Johnson & Johnson’s subsidiary, Janssen Pharmaceuticals unit lost a jury trial in Philadelphia over its drug Topamax. The jury ordered the companies to pay $11 million in a product liability lawsuit which claimed that the anti-seizure drug Topamax caused birth defects.
Jurors in state court in Philadelphia found that Janssen failed to adequately warn doctors for Haley Powell, of the risks of Topamax before she gave birth to a son with a cleft lip.
Shelley Hutson, an attorney for Powell, said that “Janssen has long known that this drug causes debilitating birth defects and yet intentionally kept this information from physicians and patients.”
2 Topamax Verdicts for Plaintiffs
Powell’s case was the second of about 134 that have gone to trial in Philadelphia over the epilepsy drug. Janssen was dinged in a $4.02 million verdict on October 30 in a lawsuit brought by Virginia resident April Czimmer for injuries to her six-year-old son. Plaintiffs are blaming the company for failing to inform pregnant women of the drug’s risks for causing birth defects including cleft palate and lip.
Johnson and Johnson Under Fire
These verdicts come on top of many recent set backs for Johnson and Johnson and its subsidiaries. Recently Johnson and Johnson settled a record $2.5 billion fine to department of justice investigations over its marketing of Risperdal, a drug approved for the treatment of schizophrenia.
Also Johnson and Johnson is going to announce a $4 billion settlement on Tuesday November 19, over its metal on metal DePuy ASR hip implants. Johnson and Johnson is also facing many lawsuits claiming liver damage and liver failure from its Tylenol brand of acetaminophen.
Topamax: Blockbuster Drug
Topamax, approved by the U.S. Food and Drug Administration in 1996, and it lost patent protection in 2009. Powell became pregnant in October 2007, more than a year after she began taking Topamax. Her five-year-old son faces at least five surgeries over the next few years to repair the facial deformities.
According to plaintiffs, Janssen knew as early as 1997 that animal studies showed an increased risk for birth defects, especially oral clefts.
Janssen’s Secrecy Culture
Plaintiffs have accused Janssen of operating in a culture of secrecy and of intentionally concealing safety reports in 2003 and 2005.
The FDA asked the company to change the label on March 4, 2011, when 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.
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.