A Pennsylvania jury has returned a $3 million verdict against a Johnson & Johnson unit in a case accusing the company of failing to warn a woman of the risk of birth defects when using its anti-epilepsy drug Tomapax during pregnancy. It was proved during the trial in the Philadelphia County Court of Common Pleas that Janssen Pharmaceuticals Inc. didn’t update Topamax’s label to reflect data showing that the drug resulted in increased incidents of cleft lips and cleft palates in newborn babies.
The family filed suit in December 2011 alleging that the child, who is now 5 years old, was born with a cleft lip after doctors continued to prescribe Topamax to her mother to treat chronic migraines during her pregnancy. This case is the third such suit filed in Philadelphia to go to trial. There are more than 130 additional cases pending as part of a mass tort program in the city’s court system.
Interestingly, the company has reached an agreement to settle a number of Topamax cases pending in the very same court, including a similar suit in which a mother’s use of Topamax around the time of her child’s conception allegedly led to him developing a cleft palate that has required at least five surgeries. According to the company, terms of the agreement are confidential.
Juries in two Topamax cases previously tried in Philadelphia have returned verdicts in favor of the Plaintiffs. A jury in October returned a $4 million verdict against Janssen in a similar suit. Another family won $10 million in damages after a jury returned a verdict in their favor in December. Trial in a fourth Topamax case in Philadelphia began in late February. In 2010, Janssen agreed to pay more than $81 million to put to rest a U.S. Department of Justice inquiry into off-label marketing of Topamax.
During closing arguments in the most recent case, David Matthews of Matthews & Associates told the jury that Janssen had received reports as early as 2000 that women taking Topamax had given birth to newborns with craniofacial defects including cleft lips and cleft palates. Dave pointed out that the company had not requested that the U.S. Food and Drug Administration include Topamax as a so-called Pregnancy Category D drug, which warns consumers that there is evidence of fetal risk based on adverse reaction data or studies in humans. Topamax was initially approved as a Category C drug, which warns that studies on animals have shown adverse effects on fetuses. The FDA issued an alert in March 2011 making the drug a Category D medication. Dave did a very good job in this case and got a good result for the child and his family.
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