It got hardly any attention in the blawgosphere at the time – aside from us, 360, and the hardcore Supreme Court junkies over at SCOTUSBlog (and even they buried it in the middle of a routine post) – but earlier this month the Supreme Court indicated interest in the certiorari petition from the Farm Raised Salmon case. They asked the Solicitor General for his views. See Albertsons, Inc., v. Kanter, No. 07-1327 (U.S. Oct. 6, 2008).
As we alluded to in those prior posts, Albertsons/Farm Raised Salmon is – or at least could be – of significant interest to those of us on the drug and device side of the FDA’s regulatory reach.
Because lurking beneath the food-specific aspects of the case, Albertsons/Farm Raised Salmon presents questions regarding the proper interpretation and application of the exclusive enforcement provision of the Food, Drug and Cosmetic Act (“FDCA”), 21 U.S.C. §337(a).
We’ve gone through Albertsons/Farm Raised Salmon before in some detail, so you’ll have to go there for the full skinny. For present purposes, we’ll only briefly review the bidding: (1) plaintiffs – so-called “private attorneys general” under the state consumer fraud statute – sued defendants alleging that they improperly used coloring agents in fish in violation of FDA food standards; (2) defendants said “you can’t do that” because §337(a) limits FDCA enforcement to the federal government; (3) the Supreme Court said “yes, they can” because: (a) 21 U.S.C. §343-1(a) allows state enforcement of FDCA violations in the food area, and (b) a private action for violating the state consumer fraud statute, incorporating the standards of California’s “little FDCA” statute (also known as the Sherman Act), which in turn just happens to incorporate the FDA’s food standards, is a matter of “state,” not “federal,” enforcement. In re Farm Raised Salmon Cases, 175 P.3d 1170, 1175, 1178, 1181-82 (Cal. 2008).
As far as §343-1(a) is concerned, maybe the salmon makers get eaten by the bears – or maybe not – it’s not our fight. But we’re very interested indeed in how the Solicitor General/DOJ/FDA, and ultimately the Supreme Court, might respond to item (2), that §337(a) limits FDCA enforcement to the feds, and item 3(b), that all it takes to get around §337(a) is for a state to “incorporate” FDCA standards verbatim.
We know from Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), that §337(a) has preemptive effect. But we’ve been pondering for some time exactly what kind of preemptive effect that is. Now, we think we’ve figured it out. The key is – surprise – what Buckman had to say about §337(a). And what the Court held is, first, §337(a) “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions” and, second, the provision is “clear evidence that Congress intended that the [statute] be enforced exclusively by the Federal Government.” Buckman, 531 U.S. at 349 n.4 (for the first quote), 352 (for the second).
In our prior post on Albertsons/Farm Raised Salmon we described §337(a) preemption as “really powerful – perhaps the most sweeping available. . .under the FDCA” and that “it essentially ousts all private litigation.”
We probably should have taken our analysis one step further, but that post was mostly about the California decision, not §337(a).
What does the Buckman language sound like?
Field preemption. A small field (limited to the enforcement of FDCA violations), to be sure, but a strategically situated one.
The classic definition of field preemption is that “state law is pre-empted where it regulates conduct in a field that Congress intended the Federal Government to occupy exclusively.” English v. General Electric Co., 496 U.S. 72, 79 (1990) (emphasis added). See, e.g., Sprietsma v. Mercury Marine, 537 U.S. 51, 64 (2002) (quoting English); American Insurance Ass’n v. Garamendi, 539 U.S. 396, 420 n.11 (2003) (“field preemption might be the appropriate doctrine. . ., without reference to the degree of any conflict, the principle having been established that the Constitution entrusts [the subject] exclusively to the National Government”) (emphasis added); Zschernig v. Miller, 389 U.S. 429, 442 (1968) (field preemption involves “a domain of exclusively federal competence”) (emphasis added). Field preemption has been found as a consequence of “overpowering federal policy in the civil enforcement provisions” of a federal statute. Rush Prudential HMO, Inc. v. Moran, 536 U.S. 355, 375 (2002), albeit a statute other than the FDCA.
The more we think about it, what §337(a) does is demonstrate Congress’ intent to carve out enforcement of the FDCA as a field from which state activity is simply excluded. Only the federal government can institute legal action to enforce allegations of violations of the FDCA:
Except as provided in subsection (b) of this section, all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.
21 U.S.C. §337(a). Food producers run into trouble with subsection b – which lists as exceptions a bunch of provisions (21 U.S.C. §§341, 343(b), 343(c), 343(d), 343(e), 343(f), 343(g), 343(h), 343(i), 343(k), 343(q), or 343(r)) relating to food.
Drug and device companies don’t have that problem, which – as we explained in our prior post – is why the California Supreme Court had to jump through all the hoops it did to avoid preemption.
So with this point in mind, we look at the defendants’ certiorari petition in Albertsons/Farm Raised Salmon. Because it’s filed by a food defendant, the petition naturally targets the disconnect between the “state” enforcement allowed by §337(b) and the “private attorney general” action permitted by the California Supreme Court.
But §337(a) is lurking through out. Right up front, in the statement of the case, the petition states: “When Congress enacted the FDCA in 1938, it deliberately and consciously rejected the possibility of private enforcement in favor of exclusive federal enforcement.” Petition at 3. That’s something we read as field preemption more or less. The petition goes on, necessarily, to discuss the 1990 food-related amendment, id., but for us drug/device types, we don’t have to worry about that. There’s a whole lot more:
From its inception in 1938, the FDCA was intended to be enforced by the federal government – and not by private parties. In fact, Congress considered and rejected a version of the statute that would have allowed a private right of action. [citations omitted] It opted instead for a provision mandating that “all” proceedings “for the enforcement, or to restrain violations” of the FDCA “shall be by and in the name of the United States.” 21 U.S.C. § 337. In keeping with its plan of exclusive federal enforcement, Congress afforded the Food and Drug Administration (“FDA”), the responsible federal agency, a wide range of enforcement options. . . . As part of its careful design, Congress also gave the FDA the power not to prosecute “minor violations of [the Act] whenever [it] believes that the public interest will be adequately served by a suitable written notice or warning.” 21 U.S.C. §336. Congress thus ensured that the federal government would decide whether and how to enforce the law.
Courts interpreting the FDCA’s enforcement framework before it was amended in 1990 held that Congress had deliberately excluded private claims by placing enforcement exclusively in the hands of the federal government, see, e.g., Pacific Trading Co. v. Wilson & Co., 547 F.2d 367, 370 (7th Cir. 1976) (“[T]he statute does not provide a cause of action for private parties suing for civil damages.”), even those claims brought under state law, see, e.g., National Women’s Health, 545 F. Supp. at 1181 (holding that a private right of action to enforce FDCA standards is “inconsistent with the federal regulatory scheme, whether the right is based in federal or state law”); Animal Legal Defense Fund Boston, Inc. v. Provimi Veal Corp., 626 F. Supp. 278, 283 (D. Mass. 1986) (same).
Cert. petition at 4-5, see also id. at 14-16 (more discussion of cases holding that §337(a) precludes various forms of private enforcement). Thus the petition takes the position that §337(a) in its original form – the form that applies to drugs and devices – precludes private FDCA causes of action and similar actions under both state and federal (usually Lanham Act) law. Again, that sounds like a field preemption argument to us.
And we know there are lots and lots more of these types of cases than just the few cited in the petition, because they’re in Bexis’ book. If we had infinite time, we’d cite them all, but we don’t.
There must be a couple hundred cases for the no-private-cause-of-action proposition. They’re in Bexis’ book §4.02 footnote 14.
Section 336, the “minor violations” provision cited in the petition, gives the government “rather broad discretion – broad enough undoubtedly to enable [it] to perform [its] duties fairly without wasting [its] efforts on what may be no more than technical infractions.” United States v. Sullivan, 332 U.S. 689, 694 (1948); see Bexis’ book §4.02 footnote 11.
Congressional preclusion of private enforcement “cannot be overstated” – because to allow courts to “provide remedies for violations of [the FDCA] solely because the violation of the federal statute is said to be a ‘rebuttable presumption’ or a ‘proximate cause’ under state law” would “flout, or at least undermine, congressional intent.” Merrell Dow Pharmaceuticals, Inc. v. Thompson, 478 U.S. 804, 812 (1986); see Bexis’ book §4.02 footnotes 42-47.
As for the Lanham Act:
[P]ermitting [plaintiff] to proceed on the theory that the defendants violated [the Lanham Act] merely by placing their drugs on the market would, in effect, permit [plaintiff] to use the Lanham Act as a vehicle by which to enforce the Food, Drug, and Cosmetic Act (“FDCA”) and the regulations promulgated thereunder. An attempt, by ingenious pleading, to escape one principle of law by making it appear that another not truly appropriate rule is applicable appears to have been attempted.
Mylan Laboratories, Inc. v. Matkari, 7 F.3d 1130, 1139 (4th Cir. 1993); see Bexis’ book §4.02 footnote 41.
Thus, we’ll be very interested in how the FDA and the Department of Justice interpret the preemptive effect of §337(a) generally – presumably before they get around to addressing the food-related aspects of the Albertsons/Farm Raised Salmon appeal.
We’re also interested in the other issue, whether FDCA-based violation claim can be “laundered” through a state statute so that it avoids §337(a) even though the state standards are substantively identical to the FDA’s standards. That issue is not treated in any great legal detail in the certiorari petition, but is preserved, with a footnote listing cases nationwide involving other state statutes where the same violation laundering could be attempted. Petition, at 23-26 & n.5.
Our view (not surprisingly, since we’re defense lawyers) is that substance controls – not form. The Congressional intent to preclude private enforcement that led it to insert an exclusivity provision in the FDCA cannot be so easily overcome by merely slapping a “state law” label on a federal standard. In this respect (and only in this respect), we think we’re helped by the language of the food provision, §343-1(a), which states, in pertinent part: “no State or political subdivision of a State may directly or indirectly establish. . . .” (emphasis added). Plainly, Congress wasn’t intending to allow states to do by indirection what they could not do directly under §337(a) – that is, to enforce FDCA standards.
The laundering of federal violation claims through state statutes incorporating those same federal standards verbatim is the same sort of “ingenious pleading” that courts such as Mylan Laboratories have already rejected in the Lanham context in cases where §337(a) fully applies. We think that, should it take the case, the Supreme Court would also be unlikely to view such slight of hand very indulgently.
So we’ll be very interested in what the FDA/DOJ has to say about this issue as well, when it responds to the Supreme Court’s invitation. The plot is only thickened by the two issues we’re following not necessarily being outcome determinative in this particular case. While it’s hard to see how the defendants in Albertsons/Farm Raised Salmon could prevail if the government took an unfavorable position on the exclusivity and violation laundering issues, it’s not that difficult to envision a brief where the government went our way on these two underlying issues, but still allowed food defendants to be sued purely on food-specific grounds.
We now come to the crux of the matter. We’ve told you that we’re very interested in these two issues that arise in Albertsons/Farm Raised Salmon. Now we’ll tell you why.
Recent preemption developments concerning drugs and devices have painted a great big target on §337(a)’s back in our area. In Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the Court apparently didn’t consider §337(a) when it decided that “parallel requirements” claims were not expressly preempted with respect to “substantially equivalent” medical devices:
Nothing in §360k denies Florida the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements. . . . The presence of a damages remedy does not amount to the additional or different “requirement” that is necessary under the statute; rather, it merely provides another reason for manufacturers to comply with identical existing “requirements” under federal law.
518 U.S. at 495 (emphasis added). “Identical” state requirements might be just peachy under 21 U.S.C. §360k, but if they amount to attempts at state enforcement of FDCA violations, then (we would argue) they fall smack within that narrow field preempted by §337(a).
The Court in Buckman recognized that §337(a) could be a barrier to the types of claims discussed in Lohr, but given all of the other things that it found wrong with fraud-on-the-FDA claims, the Court didn’t have to resolve the tension between “parallel” claims and FDCA enforcement exclusivity:
Notwithstanding the fact that [Lohr (the Court uses “Medtronic,” but there are so many Medtronic cases that we think the plaintiff name is less confusing)] did not squarely address the question of implied pre-emption, it is clear that the [Lohr] claims arose from the manufacturer’s alleged failure to use reasonable care in the production of the product, not solely from the violation of FDCA requirements, however, the fraud claims exist solely by virtue of the FDCA disclosure requirements. Thus, although [Lohr] can be read to allow certain state-law causes of actions that parallel federal safety requirements, it does not and cannot stand for the proposition that any violation of the FDCA will support a state-law claim. In sum, were plaintiffs to maintain their fraud-on-the-agency claims here, they would not be relying on traditional state tort law which had predated the federal enactments in questions.
531 U.S. at 352-53 (emphasis added). As we’ve discussed elsewhere and will not repeat here, Buckman thus disposed of the fraud-on-the-FDA claims because they were not “parallel” to anything in traditional state law, and thus did not have to resort directly to §337(a) preemption.
Then the Court in Bates v. Dow Agrosciences LLC, 544 U.S. 431, 447-48 (2005), took the “parallel requirements” concept from Lohr and applied it to a different statute (FIFRA) that didn’t have a counterpart exclusive enforcement provision like §337(a).
Then, through happenstance, the Court in Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), recognized express preemption of just about all claims against PMA medical devices except “parallel” requirements. The Court didn’t find that such claims necessarily escaped preemption, but only that plaintiffs waived the issue entirely. Id. at 1011.
To top everything off, as we’ve discussed, there are no “parallel” claims asserted in Wyeth v. Levine. Thus we don’t expect the Supreme Court to address that topic in the Levine case either. If our side wins in Levine, “parallel” FDCA violation claims would undoubtedly become more important on the drug side as well.
So, as anybody who follows drug/device preemption law knows full well, “parallel” claims involving claimed FDCA violations are one of the hottest topics around, especially on the device side, where for PMA devices they’re now just about the only game in town.
But just about all of those parallel precedential lines lead inexorably back to that narrow, but strategically situated field that, we believe, §337(a) reserves “exclusively” to actions brought by and in the name of the federal government. In short, under §337(a), the type of “parallel” violation claims that the Court in Lohr hypothesized might exist may well not exist at all, and certainly not in any great numbers.
That is, (1) if there’s field preemption, or something similar, created by §337(a)’s “exclusive” grant of FDCA enforcement to the federal government, and (2) private plaintiffs can’t avoid preemption by laundering FDCA violation claims through state statutes.
Those are precisely what we see as the sleeper issues that lurk in what, so far, has been a sleeper case.
And since those are two of the questions posed by the certiorari petition in Albertsons/Farm Raised Salmon, we will very interested indeed to find out how the Solicitor General addresses them when it the DOJ and (through DOJ) the FDA respond to the Supreme Court’s invitation.