Birth Defect Lawyer Blog

Back in October, this blog discussed how the weight loss drug Qnexa, manufactured by Vivus, posed an increased risk of birth defects for pregnant women. Qnexa contains topiramate and phentermine, with topiramate being an ingredient in antiepileptic seizure medication. Antiepileptic drugs have been linked to a higher rate of birth defects -- such as cleft palate -- if taken in the first trimester of pregnancy. In October, Vivus had resubmitted an application to the Food and Drug Administration (FDA) after making a modification: use of Qnexa would be limited to those over 55 years of age.

The FDA staff recently turned to an advisory panel to weigh in on whether the benefits of Qnexa outweigh any harmful health effects, such as heart problems or birth defects. Trials revealed that while people who took Qnexa lost more weight than those on a placebo, they also had more health problems, such as memory loss, that could worsen with time. The FDA had previously rejected Vivus's application in 2010 out of concern over rapid heart beat and an increase in birth defects. The FDA advisory panel, the Endocrinologic and Metabolic Drugs Advisory Committee, voted by an overwhelming 20 to 2 margin to recommend approval for the drug.

Although the advisory panel expressed the same concerns that led to the first application's rejection, the panel noted that Qnexa's two main ingredients were already circulating out in the market and could be prescribed off label. One panelist commented that they couldn't "doubt the benefit of weight loss." At the same time, the advisory panel cautioned that post-approval studies be conducted to monitor cardiovascular side effects. While the FDA is not required to follow the recommendations of an advisory panel, it usually does. The FDA is expected to issue its final decision on April 17th.

Even though Qnexa is being limited to women over 55 years old, topiramate is featured in many antiepileptic drugs taken by younger women. If you took antiepileptic medication while pregnant, and your child was born with a birth defect, you could sue the manufacturer and/or your physician for relief. You would sue the manufacturer under product liability theory. You would argue that the drug manufacturer had a duty to create as safe a drug as possible, but breached that duty by creating an unreasonably dangerous drug. This drug could have been made safer without a change in price or effectiveness. It may also have lacked a warning label that adequately spelled out the dangers. The manufacturer's breach caused your injury -- exposure to the harmful effects while pregnant -- and your damage was your child's birth defect.

You could also sue your physician under medical malpractice theory. To be successful, you would need to prove that the physician knew, or should have known, about the dangers of taking antiepileptic medication during the first trimester, and that the physician failed to warn you before prescribing the drug. All physicians have a duty to warn patients about potential problems with treatment so patients can make informed decisions.