Novartis wins 2nd ONJ/bisphosphonate trial

A New Jersey jury ruled October 6 that Novartis provided adequate warnings about the risk of its bisphosphonate drugs, rejecting a lawsuit by a woman who claimed the drugs contributed to her development of osteonecrosis of the jaw (ONJ), according to a story by Bloomberg.

Jane Bessemer, 73, sued Novartis after developing severe mandible damage while taking Aredia and Zometa to slow bone loss related to her battle with breast cancer. Bessemer, who was diagnosed with cancer in 1997, took Aredia from 1999 to 2002 and Zometa from 2002 to 2004, the story stated. She subsequently had several operations to remove dead bone and had a metal plate inserted in her jaw, according to her attorney.

He said the company failed to tell the U.S. FDA about a series of red flags that suggested the drugs posed risks of the injuries that Bessemer suffered.

But Novartis' attorney argued that the company adequately warned Bessemer's physician of the potential risks associated with Aredia and Zometa, and that her jaw condition was unrelated to her use of the drugs, and the jury agreed.

Bessemer's lawsuit is the second product liability case to go to trial over Novartis' bisphosphonate drugs, which had 2009 sales of $1.5 billion, according to the company's annual report. Last year, a Montana jury ordered Novartis to pay $3.2 million in damages to a woman who blamed the drug for damaging her jaw.

Both Aredia and Zometa are still on the market, and Novartis is facing about 700 lawsuits over the drugs.

In a related case, a federal judge ruled October 4 that Merck must now pay only $1.5 million in compensatory damages to Shirley Boles, a 72-year-old woman who claimed the company's bisphosphonate drug Fosamax caused her to develop ONJ and related dental problems.

Boles's original lawsuit ended in a mistrial last September, but in a retrial in June of this year, a New York jury found in favor of Boles, calling Fosamax "defectively designed" and "unreasonably dangerous," according to news reports. Merck was ordered to pay $8 million in compensatory damages.

Boles had alleged that she used Fosamax from 1997 to 2006 and suffered various jaw problems and complications following two tooth extractions in June 2002, including a several-day hospitalization in 2004 to treat her condition.

Merck is currently facing more than 1,000 similar lawsuits.

Copyright © 2010

Page 1 of 107
Next Page