Jury Awards $10 Million for Topamax Birth Defect Lawsuit
November 2013 — A jury in Philadelphia has awarded $10 million to resolve a Topamax lawsuit filed on behalf of a five year-old boy who was born with cleft palate and other birth defects after his mother took Topamax during pregnancy. The verdict came less than three weeks after another Philadelphia jury awarded $4 million for a similar lawsuit.
The juries determined that Janssen and Johnson & Johnson knew about the pregnancy risks of Topamax at least as early as 2003, but failed to warn doctors or patients. Plaintiffs allege that drug-makers intentionally and fraudulently misled them about evidence linking Topamax and birth defects.
What is Topamax?
Topamax (topiramate) was approved by the the U.S. Food and Drug Administration (FDA) to control seizures caused by epilepsy and to prevent migraine headaches. It is also used “off-label” to treat non-serious medical conditions. Between January 2007 and December 2010, approximately 4.3 million people used Topamax.
Studies of Topamax and Birth Defects
Data from a North American birth defect registry suggests that Topamax is associated with a 20-fold increased risk of oral clefts. Approximately 1.4% of infants exposed to Topamax were born with an oral cleft, compared to 0.38% – 0.55% of infants exposed to other anti-epileptic drugs, and 0.07% of non-exposed babies. Similar risks were observed in a U.K. birth defect registry, which found that 3.2% of babies exposed to Topamax had an oral cleft, suggesting a 16-fold increased risk.
FDA Warning for Topamax and Cleft Palate Birth Defects
In March 2011, the FDA published a Safety Communication to warn about the increased risk of cleft lip and/or cleft palate (oral clefts) in infants exposed to Topamax during pregnancy.
The FDA re-classified Topamax as “Pregnancy Category D,” meaning that there is positive evidence that it can cause birth defects based on human studies. Even so, doctors may still prescribe Topamax to a pregnant woman if the benefits for the mother justify any risks to a fetus.
$81 Million Topamax Lawsuit Settlement for “Off-Label” Marketing
In April 2010, the U.S. Department of Justice (DOJ) announced an $81 million Topamax lawsuit settlement with Janssen and Johnson & Johnson to resolve criminal and civil liability arising from illegal marketing of Topamax for unapproved uses.
The government alleges that Topamax was promoted for “off-label” psychiatric uses through a program in which doctors were paid to join sales representatives. Although doctors are allowed to prescribe drugs “off-label,” drug companies are forbidden from marketing drugs for any use that is not specified by the FDA.
What is Cleft Lip?
Cleft lip birth defects range from a small notch in the upper lip to a wide gap and nearly non-existent upper lip. Cleft lip may or may not occur with cleft palate, in which there is a groove in the roof of the mouth (hard palate and/or soft palate).
Oral clefts may also affect the gums and nose, which can lead to problems with eating, talking, ear infections, hearing loss, and dental development. Surgery is often needed to close a cleft lip or palate before the child is 18 months old. Additional surgery, speech therapy, and orthodontic care are often needed as the child gets older.
Do I have a Topamax Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Topamax lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Topamax Class Action Lawsuit Evaluation: Again, if you or a loved one used Topamax during pregnancy and had a baby with a birth defect, you should contact our law firm immediately. You may be entitled to compensation by joinin a Topamax class action lawsuit, or file a Topamax lawsuit and we can help.