We opposed the FDA’s ill-advised 2013 proposal to revamp the process for changing generic drug labeling from the outset. We had legal objections – that an FDA regulation could not alter the statutory “sameness” requirement imposed on generic labeling. We had practical objections – that the change was a sop to the plaintiffs’ bar,
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
That is the intriguing title of the latest law review article written by the “Rabbi of Torts,” Prof. Aaron Twerski (we’re not making this up, Prof. Twerski’s Wikipedia page is the fifth result when we just Googled that phrase). Prof. Twerski, one of the ALI’s reporters for the Restatement (Third) of Torts: Products Liability, has
As we roll out of bed on the day after Thanksgiving, we are often confronted with contradictory thoughts. For instance, “why did I have that third plate at dinner?” might be followed by “How can I eat some leftovers for breakfast?” Leftovers are as much of an American tradition on this day as watching videos
Today we have another guest post by long-time friend of the blog, Dick Dean, and his colleague at Tucker, Ellis, Mike Ruttinger. Regular readers will recall, that right after Sikkelee v. Precision Airmotive Corp., ___ F.3d ___, 2018 WL 5289702 (3d. Cir. Oct. 25, 2018), was decided, we blogged about the
An unexpected bit of good news as we go into November. Bexis will be presenting at the Reed Smith annual client CLE program on big-deal pending cases. In preparation, he took a look at the SCOTUSBlog page for Merck Sharp & Dohme Corp. v. Albrecht, No 17-290 (that’s the Supreme Court name for In
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