Johnson & Johnson’s Janssen Pharmeceuticals unit was ordered by a Philadelphia jury to pay $11 million in a case claiming its anti-seizure drug Topamax caused birth defects, the second such loss in less than a month.
Janssen failed to adequately warn doctors for Haley Powell, a stay-at-home mother, of the risks of Topamax before she gave birth to a son with a cleft lip, jurors in state court in Philadelphia found today.
“Janssen has long known that this drug causes debilitating birth defects and yet intentionally kept this information from physicians and patients,” Shelley Hutson, an attorney for Powell, said after the verdict was read. “Ironically, this case was hand-selected by the defendants to go to trial.”
Powell’s case was the second of about 134 that are pending in Philadelphia over the epilepsy drug. Janssen lost a $4.02 million verdict on Oct. 30 in a lawsuit brought by Virginia resident April Czimmer for injuries to her six-year-old son. Users are blaming the company for failing to inform expectant mothers of the drug’s risks for causing birth defects including cleft palate and lip.
Janssen said it will appeal the verdicts in both cases.
“While we empathize with the plaintiff, the evidence demonstrated that Ms. Powell, and her healthcare provider, were aware of the side effect profile before beginning her treatment,” Janssen said in a statement.
Topamax, approved by the U.S. Food and Drug Administration in 1996, was one of New Brunswick, New Jersey-based J&J’s top sellers before it lost patent protection in 2009.
Powell became pregnant in October 2007, more than a year after she began taking Topamax and another anti-epileptic drug. Her five-year-old son, Brayden, faces at least five surgeries before age 21 to repair the defect which also caused nasal deformities, according to Powell’s lawyers.
The birth defects, known as oral clefts, range from a small notch in the lip to a groove that runs into the roof of the mouth and nose.
Janssen knew as early as 1997 that animal studies showed an increased risk for birth defects, especially oral clefts, Hutson said during closing arguments on Nov. 15.
Hutson accused Janssen of operating in a culture of secrecy and of intentionally concealing safety reports in 2003 and 2005. She rejected arguments by the company that it presented the information on poster boards, in abstracts and at medical conferences. Those actions “do not keep patients safe,” Hutson said.
“As early as 1997 in admission after admission, this company knew and they didn’t tell the doctors,” Hutson said.
Lawyers for the company argued during the trial that oral clefts are a common congenital malformation with about 4,500 babies born each year in the U.S. with cleft lip.
“The label as it appeared in 2006 was adequate and appropriate for any prescribing doctor,” Kenneth Murphy, an attorney for Janssen, said in closing arguments. “In 2006, the label reflected what the company knew.”
Murphy argued that the company petitioned the FDA in 2005 to make the label “more robust” by reporting that birth defects had been reported in women taking Topamax. The regulator rejected that wording.
“Reports of cleft lip and/or cleft palate never exceeded background rates after 10 years of experience with the medicine,” Murphy said. “Janssen turned square corners with regulators and it shared what it knew with doctors.”
The FDA didn’t ask the company to change the label until March 4, 2011, when it said preliminary studies suggested Topamax might contribute to cleft lips and cleft palates in infants born to women who used the medication during pregnancy. The government asked that the label be updated to reflect a stronger classification and warning for the drug.
Additional trials are scheduled for February and March, Hutson said.
The case is Gurley v. Ortho-McNeil-Janssen Pharmaceutical, 110502251, Court of Common Pleas, Philadelphia County, Pennsylvania. The master case is In re Topamax Litigation, 110602131, Court of Common Pleas, Philadelphia County, Pennsylvania.