An explanted medical device is an interesting thing.  It was designed and made to reside within the human body, and it was implanted for the purpose of saving or improving life, even if only cosmetically.  Sometimes it has to be removed, often by design and under the applicable standards of care.  Take for example retrievable

We’ve seen a couple of decisions recently in which defendants raised the “commonly known” hazards exception for medical device labeling, so we thought we’d give it a look.

The FDA’s regulations for medical device labeling generally require that such labeling include “any relevant hazards, contraindications, side effects, and precautions.”  21 C.F.R. §801.109(c).  That requirement comes

We had occasion recently to reread Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), and here’s what the Court said about why the “reasonable assurance of safety and effectiveness” standard is preemptive of personal injury claims:

[The FDA] may thus approve devices that present great risks if they nonetheless offer great benefits in light

Here are some things you probably will not hear very often, if at all:  1) a fervent supporter of a defeated political candidate agreeing that the winning elected official has done a good job, regardless of economic growth, infrastructure projects, public health progress, or some other measure of good government; 2) a fervent supporter of

Federal law regulates medical devices differently from pharmaceuticals, and branded drugs differently from generic drugs. Whether a particular state-law tort claim is preempted often depends on whether the claim involves a medical device, a branded drug, or a generic drug. Often but not always. As today’s case illustrates, there is one implied-preemption principle that applies

As we age, we sometimes forget how things used to be.  It is not just age-related deterioration of the synapses in our hippocampi.  (We do question why hippocampi and hippopotamuses are the preferred plural forms these days and why more anatomic structures are not named for things like seahorses.)  There is also a recency effect. 

With apologies, this time, to Sir Paul − “The circuit judge, who held a grudge, has put the FDA’s banned on the run. . . .”

That’s just about what happened in Judge Rotenberg Educational Center, Inc. v. United States FDA, ___ F.4th ___, 2021 WL 2799891 (D.C. Cir. July 6, 2021) (note the

When we think about litigation involving the FDA, our first thought is about preemption of claims brought by product liability plaintiffs.  Our second is probably the relatively recent line of cases where these plaintiffs would like no mention of FDA’s existence, let alone its requirements and actions, during the trial on their claims.  However, there