[T]he common law of public nuisance is an inapt vehicle for addressing the conduct at issue. Mass harms caused by
A Big Idea from Big Sky Country
Guest Post – The AI LEAD Act: A Step Toward Regulating AI Product Liability in the United States
Today’s guest post is by Reed Smith‘s Jamie Lanphear. Like Bexis, she follows tech issues as they apply to product liability litigation. In this post she discusses a pro-plaintiff piece of legislation recently introduced in Congress that would overturn the current majority rule that electronic data is not considered a “product” for purposes
Major LCJ Submission Supporting Third Party Litigation Funding Disclosure
In what we view as a game-changing submission, on September 3, Lawyers for Civil Justice filed a 20-page analysis of no fewer than nine third-party litigation funding (“TPLF”) contracts that, one way or another, have become public. This analysis rips away the veil of secrecy that has surrounded TPLF, analyzes why and how specific TPLF
Federal Judicial Conference Evidence Rules Committee Releases Possible New Rule Pertaining to Artificial Intelligence
Almost ten years ago Bexis argued that the Federal Rules were technologically out-of-date and proposed a number of topics that would benefit from rules-based codification.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
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
Another Ohio Idea – How Far Does the Logic of the Opiate Decision Extend?
The Ohio Supreme Court’s decision in In re National Prescription Opiate Litigation, ___ N.E.3d ___, 2024 WL 5049302, 2024 Ohio Lexis 2785 (Ohio Dec. 10, 2024), which was our third best case of that year, was primarily a statutory interpretation case involving the Ohio Product Liability Act (“OPLA”), and specifically Ohio Rev. Code §2307.71(b)
If You Are Not Freaked Out, You Are Not Paying Attention
In this, the Year of Our Lord 2025, that title could apply to so, so, so many things. Soooooo many things.
But this is the Drug and Device Law Blog, product liability is our niche, and what we are referring to is the new, 2024 European Union Product Liability Directive (the “PLD”), also known as
Michigan Repeal Of Product Liability Protection Is Not Retroactive
The district court’s order applying Michigan law and dismissing one plaintiff’s complaint in the Tapezza MDL may be the last of a dying breed. The court faithfully enforced Michigan’s statute providing a presumption of non-defectiveness for FDA approved drugs and dismissed the plaintiffs’ case. But alas, Michigan repealed that law effective February 13, 2024, thus
The New EU Product Liability Directive
A long time ago, in a mass tort far, far away, the plaintiffs’ lawyers were not content with collecting plaintiffs from within the US. They also brought a putative product liability class action in federal court in the U.S. on behalf of European plaintiffs. As a result, your bloggers learned a little bit (a very
This Is Disturbing
The Drug and Device Law Blog is deliberately apolitical. Our purpose is to support the defense of prescription medical product liability litigation, and we recognize that the political views of our intended audience undoubtedly vary widely.
But one of the foundational grounds of our defense efforts is that the FDA, in its approval and subsequent regulation of prescription medical products, does so through skilled experts impartially evaluating well-conducted research and sufficiently supported facts. The agency’s adherence to the scientific method and scientific principles is essential to our clients as they develop, and seek regulatory approval for, new prescription medical products, as well as changes to existing labeling, designs, and manufacturing processes. In litigation, the FDA’s adherence to the scientific method and scientific principles is the underpinning of our clients’ two most powerful defenses – preemption and Rule 702/expert admissibility. If the FDA (and other federal agencies such as the CDC, NIH, and ACIP) ever abandoned, or were perceived to have abandoned, the scientific method in its decision-making, both regulatory and litigation chaos quite likely would result.
That’s why we are disturbed by indications that anti-vaccine crusader and all-around science denier Robert Kennedy, Jr. might be given authority over the FDA – and allowed to “go wild” over “health care” and “medicines.” Here is a video link to a recent Trump speech, and here is our transcript limited to the relevant statements:Continue Reading This Is Disturbing