Not that long ago (last time we posted), the Sixth Circuit issued an unpublished opinion that affirmed the exclusion of an expert (yay!) but missed the boat on the amendments to Federal Rule of Evidence 702 and its reinforcement of the expert exclusion test (boo!). Today, we get to tell you about a published opinion... Continue Reading| Drug & Device Law
We recently returned from our summer vacation in a small European country with a tiny but charming coastline, formidable mountains, abundant vineyards, and relentlessly friendly service. That last bit serves as a clumsy segue into today’s case, Aguila v. RQM+LLC, 2025 U.S. Dist. LEXIS 155232 (S.D. Fla. Aug. 12, 2025), which is mostly about service... Continue Reading| Drug & Device Law
Today’s decision, Croci v. Zoll Medical Corp., 2025 WL 2307728 (S.D.N.Y. Aug. 11, 2025), is a straightforward, preemption-based 12(b)(6) dismissal of a complaint involving a Class III medical device. The case involves claims about a Life Vest, which is worn externally and monitors the wearer’s heart rate. The device is able to detect ventricular tachycardia... Continue Reading| Drug & Device Law
In his latest off-label use-related law review article in 2021, Bexis pointed out: [A]lthough states have traditionally been recognized to have broad authority to regulate the practice of medicine, aside from occasional attempts to restrict use of abortifacients, state-law interventions restricting the off-label uses of prescription medical products have been infrequent. James M. Beck, “Off-Label... Continue Reading| Drug & Device Law
Today’s post is our second installment about a case in the District of Massachusetts alleging injury from a Class III medical device. We blogged about it this spring when the court dismissed plaintiff’s claim that an implanted defibrillator and associated leads caused her numerous, unnecessary shocks. The court dismissed that complaint based on straightforward, premarket... Continue Reading| Drug & Device Law
In law school, many students struggle with the distinctions between personal jurisdiction, venue, and forum non conveniens (aka, FNC). In the real world of product liability, FNC is definitely viewed as a less effective tool in the defense litigation toolbox than the other two. Part of the reason is that the showing required for a... Continue Reading| Drug & Device Law
Today’s guest post is from Jamie Lanphear and Daniel Kadar, both of Reed Smith, who follow product liability events in Europe closely. They are discussing the implications of recent changes on the availability of attorney/client and work product privileges—called “legal professional privilege” in Europe—not only in Europe itself, but how European restrictions might find their... Continue Reading| Drug & Device Law
This post comes from the non-Butler Snow side of the blog. The Bair Hugger MDL has an up and down history. First, we lauded the district court’s Rule 702 rulings that led to summary judgment across the board for the defendant. But then the Eighth Circuit reversed. The cases came back to the district court... Continue Reading| Drug & Device Law
While updating the preemption chapter of his drug and device product liability treatise, Bexis came across a proposition he had not thought about in a long time. In two opinions in the Birmingham Hip (“BHR”) MDL, the court, under the aegis of Fed. R. Evid. 702, excluded expert testimony because it solely concerned a preempted... Continue Reading| Drug & Device Law
An appellate court in Texas filed an opinion last week that very helpfully defines and applies the standard for specific personal jurisdiction under a| Drug & Device Law
This publication offers insight and commentary regarding the defense of pharmaceutical and medical device product liability litigation.| Drug & Device Law
From a doctrinal standpoint, courts rely on a well-established principle: experts are permitted to testify to assist the fact-finder, not| Drug & Device Law
When a federal agency reverses course, the Supreme Court has a test to determine whether that agency action is impermissibly “arbitrary and| Drug & Device Law
In an earlier post, we discussed how the FDA, for over twenty years, from mid-1997 through mid-2019, created and operated an “alternative summary| Drug & Device Law
Bexis has been updating the preemption chapter of his treatise on drug/device product liability litigation. He came across several preemption| Drug & Device Law
Every now and then, the Reed Smith powers that be make seats in the firm’s skybox at the Phillies’ (first place – who woulda thunk?) stadium available to| Drug & Device Law
As we blogged at the time, we believe that the Ninth Circuit made a historic error in Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir., 2013) (en banc),| Drug & Device Law
When you write a few hundred or more posts for a legal blog devoted to the somewhat niche subject of drug and device product liability law, you look for| Drug & Device Law
Stephen McConnell| Drug & Device Law
Steven Boranian| Drug & Device Law
The plaintiff in Kane v. Covidien LP, 2025 U.S. Dist. Lexis 25718 (E.D.N.Y. Feb. 12, 2025), lost the bulk of her case recently, on a motion to dismiss no| Drug & Device Law
In our first-on-the-web quickie analysis of United States v. Caronia, ___ F.3d ___, 2012 WL 5992141 (2d Cir. Dec. 3, 2012), we didn’t have time to do much| Drug & Device Law
In 2018, our blogpost on In re Johnson & Johnson Talcum Powder Products Marketing, Sales Practices & Liability Litigation, 903 F.3d 278 (3d Cir.| Drug & Device Law
Michelle Yeary| Drug & Device Law
Researchers at Temple University here in Philly recently published a scientific article, “Learning Impairments, Memory Deficits, and Neuropathology in| Drug & Device Law
In addition to its recent revamp of its “§510(k)” substantial equivalence clearance process for medical devices, (see our post here), the FDA has also| Drug & Device Law