As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702 updates that took place this year, which will carry over into 2023?), but provides a brief recap and assessment of five of the most interesting and consequential developments affecting drug and device law in 2022.
Artificial Intelligence (“AI”) is driving innovation across industries and is playing an increasing role in everyday life. AI (and, more broadly, algorithms) is being used in diagnostics, enabled medical devices, device manufacturing, drug discovery and manufacturing, industrial manufacturing, smart home and wearable devices, and vehicles. AI has the potential to benefit society in a number of ways, including by boosting efficiency, providing invaluable insights, and informing decisions. But to borrow from the likes of Winston Churchill (or Spider-man), with great AI capabilities comes great responsibility.
Many of the risks and benefits of AI systems are unique in comparison to other technologies. Regulators, governmental agencies, and consumer advocates are keenly focused on addressing unintended consequences that may result from the development and use of algorithms and AI. These issues, like the technology, are complex, and policymakers, stakeholders, and regulators are grappling with how best to address them.
FDA recently issued final guidance regarding the initiation of voluntary product recalls and its related suggestions on how to be “recall ready.” The guidance – covering voluntary recalls of food, drugs, devices, biological products, cosmetics, and tobacco – emphasizes the importance of a company’s recall readiness at all stages of a product’s distribution chain and provides companies with suggested measures to prepare for and implement voluntary recalls. It also advises companies on best practices for working with FDA to initiate a timely voluntary recall.
Faegre Drinker’s snap removal team continuously monitors snap removal updates across the country (for a basic explanation of snap removal and previous updates, see Faegre Drinker’s prior posts here; for a breakdown on how each federal jurisdiction treats snap removal, see Faegre Drinker’s interactive snap removal map here).
The United States District Court for the District of Nevada is no stranger to consideration of the practice of snap removal—indeed, the District of Nevada has issued a number of decisions in 2020 and 2021, all holding that snap removal was improper unless and until at least one defendant has been served. But a recent opinion out of the District rejects the reasoning in those earlier decisions and holds that snap removal is proper even if no defendant has been served.
Faegre Drinker’s snap removal team closely monitors snap removal updates across the United States (for a basic explanation of snap removal and previous updates, see Faegre Drinker’s prior posts here; for a breakdown on which jurisdictions allow snap removal, see Faegre Drinker’s interactive snap removal map here).
In two recent decisions out of the District of Maryland and the Western District of Washington, both courts emphasized “gamesmanship” as a reason for rejecting the practice of snap removal in each jurisdiction. Interestingly, though, one district focused on gamesmanship by plaintiffs while the other district focused on gamesmanship by defendants.
On March 25, the U.S. Supreme Court decided Ford Motor Co. v. Montana Eighth Judicial District Court, revisiting the issue of due process limitations on the exercise of personal jurisdiction, most recently addressed by the Court in 2017 in Bristol-Myers Squibb v. Superior Court, 137 S. Ct. 1783 (2017) (“BMS”). A unanimous Court (8-0, with Justice Barrett not participating) held in Ford Motor that courts in Montana and Minnesota could hear claims by residents of those states alleging injuries sustained in accidents that occurred there involving Ford vehicles. Relying on Ford’s extensive contacts with those states, which consisted of efforts to create and serve local sales and service and repair markets for the same kinds of vehicles, the Court concluded these plaintiffs’ claims were sufficiently “related to” Ford’s local contacts, even though the actual vehicles in the accidents were designed, manufactured and initially sold in other states. (We commented here on the state court decisions in these cases before Ford sought certiorari.)