Last month, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, stated that they would appeal a recent $3 million verdict awarded to a mother who claimed their drug Topamax caused her daughter’s birth defects.
In March 2014, a jury awarded $3 million to Kelly and Brian Anderson, who claimed that Kelly’s use of Topamax to treat migraines during pregnancy led to their daughter being born with a bilateral cleft palate and lip in 2008. At the time of the trial, the child had already undergone 14 surgeries to correct the birth defects.
In 2008, researchers published a study in the journal Neurology where they found that use of Topamax during pregnancy makes a woman 11 times more likely to have a child with an oral cleft defect. Additionally, an expert quoted in a corresponding CBS News article stated that women who used this drug, originally approved for epilepsy, to treat migraines likely had safer options. American Academy of Neurology spokesman Shlomo Shinnar, MD, PhD told reporters, “The tolerance for risk is different for epilepsy patients, because uncontrolled seizures are a clear risk to the fetus. Migraines can be quite debilitating for the mother, but they do not generally pose a risk to a fetus.”
The jury ruled that Janssen was negligent in their failure to adequately warn of the risks oral cleft birth defects associated with use of Topamax during pregnancy.
According to the Legal Intelligencer, Judge Ramy I. Djerassi of the Philadelphia Court of Common Pleas slammed Janssen’s appeal, stating that the defendant failed to file the papers appropriately. “Defendant Janssen has waived all issues on appeal for failure to comply in good faith with Pennsylvania Rule of Appellate Procedure 1925 by filing a multi-page, multi-paragraph statement that defies a court order redirecting that appellant should not file a statement that is ‘redundant, frivolous, or so lengthy as to defeat the purpose of the rule.'”
The judge also stated that the appeal was inappropriately lengthy, improperly worded, and redundant. However, the court did attempt to address the issues Janssen raised in the document, including insufficient evidence brought by the plaintiff and federal pre-emption.
Regarding allegations that the Andersons presented insufficient evidence about Janssen’s failure to warn of Topamax birth defects, the judge stated, “According to her testimony, Topamax warnings actually received by Dr. [Traci] Purath left her unaware of the full extent of the risk of cleft lip and palate birth defects associated with Topamax use by pregnant women. When she prescribed Topamax to Mrs. Anderson, Dr. Purath knew the drug was Category C, meaning that some birth defects had been reported in animal studies but there was no known birth defect risk of cleft lip and palate in humans. Ultimately, the jury believed that Janssen failed to disseminate known test findings in humans associating Topamax use by pregnant women with direct risk of birth defects.”
The judge also chided Janssen for using pre-emption claims in a number of previous Topamax lawsuit appeals, saying that state failure-to-warn claims cannot be pre-empted by federal law.
Despite this very strong opinion voiced by Judge Djerassi, Janssen reports that they plan to move forward with the appeal. Still, given the fact that the company has already settled more than 70 Topamax birth defect lawsuits out of court and has lost multiple costly appeals, some believe it likely that this verdict will stand.
If you believe your child’s birth defect could be related to exposure to Topamax in the womb, it is important that you learn more about your possible right to compensation. Contact our experienced dangerous drug lawyers today for a free consultation.