Fosamax Femur Fracture Lawsuits Set To Move Forward After Supreme Court Refuses Appeal

Lawsuits over atypical fractures from Fosamax have been dismissed and reinstated several times over the past 15 years, but are finally cleared to proceed.

The U.S. Supreme Court has rejected an appeal filed by Merck, which sought a second review for Fosamax femur fracture lawsuits, which first emerged more than 15 years ago, finally clearing the cases to proceed toward trial.

The litigation involves allegations that the drug maker failed to warn about atypical bone fracture risks caused by Fosamax (alendronate sodium), which was introduced in 1995 for the treatment of osteoporosis and Paget’s disease.  

Although the drug is supposed to strengthen bones, several studies published nearly two decades ago revealed that long-term use of the medication may actually increase the risk of low-energy bone fractures, usually involving the thigh bone, or femur.

The first Fosamax lawsuits were filed in 2010, after the U.S. Food and Drug Administration (FDA) required a warning label update about the bone fracture risks. By 2014, Merck faced more than 1,100 product liability lawsuits brought by individuals who say they experienced Fosamax femur fractures after taking a step, falling from standing height or other incidents that typically would not result in a broken bone.

Plaintiffs allege that Merck knew or should have known about Fosamax bone fracture risks for years before the warning label update, but kept that information from consumers and the medical community until the FDA required the new warning. However, the drug maker has maintained that federal law prevented it from adding the warning without the FDA’s permission, which it said could not have come any sooner than it did due to a lack of previous scientific evidence.

In 2014, U.S. District Judge Joel Pisano agreed with Merck, granting a motion for summary judgment dismissing all Fosamax femur fracture lawsuits on the basis that they were preempted by federal law. However, following a lengthy appeals process, the cases were restored by an appeals court in 2017, and appealed to the U.S. Supreme Court.

Following guidance from the Supreme Court ruling, the lawsuits returned to  the District of New Jersey, where the cases were again dismissed in 2022.

Last September, the U.S. District Court of Appeals for the Third Circuit reinstated the Fosamax litigation for a second time, leading Merck to petition the Supreme Court for another review. However, on June 16, the high court announced that it would not consider the case, leaving the Third Circuit’s decision, and the litigation, in place.

As a result, Merck may now have to face hundreds of Fosamax femur fracture lawsuits it once thought it had defeated, which have been sent back to the U.S. District Court for the District of New Jersey, where they were consolidated for coordinated pretrial proceedings.