Last week brought another example of the chaos being caused in preemption jurisprudence by the Supreme Court’s sloppily reasoned decision in Wyeth v. Levine, 555 U.S. 555 (2009). Prior to Levine, the Court had repeatedly held that the doctrines of express (that is, where there’s an on-point statutory provision) preemption and implied (where no statute is dispositive, but state law conflicts in some way with federal law) preemption operate independently of each other. That is, regardless of what any statute does or doesn’t say, implied preemption is still available to resolve conflicts between state and federal law.
The question whether express preemption language in a statute foreclosed the operation of implied conflict preemption arose in Freightliner Corp. v. Myrick, 514 U.S. 280 (1995), based on an express preemption clause in the National Traffic and Motor Vehicle Safety Act. The Court rejected an argument that express preemption necessarily precluded implied preemption:
[W]e must address the argument that we need not reach the conflict pre-emption issue at all. According to respondents and the Court of Appeals . . . implied pre-emption cannot exist when Congress has chosen to include an express pre-emption clause in a statute. This argument is without merit. . . . The fact that an express definition of the pre-emptive reach of a statute “implies” − i.e., supports a reasonable inference − that Congress did not intend to pre-empt other matters does not mean that the express clause entirely forecloses any possibility of implied pre-emption.
Id. at 287-88 (citations omitted).
The court followed Myrick in Geier v. American Honda Motor Co., 529 U.S. 861 (2000). In Geier, also an automobile preemption case, the relevant statute contained both an express preemption clause and an express savings clause. Discussing this issue at some length, the Court held that, whatever might be the effect of those arguably conflicting provisions on express preemption, neither statutory provision had any effect on the workings of implied preemption:
We have just said that the saving clause at least removes tort actions from the scope of the express pre-emption clause. Does it do more? In particular, does it foreclose or limit the operation of ordinary pre-emption principles insofar as those principles instruct us to read statutes as pre-empting state laws (including common-law rules) that “actually conflict” with the statute or federal standards promulgated thereunder? Petitioners concede, as they must in light of [Myrick], that the pre-emption provision, by itself, does not foreclose (through negative implication) any possibility of implied conflict pre-emption. But they argue that the saving clause has that very effect.
Id. at 869 (Myrick citation and quotation marks omitted). The Court then explicitly extended the Myrick principle (which had focused only on the statute’s preemption clause) to saving clauses:
We now conclude that the saving clause (like the express pre-emption provision) does not bar the ordinary working of conflict pre-emption principles. Nothing in the language of the saving clause suggests an intent to save state-law tort actions that conflict with federal regulations. . . . Moreover, this Court has repeatedly declined to give broad effect to saving clauses where doing so would upset the careful regulatory scheme established by federal law. We find this concern applicable in the present case.
529 U.S. at 869-70 (citations and quotation marks omitted). Finally, Geier went on to base its holding – that neither savings nor preemption clauses affected implied preemption – firmly on policy grounds:
Neither do we believe that the pre-emption provision, the saving provision, or both together, create some kind of “special burden” beyond that inherent in ordinary pre-emption principles − which “special burden” would specially disfavor pre-emption here . . . [W]e can find nothing in any natural reading of the two provisions that would favor one set of policies over the other where a jury-imposed safety standard actually conflicts with a federal safety standard. Why, in any event, would Congress not have wanted ordinary pre-emption principles to apply where an actual conflict with a federal objective is at stake? Some such principle is needed. In its absence, state law could impose legal duties that would conflict directly with federal regulatory mandates.
Id. at 870-71 (citations and quotation marks omitted).
These decisions were in turn applied to the FDCA by a unanimous court in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), a medical device case that, of course, was also governed by 21 U.S.C. §306k. The Court in Buckman did not address express preemption, 531 U.S. at 348 n.2, and instead based its decision on implied preemption, finding that nothing about the former could preclude the latter:
Respondent also suggests that we should be reluctant to find a pre-emptive conflict here because Congress included an express pre-emption provision in the MDA. To the extent respondent posits that anything other than our ordinary pre-emption principles apply under these circumstances, that contention must fail in light of our conclusion . . . that neither an express pre-emption provision nor a saving clause bars the ordinary working of conflict pre-emption principles.
Id. at 352 (citations and quotation marks omitted). See also Sprietsma v. Mercury Marine, 537 U.S. 51, 65 (2002) (“Congress’ inclusion of an express pre-emption clause does not bar the ordinary working of conflict pre-emption principles that find implied pre-emption”; finding no implied preemption either) (citing Buckman); Medtronic, Inc. v. Lohr, 518 U.S. 470, 503 (1996) (“Until such a case arises, we see no need to determine whether the statute explicitly pre-empts such a claim. Even then, the issue may not need to be resolved if the claim would also be pre-empted under conflict pre-emption analysis”) (citing Myrick).
Then along came Levine. Without even mentioning the rule that express and implied preemption operate independently (even though the Court in Levine elsewhere addressed other aspects of Geier and Buckman), Levine used the absence of any express preemption provision in the (drug portion of the) FDCA as a basis for holding that implied preemption did not exist either:
If Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express pre-emption provision at some point during the FDCA’s 70-year history. But despite its 1976 enactment of an express pre-emption provision for medical devices . . . Congress has not enacted such a provision for prescription drugs. Its silence on the issue, coupled with its certain awareness of the prevalence of state tort litigation, is powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.
555 U.S. at 574-75 (citations omitted). So in Levine we have an absence of affirmative Congressional action being used to establish a negative – that the absence of express preemption means no implied preemption either. This result doesn’t fit with Myrick, Geier, and Buckman, all of which held that even affirmative congressional action, whether a preemption clause or a savings clause, did not preclude the operation of implied preemption.
But after Levine, the Court appears to have reverted to the prior rule that express and implied preemption operate independently. See Arizona v. United States, 132 S. Ct. 2492, 2504-05 (2012) (“the existence of an express pre-emption provision does not bar the ordinary working of conflict pre-emption principles or impose a special burden that would make it more difficult to establish the preemption of laws falling outside the clause”); PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2577 (2011) (“the absence of express pre-emption is not a reason to find no conflict pre-emption”); AT&T Mobility LLC v. Concepcion, 131 S. Ct. 1740, 1748 (2011) (“Although [the] saving clause preserves generally applicable contract defenses, nothing in it suggests an intent to preserve state-law rules that stand as an obstacle to the accomplishment of the [statute’s] objectives”); Williamson v. Mazda Motor, Inc., 131 S. Ct. 1131, 1136 (2011) (“neither can the statute’s saving clause foreclose or limit the operation of ordinary conflict pre-emption principles”).
Due to the aberrant result in Levine, uniquely in the drug area courts are encouraged to disregard the general rule, followed both before and after by the Supreme Court, that express and implied preemption stand or fall on their own merits, and that the absence of express preemption does not impede the operation of implied preemption. Such is the case with Hunt v. McNeil Consumer Healthcare, 2014 WL 1116358 (E.D. La. Mar. 11, 2014), which is what got us thinking about this issue once again. Hunt involves allegations that an over-the-counter (“OTC”) drug causes SJS/TENS (the same nasty condition at issue in Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013)). The defendant in Hunt sought to apply Mensing/Bartlett to preempt a design defect claim. Mensing/Bartlett, of course, is based on a form of implied preemption – “impossibility” – positing that where federal law prohibits “unilateral alter[ation]” of a particular product attribute, state law cannot require such conduct. Hunt, 2014 WL 1116358, at *6.
Against the operation of implied preemption, Hunt interposed solely express preemption – doing what the Supreme Court implicitly allowed in Levine, but has expressly rejected (as already discussed) in more than a half-dozen decisions both pre- and post-dating that opinion. As in Geier, the OTC drug statute contains an express savings clause (which Hunt also called a “non-preemption clause”). That provision, 21 U.S.C. §379(e), exempts “action[s] . . . under the product liability law of any State”) from express preemption. The court in Hunt held that this savings clause, precluding express preemption, also barred implied preemption under the impossibility rationale of Mensing/Bartlett:
Because the statute governing non-prescription drugs contains a non-preemption clause, Plaintiff’s design-defect claim is not preempted under Bartlett. This result makes perfect sense, given that Congressional intent is the “ultimate touchstone” of any preemption analysis. There are equally compelling policy justifications for reading Bartlett and Mensing narrowly so as to preserve the viability of products liability actions. As the Court recognized in [Levine], statelaw [sic] tort suits play an important “complementary” role to federal drug regulation.
Hunt, 2014 WL 1116358, at *7 (citations omitted). Hunt also read Bartlett – at least the part of it that bemoaned lack of Congressional guidance – as supporting a finding of no preemption. Id. (pointing out that Bartlett had “lamented the fact that Congress had not expressly addressed . . . difficult pre-emption questions” and “noted that Congress had ‘explicit[ly]’ addressed preemption in other drug laws” including OTC drugs). However, absent from the analysis in Hunt was how Bartlett actually resolved the preemption question before it:
[W]e are left to divine Congress’ will from the duties the statute imposes. That federal law forbids [defendant] to take actions required of it by state tort law evinces an intent to pre-empt.
Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466, 2480 (2013) (citation and quotation marks omitted).
We think Bartlett was right on that point – the fact that federal law prohibits something is, in and of itself, indicative of “intent to pre-empt.” We think that Hunt should not have ignored (to the point of never mentioning) the contrary Supreme Court rule about express vs. implied preemption. So Hunt seems to us yet another example of anti-preemption wishful thinking – of courts doing strange things in tort preemption cases. There is nothing in Bartlett stating that the Court was reversing, or even questioning, the holdings in Myrick, Geier, Buckman, Sprietsma, Arizona, Mensing, Concepcion, and Williamson that express and implied preemption operate independently. Indeed, the majority in Bartlett expressly reaffirmed that implied preemption does operate where there is no express preemption.
Even in the absence of an express pre-emption provision, the Court has found state law to be impliedly pre-empted where it is impossible for a private party to comply with both state and federal requirements.
Id. at 2483. And the dissent? It understood that “[u]nder the majority’s approach, . . . design-defect claims are categorically displaced.” Id. at 2595.
Maybe, at some point, the Supreme Court will decide to overturn almost two decades of preemption jurisprudence (except for Levine) and hold that lack of express preemption is dispositive of implied preemption as well. But it certainly hasn’t done so yet. Until then, we’ll be of the view that Hunt was wrongly decided.