Last year we reported on Plourde v. Sorin Group USA, Inc., 2021 WL 736153 (D. Mass. 2021), which held that the plaintiff’s failure-to-warn claims were expressly preempted by 21 U.S.C. § 360k(a) because those claims were based on an alleged failure to report adverse events to the FDA and the plaintiff had not shown
This post is from the non-Reed Smith side of the blog.
This blog has repeatedly lamented the tendency of MDL courts to flout federal pleading standards when assessing the sufficiency of master complaints. All too often MDL courts disregard Rule 8(a), which—as authoritatively interpreted by the Supreme Court in Twombly and Iqbal—requires plaintiffs to
Today we report on a recent decision dismissing manufacturing-defect, warranty, and failure-to-warn claims arising from an allegedly defective breast implant. Although the decision, D’Addario v. Johnson & Johnson, 2021 WL 1214896 (D.N.J. 2021), does not stray far from the beaten path, it covers ground worth revisiting. The decision is a useful (if cursory) reminder
This is the third consecutive week a case from Indiana has been in our sights. By and large, we have been impressed with the quality of the Indiana judiciary in both the state and federal courts. One hallmark of exemplary judging is the capacity to revisit rulings and change course when necessary. We clerked for
This post is from the non-Reed Smith side of the blog.
When we posted about Sikkelee v. Precision Airmotive Corporation, 907 F.3d 701 (3d. Cir. 2018) we thought it should be the end of failure-to-report claims in the Third Circuit. But, since that decision was about an FAA failure-to-report claim, we felt it was
We’ve always hated the Ninth Circuit’s decision in Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (applying Arizona law), holding that allegations of failure to provide adverse event reports (“AERs”) to the FDA created a viable, and unpreempted, state law claim. Now our #2 worst case of 2013 is effectively gone. Kaput.
It would seem to go without saying that for a defendant to be liable for the purported “common-law” claim of failure to report adverse events to the FDA, there must actually be some adverse events that needed to be reported. One would think so, but certain California breast implant plaintiffs (yes, some still exist) would
If a court acknowledges that no state or federal appellate courts in the jurisdiction have addressed the question before it, we think at a minimum there also should be an acknowledgement of the Erie doctrine. Yet, in the case of Fogel v. Sorin Group USA, Inc., 2018 WL 4680022 (S.D.N.Y. Sep. 28, 2018) you
This post is from the non-Reed Smith side of the blog only.
We truly dislike decisions that find that claims of failure to report adverse events to the FDA are non-preempted, parallel violation failure to warn claims. Failure to report claims are not parallel. Federal law does not require warnings to plaintiff or her doctors.
Claims predicating prescription medical product liability claims on purported failure to report adverse events to the FDA – á la Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir., 2013) (en banc), Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011), and Coleman v. Medtronic, Inc., 167 Cal. Rptr.3d 300