The Demise Of The Presumption Against Preemption In Express Preemption Cases

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...