Janssen Pharmaceuticals, a unit of Johnson & Johnson, has been ordered to pay $11 million to a mother who was prescribed Topomax and gave birth to a son with a cleft lip. It is the second recent multi-million dollar verdict involving Topomax, an anti-epilepsy drug.
In this case, Haley Powell’s lawyers argued Janssen failed to adequately warn her doctors that Topomax use could lead to birth defects, but said the company had long known. The lawyers stated animal studies as far back as the 1990s showed the risks for birth defects. A jury in the Court of Common Pleas in Philadelphia County awarded the verdict on November 18.
In 2007, a year after Powell began taking Topomax, she gave birth to her son Brayden. Now 5 years old, he faces at least five surgeries before age 21 to repair the defects and nasal deformities it has caused, her lawyers said.
There are 134 Topomax lawsuits pending in Philadelphia. Janssen said it will appeal the Powell verdict along with another one from Oct. 30. On that day, a Philadelphia jury awarded April Czimmer $4.2 million for her son’s cleft lip/cleft palate.
- Topomax, an anti-epilepsy drug, was approved by the U.S. Food and Drug Administration (FDA) in 1996.
- Topomax is still on the market. It was never recalled and is prescribed under the name Topomax. The generic – Topomirate – has been available since 2009.
- The FDA has also approved it as a treatment to prevent migraines, but not to take after a migraine has set in.
- The FDA has not approved it for these uses, but Topomax has been used experimentally by some doctors to treat psychiatric conditions and side effects of medications to treat psychiatric conditions.
- In 2011, the FDA asked Janssen to update the Topomax drug labeling. The labeling now states, “If you take topiramate during pregnancy, there is a higher risk that your baby will develop a cleft lip and/or cleft palate.” Read the rest here.
- If you are a woman of a child-bearing age and your doctor prescribes Topomax, thoroughly question them about other options. Also do you own research and visit another doctor. If you take the medication, make sure to use proper birth control and be closely monitored.
- If your family has suffered a child birth defect as a result of Topomax or other medication, it is important to contact an experienced lawyer as soon as possible. Birth defects may require multiple surgeries over many years. It is important to obtain the right medical treatment as soon as possible.
J&J’s Janssen Loses $11 Million Jury Verdict Over Topomax, Bloomberg