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J&J's First Trial Over Seizure Drug Topamax Goes to Jury

A Philadelphia jury began deliberations in the first lawsuit to come to trial over claims the seizure drug Topamax, sold by Johnson & Johnson’s Janssen Pharmaceutical unit, caused birth defects.

Lawyers for April Czimmer argued that the Virginia resident wouldn’t have taken the drug for six months had the company warned pregnant users it might cause defects including cleft lip and cleft palate. Czimmer said her son Blake, born in September 2007, had conditions requiring four surgeries.

“We did not come down here for sympathy,” Tommy Fibich, an attorney for Czimmer, told the 12-member jury in closing arguments today. “We came here for justice.”

The case is the first of about 134 lawsuits pending in state court in Philadelphia over the drug, plaintiffs’ lawyers said. Another trial began yesterday with opening statements on injuries suffered by a 5-year-old boy from South Carolina.

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. Czimmer took the drug from August 2006 through February 2007 to treat migraines.

Janssen adequately warned her prescribing physicians of the risks that it made public in reports and medical literature in 2002, 2003 and 2005, John Winter, an attorney for the company, said in closing arguments.

Data Available

“It’s not that the data was hidden,” Winter said. “The data was there for anyone to look at it and make their own judgments.”

A verdict requires agreement by at least 10 jurors on whether Janssen negligently failed to warn health-care providers of the risks, Judge Victor J. DiNubile told the state court panel. That minimum must also agree on whether Janssen’s negligence was a substantial factor in bringing about the boy’s injuries.

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.

Blake Czimmer faces at least four more surgeries and future medical bills totaling more than $560,000, Fibich said. The attorney urged jurors to award a higher amount, for the pain and suffering caused by the condition. Janssen “deserves to feel a financial wound,” Fibich said.

Judge Arnold New, who is overseeing the lawsuits in Philadelphia, granted Janssen’s request before the trial to bar punitive damages in the case. DiNubile instructed jurors that any damages awarded should be “fair and reasonable” and should not be intended to punish the drug company.

The case is Czimmer v. Janssen Pharmaceuticals Inc., 110503459, Court of Common Pleas, Philadelphia County, Pennsylvania. The master case is In Re Topamax Litigation, 110602131, Court of Common Pleas, Philadelphia County, Pennsylvania.

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