Topamax Maker Failed to Adequately Warn of Cleft Risk

Kelly Anderson took Topamax for migraine headaches throughout her pregnancy from December 2007 through August 2008. The Anderson’s daughter, Payton, was born with a cleft palate and bilateral cleft lip. Payton underwent multiple surgeries to reconstruct her palate. Now five-years-old, she continues to suffer from facial deformities, as well as dental abnormalities, which cause speech problems. Payton will require additional reconstructive surgery at age eight, and major reconstructive surgery at age 18.

The Andersons sued Janssen Pharmaceuticals, Inc., the manufacturer of Topamax, alleging that the company failed to adequately warn of the risk of birth defects. Although at the time, the label stated that “Topiramate has demonstrated selective developmental toxicity, including teratogenicity, in experimental animal studies,” the plaintiffs asserted that Janssen failed to warn doctors about the risk of birth defects to unborn human babies. Medications shown to have adverse effects in animal reproductive studies are labeled by the FDA as ‘Category C’. The plaintiffs asserted, however, that topiramate should have been classified as a Pregnancy Category D, as this would have accurately conveyed to physicians the risk to unborn human babies exposed to the medication during the first trimester.

The plaintiffs presented evidence that an internal company draft for an informed consent form showed that Janssen was aware as early as 2001 that Topamax could cause serious birth defects in humans. Despite this, they contended, the company failed to warn of the risk of oral clefts until 2011. The plaintiffs also presented evidence of animal studies from the 1990s showing a link to birth defects, as well as pregnancy-outcome reports in 2000, 2002, and 2005 linking the drug to birth defects. Some company officials also reportedly testified that the company was aware of the risk of human birth defects.

Payton’s treating Neurologist testified that if Topamax had been labeled as Pregnancy Category D and had warned of the risk of birth defects in humans, she would not have prescribed the drug to Kelly Anderson during her pregnancy.

Among other damages, the plaintiffs sought medical expenses for Payton’s future surgeries.

Janssen argued that the label for Topamax was adequate and that ‘Category C’ and ‘Category D’ were no different, as both conveyed the risk of birth defects to fetuses.

The jury found that the defendant failed to adequately warn Kelly Anderson’s prescribing physician of the risk of birth defects associated with Topamax and that this failure was the proximate cause of Payton’s injuries. The jury awarded $3 million, including $1.5 million to Payton’s parents for healthcare expenses and other damages.

If you or a loved one suffered adverse side effects from prescribed medication, you may be entitled to compensation for your damages. Contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878) for more information.

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