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Shortly after Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) was decided, we put up a post, “Riegel at (Almost) Six Months,” where we surveyed the immediate aftermath of the Supreme Court’s preemption decision.  Then we did another at “Riegel” at 1 ½” post in July of last year.

The recent decision in Bryant v. Medtronic, Inc., 2010 WL 4026802 (8th Cir. Oct 15, 2010), offers us the first post-Riegel appellate guidance on preemption and PMA devices.  We did a quickie post on it before, but the decision’s important enough that it deserves a closer look.  Since Bryant effectively affirmed the dismissal of an entire multi-district litigation on the basis of preemption, one thing that’s a given is that the plaintiffs were most thorough and assiduous in making the arguments that they thought would best hold up against preemption.  That none of them did is a sign of the strength of the preemption doctrine in the medical device field.

First, the plaintiffs tried an argument that had prevailed in Wyeth v. Levine, 129 S. Ct. 1187 (2009) – that because of a defendant’s asserted ability to change FDA-approved warnings prior to FDA approval (the so-called “changes being effected” or “CBE” process) there wasn’t any preemption.  That might work against an implied preemption argument, but Riegel was an express preemption case.  Whether or not voluntary from the standpoint of the FDA, any obligation to change FDA-approved warnings would still be “in addition to” whatever the FDA had approved.  And so the court in Bryant held:

Even if federal law allowed [defendant] to provide additional warnings, as Plaintiffs alleged, any state law imposing an additional requirement is preempted by § 360k.  Where a federal requirement permits a course of conduct and the state makes it obligatory, the state’s requirement is in addition to the federal requirement and thus is preempted.  Plaintiffs’ reliance on [Levine] for a contrary rule is unavailing.  [Levine] turned on implied conflict preemption, not express preemption, because Congress did not extend the express preemption for medical devices in §360k to prescription drugs.

Bryant, 2010 WL 4026802, at *3.  So much for CBE in the express preemption context.

Second to bite the dust was the argument that, because a defendant gets an improved device modification approved by the FDA, every prior version is “defective” because it isn’t as good.  Nope.  As long as a device’s design remains FDA approved, then to impose liability because some other design exists is preempted.  “[A]s the FDA did not prohibit [defendant] from continuing to sell the unmodified [device], a state requirement to that effect would be “different from or in addition to” the federal requirement and preempted.”  Id.

Third, a claim that the defendant engaged in fraud on the FDA – “failed to provide the FDA with sufficient information” or “not timely fil[ing] adverse event reports” – failed because that claim was preempted by Buckman.  Id.

Fourth, plaintiffs argued “that [defendant] lost its federal preemption defense when the [devices] were recalled.”  2010 WL 4026802, at *2 n.4.  That one didn’t even warrant treatment in the text.  In a footnote the court rejected the contention “for the reasons stated by the district court.”  Id.  Those reasons were – just so everything’s in the same place:

(1) Recalls don’t invalidate preemption.

[T]he argument is predicated on the faulty assumption that the recall invalidated the [devices’] PMA. Plaintiffs have cited no authority for that proposition, and . . . the PMA process is governed by a completely separate statutory and regulatory regime than that governing withdrawal of a PMA-a process to which the [devices] have never been subjected.

In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147, 1155 (D. Minn. 2009), aff’d, 2010 WL 4026802 (8th Cir. Oct. 15, 2010).

(2) FDA regulatory status is determined as of the time a device is used.

Plaintiffs’ argument ignores that PMA for the [devices] was in place at the time [they] were implanted.  This is what matters, because liability under Plaintiffs’ various legal theories hinges upon whether the leads were defective at that time.

Id. at 1156.

(3) Juries aren’t allowed to second guess FDA device approvals.

[These] claims threaten[] to interfere with the PMA process because allowing them to proceed would, in essence, result in retroactive second-guessing of the FDA’s decision-making. . . .  [I]f a PMA were invalidated or withdrawn . . . a jury confronting such a situation would be required to retroactively question the FDA’s initial decision to approve the medical device at issue.  Doing so would interfere with the PMA process ipso facto.


Those are only the initial skirmishes. The real battle involved “parallel violation” claims.  The most important aspect of Bryant, from our perspective, is that it adopted the view that “violation” claims are subject to both express and implied preemption.  We consider that self-evident, but there’s always a bit of bated breath involved until an appellate court has agreed.  The express preemption part is easy – that’s Riegel and 21 U.S.C. §360k(a).  Bryant pointed out, Riegel “noted” (that’s correct, Riegel did not so hold, because of the plaintiff’s waiver) “§360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations.”  2010 WL 4026802, at *2.

The recognition that Buckman implied preemption narrowed the scope of parallel violation claims was agreed to by the entire panel.  Specifically, the court held:

The MDA also provides that all actions to enforce FDA requirements “shall be by and in the name of the United States,” 21 U.S.C. § 337(a).  In Buckman . . ., the Court construed §337(a) as barring suits by private litigants “for noncompliance with the medical device provisions.” Read together Riegel and Buckman create a narrow gap through which a plaintiff’s state-law claim must fit if it is to escape express or implied preemption.  The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by §360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman).  The contours of the parallel claim exception were not addressed in Riegel and are as-yet ill-defined.

2010 WL 4026802, at *2 (various other citations omitted).  We think that’s precisely correct.  In order for there to be parallelism, there must first be two lines: one common-law and the other the FDCA violation. I f there’s no equivalent common-law claim, then there’s nothing to parallel, and all that’s left is a Buckman-barred claim for violation of the FDCA.

The court held that you couldn’t get by with rote recitations that the defendant did whatever it did in a way that violated the statutes.  Plaintiffs’ design defect claims went to defeat in that fashion.  Plaintiffs got plenty of chances to allege something specific, but couldn’t.  “Absent concrete allegations that the product sold by Medtronic was not the product design approved in the PMA Supplement, these are not parallel claims.”  2010 WL 4026802, at *3.  Simply claiming design “violations” without identifying them were roundabout “attacks on the risk/benefit analysis that led the FDA to approve an inherently dangerous Class III device.”  Id.

Plaintiffs manufacturing defect claims at least didn’t suffer from a lack of specificity.  Plaintiffs were quite clear that they were based upon use of “direct resistance spot welding,” which they claimed was “unreliable.”  Plaintiffs’ problem was that this kind of welding was precisely what the FDA’s approval allowed.  “Plaintiffs conceded that the PMA Supplement doubtless authorized the use of spot welding.”  2010 WL 4026802, at *4.  That’s the kind of concession that sends someone packing.

Plaintiffs whined that they hadn’t had discovery, and that without any, the TwIqbal standards were impossible.  The Bryant court allowed that plaintiffs might have had a point if they hadn’t “specifically disclaimed the need for discovery in opposing [defendant’s] motion to dismiss.”  Id.  So plaintiffs were hoist by their own petard.  The dissent in part dissented on this part, saying that in light of TwIqbal, the court should have cut the plaintiffs a break:

I would hold the specificity requirements of Twombly must be applied in a practical manner that recognizes the parties’ relative access to information necessary to articulate claims with specificity.  Here, as described by the majority and determined by the district court, the parallel state claim that may escape preclusion under §360k requires the plaintiffs to prove [defendant] failed to manufacture the [device] in compliance with the requirements set forth in the confidential PMA and supplemental PMAs.  To apply Twombly rigidly without permitting discovery as to these documents effectively creates an impossible-to-achieve specificity requirement.  I do not believe the Court intended Twombly to create this type of insurmountable hurdle.

Bryant, 2010 WL 4026802, at *7 (dissent in part).

We don’t agree with these sentiments. We think that a nearly “insurmountable hurdle” is precisely what should be erected in this circumstance.  The problem is not TwIqbal, rather the reason is Congress itself.  Congress did two things:  (1) it enacted a broad express preemption clause in the Medical Device Amendments, and (2) it expressly prohibited anybody other than the government from seeking to enforce the FDCA.  Both of those congressional actions counsel against cutting plaintiffs any breaks when they purport to bring parallel violation claims.  Such claims are in derogation of not one, but two, express indications of congressional intent.  If plaintiffs can’t easily plead a parallel violation claim – that’s exactly what Congress wanted.  In light of these two provisions in the FDCA/MDLs, the courts should not be authorizing discovery “fishing expeditions” into whether manufacturers of PMA devices violated the FDCA.

Unless the FDA has already concluded that the defendant violated the terms of its PMA – something that would already be public information in the hands of the plaintiffs – and that violation affected a device in such a way that injured the plaintiffs, then state common law has no business opening the courthouse doors.  Between preemption and lack of standing, Congress has spoken twice that it does not want to see claims of this sort.  Sometimes there’s a reason for having a pleading standard that’s “insurmountable” in certain circumstances.  This is one of them.

But we digress from our main point, which is to detail what’s important in the Bryant decision.  There’s not much more.  Plaintiffs’ last card, on the merits of preemption, was express warranty.  There’s been some uncertainty about express warranty and preemption, because early case law, Cipollone v. Liggett Group, Inc., 505 U.S. 504, 525 (1992), took the view that express warranties were freely entered into and thus weren’t related to agency “requirements.”  But not all express warranty claims are of this sort – and where something as intensively regulated as PMA medical devices are concerned, most aren’t.  There was no claim in Bryant that the defendant had actually made any express warranty of the sort anticipated under the UCC.  As with the design claims, the plaintiffs’ express warranty claims were merely allegations without any specific facts or language to back them up, a supposed warranty of safety.  Thus the court (back to being unanimous, the only disagreement was over pleading) held:

To succeed on the express warranty claim asserted in this case, Plaintiffs must persuade a jury that [devices] were not safe and effective, a finding that would be contrary to the FDA’s approval of the PMA Supplement. . . .  The MDA in §360k expressly prohibits States from imposing requirements “in addition to” federal requirements.  The district court correctly concluded that this express warranty claim interferes with the FDA’s regulation of Class III medical devices and is therefore conflict preempted.

Bryant, 2010 WL 4026802, at *5 (citations omitted)

We don’t have to tell anyone doing device preemption work that Bryant now goes right underneath Riegel any briefing on this subject.  Aside from a little namby-pambyness on pleading, it makes all the major points we want, on parallel violations, recalls, warranty claims and more.

And we don’t expect an appeal, given the unfortunately timed settlement.