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
Would-Be Litigation Troll Trolled Again
We have blogged several times before about the litigation misadventures of MSP Recovery, Inc., known for bringing Medicare recovery actions of questionable merit based on assignments of questionable validity that they obtain from various Medicare Advantage Plans looking for free money. Occasionally, MSP has branched also filed RICO claims of an equally dubious nature.
In Series 17-03-615 v. Teva Pharmaceuticals USA, Inc., 2025 WL 1257677 (D. Kan. April 30, 2025), this would-be Medicare troll got trolled again, in yet another purported RICO class action. Five defendants filed five motions to dismiss – and they were all granted. Id. at *1. On most issues, the five motions raised similar grounds: lack of standing, lack of personal jurisdiction, and failure to state a claim. Id. at *12. That led to the plaintiffs’ monumental procedural mistake. Rather than bother to file separate responses to the five defendants’ motions, plaintiffs filed responsive papers that merely incorporated their responses to other defendants’ arguments by reference. “[P]laintiffs filed responses to each of the five motions to dismiss” but “aggregated their responses to similar arguments which multiple defendants raised.” Id.Continue Reading Would-Be Litigation Troll Trolled Again
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
Will the Supreme Court Turn Fraudulent Joinder into a Free Shot for Plaintiffs?
We have learned, through repeated harsh experience (e.g., Mallory, Wullschleger, Harrington) that while the current Supreme Court can be described as “conservative,” that hardly means that it is pro-business. Indeed, it appears that when the issue is p-side forum-shopping, the Notorious RBG (opponent of all things preemption) was far more
MDL Procedural Shortcuts Once Again Disadvantage Defendants
MDLs are supposed to follow the Federal Rules of Civil Procedure. That’s the reminder the Sixth Circuit gave in In re National Prescription Opiate Litigation, 956 F.3d 838, 844 (6th Cir. 2020):
[T]he law governs an MDL court’s decisions just as it does a court’s decisions in any other case. . . . Here, the relevant law takes the form of the Federal Rules of Civil Procedure. Promulgated pursuant to the Rules Enabling Act, those Rules are binding upon court and parties alike, with fully the force of law. . . . Respectfully, the district court’s mistake was to think it had authority to disregard the Rules’ requirements . . . in favor of enhancing the efficiency of the MDL as a whole. . . . But MDLs are not some kind of judicial border country, where the rules are few and the law rarely makes an appearance. For neither §1407 nor Rule 1 remotely suggests that, whereas the Rules are law in individual cases, they are merely hortatory in MDL ones.
Id. at 844 (citations omitted). More recently the Civil Rules Committee made the same point in approving new Fed. R. Civ. P. 16.1: “The Rules of Civil Procedure, including the pleading rules, continue to apply in all MDL proceedings.” Comment to Rule 16.1(b)(3)(A).
Bad things happen – usually to defendants – when an MDL adopts practices designed to cut procedural corners that the drafters of the rules put there for a reason.Continue Reading MDL Procedural Shortcuts Once Again Disadvantage Defendants
FCA Frontal Assault in Eleventh Circuit
In a series of what we entitled “reports from the front,” we discussed how the federal government asserted, and eventually won, the right to intervene in ongoing False Claims Act suits to seek their dismissal notwithstanding the objections of the “relators” who were ostensibly pursuing these actions in the government’s name. Basically, the relators claimed that, unless the government exercised its initial right to take over an FCA suit early on, the government lost all control over the relators, and they could essentially run wild using the government’s name. The Supreme Court rightfully rejected that view. United States ex rel. Polansky v. Executive Health Resources, Inc., 599 U.S. 419, 437-38 (2023) (government entitled to intervene and obtain dismissal of FCA action at any time on the basis of any “reasonable argument” regardless of the relator’s position).
However, three justices had more to add – they challenged that entire FCA private-attorney-general system as unconstitutional. Justice Thomas stated in dissent:
The FCA’s qui tam provisions have long inhabited something of a constitutional twilight zone. There are substantial arguments that the qui tam device is inconsistent with Article II and that private relators may not represent the interests of the United States in litigation. . . . [T]he Court has held that conducting civil litigation for vindicating public rights of the United States is an executive function that may be discharged only by persons who are Officers of the United States under the Appointments Clause. A private relator under the FCA, however, is not appointed as an officer of the United States under Article II. It thus appears to follow that Congress cannot authorize a private relator to wield executive authority to represent the United States’ interests in civil litigation. The potential inconsistency of qui tam suits with Article II has been noticed for decades.
Polansky, 599 U.S. at 449-50 (Thomas, J., dissenting) (citations and quotation marks omitted). Concurring Justices Kavanaugh and Barrett agreed. “I add only that I agree with Justice Thomas that “[t]here are substantial arguments that the qui tam device is inconsistent with Article II and that private relators may not represent the interests of the United States in litigation.” Id. at 442 (concurring opinion).
Thus, we commented that “another front opens.”Continue Reading FCA Frontal Assault in Eleventh Circuit
Preemption Round Up – Failure to Report
Recently, when putting together our “Staple Suit Cropped” blogpost about Kane v. Covidien LP, 2025 U.S. Dist. Lexis 25718 (E.D.N.Y. Feb. 12, 2025), we realized that, while we had a comprehensive 50-state survey on the questionable status of failure-to-report claims under state law, we did not have a similarly complete reference for preemption of the same reporting-based claims.
We’re rectifying that here.
Failure-to-report claims have been asserted against every product that has a preemption defense – branded drugs, generic drugs, and PMA medical devices. Thus, there are different ways that failure-to-report claims end up preempted.
- First, reporting-based claims against drugs or medical devices are impliedly preempted under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), and 21 U.S.C. §337(a), because they would not exist without the FDA reporting obligations that they claim were violated. Therefore, “the existence of these federal enactments is a critical element” of the cause of action, and implied preemption applies. 531 U.S. at 353.
- Second, and relatedly, in the majority of states where no state-law claim exists for failure to make mandatory reports to a governmental agency (see the 50-state survey), Buckman further precludes such claims as purely private attempts to enforce the FDCA/FDA regulations concerning adverse event reporting.
- Third, in cases involving pre-market approved medical devices, the same absence of any state-law reporting-based claims leads to express, as well as implied, preemption because there is no recognized “parallel” state-law theory of liability that could support a “parallel claim” exception to express preemption under 21 U.S.C. §360k(a).
- Fourth, generic drugs enjoy their own implied preemption defenses under PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and can take similar advantage of Buckman-based preemption precedent.
Obviously, there can be overlap between these three categories, and not all courts keep them separate.
Since the issue is preemption, a federal issue, our primary division of cases is by federal circuit rather than by state. Of the circuits, the Second, Third, Sixth, Eighth, Tenth, and Eleventh all have precedential decisions holding failure-to-report claims preempted, although the Second has only dealt with express preemption. The Second, Fifth and Ninth allow “parallel” failure to warn claims to escape preemption if state common law allows them, with the Second being stricter than the others. The Seventh Circuit has been hostile generally to FDCA-based preemption, but hasn’t decided a reporting-based case. The First, Fourth, and District of Columbia circuits have yet to decide the question. We note that no precedential decision from any federal court of appeals has flatly denied preemption in a failure-to-report case since 2013, the 2013 decision was repudiated by the highest court of the state in question (see Ninth Circuit, below), and the United States Supreme Court abolished any “presumption against preemption” in express preemption cases in 2016. See Commonwealth of Puerto Rico v. Franklin California Tax-free Trust, 579 U.S. 115, 125 (2016). Thus, defendants have good grounds to seek reconsideration of what adverse appellate authority exists.
Finally, we don’t do the other side’s research for them, so be advised, that while we try to be comprehensive in collecting favorable cases, we aren’t including all adverse decisions. Continue Reading Preemption Round Up – Failure to Report