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

In addition to having Green Mountains, maple syrup, lake houses, an ice cream company run by summer camp buddies, a mitten wearing Senator, and a history of low COVID rates, Vermont has a history of being a legal outlier.  Some of its positions might be considered progressive or regressive.  The legislation discussed here is a

Given the events of the last eleven months or so, we give ourselves and other legal commentators a preemptive pass for the following situation:  you read a case, you think about how you would describe it, and you see that you have described similar cases in a similar way more than once.  This could be

Albert Einstein supposedly said, “Insanity is doing the same thing over and over again and expecting different results.”  He may not have, but the point is well taken.  We often think the same thing – particularly about plaintiffs that sue manufacturers of FDA premarket-approved (“PMA”) medical devices with vague, boilerplate complaints.  Haven’t they heard about

Plaintiffs tend to assert a bunch of different claims.  For prescription medical device cases, setting aside preemption, our experience is that plaintiffs do best—that is, avoid summary judgment and directed verdict—with design defect (strict liability or negligence) claims.  One reason for that is that it tends not to be hard to make up some theory,

Most of the controversy in the recent decision, Hill v. Bayer Corp., 2020 WL 5367334 (E.D. Mich. Sept. 8, 2020), revolved around whether the plaintiff could assert a cause of action for failure to report adverse product events to the FDA.  Like the great majority of decisions (particularly since Conklin v. Medtronic, Inc.,