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,
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Guest Post – CMS Health Care Staff Vaccination Rule Enforceable as Challenges Continue
By Bexis
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…
Shameless Plug – Free CLE Webinar on the Best & Worst Prescription Drug/Medical Device Decisions of 2021
By Bexis
More on Choice Of Law—This Is How It Works
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…
First Circuit Asks Whether Massachusetts Recognizes a Duty to Report Adverse Events to the FDA
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…
Michigan Appellate Court Won’t Force Hospital to Administer Ivermectin to Covid Patient
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…
Defense Experts In; Plaintiffs’ Expert Out in Diabetes Drug MDL
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…
Jurors, Vaccination & Excusal for Cause
By Bexis
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…
Good Comment k Decision – and Some Mixed Holdings – in W.D. Pa. IVC Filter Case
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…
Narrowing The Scope Of Preemption-Related Discovery
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,…