The jury has spoken. The Philadelphia jury has ordered Johnson & Johnson to pay more than $4 million in damages for birth defects from Topamax.
Topamax is a popular anti-seizure medication that according to plaintiffs, caused children to develop cleft lip and other serious side effects as a result exposure before birth.
Plaintiff Complaint
April Czimmer, filed the Topamax lawsuit because her son, Blake, was born in 2007 with numerous birth defects that required surgery to correct.
Czimmer claimed that Blake developed a cleft lip as a result of side effects of Topamax. Czimmer took Topamax for six months during pregnancy.
PennsylvaniaTopamax Lawsuits
Johnson & Johnson and their Janssen Pharmaceutical subsidiary, is exposed in this trial and in others of about 134 product liability lawsuits of Topamax birth defects.
The plaintiffs allege that the drug manufacturers failed to research the medications or provide sufficient warnings for women or their doctors about the Topamax pregnancy risks.
These lawsuits are pending in the Philadelphia Court of Common Pleas, where the Topamax litigation in Pennsylvania was centralized in September 2011.
Second Topamax Trial in Progress
A second trial began in the same court, by Michael Gurley and Haley Powell, who claim that their five-year-old son was born with a cleft lip due to Topamax.
What is Topamax?
Brand name Topamax (generic topiramate) was approved by the FDA in 1997. The generic version has been available since 2006. Topamax is approved for the treatment of epilepsy, migraines and to promote weight loss.
FDA Warnings
In March 2011, the FDA issued a warning about the Topamax cleft lip and palate birth defect risk for babies born to mothers who took the drug during the first trimester of pregnancy.
The FDA has warned doctors not to give Topamax to pregnant women or women who are of child-bearing age and at a high risk of pregnancy.
What is Cleft Palate and Cleft Lip?
Cleft palate and cleft lip is also know as “Hare Lip.” Cleft palate and cleft lip occur when parts of the lip or palate fail to completely join together.
The severity of the defect varies, in mild cases the child can have a notched lip and in severe cases there is an open groove 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, requiring plastic and facial corrective surgery.
