As Fosamax Bone Fracture Lawsuits Pile Up, Merck Seeks Consolidation

An increasing number of women have filed <"">Fosamax lawsuits claiming the popular osteoporosis drug caused them to suffer a rare type of femur, or thigh, fracture. Merck & Co., the maker of Fosamax, recently motioned to have the growing number Fosamax bone fracture lawsuits consolidated in one court as a multidistrict litigation (MDL).

In October 2010, the U.S. Food & Drug Administration (FDA) warned that long-term use of Fosamax and other similar bone drugs, known collectively as bisphophonates, had been associated with subtrochanteric and diaphyseal femur fractures. Atypical subtrochanteric femur fractures are fractures in the bone just below the hip joint. Diaphyseal femur fractures occur in the long part of the thigh bone.

The FDA warning followed a study conducted by the American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force that examined more than 300 cases of such fractures. The study fund that 94 percent of the patients had taken bisphosphonates for osteoporosis, and most had been on the drugs for five years or more. The study also found that more than half of the patients studied experienced groin or thigh pain for a period of weeks or months before their fractures.

These findings prompted the FDA to ask the manufacturers of Fosamax and other oral bisphosphonates to add information to the “Warnings and Precautions” section of the drugs labels’ describing the risk of atypical thigh fractures. The agency also required that a “Limitations of Use” statement be added to the “Indications and Usage” section of the labels for these drugs describing the uncertainty surrounding the optimal length of time they should be used for the treatment and/or prevention of osteoporosis. Finally, the FDA mandated that patients be given a Medication Guide that describes the symptoms of atypical femur fracture and recommends that patients notify their healthcare professional if they develop symptoms.

Since the October 2010 warning, at least 36 lawsuits involving 100 women have been filed in eight federal court districts against Merck over Fosamax bone fractures. The lawsuits allege Merck failed to adequately research Fosamax or provide adequate warnings about its risks. Plaintiffs’ lawyers throughout the U.S. also report that they continue to receive inquiries and are reviewing additional Fosamax bone fracture claims, so the number of lawsuits is expected to grow.

In its motion seeking an MDL, Merck asked the Judicial Panel on Multidistrict Litigation of the United States Courts to consolidate all Fosamax bone fracture lawsuits in the U.S. District Court for the District of New Jersey, where it has its headquarters, or in the U.S. District for the Western District of Louisiana.

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. When lawsuits are consolidated as a multidistrict litigation, each retains its own identity. If the multidistrict litigation process does not resolve the cases, they are transferred back to the court where they originated for trial.

The Judicial Panel on Multidistrict Litigation was created in 1968. Since then, it has consolidated hundreds of thousands of lawsuits that involved high numbers of plaintiffs, including litigation over asbestos, breast implants and other matters.

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