In a Topamax lawsuit last month, a Philadelphia state jury awarded a verdict against Janssen Pharmaceuticals Inc. Janssen will have to pay more than $10 million to the parents of a child who suffered birth defects from the company’s epilepsy drug Topamax. The jury found that the Johnson & Johnson unit did not sufficiently warn doctors about the increased risks of birth defects linked to use of the drug. Janssen knew about the risks years before the drug was prescribed to patients.
The family’s 5-year-old child developed a cleft palate, as well as other defects after being exposed to Topamax during his mother’s pregnancy.
This verdict came less than three weeks after another Philadelphia state jury returned a $4 million verdict against Janssen in a related suit alleging Topamax caused another family’s child to develop similar injuries.
The U.S. Food and Drug Administration (FDA) approved Topamax as an anti-epileptic drug and to prevent migraine headaches.
In 2010, Janssen agreed to pay more than $81 million to settle a U.S. Department of Justice inquiry into off-label marketing of Topamax.
In 2011, the FDA issued a warning that Topamax increased the risk of development of certain congenital defects, particularly oral clefts in babies who were born to women who ingested Topamax during their pregnancy. Data from the North American Antiepileptic 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.
Cleft palates and cleft lips are birth defects that occur when parts of the lip or palate do not completely fuse together early in the first trimester of pregnancy. The FDA said that the pregnancy category for Topamax would be changed to Pregnancy Category D, meaning there is “positive evidence of human fetal risk based on human data,” but that the potential benefits of the drug in pregnant women may outweigh the risks in certain situations.
Plaintiffs in the Pennsylvania suits alleged the company did not fully, truthfully or accurately disclose Topamax data to the FDA, to them and to their doctors. It was alleged further that Janssen intentionally and fraudulently misled the medical community, the public and Plaintiffs about the risks to a fetus associated with the use of Topamax during pregnancy.
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