Topamax Lawsuit Underway

Philadelphia, PAA Topamax lawsuit alleging that Topamax side effects include a risk of birth defects is underway in Philadelphia. The lawsuit alleges Janssen Pharmaceuticals did not warn expectant mothers about the risk of Topamax side effects in children.

As reported by Businessweek (10/15/13), the lawsuit was filed by April Czimmer, who used Topamax for six months and gave birth to an infant with cleft lip and cleft palate, requiring four surgeries. Czimmer says she would not have taken Topamax if she had been warned about the risk to her unborn child and alleges Janssen was negligent in not warning patients about the risk of birth defects.

Topamax is used to treat epilepsy and is prescribed to treat migraines, the reason for which Czimmer was prescribed the medication. Czimmer’s son, Blake, was born in 2007, but warnings about the risk of oral clefts were not added to Topamax’s label until 2011. Plaintiffs allege, however, that Janssen was aware of the risk of birth defects in 2002. The lawsuit also alleges Janssen marketed Topamax for off-label uses.

In 2011, the Food and Drug Administration (FDA) warned about a link between the use of Topamax while pregnant and an increased risk of having a baby born with oral clefts. At the time, the FDA noted that the benefits and risks of topiramate (the generic version of Topamax) should be carefully weighed when Topamax is prescribed, “particularly for conditions not usually associated with permanent injury or death.” Of concern is that oral clefts occur in the first trimester of pregnancy, often before women are aware that they are pregnant.

When the FDA made its announcement about Topamax, it noted that it was reclassifying the drug from Pregnancy Category C to Pregnancy Category D, meaning there is evidence of human fetal risk based on human data. The FDA did state, however, that there are some circumstances in which the risk of Topamax might be outweighed by the benefits.

Meanwhile, Johnson & Johnson, parent company to Janssen Pharmaceuticals, said in its quarterly report that it has added $872 million to its fund to pay for pending litigation. The company faces thousands of lawsuits linked to a variety of medications and medical devices, in addition to allegations regarding illegal marketing of its medications.

The lawsuit is Czimmer v. Janssen Pharmaceuticals Inc., 110503459, Court of Common Please, Philadelphia County, Pennsylvania.