Today’s post is a little different in its format from what our readers are used to. What follows is a lightly edited (primarily adding full citations) version of a webinar presentation Bexis made recently for the “HLTh” Action Group of the Product Liability Advisory Council. The availability of this type of cutting-edge presentations is yet another reason why drug and medical device manufactures would be well served by joining PLAC. We’ve never been much for adding images to our blogposts, but here we have put together Bexis’ slides and speakers notes so that our readers can follow them more easily.

This post is a deeper dive into a preemption-related concern that we have raised before − how and why defendants can, and should, reconcile the beneficial holdings in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), with the rejection of the so-called “purposes and objectives” prong of implied preemption by the most conservative justices (at least in terms of federalism) on the Court.

For those of you accessing the Blog on mobile devices, this post may be hard to read. So, here are links to both the slide images and the accompanying text.Continue Reading Logical Contradiction Doctrine:  Buckman for Textualists

In a recent post, we discussed a decision that, among other things, excluded an FDA expert’s “opinion” that the defendant’s medical device was “adulterated” and/or “misbranded.”  In Robinson v. Ethicon, Inc., 2022 WL 614919 (S.D. Tex. March 2, 2022), the court held that the expert “cannot take the final step of opining that

When we last left our story, plaintiffs had lost their fight to have Pennsylvania law apply to residents of Texas ( Atkinson I) and lost a chunk of their claims as barred by the Texas statute prohibiting failure to warn claims where a drug’s label has been approved by FDA and comment k (

While it’s not prescription medical product liability litigation, per se, we’ve been aghast, scratching our heads about the recent litigation firestorm surrounding the pesticide Roundup and its active ingredient, glyphosate.  Despite consistent findings from every regulatory body in the world – save one (the IARC) – that this product is not a carcinogen, plaintiffs peddling

Last month, while grappling with an aphrodisiac false-advertising case, we joked that we felt like having a cigarette after reading the court’s opinion.  Today we get our cigarette.  Or, rather, our e-cigarette.  Today’s post is about a tobacco, not a drug or device case.  We aren’t squeamish about that, not one bit.  Before we worked on drug or device cases, we spent several years litigating tobacco cases.  It was good practice.  After dealing with tobacco cases, no internal documents worry us all that much.  Tobacco litigation is the ultimate challenge for a defense lawyer.   Judges and juries treat tobacco differently – and by differently, we mean worse. Much worse.  It was a point of faith among the defense hacks that many judges found occasions to reach down to some lower shelf and retrieve a Tobacco Rules of Evidence, which permitted judges to stiff the defendant in a myriad of ways.  This crazy, result-oriented one-sidedness was not confined to the judicial branch.  Remember how Florida passed an ex post facto law removing many tobacco affirmative defenses?

Moreover, tobacco litigation was good practice on the issue of preemption.  Most tobacco cases were and are about an alleged failure to warn.  But federally mandated warnings have been on cigarette packs for over 50 years.  One of the key express preemption decisions, Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992), is about the effect of those warnings.  That case is as important as air and as clear as mud.  Lawyers and judges are still trying to figure out exactly what it held.  Does the express preemption provision for cigarette warnings blow a hole through all failure to warn theories?  Is there a distinction between failing to warn and affirmative deceit?  To  the extent they have to try to figure out the scope of preemption,  judges usually hate it.  Preemption is so powerful, so completely dispositive of plaintiff claims, that some judges regard it with the same degree of affection they harbor for the bubonic plague or the last season of Dexter.  During one sidebar in a tobacco case, the judge sputtered that preemption “boggled his mind and boiled his blood.”  No wonder, then, that his rulings on preemption were a tad sketchy.Continue Reading Smoking Out the Scope of Preemption

Anybody who watched the Mayweather-Pacquiao fight knows that a long fight does not necessarily make for an exciting fight. Thirty-six minutes of “action” can actually contain very little action. The exceedingly long decision of the court in Grocery Manufacturers Assoc. v. Sorrell, No. 5:14-cv-117, 2015 U.S. Dist. LEXIS 56147 (D. Vt. Apr. 27, 2015), has little to keep our DDL-centric attention—its discussion of preemption based on various federal statutes, including the FDCA.  As the court forcefully rejected most preemption arguments raised by trade groups whose members were likely to be affected by Vermont’s labeling rules for foods derived in whole or in part from genetic engineering, we are reminded of another dynamic from the “Fight of the Century.”  Watching live, with the volume up, a viewer might have been swayed by the cheering of the decidedly pro-Pacquiao crowd into thinking Pacquiao was doing damage during many of the too-infrequent exchanges of punches.  However, almost invariably, the slow-motion replay between rounds showed Pacquiao’s blows had been deflected and followed by a Mayweather punch to the face, the latter almost too quick to see in real time.  Similarly—or at least as similarly as pugilistic analogy allows—the court’s analysis of preemption relied on borrowing concepts from one type of preemption and applying them to another without saying what it was doing.

As our resident state historian cum travel brochure maker (and boxing aficionado) has noted here and here, Vermont has been known to do its own thing. That has included enacting peculiar statutes that unconstitutionally impinge on national commerce.  Based upon its judgment that the various federal statutes and regulations—and the pendency of federal legislation—did not do enough to inform consumers of the existence of ingredients created through some degree of genetic engineering in products they might purchase, the Vermont legislature enacted Act 120.  It contained two provisions challenged in the GMA case, one requiring packaging or site-of-sale displays disclosing the presence of ingredients derived from genetic engineering in products for sale and one prohibiting labeling or advertising describing the product as “natural” in one way or another.  (We will skip the discussion of how much genetic engineering counts, given that humans have been eating “genetically engineered” food ever since our ancestors started selectively mating captured aurochs or zebu and have known that this was a manipulation of genetics at least since Gregor Mendel started playing with peas in his abbey.)  The legislature could not say that foods with one or more genetically engineered ingredients were less safe than those without, but cared that polls showed Vermonters wanted to know about the presence of such ingredients so they can make “informed decisions” and not be “confus[ed] and dece[ived]” by claims of “natural” products.  Before Act 120 even took effect, a multi-faceted constitutional challenge was brought.  The decision we are discussing results from the Vermont AG’s motion to dismiss and the plaintiff’s motion for preliminary injunction.  If you want to read about the Commerce Clause or First Amendment issues with Act 120, knock yourself out, but we will not discuss them here.Continue Reading Going The Distance To Limit Preemption