A little like one of those peanut-shaped asteroids, today’s post cobbles together a couple of recent developments that, other than having relevance to the FDA, do not have all that much in common.
The first deals with a recent Supreme Court decision that doesn’t even have anything to do (directly) with the FDA. In Perez v. Mortgage Bankers Ass’n, No. 13-1041, slip op. (U.S. March 9 2015), the Court overturned a D.C. Circuit gloss on the Administrative Procedures Act that purported to require administrative agencies generally (which is where the FDA comes in) to go through notice and comment rulemaking whenever they flip-flop on what is a mere “interpretive” rule. The Court shot that down, giving a significant win to the government. Slip op. at 9 (“In the end, Congress decided to adopt standards that permit agencies to promulgate freely such rules − whether or not they are consistent with earlier interpretations.”).
In the short term, that means that the FDA can change its interpretive rules – those that, like Guidance Documents, do not purport to have force of law – essentially when and how it likes (not exactly, but close enough for non-government work).
The longer term is more interesting. Three justices concurred in Perez with the caveat that the entire edifice of judicial “deference” to the views of administrative agencies needs to be re-examined. The concise words of Justice Alito are indicative:
The creation of that doctrine may have been prompted by an understandable concern about the aggrandizement of the power of administrative agencies as a result of the combined effect of . . . (3) this Court’s cases holding that courts must ordinarily defer to an agency’s interpretation of its own ambiguous regulations. I do not dismiss these concerns, but the [D.C. Circuit’s gloss] is not a viable cure for these problems. At least one of the three factors noted above, however, concerns a matter that can be addressed by this Court. The opinions of JUSTICE SCALIA and JUSTICE THOMAS offer substantial reasons why the Seminole Rock [deference] doctrine may be incorrect. I await a case in which the validity of Seminole Rock may be explored through full briefing and argument.
Slip op. at 1-2 (Alito, J. concurring). As Justice Alito indicates, the other two concurring opinions in Perez question administrative deference at greater length.
Given: (1) the very poor quality of the FDA’s cost-benefit analysis (described at length in the earlier posts); (2) the proposal’s very questionable statutory basis; (3) the numerous reversals of prior FDA positions (on confusion by dissimilar warnings, interpretation of the statute, and influencing civil litigation via its regulatory actions); and (4) disclosure of the FDA’s secret contact with the plaintiffs’ bar (also described in our earlier posts), it strikes us that, should the FDA go through with its generic warning proposal, the resultant litigation could very well provide Justice Alito’s “case in which the validity of Seminole Rock may be explored.”
Perez at least potentially places one more boulder in the already rocky course of the FDA’s generic warning proposal, and one more reason why the FDA might eventually get cold feet.
The other half of our peanut-shaped asteroid is Ouellette v. Mills, 2015 WL 751760 (D. Me. Feb. 23, 2015). Bexis’ book currently states, “[f]ield preemption has not been applied to FDA regulation of drugs and medical devices.” Beck & Vale, “Drug & Medical Device Product Liability Litigation Deskbook §5.01, at 5.02-1 (Law J. Press Supp. 2014). After Ouellette that has to change.
More generally, we keep our eyes open for unusual situations that might produce useful preemption rulings. We’ve already blogged about Massachusetts’ ill-fated effort to prohibit marketing of an FDA-approved drug. We’ll also be watching state attempts to force labeling about GMO (“genetically modified organisms” – heck, cats and dogs are GMOs) ingredients in foods, since the FDA doesn’t require such labeling.
The Ouellette case is about the state of Maine’s attempt to allow free importation of prescription drugs purchased in Canadian pharmacies. That Maine would be in the forefront of this effort is not surprising, since it’s surrounded on three sides by Canada, and thanks to Canada’s nationalized health system, drugs are much cheaper across the border.
However, the FDA doesn’t allow importation of drugs that aren’t labeled for sale in the American market. As a result, the plaintiffs in Ouellette (pharmacies in Maine whose ox had been gored) argued that Maine’s state statute was preempted. They won. In fact, they won big. The court held that, because of the international aspect of the FDA’s regulations, there was blanket field preemption of competing state law:
The importation contemplated, but not yet allowed, under the [part of the FDCA pertaining to importation of foreign pharmaceuticals], together with the complex regulatory system established by the FDCA’s drug approval, labeling, and packaging provisions, demonstrate a clear Congressional intent to tightly control prescription drug importation. Based on the foregoing, the Court concludes that the FDCA occupies the field of importation of pharmaceuticals from foreign countries.
Ouellette, 2015 WL 751760, at *7 (footnote omitted). How might this be useful? For one thing, plaintiffs sometimes attempt (usually unsuccessfully) to admit evidence of foreign regulatory activity – usually pertaining to labeling. See our “Foreign Regulations” blog topic. Our side’s usually successful evidentiary objections now may well have a preemption argument to back them up. There are FDA-labeled drugs and drugs from other countries, and ne’er the twain shall meet.
Ouelette is also useful because not only does it refuse to apply a presumption against preemption, it applies a converse presumption in favor of preemption, again because of the foreign aspect of the FDA’s regulatory scheme.
This presumption in favor of preemption where a state legislates in the traditional federal area of foreign affairs is based in part on a need for federal uniformity regarding foreign commerce, which is “pre-eminently a matter of national concern.” If Congress has spoken with respect to foreign commerce, any state law that compromises the uniformity of that federal directive must be carefully scrutinized. When undertaking preemption analysis, courts may evaluate whether the aim of the state law is to affect an area of federal regulation or interest.
Id. at *5 (citation omitted). How might this help our preemption arguments in product liability? We’re not entirely sure, but we are aware of cases in which plaintiffs residing in other countries have attempted to sue in American courts over injuries suffered in their home countries. We’ve usually fought these on forum non conveniens grounds (see the blood factor concentrate cases in Illinois for example), but perhaps preemption might also help. In any event, a lot of prescription medical product liability litigation exists, and we can’t possibly know the ins and outs of every situation. Part of what we try to do is provide tools for our colleagues in the defense bar to figure out how to use.
If nothing else, we know that in PLIVA v. Mensing, 131 S. Ct. 2567 (2011), the Court split 4-4 (with Justice Kennedy expressing no opinion) on whether there should be a presumption in favor of preemption in product liability cases, as opposed to the presumption against preemption last applied in Wyeth v. Levine, 555 U.S. 555 (2009). If that tie were to be broken in our favor, then Ouellette is some indication how a brave new preemption world might work.
So those are the two halves of our peanut-shaped FDA post. Nothing earthshattering, but both cases should give creative defense lawyers useful ideas.