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The idea that software can be a product (as in “product liability”) is not new, but gray areas remain with regard to when that should be and how courts should handle it.  Take for example a case that we wrote on a couple of years ago, in which a district judge in Virginia granted summary judgment for the manufacturer of an electronic health records (“EHR”) system.  A patient suffered severe complications after a doctor entered post-op instructions into the hospital’s EHR computer system, but the hospital implemented the orders at the wrong time.  Whose fault was that?  We don’t know, but the district court ruled that, even though the patient’s experts identified software changes that would have made the system safer, they did not identify a standard of care that the EHR system failed to meet. 

Well, a couple of weeks ago, the Fourth Circuit reversed and held that the experts had very well identified a standard of care and further that there was evidence sufficient to support a failure-to-warn claim.  The case is Lowe v. Cerner Corp., No. 20-2270, 2022 WL 17269066 (4th Cir. Nov. 29, 2022), and the facts are worth repeating.  Following surgery, the patient’s surgeon entered orders for “continuous pulse oximetry” into the EHR software developed by the defendant and deployed by the hospital.  However, although the surgeon intended for pulse oximetry—i.e., checking blood oxygen—to be continuous, she chose “once” and “daily” from the system’s dropdown menus, which defaulted to 10:00 each day.  The system correctly displayed that time on the order confirmation screen, but several orders were entered that day, and the surgeon did not scroll down to review them all.  She clicked through some version of “accept all.”  Unfortunately, checking blood oxygen at 10:00 was too late for this poor patient, who suffered severe and permanent disability.  Id. at *2-*3. 

Continue Reading Yes Virginia, Software Can Be A Product

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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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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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This post is from the non-Reed Smith side of the blog.

A lawyer is a person who writes a 10,000-word document and calls it a “brief.”— Franz Kafka

Our profession often gets criticized for purposeful confusion via legalese, fine print, or just plain old-fashioned verbosity.  We cannot deny that the loquacious and the prolific

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As we age, we sometimes forget how things used to be.  It is not just age-related deterioration of the synapses in our hippocampi.  (We do question why hippocampi and hippopotamuses are the preferred plural forms these days and why more anatomic structures are not named for things like seahorses.)  There is also a recency effect.