia Court of Common Pleas, where the Topamax litigation in Pennsylvania was centralized in September 2011.
A second trial began in the same court on Tuesday, involving a claim brought by Michael Gurley and Haley Powell, who claim that their five-year-old son was born with a cleft lip due to Topamax.
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.