Presumption Against Preemption

Subscribe to Presumption Against Preemption
Photo of Bexis

As we’ve discussed before, the United States Supreme Court, in Puerto Rico v. Franklin-California Tax-Free Trust, 579 U.S. 115 (2016), sent the presumption against preemption, in express preemption cases anyway, into the dustbin of history.

[B]ecause 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. at 125 (citations and quotation marks omitted).…

Continue Reading On the Erstwhile Presumption Against Preemption, the Third Circuit Sticks Out Like a Sore Thumb

Photo of Bexis

The decision in In re Bard IVC Filters Products Liability Litigation, 969 F.3d 1067 (9th Cir. 2020) (“Booker”), is yet another reminder that multidistrict litigation as it is currently conducted is a fundamentally flawed process, dedicated more to forcing settlements than to any of the goals envisioned by Congress when it passed…

Photo of Bexis

Not quite two years ago, the United States Supreme Court did something that we liked a lot – it abolished the so-called “presumption against preemption” in express preemption cases. It did that in a bankruptcy case, Puerto Rico v. Franklin-California Tax-Free Trust, 136 S. Ct. 1938 (2016) (“Franklin”), so it took a…

Photo of Bexis

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.…

Continue Reading The Demise of the Presumption Against Preemption in Express Preemption Cases

Photo of Bexis

Last month, in Quesada v. Herb Thyme Farms, Inc., 361 P.3d 868 (Cal. 2015), the California Supreme Court did to “organic” foods what it had done to most other foods in Farm Raised Salmon Cases, 175 P.3d 1170 (Cal. 2008) – which is to expose them to still more garbage class actions over labeling that complies with federal government standards.  As we discussed here, in the Salmon cases the court had to work reasonably hard to come up with an (uncodified) food-related exception to the general ban on private enforcement of the Food, Drug & Cosmetic Act (“FDCA”).

The court had an easier job of it in Quesada because the federal statute that conferred on the Department of Agriculture the power to certify food as “organic” didn’t have a private enforcement provision similar to the FDCA’s 21 U.S.C. §337(a).  Rather, “With respect to enforcement, . . . [t]he act contemplates a cooperative state-federal enforcement regime.”  361 P.3d at 871 (citations omitted).  See also Id. at 875 (with respect to act’s section on “sanctions for misuse of the organic label,” “nothing in [it] suggests these federal remedies are intended to displace whatever state law remedies might exist”).

So why are we telling you this?  We’re not the food blog, after all.  Unlike the Salmon decision, this latest addition to food class action mania in California doesn’t even involve the FDCA.…

Continue Reading California Supreme Court – Presumption Against Preemption Still Around

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
Learn More About This Book