Class III Medical Devices

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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

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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

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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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This post is from the non-Reed Smith side of the blog.

We don’t usually report on securities-law cases, but today we do. That is because the well-reasoned decision in question, In re Allergan PLC Securities Litigation, 2022 WL 17584155 (S.D.N.Y. 2022), has major implications for the parallel Textured Breast Implant MDL now pending in

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Product liability litigation over Class III medical devices is an interesting creature.  Absent something unusual, cases and litigations should not get past motions to dismiss.  That is pretty clearly what Congress intended when an express preemption provision was added to the Medical Device Amendments of 1976.  We understand that each plaintiff may think her case is exceptional in that it should meet the exception to the rule of preemption.  (We do not really think the plaintiff lawyers think that, although they sure argue it enough.)  But the usual is more common than the unusual by definition.  When you hear hoof beats, you should look for a horse not a zebra, unless you happen to be in a part of the world where zebras are endemic or end up in a zebra enclosure in a zoo.  When you hear Class III medical device product liability case, you should look for all claims to be dismissed unless there is something as unusual as a basis to claiming the plaintiff’s particular device deviated from its FDA-approved specifications.

In 2001, the Supreme Court made getting past motions to dismiss harder when it held in Buckman that plaintiffs could not recover claims predicated on violations of FDA regulations.  An unfortunate fiction developed post-Buckman—particularly after Riegel v. Medtronic, Inc. 552 U.S. 312 (2008)—that plaintiffs could assert “parallel claims” that were neither expressly preempted by the provisions of the MDA nor impliedly preempted under Buckman.  We, and others, have described the purported path of a parallel claim as being like navigating between Scylla and Charybdis, a monster and whirlpool on opposite sides of a narrow strait per ancient Greek mythology.  Without claiming that mythology is the same as fiction—we are not touching that with a twenty foot sarissa—we can say that a true parallel claim is as rare as a striped unicorn or perhaps a flying horse.  The unfortunate fiction of which we spoke above has taken shape with particularly egregious appellate decisions like Bausch such that some trial courts are advised, when they hear the hoof beat of a Class III medical device product liability case, to expect Pegasus or his stripy, horned pal to gallop around the corner.

Viewed over the course of more than five years and many decisions, three of which have featured in prior posts (here, here, and here, which drew honorable mention honors in 2018), we think Bausch delayed the inevitable in Gravitt v. Mentor Worldwide, LLC, __ F.Supp.3d __, 2022 WL 17668486 (N.D. Ill. Dec. 14, 2022), by insisting that parallel claims for failure to report adverse events to FDA exist.  After an unnecessary odyssey, the manufacturer of a Class III breast implant won summary judgment on the last of plaintiffs’ claims, alleged failure to report adverse events to FDA.  (We say “plaintiffs,” but the decision referred to the plaintiff with the implant—who we will call the “plaintiff”—by her first name and the consortium plaintiff by his first name.  In terms of whether the last claim was supported, the court referred the female plaintiff only and somehow omitted any reference to “burden.”  These are usually signs that at least one claim will survive summary judgment.)  A shout out to Dustin Rawlin and his colleagues for sticking it out on this case and sending us this decision.Continue Reading Fallacious FDA Reporting Claim Finally Falls

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We are not the only ones who have pointed out that every new contraceptive for the last fifty years or so has been the subject of litigation and that it is not hard to see how the burden associated with such litigation, even if the manufacturer does well, discourages the development of new options.  This

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Under Fed. R. Evid. 9(b), “[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.”  In our sphere, federal courts are quite variable in how they apply this standard when deciding 12(b)(6) motions.  In particular, MDLs seem to have an unfortunate habit of allowing general allegations to support

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This post is from the non-Winston & Strawn side of the blog.

As we write today, we are nine days from an event, two years in the planning, that we have mentioned in these pages before.  We are taking the Drug and Device Law Dowager Countess (nearly 88) and her slightly younger sister to see