Philly Jury Hits J&J With $11 Million Verdict In Topamax Birth-Defects Case

from fiercepharma;
Philly Jury Hits J&J With $11 Million Verdict In Topamax Birth-Defects Case
November 19, 2013 | By Tracy Staton

A Philadelphia jury didn't buy Johnson & Johnson's ($JNJ) argument that it had properly warned doctors and patients about the birth-defect risks associated with its seizure drug Topamax. The panel ordered J&J's Janssen unit to pay $11 million to Haley Powell, whose son was born with a cleft palate.

As Bloomberg reports, it's the second case over Topamax-related birth defects to go to trial--and the second loss for J&J. Last month, a jury awarded $4 million to Virginia mother April Czimmer, who alleged that Janssen didn't do enough to publicize Topamax's links to cleft lip and palate. Janssen says it will appeal both verdicts.

Overall, J&J faces more than 130 cases linking Topamax to birth defects, now consolidated in Philadelphia court. The two decisions so far came in bellwether cases selected to be tried first. Two other cases are scheduled to hit court in February and March.

According to the plaintiffs, Janssen knew that Topamax could trigger birth defects for years before truly warning the public. The risks showed up in animal studies, and then in reports about the children of Topamax patients, Powell's lawyer said during the trial.

But Janssen's lawyers maintained that the rates of cleft lip and cleft palate in Topamax patients mirrored the rates of those injuries in the overall population, Bloomberg reports. The FDA asked Janssen to change Topamax's label in 2011, to warn of data showing that the drug might contribute to cleft lips and cleft palates in babies born to mothers using the medicine.

J&J has been fighting a raft of litigation related to its other products as well. Most recently, the company was said to agree to pay $4 billion to wrap up lawsuits over faulty hip-replacement devices. And earlier this month, J&J wrapped up a longstanding off-label marketing probe by the Department of Justice, with $2.2 billion in civil and criminal penalties.

- read the Bloomberg story

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Thank You Ms Staton and fiercepharma.