A Virginia family has won $4.02 million in a pharmaceutical injury lawsuit involving the drug Topamax. According to Bloomberg News, jurors deliberated for less than an hour before reaching the verdict for April Czimmer, whose son was born in 2007 with a cleft lip that ultimately required four surgeries. The case was the first of about 134 pending in Philadelphia courts alone, alleging that Topamax, an anti-seizure drug also used off-label for migraines and psychiatric conditions, caused birth defects. A similar lawsuit started Oct. 29 in South Carolina; observers predict that a federal class action or multi-district litigation will eventually be filed. Topamax was a top seller for Johnson & Johnson subsidiary Janssen Pharmaceutical before its patent protection ended in 2009.
Czimmer took Topamax for its most common off-label use, prevention of migraines, between August 2006 and February 2007; her son was born in September of 2007. At that time, Topamax carried no special label, although anti-epileptic drugs were known to elevate the risk of cleft palates somewhat. In 2011, the FDA issued a warning that Topamax carries an increased risk of cleft lip and cleft palate in children of women taking the drug. It also moved the drug from pregnancy category C, which says animal studies indicate possible harm to unborn children, to category D, which says there is positive evidence of harm to unborn children. When Czimmer’s son Blake was born, he had a cleft lip severe enough to require four surgeries.
Cleft lips and palates range from a notch in the lip to a groove running all the way to the nose and the top of the mouth. They require surgical correction and can interfere with the baby’s ability to breastfeed; contribute to ear infections; and later cause problems with eating solid food and speaking. The FDA’s 2011 warning said 0.07 percent of mothers not being treated for epilepsy have cleft-palate babies; the risk was 0.38 to 0.55 percent of mothers using other anti-epileptic drugs and 1.4 percent for mothers taking Topamax. Similar numbers were reported in Britain. In deciding the case, the jury weighed arguments from Johnson & Johnson that genetics, maternal smoking or other drugs could have caused the cleft lip of Czimmer’s son.
Czimmer’s attorney predicted that Johnson & Johnson will face many more Topamax birth defect lawsuits in the future. Given the drug’s high sales and its widespread off-label uses, this seems likely. In fact, Johnson & Johnson has already faced a $6.14 million fine from the FDA for promoting Topamax for psychiatric conditions. Companies may not promote any drug for off-label use. In addition, the FDA said, no adequate clinical trials showed Topamax was safe and effective for any psychiatric use. Though the company was forced to discontinue off-label promotion, it likely added to the hundreds of women and families who could be plaintiffs in a Topamax birth defect lawsuit.
If your family has suffered a birth defect or any other injury because of a dangerous drug you thought was safe, don’t wait to call Carey, Danis & Lowe for a free, confidential consultation. You can send us a message online anytime or call us toll-free at 1-877-678-3400.
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