If we have said it once, we have said it a hundred times: medical product manufacturers are not insurers of their products. Almost as frequently uttered would be that strict liability is not the same thing as absolute liability. In the show position might be that the temporal relationship between a new medical condition and
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
California state court is not the place most products liability defendants want to end up. Unfortunately, today’s case had to stay in state court because plaintiff sued the defendant’s device representatives who had direct contact with the plaintiff. The reps, like plaintiff, were California residents and destroyed diversity jurisdiction. The decision, however, in James v.
This post is from the non-Dechert side of the blog.
After more than a month away at trial, we probably should not have picked a case that hit so close to home, so to speak. Spear v. Atrium Medical Corp., — F. Supp. 3d –, 2022 WL 3357485 (E.D. Pa. Aug. 12, 2022), is
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
Bostic v. Ethicon, Inc., 2022 WL 952129 (E.D. Pa. March 29, 2022), is a Pennsylvania mesh case raising a host of familiar issues in a motion to dismiss context. The complaint is of the typically overpleaded (14-count) variety. Dickens was not really paid by the word, but plaintiff lawyers seem to think they might
These days, you are probably expecting a vaccine post to be about Covid. And while we are sure we are not done with litigation in that field, for today at least we thought we would harken back to a good, old-fashioned, garden variety vaccine products liability case and some tried and true preemption.
The plaintiff
It’s time for the Mesh Case of the Week. In Dupere v. Ethicon, Inc., 2022 WL 523604 (S.D.N.Y. Feb. 22, 2022), the plaintiff filed a lawsuit claiming injuries from pelvic mesh that had been implanted in her to treat stress urinary incontinence. The court ended up dismissing many of the causes of action. That
We report, with excitement and apprehension, that we have tickets to see Hugh Jackman as Harold Hill in The Music Man next month on Broadway. The Drug and Device Law Dowager Countess blushes and giggles at the mention of Jackman, and the outing seemed a worthy one, not without apparent urgency given time’s ravages (the
Here are some things you probably will not hear very often, if at all: 1) a fervent supporter of a defeated political candidate agreeing that the winning elected official has done a good job, regardless of economic growth, infrastructure projects, public health progress, or some other measure of good government; 2) a fervent supporter of