We reported last year on a case in which the Arizona Court of Appeals allowed FDA-approved drug warnings to define the standard of care for a physician’s informed consent. Why does that matter? Well, in most every jurisdiction, a plaintiff bringing an action for medical negligence has to produce expert opinion that the defendant breached
We have been monitoring litigation involving tenofovir-based HIV medication for some time now. We reported a few weeks ago on oral argument in the California Court of Appeal, where the parties debated a novel “duty to innovate” under California law. We also gave you our view on the 2019 order that many say kickstarted these
When last we wrote, we had just watched our gorgeous standard poodle puppy, Luca, compete in his first weekend of dog shows. He was still learning the ropes, and, though he looked beautiful, he did not win any points. (Dog shows are worth from one to five points for each breed, depending on the number
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
In these strangest of times, we find ourselves seeking comfort in the familiar. Many times each day, we dial the numbers of faraway loved ones, just to hear their voices (the twenty-something Drug and Device Law Rock Climber has threatened to block our number). We gravitate toward favorite foods of our childhood (we just resorted
We are certain that profound revelations – scientific, economic, and political – will arise from the Covid-19 crisis. For now, we comment on bits of knowledge we have gained so far. We have learned, spending 24 hours each day with our dogs, that they bark 20 hours each day. We have learned that the concept
It is easy to articulate the core principle behind the First Amendment right to free speech: The government can’t restrict what you say or make you say what the government wants without a good reason. Ah, but how good a reason and what kind of reason? That is where it gets more complicated. How do