While updating the preemption chapter of his drug and device product liability treatise, Bexis came across a proposition he had not thought about in a long time. In two opinions in the Birmingham Hip (“BHR”) MDL, the court, under the aegis of Fed. R. Evid. 702, excluded expert testimony because it solely
This post is from the non-Butler Snow side of the blog.
In Hill v. Medical Device Business Services, Inc., No. 24-5797, 2025 U.S. App. LEXIS 17835, 2025 WL 1950300 (6th Cir. July 16, 2025), the Sixth Circuit affirmed an expert exclusion/Rule 702/Don’t Say Daubert decision in a case that we last wrote about
This is from the non-Butler Snow side of the Blog.
Readers of the Blog know that we believe in strictly applying the requirements of Federal Rules of Evidence 702 and 703. Long before the 2023 amendments to Rule 702 were a twinkle in the advisory committee’s collective eye, we were pounding the proverbial drum that
This is from the non-Dechert and non-RS side of the Blog.
We recently attended a successful Ph.D. thesis defense on the seemingly narrow issue of trap states in quantum dots. This was held in a dark wood-paneled room in a large science building on the campus of a research institution generally known by a short
Today, the summer solstice, is one of our favorite days of the year. It’s the first official day of summer, and readers in the U.S. will have anywhere from 14-16 hours of daylight (the farther north, the more daylight). We hope you get to enjoy some of the summer sunshine today—or at least this weekend. As the late, great, Brian Wilson put it, “Sunshine, can’t get enough sunshine, I’m following the sunshine, everywhere I go.”
Continue Reading Eighth Circuit Affirms Rule 702 Exclusion of Plaintiff Design Defect Expert
We’ve written a lot about the recent amendment to Federal Rule of Evidence 702. As noted here, the amendment (1) mandates that the court must determine the admissibility of evidence before presenting it to the jury, (2) integrates the preponderance of evidence standard—requiring the proponent of expert testimony to prove that it is more likely than not that all of Rule 702’s requirements are met, and (3) reinforces that each expert opinion must reliably apply the expert’s principles and methods to the facts of the case. These changes were driven by the fact that “many courts have held that the critical questions of the sufficiency of an expert’s basis, and the application of the expert’s methodology, are questions of weight and not admissibility.” Fed. R. Evid. 702 Advisory Committee’s Note to 2023 Amendment. The changes to Rule 702 are intended to prevent such erroneous “weight vs. admissibility” findings. We’re also fans of the Don’t Say Daubert movement that reminds lawyers that Rule 702 itself – not the Daubert decision – defines the applicable standard for the admission of expert testimony.
Continue Reading Rule 702 Gatekeeping by En Banc Panel of the Federal Circuit
Late last year, we discussed the dismissal of three purported California no-injury class actions alleging that certain over the counter (“OTC”) acne medicines were contaminated with carcinogenic benzene. That post also commented:
By the way, guess who says they found the benzene in the products? It was that good, old “independent” lab, Valisure − which proceeded to file a citizen’s petition with the FDA seeking action against [these] products. Sound familiar?
Last month, the FDA responded to the petition. The agency was not impressed. Its own testing – contrary to Valisure’s overblown claims in its petition (“detected high levels of benzene . . . in many specific batches”) found practically nothing to be concerned about. It tested “95 acne products containing benzoyl peroxide for possible benzene contamination,” and “more than 90% of tested products had undetectable or extremely low levels of benzene.” FDA, Statement ¶1 (March 11, 2025). THe FDA initiated a “limited number of voluntary recalls” due to “findings show[ing] a small number of products with elevated levels of benzene contamination.” Id. Only six of 95 products were recalled, and even then, only specified lot numbers. FDA Statement ¶7.
Continue Reading It’s About Time – FDA Calls Foul on Valisure
As anyone who has read more than a paragraph of what we’ve written knows, this is a forthrightly pro-defense Blog. It is not our practice to criticize the strategy or tactics of defendants or their counsel. It’s not that what defendants do is always right, but to us its almost always understandable.
We were all
This post is from the non-Butler Snow side of the blog.
When you represent medical device manufacturers in product liability litigation, you will deal with allegations that a device broke or failed because of what it was made from, and you will encounter both experts and “experts” (scare quotes intended) in materials science.
Materials science
The District Judge in Lin v. Solta Medical, Inc. is evidently on a year-end push. We reported just the other day on the court’s order granting summary on the plaintiff’s warnings-based claims, but denying summary judgment on design defect. A few days later, the court ruled on the parties’ motions to exclude expert opinions. This