Pharmaceutical Company Allegedly Knew of Harmful Fosamax Side Effects as Far Back as 2004, According to Review of Internal Documents: In Re: Fosamax Products Liability Litigation

Fosamax, a drug marketed as a treatment for osteoporosis by the pharmaceutical company Merck, is the subject of a massive amount of nationwide litigation. Many pending lawsuits allege that the drug caused osteonecrosis of the jaw (ONJ), a rare degenerative bone condition that can cause severe pain and disfigurement. Federal courts began grouping Fosamax lawsuits together for pre-trial proceedings in 2006, under the title In Re: Fosamax Products Liability Litigation. The consolidated case has included more than one thousand individual lawsuits. According to a report by Martha Rosenberg in OpEd News, newly-available internal documents from Merck suggest that scientists employed by the company knew about possible harmful side effects of the drug several years prior to the beginning of litigation over the drug.

The U.S. Food and Drug Administration (FDA) approved Alendronate, marketed under the brand name Fosamax, in 1995 for the treatment of osteoporosis resulting from menopause and other conditions. The drug is part of the bisphosphonate family of drugs. The current nationwide litigation largely alleges ONJ resulting from Fosamax use. ONJ is a rare condition in which the jaw bone begins to die from lack of blood. It can be severely painful for those afflicted, as the bone is literally dying. It is associated with certain cancer treatments, infections, and, according to the American College of Rheumatology (ACR), bisphosphonate use. The ACR estimates that ONJ occurs in somewhere between 1 in 1,000 to 100,000 cases, depending on the length of exposure to the drug.

The Judicial Panel on Multidistrict Litigation (JPML) began grouping Fosamax lawsuits together in 2006, creating a single matter in the U.S. District Court for the Southern District of New York on August 18 of that year. Federal district judges around the country may transfer pending lawsuits related to Fosamax to this court for pre-trial proceedings, in an effort to use court resources as efficiently as possible. According to the JPML, as of November 14, 2012, a total of 1,109 Fosamax lawsuits had been transferred to the Southern District of New York, and 968 were still active on that date. A handful of lawsuits against Merck have gone to trial at the state and federal level, and Merck claims that it won five of the first six trials.

Plaintiffs have claimed for years that Merck over-promoted the drug and failed to warn doctors of known risks. Merck’s defense has largely relied on a lack of definitive scientific evidence connecting the drug with ONJ, although plaintiffs’ lawyers have produced evidence of the company’s knowledge of potential harmful side effects. The documents described by Rosenberg reportedly include internal e-mails between scientists employed by Merck regarding side effects of Fosamax, including direct references to ONJ. Rosenberg describes at least one exchange in which a Merck scientist allegedly mocked a plaintiff suffering from ONJ, and she alleges that the company withheld evidence connecting the drug to conditions like ONJ. Whether these documents will have any impact on the ongoing litigation remains to be seen.

The Maryland attorneys at Lebowitz & Mzhen can assist victims of medication errors, who have been injured by drugs prescribed, dispensed, or administered incorrectly. Contact us today online or at (800) 654-1949 for a free and confidential consultation to discuss your case.

Web Resources:

Transfer Order (PDF file), Case No. 1:06-md-01789-JFK-JCF, In Re: Fosamax Products Liability Litigation, U.S. District Court, Southern District of New York, August 18, 2006

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