Truthful Scientific Information: A Compelling Health Imperative
Why is it that the Food and Drug Administration (FDA) is suggesting it will conduct a meeting in the summer of 2015? Perhaps the FDA has had its fill after reaping more than $12 billion in penalties. More likely the landmark decision in US v. Caronia, 703 F.3d 149 (2d Cir. 2012) was the watershed decision that everyone, except the FDA, said it was. Moreover, pressure has been mounting as the House Commerce Committee is considering the "21st Century Cures Act" that potentially includes a provision on off-label communications; the Medical Information Working Group's (i.e. a coalition of big pharma) 2011 and 2013 petitions still lurk; and a myriad of litigation is challenging the current scheme of regulation. While it is unclear what form any new rule may take, it has been clear for more than a decade that the current regime offends the US Constitution on many fronts, foments litigation and—by hindering the flow of truthful scientific and medical information—fails to protect the public.
As the brouhaha continues, courts are contorting themselves to untangle the spaghetti bowl of cases applying federal preemption to state law parallel claims for off-label promotion. For example, in Caplinger v. Medtronic, 2015 U.S. App. LEXIS 6630 (10th Cir. April 21, 2015), the Tenth Circuit observed in a 2-1 decision that courts need not delve into the Food Drug and Cosmetic Act (FDCA) or FDA regulations to craft a cognizable claim regarding Medtronic's Infuse® off-label promotion that the plaintiff had failed to plead. While affirming the lower court's dismissal of the complaint on preemption grounds, the court wrestled with the murky morass of Supreme Court "parallel claim" preemption precedent and the question of state-tort claim survival under the primacy of the supremacy clause stating:
All the same the Lohr majority adopted a test that leaves it to lower courts to try to resolve whether a state duty is "literally different" but "narrower" (and thus permissible) or "too different" and "broader" (and thus impermissible). Lower courts have struggled ever since when it comes to trying to decide whether particular state claims do or don't "parallel" putative federal counterparts. Id. at 8
The Court went on to suggest that perhaps there is a need for a bit of Supreme Court clarity in this arena saying:
How are we supposed to apply all these competing instructions? It's "no easy task."... One can't help but wonder if perhaps some of those rules warrant revisiting and reconciliation... It's no wonder that the difficulty of crafting a complaint sufficient to satisfy all these demands has been compared to the task of navigating between Scylla and Charybdis. Id at *12-13 (citations omitted).
Further musing on the plaintiff Caplinger's frustration and offering a prayer of hope but no guidance, the court asserted:
That's not to say another plaintiff won't ever be able to succeed where Ms. Caplinger has failed. For example, we don't question the possibility that buried somewhere in the heap of federal law parallel provisions exist to save claims like Ms. Caplinger's. After all, the FDA's medical device regulations alone cover 592 pages of eight-point type and the Supreme Court has suggested that in searching for a parallel federal duty a plaintiff may scour them all as well as the statute itself. And lurking in there somewhere might be some answer to the apparent conundrum of how a plaintiff might use state law to require more label warnings that federal law seems to prohibit. But despite the challenge of Medtronic's motion to dismiss, Ms. Caplinger has never -- in all her voluminous briefs in the district court or this one -- identified any legally viable federal requirement that might parallel and thus permit her claims. Neither are the courts under an obligation to perform that work for her, searching out theories and authorities she has not presented for herself. Indeed, we are especially hesitant to try that here, where Ms. Caplinger has been ably represented by counsel and the effort to supplement their efforts would require us to venture into a field in which so many others who've come before have struggled to find their way and there exists so much risk of going astray. Id. at *18.
The Caplinger case is not notable merely because plaintiff failed to frame a cognizable cause of action. More troubling is the Court's failure to recognize the trend adopted by plaintiffs to rely on an "off-label promotion" claim as a pretext to circumvent preemption and there the Court observed:
In not a single one of its many and involved encounters with the MDA has the Supreme Court so much as hinted at this [off-label promotion] alternative path around preemption. But Ms. Caplinger says its past obscurity shouldn't stop us from recognizing it now. Id. at *23
Off-Label Versus New Drug
The Court got a bit undone sifting through the FDCA and FDA's regulations and "guidance." It is undoubtedly true that the Supreme Court has yet to recognize if, how, when, why and under what precise analysis the Court will recognize a tort claim for conduct deemed "promotion" of an unapproved new drug or device .
The Tenth Circuit's reasoning becomes murky when it focuses on Congress' limiting the FDA's power to restrict physicians from "using" a product in a manner that is not in the approved product labeling. 21 USC §396. Here, the Court observed that Congress shifted the risk to patients and physicians. What the Court ignored and Plaintiff failed to raise, is that the FDCA goes on to state:
This section shall not limit any existing authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device that are part of a determination of substantial equivalence, established as a condition of approval, or promulgated through regulations....
Further, this section shall not change any existing prohibition on the promotion of unapproved uses of legally marketed devices." Id.
Who Is Doing What?
Conflating a physician's off-label use in the practice of medicine and a manufacturer's marketing of an unapproved device, the Court observed:
It's easy to imagine, too, why Congress adopted a preemption provision [21 USC §360k(a)] that doesn't distinguish between on-and off-label uses. Any additional state duties on top of those imposed by federal law, even if nominally limited to off-label uses, might check innovation, postpone access to life-saving devices, and impose barriers to entry without sufficient offsetting safety gains. Caplinger at *29-30.
The Court is correct suggesting any rule should not stifle innovation or limit life-saving therapy, but the Court was correct perhaps for the wrong reason. The preemption provided under §360k does not reference off-label to protect innovation but exists because clearance is premised solely on approved uses. On this point, the dissenting opinion in Caplinger would have allowed the claims to proceed.
The path forward is less clear than the Tenth Circuit supposed. The FDA views off-label promotional conduct as evidence of intent to market an unapproved new device. While §396 prohibits FDA from exerting authority over physicians "using" a device off label, the prohibition does not expressly extend to "promotion" by manufacturers. What the Court and the plaintiff in Caplinger did not recognize is that "use" falls under the umbrella of medical judgment, whereas promotion of new device falls under the realm of FDA clearance or approval.
What does this mean in the context of preemption? When marketing and promotional conduct are not tethered to FDA authorized procedures for the dissemination of scientific or medical information on new uses, manufacturers risk FDA enforcement. In addition, plaintiffs may have viable tort claims against manufacturers marketing a device without FDA clearance on the grounds that the conduct violates both the FDCA and relevant state law.
The plaintiff's inability to plead a coherent parallel claim for promoting a new use saved the defendant in Caplinger. The FDCA, as well as the Supreme Court opinions allowing a state-law tort claim where they "parallel" the FDCA remain imprecise. Until and unless the Supreme Court or Congress comprehensively review the underlying policy considerations surrounding off-label use for approved products, the "conundrum" noted by the Tenth Circuit in Caplinger will continue.
A health and public policy imperative that physicians should have more information concerning products, particularly those they use for indications that are not FDA approved or cleared underlies this purported tort of off-label promotion. While preemption has provided ample fodder for constitutional wrangling over permissible and impermissible tort claims, a greater hurdle in the saga of preemption lies ahead. Whether the emerging Supreme Court precedent on deference, due process and the First Amendment will provide the remedy for industry or create a far greater dilemma is a pressing question.
Conclusion:
The manufacturer in Caplinger obtained a good result, but the Tenth Circuit's 2-1 opinion does not put the preemption issue to rest, but instead portends more litigation. The controversy over off-label uses for approved products will continue until Congress mandates change or the FDA revises its approach. In the interim, manufacturers should tether the conduct of their marketers to recognized avenues of dissemination of medical and scientific information. Marketers' who deviate from those paths will create an Achilles' heel manufacturers will be forced to defend.
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