On November 18, 2013, a Philadelphia jury awarded over $10 million to a family whose son was born with a cleft palate and other birth defects after being exposed to the drug Topamax during his mother’s pregnancy. More specifically, in Gurley, et al. v. Ortho-McNeil Janssen Pharmaceutical, Haley Powell was prescribed Topamax for treatment of epilepsy and migraines. More than a year after she began taking the drug, she became pregnant and continued to take it throughout her pregnancy after being told by doctors that the drug was safe.
After their son, now five years old, was born with birth defects that will require at least five surgeries before turning age 21, the South Carolina couple sued the drug manufacturer, Janssen Pharmaceuticals, Inc. (formerly Ortho-McNeil-Janssen Pharmaceutical) in a Pennsylvania state court. The couple alleged that the company failed to warn the Powells doctor that Topamax taken during pregnancy could cause birth defects, despite the company allegedly being aware of the serious risks as early as 1997. Even though the judge threw out most of plaintiffs’ claims against the drug manufacturer, including strict liability-design defect, negligent design, gross negligence and express breach of warranty, and also barred a bid for punitive damages, the jury ultimately found that Janssen negligently failed to warn the patient and the doctor of the risks associated with Topamax when used by patients during pregnancy and awarded the family over $10 million in damages.
The Gurley case was the second of approximately 134 cases pending in Philadelphia relating to Topamax tried in court. Notably, it is also the second largest verdict in recent months against Janssen Pharmaceuticals, Inc., a subsidiary of Johnson and Johnson. In October 2013, a Philadelphia jury in Czimmer v. Janssen Pharmaceuticals, Inc. issued a $4.02 million verdict in favor of April Czimmer, a Virginia woman who took Topamax from August 2006 through February 2007 to treat migraines. Czimmer subsequently gave birth to a boy born with a cleft lip in September 2007. She alleged that she would not have taken the drug for more than six months had she known the risks associated with it. The jury ultimately found that Janssen was negligent when it failed to warn healthcare providers of the extent of the risk of birth defects from Topamax, and awarded approximately $562,000 in future health care costs to Czimmer’s son and an estimated $3.4 million for pain and suffering.
Janssen is appealing both verdicts. The company contends that it is not liable for the boys’ injuries because Topamax, which was approved by the U.S. Food and Drug Administration (FDA) in 1996, came with FDA-approved prescribing information that adequately set forth warnings and precautions associated with its use. Janssen also maintains that oral cleft malformations are common, as about 4,5000 babies are born with cleft lip in the U.S. each year, and that Topamax neither increases nor decreases a child’s chances of being born with the condition as a result of the drug. Additionally, the FDA did not ask Janssen to change the label until March 4, 2011, after preliminary studies revealed that Topamax might contribute to cleft lips and cleft palates in babies born to women who took the drug during pregnancy.
Even though the drug has not been recalled, the FDA moved Topamax to its Pregnancy Category D, meaning that the drug has a proven risk of causing birth defects. Specifically, according to the North American Antiepileptic Drug Pregnancy Registry (NAAED), Topamax users were more than 21-times more likely to give birth to a child with oral clefts than untreated women. At the same time, Topamax users were three times more likely to have a child with birth defects than users of other anti-epilepsy drugs. Aside from giving birth to a child with oral clefs, pregnant women who use Topamax may also face an increased risk of a child with other birth defects, including spina bifida, limb malformations, genital malformations, persistent pulmonary hypertension of the newborn, neural tube defects or other heart and lung defects.
The FDA’s 2011 Safety Announcement also disclosed that, from January 2007 through December 2010, approximately 32.3 million topiramate (Topamax and generic products) prescriptions were dispensed and approximately 4.3 million patients topiramate prescriptions from outpatient retail pharmacies. If you or a loved one took Topamax or another topiramate while pregnant and gave birth to a child with a birth defect, the San Antonio personal injury attorneys at Carabin Shaw will work to hold all negligent parties accountable. Call us today at 1-800-862-1260.
Janssen’s Topamax Users Blame Seizure Drug for Birth Defects, by Sophia Pearson, Bloomberg Businessweek
J&J’s Janssen Loses $11 Million Jury Verdict Over Topamax, by Sophia Pearson, Bloomgberg News
FDA Drug Safety Communication: Risk of oral clefts in children born to mothers taking Topamax (topiramate), U.S. Food and Drug Administration