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First Topamax® Trial Resulted in $4 Million Jury Verdict for Plaintiff

verdictsA Philadelphia jury has awarded $4 million dollars against Johnson & Johnson’s Janssen Pharmaceutical unit and in favor of a plaintiff, a mother named April Czimmer who took the company’s drug Topamax® for six months before giving birth to a son with a cleft lip. April Czimmer took the drug from August 2006 through February 2007 for the treatment of migraines. Her son was born in September 2007 with a cleft lip requiring four surgeries. Bloomberg reports that her son faces at least four more surgeries. The Czimmer case was the first of approximately 134 Topamax® lawsuits currently pending in Philadelphia state court. The case is Czimmer v. Janssen Pharmaceuticals Inc., Case No. 110503459, Court of Common Pleas, Philadelphia County, Pennsylvania.

Topamax® is an epilepsy and migraine drug manufactured by the Janssen Pharmaceutical unit of Johnson & Johnson, which has been used for off-label purposes in the treatment of psychiatric disorders. It was approved by the Food and Drug Administration (FDA) for epilepsy and seizure treatment in 1979, and later on for migraine treatment in 2004. According to Bloomberg, the drug was Johnson & Johnson’s top seller before it lost patent protection in 2009. In March 2011, the FDA issued a warning that Topamax®  may increase the risk of oral cleft birth defects among infants whose mothers use the drug during the first trimester of pregnancy. The birth defects range from a small notch in the lip, to a groove that runs in to the roof of the mouth and nose.

In 2011, the FDA changed the Topamax®  label classification to a “Pregnancy Category D drug”, signifying that there was scientific evidence the drug causes birth defects in humans. The FDA advises that Pregnancy Category D drugs should be used during pregnancy only if the drug is needed in a life-threatening situation or for a serious disease where safer drugs cannot be used or are ineffective.

Data from the North American Antiepileptic Drug Pregnancy Registry has found that children born to mothers who took Topamax®  during the first trimester of pregnancy experienced oral cleft defects at a rate of 2.55 to 4.24 times more often than those whose mothers used other epilepsy drugs. Also, in 2008, another study found that children born to mothers who used Topamax®  during pregnancy had an oral cleft defect rate 11 times higher than would be expected in the normal population, and genital defects at a substantially higher rate than the general population.


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