After SCOTUS Ruling, Merck Gets 2nd Chance to Make Preemption Argument in Fosamax Suits
Merck's opportunity for a new hearing is a victory for lawyers from King & Spalding, Skadden Arps Slate Meagher & Flom, Fox Rothschild, McCarter & English, Jones Day and Venable.
November 25, 2019 at 02:35 PM
3 minute read
The U.S. Court of Appeals for the Third Circuit has ordered a new proceeding to determine whether state-law claims are subject to federal preemption in a group of 500 suits against Merck by users of osteoporosis drug Fosamax.
Monday's court of appeals order follows a May 20 decision by the U.S. Supreme Court that said the preemption issue should be decided by judges, not juries. The Supreme Court ruling vacated a Third Circuit judgment that reopened the group of cases after they had been dismissed.
The Supreme Court was unanimous on the result in the case, Merck Sharp & Dohme v. Albrecht. At issue was whether state-law failure-to-warn suits against Merck were preempted by federal law when the U.S. Food and Drug Administration rejected Merck's effort to warn about the risk of Fosamax, and whether it was up to juries to determine why the FDA rejected Merck's proposed warnings. Justice Stephen Breyer wrote for the court that the complexity of the legal issues in the case demonstrate why the question is a legal one for a judge to answer. Judges, rather than lay juries, are better equipped to evaluate the nature and scope of an agency's determination, Breyer wrote.
Following the high court's decision, the Third Circuit conducted supplemental briefing before ordering the cases remanded to district court for a determination on whether plaintiffs' state-law claims are preempted under the standards set out by the Supreme Court.
The Third Circuit ordered the district court to determine the effect of the FDA's complete response letter and other communications with Merck on the issue of whether such agency actions are sufficient to give rise to preemption, Third Circuit Judge Julio Fuentes said in the order, joined by Judges Michael Chagares and L. Felipe Restrepo.
Merck's opportunity for a new hearing is a victory for lawyers from King & Spalding, Skadden Arps Slate Meagher & Flom, Fox Rothschild, McCarter & English, Jones Day and Venable, the firms listed on Merck's remand brief at the Third Circuit.
Merck did not respond to a request for comment on Monday's Third Circuit order. Lawyers from Kellogg Hansen Todd Figel & Frederick in Washington, D.C., and Carella, Byrne, Cecchi, Olstein, Brody & Agnello in Roseland, New Jersey, who represented the plaintiffs at the Third Circuit, did not respond to requests for comment.
The Supreme Court hearing concerned a 2017 decision in which the Third Circuit said U.S. District Judge Joel Pisano erroneously granted summary judgment to Merck in June 2014 in a suit by plaintiff 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. The District Court ruled that Glynn's case was preempted because the FDA's 2009 decision was "clear evidence that the FDA would not have approved a label change" before 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.
Apart from the current group of cases, Merck reached a separate settlement of $27 million in 2013 with approximately 1,200 Fosamax users who suffered necrosis of the jawbone.
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