Osteoporosis and Fosamax

(2/12/08)- Osteoporosis is a disease characterized by low bone density and a structural deterioration of bone tissue, leading to bone fragility and fractures. Merck & Co.'s Fosamax is a blockbuster drug, that belongs to a category of drugs known as bisphosphonates, is now the subject of lawsuits coming into the limelight even though the drug was first introduced into the market in 1995.

It lost its patent protection this year, but the company said that intends to bring a "branded" generic version of the drug to the market shortly. The drug brought in over $3.8 billion in sales in 2007.

Several hundred users of the drug have brought suit against the company, alleging that it caused a bone-wasting condition called osteonecrosis of the jaw, or ONJ. Merck has met those allegations with the response that clinical evidence shows no rise in fractures related to the drug, and that the drug's label already warns of increased risk of pain for users of the medication.

Merck has set aside $48 million in Fosamax litigation reserves for about 340 cases filed as of September 30, 2007. Plaintiffs' lawyers assert that ONJ is what is known as a signature injury, or a type of injury that is easier to link to a particular drug than is something like Merck's Vioxx pain-killer medication.

Tim O'Brien, who heads the plaintiffs' steering committee in the ONJ cases filed the first lawsuit related to a non-jaw injury in Camden County, N.J. last month. The plaintiff, 53 year old JoAnn Moranski, asserted that her stress fractures were caused by the accumulation of toxicity in the body caused by taking the drug over an 8 1/2 year period of time for her osteoporosis.

Ms. O'Brien alleges that she began to experience debilitating pain in her legs in 2003, and her physician diagnosed her with suffering from stress fractures of the legs..

Paul Strain, a partner in the law firm of Venable LLP is representing Merck in the lawsuit in N.J.

The FDA, in response to physician reports issued an alert on January 7th flagging "the possibility of severe and sometimes incapacitating bone, joint and /or muscle pain in patients taking bisphosphonates."

The alert stated that although severe musculoskeletal pain is included in the label's prescribing information for all bisphoshonates, the link may be overlooked by health professionals. It said the pain may occur within days, months or years of first taking the drug.

The first Fosamax cases involving ONJ are expected to come to trial early next year. A federal judge has denied class-action certification for the Fosamax litigation, meaning that each case must be brought individually as was the case with Vioxx.



By Allan and Harold Rubin
posted February 13, 2008

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