We must have been a little asleep at the switch, because, several weeks ago, now, the Solicitor General, on behalf of the FDA, filed the government’s merits amicus brief in the Riegel v. Medtronic PMA express preemption case. We didn’t find out about it (and none of you told us – hey, we can whine like plaintiffs when we try) until yesterday. Anyway, since we’re big fans of medical device (and all kinds of) preemption, we’re happy – if belated – puppies.

Here’s a link to the SG’s Riegel merits amicus brief. As regular readers probably recall, the SG also filed an amicus brief at the petition stage as well. In our post about that earlier brief we mentioned (among others) the following arguments made by the government. Rather than repeat ourselves (and because we’ve already dissected the Kent amicus brief today, and we’re getting tired) we’ll simply give the new citations (if any) to the merits brief after the prior bullet points:

  • FDA pre-market approval (“PMA”) of a Class III device imposes preemptive federal “requirements” as meant by §360k(a) of the Medical Device Amendments (“MDA”) to the FDCA. Riegel SG/FDA Merits br. at 6, 11 (“FDA’s premarket approval gives specific content to those general requirements as applied to a particular device”), 24 (requirements “include the specific design and labeling requirements imposed as part of the PMA process”).
  • PMA is in no way comparable to the less rigorous form of marketing clearance at issue in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). Riegel SG/FDA Merits br. at 3, 7-11, 13, 22-23.
  • Lohr recognized the FDA’s “significant role” in defining the preemptive scope of the MDA and gave “significant weight” to the Agency’s construction of the statute (so the Court should listen to the government just as much here). Riegel SG/FDA Merits br. at 23-24.
  • PMA is the Agency’s judgment about the safety and efficacy of the device, and once PMA is granted, the manufacturer cannot make any safety-related changes to its device without a supplemental application requiring further FDA approval. Riegel SG/FDA Merits br. at 3, 13 (“respondent could not have lawfully marketed a product that deviated from the approved version nor made any changes affecting the safety or efficacy of the device, including labeling changes, without first submitting a supplemental application to FDA”), 15.
  • Common law product liability claims can impose “requirements” under §360k(a), Riegel SG/FDA Merits br. 16-19 (rejecting various arguments that would exclude state tort claims, generally, from preemption), and claims alleging that the PMA device is “defective,” would impose requirements “inconsistent’ with the FDA’s requirements imposed via PMA. Thus the conflicting tort claims are expressly preempted. Id. at 4-5, 7, 20-22.
  • FDA PMA involves rigorous review of the adequacy of product labeling/warnings. Riegel SG/FDA Merits br. at 12-14, 22.
  • FDA’s “current judgment” reflects the withdrawal of the proposed rule that was the basis for the Agency’s contrary position in an amicus brief (Kernats) filed with the Court in 1998. Also, the FDA has adopted different risk-management principles since 1998. Riegel SG/FDA Merits br. at 24.

So what did the government say that was new in Riegel? Some pretty interesting stuff, it turns out, much of which can be of use on the drug side of the preemption wars. For example, the government challenges the same kind of “these are only minimum standards” argument that plaintiffs commonly make in drug cases – and it specifically cites to the NDA standards that apply to drugs in making the argument:

Contrary to petitioners’ contention that FDA reviews devices only for “minimum standards” of safety and effectiveness, the MDA directs FDA to weigh any probable benefit to health from the use of the device against any probable risk of injury or illness from such use. Under that standard, FDA conducts a risk-benefit analysis to determine whether safety risks (whatever their magnitude) are warranted in light of the potential benefits. FDA’s risk-benefit balancing for devices is parallel to the risk-benefit balancing it undertakes pursuant to 21 U.S.C. 355(d) as part of the pre-market approval process for drugs.

Riegel brief at 11 (emphasis added). Of course, this isn’t anything that the FDA hasn’t said directly about the plaintiffs’ “minimum standard” canard in the Final Rule, but if the Supreme Court were to accept the analogy while deciding Riegel, that would go a long way to interring the drug regulation as “minimum standards” point once and for all.

There’s another area where the government has offered views, that if analogized to the drug area, would be exceedingly helpful to defendants’ preemption positions. Probably the most commonly advanced argument against preemption is that the FDA’s “changes being effected” regulation (21 C.F.R. §314.60(c)(6)) defeats preemption because it allows manufacturers to strengthen warnings in advance of any FDA approval. Well, government in Riegel construes (in a regulatory construction that’s entitled to considerable deference from the courts) a similar regulation governing devices (21 C.F.R. 814.39(d)) narrowly – but we believe properly – as involving only “new” information:

While petitioners argue that applicants may make some changes without prior FDA approval, that is true only in very limited circumstances that do not appear to apply here. Some changes in labeling. . .may go into effect before FDA review if they enhance the safety of the device. [citing regulation] As FDA recently explained. . ., however, even those types of changes may be made without prior FDA approval only if the manufacturer has newly acquired safety-related information that was not previously considered by the FDA. Unilateral changes based on information available at the time of FDA’s approval could upset FDA’s balance of health risks and benefits, and thus undermine the PMA process. Indeed, it would make little if any sense to permit unilateral changes immediately following FDA’s approval based on the same information that FDA had already considered.

Riegel br. at 13-14 (citations and quotation marks omitted) (emphasis added). The government goes on to argue that changes affecting both safety and efficacy can’t be made without pre-approval, id. at 14, but the citation suggests that this particular point is device-specific.

We’ve previously advocated precisely this type new/emergent-information limitation on the drug CBE regulation, and we’re pleased to see the government making basically the same argument in the device field. We think this point is precisely right, because CBE-type regulations should not be construed so that the minor exception they provide to the FDA pre-approval requirement of 21 U.S.C. §355(a) is not misconstrued to swallow the rule.

Also as to pre-approval changes, the government strongly asserts that they do not affect the FDA’s ultimate control about what goes into the label:

[I]n any event, the statute and regulations vest in FDA, not States or juries, the authority to accept or reject the changes, whether or not the manufacturer has put them into effect in the meantime.

Riegel br. at 14.

Along the same lines, the government makes the same overwarning/overdeterrence arguments in Riegel that we’ve come to know and love on the drug side since the 2006 Final Rule. Br. at 12-13. Again, since the government specifically analogizes to drugs, any adoption of the argument by the Supreme Courts helps out on the drug side as well.

More generally, the government makes useful statements about the effect of state tort litigation upon FDA safety and effectiveness determinations – the same standard used by the Agency to approve drugs:

Permitting a state jury to impose liability on the basis that a device FDA found to be safe and effective is not safe or effective would clearly interfere with the agency’s ability to utilize the premarket approval process to balance the risks and benefits of Class III medical devices. . . . [P]remarket approval reflects FDA’s expert determination that a device is on balance beneficial to human health, and therefore should be on the market. In such circumstances, a jury’s imposition of liability based on a device’s FDA-approved design or label would interfere with the balance struck by Congress in the MDA, and by FDA in approving the particular device.

Riegel br. at 21. While the language is wonderful for makers of PMA devices, drug defendants need to be careful, because it’s rather broader than the six specified preemption areas that the FDA identified in the 2006 Final Rule – probably due to the difference between express preemption in devices and implied preemption in drugs.

We’ve also seen in some litigation (especially in states that require alternative design as an element of a products claim), claims that seek to compare a particular drugs unfavorably to others in their class – and arguing that they’re “defective” because other drugs are “safer.” There’s a discussion in the government’s brief that gives some indication that the FDA’s approval process already takes such comparisons into account, and thus correspondingly implies that FDA approval means that such negative comparisons to other drugs were necessarily considered and rejected by the FDA:

In determining whether benefits outweigh risks, FDA may also consider the availability of other drugs, devices, or courses of treatment, as well as their safety profiles. . . . FDA “must determine if each new drug or device is safe enough in view of its anticipated benefits and the comparative benefit of other available treatments. . . . If similar, safer products are on the market, the agency requires a heightened health benefit to justify the heightened risk.

Riegel brief at 12. It’s a bit of a stretch, but since there was very little along these lines before….

Useful device-specific preemption points include: (1) The FDA does more than just rubber-stamp approve submitted designs, but rather can (and frequently does) “condition” approval on specific design changes being made.” Id. at 14-15. (2) The evolution of the MDA’s express preemption provision suggests that it was expanded from types of “requirements” that would not include common law, to “any requirement” that does encompass state tort claims. Id. at 19. (3) Why PMA preemption is different from Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005) – because of the express safety and effectiveness determinations made by PMA. Riegel br. at 25-26. (4) Arguments that state law escapes preemption when it applies to things other than just devices incorrectly read the statute, are “illogical” in practice, and cannot be reconciled with Lohr. Id. at 26-30. (5) The presumption against preemption does not defeat preemption. Id. at 30.

As you can tell, we’re quite in agreement with the government’s arguments in Riegel. No real surprise there. As for why it’s important enough to devote an entire relatively long post to what’s after all just a brief, read our earlier post, where we explain a little bit about administrative deference principles and agency amicus briefs. When the government does it, it’s more than just a brief.