Judge Allows Jaw Lawsuits Against Pharma Firm Novartis

March 10, 2010

A federal judge refused to dismiss 40 lawsuits against a Switzerland-based pharmaceutical company accused of failing to warn patients that two of its drugs can cause severe jaw deterioration.

U.S. District Judge Todd Campbell’s ruling last week was the latest blow to Novartis Corp., which is facing lawsuits from hundreds of patients around the country over its bone-strengthening drugs Aredia and Zometa. The 40 cases from people treated with the drugs in Florida represent a portion of the more than 600 cases against Novartis in the U.S. District Court in Nashville. About 150 more cases are being handled by a state court in New Jersey.

Campbell’s decision clears the way for the 40 cases to go to trial.

“This was another try by Novartis to try to get a number of these cases knocked out,” said John Vecchione, a Fairfax-Va., -based attorney who represents a number of plaintiffs in the case. “By and large, they’ve failed with a broad brush to dismiss these cases.”

Trials are set to begin later this year in districts around the country.

The only case that’s gone to trial so far resulted in a $3.2 million jury verdict in October for a Missoula, Mont., woman with lymphoma who sued the drug maker, claiming she developed severe dental and jaw-related problems after taking Zometa.

A spokeswoman for Novartis said in an e-mail that the company did not comment on pending litigation. It has denied in court documents that the drugs were to blame for a condition called osteonecrosis of the jaw.

Zometa and Aredia were approved by the FDA to strengthen bones in patients with certain types of cancers. The lawsuits claim the drugs cause portions of the jawbone to die.

“We’ve had clients who’ve actually had their entire lower jaw removed,” said Patrick Flynn, a Brentwood-Tenn., lawyer who represents a number of plaintiffs. “There’s constant pain and infection that attend this kind of condition.”

The Food and Drug Administration approved Aredia in 1991 and Zometa in 2001.

An agency spokeswoman said in an e-mail that the FDA held a public meeting in March 2005 to discuss issues with osteonecrosis of the jaw involving the drugs. She said a warning about the possible side effect was later added to the prescribing information.

In spite of the side effects, one doctor says the drugs can greatly increase the quality of life for people with cancers involving the bone because they help reduce fractures and pain.

“In most patients, they’re quite a bit of a benefit,” said Dr. Sal Vasireddy, an associate professor with the University of Tennessee Health Science Center.

Still, he says, patients considering taking either drug need to talk with their doctors because necrosis of the jaw is considered a serious complication that could impede cancer treatment.

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