Janssen to Pay $11 Million in Topamax Birth Defect Lawsuit
A Philadelphia jury has ordered that Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, pay $11 million in a lawsuit alleging that treatment with Topamax resulted in a child's cleft palate.
About the Topamax Lawsuit
Bloomberg reports that the case was the second of approximately 134 cases pending in Philadelphia alleging that Janssen Pharmaceuticals failed to adequately warn doctors and patients of possible birth defects linked to their epilepsy drug Topamax.
The lawsuit was brought by Haley Powell who alleged that taking Topamax while pregnant resulted in her son, 5, suffering a cleft palate. According to Powell, her son will have to undergo at least five surgeries before the age of 21 in order correct the condition as well as resulting nasal deformities.
Powell’s attorney claimed that Janssen knew of the link between Topamax and oral clefts as early as 1997 and accused the company of concealing safety reports in 2003 and 2005.
This marks the second such loss in for Janssen in under a month with the company losing a $4.02 million verdict on October 30.
Topamax and Oral Clefts
Janssen Pharmaceutical’s Topamax was originally approved by the FDA in 1996 for the treatment of epilepsy.
The drug later gained FDA approval as a treatment for migraines in 2004 and as a weight loss drug in 2012 – as a result, more than 4 million people have been treated with Topamax.
In March of 2011, the FDA ordered that Janssen strengthen warning labels for Topamax as it was found that the drug was linked to an increased risk of birth defects, specifically cleft lips and palates.
According to data from the North American Antiepileptic Drug Pregnancy Registry, women who take Topamax during pregnancy are 21.3 times more likely to give birth to infants with an oral defect.
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