We consistently defend the ability of physicians to engage in off-label use. Bexis helped lay the scholarly foundation for courts to utilize the term “off label use,” and two of his law review articles remain go-to reads on the subject. Not surprisingly, we follow medical malpractice decisions that address off label use. Back in 2009, Mark Herrmann (the Blog’s co-founder with Bexis), published a law review article articulating the reasons why package inserts should not be admitted as standard of care evidence in medical malpractice actions. More recently, we wrote a comprehensive post collecting case law rejecting the admission of package insert evidence to establish a violation of the standard of care by physicians who used drugs or devices off label. Today’s case is a detailed opinion from the Iowa Supreme Court joining what is now the majority view—that package inserts should not be admitted as substantive evidence of the standard of care.Continue Reading Package Inserts Are Not Admissible to Establish Standard of Care
Medical Device
Failure-to-Warn Claim Implicating Class II Medical Device that Received De Novo Classification Held Expressly Preempted on Facts Presented
[This post is from the non-Reed Smith side of the blog.]
Today we report on Dickson v. Dexcom, Inc, 2024 WL 4291511 (W.D. La. 2024), an important medical-device preemption case that started with a doctrinal bang but ended on a factual whimper.
Committed to nationally uniform standards based on good science, we believe that…
Don’t Let Pennsylvania Plaintiffs Succeed with Phony Comment K Argument
Recently we discussed the latest opinion in the ongoing “controversy” over the application of Pennsylvania’s comment k across-the-board rule to cases involving medical devices. Douglas v. Atrium Medical Corp., 2024 WL 4364950 (M.D. Pa. Sept. 20, 2024). We use “controversy” advisedly, because as Douglas held, there is “no substantial ground for difference of opinion…
We Applaud The Preemption Analysis And Outcome In Mack v. CooperSurgical, Inc. (2024) While Bemoaning Those In Mack v. CooperSurgical, Inc. (2023)
Note: There is a table in this post that may be easier to view on a phone than on a computer.
Medical device preemption provides powerful protection from litigation involving Class III devices with premarket approval (or “PMA”).
These devices are a very small subset of FDA-regulated medical devices – around 1% — and they…
No Debating Pennsylvania’s Rejection of Strict Liability for Implantable Medical Devices
This is from the non-Dechert part of the Blog.
Over the years, the Blog has had many, many posts related to the issue of whether Pennsylvania recognized any form of strict liability in product liability actions against prescription medical products. In addition to the fact that several of the principal authors of the Blog have…
A Detour Through Materials Science, Followed By A Climb Up A Rule 702 Hill
This post is from the non-Butler Snow side of the blog.
When you represent medical device manufacturers in product liability litigation, you will deal with allegations that a device broke or failed because of what it was made from, and you will encounter both experts and “experts” (scare quotes intended) in materials science.
Materials science…
The Intersection of Telehealth, Privacy, and Medical Devices
One good thing that occurred during the pandemic was the expansion of telehealth. Telehealth existed already and probably would have been expanding anyway, but patient willingness to get care from home instead of risking exposure from an in-person visit paired well with provider interest in not going to or even having to maintain an office. …
Loper Bright Likely Lays Lohr Low
We recently examined one possible beneficial impact of the Supreme Court’s recent landmark decision in Loper Bright Enterprises v. Raimondo, 144 S. Ct. 2244 (2024) – that it could bring about critical re-examination of the FDA’s questionably supported ban on truthful off-label speech.
Well here’s another one: Medtronic, Inc. v. Lohr, 518 U.S.
Snap Removal, and TwIqbal, and Preemption-Oh My
If you are of a certain age and are presented with a trio of items, we bet you sometimes add “Oh My” to the end of the list, as in Lions, and Tigers, and Bears-Oh My. Or, you think of other things that come in threes, such as the past and the present…
Florida Pure Bill of Discovery and the Medicare Secondary Payer Act
This post is from the non-Butler Snow side of the blog.
When a news article starts with “Florida man…” you know you are in for a bit of crazy. Usually crazy and funny, but in a smack-my-head kinda way.
The lawsuit resulting in the decision in MSP Recovery Claims, Series LLC v. Ethicon Inc.…