Articles by :


Smart Medical Devices Open New Treatment and Litigation Doors While Confirming Age-Old Balancing Acts

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.

Continue reading “Smart Medical Devices Open New Treatment and Litigation Doors While Confirming Age-Old Balancing Acts”

Improper Texting During Remote Testimony Can Result in Significant Consequences to Litigants and Lawyers

For many litigators, sworn testimony today looks much different than it did two years ago. As the COVID-19 pandemic has required parties to limit travel and in-person proceedings, remote testimony for depositions, arbitrations and even trials has become the rule rather than the exception. With this transition, litigators have been confronted with unique circumstances and felt compelled to ask questions to confirm that the witness’s testimony is that of the witness, and only the witness. For example, is anyone else present in the room with the witness? Does the witness have any unauthorized lines of communication that could be used while the sworn testimony is proceeding? It has now become critical to ask a witness to swear under oath that there is no one else in the room with the witness and that no person is authorized to communicate with the witness during her or his testimony. Several recent decisions solidify this practice point and illustrate the consequences to litigants and lawyers when a witness surreptitiously communicates with others during the course of remote testimony.

Continue reading “Improper Texting During Remote Testimony Can Result in Significant Consequences to Litigants and Lawyers”

The Rule 702 Toolbox: Cherry-Picking Is a Recipe for Exclusion

Most courts (but certainly, and unfortunately, not all of them) recognize that cherry-picking is a cardinal sin under Rule 702.  Science generally requires a rigorous and conservative approach to evaluating cause-and-effect relationships.  This schema inherently clashes with litigation, an arena where parties prioritize results over neutral principles of process purity.

“Cherry-picking” involves the selective consideration of facts and data to support a desired or pre-determined result, rather than the analysis of all relevant facts and data to find a scientific truth (or determine that the truth remains elusive based on the available facts and data).  It evades the scrupulous adherence to principles of objectivity, rigor, and process validity that are the hallmark of the scientific method.  In Daubert-speak, such a methodology does not produce “scientific knowledge.”  Rather, cherry-picking represents a failure of methodology that cannot be waived off as a matter of weight rather than admissibility.

Continue reading “The Rule 702 Toolbox: Cherry-Picking Is a Recipe for Exclusion”

Florida Rule Change Permits Immediate Appeals on Punitive Damages

The Florida Supreme Court has accepted a proposed rule amendment to permit interlocutory appeals of court orders on punitive damages claims. On January 6, 2022, the Florida Supreme Court approved by 6-1 an amendment to Florida Rule of Appellate Procedure 9.130 to allow interlocutory appeals of nonfinal orders granting or denying leave to amend a complaint to assert a claim for punitive damages. Prior to this amendment, a party could only appeal such an order by petitioning for a writ of certiorari. And in that posture, the appellate court’s review was limited only to whether the trial court complied with the procedural requirements for making such a claim.

Practically, this means Florida appellate courts will be able to immediately review trial court orders regarding punitive damages claims on both procedural and substantive grounds. With this amendment, the merits of a plaintiff’s punitive damages claim can now be appealed prior to any discovery of a defendant’s financial information. The new rule takes effect April 1, 2022.

Continue reading “Florida Rule Change Permits Immediate Appeals on Punitive Damages”

Software Liability: Why a Michigan Federal Court Decision is Relevant to Product Manufacturers Nationwide

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.

Continue reading “Software Liability: Why a Michigan Federal Court Decision is Relevant to Product Manufacturers Nationwide”