We’ve been following the long migration of Farm Raised Salmon for some time now. Our prior posts on the California Supreme Court’s decision and on the Supreme Court’s request for the government’s views on the defendants’ certiorari petition are here, here, here, and here, respectively.

While Farm Raised Salmon is a food preemption case, it does involve some analogous issues. Our last post speculated on two such issues: (1) how much of a barrier to state-law litigation is 21 U.S.C. §337(a), granting exclusive FDCA enforcement authority to the federal government, and (2) assuming that the first issue is not dispositive, what kinds of “parallel” state-law claims are allowed by §337(a), and thus by implication, the Supreme Court’s decisions in Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005), Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), and Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).

We described these as “sleeper” issues, and indicated that we would be very interested in what the government (the Department of Justice representing the FDA) was going to say about them in the amicus brief that the Supreme Court requested.

Well, the government filed its brief recently – and it seems that the issues are still sleeping. Nobody – not even (as far as we can tell) the Supreme Court junkies over at SCOTUSblog – has had anything to say about the government’s amicus brief in Albertson’s, Inc. v. Kanter, No. 07-1327 (filed Dec. 12, 2008), since it was filed last Friday. Heck, we didn’t even know it had been filed until this morning.

All this means is that, once again, we’ll be filling a much-needed gap in the blogosphere.

So what did the government have to say about these two issues we’d spotted? Briefly: (1) not much, and (2) really, really parallel.

Split decision.

Bottom line is that the DoJ/FDA thinks that the California Supreme Court’s result in Farm Raised Salmon was correct, and that the U.S. Supreme Court should not grant an appeal. Amicus br. at 1.

The Government’s Position On §337(a)

As for §337(a), the government’s position is essentially, as long as the state-law claims actually are “parallel” (more to say about that in a bit) it’s open season for state litigants (including private state-law litigants) to bring actions that enforce standards “identical” to those set by the FDA. As a practical matter, that shouldn’t be all that surprising, we suppose. As we’ve discussed before, to make preemption work generally requires a strong administrative regime. And given some of the legitimate (we discount the self-interested bleatings of our litigation opponents) criticism the FDA has received recently, from an administrative perspective, it probably makes sense to enlist the help of states (and private attorneys general) that are willing to be of service – as long as the FDA ability to call the tune isn’t jeopardized.

Still, we had hoped for better as to §337(a) itself – outside of the food area, where a subsequent amendment specifically authorizes a state role.

The DoJ/FDA amicus brief starts off (pp. 8-11), appropriately enough, with a discussion of 21 U.S.C. §341-1, the statutory savings clause for food, which effectively amended §337(a)’s exclusive jurisdiction language to provide for a limited degree of concurrent state enforcement in the food area. We’re not going to get into that because we’re drug and device guys and all we know about seafood – well, when we see food, we eat it.

Yeah, we know…. our humor smells like a dead fish, doesn’t it?

What’s of more interest to us is the government’s position on §337(a) itself. The DoJ/FDA summarized that position:

Although 21 U.S.C. 337 precludes private actions to enforce the FDCA itself, Section 337 does not prohibit private actions to enforce parallel state requirements. A particular state-law suit might, in certain circumstances, impliedly conflict with provisions of the FDCA, implementing regulations, or a particular determination or enforcement action by FDA, but respondents’ suit poses no such conflict.

DoJ/FDA amicus br. at 8.

The government then addressed §337(a) itself – in the context of a defense argument that we suppose they had to make about the exclusivity purpose of this section effectively trumping the later addition of §343-1. The DoJ/FDA took the position that §337(a) is limited to prohibiting private actions directly under the FDCA, and does not restrict “identical” state-law cause of action:

Section 337 “applies only to proceedings to enforce the [FDCA. . .and] does not prohibit a State from enforcing an identical State law.” Similarly, Section 337 does not prohibit a State from authorizing private suits to enforce such a law.

DoJ/FDA amicus br. at 12 (quoting 58 Fed. Reg. at 2458 (1993)).

The government maintains a distinction between actions under the FDCA itself (prohibited §337(a)) and state law actions (not reached by §337(a)) even where those actions enforce “identical” standards. DoJ/FDA amicus br. at 12-13. Thus, the California statute (which “directly incorporate[d] regulations promulgated under the FDCA,” id. at 3) remained an action under “state” law even though all of the substantive standards were federal:

Actions to enforce state laws that impose requirements identical to those under the FDCA are not actions to enforce the FDCA itself. . . . Respondents’ suit can be resolved with reference to state law alone. . . . Although [the California] requirement mirrors the FDCA’s requirement. . .respondents can prove that petitioners violated the [California] Law requirement without even referring to the FDCA.

Id. at 12-13. It’s pretty clear that the DoJ/FDA ain’t buying what we once characterized as the “maximalist” preemption position with respect to “parallel requirements” litigation.

The government viewed the California claims as not preempted by §337(a) because they were the sort of “parallel requirements” claims discussed in Lohr: involving substantive federal standards to which non-substantive state-law elements (“such as damage or injury as a result of the violation”) were appended. DoJ/FDA amicus br. at 14 & n.2. Neither Lohr nor Riegel, the government argues, could have been decided the way they were had §337(a) “imposed a blanket prohibition on such claims.” Id. at 15.

As defense lawyers, we have some problems with this analysis, but those problems are primarily practical. We’ve simply seen enough purportedly “parallel” claims that aren’t, that we tend to doubt that it’s even possible for private litigants to confine themselves to merely echoing the FDA’s dictates. Inevitably, they add (or subtract) something in the governing regulations. It’s such a pervasive phenomenon that it’s probably inherent in any situation where the government isn’t actually doing the enforcing.

We’d much prefer to cut off problems with non-parallel “parallel requirements” at the source, by reading §337(a) to preclude, in the first instance, anybody else from intruding upon what the Supreme Court described in Buckman as the FDA’s “exclusive” enforcement authority. 531 U.S. at 352.

But we can’t help Lohr – because we didn’t invent the §337(a) argument until what ultimately became Buckman.

Still, for the most part, those practical problems could also be addressed (if less efficiently) through strict adherence to the FDA’s definition of “parallel requirements,” which we will be discussing shortly (pain before pleasure).

But there’s one point where the government simply takes an ex cathedra position – one with no support whatever – that seems to us quite unwarranted. That occurs on pages 16-17 of the DoJ/FDA amicus brief, where the government states:

If Section 337(b)’s restrictions on a State’s direct enforcement of the FDCA itself do not preempt or otherwise restrict a State’s enforcement of its own parallel state requirements, then it follows that Section 337(a)’s restrictions on private enforcement of the FDCA likewise do not preempt a State from allowing private suits based on those parallel state requirements.

To us, one doesn’t follow the other. Congress often permits concurrent enforcement of federal law by the states themselves, and sometimes even mandates it. But opening things up to enforcement by an unending stream of difficult-to-control private entities – well, when Congress intends that (and it has on quite a number of occasions), it says so. Here, the government doesn’t cite anything authorizing private, non-state actors to sue, because there isn’t anything.

It’s not that the “interest in uniformity” is “unyielding. DoJ/FDA amicus br. at 17. Of course it can yield – it has here, as the government properly points out, with §343-1 (and with §337(b)). But that’s the way it should be done, through act of Congress. Otherwise, §337(a) really has no purpose except keeping cases out of federal court that probably (since they involve allegations that federal standards have been violated) should be there. Section 337(b) explicitly recognizes a state role. There’s nothing in the FDCA recognizing a private enforcement role – and nothing in the legislative history of the act (because the government would have cited it) that Congress had any idea that any state would do what California has done and pass a statute generally allowing private suits under other statutes (such as California’s little FDC (“Sherman”) act).

The Government’s Position On “Parallel Requirements”

That’s enough pain.

One thing we can say, if the government’s position on §337(a) were accepted, then defense counsel are going to have to become a lot more familiar with purely state-law grounds for restricting statutory violation claims, such as these:

  • Violation claims are improper where inconsistent with legislative intent – particularly the intent (identical to the undisputed intent of §337(a)) that statutes not include private causes of action.
  • Violation claims are improper where they would impose novel duties (like reporting adverse product experience to the government) not analogous to the common law.
  • Violation claims are improper where the alleged violation was of something lacking full force of law (such as an FDA guidance document).
  • Violation claims are improper where the enactment that was violated imposed only vague or imprecise standards (like the misbranding/adulteration sections of the FDCA).
  • Violation claims are improper where only a licensing requirement is involved (particularly important in off-label use cases).
  • Violation claims (in some states) are only permitted for violations of statutes, and not for violations of administrative regulations.

As a primer on these points we offer our prior post, “Defenses to FDCA-Based Negligence Per Se.”

Beyond that, we also recommend what the DoJ/FDA amicus brief has to say about what an unpreempted “parallel requirements” case really is – because if “parallel” isn’t really parallel, the government is quite clear that implied conflict preemption is proper:

[P]rivate suits under state law to enforce state food-labeling requirements that parallel FDCA requirements do not necessarily pose a conflict with the FDCA or its enforcement scheme. . .[but u]nless the state requirement is “identical” to the federal requirement, or the statute or FDA grants an exemption, the state-law suit will be preempted.

Id. at 17 (emphasis added).

Language like that leaves us pretty well satisfied with what DoJ/FDA have to say about the scope of “parallel requirement” litigation for purposes of preemption. The Government equates the statutory savings clause for food, 21 U.S.C. §341-1, with what the Supreme Court has called “parallel requirements” in preemption cases since Lohr. Substantively, a “parallel” action cannot do anything beyond enforcing what the FDA has already decided. These are:

private actions to enforce state requirements that mirror FDCA requirements [in] accord[ance] with this Court’s interpretation of similar preemption provisions. In Lohr, the Court construed 21 U.S.C. 360k. . . . The Court concluded that Section 360k does not preempt “State or local requirements that are equal to, or substantially identical to, requirements imposed by or under the [FDCA].” 518 U.S. at 496-497 (emphasis added).

DoJ/FDA amicus br. at 10. The government goes on to cite discussions of state “parallel requirements” litigation in Riegel and Bates – particularly the Bates language describing such litigation as involving claims “equivalent to, and fully consistent with” pre-existing government standards. Id. at 11 (quoting Bates, 544 U.S. at 447).

Thus, the government takes a firm position that purportedly “parallel” claims that weren’t really parallel are subject to implied conflict preemption regardless of either §§343-1 or 337(a). DoJ/FDA amicus br. at 10 n.1 (citing government position in Wyeth v. Levine).

Thus, whenever a plaintiff bringing a supposedly “parallel requirements” action seeks to play fast and loose with how the FDA has interpreted a regulation, the claim should be preempted:

Even a suit to enforce an identical state requirement would be preempted if the particular suit actually conflicted with provisions of the FDCA, implementing regulations, or an administrative determination or enforcement action by FDA.

DoJ/FDA amicus br. at 18 (emphasis added).

Thus the DoJ/FDA effectively adopts our “third argument” in support of preemption of “parallel requirements” litigation – that purportedly “parallel” claims must be “genuinely” parallel (phrasing from Bates, 544 U.S. at 454) or else cannot escape preemption. Importantly, the government explicitly states that the requirement of actual parallelism applies to both formal and informal FDA decisions – not just the statute, not just FDA regulations – but also to FDA “administrative determinations” and “enforcement actions.” Id.

To us, it’s in the informal, day-to-day enforcement activity of the FDA that’s where the rubber figuratively meets the road in “parallel requirements” cases. Plaintiffs routinely misconstrue the FDCA and FDA regulations (such as good manufacturing practices) to invent requirements that aren’t there or to twist those that are. Given what we’ve seen, so as long as preemption strictly enforces the FDA’s own reading of the regulatory scheme it administers, then we wouldn’t be surprised if 90% of all purportedly “parallel requirements” claims end up preempted. Medical device cases, where “parallel requirements” claims have been litigated the longest, provide support for this notion. See, e.g., McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005) (“[w]here a federal requirement permits a course of conduct and the state makes it obligatory,” the state requirement is no longer parallel and “is preempted”); Kemp v. Medtronic, Inc., 231 F.3d 216, 230 (6th Cir. 2000) (supplemental premarket approval “d[id] not include” the requirement asserted by plaintiff; to permit liability for purported non-compliance with an incorrectly stated FDA requirement “would be to impose a requirement different from and in addition to those established by the FDA”); Parker v. Stryker Corp., ___ F. Supp.2d ___, 2008 WL 4716879, at *4 (D. Colo. Oct. 22, 2008) (state-law claims “not saved merely by being recast as violations of the federal adulteration and misbranding statutes”; dismissing vague violation claim for lack of “factual detail to substantiate that crucial allegation”); Clark v. Medtronic, Inc., 572 F.Supp.2d 1090, 1095 (D. Minn. 2008) (“[b]ecause plaintiff’s claims are not based on a breach of the [statute] as enforced by the FDA, the claims are not grounded in state laws that ‘parallel’ federal requirements”). Surviving claims would probably encompass little more than situations where the FDA had actually prosecuted a violation based upon its own reading of its regulations. Cf. Purcel v. Advanced Bionics Corp., 2008 WL 3874713, at *1 (N.D. Tex. Aug. 13, 2008) (parallel claim stated based upon FDA violation letters).

Beyond device cases, we’ve collected food, pesticide, and other precedent reaching similar conclusions, here.

And on this critical point, it turns out that the government even goes us one better. The DoJ/FDA demand for actual parallelism applies to matters of remedy as well. Thus, even where the FDA has itself found a violation, a plaintiff cannot allege that the product at issue should have been recalled where the FDA did not order a recall. DoJ/FDA amicus br. at 18 (private plaintiffs cannot demand recall where, due to “negligible” risk, FDA enforcement was limited to a prospective label change). See Cupek v. Medtronic, Inc., 405 F.3d 421, 424 (6th Cir. 2005) (“[a]ny claim. . .that Defendant. . .failed to recall a product” would “not parallel federal safety requirements” and was preempted).

We’ve made the same point ourselves in some of our prior discussions of “parallel requirements” claims, most thoroughly, here. We’re pleased indeed that the government essentially agrees with us that the “parallel” element of a “parallel requirements” claim must be strictly enforced, and that divergent claims unlike those in in Albertson’s (brought under a state statute that outright incorporated relevant FDA standards) would be preempted.

Thus the DoJ/FDA amicus brief both giveth and taketh away. It doesn’t go for the broad §337(a)-based preemption argument that we’ve advocated as a basis for eliminating altogether state-law actions that are functionally no different than private attempts to enforce the FDA. But the government does adopt the arguments we’ve made that “parallel requirements” claims must be “identical” and “genuinely” parallel in order to escape preemption. While we wouldn’t have made that swap (it’s cheaper to win on a motion to dismiss than on summary judgment), we’re not looking to jump out of any windows either.