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In a large Fosamax settlement, pharmaceutical giant Merck & Co. Inc. has agreed to pay $27.7 million to about 1,200 plaintiffs who claimed the osteoporosis drug caused bones in their jaws to deteriorate.
The settlement centers on one of Fosamax's more serious side effects, a painful jaw-related condition called osteonecrosis.
Fosamax and Osteonecrosis of the Jaw
Fosamax, a bisphosphonate drug made by Merck, is a prescription medicine used to prevent or treat osteoporosis in women after menopause and to treat osteoporosis in men.
The serious side effect at issue in these cases is called Osteonecrosis of the Jaw (ONJ) or "jaw death." ONJ is a medical condition in which the jawbone partially crumbles and dies. ONJ may cause severe pain, tooth loss, exposed bone, loss of function, and disfigurement.
The osteoporosis drug has been under scrutiny by the Food and Drug Administration for causing a host of other bone-related medical conditions such as unusual femur fractures and severe musculoskeletal pain.
$27.7 Million ONJ Settlement
While all medications have certain, anticipated side effects, a drug manufacturer has a duty to make its products as reasonably safe as possible, and to inform the medical community and the public of known risks associated with its drugs.
A manufacturer can be held legally responsible if patients are injured as a result of inadequate warnings or the unreasonably dangerous nature of the drug, under the legal theory of product liability.
Though Merck claims ONJ is a rare side effect, the company nevertheless opted to resolve the 1,140 ONJ-related lawsuits by settling for $27.7 million -- a drop in the bucket for the one-time blockbuster drug with $3 billion in sales in 2007.
The move was likely a strategic one as the settlement would resolve a large portion of the 5,255 product liability cases facing Merck over Fosamax, reports Reuters.