United States: No Duty To Report To FDA In North Carolina, No "Parallel" Claim

Last Updated: June 13 2019
Article by Steven Boranian

We take every chance we can get to drive nails into the coffin of the Ninth Circuit's spectacularly wrong opinion in Stengel v. Medtronic. That's the case where the court held that federal law did not preempt negligence claims alleging that the defendant medical device manufacturer failed adequately to report adverse events to the FDA. Of course, the Arizona Supreme Court later held that the Ninth Circuit was dead wrong: There is no such duty to report under Arizona law, making this so-called "parallel claim" no claim at all, which we reported here.

A recent order from the Eastern District of North Carolina has further exposed Stengel as the fraud that it was, and, in the process, the district court presented a particularly clear-minded application of express and implied preemption in the medical device context. If you ever wondered about our references to the "narrow gap" between express and implied preemption, then this is the order for you. It explains it all exceptionally well and comes to the correct result.

The case is McNeil-Williams v. DePuy Orthopaedics, No. 5:18-cv-220, 2019 WL 2179217 (E.D.N.C. May 20, 2019), and the facts are straightforward: The plaintiff was treated with the defendant's prosthetic knee device and later sued claiming that the device caused her pain. Id. at *1. Because the FDA approved the device through the rigorous Premarket Approval process, the manufacturer justifiably moved for summary judgment on the basis that federal law preempted the plaintiff's claims—both expressly and impliedly. Id. at *2.

As faithful readers know, the analysis begins with the Medical Device Amendments of 1976 ("MDA") and the Supreme Court's opinion in Reigel v. Medtronic, 552 U.S. 312 (2008). The following quotes are kind of long, but if you read them, you will know all you need to know to discuss express and implied preemption at most any cocktail party (provided you frequent parties attended by drug and medical device lawyers):

Against [the] backdrop of rigorous premarket approval, the MDA preempts state law claims in two respects. First, the MDA expressly preempts any state law "requirement . . . which is different from, or in addition to, any requirement applicable under [the MDA] to the device." The United States Supreme Court has interpreted this provision to mean that "common-law causes of action for negligence and strict liability. . . impose 'requirements' and would be pre-empted by federal requirements . . . ." Reigel, 552 U.S. at 323-24. Accordingly, "[s]tate requirements are pre-empted under the MDA only to the extent that they are different from, or in addition to the requirements imposed by federal law."

Second, the MDA "impliedly" preempts additional types of state law claims. Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 347 (2001). . . . [S]tate law claims not arising from "traditional state tort law which . . . predated the federal enactments in question . . . , but rather "solely from the violation of [MDA] requirements, " are impliedly preempted because "Congress intended that the MDA be enforced exclusively by the Federal Government."

McNeil-Williams, at *3 (citing Reigel and Buckman, emphasis added). This is where the "narrow gap" comes in: A plaintiff's state-law claims have to allege conduct that violates federal law, but the conduct also must violate a separate and independent state requirement. In other words,

[T]hese two types of preemption, operating in tandem, have created . . . a "narrow gap" for pleadings in a medical device products liability case. . . . To make it through, a plaintiff has to sue for conduct that violates a federal requirement (avoid express preemption), but cannot sue only because the conduct violated that federal requirement (avoiding implied preemption).

Id. at *4 (quoting Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1327 (11th Cir. 2017)). So the trick for plaintiffs is to allege a breach of a state-law duty that mimics (or "parallels") a federal requirement, and that is where the district court in McNeil-Williams got it so right and the Ninth Circuit in Stengel got it so wrong.

The plaintiff in McNeil-Williams attempted to plead a "parallel" claim by alleging (like the plaintiff in Stengel) that the defendant failed adequately to report adverse events to the FDA. The problem for the plaintiff is that there is no such duty to report under North Carolina law. See Our prior post on state law reporting-based claims, here. Thus, the plaintiff was suing only for violations of federal requirements, a claim which was clearly preempted:

Plaintiff's primary asserted theory of negligence liability fails, however, because North Carolina law does not recognize a parallel duty on manufacturers to report to the FDA as plaintiff asserts. Rather, North Carolina law recognizes a duty to warn only users or medical practitioners in certain circumstances.

. . . .

Plaintiff cites no case, and the court has found none, where North Carolina courts have recognized a duty under North Carolina law to inform the FDA of adverse reactions, defects, and other injury information.

Id. at *4. Does this sound familiar? It should, because it is on this precise basis that the Arizona Supreme Court skewered the Ninth Circuit's treatment of Arizona law in Stengel. As the district judge explained, "Notably, after Stengel, the Arizona Supreme Court expressly disavowed the reasoning of Stengel on the very proposition that is at issue in this case." Id. at *5 (citing Conklin v. Medtronic, Inc., 431 P.3d 571 (Ariz. 2018)).

No duty to report under North Carolina law means no "parallel" claim (of course, that also means no claim under state law, either). The plaintiff's claims were therefore preempted.

The plaintiff attempted to recast her claims as "duty to warranty" claims, but she could not explain how that duty was different from a garden variety duty to warn. Nor could she identify any warranties that ran parallel to federal requirements. McNeil-Williams, at *5. The plaintiff also asked for discovery, but the district court rejected that too because the "court's preemption determination herein turns upon the simple undisputed fact that the Product is a medical device granted premarket approval by the FDA." Id., at *6. The plaintiff could not describe discovery that would provide a basis to dispute that fact.

In the end, the discovery ruling might be the most uniquely valuable part of this order. We have seen the "narrow gap" applied correctly before, but plaintiffs will continue to try to keep cases alive, including by conducting time-consuming, but ultimately useless discovery. This district court saw through that, and correctly so.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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