We have written quite a few posts about litigation over inferior vena cava filters made by various companies. Most of those posts focused on decisions in cases pending in or remanded after a stint in one of two MDLs. Broadly speaking, those decisions involved filters intended to remain in place permanently and alleged injuries from
Maybe we have been doing this too long. Or maybe, like the prequels, spinoffs, and reboots that are so prevalent among streaming entertainment options, there is just a lot of repetition. In serial product liability cases, we hope that repetition leads to consistency of results or at least predictable rules of the game. Consider the
We came across something the other day that we don’t see very often, or really ever. The plaintiff in a medical device case served a request to inspect the two defendants’ manufacturing facilities, claiming that he was entitled to observe the premises where the device was made. Not so fast, said the defendants. And with
We have written a number of posts about pelvic mesh cases over the years. Some of us have also worked on a number of cases. At this point, many cases have gone from MDL to local district court to judgment to appeal. Over time, the tide seems to have turned. That could be because the
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.