Federal Trial Over Fosamax Femur Fracture Set to Begin Next Week

The first federal trial over claims that Fosamax causes sudden femur fractures is set to begin next week. 

Following a mistrial declared last month in a New Jersey state court lawsuit, a case filed by Bernadette and Richard Glynn may be the first out of thousands of Fosamax femur fracture lawsuits in the country to make it to a jury.

The trial is scheduled to begin on Tuesday, in the U.S. District Court for the District of New Jersey, where all federal lawsuits involving sudden femur fractures allegedly caused by use of Fosamax are consolidated as part of an MDL, or multidistrict litigation.

Merck currently faces thousands of similar lawsuits filed in courts throughout the country, and the outcome of this case will be closely watched by product liability lawyers involved in the litigation, as it may help gauge how juries will respond to similar evidence and testimony that will be offered in future cases.

Failure to Warn About Fosamax Side Effects

Fosamax (alendronate sodium) was introduced by Merck in 1995, for treatment and prevention of osteoporosis.  Before it became available as a generic in 2008, the medication generated over $3 billion in annual sales and was used by millions of Americans

In recent years, increasing evidence has emerged to suggest that use of Fosamax over long periods of time increases the risk of individuals suffering a femur fracture under circumstances that would not normally cause the bone to break, such as while taking a step or falling from standing height or less.

According to evidence that will be presented during the federal “bellwether” trial, Bernadette Glynn took the osteoporosis drug Fosamax from September 2002 through February 2008, before she suffered a fracture of her right femur on April 17, 2009.

The lawsuit alleges that Merck failed to provide adequate warnings to users and the medical community about the potential side effects of Fosamax and the risk of atypical femur fractures that can occur after little or no trauma at all.

Glynn claims that she received the medication even though she had no pre-existing bone diseases and did not suffer from osteoporosis. She began taking Fosamax to prevent the onset of osteoporosis as she got older, and allegations raised in the case indicate that Merck knew Fosamax provided no benefit after four years of treatment and knew the drug was not effective in treating non-osteoporotic patients.

Thousands of Fosamax Femur Fracture Lawsuits Pending

In addition to the Glynn case, there are currently about 1,000 Fosamax lawsuits pending in the federal court MDL. However, the bulk of the litigation against Merck is pending in New Jersey state court, which is the drug maker’s home state. There are an estimated 2,500 lawsuits pending in New Jersey state court, which have been centralized before one judge for coordinated handling.

The first Fosamax femur fracture trial in the country began early last month in the Superior Court of New Jersey for Atlantic County. That case involved a lawsuit filed by Christina Su. However, it ended in a mistrial after Su suffered an apparent heart attack following the first week of testimony, which made her unable to continue with the trial.

Most of the complaints filed throughout the country were brought after the FDA required Merck to add new warnings about the risk of bone fractures from Fosamax in October 2010.  These warnings provided new information for consumers and the medical community about the importance of identifying symptoms of new hip or groin pain, which could occur before an atypical fracture of the femur.

Last year, the FDA issued new recommended guidelines for taking Fosamax and other similar oral bisphophonate medications, such as Actonel and Boniva.  The agency suggested that users should consider limiting the medications to a three to five year period, which may allow individuals to reduce the risks of side effects associated with long-term use, while continuing to receive benefits for osteoporosis.

Last month, a study published in the Journal of Bone & Joint Surgery established a causal link between nonhealing femur fractures and Fosamax.