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 involving prescription medical products. Id. at *11-13. In so doing Schrecengost was not only wrong, but loud wrong. First, without even a serious discussion, Schrecengost
Class II Medical Devices
Med 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 the day with time to kill. The opinion started off talking about the basic medical facts of the case and we were…
One, 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, umm…., last year actually. But this year, having added possibly the best player and best catcher in the league,…
Federal 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 unfair manifestation of this myth is the entry of orders in limine in a number of recent medical device cases excluding evidence of…
