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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
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Readers of this blog know that we love preemption in all its forms, including preemption based in the Public Readiness and Emergency Preparedness (“PREP”) Act, 42 U.S.C. §247d-6d.

During the COVID-19 pandemic, a needlessly politicized public health emergency, the PREP Act provided important liability protections to health care providers, vaccine manufacturers, and others working hard to stem the death toll, treat those sickened by the virus, and invent novel treatments.

We have delved into the details of the PREP Act before:  The statute provides defenses to liability and preemption of state laws involving “covered persons” and “covered countermeasures”.  And we have covered numerous COVID-19 related opinions, both good and not-so-good.  Bexis even created a scorecard. 

Today’s PREP Act preemption opinion arose in the medical malpractice context, and comes from Puerto Rico: Marchese Torres v. Pro. Hosp. Guaynabo, Inc., 2025 PR App. LEXIS 1279; 2025 WL 1698806 (May 22, 2025 P.R. App.).

In Marchese Torres, the plaintiffs alleged the defendant doctors and hospital were responsible for negligence in the diagnosis and treatment of her husband.  The exact allegations are not terribly clear, but piecing together bits from the majority and dissenting opinions, it appears that plaintiff’s husband went to the emergency room, was given a COVID-19 test that came back negative, was sent home, and then at some point passed away.  The cause of death and its connection to the ER visit are not spelled out, but presumably the cause of death was COVID-19 related, and the theory was that earlier treatment would have prevented the death.

The trial court dismissed the case on both PREP Act and statute of limitations grounds, and the appellate court upheld on the PREP Act ground without reaching the statute of limitations issue (which is less interesting to us anyway).

According to the court, the physicians and hospital were protected by the PREP Act because

(1) the defendants were “covered persons”;

(2) the challenged actions involved “covered countermeasures” (in this case, the COVID-19 diagnostic test and associated clinical decisions);

(3) there was a causal relationship between the claim and the use of the countermeasure; and

(4) the events occurred during the public health emergency.

The court emphasized that the PREP Act displaces state (and territory) requirements related to COVID-19 countermeasures, including tort liability, and the only exception to immunity is where a death or serious physical injury is caused by “willful misconduct”—a high bar to reach, and one not alleged in this case.

This all seems straightforward, but there was a dissent.  In the view of the dissenting judge, the plaintiff’s case should not have been dismissed because there was conduct independent of a covered countermeasure.  In particular, the dissent viewed the only covered countermeasure to be the administration of the COVID-19 test, with the subsequent decision not to treat (and to send the husband home) as an instance of alleged negligence separate from that covered countermeasure. 

The dissent’s point—that failing to treat is not a “countermeasure”—has some surface appeal.  A “countermeasure” sounds like an action verb, like administering a vaccine, or manufacturing face masks, or intubating a patient whose oxygen levels have fallen dangerously. 

But lest we forget, the pandemic required those on the front lines to make tough choices in doling out care because everything was in short supply:  face masks, vaccines, hospital beds, even space to hold the deceased.  Not all who contracted COVID-19 fell seriously ill, fortunately, and resources often had to be allocated to those in most dire medical need.

Would it make good policy sense to impose liability for failure to treat, when that only would encourage health care providers to practice defensive medicine in the middle of a crisis?  It is not even useful to have doctors make clinical decisions based on malpractice concerns in ordinary times, much less during a pandemic, and we think the majority got the scope of the PREP Act right in affirming the dismissal.

As our scorecard shows, this is not the only opinion where a judge (like the dissenting judge here) has tried to cabin the sweeping immunity and preemption of the PREP Act to allow for more lawsuits than defendants might expect.  Fortunately, in the end the decision correctly affirms the robustness of the PREP Act’s liability protections.

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We spent much of the last six years opposing the government in civil litigation.  Sure, a few of the government lawyers had a certain swagger to them, but in most ways litigating against them was similar to litigating against private parties.  The government hired and collaborated with many of the same plaintiffs’ attorneys that we see in mass tort litigation.  They served discovery on us; we served discovery on them.  They requested every document under the sun, and they pushed hard to get them.  Good times. 

There was, however, one big difference:  The governmental entities on the other side of the aisle had discoverable documents.  Millions of them.  The plaintiffs that we typically see don’t usually have much of anything to produce, making the burdens of discovery astoundingly unbalanced. 

That dynamic changed with states, cities, and counties on the other side.  They had a major skin the discovery game just like we did, yet many of them were unprepared to handle it.  We can only speculate as to why.  Perhaps it was a function of government hubris and a feeling that the normal rules did not apply to them.  Maybe they and their outside counsel were just not accustomed to marshaling and producing documents in great numbers.  Or maybe they just underestimated the task and mishandled it.  We saw countless pretrial schedules slip because we could not get the documents.  One plaintiff was dropped from a bellwether trial group because it mishandled document discovery, and another lost a trial date that the court had said was firm and would not move. 

The lesson was that the rules apply to both sides.  That too is the lesson of United States ex rel. Plaintiff v. Novo Nordisk, Inc., No. 23-5459, 2025 U.S. Dist. LEXIS 115618 (W.D. Wash. June 17, 2025), where a federal district court ruled that a prescription drug manufacturer was entitled to an adverse inference jury instruction against the State of Washington because of the State’s culpable failure to preserve and produce documents. 

The State sued the manufacturer alleging violations of the False Claims Act and Anti-Kickback Statute through off-label promotion of a hemophilia treatment.  At the center of the State’s claims was its allegation that the State Medicaid program paid millions of dollars for a particular patient’s treatment.  Id. at *2-*3.  The State began to investigate in 2007, and multiple State employees reviewed records and participated in a “Hemophilia Working Group” in 2009.  Critically, the State Medicaid agency submitted a complaint to the Medicaid Fraud Unit in 2014 alleging that “extraordinary amounts” of the product were being shipped to the patient, raising concerns about waste or drug diversion.  Id. at *3.

This is the point of no return, as the State anticipated litigation no later than 2014.  The State did not, however, issue a litigation hold notice until two years later, and it took no further action to preserve the Medicaid agency’s records under March 2020.  The State did not place a legal hold on the mailboxes of some relevant document custodians until 2023—nine years after the Medicaid agency first made formal claims of fraud.  Id. at *4-*5.

To make things worse, the state did not disclose these facts to the defendant manufacturer until January 2025—after the close of discovery. 

The order does not say why the State finally came clean, but the defendant clearly challenged why the State failed to produce a single document from any of the record reviewers, the “Hemophilia Working Group,” or the author of the complaint to the Medicaid Fraud Unit.  Based on these failures, the defendant requested an adverse inference against the state that, if the documents were available, they would show that the State paid for treatments that were medically necessary.  Id.

The district court allowed the adverse interest instruction against the State.  The State’s duty to preserve documents arose no later than 2014, when it knew or should have known that documents relating to this patient, this product, and the State investigation were relevant to future litigation.  Moreover, it was reasonable to infer that, because the State paid for the patient’s treatment, at least some of the physician reviewers supported the prescriptions and that lost or destroyed records would have shown this.  This inference was bolstered by a State investigator’s testimony that she did not remember seeing evidence that the patient’s treatments were unnecessary. 

Finally, the State was culpable, and the defendant suffered prejudice.  The State did not take the necessary steps to preserve important records, and it created privilege logs anticipating litigation as early as 2014, yet waited years before following up to preserve records.  For its part, the defendant lost the opportunity to use the lost or destroyed records to prove that the treatment for which the State paid was medically necessary. 

The court could have done more, such as award attorneys’ fees, which it denied.  But still, this is a useful reminder that the government has to play by the rules, too.  With governmental entities increasingly active on the civil front, we’ll take that. 

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Skrmetti (upholding Tennessee statute forbidding gender dysphoria treatments for minors) was the SCOTUS case that got the most publicity last week, but we drug and device lawyers will always perk up most when we see the High Court issue a ruling regarding the Food and Drug Administration (FDA).  That is probably one reason (though surely not the only reason) why at parties the people with whom we are chatting invariably dart their eyes around the room, desperately searching for a more interesting conversation companion. 

Food and Drug Administration v. R.J. Reynolds Vapor Co., 606 U.S. —- (June 20, 2025), is not a product liability personal injury case, but it offers an interesting (to us, anyway) perspective on challenges to FDA actions.  Both our clients and our opponents sometimes have an interest in pursuing such challenges.   Does the R.J. Reynolds Vapor case offer a blueprint, contrast, or cautionary tale?

The R.J. Reynolds Vapor case concerned the FDA’s denial of approval of tobacco vaping products under the Family Smoking Prevention and Tobacco Control Act (TCA).  21 U.S.C. section 387j. The FDA determined that the vapor product had not been demonstrated to be “appropriate for the protection of the public health,” as required by the TCA.  21 U.S.C. section 387(c)(2)(A).  (We will not hearken back to our tobacco-law days, at least not too much, when we point out that this policy decision by the FDA is a subject of theoretical majesty. You might think that tobacco vaping products pose risks, but what if they are alternatives to riskier products? Must perfection be the enemy of better?) The key questions in the R.J. Reynolds Vapor appeal would seem to center on standing and venue, but the High Court insisted on talking about zones of interests rather than standing, and ducked the most interesting venue issue. The former was an exercise in statutory interpretation, while the latter was a matter of “prudence.” 

In reality, R.J. Reynolds Vapor is a case about persons and places, and it is about choosing the right persons to get to the right places. (Interpret that word “right” however you please.) Per statute, challenges to FDA actions can be brought in the District of Columbia or the challenger’s residence/principal place of business.  But who can be a challenger?

Obviously, the disappointed applicant can bring a challenge.  If not them, then who? In this case the manufacturer was located in North Carolina, which is in the Fourth Circuit.  Accordingly, the manufacturer had the choice of filing its challenge in either the DC or Fourth Circuit.  But prospects for overturning the FDA’s denial did not look good in those courts. By contrast, the odds of overturning the FDA’s disapproval looked a lot better in the Fifth Circuit.  (With a little help from Google you can catch up on developments explaining why that is so.) 

The manufacturer then did something clever.  It challenged the FDA denial in a joint petition with a Texas-based retailer and a trade association in Mississippi. (Critics of the R.J. Reynolds Vapor opinion like to characterize the retailer as a gas station. So what? It is still a retailer. Plus, we remember that during the interminable Engle trial – speaking of tobacco litigation – the best retail local wine selection was at a Miami gas station.)  Texas and Mississippi are both in the Fifth Circuit.  Even aside from the FDA/vaping developments referenced above, if you are even remotely sentient you know that the Fifth Circuit is perceived to be the most conservative, pro-business, anti-agency, etc., jurisdiction in the country.  That image might be simplistic or overblown, but there it is. There has been some legal and political controversy about litigants filing cases in one-judge divisions within the Fifth Circuit so as virtually to guarantee a favorable outcome.  It is an extreme and relentlessly successful form of forum-shopping. But the issue in R.J. Reynolds Vapor was who could file a challenge to the FDA’s denial of approval of the vaping products, and where could they do so. The only reason for the case being in the Fifth Circuit was the involvement of the retailer and trade association. But did they have any business being in the case?

A divided panel of the Fifth Circuit held that the retailer and trade association could bring the challenge and that, therefore, venue in the Fifth Circuit was proper.  The FDA filed for certiorari (a recent episode of the Advisory Opinions podcast entertainingly shows the remarkably different ways that word is pronounced by the Justices), and thus we have the SCOTUS opinion. Remember that while trial courts decide cases/controversies, SCOTUS decides legal questions. Here is the question teed up by the parties:  Whether a manufacturer may file a petition for review in a circuit (other than the U.S. Court of Appeals for the District of Columbia Circuit) where it neither resides nor has its principal place of business, if the petition is joined by a seller of the manufacturer’s products that is located within that circuit.  The majority decision in R.J. Reynolds Vapor was authored by the always intriguing Justice Barrett and the opinion affirmed the Fifth Circuit ruling. Justice Jackson, joined by Justice Sotomayor, dissented.  (It is interesting that Justice Kagan was with the majority on this case. Besides probably being the best writer on the Court, the former Harvard Law dean is wicked smart on procedural issues.  Recall that she dissented in Mallory. There is some speculation that Justice Kagan sided with the conservatives on recent cases in order to do some horse-trading on others.  That seems unlikely, but perhaps we shall see.)

The TCA is the main statute at issue in this case, along with the Administrative Procedure Act (APA). The TCA  sets forth the statutory zone of interest by permitting challenges to adverse FDA action by “any person adversely affected” by the FDA’s denial.  21 U.S.C. §§ 387l(a)(1).  That is the same language used in the APA, and the High Court majority interprets it the same way – to include anyone even “arguably” aggrieved by the action.  Therefore, it is not only the applicant who can sue, but in this case so can any retailers that could have sold the product for a profit.  They literally have “business” being in the case. We are all textualists now, right?  The Court cites A. Scalia & B.Garner, Reading Law (2012).  If you do not have that book on your shelf, you might want to get it. The Court points out that it would be passing strange to read the word “any” to mean “only one.”  If Congress had meant to limit standing to the applicant, it would have said so, as it has in other contexts. (More on that later.).   

The Court did not decide the interesting question of whether each petitioner must be in the correct venue. The FDA argued to the Supreme Court that even if the retailer and trade association can sue in the Fifth Circuit, a manufacturer from the Fourth Circuit should not be allowed to join in on the fun. But the FDA did not argue that position below, and SCOTUS would prefer to have that issue fleshed out below before deciding it. Too bad. There is a bit of a parallel between what happened in this case and the utilization by plaintiffs of (okay, we’ll say it: fraudulent) joinder of local defendants, often retailers, to steer a case away from federal court. There is real force to the FDA’s argument in this case, which was picked up by the dissent, that forum shopping is afoot.

While this action involves potential sellers of vaping products, could it also just as easily involve persons desiring to distribute drugs or vaccines or any other product (e.g., Ivermectin) that the FDA might refuse to approve for a particular use in the future? After all, just as with vaping products, there are retailers of drugs and vaccines who might realize profits.  What about PBMs?  What about patients who feel aggrieved by the unavailability of certain products? We plodding bloggers probably would have thought of those questions on our own but, to be honest, it was one of our faithful readers who first broached them to us.  And then he came up with a decent answer: it comes down to the relevant drug/device/vaccine language regarding standing to sue over approvals/rejections. The APA language is broad and, as the R.J. Reynolds Vapor majority points out, “not especially demanding.”  But it is likely not the only language at issue in any given case.  If the governing statute turns out to be the same as the TCA, you can expect the same answer. Find “any person adversely affected” by the denial, apply the “arguably” standard to determine who was adversely affected, and you’re off to the races. But first you must compare the governing language to what the Court construed here.  Notably, the opinion in R.J. Reynolds Vapor indicates that more narrow TCA statutory language applies to orders that a product be withdrawn, so withdrawals may not support such broad standing, er, zone of interest. The statutory language matters. It is, in fact, dispositive. 

To take just one example, for challenges to denial of a New Drug Application (NDA) under the Food, Drug, and Cosmetic Act, after exhaustion of administrative process, an “appeal may be taken by the applicant from an order of the Secretary refusing or withdrawing approval of an application under this section.  Such appeal shall be taken by filing in the United States court of appeals for the circuit wherein such applicant resides or has his principal place of business, or in the United States Court of Appeals for the District of Columbia Circuit….”  Section 505(h) (emphasis supplied by your friendly blogger). That “applicant” language is considerably narrower than “any person adversely affected.” Sorry, but there is no substitute for flipping through the statutes.   

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If Dante had practiced law, there’s a good chance he would have added a tenth circle of hell—discovery for defense attorneys. Imagine being slowly crushed under a mountain of PDFs, emails from 2007, and inexplicably sticky banker’s boxes. Let’s face it, some of us could update our bios to include—professional document archaeologist.

Discovery was theoretically designed to ensure fairness and transparency. In practice, it’s trying to figure out how to answer a 50-part interrogatory asking for every moment your client thought about the matter at issue since the Nixon administration. Then, only after countless weeks of negotiating a 32-page ESI stipulation covering every conceivable piece of metadata that could exist, comes document production.  The point at which you become your client’s part-time IT technician, therapist, and professional nag.  Which is followed by the 25,000 emails you have to comb through. Half of which are “Reply All” threads that devolved into inter-office lunch orders and passive-aggressive calendar invites. Still, you must review every single one because hidden among those chain emails is inevitably one relevant piece of information. . .followed by a dog GIF.

Which then brings us to the redaction rodeo. Where we redact things like phone numbers, addresses, and trade secrets. And plaintiffs assume we’re redacting anything that could conceivably give them the upper hand. Same goes for privilege logging.  All of which leads to the inevitable motions to compel.  It’s far from perfect; but it’s the system we’ve got and so we’ve got to work within it. Which means fighting the good fight when we need to, like the defendants did in State v. Optumrx, Inc., 2025 La. App. LEXIS 1167 (La. Ct. App. Jun. 20, 2025).

The State brought a lawsuit claiming that two Medicaid service providers inflated prescription drug prices charged to the Louisiana Medicaid program.  The State alleged that the providers “fraudulently concealed” the actual costs and failed to give the State contractually required access to records and data that would show the overpayments.  Id. at *4.   In discovery, the State sought to require defendants to turn over a huge amount of information about the defendants’ contracts and activities in other states. The trial court overruled the defendants’ relevance objections and sanctioned defendants when they refused to produce that material.  The sanction ruling created an appealable order.

Louisiana rules allow for discovery of “any matter, not privileged, that is relevant to the subject matter in the pending action.”  Id. at *10.  And while discovery statutes are “to be liberally construed” and trial courts are given “broad discretion,” that discretion is not absolute. So, the appellate court started with the subject matter of the suit: defendants’ provision of prescription drug coverage to Louisiana Medicaid recipients and whether defendants caused Louisiana to overpay for prescription drugs.  Id. at *11-12. The trial court allowed the out-of-state discovery finding that the State alleged defendants’ pricing scheme in Louisiana was part of a nationwide effort.  To which the appellate court said—not really and so what.

The State’s petition “vaguely alleges” problems with defendants’ pricing “as a whole.” But the suit is limited, as it must be, to allegations of improper price inflation in Louisiana. Moreover, defendants pricing structure with other states is governed by unique contracts with those states that were the subject of state-specific negotiations and concessions.  Therefore, the appellate court rejected “the speculative notion” that evidence of defendants’ pricing structures and contracts with other states—similar or different—was relevant or  would lead to the discovery of relevant information about how defendants administered Louisiana’s Medicaid program. Id. at *13-14. The trial court abused its discretion in ordering the out-of-state discovery.

The rest of the decision addresses various sanctions imposed on defendants regarding other discovery requests.  All but one sanction was overturned and most are case-specific. But we did want to point out that one of the sanctions was for failing to produce information that did not exist. Defendants proffered unrefuted affidavits from their in-house e-discovery director and one of their attorneys explaining that claims data from certain years did not exist because defendants did not provide services in those years.  Since defendants can only produce things that are in their “possession, custody, and control,” the appellate court found that the trial court “manifestly erred” in finding defendants had the data and abused its discretion by sanctioning defendants for not providing it.  Id. at *21. 

Discovery is a process. One filled with the constant fear that you’ve accidentally produced your client’s personal tax returns from 1998. Trial courts that order wildly disproportionate discovery that is wholly unrelated to the claims of the case and impose sanctions for failing to produce documents that don’t exist turn an already difficult and unpleasant process into a full-blown nightmare. Fortunately, this one had a happy ending, but discovery appeals are few and far between.   So, the next time someone tells you they want to go to law school to “argue in court,” take them aside and whisper softly: “Have you ever used Relativity?”

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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
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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
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When you write a few hundred or more posts for a legal blog devoted to the somewhat niche subject of drug and device product liability law, you look for themes or hooks to keep both the writer and presumptive readers engaged.  The themes may be fairly obvious based on the date of the post, the subject matter, or the name of a party.  A post may include hidden references or word play for specific readers, sometimes upon request.  Song lyrics, movie quotes, sports stuff, and events in the lives of the authors may also feature in posts.  Of course, according to the conventions of this Blog, we use plural pronouns even when referring to a singular author, and we have also referred to author’s offspring with sobriquets like Drug and Device Law Daughter or Drug and Device Law Rock Climber.  Whether these devices amuse readers may be revealed in occasional emails, texts, or other comments that we receive.  Most attempts at cleverness echo like the sound of a falling tree in a forest with no human around to hear it.

With that insight into our sausage making complete, we begin to employ a number of these devices in our present post.  We will not, however, attempt any link to Juneteenth, the day on which this post is being published, because that would be silly and demeaning.  Cordle v. Enovis Corp., No. 24-5958, 2025 WL 1570340 (6th Cir. June 3, 2025), is merely the unpublished affirmance on appeal of a dismissal of a knee brace product liability case originally brought in Kentucky federal court.  We could talk about bourbon or horseracing or even President Lincoln if we wanted an easy theme.  Nah.  This past Sunday, we attended the college graduation of the Drug and Device Law Engineer (a.k.a. Drug and Device Law Coxswain) on a beautiful day in a remote corner of New England.  Were we to go the song route, we might feature a sappy snippet from “Cat’s in the Cradle” or “Sunrise, Sunset” or perhaps an updated version of “We Didn’t Start the Fire” that started with the events of 2003, when she was born.  Again, nah.  We can take a more direct route to link the graduation to Cordle.  Back in the early 2000s, we spent a fair amount of time litigating diet drug cases all over the Commonwealth of Kentucky.  We had the win on medical monitoring in the Kentucky Supreme Court in Wood v. Wyeth.  We had the class action settlement in Northern Kentucky that ended with plaintiff lawyers in jail and/or disbarred, a judge kicked off the bench and disbarred, and the forced sale of one of the most successful racehorses of this century.  We even had cases down in Ashland, where Cordle would eventually be pending, that involved one of the most notorious “pill mill” prescribers of the era.  One of the main local lawyers with whom we worked on these cases was distantly related to both Secretary of State Henry Clay and abolitionist Cassius Marcellus Clay, the namesake for the boxer better known as Muhammad Ali, collectively some of the best known Kentuckians.

In a respite from all of this litigating in Kentucky, we took a family vacation to a Caribbean resort with a small Drug and Device Law Engineer in arms.  En route from our room to dinner one night, an elegant older woman approached and asked us to hold the elevator for her husband, who “would love to see your beautiful baby girl.”  We acceded to the somewhat unusual request.  The lady’s husband ambled slowly down the hall, clearly impacted by advanced Parkinsonian symptoms.  When Muhammad Ali got to the elevator, his face lit up as he played with the little DDLE’s toes and cheek and made cooing sounds to her delight.  Her brother got a plaintiff mock punch to the jaw.

Forgive us our long and indulgent detour to our recounting of an episode from more than twenty years ago.  We did not need to go back nearly so far to make a connection to Kentucky, knee braces, personal jurisdiction, or pleading foibles.  We did it in small part—the main reason was to fulfill our fatherly duty to offset filial accomplishment with a touch of embarrassment—to emphasize what we see as the real relevance of the Sixth Circuit’s decision in Cordle.  We have said many times that plaintiffs usually get too many chances to plead claims that survive motions to dismiss and that too many courts let vague allegations suffice even after TwIqbal.  The Cordle appellate decision got it right on both issues.  From filing to dismissal to affirmance on appeal, the case lasted less than twenty-one months.  We have seen way too many cases where plaintiffs are still amending their complaints, pursuing jurisdictional discovery, and generally fumbling around to plead factual allegations that state a claim two years or more into a case.

Below, the Cordle plaintiff amended her complaint in response to the initial motion to dismiss by the one of two defendants served in the case.  The initial motion argued that there was no personal jurisdiction over the movant and that plaintiff’s complaint was too vague to state any claims.  2025 WL 1570340, *1.  The amended complaint added some details and a third defendant, an entity related to the movant.  A second motion to dismiss by the same movant was denied on personal jurisdiction, but granted on 12(b)(6) because the complaint offered only conclusory allegations about defect and causation.  After the remaining defendants were served, they both moved to dismiss on multiple grounds.  Id. at *2.  They were both dismissed, one for both lack of personal jurisdiction and failure to state a claim and the other just for failure to state a claim.  Id.  Plaintiff was also not granted leave to file a third complaint because her proposed amendment would have been futile given its lack of allegations of conduct and causation specific to each defendant.  Id.  On appeal, plaintiff challenged only the latter personal jurisdiction ruling and the denial of leave to amend, implicitly accepting that the second complaint failed to state any claims against any of the defendants.

On personal jurisdiction, plaintiff argued below and on appeal that the defendant at issue was subject to specific personal jurisdiction because it registered to do business in Kentucky.  Registration is not enough under Kentucky cases (see here for Kentucky cases and other registration cases) and plaintiff had not offered factual allegations of the defendant’s conduct of business in the state related to the case.  Id. at *2.  She also offered the general argument that her allegations against another defendant over which the trial court exercised personal jurisdiction should be sufficient against its parent.  But the second complaint did not allege that relationship or anything that the parent did regarding the product at all.  This meant that there was not a “factual basis necessary to support personal jurisdiction” over the particular defendant.  Id. at *3.  Plaintiffs do need to plead facts, after all.  This failure also doomed plaintiff’s argument that she should have been provided an evidentiary hearing before dismissal.  The “threadbare jurisdictional argument” in her written submissions did not create any disputed issues of fact that would have made a hearing helpful.  Id. 

Next up was plaintiff’s argument that she should have been allowed a third chance at a pleading claims and personal jurisdiction before her case was dismissed with prejudice.  In evaluating futility, the Sixth Circuit looked at the proposed third complaint and saw that it “contains only vague assertions that all defendants caused her injury through defective design, manufacturing, and distribution of the knee brace.”  Id. at *4.  It neither alleged what each defendant allegedly did wrong nor facts “showing that defendants worked together.”  Id.  There was no reason to force another round of motions to dismiss, and the district court was correct not to allow plaintiff “yet another bite at the apple.”  Id.  While some wine, and perhaps some children, will improve with age, a product liability case that starts with vague allegations rarely does.  If we had them handy, we would toss our caps in the air to celebrate the work of both Cordle courts for giving plaintiff her day in court without letting the case drag on too long.  Instead, perhaps a sip of bourbon—no ice or water allowed—may have to suffice.

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Wouldn’t it be nice if all legal disputes could be sensible? But, alas, overreaching plaintiffs make work, make motions, and often make craziness.  Sometimes those overreaching plaintiffs can be the government, and that makes things even worse. 

In Hayek Medical Devices (N.Am.) v. Vermont, 2025 Vt. Super. LEXIS 117, 2025 LX 12055 (Vt. Super. May 9, 2025), it was Vermont – yes, the home of Ben & Jerry’s, Orvis, and fine maple syrup – that brought the crazy. 

Are there heroes and villains in this lawsuit? By all rights, this should be a straightforward commercial case.  The plaintiff medical device company sold 50 ventilators to Vermont during the early days of the COVID 19 pandemic. Vermont did not pay for the devices.  It sent them back.  The plaintiff would have preferred to have been paid what was promised. Time for a lawsuit. Fun fun fun. 

Vermont took the position that the ventilators were unsuitable and that the sale was infected with misrepresentations.  So far so sane. 

But farewell sanity, love, and mercy.  Vermont made bizarre and overreaching discovery demands. It sought two databases from the medical device manufacturer. Vermont contended that the databases might help to show that the device company had not mitigated damages.  

God only knows why the state could not have stopped there.  But thestate not only demanded ediscovery from the defendant’s product tracking databases, but further demanded that the plaintiff manufacturer “provide the resources necessary for the State to analyze the data to defend this case.”  Thus Vermont demanded not only production of the databases themselves, but also “the technical capability that would include a server, the software and technical expertise and any other resources that may be needed to analyze the data from the databases.”  In other words, the state was demanding that the plaintiff company pay for its analysis of the defendant’s electronic data.  Help me Rhonda. 

It is bad enough to seek burdensome discovery, and it is worse to do it again. After filing a motion to compel compliance with those broad demands, Vermont took a couple of depositions and then supplemented its discovery motion with a demand for appointment of a special master to oversee discovery.  

Now we get around to why this case, odd as it is, might matter to you. Although here we are talking about discovery demands made by the defendant, and a state at that, similar discovery demands could just as likely (maybe more likely) be made by personal injury plaintiffs against a prescription medical product manufacturer as a defendant in product-related litigation. 

But don’t worry baby. The overbroad, overly/intrusive, and overly-expensive discovery requests were denied.  “The State has failed to demonstrate any basis for such unconventional and extraordinary relief.”  

The court also shut down the state’s demands for production of a wide range of documents in connection with a deposition.  That request was denied because it was a transparent attempt to seek more document discovery after the relevant deadline had passed.  Indeed, the tardiness and evident gamesmanship of the discovery demands seem to have poisoned the well. The state’s demand that the documents be produced before, rather than at, the deposition further demonstrated the improper purpose animating the request.  

Part of the good vibrations we picked up from the Vermont superior court’s analysis was the extensive reliance on federal law, including federal rules and the “numerous” federal cases rejecting similar attempts to impose such vast and unusual discovery obligations. 

But there are some differences between federal and Vermont law, and those differences helped the device company fend off the state’s demands.  The court rejected the state’s request for the unilateral appointment of a special discovery master.  The state of Vermont had no rule allowing special masters.  The state could not force the plaintiff to pay for that, and special masters are allowed in Vermont state court matters only by agreement.  Moreover, the request was – again – late because discovery was mostly over and a summary judgment motion was pending. The state’s request for a special master just wasn’t made for these times.

The lesson is that when a litigation adversary makes crazy discovery demands, even if the adversary is a state, don’t back down. Be true to your school (and your fellow defense hacks).  

(The author of this post wrote it while lying in bed, just like Brian Wilson did.)

Photo of Michelle Yeary

Rouviere has been a long and storied litigation. We have shared many parts of that story here (Zoom depositions during Covid), here (turncoat experts), here (reflections on Rambo litigation), and here (summary judgment on statute of limitations).  After six years of litigation that ended in a summary judgment that was affirmed on appeal, we thought our post one year ago was the last we would be speaking about Rouviere. But no, there’s more. Plaintiff, proceeding pro se (without her attorney husband who previously represented her), tried to get a do over by claiming that not one, not two, but three judges who handled her original case should have been recused for various conflicts—the trial judge, the magistrate, and one of the appellate judges. Fortunately, when all that smoke settled the court saw the transparent last-ditch effort for what it was—a whole lot of nothing.

 If you don’t want to take our word for how the underlying proceedings went down (in the above-referenced posts), today’s decision sets out the history nicely. Rouviere v. DePuy Orthopaedics, Inc., 2025 U.S. Dist. LEXIS 112077, *2-9 (S.D.N.Y. Jun. 12, 2025). Which brings us to the alleged conflicts:

  • The Trial Judge: owned stock in defendant’s parent company while presiding over the case. Id. at *9-10.
  • The Magistrate: while presiding over the case, he received fixed annual payments from his former law former pursuant to a “nonemployee compensation agreement” and said law firm at some point “helped” and “advised” the defendant’s parent company, “among many other major clients.”  Id. at *10-11.
  • The Appellate Judge: her spouse is a partner at a firm who represented defendant in a separate case while the appeal was pending. Id. at *11.

Only one of these rose to the level of a conflict that warranted recusal—the trial judge. But since his decision was affirmed based on a de novo review, the decision did not need to be vacated.

Federal Rule of Civil Procedure 60(b) provides the bases on which final judgments can be vacated and includes a catch-all for “any other reason that justifies relief.” Rule 60(b)(6). That is the basis on which plaintiff brought her motion—another indication of its flimsiness. But motions under 60(b)(6) are not favored and can only be granted “upon a showing of exceptional circumstances” based on “highly convincing” evidence. Id. at *14-15. Plaintiff’s hook for her Rule 60(b)(6) motion was that the judges should have recused themselves under 28 U.S.C. §455(a) (where there is an appearance of impartiality or impartiality might be reasonably questioned) or §455(b) (where the judge knows of a financial interest that could be substantially affected by the outcome of the proceeding).

Applying those standards to the magistrate judge, the court concluded that his annual payments were “too remote to raise reasonable questions about his impartiality.” Rouviere, at *21.  Considering that a judge’s own prior representation of a party is not automatic grounds for recusal, his former law firm’s prior representation of a party is even more attenuated. Further it is “unrealistic to assume that every partner at [ ] a [large] law firm has a relationship—let alone an ongoing relationship—with every client that the firm has represented.” Id. at *22. Moreover, the fixed annual payments are not an interest affected by the outcome of the proceeding.  Even plaintiff had to concede that the outcome of this case was not going to bankrupt the magistrate’s former law firm.  Id. at *26.

While the trial judge’s stock ownership was grounds for recusal, it is not necessarily grounds for vacating the summary judgment order. “To reopen a case based on a violation of Section 455, a litigant must demonstrate that relief from judgment is appropriate under Rule 60(b).”  Id.at *28. Which—see above—is an extraordinary remedy. The court looks at three factors: a risk of injustice to the parties, a risk of injustice in other cases, and a risk of a hit to the public’s confidence in the judicial process. Id. The Second Circuit’s de novo review of the summary judgment ruling cuts against all three factors:

Plaintiff, accordingly, has already received what she is asking for on this motion: an independent review of her case by a different and unconflicted decisionmaker. Because there is no basis to conclude that yet another independent review “would lead to a more just outcome,” “[t]here is no reason to force the parties to relitigate the entire case, likely causing significant delay.”

Id. at *29 (citation omitted). Plaintiff tried to argue that Second Circuit’s review was not really de novo, but the court was bound by the appellate court’s order which explicitly stated otherwise. Id. at *29-30.

Which brings us to plaintiff’s final argument—that the appellate decision should essentially be disregarded because one member of the panel was conflicted. But the fact that a spouse’s law firm, not the spouse directly, represents a party in another matter is not grounds for recusal. Id. at *31-32. Even if it were, majority rules in a panel of three on the Second Circuit. So, the ruling of the other two members of the panel suffice to uphold the affirmance of summary judgment.  Id. at *32.  

We again would like to believe that we are finally saying good-bye to Rouviere, but we’ve already been fooled once. So we make no assumptions about this plaintiff who just doesn’t want to let go.

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