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Not quite six months ago, the Supreme Court decided Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), but then again, most or our readers know that. Since then, our prediction that the plaintiffs would try, through Congress, to strangle Riegel in its cradle have proven all too accurate. Ditto for our expectations – based upon years of hard-won experience – that Riegel would set plaintiffs off in a frantic search for loopholes in preemption – and, in particular, that almost every Riegel-controlled PMA device case would soon involve a “parallel” requirement claim of some sort.

With six months experience, what can we say so far about how Riegel has fared in the courts?

You know us – we’ll say a lot, even if there isn’t a lot to say.

Failure to Plead/Prove

Well, the first thing we notice is it that it looks like quite a few plaintiffs got caught flat-footed by Riegel. We find that pretty surprising (we try never to underestimate our opponents), given how much publicity Riegel generated while the case was pending. There are a bunch of cases involving plaintiffs who ended up with no evidence – or even bare allegations – of “parallel” claims once Riegel was decided. So much the better for our side. See McCutcheon v. Zimmer Holdings, Inc., 2008 WL 3153442, at *5-6 (N.D. Ill. Aug. 6, 2008); Heisner v. Genzyme Corp., 2008 WL 2940811, at *5-6 (N.D. Ill. July 25, 2008); Stevens v. Pacesetter, Inc., 2008 WL 2637417, at *1 (D.S.C. April 1, 2008); Mattingly v. Hubbard, 2008 WL 3895381 (Ky. Cir. July 30, 2008); Johnson v. Endovascular Technologies, Inc., 2008 WL 3139424 (Cal. Super. May 19, 2008); McGuan v. Endovascular Technologies, Inc., 2008 WL 3139418 (Cal. Super. May 19, 2008); Mullin v. Guidant Corp., 2008 WL 2785498 (Conn. Super. April 8, 2008). See also Despain v. Bradburn, 372 Ark. 272, 2008 WL 1067202 (Ark. April 10, 2008); Troutman v. Curtis, 185 P.3d 930, 935 (Kan. 2008) (pending appellate cases also dismissed for failure to prove or plead; but since an appellate record is static, we really can’t fault those guys).

Our first reaction: a win is a win is a win. But we don’t expect to be winning cases for all that much longer based solely on failure to plead – except where the statute of limitations has run. The one situation where failure to plead will continue to be fatal is where plaintiffs belatedly attempt to amend their pleadings. One case already has held violation claims to “present an entirely new cause of action,” Mullin, 2008 WL 2785498. There’s probably non-FDCA-related precedent out there as well, in the general negligence per se context, for the proposition that amendments adding violation claims should not be permitted where the statute of limitations has expired.

Beyond that, while we expect plaintiffs to become better pleaders, we nevertheless expect to see plenty of future wins based on failure to prove FDCA violation claims – because there frankly just aren’t that many real, causal violation claims out there. Our side needs to concentrate, going forward, on how to demonstrate, through affidavits, internal device tracking data, and the like, its compliance with relevant PMA requirements.

Attacks On Information Given The FDA

Some plaintiffs try to escape Riegel by claiming that manufacturers withheld or misrepresented information in their dealings with the FDA. That hasn’t worked very well, with courts holding that this gambit merely exchanges Riegel preemption for Buckman preemption. See McCutcheon, 2008 WL 3153442, at *5; O’Shea v. Cordis Corp., 2008 WL 3139428 (Fla. Cir. May 19, 2008); Johnson, 2008 WL 3139424; McGuan, 2008 WL 3139418 (Cal. Super. May 19, 2008).

McCutcheon and Heisner both avoided deciding (see the failure to prove section, above) whether an unpreempted claim could arise from purported violations of post-approval reporting requirements. Where the allegations involve withholding information from the FDA, then we’ve already discussed how we think the rationale in Buckman bars this sort of claim whether or not the alleged informational violation occurred before or after approval.

Negligence Per Se

This is another variant of the “parallel” violation claim, but with the additional infirmity of violating the FDA’s exclusive prosecutorial authority under 21 U.S.C. §337(a). It’s also proven difficult for plaintiffs to come up with a causal violation of applicable regulations. Heisner, 2008 WL 2940811, at *7. For more on defending against FDCA-based negligence per se claims, see our prior post, here.

Express Warranty

The pre-Riegel dispute over whether express warranty claims are preempted has carried over, since Riegel did not address such claims. See Johnson, 2008 WL 3139424 (express warranty claims preempted under Riegel); McGuan, 2008 WL 3139418 (same); Heisner, 2008 WL 2940811, at *7 (no preemption of express warranty); O’Shea, 2008 WL 3139428 (same).

Where express warranty is alleged, however, Twombly should be of significant benefit to the defense side, because most manufacturers simply don’t make express warranties with respect to prescription medical products. For example, while allowing plaintiff to replead, Heisner specifically pointed out, 2008 WL 2940811, at *8, that any amendment would have to contain specific facts concerning the express warranty to comply with Twombly. See also Adkins v. Cytyc Corp., 2008 WL 2680474, at *2 (W.D. Va. July 3, 2008).

Courts simply need to require plaintiffs to plead what the supposed express warranty is and how it was breached. Our guess that 90% or more of the time there won’t be anything that the plaintiff can plead to maintain an express warranty claim, and it won’t matter whether these claims are preempted or not.

Attacks Upon Allegedly Unregulated Activities

In O’Shea, 2008 WL 3139428, the court rejected the plaintiff’s argument that off-label use automatically meant there was no preemption. If the claimed defect or risk involved in the off-label use is also present during labeled use, then the claim is preempted. The court did hold that pure off-label promotion claims would not be preempted, because such activity is not FDA-approved.

In Mattingly, the court held that failure-to-train claims were preempted because they were “in addition to” the FDA’s requirements applicable to the device:

Further, while Plaintiff argues that his claims of negligent failure to train physicians properly is separate from the FDA approval process, the Court finds that such a claim would nonetheless impose an additional substantive requirement for a specific device. . . . Thus, such requirements are preempted.

2008 WL 3895381 (almost at the end).

In Johnson and McGuan, the plaintiffs unsuccessfully argued that failure-to-test claims escaped preemption under Riegel. As in Mattingly, the court in those cases held that preemption applied because the testing-related claims were “in addition to” the FDA’s requirements. “To the extent [plaintiff] contends defendants needed to perform further testing. . ., those would be additional requirements that are preempted by the MDA because of the FDA’s earlier approval through the PMA process.” Johnson, 2008 WL 3139424; McGuan, 2008 WL 3139418.

Compare these cases, however, to Adkins, 2008 WL 2680474, which went the other way. In Adkins, after finding all of the plaintiff’s ordinary product liability claims preempted, the court held that the plaintiff could nevertheless bring a claim implicating the conduct of a manufacturer’s representative who had attended the surgery at issue – although Twombly required the claim to be pleaded more specifically:

The FDA does not regulate interactions between corporate representatives and physicians on-site at a particular surgery, and where it does not mandate special physician training for a drug, it does not specify how such an interaction at surgery must be performed. These localized situations are traditional matters for the common law, not the FDA’s regulatory approval process. Such a claim does not challenge the design, manufacture, and labeling of the. . .device so as to implicate Riegel preemption, but rather challenges negligence by a corporate agent acting as a de facto physician’s assistant during a surgical procedure.

Id. at *3. We, of course, think that this type of claim should fail under the relevant “in addition to” preemptive language of the statute. But even aside from that, Adkins has potentially disturbing practical overtones.

We’ve already blogged about the diversity-jurisdiction-related implications of claims involving manufacturer’s representatives. The search for novel, unpreempted claims post-Riegel only adds urgency to this issue. We believe that having manufacturer’s representatives attend surgery, as described in Adkins, is a good thing. Such representatives provide device-specific technical services – ensuring devices are properly calibrated/functioning before implant, or pointing out the right-sized piece in a kit from among numerous alternatives designed for different-sized people – that otherwise health-care providers would have to spend time learning (and probably wouldn’t learn as well, especially for infrequently-performed procedures). But if providing these services comes to expose manufacturers to otherwise preempted liability, they will respond by withdrawing their representatives if the cost becomes too great.

The alternative to “in addition to” preemption in manufacturer’s representative cases could be: (1) to formalize protocols about what representatives are allowed to do and submit those protocols for the FDA approval. Once they are FDA approved, the umbrella of FDA preemption should protect those activities too. (2) Manufacturers should ensure that representatives document their actions and understand ahead of time what they are to do in particular situations (e.g., when encountering an off-label use), in order to better defend such claims on the facts.

Miscellaneous Claims/Arguments

Post-Riegel preemption cases have also dealt with various other issues that aren’t easily categorized. Here’s what we’ve found:

Unfair trade practices claims have been held preempted under Riegel. O’Shea, 2008 WL 3139428.

The Supremacy Clause means what it says. Riegel preemption can’t be avoided by reliance upon pre-Riegel decisions hostile to preemption. McCutcheon, 2008 WL 3153442, at *6.

That Congress might eventually overturn Riegel is not a reason for courts to refuse to apply controlling precedent, and find preemption, in the interim. McCutcheon, 2008 WL 3153442, at *6.

Finally, defendants shouldn’t expect to get relief from discovery on arguably preempted claims unless and until they obtain substantive preemption rulings. Strini v. Edwards Lifesciences Corp., 2008 WL 820192, at *2 (Mag. N.D.N.Y. March 26, 2008).