Sometimes it really is as easy as A, B, C or as simple as 1, 2, 3. Where the FDA has set specific rules for the type of labeling claims a manufacturer can make and the manufacturer abides by those rules, claims by plaintiffs seeking to require something different are preempted. Just like do, re,
2021
Appellate Commentary on MDL Master Complaints
We’ve complained before about MDL “master” or “consolidated” complaints being used to deprive defendants of the ability to pursue their rights to seek dismissal on TwIqbal and other pleading-related grounds. In individual actions, defendants have the right to put the plaintiffs’ pleadings to the test required by Rules 8 and 12. That has not necessarily…
Shameless Plug — CLE Webinar on the best and worst drug/medical device decisions of 2020
As 2020 ended, our loyal readers joined us in reviewing our worst decisions of the past year – true superspreaders of litigation against our clients – and our best decisions of the past year, which we termed “tort pandemic countermeasures.”
As we do each year, we’re pleased to announce that four of your bloggers…
Another PMA Preemption Win
Albert Einstein supposedly said, “Insanity is doing the same thing over and over again and expecting different results.” He may not have, but the point is well taken. We often think the same thing – particularly about plaintiffs that sue manufacturers of FDA premarket-approved (“PMA”) medical devices with vague, boilerplate complaints. Haven’t they heard about…
Guest – Frankenstein’s Monster: Limiting Reliance on the Park Doctrine
Here’s another quasi-guest post by Reed Smith’s blogger-in-training Dean Balaes. This one provides a critique of the scary Park doctrine, aptly described here as “Frankenstein’s Monster,” that allows imposition of criminal liability on corporate officers for illegality they didn’t even know about.
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In 1816, Mary Shelley and Lord Byron entered into a wager to…
How the Other Side Views Albrecht
We recently came across the law review article, E. Lindenfeld, “Clear Evidence Clarified,” 75 Food & Drug L.J. 346 (2020). Since it cited and critiqued a number of our blogposts, we thought it was appropriate to reply.
Our initial impression is that the Lindenfeld article is comparatively reasonable – that is, compared to some prior…
A Better Valsartan Decision
This post is from the non-Reed Smith side of the blog.
We posted last week about In re Valsartan, Losartan, & Irbesartan Products Liability Litigation, 2020 WL 7418006 (D.N.J. Dec. 18, 2020), a decision that came in just time to take a sport on our Worst of 2020 post. Just as we were…
Guest Post – Florida Adopts Practical And Fair Summary Judgment Standard
Today’s guest post is from Wendy Lumish and Daniel Rock of Bowman & Brooke. We sought them out because they wrote a successful amicus curiae brief in the case they discuss. That case is a major win for all Florida defendants, bringing Florida summary judgment practice into the Twenty-First Century. As always our guest…
Design Claims Fail Under Consumer Expectations Test With An Adequate Warning
Plaintiffs tend to assert a bunch of different claims. For prescription medical device cases, setting aside preemption, our experience is that plaintiffs do best—that is, avoid summary judgment and directed verdict—with design defect (strict liability or negligence) claims. One reason for that is that it tends not to be hard to make up some theory,…
Following up on a Recent Bottom Ten Decision
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…