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For design defect claims, a key issue is whether the relevant jurisdiction requires evidence that a suitable alternative design existed that would have allowed the plaintiff to dodge the alleged injury.  This blog has posted at length about alternative design requirements and their nuances.  These posts address everything from the existential question of “What

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Abuse of substantive law as a weapon to force settlement occurs so frequently in multidistrict litigation (“MDL”), that we’ve given it a name – “the MDL treatment.”  The linchpin of the MDL treatment is that plaintiffs are allowed to take way more liberties with state law than the Erie doctrine allows.  Readers can recall from our prior posts that both the Supreme Court and Third Circuit (to take the relevant example), view expansive federal court “predictions” of state law – and state tort law in particular – usurp the prerogatives of the states and are an abuse of power. Continue Reading CPAP MDL Overinflates Plaintiffs’ Claims

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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

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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

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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

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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