Topamax Lawsuits

Topamax is a medication manufactured by Johnson & Johnson subsidiary Janssen Pharmaceuticals (previously Ortho-McNeil Pharmaceuticals). It is approved by the U.S. Food and Drug Administration (FDA) in reducing the frequency of migraine headaches and preventing epileptic seizures in adults and children. In recent years, Janssen Pharmaceuticals has been subject to litigation claiming that Topamax causes birth defects.

Hundreds of women who have been prescribed Topamax to treat epilepsy and prevent migraine headaches have filed lawsuits alleging that Janssen Pharmaceuticals:

• negligently marketed Topamax
• knew about the risk of Topamax causing birth defects but insufficiently warned women and physicians
• withheld information about the risk of defects

The active ingredient in Topamax is Topiramate, which is also the main ingredient in weight loss drug Qsymia (formally called Qnexa). Qnexa was rejected by the FDA due to adverse side effects, including increased heart rate, suicidal thoughts, mood and sleep disorders, cognitive impairment, and potential seizures.

Topamax is linked to facial defects, low birth weight, and other organ and limb defects. In 2011, a warning was issued by the FDA linking Topamax to birth defects such as cleft lip and cleft palate. The drug registry data showed that the risk of oral birth defects was up to 16 times higher in women who took topiramate. FDA director Russell Katz issued a statement saying that “healthcare professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age … Alternative medications that have a lower risk of birth defects should be considered.”

Johnson & Johnson subsidiaries Janssen Pharmaceuticals and Ortho-McNeil Pharmaceuticals (now under the Janssen Pharmaceuticals name) are listed in the litigation.

Topamax Litigation

Following the FDA warning in 2011 that linked Topamax to birth defects, families of babies born with defects started filing lawsuits against Janssen Pharmaceuticals. By 2013, more than 130 cases were filed in the Philadelphia Court of Common Pleas, under a mass tort program (meaning a civil action about a type of injury involving a number of plaintiffs against one defendant).

By late 2013, a Philadelphia Court of Common Pleas found in favor of the plaintiffs in the first trials, resulting in a $4 million and $11 million awards to two families. These awards included future medical expenses, as well as money for pain and emotional distress and suffering. The juries found Janssen Pharmaceuticals negligible in causing the plaintiffs’ injuries and said they failed to warn doctors about the full extent of birth defect risks.

Janssen Pharmaceuticals unsuccessfully appealed both verdicts in 2015. They later agreed to settle a further 76 Topamax cases, and agreed to an $81 million fine for illegal marketing of Topamax for unapproved purposes.