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We’ve always been bothered by the presumption against preemption – so much that this blog’s first major substantive post was on that subject.  Even before that, back in the Bone Screw days, we remember the presumption against preemption accompanying the death of express preemption for 510(k) medical devices in Lohr.  In Lohr, the presumption was used as a narrowing principle of statutory construction: “[W]e use[] a presumption against the pre-emption of state police power regulations to support a narrow interpretation of such an express command.”  Id. at 485.  Then along came Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), which (as we pointed out at the time) upheld preemption of pre-market approved medical devices under the same statutory provision with nary a peep about any preemption-busting presumption.  Nonetheless, even after Riegel, some lousy circuit court decisions still invoked the presumption as a way of poking holes in PMA preemption, most notoriously the en banc Ninth Circuit in Stengel v. Medtronic Inc., 704 F.3d 1224, 1227-28 (9th Cir. 2013), which fawned over the presumption at some length before deciding that a duty to provide information to a governmental agency wasn’t any different than a bog standard product liability duty to warn.

The presumption also came up in the context of the Vaccine Act, where one court (discussed here) sought to nullify statutory preemption by latching onto a statement in Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005) (a non-FDCA case), about there being “a duty to accept the reading [of a statute] that disfavors pre-emption,” even where there are other equally “plausible” interpretations. Id. at 449.  That view was shot down by the Supreme Court in Bruesewitz v. Wyeth LLC, 562 U.S. 223 (2011), which interpreted the Vaccine Act’s preemption clause in a pro-preemption direction with nary a mention of the erstwhile adverse presumption – something else we mentioned at the time.

Then along came PLIVA v. Mensing, 564 U.S. 604 (2011), where four justices found, if anything, a presumption in favor of presumption, id. at 621-23 (viewing the Supremacy Clause as a constitutional “non obstante” provision), four justices disagreed, and one didn’t take a position.  Mensing, of course, was an implied preemption case.

For these reasons, we speculated a little over a year ago whether the presumption against preemption might be dead.  Then a little later, we thought we might be wrong.

Turns out we’re half right.

In a case decided this June, the Supreme Court appears to have killed the presumption against preemption in express preemption cases – that is with respect to express preemption clauses of the sort at issue in Lohr and Bruesewitz.  The Court did so in Puerto Rico v. Franklin-California Tax-Free Trust, 136 S. Ct. 1938 (2016).  We missed it at the time because the substantive issue was bankruptcy, which is far afield from our rather limited sandbox.  The preemption issue was whether Puerto Rico was a “state” within the meaning of the express preemption clause (11 U.S.C. §903(1)) of Chapter 9 of federal bankruptcy statute.

We’ll spare you the details and cut directly to what the Court held about the presumption against preemption. The sides offered conflicting interpretations of whether Puerto Rico was still a “state” for purposes of the preemption clause – if it was it couldn’t pass its own municipal bankruptcy statutes deviating from federal law, if it wasn’t, the local statute escaped preemption.  PR v. Franklin, 136 S. Ct. at 1946.  The Court concluded that “Respondents [entities disadvantaged by the local statute] have the better reading.  We hold that Puerto Rico is still a ‘State’ for purposes of the pre-emption provision.” Id.

Puerto Rico opposed this result by relying on the presumption against preemption – that the presumption required reading the preemption clause narrowly. The Court disagreed, holding that there was no presumption at all where a court was applying an express preemption clause:

The plain text of the [preemption clause] begins and ends our analysis. Resolving whether Puerto Rico is a “State” for purposes of the pre-emption provision begins “with the language of the statute itself,” and that “is also where the inquiry should end,” for “the statute’s language is plain.”  And because the statute “contains an express pre-emption clause,” we do not invoke any presumption against pre-emption but instead “focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.

Id. (emphasis added).  RIP presumption against preemption in express preemption clauses – “we do not invoke any presumption against preemption.”

PR v. Franklin is a 5-2 majority opinion.  Justice Thomas – the scourge of the presumption against preemption in Mensing – wrote it, and was joined by Chief Justice Roberts, Justice Kennedy (who created a 4-4 split in Mensing by joining neither side), Justice Breyer, and Justice Kagan.  Another Mensing foe of the presumption against preemption, Justice Alito, did not participate.  The bolded language above quotes from United States v. Whiting, 563 U.S. 582, 594 (2011), a decision that we observed in a prior preemption post was a plurality “split in more ways than are worth describing.” Whiting, which preempted most of Arizona’s 2007 Trumpist precursor immigration restriction, simply stated that “[w]hen a federal law contains an express preemption clause, we ‘focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ preemptive intent.’”  563 U.S. at 594 (quoting CSX Transportation, Inc. v. Easterwood, 507 U.S. 658, 664 (1993)).

Obviously, the plurality in Whiting didn’t say anything about the presumption against preemption in that quote – that was added, entirely and intentionally, by the majority in PR v. Franklin.  Equally obviously, by splicing in the language “we do not invoke any presumption against preemption,” the majority knew exactly what it was doing – killing the presumption in express preemption cases.

Nor is it just us who thinks that. We found out about PR v. Franklin last week when we read In re Syngenta Ag Mir 162 Corn Litigation, 2016 WL 4382772 (D. Kan. Aug. 17, 2016), a food case interpreting the preemption clause (7 U.S.C. §87g(a)) of something called the Grain Standards Act.  That case involved the type of federal preemption of common-law tort claims that we deal with all the time, which is why we were reading it.  Not unexpectedly, the plaintiffs trotted out the presumption against preemption to oppose the defendants’ preemption arguments.  To no avail:

[P]laintiffs argue that the Court should apply a presumption against preemption. The parties acknowledge that the Supreme Court has appeared to take inconsistent positions with regard to whether such a presumption applies in the case of an express preemption provision.  The Supreme Court ruled on the issue fairly definitively in recent months, however, concluding in one case that “because the statute contains an express pre-emption clause, we do not invoke any presumption against pre-emption but instead focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.”  Thus, this Court will not invoke any presumption in applying the [statutory] express preemption provision.

2016 WL 4382772, at *3 (quoting PR v. Franklin, as previously quoted above).

The 2016 demise of the presumption against preemption in express preemption cases will affect the application of preemption for every federally regulated product where the organic statute has a preemption clause. Of particular importance to us and our clients, PR v. Franklin should eliminate the presumption against preemption in all cases involving medical devices, meaning that, in this respect, Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), can no longer be considered good law.