Medical device companies have for many years used 3D printing to create innovative products such as custom patient-matched devices and individualized anatomical models for surgical planning. Typically, these activities have occurred within traditional manufacturing facilities. Over the past two years, however, supply chain disruption caused by the COVID-19 pandemic has created medical device shortages that have amplified the use of 3D printing technologies at the point of care. Indeed, healthcare providers have collaborated with 3D printing companies to produce face shields, face mask holders, nasopharyngeal swabs, and ventilator parts within healthcare facilities. As 3D printing technologies improve and healthcare facilities innovate in the face of economic opportunities and pandemic-related challenges, the industry can expect increasing use of 3D printers within the healthcare setting. In turn, FDA is taking notice and has recently issued a paper to facilitate discussion about potential approaches to regulating 3D printed devices at the point of care.
Eastern District of Virginia Denies Motion to Certify Class, Sheds Light on Rule 23(b)(3) Predominance and Superiority Requirements for Class Actions
The U.S. District Court for the Eastern District of Virginia analyzed Federal Rule of Civil Procedure 23(b)(3)’s predominance and superiority requirements for class actions in a recent decision denying a motion to certify a purported class of motor vehicle purchasers. The decision underscores that plaintiffs seeking to certify classes asserting claims that will render the process of identifying class members to be a mere series of individualized inquiries will not pass muster under Rule 23.
The Facts in Dispute
Garcia, et al. v. Volkswagen Group of America, Inc., et al. involved a purported class of plaintiffs residing in multiple states who purchased vehicles manufactured by defendants within the last 14 years. The plaintiffs sued a group of auto manufacturers alleging damages resulting from defendants’ alleged fraudulent misrepresentations about the vehicles, and asserting claims for violations of the Federal Odometer Act, fraud, breach of contract, and unjust enrichment, in addition to state law claims under the laws of California, Colorado, Florida, Illinois, New Jersey, and Washington.
Let Me Google That for You: A Recent Central District of Illinois Opinion Highlights the Limits of Googling by Expert Witnesses Under Rule 702 and Daubert
While we all rely on Google or other internet search engines to find and absorb information quickly these days, a recent decision in the Central District of Illinois highlights the problems for expert witnesses relying on internet research as a methodology. See Sherman v. BNSF Railway Co., Case No. 1:17-cv-01192, 2022 WL 138630 (C.D. Ill. Jan. 14, 2022). While Googling is likely a practice that many experts may engage in (though may be loathe to admit it), Google searching alone is a suspect methodology upon which to base expert opinions.
In Sherman, Plaintiff sued Defendant BNSF Railway Co. (BNSF) pursuant to the Federal Employers’ Liability Act, alleging that during her employment with BNSF, she was exposed to toxic substances and carcinogens, including asbestos, that caused her to develop rectal cancer.
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.
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.
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.
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