Even after Merck reached agreements to settle Fosamax lawsuits involving jaw injuries, the pharmaceutical company continues to face more than 4,000 product liability cases nationwide that allege inadequate warnings were provided about the risk of femur fractures from Fosamax, with trial dates expected to begin this year in several cases.
Fosamax (alendronate sodium) is a blockbuster medication that 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.
Late last year, it was announced that Merck agreed to pay $27.7 million in Fosamax settlements to resolve more than 1,100 product liability lawsuits filed on behalf of former users of the drug who experienced severe jaw problems following long-term use of the medication, including osteonecrosis of the jaw, which involves the deterioration and death of portions of the jaw bone.
The drug maker has indicated it intends to continue to defend against other complaints that claim Merck failed to adequately warn consumers or the medical community about the risk of atypical femur fractures, which users have experienced following little or no trauma at all, such as falling from standing height or less.
A series of trial dates are expected in 2014, which are designed to help the parties gauge how juries may respond to certain evidence and testimony that may be repeated throughout the femur fracture litigation.
Fosamax Femur Fracture Concerns
Most of the femur fracture lawsuits over Fosamax have been filed since late 2010, when the FDA required Merck to add new warnings about the risk of bone fractures. 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.
In a study published by the medical journal Calcified Tissue International in November 2013, researchers indicated that the increased risk of bone fractures with Fosamax and other osteoporosis drugs may have a genetic factor to explain why some users experience these atypical breaks in circumstances that would not normally cause a femur fracture.
The lawsuits allege that Merck knew or should have known about these risks long before the warnings were provided, and claim that if adequate information had been provided to users and the medical community plaintiffs could have avoided suffering complete fractures on Fosamax by avoiding the medication or stopping use earlier.
Federal Fosamax Bellwether Trials for Femur Fractures
About 25% of the Fosamax femur fracture lawsuits filed nationwide are pending in the federal court system, where the cases have been centralized before U.S. District Judge Garrett E. Brown, Jr. in the District of New Jersey, as part of an MDL or multi-district litigation. The cases are consolidated to reduce duplicative discovery, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.
As part of the pretrial proceedings, Judge Brown previously selected a group of 40 cases to go through case-specific discovery, which was subsequently narrowed down to a group of four cases that are eligible for early trial dates, known as “bellwether” cases. These early trial dates are typically scheduled in complex pharmaceutical litigation to put representative cases before juries, and promote settlement negotiations between the parties.
The first Fosamax femur fracture trial went before a federal jury April 2013, resulting in a defense verdict for Merck. Following that trial, Judge Brown also granted Merck’s motion for summary judgment as a matter of law in the case, finding that a claim for failure to warn filed by Bernadette Glynn was preempted.
In August 2013, Judge Brown issued an order requiring all plaintiffs who allege they suffered a femur fracture from Fosamax prior to September 14, 2010 to submit responses to the Court arguing why their cases should not also be pre-empted by federal law. Plaintiffs and Merck have filed response briefs, and Judge Brown is expected to rule on the preemption issue in the coming months, which could result in the dismissal of a number of cases.
Additional “bellwether” trials in the federal Fosamax femur fracture MDL are expected to begin on May 5, 2014. Judge Brown has not yet selected the specific case that will go to trial, but it is expected to involve a case where the alleged injury occurred after January 31, 2011. These cases allege that the warnings added in 2010 were inadequate.
State Court Fosamax Fracture Lawsuits
In addition to federal litigation, hundreds of cases are pending in various state court systems, with at least 2,500 pending in New Jersey and about 500 pending in California. The New Jersey litigation has already been consolidated before one judge for centralized management, and a similar request is pending in California.
Similar to the federal court system, a group of 30 cases were selected for fact discovery in the New Jersey state court litigation. Trial began in a case filed by Christina Su in March 2013, but a mistrial was granted after the plaintiff suffered a serious medical issue unrelated to the use of Fosamax.
A second trial in New Jersey state court was originally expected to begin in November 2013, but that trial date was postponed. That same case is now expected to begin in March 2014, and the Court is expected to add one or two other cases for a combined trial.