Wednesday, February 20, 2008

More on Riegel

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 Ginsbert'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.


Anonymous said...

You shouldnt be celebrating, unless you are Irish, in which case you are attending a wake. "Out of a job" is absolutely right. There will be a legislative fix. Has to be.

Andrew Oh-Willeke said...

A quick read seems to leave open the door to a state law tort suit based upon the theory that there was not compliance with the federal standards established for the MDA -- e.g. a failure to follow the agreed manufacturing standard, or a failure to employ marketing in the manner approved.

Essentially, federal approval would constitute conclusive proof of the applicable standard of care -- the duty prong if you will, of a negligence suit.

Anonymous said...

Your preference for total preemption of all plaintiffs' cases involving drugs and devices is understandable since drug and device manufacturers are the entities which support your quality of life but, while you're out having drinks tonight and thoroughly celebrating the fruits of your hard work, please take a moment to think about the families who will have loved ones maimed or killed in the future by faulty medical devices.

As you know, these poor souls will have little or no recourse and this, at least in part, is a result of your recent efforts. Ironically, the risk of loss will now be shifted from the drug and device companies to the american and Medicaid. Thanks a lot we'll get taxed even more than we already are. Wonderful!

In fact, since you love to blog about preemption so much, maybe you'd like a long list of grieving families to call. If you're really lucky, maybe the plaintiff's bar will lend you a list of recently disengaged clients so that you may gleefully discuss with them how much better off they will be with preemption.

The fact of the matter is that you would never speak with any of these families or any injured person about preemption because (1) you don't have to; (2) none of your clients even remotely resemble people who have been seriously injured; and (3) you would avoid the subject like the plague because, from a moral standpoint, you guys don't have a leg to stand on.

In conclusion, I recommend you take a moment to reflect on the shear gravity of what you're doing right now. Because of your efforts, some very good and decent families will be totally screwed over.

Doesn't this bother you even a little bit?

Anonymous said...

If we're starting a list, I'd like to add my mother and my family's name to it. My mother died two years ago tomorrow because of a serious reaction to a medical device that was placed in her. She lived the last three weeks of her life in the hospital in the ICU. In an attempt to find out what went wrong, my family and I have studied this device and the company that manufactures it. We know that there is a problem with the device, the FDA's own adverse event database shows hundreds of injuries and many deaths related to it. We also know that the company is not doing what it should be doing to find out why these adverse events are happening.
Because of the Supreme Court's ruling, we probably have no legal recourse. We don't want to sue because we want to make money off of this, that thought is repulsive to us, we want to sue because we know that this medical device is being placed in people's bodies daily and they are reacting to it. This needs to be stopped.
So have a drink, and then another, and then another so that you can drown your guilt for the position you have placed my family and many other families in.

Anonymous said...

Be careful what you wish for--no individual or family member is immune from the ravages resulting from a defectively designed and/or manufactured drug or medical device. I guess it is not axiomatic that every person and entity shall be held accountable for the consequences of his,her or its actions. How ironic(tongue in cheek) that the individuals, who argue for less government involvement and deregulation of american industry,are the same individuals who are tripping over each other to kiss the FDA (hand) (that provides them with windfall profits), the under staffed, under funded and over worked federal agency entrusted with protecting America's most precious asset, the American citizen. And if a few of our citizens (for this purpose a few hundred, a few thousand, give or take multiple thousands)are injured, maimed or simply perish because they injested an approved medication that was supposed to cure them or improve their quality of life , what the heck,no one is perfect, certainly not the FDA.

Anonymous said...

FDA Science Board Advisory Committee Meeting
Table of Contents – (Edited to show only the statements on the conditions of the FDA)
Major Findings..........................................................................3
1.2.1 The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.........3
1.2.2 The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.............4
1.2.3 The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate................................5
2.1 Growing Disparity between Responsibilities and Resources.....9
3.1 Science: Capability, Capacity and Organization.......................20
3.1.1 Finding: FDA does not have the capacity to ensure the safety of food for the nation..............................................................21
3.1.2 Finding: The development of medical products based on “new science” cannot be adequately regulated by the FDA...................24
3.1.3 Finding: There is insufficient capacity in modeling, risk assessment and analysis.........................................................30
3.1.4 Finding: The FDA science agenda lacks a coherent structure and vision, as well as effective coordination and prioritization.......33
3.2 Workforce: Securing Critical Scientific Capability and Capacity38
3.2.1 Finding: The FDA has substantial recruitment and retention challenges.............................................................................40
3.2.2 Finding: The FDA has an inadequate and ineffective program for scientist performance.........................................................42
3.2.3 Finding: The FDA has inadequate funding for professional development..........................................................................42
3.2.4 Finding: The FDA has not taken sufficient advantage of external and internal collaborations...........................................43
3.3 Information Infrastructure.....................................................45
3.3.1 Finding: The Subcommittee believes that there is evidence of important, but slow, progress to improve information sciences and technology at the FDA over the past few years, yet significant gaps remain......................................................46
3.3.2 Finding: The FDA lacks the information science capability and information infrastructure to fulfill its regulatory mandate............47
3.3.3 Finding: The FDA cannot provide the information infrastructure support to regulate products based on new science.................................................................................49
3.3.4 Finding: The FDA IT infrastructure is obsolete, unstable, and lacks sufficient controls to ensure continuity of operations or to provide effective disaster recovery services............................50
3.3.5 Finding: The IT workforce is insufficient and suboptimally organized..............................................................................51

By their own admission the FDA is not able to do their job and we are suppose to depend on them to keep us safe?

Beck/Herrmann said...

Industry has consistently pushed for more funding and more authority for the FDA. Yet when industry even agrees to tax itself for the benefit of the FDA (ever seen lawyers agree to do that?), the plaintiffs' side criticizes user fees as some sort of conflict of interest.

What has the plaintiffs' side ever done to try to fix problems at the FDA? A big fat nothing. It's easy to sit around and criticize everyone. It's another thing entirely to try to make things better.

Anonymous said...

How will medical device preemption "fix problems at the FDA"? Have you ever heard of ACCOUNTABILITY? That's what will fix the problem. Congress, FDA and medical device companies have to be held accountable for what is presented to the public as safe and effective products. The only accountability that has been addressed with Riegel v Medtronic concerns the accountability of the medical device companies and that accountability has been taken away.Does anyone honestly believe that by removing the threat of lawsuits, medical device companies will be freed up to produce better products? What they will be freed up to do is to make more money with no concern for consequences that may occur if they place a dangerous product on the market.

Anonymous said...

"It did not do so, but instead wrote a pre-emption clause that applies only to medical devices."

scalia is saying that the device law doesn't apply universally to drugs.