Topamax (generic name topiramate) is an anticonvulsant drug prescribed by doctors to treat epilepsy and prevent migraine headaches. Topamax is manufactured by Johnson & Johnson’s Janssen Pharmaceuticals subsidiary, with a market share of nearly 21%.
The Food and Drug Administration (FDA) issued a warning in early 2011 of a hidden danger for women who were taking Topamax during pregnancy. These expectant mothers are 21 times more likely to develop oral cleft defects in their newborns than babies born to women who did not take the drug. Topamax may also decrease the effectiveness of estrogen-containing oral contraceptives, leading to unplanned pregnancies.
A number of lawsuits have followed the FDA announcement. In late 2013, the first of several Topamax birth defect trials resulted in awarding verdicts for the plaintiffs, with one jury awarding $4 million to one family in October and $11 million to another family in November.
The juries who delivered the verdicts ultimately found that Janssen failed to warn doctors about the full extent of Topamax’s birth defect risks. They also determined that the company’s negligence was a substantial factor in causing the plaintiffs’ injuries.
Topamax has faced legal problems before in marketing its drug. In 2008, Neurology published a report disclosing increased birth defect risks: “Overall, the rate of oral clefts observed was 11 times the background rate.” Topamax’s U.S. sales had had already exceeded $10 billion by 2008 and the drug manufacturer was promoting Topamax for “off label” treatment for bipolar disorder and alcohol dependency.
Serious Birth Defects Linked to Topomax
- Cleft lip or palate (leads to ear infections and difficulty eating or talking)
- Hypospadias (defect of the urethra in male babies)
- Limb malformation
- Lung defects
- Heart defects
- Spina bifida (split spine)
We Can Help
The experienced attorneys at Charles G. Monnett III & Associates provide a free initial consultation, support, and assistance in finding resources to help you and your family deal with injuries caused by Topamax. We can also help you pursue legal action.