Merck & Co. has been fighting to take its appeal in the years-long Fosamax product liability litigation to the Supreme Court, and if it succeeds, the ruling could affect liability lawsuits across Big Pharma. So when the respondents in the case filed a brief urging SCOTUS to ignore the company's appeal last week, Merck fired back with a strongly worded brief of its own.
The war of words emanated from a brief (PDF) that the U.S. Solicitor General filed a few weeks back supporting Merck's contention that SCOTUS should take up Merck’s appeal. The court had asked the solicitor general to weigh in on the key issue that the case revolves around: “preemption,” which is the question of whether FDA decisions shield drugmakers from state legal challenges.
The solicitor general suggested that the question should be resolved by judges, not a jury.
The respondents in the Fosamax case are patients who allege they weren’t adequately warned of a fracture risk while taking the osteoporosis drug. More than 500 Fosamax users had femoral fractures before the FDA ordered Merck to add language about the risk to the product’s label in 2011.
Merck won two bellwether lawsuits filed over the side effect, and in 2014, a federal court threw out 5,000 lawsuits from patients alleging their fractures were caused by the drug. Three years later, a federal appeals court in New Jersey threw out that dismissal, reviving the legal battle.
Merck had argued that preemption applies because it attempted to update the label earlier, but the FDA rejected its proposed wording. The solicitor general said in his brief that the FDA’s decision clearly supported preemption because it “prevented [Merck] from modifying the relevant labeling before late 2010.” Thus, he added, the court of appeals made a mistake in rejecting Merck’s defense.
Lawyers representing the respondents addressed the notion that SCOTUS should take up the matter by blasting the solicitor general for ignoring “several unusual aspects” of Merck’s appeal. They suggested in the latest brief (PDF) that the factual record is “underdeveloped” because Merck based its preemption argument on an internal memo recounting one employee’s phone chat with the FDA.
“Respondents are aware of no other preemption case in which the manufacturer relied on hearsay accounts of informal FDA communications,” the lawyers said in their brief. They added that a review by SCOTUS would have “limited impact” on other product liability cases in the pharmaceutical industry.
Merck shot back by saying in its brief (PDF) that it “has already rebutted” the alleged problems with FDA communications that the respondents cite.
“Those arguments have not improved with age or repetition. They amount to nothing,” the company’s lawyers wrote.
Merck’s brief goes on to quote the solicitor general’s conclusion that if the FDA had come to believe there were scientific grounds to support a label change, the agency would have to pursue that revision as required by federal statutes.
“Consistent with that legal background, FDA’s rejection of Merck’s proposed warning ‘was based on the agency’s determination that the data was then insufficient to justify such a warning,’” Merck lawyers wrote in the brief, quoting the solicitor general’s argument.
Merck also rejected the idea that a Supreme Court ruling on the question of preemption would have a limited impact on the drug industry. Such a ruling, the brief said, “would clarify a confused area of law that governs a high volume of cases with substantial policy implications.”
Now it’s up to the justices to decide whether they agree with Merck’s contention that the case warrants their review. The company petitioned the Court to weigh in on the Fosamax case last December, arguing in part that resolving the preemption puzzle would be vital to public health.
Merck’s attorneys noted in its petition that even when drug companies collaborate with the FDA and propose a label warning, “they remain on the hook based on a lay jury's psychoanalysis of why the agency had blocked compliance with state law." Such an approach is “untenable” and “of great importance,” they said, “as proliferating tort suits stifle innovation, raise drug costs, undercut the FDA's role and ultimately hurt public health."