In a far-reaching opinion, the Third Circuit US Court of Appeals revived 5,000 product liability cases involving the osteoporosis drug Fosamax, ruling that federal preemption of state-law claims is a question of fact for a jury to decide, not a question of law for a judge.
The ruling in In re Fosamax Products Liability Litigation, Case No. 14-1900 et al, decided March 22, 2017, is a major setback for Merck and other Big Pharma companies that seek to torpedo patient claims in summary judgment motions, by arguing that:
- State-law failure-to-warn lawsuits are pre-empted by federal law
- When there is “clear evidence” that the FDA would not have approved a warning label that the plaintiffs claim is necessary.
On the other hand, the ruling is a boon to plaintiff lawyers who are striving to preserve their lawsuits against preemption attacks that have nothing to do with the merits of the case.
For example, the Fosamax opinion is already being cited in an appeal to the 9th Circuit in Incretin-Based Therapies Products Liability Litigation, MDL 2452 in US District Court for the Southern District of California. In that case, the trial court made a summary judgment ruling in favor of the defendant — including Merck — knocking out the plaintiffs’ state law failure-to-warn claims.
In the Incretin case, Plaintiff attorney Ryan L. Thompson of Watts Guerra in San Antonio, TX, notified the 9th US Circuit Court of Appeals about the Third Circuit’s Fosamax ruling in a March 23 letter, seeking to vacate the trial court’s adverse summary judgment, discovery and disqualification orders.
What is “clear evidence”?
The source of the confusion stems from a fuzzy US Supreme Court Opinion, Wyeth v. Levine, 555 U.S. 555 (2009), that says that state-law failure-to-warn claims are preempted by federal law when there is “clear evidence” that the FDA would not have approved a label change. “This standard is cryptic and open-ended, and lower courts have struggled to make it readily administrable,” the Third Circuit commented.
Resolving the issue, the Third Circuit held that “The meaning of “clear evidence,” as Supreme Court usage confirms that the term is synonymous with “clear and convincing evidence.” The latter is a well-recognized intermediate standard of proof—more demanding than a preponderance of the evidence, but less demanding than proof beyond a reasonable doubt.”
Furthermore, the appeals court ruled:
- Whether the FDA would have rejected a label change is a question of fact for the jury.
- At the summary judgment stage, the court cannot decide for itself whether the FDA would have rejected a change, but must instead ask whether a reasonable jury could find that the FDA would have approved the change.
- A mass tort MDL is not a class action. Merck’s actual burden at the summary judgment stage was to prove that there is no genuine dispute in every single MDL case that plaintiffs’ doctors would have continued to prescribe Fosamax even if a fracture warning had been added to the Adverse Reactions section before May 2009.
The successful argument to the Third Circuit was made by plaintiff attorneys Edward Braniff of Simmons Hanly Conroy LLC in New York, Michael E. Pederson of Weitz & Luxenberg in New York, and Donald A. Ecklund of Carella Byrne Cecchi Olstein Brody & Agnello in Roseland, NJ.
Beginning in 2010, hundreds of plaintiffs filed personal-injury suits against the drug manufacturer Merck Sharp & Dohme, alleging that the osteoporosis drug Fosamax caused them to suffer serious thigh bone fractures.
Each Plaintiff brought a state-law tort claim alleging that Merck failed to add an adequate warning of the risk of thigh fractures to Fosamax’s FDA-approved drug label. Many Plaintiffs also filed additional claims including defective design, negligence, and breach of warranty. Plaintiffs’ suits were consolidated for pretrial administration in a multi-district litigation in the District of New Jersey. Following discovery and a bellwether trial, the District Court granted Merck’s motion for summary judgment and dismissed all of Plaintiffs’ claims on the ground that they were preempted by federal law.
Plaintiffs’ suits were consolidated for pretrial administration in a multi-district litigation in the District of New Jersey. Following discovery and a bellwether trial, the District Court granted Merck’s motion for summary judgment and dismissed all of Plaintiffs’ claims on the ground that they were preempted by federal law.
Fosamax is a treatment for osteoporosis, but plaintiffs claim that the drug actually increases the risk of thigh bone fractures. Plaintiffs claim that while stress fractures typically heal on their own, “some Fosamax users who develop insufficiency fractures have reduced bone toughness, and Fosamax prevents the normal repair of the fracture.” According to Plaintiffs, these patients may then go on to develop what are known as “atypical femoral fractures”: severe, non-traumatic, low energy complete fractures of the femur.
In 2013, Merck reached a separate settlement of $27 million with 1,200 Fosamax users who suffered necrosis of the jawbone.