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
How Not To Create “Newly Acquired Information”
Bexis is updating (probably for the last time) the preemption chapter of his drug and device product liability treatise, so expect blogposts like this on preemption-related topics.
Briefly, preemption in the prescription drug context is limited to implied preemption because, unlike medical devices, the FDCA lacks any preemption language applicable to those products. The
Odds and Ends
Every week Bexis circulates an email with new, bloggable cases, but sometimes there are more new decisions than blogging days, and cases get passed over.
Here are three (relatively) recent examples
Gonzalez v. International Medical Devices, Inc., ___ F. Supp.3d ___, 2025 WL 2054361 (W.D. Tex. June 20, 2025), arose from the plaintiff’s apparent
Guest Post – The Product Line Is Moving – and Software Might Be Switching Sides
Today we have a guest post on some recent developments on whether strict liability applies to software, apps, artificial intelligence, and other forms of electronic data, which depends, as this 50-state survey addresses, on whether such intangible items meet the common-law definition of “product.” It is by Reed Smith attorneys (and repeat guest posters) Mildred
Gardasil POTS Expert Gets Panned
We’ve gleefully detailed the plaintiffs’ utter failure in the Zostavax MDL to establish causation. Now, the Gardasil MDL likewise seems well on the way to a place on the list (along with Bone Screw, Aredia/Zometa, Taxotere, and Zantac) of MDLs that plaintiffs’ counsel wish they’d given a miss. Maybe plaintiffs will
Recent TPLF Disclosure Developments
Here are a couple of recent favorable developments concerning the effort to require public disclosure of p-side third-party litigation funding to the same extent as defendants must disclose relevant insurance coverage. In addition to litigation-related benefits, such disclosure would (unfortunately) benefit plaintiffs by allowing them to shop for the best terms (as one can with insurance), rather than essentially have to take what they are offered in the current utterly opaque market.Continue Reading Recent TPLF Disclosure Developments
Arbitrary and Capricious Action as a Management Style
When a federal agency reverses course, the Supreme Court has a test to determine whether that agency action is impermissibly “arbitrary and capricious.” FCC v. Fox Television Stations, Inc., 556 U.S. 502 (2009), set the current APA standard for review of federal agency flipflops. While no “heightened standard” exists under the APA for reversals
Using Protective Orders To Protect Against Data Breaches
We get paranoid in our old age. We know that our clients spend a great deal of effort and money on keeping their internal data safe from criminal hackers. We assume that hospitals and other repositories of electronic medical records are doing the same. However, once such data, such as corporate trade secrets and personnel files, are turned over during discovery, we have no confidence whatever that the other side is employing similarly robust data security measures. Equally, if not more, problematic is the degree of data security maintained by expert witnesses and the plethora of other litigation-related vendors who may receive confidential material − translators, court reporting services, copying services, data processors, database and remote deposition hosts, coders, document reviewers, graphics producers, jury researchers, and trial preparation services. Similar confidentiality issues exist, although less of a concern for us, concerning plaintiffs’ personal medical records after they are collected.
Is there any way we can require them to upgrade their security?Continue Reading Using Protective Orders To Protect Against Data Breaches
Excellent MDL Early Vetting Order Raises Hopes for Rule 16.1
When the proposed (soon to be approved) Fed. R. Civ. P. 16.1, concerning MDL practice was finalized last year, we gave it one cheer in our “New Rule 16.1 – Better Than Nothing, But Not by a Lot” blogpost. We were, and remain, concerned that the provision concerning early vetting of MDL claimants will prove inadequate to address the serious problem created by huge numbers of meritless claims. But we did point out that the section about exchanging information about the “factual basis” of claims was different from the other items on the rule’s topic list: it used “how and when,” as opposed to “whether” or “if” – indicating that such early exchanges were viewed as mandatory (in some form). This, we thought, gave the defense an opening for seeking serious early vetting of MDL claims.
That may already be happening.Continue Reading Excellent MDL Early Vetting Order Raises Hopes for Rule 16.1
Unanimous Supreme Court Slaps Down Familiar Sounding Marketing Allegations In Landmark Gun Decision
We weren’t expecting to find anything bloggable when we reviewed the Supreme Court’s recent unanimous decision in Smith & Wesson Brands, Inc. v. Estados Unidos Mexicanos, ___ U.S. ___, 2025 WL 1583281 (U.S. June 5, 2025). But we were struck by the familiarity of the allegations of illegal marketing that the Court in S&W held could not be passed off as “aiding and abetting.” These were the same tired and repetitive allegations of purported “illegal marketing” by independent actors in the distribution chain that we have seen in so many drug/device cases – sometimes masquerading as “public nuisance.”
We think our clients can use S&W against such allegations, at least by analogy.Continue Reading Unanimous Supreme Court Slaps Down Familiar Sounding Marketing Allegations In Landmark Gun Decision