Kelley v. C.R. Bard, Inc., 2023 WL 2565853 (N.D. Ga. March 17, 2023), reconsideration denied, 2023 WL 3032063 (N.D. Ga. April 21, 2023), became the latest decision to follow what used to be (before the Pelvic Mesh litigation used the law in this area as a settlement tool) the overwhelming majority rule, that FDA decisions to allow products to be marketed – including §510(k) clearance – were routinely admissible.
Continue Reading Another Decision Admitting Evidence of FDA §510(k) Clearance
Several weeks ago, we reported on Greisberg v. Boston Scientific Corp., 2022 WL 1261318 (3d Cir. 2022), in which the Third Circuit affirmed dismissal of a failure-to-warn claim because the plaintiff had failed to allege facts sufficient to overcome New Jersey’s “compliance presumption,” a statutory presumption (adopted by numerous states) under which a medical
We tend to favor a “glass half full” outlook. We are preternaturally sunshiny during our daily “how was your day” calls from the 86-year-old Drug and Device Law Dowager Countess. (We have not mentioned, for example, that our aging dog has begun sleeping most of the day and barking most of the night, resulting in
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 we rushed to the vet one last time, this time to address the Pom’s allergic skin reaction to
It is now 2019, but we are still finding bits of leftover 2018 business on our desk and in our emails. Towards the end of last year, we encountered an avalanche of good rulings from the Southern District of Indiana in the Cook IVC filters litigation. Here is one we found hidden in the toe
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 much as sixteen inches of snow fell in some suburbs, and thousands of people, some