Mostly Favorable MIL Rulings in IVC Filters Litigation
Here in Philadelphia, less than a week before the first day of Spring, it is sunny and calm, albeit a bit chilly. Not so last week, when we were hit with the second Nor’easter in less than a week. As...
View ArticleFederal Court Rules That 510(k) Clearance Relates To Safety And Effectiveness
A myth that has regrettably gained some traction lately is that the FDA’s clearance of a medical device under the 510(k) substantial equivalence process is unrelated to safety and efficacy. One notably...
View ArticleOne, Two, Three Strikes You’re Out
With new grass on the field, the 2019 baseball season is underway and optimism springs eternal. Here in Philadelphia, the Phillies have actually around the top of the NL east for the first time since,...
View ArticleMed Mal Case Dives Deep Into Device Regulation
Reading through Obermeier v. Northwestern Memorial Hosp., __ N.E.3d __, 2019 IL App. (1st) 170553 (Ill. App. Div. June 28, 2019), reminded us of scrolling through television channels in the middle of...
View ArticleWrong Court and Wrong-er Reasoning − Ignoring 75 Years of Controlling Precedent
The opinion, Schrecengost v. Coloplast Corp., 2019 WL 6465398 (W.D. Pa. Dec. 2, 2019), recently “predicted” that Pennsylvania would allow strict liability design and warning defect claims in cases...
View ArticleEvidence of 510(k) Clearance Is Relevant and Admissible, Says E.D. Pa. IVC...
As we write this, it is a glorious Labor Day Monday in the suburbs of Philadelphia. We are pleased to confirm that the Drug and Device Law Rock Climber retrieved her dogs last week, though not before...
View ArticleFifth Circuit Affirms Dismissals and Summary Judgment in Defibrillator Case...
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...
View ArticleE.D. Pa. Trims Pelvic Mesh Claims
Bostic v. Ethicon, Inc., 2022 WL 952129 (E.D. Pa. March 29, 2022), is a Pennsylvania mesh case raising a host of familiar issues in a motion to dismiss context. The complaint is of the typically...
View ArticleDoctors Without Burdens: Another Mesh Court Goes Backwards
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...
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