Bisphosphonate Litigation: First Femur Fracture Trials Looming

There have been some significant developments in the bisphosphonate litigation over the past few months.  Now that the two-year anniversary of the FDA’s safety alert over atypical femur fractures has passed, we anticipate that nearly 70 to 80% of the bisphosphonate cases in the country have now been filed.

The New Jersey coordinated bisphosphonate proceedings before Judge Higbee now include approximately 2,000 individual lawsuits. The state court cases before Judge Higbee all involve some use of the brand name version of Fosamax.

The MDL, also pending in New Jersey, has grown from less than 100 cases a few months ago to nearly 400 pending lawsuits.  A recent order from the MDL judge expanded the scope of this federal court coordination to include cases involving Boniva and Reclast.  It is anticipated that the MDL might be expanded further to include use of other bisphosphonate drugs, such as:

• Alendronate
• Zometa
• Aredia, Didronel
• Skelid
• Aredia
• Aclasta
• Bondronat
• Fosavance
• Atelvia

The expansion of the MDL has given plaintiffs yet another option for pursuing atypical femur fracture cases, and it is anticipated that the number of cases pending in the MDL could increase significantly.  There are also cases pending in state court in California, which utilizes a mass tort coordination process much like that used in New Jersey and in the MDL.

Judge Higbee has selected 9 cases involving local plaintiffs for trial preparation. The first trial is tentatively scheduled to begin in September of 2012, which means that there is a lot of work that needs to be completed in the coming months with regard to the development of case-specific and generic liability, scientific, and causation evidence.  Six cases involving New Jersey plaintiffs have also been selected in the MDL proceedings for case-specific discovery and trial preparation.  The first MDL trial is expected to occur in New Jersey in April of 2013.

The scheduling of these trial dates is an important step forward in the national litigation efforts. The general liability and causation evidence that is developed with these first trial cases will be available to all of the plaintiffs in the coordinated state and federal litigation and will streamline the prosecution of their individual lawsuits.

At this time, it is too soon to know whether settlement negotiations are likely, although Judge Higbee is well known for being a resolution-oriented judge and will certainly encourage conclusions in the best interests of all concerned. Merck has been successful in obtaining defense verdicts in several recent trials involving Fosamax-induced jaw osteonecrosis, so we anticipate that Merck will be resistant to global settlement talks. Judge Higbee, however, was one of the judges instrumental in orchestrating Merck’s landmark $5.8 billion Vioxx settlement program, which resolved nearly 50,000 pending state and federal court lawsuits several years ago.