A federal panel has agreed to Merck & Co.’s request that 37 Fosamax lawsuits claiming the osteoporosis drug caused low impact femur fractures be consolidated in a multidistrict litigation (MDL) in the U.S. District Court for the District of New Jersey. The U.S. Judicial Panel on Multidistrict Litigation also assigned Judge Garrett E. Brown, Jr. – another Merck request – to oversee the litigation.
An MDL allows lawsuits associated with a particular product to be coordinated under one judge for pretrial litigation to avoid duplicative discovery, inconsistent rulings and to conserve the resources of the parties, witnesses and the court.
All of the lawsuits in the new MDL claim Merck failed to adequately warn about the risk of thigh fractures from Fosamax. About 2/3 of Fosamax lawsuits had already been filed in the New Jersey court now hosting the MDL. Merck’s headquarters is also located in that jurisdiction.
Evidence of the link between bisphosphonates like Fosamax and femur fractures has mounted over the past several years. Last year, the U.S. Food & Drug Administration (FDA) asked the manufacturers of bisphosphonates to add information to the “Warnings and Precautions” section of the drugs’ labels describing the risk of atypical thigh fractures after a study saw a fracture risk in women who took the osteoporosis drugs over a long period of time.
According to this report from Newsinferno.com, a study published in the May 4 issue of the New England Journal of Medicine is the latest to add to this accumulating evidence. The study found that the women who took the drugs the longest faced the highest risk, while the fracture risk was reduced when patients stopped taking the drugs.
The growing concern surrounding Fosamax fractures has led many experts to advise that women being treated with it and similar drugs take a “drug holiday” after they have used the medications for several years. Some have also advised the drugs shouldn’t be used to treat women who don’t have osteoporosis, including those with a condition called Osteopenia, as a way to prevent the bone weakening disease. Osteopenia is a condition that causes lower-than-normal bone mass, and is often considered a precursor to osteoporosis.