Today’s case is not our usual fare.  But we’ve never seen this kind of appeal succeed before, so we’re going to spare a few minutes for something a little odd but important. First of all, the patient and the medical device manufacturer are on the same side – they’re both plaintiffs in Alcresta Therapeutics, Inc. v. Azar, 2018 U.S. App. LEXIS 33961 (D.C. App. Dec. 3, 2018).  Because in this suit, the medical device manufacturer…

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 Modernization Act), and provides: (ii) In lieu of submitting a report under section 360(k) [a/k/a/ §510(k)] . . ., if a person…

A federal court in Utah ruled the other day that it had no personal jurisdiction over a corporate parent, even though the plaintiffs alleged that the defendant subsidiary was the “alter ego” of its owner.  We read the order with great interest for a couple of reasons.  First, one of our first assignments out of law school was to respond to discovery and write motions for an insurance company’s parent—a holding company that held considerable…

Late last month Bexis attended the annual ACI Drug and Medical Device Conference in New York.  In between helping to lead the discussion in the pre-conference Defense Counsel War Room and speaking on 3D printing and product liability, Bexis picked up a couple of interesting ideas about dealing with problems concerning federal multi-district litigation (“MDL”) that he hadn’t heard before.  We’re passing them along.  Even if they don’t ultimately get anywhere, at least our readers…

We typically steer clear of discussing any opioid cases for client reasons. But today we have a case that did not involve our client in any way and that involves a discrete and important issue. Accordingly, we hereby render a bare-bones report. The case, Floyd v. Feygin, et al., No. 507458/17 (Kings County, N.Y. Supreme Court Nov. 28, 2018) (available here: https://druganddevicelaw.reedsmithblogs.com/wp-content/uploads/sites/30/2018/12/Dabiri.pdf) is a civil case, but it pretty much was a follow-on to a…

This post comes from the Cozen O’Connor side of the blog only.    Last year, we favorably cited Canary v. Medtronic, Inc. 2017 WL 1382298 (E.D. Mich. April 18, 2017), on two occasions, once to highlight its use of TwIqbal at the motion to dismiss stage and again as a part of our preemption scorecard.  Canary was a winner. That decision, however, dismissed only plaintiff’s product liability claims, letting her fraud claim move forward.…

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 probably spilled as much ink as anyone in making sense of Restatement (Second) of Torts §402A, comment k (1965), one…