When we (belatedly) learned of the Supreme Court’s abolition of the so-called “presumption against preemption” in express preemption cases, that knowledge just about made our year. Since then we’ve written several posts about that case, Puerto Rico v. Franklin-California Tax-Free Trust, 136 S. Ct. 1938 (2016), and its effect on preemption cases in our
In our 2017 post, “Medtronic v. Lohr Has Two Shadows,” we pointed out that the “presumption against preemption” that was the linchpin of that decision’s limited and atextual reading of the FDCA’s express preemption clause for medical devices, 21 U.S.C. §360k(a), was no more. Lohr had justified its specificity gloss on the broad
In our 2017 post, “Medtronic v. Lohr Has Two Shadows,” we pointed out that the “presumption against preemption” that was the linchpin of that decision’s crabbed and atextual reading of the FDCA’s express preemption clause for medical devices, 21 U.S.C. §360k(a), was no more. Lohr had justified its specificity gloss on the broad
Late last year we awarded our #10 spot on our Worst of 2020 post to In re Valsartan, Losartan, & Irbesartan Products Liability Litigation, 2020 WL 7418006 (D.N.J. Dec. 18, 2020) (“VLI”). At that point the decision was brand new, and we promised a more in-depth analysis. Here it is.
VLI fits
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
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
Last week appears to have been a bit of a slow week in the drug and device litigation arena. It was after all a short work week. It was back to school week (at least in the North East), which while bringing delight to parents everywhere also brings the chaos of last minute school supply
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
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
Not so long ago in a Circuit not so far away, the issue of whether design defect claims against branded prescription drug manufacturers are preempted was joined. Much like the origins of the Jedi or the major end-of-year holidays as we know them, one would expect a clearer published record of how this came to be. There can be a tendency to read back from recent experience and imbue our past selves with more knowledge or foresight that we actually had. For preemption of design defect claims against branded prescription drug manufacturers, we know we have been arguing for it for years and we are not quite sure why it took so long for a Circuit Court to adopt it. As we noted a few weeks ago, Yates v. Ortho-McNeil-Janssen Pharms., Inc., No. 15-3104, 2015 U.S. App. LEXIS 21428 (6th Cir. Dec. 11, 2015), did find preemption, and did it pretty definitively. So definitively that it took our spot as top decision of 2015. Along the way, the court declined to follow a prior decision of the same court, Wimbush v. Wyeth, 619 F.3d 632 (6th Cir. 2010), which itself reversed decisions of the trial court in Longs v. Wyeth, 536 F. Supp. 2d 843 (N.D. Ohio 2008) (granting summary judgment), and Longs v. Wyeth, 621 F. Supp. 2d 504 (N.D. Ohio 2009) (denying motion to alter judgment), each of which included the holding that pre-approval design defect and negligence claims were preempted. It is with the Longs/Wimbush decisions where our story starts, subject to some back story and with a healthy dose of links to past posts.
We first note, however, that it has long been our view, expressed in many posts and elsewhere, that design defect does not make much sense as a theory of liability for a prescription drug. In most cases, what the plaintiff alleges made the drug excessively risky and thus defectively designed cannot possibly be changed without making it a different drug. One of the principles of pharmacology is that changes to the chemical compound will typically affect both the desired and undesired effects in the body–or as the Supreme Court observed in Bartlett, “because of [a drug’s] simple composition, [it] is chemically incapable of being redesigned.” 133 S. Ct. 2466, 2475. Rarely, a true change to the “design” of the active compound can be identified—maybe chop off this ethyl group or change it from a racemic mixture to a stereoisomer—that will plausibly reduce the pertinent risk, while maintaining benefits and avoiding new risks. Even where that kind of proposed design change exists, the change would make the drug a different product, not a better version of the same product, which is what design defect is supposed to be about. There may be some cases where a plaintiff claims that a different balance of a combined drug’s ingredients, or an
inactive ingredient, or the delivery system should be changed to reduce the risk without making it a different drug. Even those cases, though, seem better suited to warnings-based claims.
Continue Reading The Saga of Preempting Prescription Drug Design Defect Claims