J&J’s Janssen Must Pay $4 Million Over Topamax, Jury Says

Johnson & Johnson’s Janssen Pharmaceutical unit must pay $4.02 million in a lawsuit claiming that its seizure drug Topamax caused birth defects, a Philadelphia jury said.

Jurors in state court deliberated less than an hour before rendering a verdict in favor of Virginia resident April Czimmer who took the drug for six months and gave birth to a boy with cleft lip. Czimmer said her son Blake, born in September 2007, had injuries requiring four surgeries.

“This was our first case to go to trial and there are many more behind it,” Czimmer’s attorney Tommy Fibich said after the verdict. “This will expose the company to many more lawsuits.”

Czimmer’s case is the first of about 134 cases 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.

Janssen said it will appeal the verdict.

“We are extremely disappointed with the jury’s verdict,” Teresa Mueller, a spokeswoman for the company said. “The evidence showed that the company clearly warned Ms. Czimmer’s prescriber that the product had the risk to cause birth defects and she understood and conveyed those warnings to Ms. Czimmer.”

Oral Clefts

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.

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.

Lawyers for the company argued that oral clefts are a common congenital malformation with about 4,500 babies born each year in the U.S. with cleft lip.

Mueller said other factors, “including genetics, maternal smoking and other prescription drug use,” could have been the cause of Blake Czimmer’s defect. Czimmer smoked during her pregnancy and took another drug for anxiety when she became pregnant, John Winter, an attorney for the company, told jurors during the trial.

Johnson & Johnson fell 21 cents to $92.93 at 3:31 p.m. in New York. Before today, the shares had gained 33 percent this year.

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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