Janssen Faces 2nd Trial Over Drug’s Link to Birth Defects

Johnson & Johnson’s Janssen Pharmaceuticals unit is facing a second trial over the links between its Topamax seizure drug and birth defects.

A trial began today in Philadelphia over claims brought by a South Carolina couple, Michael Gurley and Haley Powell, on behalf of their 5-year-old son who was born with a cleft lip. The boy’s injuries were caused by Topamax, lawyers for the Gurleys told jurors today. Another case involving Topamax’s alleged effect on a 6-year-old Virginia boy is scheduled to close tomorrow in the same court.

Topamax, approved by the 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. Janssen is being blamed by users for failing to inform expectant mothers of the drug’s risks of birth defects including cleft palate and lip. There are about 134 cases pending in state court in Philadelphia over the epilepsy drug, according to plaintiffs’ lawyers.

“Janssen acted appropriately when it was required to act,” Charles Morrow, an attorney for the company, told jurors in opening statements. “Topamax has been extensively studied and approved by the FDA multiple times as safe and effective.”

Powell, a stay-at-home mother who suffers from seizures, was prescribed Topamax in 2006, a year after she began taking another anti-epileptic drug. She continued taking both drugs until October 2007 when she became pregnant.

Defects Revealed

Janssen failed to adequately warn Powell’s doctor of the risks of birth defects even though animal studies done before the drug’s approval revealed such defects, Shelley Hutson, an attorney for Gurley said in opening statements.

“They know they’re supposed to act on safety signals and they didn’t,” Hutson told jurors.

Powell’s son Brayden was three months old when he had an initial surgery to repair his cleft lip, Hutson said. He faces at least five additional surgeries including rhinoplasty to repair nasal deformities by age 21, Hutson told jurors.

Janssen has denied allegations that the the company failed to warn health-care providers of the risks and said in a statement today that Powell’s “lawsuit is without merit.”

“The evidence shows the company adequately warned health-care providers, including the plaintiff’s prescribing physician,” Teresa Mueller, a spokeswoman for the company, said in the e-mailed statement.

Common Malformation

The birth defects, known as oral clefts, occur when parts of the lip or palate don’t completely fuse together in the first trimester of pregnancy. The condition is a common congenital malformation, Morrow said. About 4,500 babies are born each year in the U.S. with cleft lip, he said.

Pharmacy records also show Powell wasn’t taking Topamax at the time she conceived, Morrow said, noting a gap of about three months between her last refill and the approximate date of conception.

Hutson said Powell was sharing a prescription with her mother during that time and took the drug consistently since March 2006.

Closing arguments are scheduled to take place tomorrow in the case involving the Virginia boy. His mother April Czimmer took the drug for seven months beginning in August 2006 to treat migraines. Czimmer’s son Blake was born in September 2007 with defects requiring four surgeries since birth, her attorney Tommy Fibich said in opening statements Oct. 15.

The case is Gurley v. Orth-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.

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