Our last preemption-related post was more than three weeks ago, on July 2. Can you believe it? What ever happened to “all preemption, all the time,” as we used to be called?

The Supreme Court decided all of its pending cases, that’s what. Device preemption is pretty much settled, unless Congress upsets the applecart. Drug preemption is in a bit of a hiatus as appellate courts digest Levine and have yet to rule in pending cases. There just aren’t that many fraud-on-the-FDA preemption cases around.

Be that as it may, we’ll try to make up for our appalling oversight today. We’re turning to our post-Riegel device preemption scorecard as we examine a year and a half’s worth of cases to see what conclusions we can draw about the scope of the “parallel violation claim” exception to preemption in cases involving PMA approved medical devices. Even before Riegel, we predicted that a preemption ruling would prompt the other side to rely heavily on this type of claim.

We use “scope” a bit advisedly. When Riegel was first decided, we weren’t sure that there was even a “parallel violation” exception worthy of the name, since the Supreme Court did not really decide the issue, due to a plaintiff-side waiver. See Riegel v. Medtronic, Inc., 128 S. Ct. 999, 1011 (2008). However, the Court also stated that preemption “does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case “parallel,” rather than add to, federal requirements.” Id. Since Riegel, the lower courts have pretty much all taken that statement as a recognition of the exception, so we’ll assume (not without a fair degree of grumbling) that such an exception exists.

Looking at the cases, we think we can distill three basic principles that establish some general parameters for what can be, and what isn’t, an unpreempted “parallel violation claim” (this is the last time we’ll be bothered with the quotation marks). These are:

• There must be evidence of an actual violation of an actual FDA requirement.
• The claim must have a common-law basis in addition to being a violation of an FDA requirement.
• The violation claim must bear a plausible causal relationship to the plaintiff’s injuries.

We’ll discuss each of these in turn.

The most basic element of any violation claim is that there must be a violation. That element was cogently summed up in Riley v. Cordis Corp.:

[T]he conduct that is alleged to give the plaintiff a right to recover under state law must be conduct that is forbidden by the FDCA. Thus, to determine whether [plaintiff’s] claims are preempted, it is first necessary to identify precisely what conduct by [defendant] is alleged to give rise to a claim under state law. If that conduct is not prohibited by the FDCA, then [plaintiff’s] claim, if successful, would have the effect of imposing on [defendant] a requirement that is different from or in addition to the requirements imposed by the FDCA-and, for that reason, [plaintiff’s] claim would be expressly preempted.

___ F. Supp.2d ___, 2009 WL 1606650, at *3 (D. Minn. June 5, 2009).

The violation must also in fact be parallel to the relevant FDA requirements. True parallel claims “do not add to or differ from federal requirements.” In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147, 1152 (D. Minn. 2009). Simply as a matter of common sense, a claim based upon the falsity of FDA approved language cannot be a parallel claim. Bencomo v. Guidant Corp., 2009 WL 1951821, at *6 (E.D. La. June 30, 2009). Likewise, “[i]n order to be considered parallel to federal regulations, the state requirements must be ‘genuinely equivalent’ to the federal requirements.” Link v. Zimmer Holdings, Inc., 604 F. Supp.2d 1174, 1179 (N.D. Ill. 2008); see Bausch v. Stryker Corp., 2008 WL 5157940. at *6 (N.D. Ill. Dec. 9, 2008) (claim is not parallel when “not based on a duty that is ‘substantially identical’ to the duty that is imposed. . .by FDA regulations”). Thus a claim that would require “fine detail” not included in “inherently flexible” and “generic” FDA manufacturing regulations was not a parallel claim that could escape preemption. Sprint Fidelis, 592 F. Supp.2d at 1157-58; see Clark v. Medtronic, Inc., 572 F. Supp.2d 1090, 1095 (D. Minn. 2008) (“[b]ecause plaintiff’s claims are not based on a breach of the MDA as enforced by the FDA, the claims are not grounded in state laws that ‘parallel’ federal requirements”).

Likewise, a warning defect/violation claim having the effect of converting a voluntary option into a mandatory obligation is not a parallel claim:

[T]he FDA regulations cited by Plaintiffs permit a device manufacturer to give certain warnings, but Plaintiffs’ failure-to-warn theory necessarily requires a showing that [defendant] was required to give those warnings. And, Plaintiffs have not identified in the Complaint any federal regulation, rule, or other source of obligation that would require such a warning to be given.

Sprint Fidelis, 592 F. Supp.2d at 1160.

But there’s more to it than simply pleading a violation. In the post-Twombly/Iqbal world, a plaintiff can’t just allege that “the defendant violated FDA regulations” and leave it at that. “Plaintiffs cannot simply incant the magic words “[defendant] violated FDA regulations” in order to avoid preemption.” Sprint Fidelis, 592 F. Supp.2d at 1158.

[I]n a multidistrict litigation like this one, involving hundreds of cases, thousands of plaintiffs, and millions of dollars – the cost of the discovery on the horizon is substantial and the potential for abuse is great. For this reason, courts have repeatedly held that the price of entry, even to discovery, is for the plaintiff to allege a factual predicate concrete enough to warrant further proceedings, which may be costly and burdensome.

In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 2009 WL 294353, at *2 (D. Minn. Feb. 5, 2009) (citation and quotation marks omitted).

Thus, “[m]ost courts have instead held that a plaintiff must allege the particular federal requirement that was violated, and how.” Prudhel v. Endologix Inc., 2009 WL 2045559, at *9 (E.D. Cal. July 9, 2009). The complaint must “plausibly” state what the violated requirement was and what the defendant did that constituted the violation. See Riley, 2009 WL 1606650, at *10-11 (plaintiff must plead what off-label uses allegedly illegally promoted); Delaney v. Stryker Orthopaedics, 2009 WL 564243, at *6 (D.N.J. March 5, 2009) (“bald” manufacturing violation claim dismissed); Parker v. Stryker Corp., 584 F. Supp.2d 1298, 1301-02 (D. Colo. 2008) (alleged “direct violation of the Code of Federal Regulations” too general to state violation), Heisner v. Genzyme Corp., 2008 WL 2940811, at *5 (N.D. Ill. July 25, 2008) (a “vague suggestion that Defendant violated these reporting requirements does not help Plaintiff avoid dismissal of his claims”); Colombini v. Westchester County Health Care Corp., 2009 WL 2170230, at *4 (N.Y. Sup. July 6, 2009) (claim dismissed where “plaintiffs cite[d] to no document from the FDA which
specifically mandates” the feature at issue); but see Hofts v. Howmedica Osteonics Corp., 597 F. Supp.2d 830, 838 (S.D. Ind. 2009) (to dismiss a claim alleging “an impurity, imperfection, and/or another product defect” caused by a “deviation” from “design and quality manufacturing standards for the [device] approved by the FDA” would be “an unusually stringent application of Twombly”).

We’ve always advocated the position (see here, and here) that, given what the Court had to say in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 352 (2001), about the FDA’s exclusive enforcement authority, that a bare violation claim that didn’t parallel some pre-existing common-law state tort duty was preempted.

Note that the issue of exclusive FDA enforcement authority isn’t solely a preemption argument. The same result can be reached as a matter of lack of a private plaintiff’s standing to assert the alleged violation. See In re Epogen & Aranesp Off-Label Marketing & Sales Practices Litigation, 2009 WL 1703285, at *7 (C.D. Cal. June 17, 2009). But that’s a subject for another post.

Courts have begun to agree with us that the bare violation “is not the end of the inquiry.” Riley, 2009 WL 1606650, at *3. If there’s only a bare allegation of a violation, without any common-law basis for a claim, the claim can be impliedly preempted under Buckman even if not expressly preempted under Riegel. Riley, 2009 WL 1606650, at *3 (“even if a claim is not expressly preempted. . ., it may be impliedly preempted under Buckman”). Under Buckman:

[A] private litigant cannot sue a defendant for violating the FDCA. Similarly, a private litigant cannot bring a state-law claim against a defendant when the state-law claim is in substance (even if not in form) a claim for violating the FDCA-that is, when the state claim would not exist if the FDCA did not exist.

Riley, 2009 WL 1606650, at *3; accord Sprint Fidelis, 592 F. Supp.2d at 1161 (“claims alleging violations. . .are not preempted [by] §360k(a)” but “such claims are impliedly preempted by 21 U.S.C. §337(a), which states that all proceedings for the enforcement or to restrain violations of the FDCA ‘shall be by and in the name of the United States’”).

This means that the plaintiff, in addition to alleging a violation, must allege the violation in the context of some sort of recognized state-law claim.

[T]he conduct on which the claim is premised must be the type of conduct that would traditionally give rise to liability under state law-and that would give rise to liability under state law even if the FDCA had never been enacted. If the defendant’s conduct is not of this type, then the plaintiff is effectively suing for a violation of the FDCA (no matter how the plaintiff labels the claim), and the plaintiff’s claim is thus impliedly preempted under Buckman.

Riley, 2009 WL 1606650, at *4; see id. (“[f]or a state-law claim to survive, then, the claim must be premised on conduct that both (1) violates the FDCA and (2) would give rise to a recovery under state law even in the absence of the FDCA”). See also Sprint Fidelis, 592 F. Supp.2d at 1160-61 (claim based exclusively on alleged violations of reporting requirements preempted as a private enforcement claim); Prudhel, 2009 WL 2045559, at *8 (“a state law claim that requires more than mere noncompliance with federal requirements – for example, that the violation of federal requirements [was also] reckless or unreasonable” would escape preemption”); Parker, 584 F. Supp.2d at 1301 (“claims [that] are merely derivative. . .are not saved merely by being recast as violations of the federal adulteration and misbranding statutes”).

Thus, the parallel violation exception, while “narrow,” can be viable under an appropriate set of facts. Riley, 2009 WL 1606650, at *4 (“[t]his does not mean. . .that a plaintiff can never bring a state-law claim based on conduct that violates the FDCA”). Presumably, depending on the particular FDCA violation being alleged, that claim could take the form of a manufacturing, design, or warning claim. To date, manufacturing defect/violation claims have been the most common. See Hofts, 597 F. Supp.2d at 835 (manufacturing claim avoids preemption where the “deviation from the FDA’s manufacturing requirements was [also] unreasonably dangerous” or negligent); Sprint Fidelis, 592 F. Supp.2d at 1161 n.17 (“an adequately pleaded claim that a specific device was not manufactured in accordance with its PMA specifications can survive preemption”); Prudhel, 2009 WL 2045559, at *8 (manufacturing defect/violation claim based on product recall escaped preemption); Riley, 2009 WL 1606650, at *15 (manufacturing/violation claims hypothetically possible but too vaguely pleaded); Rollins v. St. Jude Medical, 583 F. Supp.2d 790, 800-01 (W.D. La. 2008) (specifically pleaded claim about improper packing of devices survived preemption); Purcel v. Advanced Bionics Corp., 2008 WL 3874713, at *3-5 (N.D. Tex. Aug. 13, 2008) (manufacturing claim “predicated solely on violations of federal law” not preempted); Mitaro v. Medtronic, Inc., 2009 WL 1272398, at *3 (N.Y. Sup. April 9, 2009) (manufacturing claim focused on particular process survived preemption); but see Miller v. DePuy Spine, Inc., 2009 WL 1767555, *4 (D. Nev. May 1, 2009) (manufacturing defect/violation claim that survived pleadings dismissed on summary judgment where “no evidence” supported any relevant violation).

Conversely, it has proven difficult for plaintiffs to allege plausible warning or design-based violation claims. See Sprint Fidelis, 592 F. Supp.2d at 1162 (claim that device recall established defectiveness of prior design not parallel because prior design was FDA approved); Riley, 2009 WL 1606650, at *7-9, 12 (broad warning violation claim based on off-label uses held preempted; narrower claim based upon false statements made while promoting off-label use might survive); Rollins, 583 F. Supp.2d at 802 (claim of failure to train physicians preempted where nature of violation not stated); Bausch, 2008 WL 5157940, at *6 (“[t]here are no allegations in the complaint that might put Defendants on notice of a claim that is based entirely on a specific defect in the [device] that existed outside of the knowledge and regulations of the FDA”); Troutman v. Curtis, 185 P.3d 930, 935 (Kan. 2008) (“[p]laintiffs’ allegation that [defendant] had violated FDA requirements remained only that – an allegation”); Mitaro, 2009 WL 1272398, at *3 (that device was recalled does not establish that recalled design violated FDA requirements); Lake v. Kardjian, 874 N.Y.S.2d 751, 755 (N.Y. Sup. 2008) (warning claim alleging failure to report adverse events “would merely be an attempt to recast plaintiff’s state law claims as violations of federal statutes”); Mattingly v. Hubbard, 2008 WL 3895381 (Ky. Cir. July 31, 2008) (no evidence of claimed unauthorized design change); O’Shea v. Cordis Corp., 2008 WL 3139428 (Fla. Cir. May 19, 2008) (“general” marketing claims preempted; claims specific to off-label promotion not preempted).

Conceivably, the state-law-based violation claim could be something like negligence per se, assuming: (1) that the claim is not mere private FDCA enforcement and (2) otherwise meets the state-law elements of such a claim. No cases have yet allowed such a claim, except in the abstract. See Hofts, 597 F. Supp.2d at 838 (suggesting that unspecified negligence per se claims survive preemption). A parallelism determination, however, is not based on the “abstract” nature of the claim, but on whether the particular allegations being asserted actually differ from FDA requirements. Purcel, 2008 WL 3874713, at *3. Negligence per se claims that merely restate non-parallel, and therefore preempted, claims remain preempted. Sprint Fidelis, 592 F. Supp.2d at 1163 (negligence per se “is not a magic transforming formula that automatically creates a private right of action”); Mitaro, 2009 WL 1272398, at *4 (negligence per se claim preempted under Buckman as private attempt to enforce the FDCA).

Obviously, causation is an element of a parallel violation claim, just as it is for any other tort. Causation can mean a number of things. “[A] plaintiff must demonstrate a cognizable link between the defendant’s federal violations and plaintiff’s injury.” Horowitz v. Stryker Corp., 613 F. Supp.2d 271, 282 (E.D.N.Y. 2009). The violation must involve the actual device that was implanted in the plaintiff, and not other similar devices that the defendant manufactured. Id. (“recalls [that] did not include the [device] or any of its components” could not defeat preemption; same holding with respect to violations noted in inspection where inspected plant was not alleged to have made the device).

Timing can also be an issue. Claims that a defendant was obligated to conduct a recall before so ordered by the FDA have been held preempted. Sprint Fidelis, 592 F. Supp.2d at 1159. If the alleged violation post-dated the manufacture of the device that was implanted, there’s no claim either. Horowitz, 613 F. Supp.2d at 282 (implant occurred two years before FDA inspections that allegedly found violations); Riley, 2009 WL 1606650, at *15 (claims based upon FDA findings “well after” plaintiff’s surgery dismissed); Heisner v. Genzyme Corp., 2009 WL 1210633, at *2 (N.D. Ill. April 30, 2009) (alleged violations that took place after plaintiff’s death from claimed defect “could not have proximately caused her injury”); Parker, 584 F. Supp.2d at 1301 (dictum noting “potential problems of causation posed by attempting to link letters issued in 2007 with plaintiff’s injury in 2004”).

Finally, the alleged violation must relate to some condition of the device that could have caused the particular type of injury that the plaintiff alleges. Horowitz, 613 F. Supp.2d at 282 (“nor does [plaintiff] provide a necessary link between the federal violations and her specific injury); Riley, 2009 WL 1606650, at *11 (must plead that specific off-label use plaintiff underwent was illegally promoted); Parker, 584 F. Supp.2d at 1301-02 (warning letters must be tied to plaintiff’s claim; plaintiff “fails to give the court reason to believe that this plaintiff has a reasonable likelihood of mustering factual support for these claims”) (citation and quotation marks omitted) (emphasis original); Rollins, 583 F. Supp.2d at 803-04 (“neither [plaintiff’s] amended complaint nor her opposition memorandum contains any allegation as to how this alleged failure, standing alone, caused her injuries”).

That’s what we’ve learned from litigation violation claims for a little less than a year and a half since Riegel. We expect we’ll learn at least as much in the next year and a half.