Preemption Defense Opportunities, Pitfalls
Trump 2.0 appears to be changing the FDA approval landscape, and new opportunities and pitfalls abound for defendants seeking to establish a preemption defense. That’s the view of attorney Grant Hollingsworth (Hollingsworth) writing in an online post.
Hollingsworth says there are already regulatory pilot programs and deregulatory initiatives that could affect litigation involving FDA-approved drugs and medical devices. “Defendants’ most powerful defense in such litigation is often preemption,” Hollingsworth writes, “and the administration’s recent changes may both positively and negatively impact preemption arguments under the ‘clear evidence’ standard.”
The post says the Supreme Court has clarified that “clear evidence” is a two-part test that requires drug manufacturers to establish (1) they fully informed FDA of the justifications for the warning required by state law, and (2) FDA said it would not approve a labeling change to include the warning.
“To satisfy that standard,” Hollingsworth writes, “defendants must come forward with evidence of formal agency actions to support the position that FDA either rejected or would have rejected the warning that is purportedly necessary to protect plaintiffs bringing state law failure-to-warn claims.”
Hollingsworth also discusses two regulatory initiatives that could affect defendants’ preemption success. The first is FDA’s accelerated reviews under the Commissioner’s National Priority Voucher Pilot Program. He says the pilot aims to speed approvals and increase communications between sponsors and FDA. “If courts deem communications sufficient,” he says, “this accelerated review process could lead to more preemption wins in this narrow subset of cases.”
The second change Hollingsworth cites is the deregulatory approach that calls for cutting 10 regulations for each new regulation promulgated. “This approach will likely lead to fewer guidances, fewer formalized labeling positions, and overall less documentation of FDA regulatory positions that could be construed by courts as clear evidence supporting preemption,” he says.