Third Circuit Panel Reverses Earlier Dismissal Of Plaintiffs Cases By District Court Judge Pisano On Federal Preemption Grounds
In a lengthy and long-awaited Opinion issued March 22, 2017, the Third Circuit Court of Appeals decided to reverse a ruling by U.S. District Court Joel Pisano which had dismissed all the federal court Fosamax - femur fracture cases on federal preemption grounds. In turn, hundreds of those Fosamax lawsuits have been reinstated at the trial court level.
Essentially, the Third Circuit held that the ultimate question of whether the FDA would have rejected a Fosamax label change by Merck to warn about an increased risk of femur fractures is a question of fact for the jury -- rather than for Judge Pisano -- to decide.
From a March 22, 2017 Reuters news report, "Merck must face renewed Fosamax warning claims: U.S. appeals court", we get these basic facts about this recent appellate decision in the Fosamax - femur fracture MDL litigation:
In a 3-0 decision, the 3rd U.S. Circuit Court of Appeals in Philadelphia said the plaintiffs may proceed to trial on their failure-to-warn claims, and a lower court judge erred in finding the claims pre-empted by federal law.
Merck said it is reviewing its options, and that a judge, not a jury, should decide the pre-emption question. It also said it remains "confident" in Fosamax's safety and effectiveness....
[Plaintiffs] said Merck knew about the risk for more than a decade before adding it to the Fosamax warning label in January 2011.
[Merck] changed the label four months after an outside task force hired by the U.S. Food and Drug Administration published a report associating Fosamax with the fractures....
[U.S. District Judge Joel Pisano] cited a 2009 U.S. Supreme Court decision that state law-based failure-to-warn claims were pre-empted when there was "clear evidence" that the FDA would not have approved a warning that plaintiffs requested.
Writing for the appeals court, however, Circuit Judge Julio Fuentes found enough evidence for a reasonable jury to conclude that the FDA would have approved "a properly-worded warning" about Fosamax, "or at the very least, to conclude that the odds of FDA rejection were less than highly probable."
Fuentes said a jury could also find that some doctors would not have prescribed Fosamax had Merck discussed the risk of fractures on a warning label.
In more detail, the so-called federal court Fosamax MDL is properly titled: In re: Fosamax (Alendronate Sodium) Products Liability Litigation.
The following excerpt from "Suits Over Fosamax Link to Femur Fractures Get New Life", by reporter Charles Toutant, which was published by the New Jersey Law Journal on March 22, 2017 provides a more in-depth legal analysis of this significant ruling:
In the Fosamax case, Third Circuit Judges Jose Fuentes, Michael Chagares and L. Felipe Restrepo said Merck failed to prove that it is entitled to the affirmative defense of pre-emption.
The appeals court said U.S. District Judge Joel Pisano erroneously granted summary judgment to Merck in June 2014 in a suit by Bernadette Glynn after wrongly concluding that the clear evidence standard had been met in that case. In 2009, the FDA rejected Merck's proposed revision of language on the Fosamax label to warn of the potential danger of bone fractures. Pisano ruled that Glynn's case was pre-empted because the FDA's 2009 decision was "clear evidence that the FDA would not have approved a label change" prior to her injury. After that ruling was issued, Merck then was granted summary judgment on all cases stemming from injuries that occurred before September 2010, the date of a task force report linking Fosamax usage to femur fractures.
Courts have struggled with the "clear evidence" standard, which is "cryptic and open-ended," Fuentes wrote for the court. The Fosamax case requires the court to address what "clear evidence" is and who should decide when it exists, he wrote. The panel wrote that "clear evidence" applies solely to the applicable standard of proof, and that the question of whether the FDA would have rejected a label change is a question for the jury and not a judge.
Certainly the Third Circuit's ruling on the Fosamax appeals is a positive development for the patients who suffered femur fractures after long-term Fosamax use and filed drug injury lawsuits against Merck.
However, it is just a first step in terms of the Fosamax - femur fracture litigation moving forward. Significantly, at the present time we do not know Merck’s plans regarding any further appeal to the United States Supreme Court.
Once the further appeal issue is resolved, we will have a better idea about what comes next for the many femur fracture lawsuits which are part of this Fosamax MDL.
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