“Parallel” requirements.

That’s where they’re going to come after us. We know it. They know it.

Plaintiffs have no choice. Under Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), supposedly “parallel requirements” – alleged tort duties congruent with FDA requirements – are essentially the only thing the Supreme Court did not find preempted in a product liability case brought against the manufacturer of a pre-market approved (“PMA”) medical device.

Note that we’re not saying (we’d never say) that “parallel” requirements claims aren’t preempted. Riegel doesn’t contain any affirmative holding that such claims escaped preemption in a PMA device case. “Parallel” claims just weren’t addressed one way or the other in Riegel. They escaped preemption analysis because the Supreme Court held that the plaintiff had waived any argument about such claims:

The District Court in this case recognized that parallel claims would not be pre-empted, but it interpreted the claims here to assert that [defendant’s] device violated state tort law notwithstanding compliance with the relevant federal requirements. Although [plaintiffs] now argue that their lawsuit raises parallel claims, they made no such contention in their briefs before the Second Circuit, nor did they raise this argument in their petition for certiorari. We decline to address that argument in the first instance here.

128 S. Ct. at 1011.

Talk about plaintiffs getting lucky because they messed up their own case. It’s enough to make a conspiracy theorist wonder….

But be that as it may, after Riegel “parallel” requirements is where any plaintiff asserting injury from a PMA-approved device has to go to have any kind of viable claim at all.

So what can we on the defense side argue in favor of the preemption of “parallel” requirements?

Glad you asked.

Right now, we see three basic sets of arguments in favor of preemption of “parallel” requirements allegations.

The first argument: This approach takes the maximalist position that purported “parallel” violation claims are preempted – notwithstanding Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) – because the FDCA expressly forbids private enforcement of the statute. “[A]ll such proceedings for the enforcement, or to restrain violations of this chapter shall be by and in the name of the United States.” 21 U.S.C. §337(a). Lohr never considered §337(a), and we’ve got post-Lohr Supreme Court precedent on our side.

A unanimous Supreme Court relied on §337(a) in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), as one piece of its rationale holding that private “fraud on the FDA” claims were preempted. This section, Buckman held, demonstrates the intent of Congress that private litigation must not interfere with how the FDA does its job: “The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions.” 531 U.S. at 349 n.4. In §337(a), “we have clear evidence that Congress intended that the MDA be enforced exclusively by the Federal Government.” 531 U.S. at 352.

Both before and after Buckman, this rationale has barred a wide range of claims brought by private litigants, including tort claims, e.g., In re Orthopedic Bone Screw Products Liability Litigation, 193 F.3d 781, 791 (3d Cir. 1999) (§337(a) “expressly restricts its enforcement to the federal government”); and (even more frequently) in Lanham Act claims. E.g., Mylan Laboratories, Inc., v. Matkari, 7 F.3d 1130, 1139 (4th Cir. 1993); Sandoz Pharmaceuticals v. Richardson Vicks, 902 F.2d 222, 231 (3d Cir. 1990); Ethex Corp. v. First Horizon Pharmaceutical Corp., 228 F. Supp.2d 1048, 1059 (E.D. Mo. 2002); see generally Schwarz Pharma, Inc. v. Breckenridge Pharmaceutical, Inc., 388 F. Supp.2d 967, 974-75 (E.D. Wis. 2005).

The bounds of preemption under a straight §337(a) analysis include any private claim in which “the court would be required to interpret or apply” either “the FDCA or its accompanying regulations.” Schwartz Pharma, 388 F. Supp.2d at 975.

With respect to “parallel” violation claims, §337(a) preemption has been addressed most recently in litigation concerning food. We’ve discussed a couple of these cases before, here and here.

While these cases have allowed claims that would seem to violate §337(a) escape preemption, they’ve done so solely on a food-specific rationale. Section 337(a) preemption is avoided only due to an FDCA provision that’s unique to food and has no counterpart in the medical device (or drug) arena. See In re Farm Raised Salmon Cases, 175 P.3d 1170, 1178 (Cal. 2008); Vermont Pure Holdings, Ltd. v. Nestle Waters North America, Inc., 2006 WL 839486, at *5 (D. Mass. 2006).

Specifically, those cases rely on an FDCA provision, 21 U.S.C. §343-1(a), that expressly preserves state enforcement of “identical” state food regulations. Indeed, they concede generally that §337(a) prohibits private enforcement of purported FDCA violations, but go on to hold that §343-1(a) preserves “identical” state law that the states can then enforce. Farm Raised Salmon, 175 P.3d at 1181; Vermont Pure Holdings, 2006 WL 839486, at *6 n.3. These cases thus imply that, where no such exception exists, §337(a) would apply with full force, and state-law violation claims would be preempted.

That’s one.

Approaches two and three are claim specific. They rely on what it must mean for state-law claims and FDA violations to be “parallel.” At minimum, parallelism imposes two restrictions on putative state-law claims.

First, for an FDCA violation to be “parallel” to a state law claim of any sort, a traditional state tort duty must actually exist. There must be something for the asserted FDCA violation to be “parallel” to. If there’s only an FDCA violation without any “parallel” in state law, then there’s nothing to prevent preemption. That’s what was going on in Buckman – preemption would exist because, as in Buckman, the claimed violation would give rise to a novel claim under state law.

Second, even where there is a corresponding state-law claim, that claim must actually be “parallel” to the federal claim. The state-law plaintiffs can’t base their “violation” claim on some unique and bizarre interpretation of an FDA regulation that the Agency has never agreed with. The claims must be “genuinely” parallel. This type of situation is what the Supreme Court was talking about in Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005):

In undertaking a pre-emption analysis. . ., a court should bear in mind the concept of equivalence. To survive pre-emption, the state-law requirement need not be phrased in the identical language as its corresponding [federal] requirement; indeed, it would be surprising if a common-law requirement used the same phraseology as [the federal standard]. If a case proceeds to trial, the court’s jury instructions must ensure that nominally equivalent labeling requirements are genuinely equivalent. . . . [A] manufacturer should not be held liable under a state labeling requirement. . .unless the manufacturer is also liable for misbranding as defined by [governing federal law].

Id. at 454 (emphasis added).

Now, we’ll discuss approaches two and three in a little more detail.

The second argument: The fraud on the FDA-related violation claims in Buckman, that Court held, “exist[ed] solely by virtue of the FDCA disclosure requirements.” 531 U.S. at 353. This fact distinguished them from the “parallel” claims in Lohr, which “arose from the manufacturer’s alleged failure to use reasonable care in the production of the product, not solely from the violation of FDCA requirements.” Id. Not every “violation of the FDCA will support a state-law claim.” Id. Rather, Lohr only referenced “certain state-law causes of actions that parallel federal safety requirements.” Id. This exception demanded a cause of action parallel to “traditional state tort law”:

[W]ere plaintiffs to maintain their fraud-on-the-agency claims here, they would not be relying on traditional state tort law which had predated the federal enactments in questions. On the contrary, the existence of these federal enactments is a critical element in their case.

Id.

This aspect of what “parallel” means supports preemption of violation claims alleging, for example, that products should have been recalled (either sooner or at all). That’s because state law does not recognize claims for failure to recall or retrofit. See Restatement (Third) of Torts, Products Liability §11 (1998). Similarly, there can’t be “parallel” claims in many states with respect to a defendant’s alleged FDCA violations involving post-marketing suppression of risk information and/or failure to modify labels. That’s because a lot of states don’t recognize claims for post-sale duty to warn. There are undoubtedly plenty of other examples of “violation” claims without any close state-law analogs.

In this respect, Buckman-style preemption of supposedly “parallel” violation claims is a lot like the requirement already imposed upon negligence per se claims as a matter of state law in a number of jurisdictions – that negligence per se cannot create novel state tort duties. See, e.g., Perry v. S.N., 973 S.W.2d 301, 306 (Tex. 1998); Elder v. Allstate Insurance Co., 341 F. Supp.2d 1095, 1102 (D. Minn. 2004).

A significant practical advantage of this second preemption argument is that it can be determined largely a matter of law. That is: (1) the comparison between the claimed violation and the accepted state law theories, and (2) the determination whether there is any reasonably close match, is the kind of argument that does not require extensive discovery and could be decided (perhaps on motion to dismiss) without the need for a great deal of expensive discovery.

The third argument: The requirement that the state law claim must (in practice as well as in theory) actually – or as Bates puts it, “genuinely” – be “parallel” has a fair amount of precedential support. For example, in a prior post we already discussed Kemp v. Medtronic, Inc., 231 F.3d 216, 230 (6th Cir. 2001). There, the court concluded that the purported “violations” weren’t actually violations. Rather the plaintiffs had erroneously interpreted FDA requirements. Id. at 230 (FDA “d[id] not include” Plaintiffs’ claimed requirement); 231 (describing “specious nature of plaintiffs’ claim”); 231-32 (claims based upon “inapplicable” materials). Because the supposedly “parallel” claims actually weren’t, Kemp found preemption. “To permit a jury to find [defendant] negligent for failing to [comply with a incorrectly stated FDA requirement] would be to impose a requirement different from and in addition to those established by the FDA.” Id. at 230.

After Bates, a number of other courts – mostly outside the drug and device field – have addressed this aspect of parallelism. The closest is Bruesewitz v. Wyeth, Inc., 508 F. Supp.2d 430 (E.D. Pa. 2007), decided under the Vaccine Act – which prescription-only products overseen by the FDA. We’ve already discussed other aspects of Bruesewitz here. The Vaccine Act decrees all vaccines to be “unavoidably unsafe” within the meaning of Restatement (Second) of Torts §402A, comment k (1965). In Bruesewitz, the court rejected a plaintiff’s contrary argument for case-by-case determination. That argument was preempted because it could not possibly involve a “parallel” requirement:

Applying the “parallel requirements” holding of Bates, the Court concludes Congress did not intend to allow a case-by-case determination as to whether a vaccine is unavoidably unsafe. Doing otherwise would allow state common law to impose additional requirements on vaccine manufacturers wishing to avoid liability, rather than merely providing additional remedies for violating federal law.

508 F. Supp.2d at 446. Thus, if the effect of the claim is to deviate from how the agency judges the product, there is preemption. Only the remedy for a violation can be different – not the particulars of the violation claim itself. Id.

Of somewhat lesser relevance – given the greater differences in statutory language already discussed above, are the food preemption cases. In Vermont Pure Holdings, a Bates “parallel requirements analysis” required that the state-law claim be in “substantially the same language as the comparable provision of the [FDCA],” and “any difference [must] not result in the imposition of materially different requirements.” 2006 WL 839486, at *5. See id. at *6 (state standards “must mirror” federal standards).

The court in Reyes v. McDonald’s Corp., 2006 WL 3253579 (N.D. Ill. 2006), looked to whether the plaintiff’s false labeling claim paralleled FDA nutritional labeling requirements. Id. at *5. This comparison extended to both the administrative burden of proof and the details of the plaintiff’s claims. “General” allegations would sweep too broadly:

Plaintiffs will still bear the burden of establishing that the [National Labeling Education Act] A was violated because they seek to enforce state common law claims identical to the NLEA. Plaintiffs cannot rest on general allegations of consumer deception alone, because any allegation that [defendant] be required to act in a way that is not identical to the requirements of the NLEA would be preempted. Plaintiffs must be able to show that the allegations are identical to acts deemed misbranding under the terms of the NLEA.

Id. at *6. Further, the plaintiffs’ claim had to conform to the FDA’s regulations, and not just the statute. Id. at *7 (“any analysis of the preemptive effect of NLEA. . .requires an examination of the regulations governing the NLEA”).

Because the plaintiff’s state-law claims were “broader” than what the applicable federal regulations imposed, preemption imposed “important limits” on the non-parallel aspects of those claims. Id. at *7. For example, the FDA’s regulations allowed 20% margin for error in nutritional labeling. Two of the plaintiff’s three claims fell within this margin, and were therefore preempted. Id. (within-margin claims “would be seeking to recover under a broader definition of “misbranding”. . ., resulting in an inconsistent standard for labeling”).

Entirely outside the FDCA context, in Mortellite v. Novartis Crop Protection, Inc., 460 F.3d 483 (3d Cir. 2006), a truly “parallel” requirements claim had to involve “requirements that are consistent with [federal] requirements and which only provide new remedies.” Id. at 491. In another FIFRA case, there was no directly applicable federal regulation. Thus, the court in Indian Brand Farms, Inc. v. Novartis Crop Protection, Inc., 2007 WL 4571087 (D.N.J. Dec. 20, 2007), decided that mere general congruity between the purposes of tort law and FIFRA to ensure that products are “reasonably safe for use” didn’t make the tort claims “parallel” to the federal statute. Id. at *9. A state claim concerning an unregulated product aspect could not be “parallel” to the federal scheme, but instead was both “different from” and “in addition to” federal requirements – and was thus preempted. Id. at *8.

Finally the Bates “genuine” parallelism requirement was also discussed in Fox v. Cheminova, Inc., 387 F. Supp.2d 160 (E.D.N.Y. 2005). Fox held that Bates imposed preemption to the “extent that [state law claims] add to or differ from what [federal law] requires. That question could not be answered until “[t]he parties. . .flesh out the precise contours of the State labeling laws.” 387 F. Supp.2d at 167.

As Fox indicates, in contrast to the Buckman approach, a preemption motion brought pursuant to the Bates “genuinely” parallel standard will usually require a full summary judgment record. To make the necessary comparisons, the precise nature of the plaintiff’s FDCA violation claim must be known in some detail.

Finally by laying out these three approaches to “parallel” violation claims, we’re certainly not by any means implying that these are the only arguments that defendants can make. There are all kinds of common-law, non-preemption arguments. We’ve discussed those at some length, here. Even as to preemption, we passed along another possible formulation, here. All we’re saying is that these three preemption arguments: (1) are what comes to our all-too-limited brains at the moment, and (2) are supported by significant existing precedent, and thus good candidates for immediate use in appropriate cases.

Undoubtedly there are other defense-minded folks out there who have also been thinking about how to deal with preemption and “parallel” requirements claims. If anybody has additional bright ideas of their own, we’re all ears.