For much of the sixteen and a half years of this Blog, we have been tracking the acceptance and rejection of the learned intermediary doctrine. The first year that we compiled a worst decisions of the year list it was topped by a case that still holds the title for worst, most thinly veiled legislation
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
When we say “bananas,” today’s case is actually about bananas, that herb people tend to call a fruit. It is also quite unusual and complicated. Because it also involves some tragic underlying events, our quips are done. A bit of etymology is warranted, though. We used the term “judge-made law” in the title and that
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
We tend not to post much on appellate statute of limitations decisions. There are a few reasons for that. First, they are often very fact-specific, rarely delivering holdings with clear applications to other cases. Second, because they can be fact-specific and plaintiffs are known to plead around defenses, good decisions on motions to dismiss are
If you are even a casual reader of this blog, you have probably come upon a post disparaging the rulings coming out of the In re BHR Hip Implant Products Liability Litigation. That court’s PMA preemption opinion made our worst decision list for 2018. It rendered an abysmal decision finding that failure-to-report claims
Now that all three parts of our 50-state survey examining the state of state law concerning allegations that a defendant can state a common-law cause of action where the allegedly liability creating conduct is failure to make a statutorily mandated report to a governmental agency has been published, we have consolidated all fifty states under
Now that all three parts of our 50-state survey examining the state of state law concerning allegations that a defendant can state a common-law cause of action where the allegedly liability creating conduct is failure to make a statutorily mandated report to a governmental agency has been published, we have consolidated all fifty states under
Not too long ago we discussed the decision in In re Allergan Biocell Textured Breast Implant Products Liability Litigation, 537 F. Supp.3d 679 (D.N.J. 2021) (“TBI”). TBI addressed quite a few topics, one of which was the first nationwide (or close to it) analysis of whether a given jurisdiction permitted, under state
Given the events of the last eleven months or so, we give ourselves and other legal commentators a preemptive pass for the following situation: you read a case, you think about how you would describe it, and you see that you have described similar cases in a similar way more than once. This could be