Artificial Intelligence (AI) is changing the landscape of the health care industry. But to date, litigation in this space has largely centered on the use of AI by health care payers in making coverage decisions. But we are beginning to see hints of litigation impacting providers and life science companies. The Texas Court of Appeals recently weighed in on questions of pre-suit discovery in one such case.
On August 15, 2023, in In re Acclarent, Inc., a petitioner in Texas state court sought pre-suit discovery alleging that she sustained injuries while undergoing a medical procedure–a balloon sinuplasty– that had an AI component. Specifically, she alleges that the AI component used as part of Acclarent's Navigation Balloon Dilation System ("NBDS") was defective.
The petitioner has not yet filed a lawsuit but under Texas Rule of Civil Procedure 202, sought pre-suit discovery, including from the surgeon and manufacturer of another device used during the surgery that did not include an AI component. When petitioner apparently still could not derive claims from that discovery, she sought the deposition of Acclarent, with a focus on the use of AI during the surgery. Specifically, petitioner sought information regarding the identity of the supplier of the AI component and insight into Acclarent's decision to include AI capabilities in the device.
Acclarent's counsel offered to proffer an affidavit identifying the AI supplier and whether the AI inclusion was FDA-approved, but petitioner rejected the offer and pursued the requested discovery with the trial court. The trial court granted petitioner's motion for pre-suit discovery on April 29, 2024, ordering a deposition of an Acclarent corporate representative. Acclarent filed a petition for writ of mandamus on May 21, 2024 after the trial court denied Acclarent's motion for reconsideration.
On June 7, 2024, the Texas Court of Appeals agreed with Acclarent, finding that petitioner could not adequately show the need for the deposition outweighed the procedural burden.
The case poses interesting questions to watch regarding potential tort liability among the different players when an AI component is relied on during a medical procedure. For example, in a private action, how will liability be apportioned among the supplier of the AI component, the manufacturer who chooses to adopt, and the provider? The Texas trial court was receptive to allowing discovery specific to these issues, and other courts will likely follow. Manatt will continue to monitor In re Acclarent and the many suits we anticipate will tackle these same novel questions.
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