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Drug Companies and Failure to Warn

By Tim O'Brien
January 31, 2007

[Editor's Note: The author, Tim O'Brien, was recently appointed Lead Counsel by the U.S. District Court for the Southern District of New York in MDL No. 1789, In re Fosamax Products Liability Litigation. The opinions expressed herein are those of Mr. O'Brien, and represent some of the arguments the plaintiffs are or will be making in the litigation.]

For more than one year, product liability cases have been pending against Merck's osteoporosis drug, Fosamax'. Despite having one of the highest side effect profiles of any drug in the U.S. prescription database, Fosamax remains on the market, and available by prescription. When a drug remains on the market during litigation but the manufacturer refuses to warn about a known risk, places the information about the risk in an obscure location or provides inadequate information about the severity of the risk, there is a public problem ' for both patients and prescribers alike ' in the form of a health hazard about which most prescribers have insufficient information.

Studies have shown that Fosamax can cause osteonecrosis of the jaw ' literally, rotting of the jaw bone. There is very little debate in the oral surgery community about the link between that drug and osteonecrosis. However, Merck has failed to disclose to prescribers the nature of the risk.

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