Not too long ago we researched and posted about how preemption precludes private plaintiffs from second-guessing FDA decisions on the marketing and classification of the products the Agency regulates.  Looking through that post again, we note that quite a few of those decisions (although well less than half) involved commercial disputes of one sort or another.  See Sandoz Pharmaceuticals Corp. v. Richardson-Vicks, Inc., 902 F.2d 222 (3d Cir. 1990); Hi-Tech Pharmaceuticals, Inc. v. Hodges Consulting,…

We slipped our summer vacation in just before summer slipped away. Last week, we walked the rocky shores of Cape Cod, ate lobstah rolls the size of trolley cars, and navigated our way through the traffic catastrophes charmingly known in New England as “rotaries.” On our last day in the Bay State, the temperature plunged. Many fellow strollers on the sand donned down jackets. Summer in Massachusetts has a way of vanishing suddenly. On our…

We’ll be very clear – as we have before:  We don’t like most class actions.  Indeed, if given our druthers, we would abolish Rule 23, as it applies to class actions for damages, altogether.  But that’s not in the offing anytime soon.  Today, we offer a class action decision that we think both sides, us on the defense and those on the plaintiffs side, can agree on, excluding only those responsible for the problem. In…

Stop us if you have heard this before.  A group of plaintiffs bring a purported class action under a range of California consumer protection laws seeking damages related to the purchase of a medical product (or collection of somewhat related medical products) that they claimed failed to comply with FDA requirements.  The defendants raise preemption and/or primary jurisdiction in a motion to dismiss.  We blog about the resulting decision.  While the problem may be with…

Defendant manufacturers of FDA-approved Class III medical devices generally do pretty well with preemption motions, as our PMA Preemption Score Card (now with well over 500 decisions) demonstrates.  Conley v. St. Jude Medical, LLC, ___ F. Supp.3d ___, 2020 WL 5087889 (M.D. Pa. Aug. 28, 2020), is one of these, but some aspects of Conley make it more interesting than most PMA preemption decisions – presumably why West chose it for publication in F. Supp.…

In what’s a bit of a mixed bag decision, the ultimate takeaway from Bird v. Globus Medical, Inc., 2020 WL 5366300 (E.D. Calif. Sep. 8, 2020) is that the complaint was generally lacking.  So, plaintiff is going to get a second chance.  Meanwhile, we can take a look at just what wasn’t up to par on the first go-round. Plaintiff underwent surgery on her cervical spine (neck) during which her surgeon implanted a device allegedly…