October 31, 2013 — A jury in Philadelphia has awarded $4.02 million in the first Topamax birth defect lawsuit to go to trial, reports Bloomberg Businessweek.
The award will be paid by the manufacturer of Topamax, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. The jury found that Janssen failed to properly warn doctors and patients about the substantial increased risk of cleft palate and other birth defects when Topamax is used during pregnancy.
Mild cases of cleft lip involve a tiny notch in the upper lip. Severe cases involve clefts in the entire upper lip, nostrils, and the roof of the mouth (hard palate and soft palate).
The plaintiff, April Czimmer, took Topamax to treat migraine headaches for six months, between August 2006 and February 2007. In September 2007, she gave birth to a boy, Blake, who had cleft lip. He has undergone four surgeries. After the jury heard testimony, they deliberated for less than an hour before reaching their verdict.
There are at least 134 Topamax lawsuits pending in Philadelphia state court. Yesterday, a second trial began on behalf of a 5 year-old boy. Plaintiffs in the litigation allege that Janssen should be financially liable for birth defects caused by Topamax because they failed to adequately warn pregnant women about the risk.
The FDA issued a Drug Safety Communication about the link between Topamax and cleft lip in March 2011. According to the warning:
“The prevalence of oral clefts [from Topamax] was 1.4% compared to a prevalence of 0.38% – 0.55% in infants exposed to other antiepileptic drugs (AEDs), and a prevalence of 0.07 % in infants of mothers without epilepsy or treatment with other AEDs.”
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