We’ve re-read Monsanto Co. v. Durnell, No. 24-1068, 609 U.S. ___, 2026 LX 336645, 2026 WL 1825691 (June 25, 2026) (“Durnell”), a few times over the past few weeks. As Bexis noted in his quick-out-of-the gate (and great) analysis, there is a lot in there to use in our medical device
We have been mulling over Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024) and federal preemption.
Yes, we need a life, but let’s put that aside for the moment.
In particular, we’ve been reviewing a rash of complaints where plaintiffs contend that the FDA’s decisions about whether to grant or deny premarket approval
We write from Tampa, Florida, where we attended the bridal shower of a lifelong friend’s daughter. In a happy coincidence, the event fell on the last weekend of a two-week stretch of dog shows in which our puppy’s sire, a spectacular white corded Standard Poodle named Joel, was being shown. A lovely interlude, except for
This post is from the non-Winston & Strawn side of the blog.
As we write today, we are nine days from an event, two years in the planning, that we have mentioned in these pages before. We are taking the Drug and Device Law Dowager Countess (nearly 88) and her slightly younger sister to see
As we write this, our firm’s “return to office” date is less than two weeks away. We will be delighted to see, hug, and collaborate in person with colleagues we’ve missed for two long years (computer visages notwithstanding), though we confess to panic at the prospect of “real clothes.” And shoes. It’s all a bit
Before we turn to today’s case, a quick update: when last we spoke, we were about to board a plane for Peoria – our first work trip in sixteen months. We were excited about it. We regret to report that we stepped out of the plane into something resembling a weird post-apocalyptic Mad Max movie.
We were in western Tennessee last week for an argument. We stayed at a beautiful and venerable hotel, most famous for twice-daily “march of the ducks.” Every morning, at 11 a.m. sharp (at least 30 minutes after guests have packed the lobby), an elevator door opens, and a uniformed “duck master” leads a perfect procession
On our office bulletin board, we keep a post-it listing the states we have not yet visited. We are down to ten, and we expected to cross Oregon off after a deposition last week. But our deponent moved from Bend, Oregon to St. George, Utah. We’ve been to Utah lots of times, and were annoyed
A couple of weeks ago, our co-blogger, Mr. McConnell, published a post on the benefits of brevity. That post sprang from an argument before the JPML, but we can riff on it today as we examine a short and lovely decision from the Northern District of New York. We have all suffered through opinions in
This post is from the non-Reed Smith side of the blog.
We post a lot about preemption. We post a lot about PMA preemption. That’s because thanks to Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) and Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), almost all claims brought against pre-market approved medical devices are either expressly or impliedly preempted. What remains is a “narrow gap” through which a PMA medical device claim must fit in order to withstand a preemption challenge. And as demonstrated by our Device Preemption Scorecard which now has 336 entries – the gap just keeps getting narrower.
There are still a few claims that continue to squeeze by as “parallel violation” claims – misrepresentation claims come to mind – but they tend to fail on pleadings grounds and/or tend to be the more difficult of the claims to prove (with elements like reliance often being the sticking point). And a few courts have allowed some claims to slip through that we think should have crashed on the shoals. One word, Stengel. Even these, however, remain in the minority.
But all of this defense-friendly case law hasn’t stopped plaintiffs from still trying to thread the needle. We’ve seen some creative pleading in recent years and PMA complaints have become more upfront with allegations of alleged parallel violations. Fortunately most courts haven’t been persuaded by the use of “magic words” to create a parallel claim. It’s not enough to say the claim violates federal law. If we are talking about a duck, you better show that what you have looks like a duck, swims like a duck, and quacks like a duck. Otherwise, it’s no duck. It’s a preempted claim. Plaintiffs in Gates v. Medtronic, Inc., slip op., No. 1:15-cv-00726-RP (W.D. Tex. Jun. 29, 2016) didn’t have a duck.Continue Reading Post-Recall Negligence Claims Preempted