Shay Dvoretzky Shay Dvoretzky.

Pharmaceutical company Merck has asked the U.S. Supreme Court to remedy what it perceived to be “unduly high hurdles” imposed by courts on pharmaceutical drug manufacturers asserting federal pre-emption in tort cases.

In an opening brief filed on Thursday, Merck counsel Shay Dvoretzky, a Jones Day partner in the Washington, D.C., office, urged the Supreme Court to clarify its holding in Wyeth v. Levine that manufacturers must show “clear evidence” that the U.S. Food and Drug Administration would have rejected certain warning labels in order to assert federal pre-emption. In asking to reverse a 2017 decision by the U.S. Court of Appeals for the Third Circuit that reinstated more than 500 cases over its osteoporosis drug Fosamax, Merck argued that its case, like many others, was a “slam dunk,” because the FDA actually rejected its proposed warnings about the drug’s possible risk of causing bone fractures, specifically of the femur.

“This should have been an easy case,” Dvoretzky wrote. “Respondents believe that state law required Merck to warn them about atypical femoral fractures but Merck tried to do so and the FDA turned its back. There could be no clearer evidence that compliance with both state and federal law was impossible.”

But Merck said it’s not alone. As an example, the pharmaceutical giant cited last month’s ruling by the U.S. Court of Appeals for the Seventh Circuit tossing out a $3 million verdict for the widow of a former Reed Smith partner who committed suicide after taking a generic version of the antidepressant Paxil. The Seventh Circuit held that a district court judge should have tossed the claims prior to trial because the FDA had rejected manufacturer GlaxoSmithKline’s proposed suicide warnings several times.

“If manufacturers must face tort suits even when the FDA has made clear that no warning was necessary, they will continue to face an onslaught of troubling, coercive litigation,” Dvoretzky wrote.

The Fosamax case addresses one of the most significant federal pre-emption issues for brand drug companies since Wyeth, which found in 2009 that the FDA’s approval of labeling changes on a drug didn’t guarantee a federal pre-emption defense in failure-to-warn cases. Drug manufacturers bore some responsibility for the labeling of their products, the Supreme Court found, but could argue there was “clear evidence” the FDA would not have approved their proposed changes.

Courts are grappling with that “clear evidence” definition, and lawyers in other mass torts are closely monitoring the Supreme Court’s decision in the Fosamax case.

In 2014, U.S. District Judge Joel Pisano in New Jersey granted summary judgment to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc., on its federal pre-emption defense. But the Third Circuit found that Merck had not proven there was “clear evidence” that the FDA would have rejected changes to Fosamax’s labels warning of possible femur fractures. The panel insisted that there was no evidence that the FDA, which ended up ordering those label changes to Fosamax in 2010, had rejected the warning because of the science rather than simply the wording.

In May, Principal Deputy Solicitor General Jeffrey Wall urged the high court to take up Merck’s petition, in part because the Fosamax case dealt with an actual FDA labeling change—not a hypothetical one like in Wyeth.

Merck honed in on that distinction in this week’s brief, which noted that the FDA had rejected its proposed warning in a 2009 letter.

“If a manufacturer proposes to warn about a risk, discloses what it knows about that risk, and gets rebuffed by the FDA, failure-to-warn claims against it are pre-empted as a matter of law,” Dvoretzky wrote.

The solicitor general’s brief also noted that the FDA rejected Merck’s proposal because “the data was then insufficient to justify such a warning,” not because of the warning’s semantics. It was only after a 2010 external task force report that the FDA approved the label changes.

“Because the FDA itself has now provided the very ‘smoking gun’ the Third Circuit demanded, respondents’ claims must fail,” Dvoretzky wrote.

He also wrote that the Third Circuit’s approach “led it astray” in ruling that a jury, not a judge, should decide whether the FDA would have rejected labeling changes. The Third Circuit also misconstrued the Supreme Court’s “clear evidence” language in Wyeth to mean “clear and convincing evidence,” which is generally used in cases about parental rights or involuntary commitment, he wrote.

Three amicus groups—the Product Liability Advisory Council Inc., the Pharmaceutical Research and Manufacturers of America and the U.S. Chamber of Commerce—filed amicus briefs supporting Merck’s petition.

Plaintiffs’ lawyer David Frederick, a partner at Kellogg, Hansen, Todd, Figel & Frederick, is due to file his response before the Supreme Court on Nov. 14.