Drug Company Faces Second Lawsuit Over Risk of Birth Defect
Johnson & Jonhson owned pharmaceutical company Janssen is under fire once again as a second trial ensues over claims the the company's seizure drug Topamax resulted in birth defects.
The suit was brought by a set of parents on behalf of their 5-year-old son. The child suffered from a cleft palate that is the parents allege is attributable to Topamax.
About Topamax and the J&J Lawsuit
Topamax, which was approved in 1996, was one of Johnson & Johnson’s top selling medications.
Accroding to Business Week, Janssen and Johnson & Johnson are now being criticized for failing to disclose the potential for birth defects to pregnant women who are prescribed the drug. There are currently 134 suits against the drug maker, regarding Topamax, pending in Philadelphia.
Lawyers to Janssen contend that the drug has been carefully and intensively studied, was deemed by the FDA to be safe and effective, and that Janssen has taken adequate measures to ensure the safety of its drug.
The paintiff claims that she was not warned of the risks of Topamax nor was the doctor who prescribed the drug as Janssen failed to relay the risk of birth defects.
It was found even in the preliminary animal studies, that birth defects could result from Topamax.
Janssen refutes any claims that they took inappropriate and inadequate measure to inform doctors and users of the effects and holds that the suit is illegitimate.
Birth Defect Caused by Topamax
- Cleft palates, known as oral clefts, occur when parts of the lip or palate don’t completely fuse together in the first trimester of pregnancy.
- The condition is a common congenital malformation.
- About 4,500 babies are born each year in the U.S. with cleft lip.
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