In our 2017 post, “Medtronic v. Lohr Has Two Shadows,” we pointed out that the “presumption against preemption” that was the linchpin of that decision’s limited and atextual reading of the FDCA’s express preemption clause for medical devices, 21 U.S.C. §360k(a), was no more. Lohr had justified its specificity gloss on the broad
Today’s somewhat unusual guest post is by Reed Smith‘s Matt Loughran. It concern’s the Supreme Court’s 6-3 decision to permit the government to continue enforcement of its requirement that healthcare workers (at least those in facilities that accept Medicare/Medicaid, which is most of them) be vaccinated to avoid infecting themselves and their patients
2021 has come to a close, and our loyal readers joined us as we reviewed the best and worst drug/medical device decisions of the year.
As we have done for a number of years, now, we are delighted to announce that we will be presenting a free 90 minute CLE webinar on “The good, the
We heard the other day from attorneys involved in the MDL direct filing, choice-of-law case that we wrote about a couple of weeks ago, Looper v. Cook Inc. Engaging in this kind of dialogue is one of the joys of blogging, even when our friends and colleagues write to tell us we got
Last year we reported on Plourde v. Sorin Group USA, Inc., 2021 WL 736153 (D. Mass. 2021), which held that the plaintiff’s failure-to-warn claims were expressly preempted by 21 U.S.C. § 360k(a) because those claims were based on an alleged failure to report adverse events to the FDA and the plaintiff had not shown
Some of our posts about challenges to Covid-19 vaccines or treatments might have been a bit … strident. It is hard to be otherwise when the cases involve such high stakes and so little merit.
But this time we will try to take our cue from the court in Frey v. Trinity Health-Michigan, 2021
In In re: Onglyza and Kombiglyze XR Products Liability Litigation, MDL 2809, 2022 WL 43244 (E.D. Ken. Jan. 5, 2022), the MDL judge bifurcated discovery into two phases with general causation proceeding first. At the close of expert discovery, plaintiffs move to exclude three defense experts and defendants moved to dismiss one plaintiff expert.
There are two main questions that surround the issue of all-vaccinated juries in the COVID-19 era. The first is can you seek to exclude non-vaccinated persons from the venire for cause. The second is do you want to. At just about every CLE program we attend these days, whether in person or electronically, where judges
We begin by introducing a new Drug and Device Little Rescue Dog. We lost the oldest of our rescued angels – a perfect soul we will miss as long as we are breathing – in the fall. Our other dog was sad and lonely, so we set out to adopt a companion for him. Our
Discovery can be very expensive. Defendants really like to win on motions to dismiss in part because they get to avoid the costs of discovery. We can pile on these shockingly obvious statements with two more. From a defense perspective, a narrow scope of discovery tends to be a good thing. If narrow discovery leads