Two recent cases, one good and the other not, have us thinking about the presumption against preemption in the context of “parallel” claims – that would be medical device preemption – and allegations of fraud on the FDA, which could be either.  We think it would be a good idea for defense counsel to review first principles.

The good case, about which we’ve already blogged in one of our “hey, look at this” posts, is Bass v. Stryker Corp., 2010 WL 3431637 (N.D. Tex. Aug. 31, 2010).  The not-so-good case, which just turned up the other day, is Stanley v. Mylan, Inc., slip op., 2010 U.S. Dist. Lexis 97939 (D. Utah Sept. 17, 2010) (because it has a service cite, we feel comfortable discussing it).  The first (Bass) struck us in not mentioning the presumption against preemption at all.  The second (Stanley) struck us for just the opposite reason – that case didn’t discuss very much else (in the relevant section, anyway – there’s other stuff in Stanley that we’re not concerned with here).

Bass was a PMA medical device case, and the primary preemptive focus was, of course, express preemption as posited by Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  However, as is common in these cases – as our medical device preemption scorecard addresses – there are also so-called “parallel violation” claims.  The court in Bass threw them out, finding that they were simply disguised attempts at private enforcement of the FDCA, which is prohibited by the express terms of the statute:

[E]ven if Plaintiff’s state-law claims are premised on Defendants’ alleged failures to comply with federal requirements, those claims are nevertheless preempted because the FDCA and FDA regulations do not provide a private cause of action.  See Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 349 n.4 (2001).  It is on this point that the Court allowed additional briefing.  Section 337(a) has been held to impliedly preempt private claims based on its language that “all proceedings for the enforcement or to restrain violations of the FDCA ‘shall be by and in the name of the United States.’”  In re Medtronic, Inc., 592 F. Supp.2d 1147 (D. Minn. 2009) (discussing Buckman).  Thus, although the Supreme Court in “Riegel expressly recognized that ‘parallel’ claims – that is, claims ‘premised on a violation of FDA regulations’ – are not preempted [under § 360k(a) ],” a plaintiff’s characterizing his claims as parallel would be no response to a preemption argument under §337(a).  See id. 1160-61 & n. 17.

Generally, therefore, a plaintiff cannot get around the absence of a federal private right of action by invoking state law.  The Medtronic court, however, recognized two potential exceptions. . . . Under the first exception . . . a properly pleaded claim alleging a failure to adhere to PMA specifications could avoid preemption completely.  Id. . . .  [T]he persuasiveness of the reasoning behind this exception is diminished considering that, under Buckman, a claim that is “parallel” – and thus not preempted by §360k(a) – is nevertheless preempted by §337(a)’s language giving the United States the exclusive right to enforce the FDCA.  Buckman, 531 U.S. at 349 n. 4. . . .

Under the second exception of In re Medtronic, a state statute may itself create a cause of action for violations of the FDCA.  In re Medtronic, Inc., 593 F. Supp.2d at 1161 n.17.  Here, however, even after additional briefing, Plaintiff has not cited any such statute.  The only state statute that Plaintiff has mentioned is the Texas Deceptive Trade Practices Act, which does not provide a private cause of action for FDCA violations.  Consequently, sections 337(a) and 360k(a) work in combination to preempt Plaintiff’s claims.

Bass, 2010 WL 3431637, at *5 (citations other than Buckman, Riegel, and Medtronic omitted).

Nice, clean result (a little off as to the “state statute” exception, as that is limited to exceptions recognized in §337(b), but that’s irrelevant today).  The entire discussion of implied preemption under Buckman, however, occurred in Bass without any reference to the presumption against preemption.  After Wyeth v. Levine, 129 S. Ct. 1187 (2009), we think that’s a potentially dangerous omission.  As we’ll discuss below, there’s no reason not to confront the presumption in a §337(a) case.

The other extreme is Stanley.  Perhaps because Stanley involved a drug rather than a device, the court was as fixated upon Levine and the presumption against preemption as Bass seemed oblivious.  Conversely, the Stanley court ignored §337(a) altogether, although it’s equally applicable to drugs and devices (just as is Buckman).  The presumption was essentially the only reason given for not finding a statutory fraud-on-the-FDA exception to punitive damages not preempted under Buckman:

In the case presently before the Court, Defendants invoke the Utah statute in seeking a dismissal of the punitive-damages claim.  Plaintiffs argue that Subsection 2 of the statute allows them to pursue punitive damages because they allege that “Defendants knowingly withheld or misrepresented information required to be submitted to the [FDA] under its regulations.”  The Court finds [that] . . . given the intervening Supreme Court decision in Wyeth [it] will allow the claim to proceed to discovery.  The Court notes that the effect of Wyeth is to strengthen the presumption against preemption that was weakened in Garcia [v. Wyeth-Ayerst Laboratories, 385 F.3d 961 (6th Cir. 2004)]. . . .  Defendants now before the Court offer no evidence that Congress intended to preempt the Utah statute.  Therefore, the presumption against preemption holds, and Plaintiffs should get the chance to prove the elements of their claim.  Consequently, Defendants’ Motion to Dismiss as to this claim is denied.

Stanley, 2010 U.S. Dist. Lexis 97939, at *24-25 (other citations omitted).  That’s not a presumption – that’s a talisman – the way that the Stanley court invokes it.

Neither case really analyzes the presumption against preemption in light of the specific types of claims involved, so we’ll give it a shot.  We’ll go right to the source and start with Levine, since, as the Stanley court correctly indicates, that’s the most recent of the relevant precedents.  Here’s how Levine describes the basis for the presumption against preemption:

[I]n all pre-emption cases, and particularly in those in which Congress has legislated in a field which the States have traditionally occupied, we start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.

129 S. Ct. at 1194-95 (all internal quotations – and there were a lot – omitted).

The three predicates for the presumption against preemption, according to Levine, are thus:  (1) “a field which the States have traditionally occupied”; (2) “the historic police powers of the States”; and (3) a “clear and manifest purpose of Congress.”  We call this the “Levine tripod” – standing for the three legs that support the presumption against preemption in the case.

We’d also be remiss if we ignored the footnote that follows what we just quoted.  That footnote did two things.  First, it rejected an attack on the “traditional occupation” prong of the presumption based upon the length of FDA drug regulation:

[Defendant] argues that the presumption against pre-emption should not apply . . . because the Federal Government has regulated drug labeling for more than a century.  That argument misunderstands the principle:   We rely on the presumption because respect for the States as independent sovereigns in our federal system leads us to assume that Congress does not cavalierly pre-empt state-law causes of action.  The presumption thus accounts for the historic presence of state law but does not rely on the absence of federal regulation.

129 S. Ct. at 1195 n.3.  So the existence of concurrent federal regulation doesn’t oust presumption where the topic is something that the states have “historic[ally]” done.

Second, and probably more importantly for our purposes, the footnote distinguishes Buckman as to the applicability of the presumption:

The dissent’s reliance on Buckman. . ., is especially curious, as that case involved state-law fraud-on-the-agency claims, and the Court distinguished state regulation of health and safety as matters to which the presumption does apply.  See 531 U.S. at 347-348.

129 S. Ct. at 1195 n.3. Thus, Levine leaves intact Buckman’s “fraud-on-the-agency” rationale, but holds that it does not apply to “state regulation of health and safety matters,” which are different.

Significantly, in Levine there was no claim of any sort that the defendant breached any FDA regulation.  The Levine decision – including the lengthy concurrence and vehement dissent – doesn’t mention §337(a) at all.

Let’s then turn to a case that does – Buckman itself.  As Levine indicated, Buckman found that there was no presumption against preemption protecting a state-law “fraud-on-the-agency” claim.  Why?  Because it’s not a “traditional” state-law function to regulate a federally regulated entity’s compliance with federal statutes:

Policing fraud against federal agencies is hardly a field which the States have traditionally occupied, such as to warrant a presumption against finding federal pre-emption of a state-law cause of action.  To the contrary, the relationship between a federal agency and the entity it regulates is inherently federal in character because the relationship originates from, is governed by, and terminates according to federal law.  Here, petitioner’s dealings with the FDA were prompted by the MDA, and the very subject matter of petitioner’s statements were dictated by that statute’s provisions.  Accordingly – and in contrast to situations implicating federalism concerns and the historic primacy of state regulation of matters of health and safety – no presumption against pre-emption obtains in this case.

Buckman, 531 U.S. at 347-48 (various quotes and citations omitted) (emphasis added).

Right off the bat, Buckman’s holding that no presumption against preemption applies demonstrates that Stanley is just plain wrong.  The presumption is ousted in “fraud on the agency” cases because “the relationship between a federal agency and the entity it regulates is inherently federal in character.  531 U.S. at 347.  There’s no caveat in Buckman about anything being a claim or a defense – and Levine’s manner of distinguishing Buckman didn’t in any imply that any presumption (whether “strengthened” or otherwise) could encroach upon the “inherently federal” nature of a relationship that “originates” and “is governed by” federal law – specifically the Food, Drug and Cosmetic Act (“FDCA”).  The federal “relationship,” not the fact that underneath everything there’s a claim for personal injury, drove the result in Buckman, and that’s precisely what the Levine court said about Buckman.

Since Stanley simply ignores the Supreme Court’s treatment of the presumption against preemption in what we’ll call “federal relationship” cases, there’s little more to say about it beyond it being flat out (although not spherical) error.  So we’ll turn to the presumption discussion that’s missing from Bass.  Why doesn’t the presumption against preemption apply to “parallel violation” claims that might otherwise escape the express preemption clutches of Levine?

We think it’s because the three legs of the Levine tripod aren’t present in a “parallel violation” case.  Those legs are, at the risk of being repetitive, (1) “a field which the States have traditionally occupied”; (2) exercise of “the historic police powers of the States”; and (3) no “clear and manifest purpose of Congress” to preempt the claims.

The sort of parallel violation claim at issue in Bass was “a failure to comply with any particular [FDA] regulation” that “caused [plaintiff’s] injuries.”  2010 WL 3431637, at *4.  In other words Bass involved allegations under state law that the defendant violated federal law (the FDCA).  That raises the same question as in Buckman – is it “traditional” for state courts to be in the business of identifying federal law violators and finding them liable to individuals for such violations?

Such a thing certainly can happen, we can think of Magnuson-Moss and FELA as two examples right off the bat.  But in both of those examples, the statutes expressly provide for private plaintiffs bringing causes of action in state court.  The exact opposite is true of the FDCA.  We’re back to Buckman and §337(a) again. As the Supreme Court there held, not only does the FDA “ha[ve] at its disposal a variety of enforcement options that allow it to make a measured response,” Buckman, 531 U.S. at 349, but the FDCA makes crystal clear that the FDA – and only the FDA – determines if there’s been a violation and what to do about it:

The FDCA 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:  “[A]ll 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).

Buckman, 531 U.S. at 339 n.4 – the footnote being to the earlier quotation.

And again, a few pages later on, when plaintiffs tried to claim “a virtually irrefutable presumption against implied preemption,” id. at 352, the Court returned to §337(a).  “[W]e have clear evidence that Congress intended that [the statute] be enforced exclusively by the Federal Government. 21 U.S.C. §337(a).”  (Emphasis added, and how).

“Clear evidence?”  Where else have we heard that phrase lately?

Oh, wait, we remember, now – that’s the standard for finding implied preemption under Levine.  See 129 S. Ct. at 1198 (rejecting impossibility preemption “absent clear evidence that the FDA would not have approved a change”). It’s almost as if there’s a conversation between these two Supreme Court cases:

Levine – “You need this.”

Buckman – “That’s exactly what we got.”

Thus, Buckman and Levine – far from being contradictory – work in tandem where violation claims are concerned.  Levine holds that, in general, for implied preemption there has to be “clear evidence” of a conflict.  Buckman holds that, with respect to whether plaintiffs can bring claims that the defendant violated the FDCA, “clear evidence” supporting a preemptive conflict with congressional intent exists.

Thus, in addition to §337(a) being a source of implied preemptive power, as the court did recognize in Bass, the same statutory section also knocks out the legs from the Levine tripod.

Is the imposing of sanctions upon an alleged violator of the FDCA “a field which the States have traditionally occupied”?  Given that §337(a) explicitly reserves “enforcement” and “restrain[ing] violations”  of the FDCA to the federal government, it’s pretty hard to say that.  Purported FDCA violations are also part of the same “inherently federal relationship” referenced in Buckman.  If the defendant violated the FDCA in some way, that determination springs from something in that federal statute and the FDA’s regulatory construction of it.

Likewise, is ferreting out FDCA violations something within “the historic police powers of the States”?  While state-law doctrines such as negligence per se exist, their application to federal, as opposed to state, statutory/regulatory violations is relatively uncommon – and at least as much dependent upon what Congress was willing to tolerate as upon state law.  That’s what one of the first appellate decisions to consider the subject in the FDCA context pointed out:

It is clear that whether a state chooses to recognize violations of its own statutes as negligence per se is purely a question of state law. . . .  However, the determination that a violation of a federal statute such as the FDCA will create state tort liability is not a matter solely of state law.  A state’s ability to use a federal statute violation as a basis for state tort liability and negligence per se depends on the intent of Congress, and not merely on the intent of the state.  Thus, the congressional decision not to provide a private cause of action under the FDCA becomes quite important in considering the propriety of a state negligence per se action for violation of the FDCA.  It may be that a decision by Congress not to create a private remedy is intended to preclude all private enforcement. If that is so, then a state cause of action that makes relief available to private individuals for violations of the FDCA is pre-empted.

In re Bendectin Litigation, 857 F.2d 290, 313-14 (6th Cir. 1988) (other citations omitted) (emphasis added).  Thirteen years later, along comes Buckman, where the Supreme Court holds that §337(a) is indeed “intended to preclude all private enforcement.”  See Buckman, footnote 4, above.

And finally, the last leg of the Levine tripod – is there “clear and manifest purpose of Congress” to preempt violation claims?  Buckman sure seems to hold that there is, and that this purpose is to be found in §337(a).  That section “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance” and is “clear evidence that Congress intended” that FDCA enforcement be “exclusively by the Federal Government.”  531 U.S. at 349, n.4, 352.

Thus we think that 21 U.S.C. §337(a), as interpreted in Buckman, means that defense counsel have no reason to shy away from addressing the presumption against preemption head on in cases involving fraud on the FDA/FDCA regulatory violation claims.  The Buckman analysis of the presumption against preemption and of §337(a) not only isn’t adversely affected by anything in Levine, but the two cases complement each other rather well – in both the analysis of Levine’s three bases for the presumption and again in what constitutes “clear evidence” that supports preemption in this particular category of implied preemption cases.