Each of these cases is significant enough to merit its own post, but since they came down within a week of each other, we’re discussing both of them here. They are: Gahl v. Aurora Health Care, Inc. ___ N.W.2d ___, 2023 Wisc. LEXIS 137 (Wis. May 2, 2023), and M.T. v. Walmart Stores, Inc., ___ P.3d ___, 2023 WL 3135662 (Kan. App. April 28, 2023).
Continue Reading Two New Appellate COVID-Related Developments
We start with the usual poodle report – actually with a comment that these may be drawing to a close, as Luca is only a few points from finishing his championship and coming home. We suspect this will cause little grief for readers of this blog (the Drug and Device Law Rock Climber and other
Last week we told you about two decisions in the In re Acetaminophen − ASD-ADHD Products Liability Litigation, MDL No. 3043, that were improvements over last November’s debacle of a preemption decision. Today we report on a decision that makes it a trilogy. We are still reserving judgment, but with hope.
This MDL is
When last we wrote, we had just watched our gorgeous standard poodle puppy, Luca, compete in his first weekend of dog shows. He was still learning the ropes, and, though he looked beautiful, he did not win any points. (Dog shows are worth from one to five points for each breed, depending on the number
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
When last we spoke, we were about to deliver our beautiful standard poodle puppy, Luca (registered name Tivin Dreamcatcher), to his show handler, who would trim him and train him and launch his dog show career. The transfer was accomplished without incident, if you don’t count mommy’s predicable reaction to the separation. It also included
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
One of 2022’s top-ten cases, In re Zantac (Ranitidine) Products Liability Litigation, ___ F. Supp.3d ___, 2022 WL 17480906 (S.D. Fla. Dec. 6, 2022), opened with a 4-page critique of the shortcomings of the product testing conducted by a purportedly “independent” laboratory that touched off that massively meritless MDL litigation. Id. at *1-4.
More bogus product “testing” formed the basis for Sapienza v. Albertsons Companies, Inc., et al., 2022 WL 17404919 (D. Mass. Dec. 2, 2022), which was likewise dismissed four days earlier, only on preemption rather than Rule 702 grounds. Sapienza was a putative nationwide class action based on allegations that “independent testing” showed the defendant’s over-the-counter (“OTC”) “rapid release” acetaminophen product “dissolve[d] more slowly than” similar products that were not labeled “rapid release.” Id. at *1. The rest of the complaint consisted of the usual boilerplate economic loss/“premium” pricing claims. Id.
Continue Reading OTC – One Terrible Class Action – Dismissed
We write from Tampa, Florida, where we attended the bridal shower of a lifelong friend’s daughter. In a happy coincidence, the event fell on the last weekend of a two-week stretch of dog shows in which our puppy’s sire, a spectacular white corded Standard Poodle named Joel, was being shown. A lovely interlude, except for
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
