NEW YORK-Merck & Co, which is already facing a raft of cases over its pain reliever Vioxx, may need to hire additional attorneys to fight a recently filed lawsuit alleging the company was negligent in promoting its osteoporosis drug Fosamax.
According to a lawsuit filed Monday in U.S. District Court in Fort Myers, Fla., Fosamax is a defective product because it can cause osteonecrosis of the jaw, or a rotting of the jaw bone. The suit, which seeks class action status, alleges that Merck concealed and continues to hide Fosamax’s potentially dangerous side effects from patients and doctors.
Fosamax is Merck’s second best-selling drug with last year’s revenue essentially flat at $3.2 billion.
In a statement, Merck said that in all of its clinical trials of Fosamax, which have included more than 17,000 patients, it has not had any reports of osteonecrosis of the jaw. Merck said that there have been reports of patients taking Fosamax developing the condition but that doesn’t necessarily mean the drug caused it.
Fosamax belongs to a category of drugs known as nitrogenous bisphosphonates, according to the lawsuit. Some other drugs in that category are used for chemotherapy and the lawsuit says medical journals had been reporting a connection between those medicines and the jaw condition. The suit
contends that since Fosamax is in the same class of drugs, Merck should have known its product could lead to such problems.
The lawsuit further alleges that the U.S. Food and Drug Administration asked Merck to add a warning to Fosamax’s label in August of 2004 and that it has yet to comply with that request.
Merck counters that it received a request from the FDA to update the label with information about the condition in January 2005. It says that by July 2005 information regarding the problem was on the label.
But Tim O’Brien, who filed the suit, said the information in the label isn’t an adequate warning.
The FDA didn’t immediately return a call Wednesday. Merck faces nearly 10,000 lawsuits Vioxx, which it withdrew from the market in September 2004 after a study showed it doubled patients risk of heart attacks and strokes.
Merck shares fell 21 cents to close at $33.85 Wednesday on the New York Stock Exchange.