The definitive source for intelligent commentary on the law that matters for drug and device product liability cases
That title might be overblown, because we are discussing only two cases. But one of them is the Roundup case, and we could not resist the cheesy wordplay.
Roundup is neither a drug nor device. It is regulated by the Environmental Protection Agency (EPA), not the Food and Drug Administration (FDA). Nevertheless, the Federal Insecticide…
This post is not from the Bryan Cave side of the Blog.
The Third Circuit’s preemption decision in Schaffner v. Monsanto Corp., ___ F.4th ___, 2024 WL 3820973 (3d Cir. Aug. 15, 2024), is certainly a big deal in that litigation. As observed in the Bloomberg story about the decision, carried in the August…
…[B]ecause the statute contains an express pre-emption clause, we do not invoke any presumption against pre-emption but instead focus on
When we have given talks on preemption, whether to law firm personnel, attendees of professional conferences, or new FDA employees, we have tended to start with the Supremacy Clause and then break up the types of preemption and the issues related to them into different buckets. We have not had to name those buckets or…
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 TextualistsIn 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 (…
One of the cases we follow closely, with daily searches, is Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019). It’s an implied preemption case, so while we like to think we catch all the drug/device cases anyway, Albrecht can affect preemption in a wide variety of tort situations.
We’d…
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