Express And Implied Preemption For Premarket-Approved Medical Devices: A Dual Shield Against Tort Claims
By Elizabeth Minerd, Reed Smith
The doctrines of express preemption and implied preemption may shield medical device manufacturers from lawsuits involving state personal injury tort claims.
In 2008, the U.S. Supreme Court issued a landmark decision, Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), ruling that the state law tort claims involving a Premarket-Approved (PMA) Class III medical device were expressly preempted (or barred) by federal law. Prior to Riegel, the Supreme Court had recognized that claims brought by private plaintiffs to enforce federal regulations relating to medical devices were impliedly preempted. Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001).
In the ten years since Riegel, manufacturers have been using express and implied preemption to shield themselves from personal injury tort lawsuits involving PMA medical devices, but plaintiffs’ attorneys have sought to poke holes in these shields. Although plaintiffs’ attorneys have been able to establish certain limited exceptions to these preemption defenses, they remain sturdy shields that can be wielded early in a case to limit, if not eliminate, the claims.
The Express Preemption Shield
When Congress enacted the Medical Device Amendment to the Food, Drug, And Cosmetic Act (FDCA), it included an express preemption provision, 21 U.S.C. § 360k(a), which prohibits any state from establishing any requirement “different from, or in addition to” a federal requirement relating “to the safety or effectiveness” of a medical device. In other words, if a court answers the following two questions affirmatively, the plaintiff’s state law claims will be expressly preempted (or barred) by section 360k(a):
1. First, did the federal government establish requirements applicable to the particular medical device?
2. Second, do the plaintiff’s state law tort claims impose requirements “different from, or in addition to” those imposed by federal law relating to safety and effectiveness?
See Riegel, 552 U.S. at 321-322.
Under Riegel, we know that the answer to the first question is indisputably “yes” when the device at issue is a Class III medical device approved by the FDA through the PMA process. Id. at 322. We also know that, generally, the answer to the first question is “no” when the device at issue was cleared by the FDA through the separate 510(k) clearance process. Id.
After Riegel, we know that the answer to the second question is “yes” for many standard state personal injury tort claims. In particular, courts across the country have answered the second question “yes” when a plaintiff’s claims attack the FDA-approved manufacturing process, design, and warning label for a PMA device. For example, in Riegel, the Supreme Court affirmed dismissal of the plaintiff’s claims for (1) strict products liability, (2) breach of implied warranty, and (3) negligence. Id. at 320.
Because Riegel ruled that a state law claim is only preempted if it imposes requirements that are “different from, or in addition to” federal requirements, an exception exists for a so-called “parallel” claim where the state law claim seeks to impose requirements that “parallel” the federal requirements imposed through the PMA process — for example, if a plaintiff alleges that his or her injury was caused by a device that was defectively manufactured in violation of state tort law, and further alleges that the device was not manufactured in compliance with the federal requirements imposed through the PMA process.
In short, to state a claim relating to a PMA medical device that has a chance of surviving express preemption, a plaintiff must allege that the manufacturer engaged in conduct that violated a state tort law, and that the same conduct violated a federal requirement, resulting in the plaintiff’s injury.
The Implied Preemption Shield
Even if a plaintiff is able to assert a “parallel” claim that survives express preemption based on a violation of a federal requirement, such a claim may still be impliedly preempted. When Congress enacted the FDCA, it included a provision, sometimes referred to as the “no private right of action” provision, which provides that any action to enforce the FDCA “shall be by and in the name of the United States.” 21 U.S.C. § 337(a).
In Buckman, the Supreme Court found that this provision requires that the FDCA (and any regulations implementing the FDCA) be “enforced exclusively by the Federal Government,” and impliedly preempts any private enforcement action where “the existence of these federal enactments is a critical element” of the plaintiff’s claims. Buckman, 531 U.S. at 352-353. Therefore, a plaintiff’s claims will be impliedly preempted if the existence of the federal requirements is a “critical element” of his or her claim.
The Narrow Gap Between The Two Shields
Manufacturers of PMA medical devices can wield these dual preemption shields against state personal injury tort claims. However, courts have described a “narrow gap” that exists between these two shields. Bryant v. Medtronic, Inc., 623 F.3d 1200, 1204 (8th Cir. 2010). To slip through this narrow gap, a plaintiff “must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by section 360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA ([because] such a claim would be impliedly preempted under Buckman).” Id.
Navigating through this narrow gap between express and implied preemption—sometimes referred to as the Scylla and Charybdis — often has proven too difficult for plaintiffs, resulting in many cases being dismissed in their preliminary stage.
Plaintiffs’ Common Attempts To Slip Through The Narrow Gap
Through a decade of trial-and-error, plaintiffs’ attorneys have developed certain personal injury tort claims that have managed to slip through the narrow gap between express and implied preemption — at least when the lawsuit is first filed.
Perhaps the most common such claim is that the manufacturing process for the plaintiff’s device deviated from the FDA-approved manufacturing process, and therefore violated both a state law requirement that the device be manufactured without defect and a federal requirement that the device be manufactured in accordance with the PMA manufacturing process. Plaintiffs often will attempt to bolster these claims by alleging that the defendant manufacturer issued a recall or received a warning letter from the FDA addressing deficiencies in the manufacturing process. See, e.g., Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012).
But, while these claims often survive a challenge at the pleadings stage — i.e., the beginning of a lawsuit, when courts must generally accept the plaintiff’s version of the facts as true and cannot consider the defendant manufacturer’s contrary evidence — they often fail once the defendant manufacturer is allowed to present evidence that the device in question was manufactured according to the PMA manufacturing process.
Another common claim that plaintiffs argue should slip through the gap between express and implied preemption proffers that the defendant manufacturer failed to adequately warn the plaintiffs’ physician, because the defendant manufacturer failed to report adverse events to the FDA as federal regulations require. But, notably, a few courts have rejected these claims on the grounds that they are preempted — i.e., that they do not, in fact, slip through the narrow gap. See, e.g., McClelland v. Medtronic, Inc., 944 F. Supp. 2d 1193 (M.D. Fla. 2013).
Even if a court finds that these claims do slip through the gap, they often are pled in a bare-bones fashion with little, if any, facts pled in support of the assertion that the defendant manufacturer failed to report adverse events to the FDA. While some courts have allowed such bare-bones claims to survive at the pleadings stage, many others have required the plaintiffs set forth facts to support such a claim. See, e.g., Funke v. Sorin Group USA, Inc., 147 F. Supp. 3d 1017 (C.D. Cal. 2015).
Even when these “failure to report adverse events” claims survive past the pleadings stage, the plaintiffs have a steep causation hill to climb in order to prove such a claim. Specifically, the plaintiffs not only have to show that the defendant manufacturer failed to report adverse events to the FDA, but also show that, had those adverse events been properly reported, the FDA would have required the defendant manufacturer to add warnings to the label or otherwise disseminate the additional adverse event information to the plaintiff’s physician — and that the plaintiff’s physician would have changed the plaintiff’s course of treatment based on this additional information. See Stengel v. Medtronic, Inc., 704 F.3d 1224, 1234 (9th Cir. 2013) (Watford, J., concurring). This scenario presents a steep, possibly insurmountable, causation hill to climb.
Plaintiffs also have attempted to slip through the gap by claiming that the manufacturer engaged in off-label promotion. Unfortunately, challenges to such claims have had mixed results. Some courts have rejected such claims as expressly preempted, finding that truthful, non-misleading off-label promotion is not prohibited by any federal regulation. See, e.g., Otis-Wisher v. Fletcher Allen Health Care, Inc., 951 F. Supp. 2d 592 (D. Vt. 2013). Contrarily, other courts have found that such claims are improper attempts to enforce federal regulations, and are therefore impliedly preempted. See, e.g., Caplinger v. Medtronic, Inc., 921 F. Supp. 2d 1206 (W.D. Okla. 2013), aff’d, 784 F.3d 1335 (10th Cir. 2015). Still other courts have found that such claims fit through the narrow gap between express and implied preemption. See, e.g., Coleman v. Medtronic, Inc., 223 Cal. App. 4th 413 (2014); Shuker v. Smith & Nephew, PLC, ---F.3d---, 2018 WL 1096185 (3d Cir. 2018).
Moreover, some courts have recognized that the First Amendment protects truthful off-label promotion, raising yet another possible shield to defend against such claims. See, e.g., United States v. Caronia, 703 F.3d 149 (2d Cir. 2012). And, while some courts may hesitate to dismiss off-label promotion claims at the pleadings stage, plaintiffs still have a difficult hill to climb to show that off-label promotion affected the plaintiffs’ course of treatment.
Plaintiffs also have asserted more novel theories in an effort to slip through the gap between express and implied preemption. For example, in a recent case, the plaintiffs asserted personal injury claims based on a theory that the manufacturer failed to conduct post-market surveillance studies according to specific requirements set forth in its PMA letter. While this theory did get past the shield of express preemption because the plaintiff alleged conduct in violation of a federal requirement, it ran headlong into the shield of implied preemption because there was no state law requirement to conduct postmarket surveillance studies. Gravitt v. Mentor Worldwide, LLC, 2018 U.S. Dist. LEXIS 4822 (N.D. Ill. Jan. 11, 2018).
There is no doubt plaintiffs will continue to seek new ways of slipping through the gap between express and implied preemption. But many courts have demonstrated a willingness to sort through these claims and to throw out those that do not fit through the gap. Manufacturers should take full advantage of these dual preemption shields, in the early stages of a lawsuit, in order to minimize, if not eliminate, personal injury claims relating to PMA medical devices.
About The Author
Elizabeth Minerd is an associate in the Reed Smith Life Sciences Health Industry Group. She focuses her practice on advising medical device companies facing complex product liability litigation. She can be reached at firstname.lastname@example.org