Artificial Intelligence

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Federal Judicial Conference Evidence Rules Committee Releases Possible New Rule Pertaining to Artificial Intelligence

By Bexis on June 2, 2025

Almost ten years ago Bexis argued that the Federal Rules were technologically out-of-date and proposed a number of topics that would benefit from rules-based codification. One of those topics involved machine learning – specifically use of predictive coding in ediscovery.

That didn’t go anywhere, but on May 2, 2025, the Advisory Committee on Evidence Rules proposed language for a new rule – Fed. R. Evid. 707 – addressed to the impact of artificial-intelligence-generated evidence in the courtroom. Here’s the proposed language:

Rule 707. Machine-Generated Evidence

When machine-generated evidence is offered without an expert witness and would be subject to Rule 702 if testified to by a witness, the court may admit the evidence only it if satisfies the requirements of Rule 702 (a)-(d). This rule does not apply to the output of basic scientific instruments.

Committee on Rules of Practice and Procedure, Agenda Book, at Appendix B, page 75 of 486 (June 10, 2025). This proposal is the product of three years of research and investigation. Id.Continue Reading Federal Judicial Conference Evidence Rules Committee Releases Possible New Rule Pertaining to Artificial Intelligence

Guest Post – Heads Up: A New Era of Digital Product Liability in the EU

By Lisa Baird on May 7, 2025

Today’s guest post comes from our Reed Smith colleague Jamie Lanphear on a topic near and dear to the Blog’s heart: The new EU Product Liability Directive. As always, our guest posters deserve 100% of the credit, and any blame, for their posts. But, also as usual, our guest posters deliver the goods, so we…

Some Semi-Intelligent Takes on Artificial Intelligence

By Stephen McConnell on December 11, 2024

December is both a festive and frantic month. Along with all the caroling, wassailing, and gift-buying, the last month of the year invariably sees us squeezing in continuing legal education (CLE) credits, reconnecting with old friends at the ACI drug and device conference in New York City, and wrapping up the Fall/Winter semester class we…

Musing about Discovery and Artificial Intelligence

By Bexis on December 7, 2023

Some of us are participating in beta testing of generative artificial intelligence (“AI”) for legal applications in the law firm environment. So far the verdict is – associates can breathe easy, at least for now. Nothing we’ve seen is capable of replicating legal research even at a first-year level of quality.

But that doesn’t mean that AI won’t impact prescription medical product liability litigation. In particular, we’re not surprised to learn that AI is being used in the context of FDA-required adverse event reporting, purported problems with which have become one of the other side’s go-to preemption dodges. Just a few examples from a simple Google search:Continue Reading Musing about Discovery and Artificial Intelligence

Guest Post – A Trip In The Wayback Machine Reveals What FDA Has In Store for Artificial Intelligence/Machine Learning in Medical Devices

By Bexis on February 8, 2021

We’re interested in artificial intelligence, particularly as it affects medical devices, but we don’t know all that much about it, and it’s yet to make much of an impact in our product liability sandbox. Fortunately, we know some folks who do stay informed on this topic, and that’s what today’s guest post is about. In…

Guest Post – Is Artificial Intelligence a “Product”? The Third Circuit Says, “No.”

By Bexis on March 27, 2020

Today’s guest post is by Corinne Fierro, Mildred Segura, and Farah Tabibkhoei, all of Reed Smith. These three are all part of the firm’s left-coast, techno side of the product liability practice, and bring our readers a recent appellate decision that addresses the intersection of 21st Century high technology and 20th Century…

Artificial Intelligence Is No Threat to PMA Preemption

By Bexis on May 27, 2019

A week or so ago, Bloomberg Law published (behind a pay wall) an article entitled “Medical Device Makers May Risk Liability Following FDA Effort.” The Bloomberg article relied upon the same FDA initiative regarding artificial intelligence/machine learning (“AI/ML”) in medical devices that we covered here, in a guest post. Our guest post raised preemption…

Guest Post – Not a Moonshot, But Not a Fizzle Either − FDA’s Proposed Regulatory Framework for AI/Machine Learning Medical Devices Is A First Step Toward Total Product Lifecycle Regulation

By Bexis on April 22, 2019

If the promise of adaptive artificial intelligence (sometimes called “Machine Learning”) is to be achieved in the medical area, FDA’s regulation of medical devices is going to have to graduate from geometry to calculus. By its nature, machine learning changes the details of its output constantly. The rigid regulatory model requiring FDA pre-approval of all…

The Diagnostic Artificial Intelligence Speedbump Nobody’s Mentioning

By Bexis on November 8, 2018

The 21st Century Cures Act is noteworthy as the first legislative attempt at regulating artificial intelligence (“AI”) in the medical field. The Act added this provision to the FDCA:

(o) Regulation of medical and certain decisions support software: (1) The term device . . . shall not include a software function that is intended

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Artificial Intelligence and Learned Intermediaries

By Bexis on July 24, 2017

In the July 7, 2017, “Artificial Intelligence” issue of Science, we were intrigued by a short piece in the “Insights” section on “Artificial Intelligence in Research” that discussed the future use of autonomous robots in surgery. Surgeonless surgery would “allow[] work around the clock with higher productivity, accuracy, and efficiency as well as shorter…

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