Janssen’s Topamax Users Blame Drug for Birth Defects

Johnson & Johnson’s Janssen Pharmaceuticals failed to inform expectant mothers of risks that its epilepsy drug Topamax could cause birth defects, a lawyer for the mother of a 6-year-old in Virginia told a jury.

April Czimmer wouldn’t have taken Topamax for more than six months had she known the risks associated with the drug, her attorney Tommy Fibich said in opening statements today in state court in Philadelphia.

Czimmer blames the drug for her son’s cleft palate and lip and claims Janssen negligently failed to inform patients about its risks until the U.S. Food and Drug Administration ordered stronger warnings in 2011.

“It is the pharmaceutical equivalent of a drive-by shooting,” Fibich said. “The pharmaceutical company, when they put this drug out into the market knowing it has these causes, they don’t know who it’s going to hit.”

The company this month is facing the first two of 134 cases pending in Philadelphia over the seizure drug, according to plaintiffs’ lawyers. Topamax, approved by the FDA in 1996, was one of New Brunswick, New Jersey-based J&J’s top sellers before it lost patent protection in 2009 and sales plummeted 58 percent to $1.15 billion, according to the company’s annual report.

Czimmer said she was prescribed Topamax from August 2006 through February 2007 to treat migraines. Her son Blake was born in September 2007 with defects requiring four surgeries since birth, Fibich said.

Company Argument

Janssen isn’t liable for the boy’s injuries, John Winter, an attorney for the company, told jurors. Topamax came with FDA-approved prescribing information that adequately set forth warnings and precautions associated with its use, he said.

“This case is not about a drive-by shooting,” Winter told jurors. “This is about a responsible company creating a medicine that helps people.”

The FDA on March 4, 2011, said 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 the company to update the label enclosed with the medicine to reflect a stronger classification and warning for the drug.

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 FDA said. The defects range from a small notch in the lip to a groove that runs into the roof of the mouth and nose. The condition can lead to ear infections and problems with eating and talking and often requires surgery.

Raise Risks

Lawyers for mothers who took the drug during pregnancy claim Janssen knew as early as 2002 that Topamax could raise the risk of birth defects, according to a master complaint filed in September 2011.

By 2004, more than 3 million people took the drug, including 1.2 million women, Winter said in his statements. There were at least 76,000 births by those women resulting in 76 expected cases of oral clefts, Winter said.

Fibich countered that internal company documents dating back to 2000 showed more reports of adverse incidents. A 2000 Pregnancy Report showed 91 cases of adverse incidents and a 2003 Safety Signal Report showed at least four cases of cleft lip/cleft palate combination defects along with 13 other birth defects, Fibich said.

Janssen and its predecessor, Ortho-McNeil Pharmaceutical, promoted Topamax for off-label use since at least 2001, plaintiff lawyers said in court papers. The uses included weight loss, anxiety disorders, cluster headaches, sleep apnea, diabetes and substance abuse, according to the documents.

Off-Label Uses

Janssen aggressively advertised and sold Topamax for these off-label uses “without any valid scientific evidence” that supported the use of the drug for the treatment of such ailments, according to the master complaint.

The company hired outside physicians to promote the drug for off-label use and implemented programs such as “Doctor-For-a-Day,” in which physicians accompanied sales representatives on calls to push the drug, according to court papers.

In April 2010, J&J paid $81 million to resolve criminal and civil cases over illegal promotion of the drug. A month later, Ortho-McNeil admitted that it illegally marketed Topamax and pleaded guilty to a misdemeanor charge of selling a misbranded drug as part of the settlement.

Topamax was approved to treat people like Czimmer with debilitating migraines, Winter said. Czimmer, who smoked during her pregnancy, was told to stop the drug and another she took for anxiety when she became pregnant, Winter said.

‘About Evidence’

“If this case is about who we feel sympathy for, who we empathize with, then I’m just going to sit down because this case is over,” Winter said, referring to pictures Fibich showed of Blake Czimmer as an infant. “We’re sorry that happened, but that’s not what this case is about. It’s about the evidence.”

Blake’s scar is “well healed and nearly imperceptible,” Winter said, showing a later photo of the boy and his father.

“The evidence shows the company adequately warned health-care providers of the potential risk for women who use the medicine during pregnancy,” Teresa Mueller, a Janssen spokeswoman, said in an e-mailed statement. “In addition, there are other factors such as genetics, weight, smoking and lifestyle that should be considered when determining the cause of birth defects.”

Judge Arnold New, who is overseeing the lawsuits in Philadelphia, granted Janssen’s request to bar punitive damages in the case. He also dismissed an accusation that Janssen failed to warn patients and claims that the drug was defective in design, according to a July 16 court order. The trial is going forward on claims of negligence, fraud and misrepresentation.

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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