A November 30, 2017 post discussed the Food and Drug Administration’s (FDA) return to third-party courtroom advocacy for national, uniform regulation of products under its authority. In separate amicus briefs, the agency argued that federal law preempted both New York City’s enforcement of an expanded menu-labeling ordinance and certain claims in a products-liability suit against a medical-device maker. FDA also urged the International Trade Commission (ITC) to terminate an investigation into the drug-or-dietary-supplement status of an imported omega-3 substance because the inquiry would directly conflict with the agency’s authority in that area.
As a long-time proponent of regulatory uniformity, Washington Legal Foundation is encouraged by these developments, and we trust that FDA’s courtroom advocacy is a work in progress. The agency can make an even bigger difference in 2018 by weighing into litigation involving one of FDA’s most highly regulated class of prescription drugs: opioid-based pain medications.
In 2017, what had been a trickle of government lawsuits against opioid-based pain-medication manufacturers and others in the distribution chain became a flood as over 100 states, counties, cities, and even fire districts filed claims. The suits, conceived by private contingent-fee counsel, are analogous to the failed “overmarketing” litigation crusade cities and states launched against gun makers in the 2000s. As with those suits, government plaintiffs want courts to shift the blame and financial burden of other parties’ illegal diversion, misuse, and abuse of opioids to deep-pocket businesses.
On December 5, the U.S. Judicial Panel on Multidistrict Litigation (MDL) transferred 115 local-government claims against pain-medication makers, distributors, sellers, and prescribers to the U.S. District Court for the Northern District of Ohio. More suits are expected to be added to the Ohio MDL. Scores of other lawsuits filed by state attorneys general are pending in state courts.
In a nutshell, the suits allege that the defendants created a public nuisance and violated other state laws by improperly marketing opioid-based medications for long-term use to treat chronic pain. A decision for the MDL plaintiffs, or any one of the states, would directly impact what drug makers can and cannot say about that particular product use. Such an outcome would place opioid manufacturers in a Catch-22.
Long-term use of opioids for chronic pain is FDA-approved and the labeling for such use is strictly controlled. Manufacturers could not comply with a court order to reduce or increase information about that opioid use without running afoul of FDA regulations. When compliance with both state and federal labeling requirements is impossible, courts have held that federal law can impliedly preempt the state-law legal action.
The opioid manufacturers can present clear evidence that FDA would reject a label-change request for long-term, chronic-pain use. A public-health activist group petitioned FDA in 2012 to exclude treatment of chronic pain as an indication on all opioid-based drugs. The petition also called for dose and time limits for non-cancer pain prescriptions. FDA rejected the group’s request in September 2013. A May 2017 Tenth Circuit decision involving drug preemption concluded that a rejected citizen petition provides sufficient evidence that FDA would not permit warnings sought in a state-law products-liability suit.
Despite its deep involvement in the regulation of opioids, FDA has stood idly by as the opioid litigation crusade has unfolded. It’s time for FDA to end the silence. At the opportune moment in the MDL or a state suit, the agency should defend its regulatory primacy and the concept of national uniformity through an amicus brief arguing that the state-law claims conflict with FDA labeling requirements.
The case for FDA involvement is a compelling one. The state and local government suits controvert the public-health goal FDA advances through opioid-based medicines’ approval and availability. In rejecting the 2012 citizen petition, FDA stated that “opioids can effectively manage pain and alleviate suffering—clearly a public health priority.” It added, “Chronic pain is a serious and growing health problem.” Opioid abuse and misuse present serious consequences, including addiction. With those concerns in mind, FDA ordered manufacturers to further study the benefits and risks of chronic opioid therapy, with results expected soon.
The lawsuits’ ultimate outcomes could directly contradict what actions FDA takes after receiving those results, leading to inconsistent limitations on opioids’ use. The agency stressed such potential conflict when urging the ITC to end its investigation into a dietary supplement, noted in our November 30 post. Such regulatory confusion, as one state judge remarked when ordering a stay on a California county’s opioid suit, causes “a potential chilling effect on the prescription of these drugs for those who need them most.”
FDA’s amicus involvement in one or several opioid suits would also send a vital, broader message: government litigation is an inappropriately blunt, haphazard regulatory device for weighing the competing risks and benefits of complex pharmaceutical products. If the localities and states succeed in imposing controls on opioids, they and their avaricious allies in the plaintiffs’ bar will be looking for the next FDA-regulated target to sue. That’s a state of affairs FDA certainly wants to avoid.
Opioid abuse, its causes, and potential remedies have become politically charged, highly emotional issues. That reality will weigh heavily on FDA if it does consider asserting its considerable legal influence in the opioid litigation. Perhaps the federal judge presiding over the MDL might consider inviting the agency to express its views on preemption once the issue is raised in court filings, as the U.S. Court of Appeals for the Third Circuit did in the Shuker case discussed in our November 30 post.
Whether acting at the request of a court or on its own initiative, FDA should take the opportunity to continue the welcome courtroom defense of regulatory uniformity it began in August 2017.
Also published by Forbes.com on WLF’s contributor site.