Fosamax Fracture Settlement Negotiations Ordered in MDL

As Merck is pushing for an order that may result in the dismissal of hundreds of Fosamax femur fracture lawsuits, the federal judge presiding over the cases has ordered the parties to enter into mediation efforts to see if settlements can be reached to resolve the litigation.

Several thousand product liability lawsuits have been filed against Merck, which all involve similar allegations that plaintiffs suffered a sudden femur fracture after using the osteoporosis drug Fosamax.

In the federal court system, the cases have been centralized before U.S. District Judge Joel A. Pisano in the District of New Jersey as part of an MDL, or multidistrict litigation. Additional cases are also centralized in New Jersey state court, which is where Merck’s U.S. headquarters are located.

Mediation Ordered

Earlier this year, Judge Pisano entered an order dismissing hundreds of Fosamax cases where plaintiffs claimed that they suffered a femur fracture prior to September 14, 2010, finding that any failure to warn claims prior to that date are pre-empted by federal law, since the Court found that there was evidence that the FDA would have rejected any request to strengthen the Fosamax warning label prior to that date.

In June, Judge Pisano granted summary judgement in a Fosamax lawsuit involving a femur fracture after 2011, finding that the label warnings at that time were sufficient.

In response, Merck filed a motion (PDF) last month, seeking a show cause order why the remaining cases should not also be dismissed. While plaintiffs have not yet responded to this motion, and have indicated they plan to appeal the summary judgments, it appears that Judge Pisano plans to push the parties towards a settlement in the Fosamax fracture litigation, which may put an end to the cases.

In a court order (PDF) issued September 4, Judge Pisano directed the parties to promptly consult and reach an agreement on a Mediator to facilitate resolution of the cases. It is expected that the mediator will be appointed next month, to meet with the parties together or separately, to promote possible Fosamax femur fracture settlements that may avoid lengthy appeals in the litigation.

Attorneys representing plaintiffs and Merck have been directed to provide the Court with a written status update concerning the mediation within 45 days after the selection of a mediator.

Fosamax Fracture Risk

All of the claims involve similar allegations that Merck failed to adequately warn consumers and the medical community about the risk of femur fractures from side effects of Fosamax.

Plaintiffs claim that they suffered spontaneous femur fractures following long-term use of the osteoporosis drug, typically occurring with little or no trauma at all, such as while taking a step or falling from standing height or less.

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 more than $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. However, the recent rulings may present an opportunity for the drug maker to resolve the litigation and avoid the risk of Judge Pisano’s decisions being overturned on appeal.

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.