The FDA has recently released a proposed rule “to establish requirements for the medical device De Novo classification process” provided in 21 U.S.C. §360c(f)(2).  FDA, “Medical Device De Novo Classification Process,” 83 Fed. Reg. 63127 (Dec. 7, 2018).  This de novo classification option is a relatively recent addition to the FDCA (via the 1997 FDA

A year and a half ago we celebrated a rare prescription drug preemption win in the Philadelphia County Court of Common Pleas.  Then the decision was appealed, and we held our breath.  Preemption is never an easy sell in state courts, and Pennsylvania appellate courts are not exactly defendant friendly in prescription medical product liability

This post comes from the Cozen O’Connor side of the blog.

Today’s story is about a class action, one in which the defendant was sued for labeling its product “No Sugar Added” even though everyone involved, including the plaintiff, understood from the very start that no sugar had been added to the defendant’s product.

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