Class III Medical Devices

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Not too long ago we saw a story in the legal press about a newly filed case in Minnesota where the plaintiff claimed that the FDA was going easy on the defendant because it approved “hundreds of premarket supplements” rather than requiring “a new PMA application.”  Supposedly “[b]y utilizing the [premarket approval] supplement process instead of filing a new PMA application, [the defendant] avoided the rigorous scientific review, public comment and clinical trial requirements.”

That’s barnyard excrement.  This plaintiff isn’t just wrong s/he is loud wrong – which, for plaintiffs, is unfortunately rather common.Continue Reading Supplemental Authority

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A month or so ago, we castigated some extremely poorly reasoned expert exclusion decisions in the Bulox v. Coopersurgical litigation.  The end results weren’t horrible (p-side motions were denied), but th0se Rule 702 opinions completely ignored the changes wrought by the 2023 amendments to that Rule.  It was so striking that we went on PACER to see whether defense counsel was to blame for any of that – they weren’t.

Well, today we’re cheering the latest decision(s) in the same litigation.  Bulox v. Coopersurgical, Inc., 2025 U.S. Dist. Lexis 56370 (Mag. S.D. Tex. March 6, 2005) (“Bulox I”), adopted, 2025 U.S. Dist. Lexis 54755 (S.D. Tex. March 25, 2025) (“Bulox II”), is as good a PMA medical device preemption decision as a defendant has a right to expect.  This Bulox decision should go a long way towards defeating the other side’s latest campaign to deprive women of contraceptive choice.Continue Reading Clip, Clip Hooray

Photo of Susanna Moldoveanu

Today’s case has shocking facts but not a shocking result. It should come as no surprise that a complaint attacking the safety of an FDA-approved Class III medical device is squarely preempted by the express preemption provision of the Medical Device Amendments, 21 U.S.C. § 360k(a). But somehow, 17 years post-Riegel, that still does not seem to deter plaintiffs from filing plainly preempted claims.Continue Reading No Shock Here: D. Mass. Holds Complaint Regarding Class III Medical Device Preempted

Photo of Michelle Yeary

And patience is a virtue…all great achievements require time…trust the process.  All easier said than done.  Waiting can be a breeding ground for discouragement or frustration—like in litigation where, unfortunately for defendants that waiting usually comes at the significant cost of having to defend against and conduct discovery.  Especially when the result after all…

Photo of Susanna Moldoveanu

Today we report on the court’s order granting Defendant’s motion to dismiss in Keim-Bacon v. Stryker Corp., No. 4:22-CV-00383-WPJ-MTS, 2024 WL 4886051, at *1 (N.D. Okla. Nov. 25, 2024). It is a straightforward application of Riegel preemption that gets it right on all fronts.

The Scandinavian Total Ankle Replacement System (“STAR”) is a Class…

Photo of Susanna Moldoveanu

Today we discuss an excellent express preemption decision from the District of Arizona, Skinner v. Small Bone Innovations Inc., 2024 WL 3639296 (D. Ariz. Aug. 2, 2024).

This decision involved the Scandinavian Total Ankle Replacement device (“STAR”).  The STAR® Ankle is a Class III medical device subject to the Medical Device Amendments’ express preemption provision, 21 U.S.C. § 360k(a).  This was Plaintiff’s second bite at the apple:  The Court had already granted Defendants’ motion to dismiss but with leave to amend to attempt to state a parallel claim.  See Skinner v. Small Bone Innovations Inc., No. CV-23-01051-PHX-MTL, 2023 WL 6318014, at *6 (D. Ariz. Sept. 28, 2023).  After striking out in round one, Plaintiff fared no better in round two.Continue Reading Slam-Dunk Express Preemption Decision from the District of Arizona

Photo of Stephen McConnell

We have often characterized judicial options as mixed bags, and a recent example of such a mixed bag can be found in Muldoon v. DePuy Orthopaedics, Inc., 2024 U.S. Dist. LEXIS 130020 (N.D. Cal. July 23, 2024). The plaintiff claimed injuries from a ceramic-on-metal hip implant.  He alleged that friction and wear caused the…

Photo of Lisa Baird

We write a lot of briefs involving federal preemption and Class III medical devices with premarket approval (or “PMA”).  Many of those briefs are in support of motions to dismiss lawsuits brought by attorneys who don’t regularly practice in the pharmaceutical and medical device product liability space. 

The complaints filed by such attorneys often are…

Photo of Stephen McConnell

Last week we saw an article on a baseball website about batters who, through umpire forgetfulness or whatever, were not called out until strike four.  Then we read Comatov v. Medtronic, Inc., 2023 WL 2922830 (C.D. Cal. March 16, 2023), in which the court did not call a complete and final stop (like what the teenagers…

Photo of Eric Alexander

When we started seeing a smattering of cases over long-term contraceptive devices used in connection with tubal ligation surgery, we were not surprised.  Plaintiff lawyers have targeted a wide range of contraceptive drugs and devices for decades.  Commentators beyond this Blog have described how this bent affects contraceptive choice and public health.  When we saw…

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Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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