U.S. Solicitor General Noel Francisco is siding with the drug company and together they will tell the justices Jan. 7 that the Food and Drug Administration prevented Merck from changing its Fosamax label to include a warning about atypical femoral fractures.
Atypical femoral fractures are breaks that happen without impact.
The FDA’s rejection of Merck’s proposed label change left the drugmaker unable to satisfy both federal regulations and the warning plaintiffs say was needed to meet state tort law duties, according to Merck. Consequently, the suits are preempted as a matter of law, Merck’s brief argues.
The women suing the company, meanwhile, will tell the court the FDA merely rejected specific words describing a less serious injury than the one that affected them. Regulators might have allowed a differently phrased warning, they’ll say.
The Third Circuit revived the suits in 2017 and, in doing so, created a high bar for Merck and other branded drugmakers to defeat suits based on federal law preemption. The appeals court said claims aren’t barred unless a jury finds it “highly likely” the FDA would have rejected the warning the plaintiffs say should have been given.
Preemption has its roots in Wyeth Inc. v. Levine, where the U.S. Supreme Court said warning-based claims are barred if a drugmaker can show “clear evidence” the FDA would have rejected the label change the plaintiffs sought.
In Levine, the manufacturer didn’t seek to warn about the risk at issue, and the Levine court didn’t define “clear evidence,” leaving lower courts to grapple with what that means.
The Third Circuit held it was a standard of proof, which it equated to a high probability.
The court’s Levine decision came down in 2009, and attorneys tracking the Merck case on both sides have strong arguments.
Attorneys experienced in pharmaceutical litigation but not involved in the Merck case told Bloomberg Law how the court rules, and the decision’s expected impact, will depend on how extensively the justices decide to revisit their prior preemption analysis.
The case specifically asks whether Wyeth’s “what-would-the-FDA-have-done” defense applies under the circumstances presented by the Fosamax litigation, and the subsidiary matter of who decides that question, court or jury?,” said Brian Wolfman, who was one of the attorneys representing plaintiff Diana Levine in the earlier top court case.
If the justices stick to those questions, the ruling could be narrow and not affect drug litigation much, Wolfman told Bloomberg Law.
The Fosamax case “does not challenge Wyeth, but involves only a quirky application of it,” said Wolfman, who now runs the Georgetown University Law Center’s appellate courts immersion clinic.
In most drug-injury cases, the warning that the plaintiff says would have prevented her injuries was never before the FDA, and so, under Wyeth, preemption is no defense, Wolfman said.
And the question whether it is possible to comply with both federal requirements and state tort law will often be a question of fact for the jury to decide, he said.
But two pharma defense attorneys not involved in the case see it differently.
Question of Law
The implication of FDA regulatory action is a question of law for a court, Michelle Bufano of Patterson Belknap in New York told Bloomberg Law.
“If the Supreme Court were to agree that jury speculation should be part of the analysis, it would create an impossibly high evidentiary burden on defendants asserting preemption and would lead to inconsistent results,” Bufano said.
Industry is following this case closely, another defense attorney said, with the hope that the court will clarify when this type of preemption can exist.
The Fosamax case, with the FDA’s rejection of the proffered warning, offers “an excellent record” on which to present this issue, Colleen Hennessey of Peabody & Arnold in Boston said.
It’s possible the Supreme Court could avoid the standard of proof or “who decides” questions, but “given what’s gone on in the lower courts, and the inconsistency with how the lower courts have interpreted Levine,” the Supreme Court is likely to address those issues, Hennessey said.
This is particularly so because “you have the other side pushing that this is not a real rejection but a factual issue,” she said.
Government: FDA Rejected Change
The Third Circuit’s decision applies to women who used Fosamax before September 2010, when a medical group reported an association between the osteoporosis drug and AFF.
The FDA’s 2009 decision and its later actions in requiring a label change after another data review show that Merck couldn’t have altered Fosamax’s labeling sooner than it did, the government said in a friend-of-court brief supporting Merck.
The agency found insufficient data in 2009 to support an AFF warning but in late 2010 concluded the label should be revised based on the medical report. At that time, agency personnel edited Merck’s proposed wording to remove language relating to stress-fractures that wasn’t deemed clear enough, the government said.
But the plaintiffs said the agency hadn’t mandated a label change before September 2010.
Therefore, Merck might have been able to unilaterally augment the label through a different pathway, called the “changes being effected” procedure, the plaintiffs said.
Merck’s 2009 proposal addressed minor “stress fractures,” a much less serious break than the atypical femur fractures suffered by the plaintiffs. The FDA rejected the stress fracture language, and invited Merck to submit a revised application, the plaintiffs’ brief said.
The agency later was swayed by the medical society report, which summarized existing data and helped the agency understand the issues more clearly, the plaintiffs said.
FDA presumably would have welcomed a similar clarification from Merck, they said.
Jury Overreach Unlikely, Women Say
And as for who makes the decision, “Whether FDA would have rescinded a different warning presents the type of counterfactual question juries routinely decide,” they said.
A warning about atypical femur fractures was added to the Fosamax label in 2011.
Two tort professors supporting the plaintiffs saidMerck’s “understated and muddled warning” isn’t clear evidence the FDA would have rejected a warning from atypical femoral fractures.
Professor John C. P. Goldberg at Harvard Law School and Fordham Law School Professor Benjamin C. Zipursky also urge the court to take a “restrained approach to implied preemption,” and said defense attorneys’ concerns about the Third Circuit’s giving to much power to the jury are overblown.
The learned intermediary rule, the defense of regulatory compliance, and trial judges’ screening of proposed expert testimony are robust protections against jury overreach, the professors said.
David C. Frederick of Kellogg, Hansen, Todd, Figel & Frederick PLLC in Washington represents the plaintiffs. Shay Dvoretzky of Jones Day in Washington represents Merck.
The case is Merck, Sharp & Dohme Corp. v. Albrecht, U.S., No. 17-290, argument 1/7/19.