Now we’ve read it, and before we go off to celebrate (and maybe to look for new jobs as IP lawyers – that’s a joke, folks), we thought we’d tell our readers why that’s exactly what we’re doing.
The 7-1 Riegel decision definitively demolishes a lot of the arguments we’ve been seeing for years (if not decades) from plaintiffs opposing preemption. In particular:
The PMA process creates “specific counterpart regulations” within the meaning of Medtronic v. Lohr, since the PMA process is concerned precisely with safety and effectiveness. “[P]remarket approval is specific to individual devices. And it is in no sense an exemption from federal safety review—it is federal safety review.” Op. at 9 (emphasis original). Unlike Lohr PMA approval “is focused on safety, not equivalence.” Id.
Manufacturers are not free simply to change the attributes of their devices after approval. “[T]he FDA requires a device that has received premarket approval to be made with almost no deviations from the specifications in its approval application.” Op. at 10.
The majority “adhere[s] to the view” “that common-law causes of action for negligence and strict liability do impose “requirement[s]” and would be pre-empted by federal requirements specific to a medical device.” Op. at 10. Not only that, unless there’s some specific qualifier, the word “requirement” henceforth in any federal statute will be read to include the common-law, because “Congress is entitled to know what meaning this Court will assign to terms regularly used in its enactments.” Op. at 11. So essentially all other statutes using “requirement” in preemption clauses will be found to preempt the common law. That’s a big spillover effect.
There’s another possible spillover effect – from something that the majority does not mention, either here or anywhere else in its opinion. That’s the so-called “presumption against preemption,” which is conspicuous by its absence in all but Justice Ginsburg’s lone dissent. Since this “presumption” previously arose in express preemption cases such as Cipollone and Lohr, it’s utter absence from the analysis of seven justices in Riegel – also express preemption – is telling.
The majority holds that state tort law is less – not more – deserving of protection from preemption than state statutory or regulatory enactments:
[E]xcluding common-law duties from the scope of pre-emption would make little sense. State tort law that requires a manufacturer’s catheters to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme no less than state regulatory law to the same effect. Indeed, one would think that tort law, applied by juries under a negligence or strict-liability standard, is less deserving of preservation. A state statute, or a regulation adopted by a state agency, could at least be expected to apply cost-benefit analysis similar to that applied by the experts at the FDA: How many more lives will be saved by a device which, along with its greater effectiveness, brings a greater risk of harm? A jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court. As JUSTICE BREYER explained in Lohr, it is implausible that the MDA was meant to “grant greater power (to set state standards ‘different from, or in addition to’ federal standards) to a single state jury than to state officials acting through state administrative or legislative lawmaking processes.” 518 U. S., at 504. That perverse distinction is not required or even suggested by the broad language Congress chose in the MDA, and we will not turn somersaults to create it.
Op. at 11-12 (emphasis gleefully added).
The old saw from Silkwood v. Kerr McGee, that it is “difficult to believe that Congress would, without comment, remove all means of judicial recourse,” by plaintiffs through preemption also takes a big hit. The majority answers the dissent’s reliance upon this assertion thusly:
But, as we have explained, this is exactly what a pre-emption clause for medical devices does by its terms. The operation of a law enacted by Congress need not be seconded by a committee report on pain of judicial nullification. It is not our job to speculate upon congressional motives. If we were to do so, however, the only indication available — the text of the statute — suggests that the solicitude for those injured by FDA-approved devices, which the dissent finds controlling, was overcome in Congress’s estimation by solicitude for those who would suffer without new medical devices if juries were allowed to apply the tort law of 50 States to all innovations.
Op. at 13 (more gleeful emphasis).
Next there’s some dictum (because the majority finds the statutory language controlling) to the effect that the FDA’s amicus views in this case are entitled only to so-called Skidmore (relatively low) deference because of the “different” position taken by the FDA previously. The FDA’s prior anti-preemption position, however, “is even more compromised, indeed deprived of all claim to deference, by the fact that it is no longer the agency’s position.” Op. at 13. Thus the old Kernats brief is interred with a stake through its heart.
Then, in what is probably the most significant spillover in the opinion, the majority addresses the dissent’s reliance upon precedent involving preemption in prescription drugs and food additives. It’s in the nature of “wait a minute, we’ve never rejected drug preemption”:
Two points render the conclusion [about drugs and additives] the dissent seeks to draw from that experience — that the pre-emption clause permits tort suits — unreliable. (1) It has not been established (as the dissent assumes) that no tort lawsuits are pre-empted by drug or additive approval under the FDCA. (2) If, as the dissent believes, the preemption clause permits tort lawsuits for medical devices just as they are (by hypothesis) permitted for drugs and additives; and if, as the dissent believes, Congress wanted the two regimes to be alike; Congress could have applied the pre-emption clause to the entire FDCA. It did not do so, but instead wrote a pre-emption clause that applies only to medical devices.
Op. at 13-14 (emphasis added that goes beyond glee). The court thus considers the issue of prescription drug preemption open, and not foreclosed by any prior precedent. We’ll see what happens, but we have to say that we feel better about Wyeth v. Levine after reading this.
Because we defend both drugs and devices, we also note that a lot of the court’s description of the PMA process (Op. at 4-6) strongly resembles the kind of FDA approval gauntlet that applies to New Drug Applications – both in terms of the requirements for safety and effectiveness and with respect to the size of the application and the comprehensiveness of the FDA’s review. We put that in the plus category, too.
Nor are common-law tort claims ao “general” that they escape preemption. Rather plaintiff’s “suit depends upon [a state’s] ‘continu[ing] in effect’ general tort duties ‘with respect to’ Medtronic’s catheter.” Op. at 14-15 (quoting preemption clause). That is enough for preemption:
Nothing in the statutory text suggests that the pre-empted state requirement must apply only to the relevant device, or only to medical devices and not to all products and all actions in general.
Op. at 15. Thus ends the plaintiffs’ would-be “this device only” gloss on the MDA’s preemption clause. Here the FDA’s position, being a regulatory interpretation, rose to the level of Auer deference (better than Skidmore; not as definitive as Chevron). The regulation plaintiff relied upon didn’t mention common-law claims at all, and “the regulation excludes from pre-emption requirements that relate only incidentally to medical devices, but not other requirements [like g]eneral tort duties of care.” Id. Instead the regulation (21 C.F.R. §808.1(d)(1), for you hard core types) “sets forth a ‘general rule’ pre-empting state duties ‘having the force and effect of law (whether established by statute, ordinance, regulation, or court decision)….'” Op. at 16 (emphasis original with the court). The majority’s reaction is that this language has to refer to the common law:
We are aware of no duties established by court decision other than common-law duties, and we are aware of no common-law duties that relate solely to medical devices.
Id. (sarcasm original with the Court). Ultimately, though, the majority decides that the regulation is simply too confusing to be worth anything. Id. (“All in all, we think that §808.1(d)(1) can add nothing to our analysis but confusion”).
At the tail end of the opinion the majority refuses to address plaintiff’s belatedly raised argument that their claims involved “parallel” claims under Lohr. Op. at 17. Thus it leaves Lohr intact on the point. We suspect that the Court will have more to say on this subject when it decides Warner-Lambert v. Kent (which will be argued next week – on February 25).
Stevens concurs in the result, essentially because the plain language of the preemption clause trumps any absence of any specific congressional intent to preempt.
Ginsberg dissents, essentially because she believes the absence of any specific congressional intent to preempt trumps the plain language of the preemption clause.
Now, you’ll have to excuse us – we’re going out to join the party.