For the decades that we have been handling drug and medical device product liability cases, it has been a given that we wanted to make it clear that our clients did not provide medical care or healthcare directly to patients. For one thing, unauthorized practice of medicine would be bad. Also, when dealing with prescription
Negligence
Flooding The Zone Does Not Work For Opioid Plaintiffs In Maine
No Liability For Contributing Funding For Research Activities

Public policy favors scientific and medical research. So do we. While the theories of various claims asserted against sponsors of medical research—and the reasons for rejecting them—vary greatly, the underlying incentive to promote good research certainly plays a role in protecting those that sponsor and conduct medical research from virtually unlimited liability for alleged…
No Debating Pennsylvania’s Rejection of Strict Liability for Implantable Medical Devices

This is from the non-Dechert part of the Blog.
Over the years, the Blog has had many, many posts related to the issue of whether Pennsylvania recognized any form of strict liability in product liability actions against prescription medical products. In addition to the fact that several of the principal authors of the Blog have…
Duty to Innovate Before The California Supreme Court: The Briefs Are In

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…
California Court Considers Expanding Tort Law in “Duty to Innovate” Case

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…
Yes Virginia, Software Can Be A Product

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
Bid To Impose Liability On Trade Association Fails

In the movie Thank You for Smoking, lobbyists for the tobacco, alcohol, and firearm industries got together periodically at a DC watering hole to swap stories about the challenges of representing unpopular clients under increasing scrutiny by the federal government. Hilarity ensued, along with some other stuff we do not remember very well. Of course,…
Can – or Should – State Tort Law Force Defendants To Prevent Off-Label Use?

The United States Supreme Court in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), determined that “off-label usage” is “accepted and necessary” by both the FDA and the medical community. Id. at 350. Thus, “[p]hysicians may prescribe drugs and devices for off-label uses.” Id. at 351 n.5 (citation and quotation marks omitted). …