Jury Awards $10 Million for Failure to Warn About Topamax’ Birth Defects

A Pennsylvania jury has awarded $10 million to a South Carolina couple who alleged their child’s birth defects were caused by in vitro exposure to the anticonvulsant drug, Topamax, manufactured by Johnson & Johnson subsidiary, Janssen Pharmaceutical Inc.

Michael Gurley and Haley Powell of South Carolina sued Janssen, alleging that their son Brayden was born with a cleft lip as a result of Powell’s ingestion of Topamax during her pregnancy. They accused the drug maker of failing to inform expectant mothers about the drug’s risks of birth defects, including cleft palate and cleft lip, despite the fact that animal studies revealed these defects.

According to the complaint, Powell was prescribed Topamax in 2006 for her seizures and continued taking the drug until October 2007 when she became pregnant. Plaintiffs accused Janssen of concealing Topamax’s safety reports in 2003 and 2005.

Baby Brayden underwent surgery to repair his cleft lip when he was just three months old and is expected to undergo five additional surgeries to repair his nasal deformities.

The jury in the Philadelphia County Common Pleas Court found that defendant Ortho-McNeil-Janssen Pharmaceutical Inc. failed to warn the doctor of Haley Powell that Topamax taken during pregnancy could cause birth defects.

“Janssen knew about Topamax’s serious risk of causing birth defects years before these mothers were prescribed the drug but did not advise physicians of those risks. Instead, Janssen elected to continue to market its billion-dollar drug,”

the family’s lawyers said in a press release. This case is the second of approximately 134 pending in Philadelphia.

Topamax was approved by the U.S. Food and Drug Administration (FDA) in 1996 for use as an anti-epileptic drug and also approved to prevent migraine headaches before it lost patent protection in 2009.  In 2010, Janssen agreed to pay more than $81 million to settle a U.S. Department of Justice inquiry regarding Janssen’s off-label marketing of the drug.

Just three weeks ago, a jury in the same court awarded a family $4.02 million in the first Topamax birth defect trial, causing their 6-year-old son similar injuries.

According to the FDA, data from the North American Anti-Epileptic Drug Pregnancy Registry linked an increased risk of cleft lips and cleft palates to infants who are exposed to Topamax and its generic versions during the first trimester of pregnancy. The agency said the pregnancy category for Topamax would be changed to Pregnancy Category D, which means there is “positive evidence of human fetal risk based on human data.”

Additionally, recent data revealed that women taking Topamax while pregnant were 21 times more likely to give birth to a child with cleft palate deformities or cleft lips.  In older children, several birth defects have been linked to Topamax, such as limb malformations, genital birth defects, spina bifida, craniofacial defects, hypospadias, neural tube defects, as well as lung and heart defects.

This is just the beginning of more than one hundred cases awaiting trial over the deceit, concealment and greed on Janssen’s part. We will keep you updated on the outcomes.  For more information, feel free to contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).

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