Stop us if you have heard us say “stop us if you have heard this before.” Pelvic mesh cases on remand have often faced the harsh realities of procedural requirements and burdens of proof because transferee judges have treated them like individual cases rather than items in an inventory. Decisions about the impact of failure
Pro Se Plaintiff Tries and Fails To Plead Claims For Failure To Withdraw And Failure To Warn
We have made no secret of our long-held views that “failure to withdraw” or “stop selling” theories of liability for FDA-authorized medical products are unwarranted perversions of state design defect law and preempted anyway. When we say long-held, we mean it, because we had a few of the first cases where this theory was put
Plaintiffs Cannot Turn Their Burden To Prove Causation Into Partial Summary Judgment
Duh. We apologize for the depth of our profundity, but there are some legal principles we think are really obvious. So obvious, in fact, that we might respond to question about these principles with this most dismissive of (clean) interjections. (We were somewhat surprised to learn from the interwebs that duh was supposedly first used
Stretching Specific Personal Jurisdiction And Shrinking Preemption At The Pleadings Stage
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
Even The Most Lenient Of MDL Judges Has A Limit For Excusing Plaintiff Lawyer Neglect
Stop us if you have heard this before. One of the big problems with MDLs in the era of unchecked lawyer advertising, litigation funding, and the focus of MDL judges on mass settlement is that a high percentage of plaintiffs never have to do any heavy lifting between filing their cases and participating in some
Unusual Indictment of MDL Practices
We have not been terribly shy in voicing our concerns over certain practices we see in drug and device MDLs. Some of these concerns are directed to plaintiff lawyers, some to the judges overseeing the MDLs, and some to both. For instance, we think many MDL judges are far too lenient in allowing plaintiffs
Litigation Over COVID-19 Policies Continues
If we had forgotten that there continue to be abundant U.S. cases of COVID-19, then there was plenty around us to remind us. Public mask usage seems to have increased. We heard how the “tripledemic” of viruses had made hospital beds scarce. We have had colleagues out of commission instead of completing our assignments. The
Punting Generic Drug Preemption In The Taxotere MDL
We have posted quite a bit about the Taxotere MDL and some Fifth Circuit decisions on appeals from it. The decisions have mostly been pretty good. We have posted even more about the treatment of broad preemption issues in MDLs in recent years. From our perspective, there have been too many denials of strong defense
Fallacious FDA Reporting Claim Finally Falls
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
Criticizing FDA Reporting Systems Should Not Be Enough To Plead A Warnings Claim
Two weeks ago, we decried the pattern that some courts follow in allowing shifting slates of boilerplate allegations to cases to discovery. The decision in Corrigan v. Covidien LP, No. 22-cv-10220, 2022 U.S. Dist. LEXIS 210296 (D. Mass. Nov. 21, 2022), reminded us of another of our post-TwIqbal pet peeves: when courts treat sweeping legal conclusions as if they were plausible factual assertions. The basic allegations in Corrigan were that the plaintiff’s surgeon used defendant’s surgical stapler to perform an anastomosis—reattachment of two parts of the digestive tract—in connection with removing part of his sigmoid colon (for unspecified reasons, but often diverticulitis or cancer) and the anastomosis later leaked, leading to further surgical intervention. As we said two weeks ago, medical device manufacturers are not insurers. That makes sense because surgery on humans, even done by the best surgeons, in the best hospitals, and with the best devices and equipment, has less than a 100% success rate. Anastomoses leak, infections develop, hernias recur, patients report post-operative pain, and all manner of complications and less than optimal outcomes occur. A common refrain when scientists are presented with a surgical study reporting no complications or failures is that the study was too small, too short, and/or insufficiently rigorous. Thus, a common procedure with a very high success rate will still generate large numbers of reported failures, like anastomoses that leak. This is part of why rates, and particularly comparative rates, provide more useful information about devices and surgeries than do gross numbers.
Even more authoritative sources than this Blog agree with us. FDA, for instance, makes clear that data from its Manufacturer and User Facility Device Experience (“MAUDE”) database “is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices.” The reasons for this are not a secret: “The incidence, prevalence, or cause of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use.” Directly stated, “[t]he submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event.” FDA’s description of the MAUDE database also makes clear in a number of places that the data may be outdated or incomplete for various benign reasons.
Continue Reading Criticizing FDA Reporting Systems Should Not Be Enough To Plead A Warnings Claim