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The Pennsylvania Superior Court upheld an $11 million verdict returned in a product liability lawsuit against Johnson & Johnson’s Janssen Pharmaceuticals, which alleged the drug maker failed to adequately warn about the risk that side effects of Topamax use during pregnancy may cause children to suffer cleft lip and other birth defects.
The ruling stems from a November 2013 verdict in a Topamax cleft lip lawsuit filed by Haley Powell, whose son suffered facial malformations following use of the anti-seizure drug during pregnancy. As a result of the birth defects, the child has required multiple surgeries, which has left him with permanent deformities and disabilities.
The panel of appellate judges rejected an argument by Johnson & Johnson that the lawsuit was pre-empted by federal law and that the plaintiffs were unable to establish a link between Topamax and birth defects.
The Court found that the plaintiffs proved that Janssen failed to provide adequate label warnings on Topamax regarding the risk of cleft palate, cleft lip and other birth defects associated with use of the anti-seizure drug during pregnancy. The judges determined that it was reasonable for the jury to find that if Powell’s doctor been adequately warned, it is likely she would not have been prescribed Topamax while pregnant.
Johnson & Johnson also attempted to attack the $11 million damage award, arguing that the judgment was excessive. However, the appeals court found that the award demonstrated that the jury was informed and educated.
Topamax Pregnancy Risks
Topamax (generic topiramate) is a medication approved for treatment of epilepsy, migraines and for weight loss. It was first approved by the FDA in 1997, and has been widely available as a generic since 2006.
While Johnson & Johnson has maintained that adequate Topamax warnings were provided about the potential pregnancy risks, the FDA required the drug maker to update the label information in March 2011, warning about a potential link between Topamax and oral cleft birth defects when the medication is used during the first trimester of pregnancy. The FDA has urged doctors to avoid giving Topamax to pregnant women or women who are of child-bearing age and at a high risk of pregnancy.
Oral cleft birth defects include cleft palate and cleft lip, which occur when parts of the lip or palate fail to completely fuse together. The defect results in the child being born with defects as small as a notched lip to extreme as an open groove that goes from the roof of the mouth to the nose. Cleft palate and cleft lip can cause problems eating and talking and can increase the risk of ear infections, resulting in the need for corrective surgery.
The Powell case was one of three early test trials involving lawsuits over Topamax birth defects that went before juries in the Philadelphia County Court of Common Please, with each resulting in multi-million dollar damage awards.
In April 2014, the drug maker reached an agreement to settle at least 76 complaints, although details of the Topamax settlement were not disclosed at that time.