Search results for: "artificial intelligence"

At the recent ACI Drug and Medical Device annual conference, Bexis created something of a stir by broaching the subject of litigation discovery into the “prompts” that are typically used to create output from generative artificial intelligence.  A fair number of the attendees apparently had not considered that possibility.  Well, it’s already being done, and…

Almost ten years ago Bexis argued that the Federal Rules were technologically out-of-date and proposed a number of topics that would benefit from rules-based codification.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

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…

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

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…

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…

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

*         

…

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…

We’ve become aware that some clients are using artificial intelligence (AI) to summarize or analyze things like complaints, briefs, internal documents, or even – horror of horrors! – law firm bills.  If the client performing these tasks is an in-house lawyer, such work might be protected by the attorney client privilege or work product doctrine…

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
Learn more about this book