Matthew Keris: AI in Healthcare Anticipated to Change Medical Negligence Cases as We Know It

Artificial intelligence (AI) is likely involved in your current healthcare and its use will continue to grow exponentially into the near future. As healthcare technology grows, two recent cases of interest, Lowe v. Cerner, 2022 WL 17269066 (6th Cir., Nov. 29, 2022) and In Re: Acclarent, 2024 WL 2873617 (Tex. App. 2024) foreshadow the future of claims associated with errors due to the electronic medical record (EMR) systems enhanced by AI. Very soon, expect cases involving healthcare errors to be based on both negligence and products liability principles using academically-trained EMR clinical informatics as experts and that will change the way cases are raised and defended. 

In Lowe v. Cerner, the court held that an EMR system vendor can be sued after a patient was injured due to a charting error by a physician who admitted confusion in how to document the timing of an order. Given that EMRs are used almost universally with every patient, the Lowe decision has set the precedent for a whole host of new medical device cases based upon medical provider user error due to a confusing EMR system. As the EMR becomes more complex and boosted by AI, it should be anticipated that health care providers and EMR/AI vendors will be sued together more regularly. 

This was demonstrated with the very recent decision from the Texas appellate courts from In Re: Acclarent. In this case, the prospective plaintiff sought pre-complaint depositions of physicians and a medical device manufacturer surrounding an event involving a sinus surgery. The prospective plaintiff wanted a deposition of the device manufacturer to learn more about an AI-enhanced feature of the product used during the surgical procedure at issue that may have malfunctioned, causing injuries. One of the reasons for the prospective plaintiff’s request for pre-complaint depositions was to vet whether she had a products liability case, a straight medical malpractice case, or a hybrid case involving the physicians and the medical device manufacturer. 

Hybrid medical malpractice/products liability claim may lead to more cases being filed in plaintiff-friendly venues, similar to the mass tort cases, given that EMR systems are used almost universally and in every state. Jurisdiction may also be in play, particularly if the medical device was FDA-approved and eligible for a preemption defense. Applicable statutes of limitations will also be of even greater importance moving forward. Where plaintiffs choose not to file against the EMR/AI vendor and pursue a malpractice case only, the medical defendants may decide to join the EMR/AI vendor in their cases in order to attempt to reduce their comparative negligence. However with joinder comes additional legal burdens and costs for the defendants.  They too will have to consider venue and jurisdictional consequences in bringing an EMR/AI vendor into a case.

Another important change to medical error cases in the age of AI-enhanced EMR systems is the importance of having a qualified medical informatics expert to support the prosecution or defense of the case.  The American Medical Informatics Association (AMIA) has recently published guidance for the retention of qualified experts on EMR issues in litigation^[1] and there is an ample supply of these specialists.  In short, these guidelines suggest the retention of a specialist academically trained in clinical informatics with experience in EMR design, development, implementation and use with a robust involvement in promoting the profession and its issues. Essentially, these specialists are “chart physicians” and will guide the parties through litigation using scientifically supported techniques to verify or refute information within a patient’s record; efficiently assist with investigations whether the AI-enhanced EMR caused or contributed to a plaintiff’s injury; and, serve as a conduit between the parties and EMR/AI vendors in locating specific relevant information.  

AI-enhanced healthcare may finally fulfill the promise that EMR adoption would reduce errors, but make no mistake, errors will continue and cases will be harder to explain given the complexity of the EMR. These will not be the cases we are used to. Farewell to simple negligence and greetings to use of “chart physicians” and products liability concepts.    

[1] Identifying a Clinical Informatics or Electronic Health Record Expert Witness for Medical Professional Liability Cases, Sittig, D. and Wright, A. Appl Clin Inform 2023;14:290–295.

Matthew P. Keris is Chair, Electronic Medical Record and Audit Trail Practice Group and Shareholder at Marshall Dennehey

Shareholder