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We previously blogged about the bogus “scientific” articles in the cosmetic talcum powder litigation and the defendant’s relentless efforts to expose the likely fraud. Prior posts are here, here and here.  If you do not recall the ongoing saga, here’s the quick refresher. Plaintiffs’ paid experts in the talc litigation published two articles that purported to study groups of individuals whose only potential asbestos exposures involved talcum powder. Those “studies” were based on plaintiffs in litigation where the authors served as experts. The defendant discovered that several of the subjects in the articles were plaintiffs in ongoing cases, and the defendant knew from those cases that certain subjects had numerous, potential exposures to asbestos other than talcum powder—thus undercutting the entire foundation of the articles.  The defendant aggressively sought discovery about the study subjects’ identities and filed trade libel lawsuits against the authors.

Today’s decision, Moline v. Pecos River Talc LLC, 2025 WL 2898086 (S.D.N.Y. Oct. 10, 2025), involves a motion to quash a subpoena issued to Dr. Jacqueline Moline (who authored one of the papers) by Pecos River in the trade libel lawsuit brought against the other authors, Pecos River Talc LLC v. Emory et al., No. 4:24-cv-75 (E.D. Va.) (Pecos River was the entity created as part of Johnson & Johnson’s effort to resolve the talc-related claims through bankruptcy).  We’ll call the defendants in that case the Emory defendants.

Continue Reading Plaintiff Talc Expert Must Give Deposition Testimony in Trade Libel Lawsuit
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We start with some disclaimers.  Not the usual disclaimers about which of the Blog authors’ respective firms deny responsibility for the post.  We disclaim that we care much about the availability of cigarettes and vaping products, except insofar as litigation over them says something about litigation over medical products and the general interplay between state law, federal law, and public health.  We also disclaim that we are ascribing the positions of the three appellate judges on the case we are discussing to their respective backgrounds and political leanings.  The internet allows our readers to engage in that exercise if they wish.

Anecdotally speaking, there seem to be many consumer protection actions related to regulated non-prescription products being brought these days.  There also seem to be many investigations and actions brought by state attorneys general that a cynic might describe as performative.  In State ex rel. Yost v. Cent. Tobacco & Stuff, Inc., No. 24 CAE 11 0103, 2025 WL 2828526 (Ohio Ct. App. Oct. 1, 2025) (“CTS”), an intermediate appellate court in Ohio affirmed the dismissal of a state AG action brought under the state consumer protection act as to the sale of certain vaping products at a specific brick-and-mortar store.  The trial court had dismissed on preemption—details of that analysis not specified in CTS—the state appealed, and the appellate court considered the issue de novo.  The CTS decision is interesting to us for two main reasons.  First, whereas most Buckman decisions involve private plaintiffs trying to enforce FDCA requirements, this was a state AG civil action that was held to be impliedly preempted.  Second, the dissent conflated express preemption and implied preemption principles and resurrected the presumption against preemption that does not apply to either.  After hundreds of published decisions that evaluate express preemption and implied preemption as independent bases for preempting state law claims under the Supremacy Clause, we did not expect such confusion.  We have authored many purportedly clever posts discussing the need to analyze both types of preemption in certain cases (e.g., Class III devices) as navigating between Scylla and Charybdis on opposite sides of the Strait of Messina.  Just because there is an express preemption provision in a relevant portion of the FDCA and the plaintiff’s claims are not engulfed by the whirlpool (Charybdis) of express preemption does not mean the six-headed sea monster (Scylla) will never be an issue.  We would not analogize to such a non-sensical myth.

The FDCA’s express preemption provisions relating to tobacco products are different from the ones we have discussed relating to Class III medical devices and OTC drugs, for example, and include both a preservation clause and a savings clause, each with carve-outs.  The net result is that some additional state requirements for tobacco products are possible, but not if they are different from or in addition to the FDCA requirements on product labeling, misbranding, and some other things.  2025 WL 2828526, *2.  These details did not really matter to the CTS majority’s decision finding implied preemption, though.  The state’s claims were based on “failing to inform consumers [via product labeling] that the e-cigarettes lack FDA authorization,” which allegedly rendered them illegal, and not on any Ohio law that made their sale illegal.  Id. at *4.  Like the sections of the MDA at issue in Buckman, FDA retains sole enforcement authority as to FDCA requirements for tobacco products.  Id.  Under the Sixth Circuit decision in Loreto v. Procter & Gamble Co., 515 Fed. Appx. 576, 579 (6th Cir. 2013), an OTC drug consumer protection class action we discussed here and here:  “If the claim would not exist in the absence of the FDCA, it is impliedly preempted.”  2025 WL 2828526, *4.  Because the state’s theory was predicated on violations of the FDCA and not any independent state law requirement, its “claim that the e-cigarettes are not in compliance with the FDCA is a claim that would not exist in the absence of the FDCA.”  Id.  The state’s last argument was that preemption decisions involving individual product liability plaintiffs and individual consumer protection plaintiffs could not bar its claims:

However, there is no authority to distinguish such cases based on public vs. private litigants or to limit their application as suggested by the State.  The reasoning set forth in both Buckman and Loreto does not depend upon the nature of the litigant.

Id. at *5.  We might have added “as long as the litigant is not the United States,” but this seems like sounds reasoning to us.

This brings us to the dissent.  There are a few issues with it, including making up something called “explicit preemption,” but we will try to limit ourselves to the two we flagged earlier, the interplay between express and implied preemption and the purported presumption against preemption.  Taking the latter first, the dissent offers that, “[f]rom a review of federal law, it appears that the presumption against preemption would apply generally [to both express and implied preemption]” and that the entirety of the federal regulatory scheme needs to be considered in interpreting an express preemption provision.  Id. at *7-8.  These propositions were purportedly based on Geier v. American Honda Motor Co., 529 U.S. 861, 870 (2000), and the Thomas dissent in Altria Group, Inc. v. Good, 555 U.S. 70, 95-98 (2008).  Geier—on the exact cited page—rejected any presumption against implied preemption.  The Thomas dissent in Altria—the CTS dissent gives 958 as the pinpoint, which we take to be 95-98—argues that there should be no presumption against express preemption and did not address implied preemption.  Later, the Supreme Court rejected any presumption against express preemption in Puerto Rico v. Franklin-California Tax-Free Trust, 579 U.S. 115 (2016), which the CTS dissent did not cite.  The only surviving presumption against preemption is in field preemption.  So, the CTS dissent’s use of a presumption against preemption for both express and implied preemption makes no sense.

We also are not sure why the CTS dissent spent so much time arguing that express preemption, with the detriment of the fictional adverse presumption, did not apply in this case.  The majority decision found implied preemption without analyzing express preemption.  The reason seemed to be that the dissent created a super-presumption that there can be no implied preemption if express preemption did not apply because of a preservation clause:  “Since the statute expressly preserves state action, it would be discrepant to hold that the portion preserving and saving state actions regulating deceptive sales is somehow an obstacle to federal enforcement.”  2025 WL 2828526, *10.  Nope.  As to the majority’s analysis of implied preemption, the CTS dissent minimizes Loreto as being unpublished and ignores Buckman entirely.  The U.S. Solicitor General cited this same portion of Loreto with approval in a 2015 Supreme Court amicus brief on implied preemption, as we discussed here.  Loreto, in turn, cited a portion of Buckman, which would have been sufficient to support implied preemption in CTS even if Loreto did not count:

On the contrary, the existence of these federal enactments is a critical element in their case. For the reasons stated above, we think this sort of litigation would exert an extraneous pull on the scheme established by Congress, and it is therefore pre-empted by that scheme.

531 U.S. 341, 353 (2001).  Like we said, we have no particular investment in the availability of vaping products, but we do care about courts getting preemption right when it comes to FDA-regulated products.  It certainly helps to read the cases being cited, but we also have plenty of readily-available posts that explain a number of the subjects presented in the two opinions in CTS.

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Today’s case, Hartney v. Zoetis, Inc., 2025 WL 2924661 (D.N.J. Oct. 15, 2025), is about a canine medicine allegedly gone wrong.  But lest you think the DDL blog has gone to the dogs, this case addresses issues such as preemption and learned intermediary that are key in cases with thumbed, supposedly sapient, biped plaintiffs. 

Mind you, we’re not among those who pronounce dogs to be superior to humans, though there have been times when the issue has at least seemed to be a jump ball.  We haven’t yet met a dog who twisted our words or made up fake precedents.  Now, you might point out that nor have we met a person who piddled on our floor. Well … are you sure about that?  For a funny, touching nuanced take on our relationship with the faithful, adorable, filthy, best possible pets (sorry, cat people – your felines barely tolerate you), see The Oatmeal comic masterpiece, “My Dog: The Paradox.”

As we write this, the Drug and Device Law Portuguese Waterdogs — Maks and Bailey — are taking their tenth nap of the day. They will contribute no learning, no analysis, not even cite-checking to this blogpost.  But their snores and groans (probably dreaming of chasing infernal squirrels) ensure that we will be more sympathetic to the plaintiffs than is normally the case. 

Hartley is styled as a consumer fraud nationwide class action invoking the laws of multiple states and targeting an FDA-approved veterinary drug.  Early on, the court tells us that there are eight named plaintiffs and, for a moment, we thought those named plaintiffs would be dogs. But, no, the named plaintiffs are people.  Still, we do learn that the allegedly injured dogs included Jake, Blue, Dixie, Jack, and Maisley, among others. Those are good dog names. We can almost picture those pups, and we grieve over the injuries they allegedly suffered after being administered a medicine intended to treat osteoarthritis. At least one dog (Jake) had to be euthanized.  If you’ve ever taken a pooch for that one-way ride, you know how dreadful that is.  

The plaintiffs’ complaint alleged that the drug was defectively designed, that the manufacturer should have warned of the serious potential side effects, and that the manufacturer underreported adverse events.  By the time we get to the Third Amended Complaint, the causes of action in play were consumer fraud (under the laws of New Jersey, California, Illinois, Missouri, Texas, and Virginia), product liability under the New Jersey Products Liability Act, express warranty, implied warranty, negligence, and unjust enrichment. The defendant filed a motion to dismiss and a motion to strike the class allegations. 

The court dismissed the Third Amended Complaint, but not with prejudice.  As is usual with class actions, the complaint sought to obscure individualized reliance/loss causation issues.  Whichever state consumer fraud statute applied, the problem with the Third Amended Complaint was that it failed to identify any affirmative misrepresentations, describe what was purportedly false, or how the would-be class representatives relied on any falsehoods. Moreover, in New Jersey, product-related warning claims must be pursued as product liability, not consumer protection, claims.  Here is where we get to application of the learned intermediary doctrine. Yes, it applies to veterinarians.  The problem is that the complaint is devoid of warning causation allegations as to the plaintiffs’ veterinarians.  The plaintiffs invoked the New Jersey Perez case exception to the learned intermediary doctrine when there was direct to consumer advertising, “but they do not plead reliance  on any identified advertisement, so the exception does not apply.”

Further, New Jersey has a rebuttable presumption of adequacy in FDA-approved warnings and the plaintiffs did not plead anything to avoid the presumption.  

The design defect claim was preempted because the plaintiffs were attacking the FDA-approved design. The plaintiffs offered no FDA-approved alternative design.

The express warranty claim, as usual, failed to plead any warranty language.  The plaintiffs generally alleged that the manufacturer warranted the drug to be “safe and effective,” but they identified no advertisement or promotional statement containing such a representation. Most courts require that an express warranty be part of formation of the bargain, and that was absent here.  Also absent were presuit notice to the defendant (required in many jurisdictions) or privity (required in even more jurisdictions).  

The Third Amended Complaint listed claims for implied warranties of merchantability and fitness for a particular purpose. To state such claims, the plaintiffs must allege that the drug was unfit for its ordinary use or for a particular purpose that was actually communicated. They did not do that. That dog won’t hunt. 

The negligence claims alleged that the defendant “failed to exercise reasonable care in testing, marketing, and selling” the medicine, “including by adequately testing the drug and withholding results.”  To the extent the claim was based on a failure to report information to the FDA, it was preempted by Buckman. The other negligence theories were subsumed by statute if brought under New Jersey law, and, again, failed to plead learned intermediary causation.  

The unjust enrichment claim (almost always makeweight) failed because the plaintiffs “plead no facts beyond those underlying their statutory and product liability theories, and they do not allege why legal remedies would be inadequate.”  

With all these pleading defects, the plaintiffs would be afforded the opportunity to try again. Perhaps they will learn some new tricks and produce a Fourth Amended Complaint.  So maybe now we’re just at a paws, er, pause, in the proceedings. 

Meanwhile, the court held that it was premature to strike the class action allegations on the pleadings. The plaintiffs were entitled to undertake some discovery to support class certification.  That is a pity. It means that a weak case will continue to visit expense and inconvenience on a defendant that should probably be unleashed from this litigation. 

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Is the question we were left pondering after reading Jensen v. Walgreen Co., — P.3d —, 2025 WL 2799200 (Utah Oct. 2, 2025). It’s certainly a question that is answered in the affirmative in strict product liability prescription drug and device cases, as discussed here. And there is a certain logic to extending that reasoning to pharmacy cases. Sure, pharmacists play a crucial role in healthcare. But they’re not the prescribing authority — that’s the doctor. So, when it comes to whether a pharmacist should be held liable for failure to warn of a contraindication, shouldn’t the question be who had the final say in whether the patient got that medication? And if the answer is a confident learned intermediary, one who even if questioned by a pharmacist would still have ordered the prescription, doesn’t that defeat causation?

Plaintiff in Jensen suffered from severe chronic pain for which he was prescribed oxycodone for many years. The same doctor who prescribed oxycodone, also diagnosed plaintiff with anxiety and depression for which he prescribed clonazepam. The combination of the two drugs has been associated with severe respiratory side effects and in 2016 the FDA added a black box warning to both drugs warning of the risk. Id. at *1-2. When plaintiff filled the clonazepam prescription, the pharmacist received a warning on his computer about the combination with opioids, but the pharmacist overrode the warning and filled the prescription without calling the prescriber. Plaintiff died a few days later from “oxycodone clonazepam toxicity.” Id. at *2. On these facts, we can understand a court finding the pharmacist had a duty to act reasonably.

But that is not the end of the story. Two other key facts were established during discovery. First, at the appointment where the physician prescribed clonazepam, plaintiff and his wife both “expressed concern about adding clonazepam to [plaintiff’s] existing medications, and they specifically asked if it might case him side effects.” Id. The prescriber advised it would be fine. Second, the prescriber testified that even if the pharmacist had called him, “he would have instructed the pharmacist to fill the prescription exactly as written.” Id. When you add in these facts, we go back to our opening question: how can we reasonably say the pharmacist caused the harm.

The majority of the Jensen opinion focuses on the scope of the application of the learned intermediary doctrine to pharmacists under Utah law. Utah recognizes the learned intermediary rule as creating an exception to a pharmacist’s general “duty to possess and exercise the reasonable degree of skill, care, and knowledge that would be exercised by a reasonably prudent pharmacist in the same situation.” Id. at *6. Like most courts that have extended the learned intermediary doctrine to pharmacists, Utah agrees that the primary reason for not imposing a duty to warn on pharmacists is to prevent interference in the doctor-patient relationship. Id. at *7. However, Jensen goes on to hold that in negligence cases, there are circumstances where the exception does not apply. Namely, when the pharmacist is “aware of a patient-specific risk” or where the prescription contains an obvious error that a reasonably competent pharmacist would notice (like a lethal dosage). Id. at *6-7. In other words,

[W]hile the learned intermediary rule exempts pharmacists from the duty to warn patients of the general risks of FDA-approved drugs, outside of that, it does not create an exception to the general rule that a pharmacist owes a duty to care to patients.

Id. at *7. But the court also “emphasized” that in situations where the learned intermediary rule does not apply, “it does not necessarily follow that the pharmacist is liable for negligence.” Id. The plaintiff still needs to prove the other elements of a negligence claim—including causation.

So, while we agree that the learned intermediary doctrine, in this case, was not grounds for summary judgment as to the pharmacist’s duty, we disagree with the court’s conclusion that the prescriber’s testimony was insufficient for summary judgment on causation.

Because liability requires causation, the pharmacist’s action (or inaction) must have been a substantial factor in causing the injury. But if the doctor — the only one with the power to change or cancel the prescription — says they would have made the exact same decision even after being warned, then the pharmacist’s failure to warn didn’t change the outcome.

Holding the pharmacist liable in this kind of situation creates a double standard. It essentially punishes the pharmacist for not overriding a physician’s judgment, even when that judgment would have remained the same. In Jensen, it was undisputed that when asked about how clonazepam might interact with plaintiff’s other medications, the prescriber said it would be fine, and plaintiff went ahead and filled the prescription.  Further, the prescribing physician testified unequivocally that if the issue had been re-raised by the pharmacist, the doctor would have reiterated his advice that the prescription was fine. This testimony breaks the chain of causation as a matter of law. No reasonable jury could find that the pharmacist’s alleged failure to warn caused the injury if the prescribing decision would have been the same.

Here, however, the court gave credence to plaintiff’s assertions that her husband would not have taken the drug had he been warned of the contraindication. But self-serving, hindsight drive statements should be insufficient to defeat summary judgment. In the context of a prescription drug, the key question should remain whether the physician’s prescribing decision would have changed.  A plaintiff’s after-the-fact claim that they would have made a different decision should not rebut direct, unequivocal physician testimony. Particularly where the evidence demonstrates, as it does in Jensen, that plaintiff asked for the doctor’s opinion on drug interactions, accepted it, and took the drug. Where it is clear that the doctor’s advice would not have changed, it is likewise clear that the plaintiff’s actions would not have changed.

In short, the pharmacist might have had a duty to warn, but if that warning wouldn’t have changed a thing, then the failure didn’t cause the harm. No change, no causation. No causation, no liability. That’s how it should be.

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We’ve bashed the horrible decision in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), more times than we care to count.  This time we’re taking a look precedent contrary to Bausch’s statement that “[t]here are no special pleading requirements for product liability claims.”  Id. at 558.  While that is true as a platitude, the fact of the matter is that TwIqbal does not recognize legal conclusions such as “X violated the FDCA” unless they are supported by facts that plausibly establish the purported violation.  Plaintiffs “cannot simply incant the magic words [defendant] violated FDA regulations in order to avoid preemption.”  Caplinger v. Medtronic, Inc., 921 F. Supp.2d 1206, 1224 (W.D. Okla. 2013), aff’d, 784 F.3d 1335 (10th Cir. 2015)

Thus, in the specific context of allegations of “parallel” claims that seek to evade preemption, most courts have recognized that “[p]arallel claims must be specifically stated in the initial pleadings.”  Wolicki-Gables v. Arrow International, Inc., 634 F.3d 1296, 1301 (11th Cir. 2011).

Continue Reading Preemption, Plausibility, and Parallel Claims
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As our loyal readers take a break from Halloween costume planning and other fall festivities, don’t forget to add registration for ACI’s Drug and Medical Device Litigation Conference, taking place December 3–4, to your to-do list.

As we mentioned, the good people at ACI have once again invited the blog to serve as a media sponsor, and they’re offering our readers a special discount. Use code D10-999-DDLB26 when you register to save 10% on your conference fee.

Several of our bloggers will be in attendance, and we’re looking forward to insightful presentations from the consistently outstanding faculty of in-house counsel, top defense firms, and seasoned jurists.

You can register here. We hope to see you in New York!

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We have always been flummoxed by California’s Sherman Law.  That is the California statute that purports to incorporate by reference the Food, Drug, and Cosmetic Act, supposedly making violations of that federal also offensive to state law.  Why does this matter?  Because there is no private right of under the FDCA, and 21 U.S.C. § 337 expressly reserves the right to enforce the FDCA to the United States, not private parties.  Despite this, some courts have allowed private parties to evade section 337 by permitting private actions under California’s Sherman Law, even though the allegations amount to violations of the FDCA.  It’s a federal wolf in California sheep’s clothing. 

The Ninth Circuit recently took on this conundrum in an unpublished opinion and held that the FDCA means what it says—there is no private right of action, even if the plaintiff has shrouded its claims in the Sherman Act’s rubric.  In Bubak v. Golo, LLC, No. 24-492, 2025 WL 2860044 (9th Cir. Oct. 9, 2025), the plaintiff brought a claim under California’s Unfair Competition Law (or “UCL”), which permits lawsuits by private parties who have suffered injuries because of any “unlawful, unfair, or fraudulent business act or practice.”  Id. at *1.  The claim was premised on an alleged violation of the FDCA “as incorporated into California law in the Sherman Food, Drug, and Cosmetic Law,” which is a typical use of the Sherman Law as an end run. 

The district court dismissed the complaint, and the Ninth Circuit affirmed in an unpublished opinion, with a concurring opinion that confronts the issues head on.  Citing its precedential opinion in Nexus Pharmaceuticals, Inc. v. Central Admixture Pharmacy Services, Inc., 48 F.4th 1040 (9th Cir. 2022) (discussed here), the Ninth Circuit held that the plaintiff’s claims were prohibited by federal law:

The FDCA expressly prohibits private enforcement.  In Nexus, the plaintiff sought to avoid this prohibition by bringing claims under the UCL and other state laws that “incorporate” the FDCA.  We explained, however, that these claims are preempted because they “rest upon a violation of the FDCA,” and proceedings to enforce or restrain violations of the FDCA “must be by and in the name of the United States, not a private party.”

Bubak’s claims face the same problem.

Bubak, at *1 (citing section 337, quoting Nexus Pharma).  Because the plaintiff’s claims required litigating violations of the FDCA, the plain language of the statute prohibited them.  Moreover, the plaintiff’s attempts to distinguish Nexus fell flat—both cases involved the Sherman Law; Nexus was not limited to pharmaceuticals; and both brought claims that existed “only by virtue of the FDCA.”  Id. at *1-*2.  The plaintiff’s reliance on a more recent Ninth Circuit opinion going the other way, Davidson v. Sprout Foods, Inc., 106 F.4th 842 (9th Cir. 2024), was misplaced.  In Davidson, the Ninth Circuit allow state-law claims based on violations of the FDCA because the alleged violation was “plain,” whereas the alleged violations in Nexus and Bubak “required litigating.”  Id. at *2.  (You can read our take on Davidson case here.) 

The court therefore affirmed the dismissal, but the concurring opinion offers the greater insight, particularly in urging that the court overrule Davidson.  The Davidson opinion cannot be reconciled with the earlier Nexus opinion, and the idea that the plaintiffs in either case alleged claims under California’s Sherman Law, and not the FDCA, is pure fiction.  The FDCA’s bar on private enforcement does not carve out an exception for “plain violations,” and there is no principled basis for concluding that the FDCA reserved enforcement of some violations to the federal government, but not others.  Bubak, at *3. 

The concurring opinion saw only one way to reconcile Davidson with earlier precedent.  In Davidson, the plaintiffs’ claims predated enacted of the relevant provisions of Sherman Law and “thus exist[ed] independently of” federal law.  Id.  In the view of the concurring judge, the FDCA’s bar on private enforcement would not reach such claims, since they would not be predicated on violations of the FDCA. 

We see the concurring opinion’s point, but this judge might be slicing the onion a bit too thin.  If a plaintiff brought a UCL claim invoking some violation of the Sherman Law that was truly outside the FDCA, that claim theoretically could proceed.  But would have to see a concrete example to believe it.

The more useful takeaway from Bubak is that California’s Sherman Law is not a highway around the FDCA’s ban on private enforcement.  The opinion correctly treats Nexus as prohibiting state law claims alleging violations of the FDCA, and its attempt to cabin Davidson is equally useful, since most every claim under the FDCA will “require litigating” and thus will be preempted.  Not that we would object to an opinion expressly overruling the wrongly decided Davidson opinion.  That would be good, too.    

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As defense lawyers, we have dealt many a time with plaintiffs’ attorneys who get away with just about everything. Failing to appear for hearings. Failing to oppose motions. Ignoring court orders. Ignoring discovery requests.

When unjustified, such acts of neglect should not be excused, but they often are. Courts are predisposed to decide cases on the merits, and loathe to force plaintiffs to bear the consequences of the actions (or inactions) of poorly-chosen legal counsel. Thus, more frequently than you might expect, courts will overlook blown deadlines and court-imposed requirements for those on the other side of the “v.”

Rule 60(b) of the Federal Rules of Civil Procedure provides guidance for discerning between errors that are justifiable and those that are not, but we’ve always found it a bit cryptic:

On motion and just terms, the court may relieve a party or its legal representative from a final judgment, order, or proceeding for the following reasons:
(1) mistake, inadvertence, surprise, or excusable neglect

You do not wind up in Rule 60 motion territory without some kind of mistake or neglect, or inadvertence or surprise. The ultimate question is whether the goof-up is one that can be justified or excused, and that is where we think Rule 60 could do with a little more detail.
Our griping aside, some attorney errors are obvious even under the vague Rule 60(b)(1) test. Which brings us to Donate v. Smith & Nephew, Inc., 2025 U.S. Dist. LEXIS 197226, 2025 WL 2829196 (Oct. 6, 2025 E.D. La.).

Donate came to our attention because it is a medical device (knee replacement) product liability action. After the defendant removed the case to federal court, the plaintiff’s lawyer registered with the federal court ECF system.

And that apparently was about the last thing he did, until five months after the court entered judgment against the plaintiff for failing to oppose a motion to dismiss and failing to respond to an order to show cause about said failure to oppose the motion to dismiss.

Once plaintiff’s counsel finally came to, he moved for relief from judgment under Rule 60(a)(1), arguing excusable neglect in that his email address had changed, he failed to update it in the ECF system, and thus he had not received any filings or orders after the removal.

The court—the venerable Judge Eldon Fallon, not one who is quick to penalize plaintiffs for their attorneys’ minor mistakes—rejected plaintiff’s arguments, emphasizing that local rules require attorneys to maintain current contact information in the electronic filing system. Indeed, the rules also require attorneys to diligently monitor the status of their cases, and plaintiff’s counsel did not check the docket or contact the court’s clerk either.

Relying on the Fifth Circuit’s gloss on Rule 60(b)(1) from Trevino v. City of Fort Worth, 944 F.3d 567 (5th Cir. 2019), Judge Fallon agreed that this conduct amounted to gross carelessness, and counsel’s ignorance of his obligations under court rules did not justify relief under Rule 60(b)(1) either.

The court also addressed the appropriateness of dismissal with prejudice, noting that lesser sanctions would have been futile under the circumstances. It had attempted to reengage plaintiff’s counsel through the show cause order, but counsel’s failure to update his contact information rendered such efforts ineffective.

It seems like it should not be necessary to say this, but apparently it is: Lawyers need to keep their addresses updated with the court, and keep an eye on their cases, particularly if things have unexpectedly gone silent.

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There is a documentary out on the actor Charlie Sheen and it reminded us that, long before the current denizen of the White House crowed about “winning,” that was a staple of many bizarre rants by Sheen. 

We’re not ranting, whether bizarrely or sanely, but it is nice to post about yet another defense win in Filshie clip litigation.  The case is Banet v. Cooper Co., 2025 U.S. Dist. LEXIS. 193141 (W.D. Kentucky Sept. 30, 2025).  The plaintiff made the usual claim – that the Filshie Clip tubal ligation device migrated and caused an injury.  The particular injury in Banet seemed serious. The clip could not be removed safely.  

The plaintiff filed a complaint with three counts: strict liability design and marketing defect; (2) negligence; and (3) punitive damages.  Of course, punitive damages is a form of relief, not a separate cause of action. The court pointed that out and – spoiler alert – the count was going nowhere.  Why do plaintiff lawyers keep making this mistake? Anyway, the key issues in the Banet case were personal jurisdiction and federal preemption. 

Personal Jurisdiction

A couple of entities escaped on personal jurisdiction grounds, because they were merely corporate affiliates that did not actually do anything in Kentucky and did not constitute alter egos of the main defendant.  One entity (CSI) did not escape on jurisdictional grounds, and the court’s reasoning is a bit fishy.  The court applied a version of Kentucky’s long-arm statute that has since been repealed and replaced, so maybe the ruling is no big deal.  Still … while CSI had ceased being a distributor before the date of the plaintiff’s surgery, the court kept it in the case based on a “possible inference” that “by establishing a pre-existing sales arrangement with Twin Lakes, CSI caused Banet to be implanted with defective Filshie Clips. To wit, had CSI not regularly marketed and/or sold Filshie Clips to Twin Lakes, Utah would not have continued to provide Filshie Clips to the hospital and Banet’s medical provider would have used another contraception device.” That sounds less like reasoning than speculation.  Indeed, it sounds like a judicial exercise in counterfactuality with all the plausibility of the glorious Hot Tub Time Machine movie franchise. But whatever, the case gets dismissed anyway, and now we’ll get to the good part. 

Federal Preemption

The Filshie Clip is a class III medical device that received premarket approval (PMA) by the Food and Drug Administration (FDA), meaning that broad express preemption applies, barring claims for both design defect (a different design would require a new FDA approval) and inadequate warning (the proposed new warning would vary or add to the device’s FDA-approved warnings). 

The plaintiff argued that she “sufficiently pleaded that the Defendants violated the requirements of the Filshie Clips’ PMA,” but the court pointed out that “nowhere in the paragraphs she cited in support of this contention (nor anywhere else in the Complaint) does she allege that the design for the Filshie Clip used in her surgery different from the design approved by the FDA.” Accordingly, adios to the design defect claim. 

As is usual in Filshie Clip cases, the plaintiffs ultimately asserted a claim for failure to report adverse events to the FDA. (The “marketing defect” claim originally offered nine different theories, including, inter alia, “failing to disclose that the Filshie Clip was inadequately tested,” and failing to convey post-marketing warnings, but the plaintiff abandoned those theories and pushed all her chips in on the alleged failure to report adverse events. That claim was also preempted because it presupposed the insufficiency of the device’s FDA-approved warnings.   

Any duty to warn physicians, whether directly or indirectly through the MAUDE database, is different from, or in addition to, the FDA-approved warnings.  “Any claim that Defendants were required to provide additional ‘warnings’ via MAUDE necessarily presupposes that the FDA-approved warnings contained within the Filshie Clips labeling and marketing were themselves insufficient to ‘adequately guard against the inherent danger.’” Allowing a jury “to determine whether Defendants’ FDA-approved warnings were inadequate based on ‘any non-disclosed information is the kind of inter-branch meddling that concerned the court in Buckman … and would both usurp the agency’s role and go beyond the court’s institutional expertise.’” Just so. 

Lately, in all sorts of litigation, this structural, separation of powers point seems to be packing a powerful punch. The intemperate and inaccurate political yammerings about abuse of judicial authority are regrettable, but it is possible that at least some courts have shown an increased sensitivity to accusations of judicial overreach. Incursions on executive branch authority are to be studiously avoided. Incursions on Congressional authority … well, actually, what is that, anyway, these days?

The negligence claims in Banet failed for the same reasons as the strict liability claim failed. Again, the squishy litany of allegations boiled down to failure to report adverse events and, again, preemption ruled the day. Moreover,  a “laundry list” of negligence allegations was not specific enough to state a claim. The court dismissed the claims. Even without “tiger blood,” winning by the defense is always welcome news in this blog. 

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We call a treating physician who testifies to more than just their treatment a hybrid expert. But doctors who both treat and testify can sometimes be less “Doctor Do No Harm” and more “Doctor Show Me the Money.” And when their treatment comes under a letter of protection (“LOP”), things get even murkier. Like, swampy Florida-murky. Which is oddly fitting since today we are talking about Dyer v. Coloplast Corp., 2025 U.S. Dist. LEXIS 200241 (M.D. Fla. Oct. 9, 2025).

Before we get into the case specifics, this is not an attack on treating physicians. Most are competent, ethical professionals who want to help people. But when a doctor is treating under an LOP and then testifying in court with the flair of a paid actor in a late-night infomercial, defendants have to ask–is this about the patient, or the payout?

Plaintiff in Dyer sued the manufacturer of the pelvic sling that was surgically implanted to treat her stress urinary incontinence and pelvic organ prolapse. The sling later was removed due to side effects. Defendant served discovery requests on both plaintiff and her explanting surgeon seeking production of documents related to plaintiff’s counsel’s relationship to the explanting surgeon, including any LOPs, billing agreements, or other documents reflecting referrals and financial relationships.  Plaintiff and her doctor moved to quash and defendant moved to compel.  The opinion starts by dealing with technical and procedural issues. Like that both plaintiff and the physician filed motions to quash in the wrong court–not the court where compliance would occur—and that they filed too late. Id. at *7-9. Or that personal service of Rule 45 subpoenas was not required; giving the subpoena to an employee at the address listed for the physician in plaintiff’s disclosures was reasonably calculated (and did) ensure receipt. Id. at *11-12.

The court also rejected the surgeon’s arguments that the requests sought protected health information (“PHI”) that patient-physician privilege prohibited him from disclosing. Not only did the requests for financial relationship documents not call for PHI, the defendant agreed that if responsive documents did contain such information, it could be redacted. Id. at *13.

So that left only whether discovery of LOPs or financial relationships should be permitted at all. For those blissfully unaware, an LOP is an agreement between a plaintiff’s attorney and a medical provider.  The medical provider agrees to treat the plaintiff now, and in return, the attorney promises to pay the treater later, out of any settlement or award the plaintiff may receive. It’s like a medical IOU. While there may be instances where an LOP is used because a plaintiff cannot otherwise get medical treatment (uninsured), it can also be a litigation strategy. Plaintiff’s counsel refer their clients to physicians who are experienced courtroom testifiers. Now you have a doctor testifying in court who has a quiet financial interest in the outcome, or maybe a not-so-quiet one.

Hybrid expert witnesses are unique creatures. They testify as treating doctors (so they’re supposedly neutral), but they also function like retained experts. That’s not inherently bad. But there is no dispute that discovery of how much retained experts are getting paid to testify is warranted. Everyone agrees it can go to bias. So, the same rule should apply to treating doctors. Defendants should be able to know and cross-examine treaters on their financial interest in the litigation and their financial relationship to plaintiff’s counsel.

Afterall, if a doctor has treated dozens of patients referred by the same law firm, all under LOPs, and all leading to litigation… well, we’re not in Hippocratic territory anymore. We’re in transactional medicine, dressed up as medical opinion. Without discovery, the defense is left poking around in the dark, while the jury sees a white coat and assumes objectivity.

Which brings us back to Dyer and Fla. Stat. §768.0427(3), enacted in March 2023. The statute requires disclosure of any LOP (broadly defined), as well providing generally that the nature of the financial relationship between a law firm and a medical provider is relevant to the issue of bias—making it discoverable. Plaintiff in Dyer, however, tried to rely on pre-2023 cases to quash the discovery. Such as Worley v. Central Florida YMCA, Inc., 228 So. 3d 18 (Fla. 2017), in which the court held that “a lawyer’s referral of a client to a treating physician was a confidential communication protected by the attorney-client privilege.” Dyer, at *15. Fortunately, §768.0427 overturns Worley; therefore, plaintiff and her surgeon were ordered to respond to the discovery. 

Hybrid experts are not the enemy—but unchecked financial bias is. Pulling back the curtain and allowing some of that Florida sun to shine on LOPs is doing the right thing. 

Drug & Device Resources

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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