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.
On March 15, 2022, the Georgia Supreme Court revived a negligent design claim that had been brought against Snapchat, Inc. (n/k/a Snap, Inc.) involving Snap’s “Speed Filter.” As one of the few decisions across the country addressing products liability law in the context of platform “products” (more accurately categorized as services) such as Snapchat, the opinion provides a glimpse of the sort of issues that other courts may soon be required to address.
The Factual & Procedural Background:
Plaintiffs Wentworth and Karen Maynard alleged that Defendant Christal McGee was using Snapchat’s “Speed Filter” and driving over 100 miles per hour when she rear-ended them, causing severe injuries. The “Speed Filter” is a feature that allows the user to record their real-life speed on a photo or video and share it with other users. Plaintiffs sued Snap as well, alleging that Snap had negligently designed the “Speed Filter” because the filter promoted unsafe driving and encouraged dangerous behavior.
On March 14, 2022, a bipartisan trio of U.S. Senators introduced a bill (S.3830) that would require manufacturers to provide the tools and documentation necessary for consumers and third parties to repair electronic equipment. Dubbed the Fair Repair Act of 2022, the bill is the Senate version of a similar bill (H.R.4006) introduced in the House last June. The proposed legislation covers products ranging from agricultural equipment to consumer electronics and is the latest in a series of federal and state proposed laws seeking to codify the “right to repair.” If the bill becomes law, manufacturers will not only have to comply with the Act’s requirements, but they will also need to prepare for potential liability implications.
Attempts at codifying a right to repair are not new in the United States. Calls for automotive right-to-repair legislation go back to the 1970s. But the movement has hit its stride in the last decade. In 2013, Massachusetts became the first state to pass a right-to-repair law requiring vehicle manufacturers to sell their proprietary diagnostic tools and software to third-party repair shops, spurring a flurry of similar bills across the nation and bringing attention to the right-to-repair movement. Though the movement has had little success in codifying a right to repair so far, the tides may be shifting. Indeed, in July 2021, President Joe Biden signed a sweeping executive order that, among other things, encourages the Federal Trade Commission (“FTC”) to enact regulations prohibiting manufacturers from barring the repair of equipment and devices by consumers and independent repair shops.
Telemedicine and telehealth have significantly reshaped how consumers access health care services. Even before the COVID-19 pandemic, online portals were jockeying to replace visits to primary care providers and urgent care clinics for minor illnesses or simple-to-prescribe medications. The last two years shifted that race into high gear, particularly with new products and platforms being introduced that range from virtual clinic platforms that allow patients—and their programmable implanted medical devices—to connect with their providers from the comfort of their own homes, to passive smart devices that remotely monitor patient vital signs, analyze that data using proprietary algorithms, and evaluate whether a patient is having a medical emergency or needs to schedule an appointment with their provider. These technologies are now so ubiquitous that they are being showcased at the 2022 Consumer Electronics Show.
To be sure, regulatory changes in response to the COVID-19 pandemic made telemedicine more permissible—and reimbursable—than in the past. But that alone is not driving medical device companies forward. Instead, medical device manufacturers are rapidly developing smart or algorithm-driven medical devices that take advantage of the ever-increasing power of those technologies and leveraging telemedicine to make the remote treatment and management of medical conditions less complicated. A recent article in Nature’s npj Digital Medicine confirmed the growth in this area, counting 64 separate smart- or algorithm-driven medical devices currently on the market as of 2020. See Stan Benjamens, et al., The State of Artificial Intelligence-Based FDA-Approved Medical Devices and Algorithms: An Online Database, 3 npj Digital Medicine Article No. 118 (2020). Each of these new devices endeavor to enable physicians to practice more effectively and efficiently than they could before. The future for smart or algorithm-driven medical devices looks promising.
Numerous products in our day-to-day lives incorporate or consist of software. The legal system, however, has been hesitant (at best) to bring software within traditional product liability regimes. Courts have grappled with whether to consider software a product and have largely found that it is not. However, a recent decision in the Western District of Michigan holds that software is a product—Holbrook v. Prodomax Automation Ltd., No. 1:17-cv-219, 2021 U.S. Dist. LEXIS 178325 (W.D. Mich. Sept. 20, 2021). While Holbrook may be an outlier, it is significant. It bucks the trend, and potential defendants should be aware of it.
Background: Holbrook involved a wrongful death suit arising out of an accident on a robotic assembly line. The decedent’s estate (Plaintiff) brought a common-law negligence claim against multiple defendants, including the manufacturer who designed, built, and installed the assembly line. Plaintiff’s claim was based, among other things, on the software controlling the robots.