Did you remember that there can be express preemption for over-the-counter drugs? We sometimes forget too, but there are really good reasons for that. The Food Drug and Cosmetic Act includes the following provision:
[N]o State or political subdivision of a State may establish or continue in effect any requirement – (1) that relates to
Offhand, we cannot think of opinions we have blogged on that pleased us more than today’s cases, Jacob v. Mentor Worldwide, LLC, et al., 2019 WL 3500325 (C.D. Cal. Aug. 1, 2019) and Vieira v. Mentor Worldwide, LLC, et al., 2019 WL 3500331 (Aug. 1, 2019). The two decisions are virtually identical and
We have taken a daily multivitamin ever since our doctor told us that we were chronically deficient in a particular vitamin, the one you can get from being out in the sun. Given our chosen line of work, we should not be surprised that we don’t get enough sunlight. We should also not be surprised
We understand that we write a lot about federal preemption. You might even be rolling your eyes at yet another post on this most powerful of defenses, but we just can’t help ourselves. Federal regulation runs deep in the drug and medical device world, and the possibility that federal law might preempt state-law claims is
We have made it no secret that we think the Ninth Circuit wrongly decided Stengel v. Medtronic. That is the case where the Ninth Circuit reversed express preemption of claims involving a pre-market approved medical device by divining a “parallel” state-law duty to report adverse events to the FDA. As we have said here
Last year’s list of the Ten Worst DDL cases was remarkable because all ten decisions came from appellate courts. Yikes. And it is not as if the bad appellate decisions were spread around. Two came from our home circuit, the Third. Two came from the reliably problematic Ninth Circuit. But the ‘winner’ was the Eleventh
Today we have a guest post from Reed Smith‘s Elizabeth Minerd discussing a PMA preemption case dealing with unusual “parallel claim” allegations involving the conduct of clinical trials. As always our guest posters are 100% responsible for what they write and deserve 100% of the credit (and any blame) for what follows. Take it
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.