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
Legislation
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Almost ten years ago Bexis argued that the Federal Rules were technologically out-of-date and proposed a number of topics that would benefit from rules-based codification.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
New Rule 16.1 – Better Than Nothing, But Not by a Lot
As many of you no doubt already know, the federal judiciary’s Committee on Rules of Practice & Procedure gave its final approval to new Fed. R. Civ. P. 16.1, concerning MDL practice, on June 4. Here’s some commentary. We’ve also mentioned the proposed rule here on the Blog. Bexis went so far as to file an extensive comment on the proposed rule, primarily decrying the frequency with which MDL judges simply ignored the existing federal rules – most significantly (although hardly exclusively) those rules that act to weed out meritless claims in non-MDL situations.
Throughout the process that led to new Rule 16.1, the drafters consistently refused to impose any mandatory procedures at all for early vetting of the hordes of meritless to utterly frivolous claims that are routinely filed in mass tort MDLs. Thus, we bloggers were skeptical that all the effort to create a new, entirely voluntary list of potential MDL management tools was worth the candle. Indeed, new Rule 16.1 stands out like a sore thumb among the Federal Rules of Civil Procedure, precisely because it lacks any mandatory requirements. The new rule has lots of “shoulds” but practically no “shalls.” See Approved Committee Note and Text of Fed. R. Civ. P. 16.1.
Taking a closer look, we now believe that, if used according to its terms, new Rule 16.1 would actually be better than no rule at all, albeit not by a lot. MDL cases now comprise over 70% of the total federal caseload, so we still believe it is ludicrous that those cases are not subject to a single mandatory MDL-specific rule. But Rule 16.1 it is what it is.Continue Reading New Rule 16.1 – Better Than Nothing, But Not by a Lot
Guest Post – Michigan Product Liability Law: Retroactivity of New Law and Primer
Today’s guest post is by Sherry Knutson and Brenda Sweet of Tucker Ellis, and concerns the recently passed legislative repeal of a Michigan statute that, for several decades had effectively immunized prescription drugs from ordinary product liability actions under Michigan law. For background, here’s a prior blogpost that focused on the now-repealed statute. As…