This post is from the non-Reed Smith side of the blog.
We’ve been reporting on the amazing success Medtronic has had in the InFuse litigation for over two years. And, it all started with Caplinger. Caplinger was the first (and arguably one of the best) of the lot, accepting propositions that PMA preemption applies to devices, not uses; that “off-label promotion” is not a proper parallel claim; that any claim dependent on the scope of the FDA’s label is really a disguised FDCA violation claim; and any claim premised on a PMA device’s safety and effectiveness is preempted. What more could we have asked for? A Tenth Circuit affirmance. Now we’ve got it.
In an extremely well-written decision the Tenth Circuit (2-1) affirmed the complete dismissal of Caplinger v. Medtronic, Inc., No. 13-6061, slip op. (10th Cir. Apr. 21, 2015). It is so well-written we really could quote from most of it verbatim. But we’ll try to resist that urge and give you an abbreviated version today (we do however recommend reading the whole thing, we think you’ll enjoy it).
Caplinger is essentially no different than all the other InFuse cases. Plaintiff alleges that because her surgeon opted to implant the InFuse device posteriorly (from the back) instead of anteriorly (from the front), this off-label use transforms the case from an otherwise preempted PMA medical device case into a non-preempted, off-label, parallel violation claim. The Caplingerappellate decision carefully explains why plaintiff is just wrong. It begins with a close examination of preemption law that starts where we always start – doesn’t §360k(a) foreclose “all private state law tort suits.” Slip op. at 5. But then come Lohr, Riegel, and Buckman. Reading those Supreme Court decisions together, the 10th Circuit reached the following conclusion as to the preemption analysis
it seems we aren't supposed to ask whether Ms. Caplinger wishes to use state tort law to impose on Medtronic a safety requirement that is “different from, or in addition to” a federal requirement so much as whether she seeks to vindicate a state duty that is “narrower” or “broader” than a federal duty. To the extent the state law duty is narrower than or equal to the federal duty it survives, through what seems a sort of Venn diagram approach to preemption. Still, even if the state claim fails that test because it would impose a “broader” duty than can be found in federal law, it appears we may not find the claim preempted just because it conflicts with “any” federal requirement. Instead, we may find the state law claim preempted only if there exists a device-specific federal requirement . . . Finally, should the state claim survive this far, we must ask whether it exists “solely by virtue” of the federal statutory scheme (unacceptable) or “predates” the scheme (acceptable). It's no wonder that the difficulty of crafting a complaint sufficient to satisfy all these demands has been compared to the task of navigating between Scylla and Charybdis.
Id. at 11.
Using this template, the court answers question number 2 first – the easiest question – device-specific requirements apply to InFuse because it has been through the PMA process. Id. at 12. With that box checked, the court moves back to question number 1 – do plaintiff’s claims parallel federal requirements? As we move on to the specific claims, we should note that the court did not decide whether plaintiff’s fraud claim was preempted, agreeing with the district court that the claim was not pleaded with the particularity required of Federal Rule of Civil Procedure 9(b). Id. at 12n.1.
On design defect and breach of warranty, the court found that plaintiff failed to even identify a purported parallel federal regulation. So, they turned to failure to warn, negligence and negligent misrepresentation. For these claims, plaintiff cited federal requirements that the device’s label not be “false or misleading” and contain “directions under which the layman can use a device safely and for purposes for which it is intended.” Id.at 13.
First, the court points out that these requirements go to labeling only and plaintiff’s claims “go well beyond that,” challenging advertising and other representations. “So as a matter of law Ms. Caplinger’s state law claims substantially exceed the potential scope of any federal regulation she’s identified.” Id. But the labeling claim also fails because plaintiff relies on an inapplicable federal regulation. InFuse is a prescription only medical device and therefore, the FDCA recognizes that its directions for use won’t adequately inform alayman how to use the device safely. So, manufacturers are absolved from compliance with this regulation “so long as they label their prescription devices in a certain manner approved by the FDA.” Id. Moreover, once a PMA device label is approved, “the manufacturer usually may not alter the label’s warnings without prior agency approval.” Id. at 14. And, plaintiff “offers no answer to the conundrum how she might impose a state tort duty on Medtronic to revise a label that federal regulation precludes it from revising.” Id.
So, plaintiff failed to identify “any legally viable federal requirement that might parallel and thus permit her claims.” Id.at 16. But now we turn to the heart of the InFuse cases – plaintiff’s allegation that “off-label use is enough all by itself to insulate all her claims from preemption.” Id. at 18. In other words, plaintiff asked the court to find that parallelism isn’t the only way to avoid preemption – attacking off-label use “should be another entirely separate way around the problem.” Id. at 19. But the court found that route blocked as well.
The first obstacle is §360k(a) itself. It preempts state laws that impose “any requirement” that relates to the safety or effectiveness of [a] device that is different from, or in addition to, any requirement applicable . . . to the device.” Id. at 19. It’s all about the device, not uses. The second bump was the court’s recognition that if Congress wanted to preempt claims as to uses, it knew how to do it. Indeed Congress specifically protected off-label uses when it provided that “[n]othing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device.” Id. at 20 (citing 21 U.S.C. §396). Looking at preemption in this context, the court concluded:
Knowing about (even encouraging) off-label uses in § 396, Congress proceeded in § 360k(a) to preempt any state tort suit challenging the safety of a federally approved device without qualification about the manner of its use. Given that Congress well understood the difference between on-and off-label uses and exhibited its facility with those terms in § 396, the absence of any mention of them in § 360k(a) becomes all the harder to ignore, a sort of dog that didn't bark.
Id. So, off-label use alone doesn’t change a thing in the preemption world.
But plaintiff didn’t stop there. She next argued that preemption should only apply when a “state requirement differs from or adds to a federal regulation covering the ‘same subject.’ And because there are no federal regulations on the ‘subject’ of off-label uses . . . off-label claims should not be preempted.” Id.at 21. But, that reads in a pre-condition that is clearly not part of §360k(a). This section “specifies its preemptive reach plainly and broadly: any state requirement that adds to federal requirements and that relates to the safety or effectiveness of the device is preempted. No other qualification exists.” Id. at 22.
And finally, plaintiff’s last attempt to find some support for her position was to cite the FDA’s amicus brief in Medtronic v. Stengel (U.S. 2014). But the court was unpersuaded:
Neither does the agency's latest brief mention—let alone seek to explain why it has deviated from—its prior litigating position. And the FDA acknowledges candidly that its (current) litigating position would require a court to reject “every [circuit] case since Riegel ” because none has suggested that § 360k(a)'s preemptive effect depends on a dichotomy between on-and off-label uses. Without any good reason to defer to the FDA's current position over its previous position—and the textual and precedential acrobatics that would be required to land there—we decline the attempt.
Id. at 24.
So, having undertaken this thoughtful and complete analysis, the court concluded that Congress undertook to balance the competing interests between those injured by FDA-approved devices and those who would suffer if innovation was checked, postponing access to new devices. “[A]nd it is not for this court to revise it by beating a new path around preemption nowhere authorized in the text of the statute and nowhere recognized in any of the Supreme Court’s may forays into this field.” Id. at 26.
While we like to leave it there, we can’t end this post without a brief discussion of the dissenting opinion. The dissent claims that it is not fundamentally disagreeing with the majority on the substance of federal preemption law, only on whether preemption sinks plaintiff’s claims as a matter of law at the pleadings stage of this case. Dissent, at 19. We think the problems with the dissent are more substantive than they want to let on; but more importantly, it is the arduous lengths the dissent goes to to find a claim that might survive beyond a motion to dismiss that we take issue with.
If we had to sum up the biggest problem with the dissent it would be its apparent recognition of a state law claim for adulteration and misbranding. That’s Buckman preemption 101. The dissent goes on for pages about the labeling requirements in the FDCA and its prohibitions on misbranding and adulteration. But these are federal requirements without a state law parallel counterpart. Allowing a plaintiff to sue a manufacturer because a device was “adulterated” is the very definition of allowing a private right of action to enforce the FDCA. No way says the Supreme Court.
Tied up in their misbranding argument, the dissent also argues that Oklahoma failure to warn law doesn’t require that “Medtronic provide additional warnings or labeling in order to escape state tort liability.” Dissent, at 17. Rather, Oklahoma law provides that a device can be defective due to an inadequate warning. The focus on “inadequate” doesn’t save plaintiff’s claim. If a something is inadequate, it is lacking. And if something is lacking, something more is required. “More” is both additional and different.
The dissent also tries to read misbranding and adulteration into a state law failure to warn claim:
Once the specific elements of state law are apprehended, it becomes clear that Oklahoma is merely providing a mechanism for recovery if Medtronic violates federal law by introducing Infuse for an adulterated or misbranded use and the warnings accompanying Infuse are inadequate for that adulterated or misbranded use. The state duty, like the federal duty, requires that Medtronic provide adequate directions for use.
Dissent, at 17. Isn’t this just negligence per se in disguise? The defendant was negligent in its warning because the warning violates federal law. And so we’re back to an unlawful private enforcement action. Actually, if you look a little deeper, the disguise is quite thin:
To hold otherwise would allow Medtronic to shift liability for its illegal misbranding and adulteration to patients and physicians and provide a strong disincentive for Medtronic to seek supplemental FDA approval when the intended use of a device changes.
Id. (emphasis added). There is no civil liability for misbranding and adulteration. The incentive for seeking supplemental approval is avoiding prosecution under the FDCA. That’s the balance that Congress struck and as the majority found, it is not for this court (or any court) to beat a new path around preemption not recognized in the statute or by the Supreme Court.