Find a Topamax Lawyer
Topamax use during pregnancy has been linked to a heightened risk of birth defects in children. Evidence suggests the manufacturer of the drug may have been aware of significant safety concerns but failed to adequately warn physicians and consumers. If your family has been affected by birth defects such as cleft lip or cleft palate, you may wish to consult a Topamax lawyer about your legal rights.
Our experienced drug injury attorneys understand the sensitive nature of these cases and can evaluate your potential claim at no cost. To speak with a Topamax lawyer in our office call (866) 808-2424 or send a message using our brief online form at any time.
Topamax Lawyers Allege Failure to Warn
In March 2011, the U.S. Food and Drug Administration issued a safety communication to warn patients about using Topamax during pregnancy. At that time, the FDA changed what is known as the Pregnancy Category for Topamax. The drug was originally placed under Pregnancy Category C, which meant data from animal studies showed potential fetal risks but no adequate data from humans or clinical trials was available. In light of growing medical evidence, however, the FDA subsequently changed Topamax to Pregnancy Category D based on “positive evidence of human fetal risk based on human data.”
The FDA action followed data from the North American Antiepileptic Drug Pregnancy Registry that found an increased risk of cleft lips and cleft palates in infants exposed to Topamax or topiramate during the first trimester of pregnancy. Additional data from the U.K. Epilepsy and Pregnancy Register showed similar findings.
Our Topamax lawyers are investigating whether the manufacturer was aware of this data before the FDA issued its safety alert in March 2011 and whether the company intentionally or negligently failed to warn patients and their doctors.
The FDA went on to advise that unless permanent injury or death could result, women of childbearing age should carefully consider using alternative seizure or migraine medication in place of Topamax or begin effective birth control treatment.
Topamax Jury Verdicts
The most recent Topamax lawsuit completed a jury trial in March 2014 with a verdict of $3 million in favor of the victims and against the drug company. Attorneys for the plaintiffs argued that the manufacturer should have included Topamax as Pregnancy Category D when the drug first came on the market in 1996, and that the company should have informed doctors and consumers about the true risk of oral clefts irrespective of the FDA pregnancy category.
At trial, Topamax lawyers also presented arguments that the manufacturer had received reports as early as 2000 that women using Topamax during pregnancy gave birth to infants with craniofacial defects such as cleft lip and cleft palate.
Previous trials resulted in awards of $10 million in November 2013 and $4 million in October 2013. Additional cases are awaiting trial as Topamax lawyers and the drug company consider a comprehensive settlement of pending claims.
Consult an Experienced Topamax Lawyer
If your family was affected by birth defects, you may have important legal rights. The first step is to receive a case evaluation from an experienced Topamax lawyer. Our attorneys review cases at no cost and represent all drug injury clients on a no-fee, contingency basis. We welcome your phone call or online inquiry at any time.