Both sides in Gilead v. Superior Court have filed their opening briefs in the California Supreme Court, and the extreme nature of the California Court of Appeal’s opinion extending a manufacturer’s duties has been laid bare. As expected, the defendant convincingly argued that the California Court of Appeal has imposed potentially unlimited liability on product
The California Supreme Court has granted review in Gilead Life Sciences v. Superior Court, the case in which the California Court of Appeal ruled that the defendant could be liable to users of one drug for alleged negligence in connection with a different drug, even while admitting that the drug they actually used
We reported a few months ago on oral argument in the California Court of Appeal in Gilead Life Sciences v. Superior Court, where the parties argued about whether California law recognizes a broad “duty to innovate.” At issue was whether a product manufacturer could be liable to patients taking one drug for failing to
We observed oral argument the other day in a case that could have a significant impact on potential liability under California tort law for pharma companies and all other innovators. In Gilead v. Superior Court, No. A165558 (Cal. Ct. App. First Dist.), a panel of the California Court of Appeal is considering whether a
We have blogged several times about the somewhat esoteric issue of whether intangible items – chiefly computer software, website algorithms, and other electronic information – is treated as a “product” for purposes of imposing strict liability on their creators. It’s an interesting topic; Eric recently wrote a paper on it, and Bexis is putting together a “white paper” for the Product Liability Advisory Council on the same subject. From these exercises we concluded that a 50-state survey on intangibles as “products” for product liability purposes would be both doable and useful.Continue Reading How the Fifty States View Electronic Data as a “Product”
When this blogger thinks about the “Big Three” her mind goes to This is Us – Kevin, Kate and Randall. Admittedly, that’s not the only “Big Three.” Most people probably go to Great Britain, the United States, and the Soviet Union in World War II. But that alliance certainly was shorter than the Pearsons. Now
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
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
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
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