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Keralink Intl., Inc. v. Stradis Healthcare, LLC, 2025 WL 1947764 (4th Cir. 2025), is a rare published appellate decision on common-law implied indemnity in the context of prescription medical product liability litigation.  The case involves two commercial intermediate seller parties already held liable to a buyer of the product (corneal eyewash) that had been rendered useless due to contamination.  

The rarity of this kind of decision is underscored by the almost total lack (remarked in the opinion) of legal standards for implied indemnification. Doing what it could with available Maryland precedent, the decision more or less split the baby, in the sense that the downstream party succeeded on its claim for indemnification against the upstream party, but did not succeed on its claim for attorney fees. 

Tort indemnity is a form of indemnification implied in law. Implied indemnity could exist even though the party seeking indemnification has some degree of fault (some states require blamelessness, but not Maryland). Indemnification can also be contractually bargained for, but that is not what happened here. In cases of contractual indemnification, the task for the court is, obviously, contractual interpretation.  That might have been easier for the Keralink court than figuring out, against an almost blank slate, whether Maryland law would imply indemnification.

The key principles for implied indemnification were categorization of fault and avoidance of unjust enrichment.  The upstream seller, who arranged to purchase the product from its Korean manufacturer, was more extensively involved with the product and had more extensive culpable conduct.  The upstream entity’s liability to the original plaintiff could be categorized as “primary, active, and direct” while the downstream distributor’s liability could be categorized as “secondary, passive, technical, or imputed.” That’s how the district court saw it, at least in relative terms, and granted the downstream entity’s motion for summary judgment and awarded it indemnification. 

The Fourth Circuit reviewed the grant of summary judgment de novo and affirmed. The upstream entity put its name on the product as apparent manufacturer (no other entity had its name on the package), it reviewed the label for “accuracy,” made changes to the Drug Facts section of the label, and received FDA registration. The appellate court agreed with the district court’s assessment of relative liability.  

Moreover, the court was concerned that if the upstream manufacturer’s no-indemnification position prevailed, then only the actual manufacturer, which was in South Korea, could be subject to tort indemnification in favor of a downstream supplier.  No Maryland precedent stood for that proposition. Further, the trial court’s conclusion “also was consistent with the equitable nature of the remedy of implied indemnity under Maryland law, ensuring that [the upstream entity] was not ‘unjustly enriched’ by [the downstream entity’s] exposure to payment of the entire judgment despite [the upstream entity’s] primary culpability.” The upstream company was properly held liable for indemnity.  

But tort indemnity extends only to the recoverable damages, not to attorney fees. Again, Maryland law was hardly pellucid as to the issue, and the district court seized upon dicta from an earlier case in denying attorney fees. Again, the Fourth Circuit again smiled upon the district court’s decision, reasoning that Maryland follows the American rule that each side bears their own attorney’s fees.  The only exception is for innocent parties, who may recover fees. But while the downstream entity could be characterized as less culpable than the upstream entity, it could not be characterized as entirely innocent. 

The downstream company fought hard for attorney fees. That is unsurprising.  In some cases, the attorney fees can be significant, sometimes even approaching the substantive damage awards. The downstream entity relied on a couple of cases awarding attorney fees where there were indemnity contracts. But the Keralink district court held, and the Fourth Circuit agreed, that cases involving contractual indemnification were inapplicable.  In sum, the Fourth Circuit declined the downstream entity’s “request that we recognize an exception to the American rule to permit indemnification of attorneys’ fees incurred in defending against a tort action in which that defending party has been found secondarily culpable.”

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From a doctrinal standpoint, courts rely on a well-established principle: experts are permitted to testify to assist the fact-finder, not to persuade them with rhetorical flourish. Federal Rule of Evidence 702 permits experts to offer opinions grounded in their expertise, but that doesn’t open the floodgates to courtroom TED Talks. The moment an expert starts editorializing—injecting value-laden commentary, offering thinly veiled advocacy, or styling their testimony like an op-ed—they’ve crossed the line from helpful interpretation to persuasive advocacy. That’s what plaintiff’s expert, Dr. Fugh-Berman, a frequent flier in pharmaceutical litigation, tried to do in in United States es rel. Siegel v. Novo Nordisk, Inc., 2025 U.S. Dist. LEXIS 135854 (W.D. Wash. Jul. 16, 2025).  But the court nudged her, not all that gently, back into her lane — behind the witness stand, not on the bench, at counsel table, or in the jury box. 

Dr. Fugh-Berman was proffered to opine that defendant’s marketing and promotion of its drug used in the treatment of hemophilia caused physicians to use more of the drug and to use it for off-label purposes. Experts are supposed to play a role in helping the jury understand facts beyond common knowledge. So, calling an expert to testify that marketing is designed to increase sales seems a little like calling a marine biologist to confirm that fish live in water. No one in the jury box needs that explained. But we’ll allow, because the court did, that perhaps Dr. Fugh-Berman’s 35 years of researching pharmaceutical marketing will offer the jury something beyond common sense. However, there’s a line, especially with a marginally relevant expert — experts may illuminate, they should not pontificate.

That is why the court allowed testimony about what can influence a physician’s prescribing behavior generally, but precluded testimony that defendant’s “promotional methods” caused the plaintiff’s physician to prescribe the drug to plaintiff.  Not only had the expert not reviewed any data specific to plaintiff or the prescribing physician, the ultimate causation question is a legal conclusion for the jury.  Id. at *5-6.

While not all of the plaintiff’s expert’s opinions are spelled out in the decision, the court repeatedly made clear that she could “summarize” the promotional benefits offered to plaintiff and his physician and offer her opinion that they are the type of benefits that may influence physician prescribing behavior, but she could not offer opinions that crossed the line into argument or legal conclusions – such as these gifts/services influenced the prescriptions written or such promotion increased off-label use.  Id. at *6. Those are legal conclusions cloaked in a lab coat.

Nor could plaintiff’s expert offer her “speculative editorial” factual narrative regarding defendant’s marketing practices:  

[N]o expert shall testify in a form of an advocate editorializing, or present a conclusory narrative akin to attorney argument, rather than as an expert witness.”

Id. Otherwise, the courtroom division of labor gets a little blurry. Lawyers argue. Judges instruct. Juries decide. Experts inform. Once experts start slipping into the role of advocates, not only can juries become confused about who is doing what, legal conclusions dressed up as “professional opinions,” step on the toes of both the judge and the jury.

The court also excluded the expert’s opinions based on “discourse analysis” because it was not mentioned at all in her report. Id. at *4-5. And found she was not qualified to opine on whether a high dosage use of the product was “unproven.” Id. at *6.

We still take issue with whether her “expert” testimony will assist the jury in understanding evidence that is beyond their lay knowledge, but at least the court is making her pull up short of editorializing or offering legal conclusions.  Afterall, editorializing is about helping the jury understand “why” certain evidence matters, and that’s our job. Let the lawyers argue, let the experts inform, and let the jury decide—without the running commentary.

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We’ve gleefully detailed the plaintiffs’ utter failure in the Zostavax MDL to establish causation.  Now, the Gardasil MDL likewise seems well on the way to a place on the list (along with Bone Screw, Aredia/Zometa, Taxotere, and Zantac) of MDLs that plaintiffs’ counsel wish they’d given a miss.  Maybe plaintiffs will learn not to seek vaccine-related MDLs.  Not long ago we discussed an excellent Gardasil preemption decision.  Today’s post is about In re Gardasil Products Liability Litigation, 2025 WL 1782576 (W.D.N.C. Feb. 20, 2025), an interesting  Fed. R. Evid. 702 decision that was actually decided a few weeks before the preemption decision, but only recently appeared on Westlaw/Lexis.

The issue in this Gardasil opinion – since it preceded the merits ruling on preemption – dealt with experts and preemption, something we speculated about shortly after Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (2019), but that has not received a lot of judicial attention since. Now that the Supreme Court has declared preemption to be a question of law for courts, not juries, to decide, what if any role can expert witnesses (particularly FDA experts) play?  We commented in 2019:

Instead of juries hearing dueling testimony of plaintiff and defense FDA experts on whether some arcane CGMP was violated in some possibly causal fashion, judges should decide such issues, since the Albrecht Court has unanimously concluded that judges are “better equipped to evaluate” the intricacies of the FDA’s regulatory scheme.  Purported FDA experts . . . regularly violate the limitation that expert witness should not offer conclusions of law, so confining them to testifying to judges rather than juries is more in keeping with the proper roles of expert witnesses generally.

Only a couple of cases have addressed this expert issue directly following Albrecht.  The first happened right away.  Delfino v. Medtronic, Inc., 2019 WL 2415049 (Minn. App. June 10, 2019), was an unpublished decision holding that, because “expert opinion as to a legal matter is generally inadmissible” in deciding preemption after Albrecht, a trial court “did not abuse its discretion by prohibiting [plaintiff’s expert] from opining on a legal question.”  Id. at *12.  The other is In re Zofran (Ondansetron) Products Liability Litigation., 57 F.4th 327 (1st Cir. 2023), which held:

[T]he question of whether the studies constitute newly acquired information [i]s a question of law.  Expert testimony on questions of law is rarely admissible because such testimony cannot properly assist the trier of fact.  To that end, [plaintiffs’ expert’s] opinion is likely inadmissible.  Although experts can opine on the underlying factual questions, including providing interpretations of pharmaceutical studies, they provide little, if any, relevant assistance when they opine on the ultimate legal question of whether something is “newly acquired information.”

Id. at 340 (citations and quotation marks omitted).

The Gardasil opinion had more to say along these lines.  It addressed dueling Rule 702 (don’t say Daubert) motions filed against both sides’ regulatory “experts.”  Most of the discussion focused on the plaintiff’s expert.  He had plenty of credentials.  2025 WL 1782576, at *2-3.  However, since the issue was preemption, his opinions concerned what was ultimately a question of law.

[H]is general expertise does not allow the Court to consider all of [plaintiffs’ expert’s] opinions, and the Court must limit [his] testimony. . . .  Plaintiffs ask the Court to rely on [their expert’s] testimony that [defendant] met the governing regulatory test to unilaterally include additional warnings on the Gardasil label as to [Postural Orthostatic Tachycardia Syndrome] POTS and [Primary Ovarian Insufficiency] POI.  While that opinion is of course generally relevant to the Court’s ruling on preemption, the Court finds [his] opinion on the ultimate issues of regulatory authority is outside the scope of proper expert testimony because he is opining on questions of law.

Id. at *3.

Generally, “[e]xpert testimony on questions of law is rarely admissible because such testimony cannot properly assist the trier of fact.”  Id. (quoting Zofran and collecting cases).  Further, “[t]he issue of whether Plaintiffs’ state law failure to warn claims are preempted by federal law is a question of law, which must be determined solely by the Court.”  Id. (citing Albrecht).  Thus, plaintiff’s regulatory expert cannot “go[] beyond presenting evidence of the alleged ‘newly acquired information’ for the Court to itself consider.”  Id.  To the extent that the expert “offer[ed] his own interpretation as to whether the data was sufficient to meet the governing standard,” that legal opinion was excluded.  Id.  It went “to the heart of what the Court must decide and will be barred.”  Id.  However, “factual information” about “evidence and data that he contends [defendant] should have considered” could “assist” the court and would be considered.  Id.  At that point, testifying to facts rather than opinions, he would not really be acting as an expert at all.

Plaintiffs’ regulatory expert had his wings clipped in another respect as well.  He had zero medical background, and thus “opinions on whether patient case studies, symptoms, etc., reflect a ‘causal association’” between the product and POTS/POI were entirely beyond his competence to give.  2025 WL 1782576, at *4.  He was “not qualified to offer opinions as to ‘causal association’ at the patient level” because that subject was “indistinguishable from ‘medical causation.’”  Id.  Gardasil offers a useful collection of cases (which all appear to be courtesy of the aforementioned Aredia/Zometa litigation) for the proposition that FDA regulatory experts “are prohibited from testifying as to causal association/medical causation.”  Id. (citing Jones v. Novartis Pharmaceuticals Corp., 235 F. Supp.3d 1244, 1257 (N.D. Ala. 2017), aff’d in pertinent part, 720 Fed. Appx. 1006 (11th Cir. 2018); Earp v. Novartis Pharmaceuticals Corp., 2013 WL 4854488, at *4 (E.D.N.C. Sept. 11, 2013); Guenther v. Novartis Pharmaceuticals Corp., 2013 WL 1278089, at *3 (M.D. Fla. March 28, 2013)).

In the absence of any competent POTS/POI diagnosis in the materials he reviewed, plaintiff’s expert had no expertise to make such diagnoses on his own, which he purported to do several times.  2025 WL 1782576, at *4.  The expert “admit[ted] he is not qualified to makes these diagnoses, which underscore[d] his inability to differentiate causal association from medical causation.”  Id.  He “neither provided a proper foundation for linking various symptoms to POTS and POI, nor identified or applied an accepted method of analysis in reaching his diagnosing conclusions.”  Id. at *4 n.4.  That he would even try to get away with such incompetent and threadbare opinions also underscores the weakness of plaintiffs’ factual position – something that no doubt contributed to the defense win on preemption a few weeks later.

In sum, while the expert’s discussion of the underlying “evidence and data which he contends [defendant] could have used to support a decision to give warnings . . . about POTS and POI,” was admissible:

the Court cannot consider his opinion on the ultimate legal question of whether [defendant] had “newly acquired information” (i.e. whether or not [it] could have legally given the proposed warnings) or his opinions on whether any patient or study participant had POTS or POI (i.e. patient level causation) because they are outside the scope of proper expert testimony.

Id. at 9.  Since p-side regulatory experts do these kind of things all the time, Gardasil is a useful addition to the defense armamentarium.

And what about the defense regulatory expert?  While the court held that, generally, the same standards would apply to both sides, id. at *5 (“strictly limit its consideration in the same way”), the opinion does not suggest that the defense expert in fact committed any of the sins that the opinion detailed (with record citations) about the plaintiffs’ expert.  Plaintiffs’ argument that the defense expert should be excluded altogether because “he most often testifies for defendants” received the back of the judicial hand in a footnote stating that “it is of little surprise to the Court that the Parties have each selected experts who most often . . . testify for” the same side.  Id. at *5 n.6.

Thus, with regulatory experts in preemption situations, the court would “only consider the factual evidence and data that [the expert] contends should be evaluated,” and not any legal opinions on what did, or did not meet pertinent regulatory standards.”  Id.  FDA issues can be complicated, and courts can use that kind of help, so we can live with that.

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Snap removal is one of the few ways that defendants can counter plaintiffs’ efforts at forum shopping. When a case analyzes snap removal and expressly adopts fraudulent misjoinder in the Third Circuit, you know it gets our attention.

Today’s decision, Paddock v. Novartis Pharms. Corp., 2025 WL 1908806 (D. Del. July 11, 2025), is a report and recommendation denying remand following the defendant’s snap removal.  The case involves claims by multiple plaintiffs that the defendant wrongfully promoted the off-label use of terbutaline (an asthma drug) to treat pre-term labor in pregnant women, and that the plaintiffs’ children developed autism as a result of their ingestion of the drug during pregnancy.

Continue Reading Snap! Sometimes the Third Time Isn’t a Charm
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This is from the non-Dechert and non-RS side of the Blog.

We recently attended a successful Ph.D. thesis defense on the seemingly narrow issue of trap states in quantum dots.  This was held in a dark wood-paneled room in a large science building on the campus of a research institution generally known by a short acronym.  In our work world, this is the sort of place we like to see on the resumes of our experts.  A few things about that thesis defense resonate with us as we discuss a recent decision from the Delaware Supreme Court that will have significant implications in a national litigation we have written about many times before, as well as ripples for drug and device litigations where plaintiffs may be looking at Delaware as a favorable venue.  First, just because you are an expert in your field does not mean you can speak intelligently and reliably on a specific area of science.  This is not a comment on the candidate, who was knowledgeable, articulate, and enthusiastic, but on at least some of the audience.  We know some stuff in our own field and have spent quite a bit of time reading scientific and medical literature for our cases.  Still, we have been hard pressed to do more than regurgitate parts of what we heard were we required to speak about trap states with quantum dots, let alone weigh in on the correctness of any of the conclusions in the research we heard described.  When judges let in questionable expert evidence, it can be because the judge allows experts to disregard adverse authority without a good reason.  Second, appreciating the scope and scale of what is being discussed can be critical.  Quantum dots are between one-billionth of a meter and one-hundred-millionth of a meter in size.  Their behavior is measured in trillionths of seconds.  A proper understanding of research on them requires grasping the significance of those fractions.  In dealing with the admissibility of general causation opinions related to allegedly harmful substances in product liability litigation, you better understand scope and not get confused by what is being measured.  One of the recurring issues is when a plaintiff expert relies on a study that involves exposures at levels hundreds or thousands of times above the plaintiff’s, particularly if the exposure is not really to the same thing.  Third, it helps to know the standards in advance.  What is expected from a successful thesis defense or admissible expert causation evidence can vary depending on where you are, but both properly test both procedure and substance.

With that in mind, we note that we have written quite a bit over the years about how weak the plaintiffs’ general causation evidence has been in litigation over cancer allegedly caused by nitrosamines allegedly present in various forms of the drug ranitidine.  Notably, the major reason why the plaintiffs lost in the MDL is because they could not come up with admissible general causation opinions about a link between ranitidine and any kind of cancer in humans.  The outlier came from Delaware, where what might have been considered a defense-friendly venue, gave a free pass to plaintiffs’ general causation experts.  In In re Zantac (Ranitidine) Litig., — A.3d –, 2025 WL 1903760 (Del. July 10, 2025), the Delaware Supreme Court took an interlocutory appeal and reversed the order on plaintiffs’ causation experts, reestablishing that Rule 702 in Delaware state court should be applied the same as Rule 702 is supposed to be applied in federal courts.  Beyond the impact on the litigation—more on that later—we clearly have an enunciation of more rigorous standards for the admissibility than the Zantac trial court and perhaps other Delaware trial courts had been applying.  That may make Delaware a less attractive option for plaintiffs seeking to avoid federal court.  As for the actual decision and what it means for the Delaware Zantac litigation, we will explain our views without continuing to draw links to our observations from the introduction.

The basic facts of the litigation should be familiar from prior posts, including on the Delaware Superior Court’s decision last year and an Illinois appellate decision last month.  The litigation has been driven from the start by questionable data from a questionable lab and the efforts of plaintiffs to cobble together a causation case even though many studies on the direct issue have failed to find a statistically significant increased risk of any cancer with the use of ranitidine.  In the Delaware proceeding, plaintiffs offered up a slate of ten experts to try to prove general causation for ten different types of cancer.  (Recall that, in the MDL, the plaintiffs ultimately only tried to prove causation for five types of cancer, implicitly recognizing the supporting evidence was even weaker for other types.) 

The Zantac decision identified two basic errors by the court below in denying the defendants detailed challenges to the experts’ causation opinions.  First, it had adopted “a standard that favored or presumed the admission of expert testimony,” which was inconsistent with the burden being on the proponent of the expert testimony.  Id. at *1.  “A trial judge must act as the gatekeeper of expert testimony and should not dismiss challenges to the sufficiency or reliability of an expert opinion by viewing the disputes as questions for the jury to weigh.”  Id.  The rejected approach was basically why Fed. R. Evid. 702 was revised and what we have decried in judges since who have stuck to their old ways.  Second, the court had permitted plaintiffs’ experts to “base their conclusions on studies regarding the alleged disease-causing agent rather than the product at issue in the case, without establishing a reliable bridge between the product at issue and the scientific data regarding the toxic agent.”  Id.  The rejection by the MDL court of the attempt by the plaintiffs’ experts to do the same thing was a key part of the lengthy—and correct—analysis there.  There was an issue raised by the appellants that the Delaware Supreme Court did not resolve: whether the plaintiffs’ experts have to identify a threshold dose of ranitidine or nitrosamines from ranitidine that can cause each of the types of cancer.  Id. at **12 & 18.  The Superior Court had concluded there was no such requirement and the MDL had ruled that there was.  With such a requirement, the plaintiffs’ experts in Delaware would surely be unable to offer an admissible general causation opinion.  They also would not be able, in all but the rarest cases, to show that any plaintiff’s exposure to nitrosamines from ranitidine was above that threshold, which is part of why plaintiffs argue against thresholds.

The Delaware Supreme Court’s analysis of the first issue began with the review of Daubert, the 2023 amendments to Fed. R. Evid. 702, and Delaware’s historic approach with its Rules of Evidence.  Even though Delaware had not amended its Rule 702 to match the current federal version, “[n]othing in the recent amendments conflicts with our existing precedent, and the commentary accompanying those amendments offers additional guidance as trial courts confront the difficult task of evaluating the admissibility of an expert opinion.”  Id. at *10.  The requirement that the trial court had to act as a gatekeeper and decide if the plaintiffs established the admissibility of their experts’ opinions meant that the decision below, which had largely punted, could not stand. 

. . . Defendants repeatedly challenged Plaintiffs’ experts for “cherry-picking” favorable data regarding NDMA while ignoring studies focusing directly on ranitidine. Rather than addressing Defendants’ arguments and determining whether the challenged experts reliably applied appropriate methodologies, the court dismissed these objections and labeled them as questions for the jury.

Id. at *13.  The proper role for the trial judge “may present a substantial challenge, as few judges are steeped in scientific knowledge, the trial judge may receive and evaluate testimony and ask questions of the experts and the parties’ lawyers until the court feels comfortable drawing conclusions on sufficiency and reliability.”  Id.  The failure of the court below to fulfill this role “resulted in the court finding that Plaintiffs’ experts’ opinions were admissible even though their sufficiency and reliability was not established by a preponderance of the evidence.”  Id. at *14.

The second issue involved a dive into Delaware law to find the prior focus of what must be shown to cause the injury at issue.  The law squared with common sense to require the expert “focus on the product at issue and must show that exposures examined in non-product studies on which the expert relied are reliably linked to the exposures caused by the product at issue.”  Id. at *15.  Federal decisions have long made the same distinction, which squares with the oft-repeated saying that “the dose makes the poison.”  Because nine of plaintiffs’ ten experts focused on studies on exposure to NDMA from occupation or diet, rather than presumed exposure through ranitidine use, they were clearly inadmissible under the proper test absent an admissible link.  Plaintiffs’ tenth expert offered an opinion on a link, which the trial judge had doubted but characterized as a jury question.  Id. at *17.  Under the gatekeeping duty, the trial judge was required to resolve the challenges raised as to the reliability of that opinion, along with all the others. 

The disposition of the interlocutory appeal was reversal and remand “for further proceedings consistent with this decision.”  Id. at *18.  We expect the defendants will argue that the experts have been excluded already, so summary judgment is the next step (as it was in the MDL).  After all, the court noted in a number of places with plaintiffs did not carry their burden to establish admissibility and that the experts failed to justify critical issues with their opinions.  “Correctly understood, DRE 702 and its interpretive precedent required exclusion of the challenged expert opinions.”  Id. at *10.  On the other hand, plaintiffs will surely argue that the trial court should redo its analysis applying the standards articulated by the Delaware Supreme Court and with the benefit of new arguments and, if the trial court is so inclined, new experts.  In places, the appellate court was careful not to tell the Superior Court what conclusion it should reach when applying the correct standard.

We do not suggest that the Superior Court should have simply adopted the MDL court’s conclusions. The trial court correctly undertook an independent analysis of the admissibility of Plaintiffs’ experts’ opinions. But the Superior Court’s dismissal of the significant methodological flaws identified by the MDL court—flaws that also appeared in the expert reports in Delaware—on the basis that Delaware has a different standard, was error.

Id. at *12.  If there is a redo, with or without a threshold requirement, however, the Delaware Supreme Court’s clearly sent the message that the admission of opinions riddled with so many “significant methodological flaws” would get reversed on appeal.  As it should.

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 ”He that violates his oath profanes the divinity of faith itself.” — Cicero. 

It might seem unlikely that, long ago, we noticed the above maxim inscribed on the south side of the Los Angeles City Hall while walking to our first jury trial (almost as unlikely as the fact that we were walking in L.A.).  It might seem even more unlikely that we found a way to use that maxim in our closing argument.  It is not exactly catchy.  But, yes, we tossed a little bit of old Cicero at the 12 citizens good and true. We wanted to remind the jurors of their oaths (we had some concern that jurors might engage in nullification because the case involved a so-called “victimless crime”) and we wanted to highlight how our semi-brilliant cross-examination caught the defendant in a lie. Cicero’s point was that a person who lies under oath probably does not really believe in anything, except pursuit of personal advantage.

Over the last several years, it has been a disappointing revelation that our government runs on the honor system. It has been even more disappointing to learn that honor is in short supply.  The news is mostly a cascade of lies. 

It has also been disappointing to encounter, almost every week, proof that witnesses occasionally lie under oath. Sure, cross-examination is an engine of truth, and, sure, there is the threat of a perjury prosecution. But if you think witnesses seldom lie, then you have been walking the earth in a fog. We teach young lawyers about to take depositions to study the deponent closely when they answer the question as to whether they discussed the case with anyone besides their lawyers. Why?  Because the expression on the witness’s face when they answer the question tells you what they look like when they lie. 

Maybe testifying is not always testi-lying, but any deposition or trial transcript is chock full of truth-shading. There are expert witnesses who are experts at precisely that. We are not saying that all plaintiff expert witnesses lie. But there are some who ought to add “prevarication” to their overblown list of competencies. The sad thing is that they usually get away with it.

Let’s not linger on such a depressing thought. Let’s be lawyers. Putting aside the issue of whether or not an expert witness has deceptive intent, is one necessarily stuck with an adverse expert’s say-so if cross-examination does not quite do the trick? Are there other ways to cut through a blizzard of expert nonsense?

Yes, indeedy.  And that brings us to the saga of plaintiff talcum powder experts who invariably attribute an unfortunate plaintiff’s mesothelioma to talcum powder exposure. The theory is that talcum powder contains asbestos. From what we can tell, the theory is bunk. The valid epidemiology does not show that shaking cosmetic talcum powder onto one’s body, even over the course of many years, causes illness.  But you can be sure that a plaintiff lawyer will not only find an expert who will say that epidemiology shows that talcum powder causes mesothelioma, but also that such expert has written an article documenting that selfsame bogus causation. That article will purport to show a group of people (“subjects”) who suffered mesothelioma and had no conceivable exposure to asbestos save talcum powder.      

Except that some of the subjects almost certainly did have other potential exposures to asbestos. (That’s even putting aside background exposure.  Believe it or not, asbestos is everywhere.) We have written posts about the saga of plaintiff talcum powder experts, including Dr. Moline, whose articles were not entirely accurate about the subjects. See here, for example. 

Today’s case is Pecos River Talc LLC v. Dr. Theresa Swain Emory, et al., 2025 WL 1888565 (E.D.Va. July 8, 2025). The plaintiff in that case was “formed as part of Johnson & Johnson’s effort to resolve talc-related claims through bankruptcy.” The plaintiff sued authors (not Moline this time, but wait, for she plays a role in this drama — or farce) of an article that allegedly made false statements about talcum powder, asbestos, and malignant mesothelioma. The lawsuit proceeded on a theory of trade libel. The defendants were “plaintiff-side expert witnesses in litigation between individuals with mesothelioma and manufacturers of cosmetic talc.” They had published an article in March 2020 that said two things that the plaintiff alleged were false:

1. The article stated that it “presents 75 subjects with malignant mesothelioma, whose only known exposure to asbestos was cosmetic talc,” and

2. These subjects were “additional” to the 33 subjects in an earlier study by Moline. 

The authors had selected the 75 subjects “from medical-legal consultation practice.”  That is, the subjects were talc plaintiffs.  

Why did the plaintiff think there was something fishy about these subjects? The article did not supply the names of the subjects, but described certain facts concerning them. From prior talc product liability cases, the plaintiff spotted some remarkable similarities.  Its complaint alleged that at least six of the 75 subjects in fact had exposures to asbestos other than talc (for example, one had smoked cigarettes with asbestos, and another lived with parents who might have brought asbestos home in their clothes), and that at least one was also included in the Moline study.  To prove those allegations, the plaintiff sought the names of the subjects.  The author-defendants refused. The plaintiff filed a motion to compel identities of the article’s subjects. 

Previously, Moline had also tried to keep hidden the names of the subjects in her study.  That resistance worked … until it didn’t. 

The noose appears to be tightening around the talc plaintiff side experts who conducted these made-for-litigation studies. The authors in this case (again) argued that discovery of the subjects’ names was not appropriate, as the names were not relevant and production of such names would be disproportionately burdensome. 

But the plaintiff successfully argued (and past history supports) that the names will reveal not only that those “subjects” were exposed to other asbestos sources, but that these experts had evaluated them in other cases and thus knew that the statements in the studies at issue were false. Such knowledge constitutes “malice” − which is what trade libel requires. The court saw through the authors’ desire to “demarcate the universe of Pecos River’s discovery based on their preferred outcome of this key legal question.”  

Proof of intent is obviously central to the case.  Names are by far the simplest and strongest way to establish that the defendant’s statements were false, and known to them to be false.  A trade libel plaintiff is entitled to prove malice however it thinks best.  The authors were not entitled to limit such methods artificially. The plaintiff could use the names to seek corroborating evidence from other litigations. 

Further, release of the names was not burdensome.  The authors were willing to supply information about the subjects, but with the names redacted.  Unredactions, by themselves, are no trouble and no expense. Proportionality was satisfied.  

The experts also resisted disclosure based on “principles of research ethics.” That was risible. These “subjects” were all asbestos plaintiffs who provided information knowing such information was going to be used in litigation.  They had no privacy interest in their names, which were never confidential.  There was no patient-physician relationship. The simple fact is that the authors did not solicit the subjects “to participate in a medical research study, obtain written consent from them, or even notify them that they were included in the study.”

What about HIPAA? Nice try. HIPAA has an exemption for litigation, and does not even apply to the author-defendants, who were acting as litigation experts. They were not “covered entities” under HIPAA. Moreover, the court emphasized that “this is a trade libel case. The veracity of the statements in the article is directly at issue, shifting the calculus on the appropriateness of disclosing the subjects’ names when balanced with ethical or confidentiality concerns.”

In short, the defendants could not successfully oppose production with their own subjective beliefs about confidentiality.  Contrary to the defendants’ protestations, medical research would not be chilled, since the business of litigation consulting is not medical research at all.  Peer review of a study does not create confidentiality that did not exist otherwise.  It is not the source material underlying the study that the defendants fear, but the outside information that plaintiff may obtain once it has the names.  Such a chilling effect was at best speculative.  Importantly, the information here was being sought directly from parties to the litigation, not from third-party scientists. 

The court also stated that it could not “turn a blind eye to the elephant in the room.”  One of the authors had called Moline to see if she could get access to information that would help ensure there was no overlap between their articles.  Moline declined to discuss patients’ names. As the court acutely observed, “At that time, defendant Emory was seemingly content with discussing the same information she now claims the disclosure of which would violate research ethics with a third party.”  Touché. 

The court permitted discovery of the subjects’ names. Disclosure was subject to a protective order as to public release of identifying information. But the bottom line was that the plaintiff was free to use this information in other litigation.  There will be some juicy cross-examinations in future talc cases.  

We applaud the court’s reasoning. Even more, we applaud the defense lawyers’ energy, ingenuity, and persistence. 

It reminds us of our days working on tobacco cases.  Similar to the talc cases, plaintiff lawyers and their experts seemed to be governed by an extreme ends-justifies-the-means attitude.  A well known polling company grew annoyed that tobacco companies seized upon polls as evidence that Americans have long believed that cigarette smoking posed serious health risks.  Too bad. It was the truth. Nevertheless, some employees of that polling company authored an article that purported to refute the defense interpretation of the polls.  Rather than take that indignity lying down, one of the tobacco companies undertook discovery of what went into that plaintiff-friendly article.  The answer: a lot of hooey.  We particularly remember the deposition of one of the polling company anti-tobacco die-hards.  The tobacco lawyer had them dead to rights. Just before asking a particularly devastating question, he turned to the row of fellow defense lawyers along the table, grinned, and said, “Watch this.”  And then came the coup de grace.  Good times. We defense hacks need to follow the lead of such lawyers, including the plaintiff lawyers in the Pecos River case. When we espy chicanery from the other side’s experts, let’s try to get behind it. Let’s test it. Let’s be enterprising and clever.  And then … watch this. 

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Mulitdistrict litigations – both federal MDLs and their state-court equivalents – sound like noble endeavors.  The concept is simple: consolidate similar lawsuits under one judge to streamline proceedings. This, in theory, avoids contradictory rulings and saves court resources. But when you pan out past the injured plaintiffs and mountains of medical records, you’ll spot one constant: the plaintiffs’ attorneys, quietly — or not so quietly — raking it in like blackjack dealers at a high-stakes casino. That’s because behind the judicial curtain, there’s a familiar tale unfolding: an elite cadre of plaintiffs’ lawyers ascend to “leadership positions,” and suddenly they’re holding the keys to a billion-dollar vault.

Plaintiffs’ “leadership” have turned what was once a tool for judicial efficiency into a revenue-generating juggernaut. To be fair, depositions, discovery, Rule 702 hearings, etc. take real work. But the math doesn’t lie. Take a $2 billion settlement. If the leadership team takes home 6% to 10% in common benefit fees (on top of their own individual client fees), that’s $120–$200 million going to a handful of firms. That’s not a contingency — that’s a conquest. The actual plaintiffs, the people plaintiffs’ leadership spent years arguing were devastatingly injured, get a few thousand dollars each, and that’s before they learn that half their award is going to a Medicare lien and a third to their lawyer. Meanwhile, their lawyers walk away with enough to buy a vineyard, a yacht, or possibly a minor European fútbol club.

So, we werent surprised when we happened upon Johnson v. Mazie, — F.4th –, 2025 WL 1909974 (3rd Cir. Jul. 11, 2025)—a group of plaintiffs suing their mass tort attorneys post-MDL settlement for breach of contract, legal malpractice, conversion, and unjust enrichment.  Id. at *1. The underlying product liability MDL, concerning a blood pressure medication, was venued in the District of New Jersey.  It settled for over $300 million. Id. at *1. Plaintiffs filed suit in New Jersey state court alleging that plaintiffs’ co-lead counsel in the MDL collected fees (both contingency and common benefit) in violation of New Jersey state court rules made applicable to federal litigation by the district’s court local rules. Id.  Plaintiffs are citizens of various states other than New Jersey and alleged that the amount in controversy for each plaintiff is less than $75,000.  Id.

Defendant (plaintiffs’ MDL counsel) removed the case to federal court on both diversity and federal question grounds and plaintiffs moved to remand. The district court denied plaintiffs’ motion holding sua sponte that it had “ancillary enforcement jurisdiction over the matter because Plaintiffs challenged attorney’s fees awarded from the MDL settlement.” Id. at *2. Ancillary enforcement jurisdiction gives “federal courts the power to enforce their judgments and ensure that they are not dependent on state courts to enforce their decrees.” Id.  However, it cannot serve as the basis for removal of a state court action to federal court.

To remove a case, defendant must “demonstrate that original subject-matter jurisdiction lies in the federal courts.” 28 U.S.C. §1441(a) (emphasis added). In the case of a previously settled matter,

[a]lthough the federal court retain[s] jurisdiction over the settlement, that d[oes] not “authorize[ ] removal” because the “invocation of ancillary [enforcement] jurisdiction” d[oes] not “dispense with the need for compliance with statutory requirements.”

Id. at *3. Therefore, the Third Circuit held that the denial of plaintiffs’ motion to remand on this basis was an error.

The district court did not rule on either the federal question or diversity jurisdiction arguments, but the appellate court looked at both.  On federal question, defendant argued that while plaintiffs brought state law claims, those claims challenge a federal district court’s MDL fee awards. The Third Circuit ruled that was not enough to raise a “disputed and substantial” federal issue. Id. On diversity jurisdiction, there was no dispute that the parties were diverse, only whether the value of the claim exceeded $75,000 as required by federal statute. Plaintiffs alleged that each claim was less in value, and such an allegation typically controls the question. But there are exceptions, such as where state law permits recovery of damages in excess of the amount demanded.  In that case, if a defendant shows by a preponderance of the evidence that the amount in controversy exceeds $75,000, a district court can find removal based on diversity jurisdiction proper. Id. at *4. Because the district court made no findings regarding the amount in controversy, the Third Circuit vacated the judgement and remanded the case to the district court on that issue.   

Yes, this case is basically about removal, but a knock-down, drag-out between MDL plaintiffs and their lawyers is pure popcorn entertainment to us.  Especially because we know in the MDL economy, the real winner is the person who filed the motion to be appointed co-lead counsel. If you’re looking for profit — the MDL casino is open, and plaintiffs’ leadership is the house.

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Here are a couple of recent favorable developments concerning the effort to require public disclosure of p-side third-party litigation funding to the same extent as defendants must disclose relevant insurance coverage.  In addition to litigation-related benefits, such disclosure would (unfortunately) benefit plaintiffs by allowing them to shop for the best terms (as one can with insurance), rather than essentially have to take what they are offered in the current utterly opaque market.

Continue Reading Recent TPLF Disclosure Developments
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Here at the DDL Blog, we love phrases denoting that two things are acting together or in close succession to produce a result.  We have written more than once on the “one-two punch” of causation and implied preemption, and who doesn’t appreciate a good “double whammy” in whatever context?  Cases with different outcomes are often the “yin” and the “yang” of the law, and we like it when defendants have the plaintiffs caught “between a rock and a hard place.”  And don’t forget the narrow gap between express and implied preemption. 

Yes, noteworthy things often come in pairs.  But what do you call it when a patient gets two vaccines on the same day and only one is entitled to statutory immunity, but no one knows which vaccine came first or whether one or the other caused the patient’s alleged injury?  You might call it a double fault, or strike two, or any other clever phrase you can come up with.

The Fourth Circuit called it “summary judgment.”  In Watts v. Maryland CVS Pharmacy, LLC, No. 23-2025, 2025 WL 1802385 (4th Cir. July 1, 2025) (to be published in F.4th), the plaintiff received two vaccines during the same visit in the same spot on her arm, but only one vaccine was subject to immunity under the National Childhood Vaccine Act.  Lo and behold, when the plaintiff sued for alleged injuries, she sought to hold the provider liable only for the non-immune vaccine.  She didn’t even mention the other vaccine in her complaint. 

That was a big mistake.  The plaintiffs’ expert reports made no mention of the other vaccine, and her causation expert attributed her injuries only to the one mentioned in the complaint.  It got awkward when both experts had to admit in their depositions that they had not known about the other vaccine when they wrote their reports and that although one vaccine or the other caused the plaintiff’s injuries, they could not say which one.  Id. at *2-*3. 

It got even more awkward when the causation expert served a “Notice of Errata” a month after his deposition purporting to add a sentence to his report stating that both vaccines caused the injury.  Id. at *3. 

That was out of bounds.  The rules allow an errata to correct misstatements or clarify existing answers, not to “materially change the answers or fully supplant them.”  This expert’s errata crossed the line.  He previously stated in report that he had “considered other potential causes” and that the one vaccine had caused the harm, but he now was attributing the plaintiff’s injuries to both vaccines.  The light is red, not green.  (For more on errata abuse see our post on the topic here.) 

On the merits, the parties debated “substantial factor” causation and “alternate liability” under Maryland law (remember the two hunters in Summers v. Tice from law school?).  But this case was governed by federal law—the Vaccine Act, under which the defendant was immune unless the plaintiff could prove that her injuries were caused by the non-immune vaccine and not the other.  That was a problem for the plaintiff because both her experts said that one vaccine caused her injuries, but neither could say which one.  Without evidence on which vaccine (if any) caused the harm, “a jury could do no more than ‘guess’ as to that crucial element.”  Id. at *4. 

Still further, even if the causation expert had been permitted to opine that both vaccines caused the harm, the defendant would still be entitled to summary judgment.  That is because the plaintiff would then be relying for liability upon the immunized vaccine “as a second, separate negligent act,” which the Vaccine Act bars.  This plaintiff alleged one set of indivisible injuries, and it was not possible to apportion the harm to one vaccine or the other.  The plaintiff certainly presented no evidence that would allow any jury to make that call. 

Plaintiff could have pursued claims under the National Vaccine Injury Compensation Program, but she chose not to, and now she is stuck.  Perhaps she was trying to kill two birds with one stone, or maybe dance a two-step through the litigation lottery.  For our two cents worth, this is the correct outcome. 

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Legal problems are often multi-faceted.  Turned one way, the problem looks like one issue.  Turn it around, and a different issue glimmers in your eye.

For example, in Saulsby v. Amphastar Pharm., Inc., __ S.E.2d ___, 2025 N.C. App. LEXIS 420, 2025 WL 1812450 (N.C. App. July 2, 2025), the North Carolina Court of Appeals affirmed summary judgment on contributory negligence grounds, but it just as easily could have relied on a warnings causation theory.

Saulsby is a product liability case involving, sadly and unfortunately, a death.  Nothing in the opinion discusses medical causation, and we have no basis to understand how this would be scientifically plausible, but the complaint alleged the decedent died after self-administering a single dose of an over-the-counter (OTC) asthma inhaler.   

The OTC inhaler been purchased by the decedent’s long-term boyfriend to alleviate her shortness of breath.  The product’s intended use was for “temporary relief of mild symptoms of intermittent asthma,” and it carried express warnings: “Do not use unless a doctor said you have asthma” and “Ask a doctor before use if you have . . . heart disease [or] high blood pressure.”

Contrary to those warnings, the decedent had not been diagnosed with asthma, and she did have multiple underlying health conditions including heart disease and high blood pressure.  In addition, no doctor was consulted.  The boyfriend allegedly asked a pharmacist whether the product was “good for breathing” but the question was posed without any context about the decedent’s health history or immediate medical need.

Moreover, the product’s warnings were not read by the boyfriend at the time of purchase, and there was no evidence the decedent read them prior to use either. 

North Carolina’s product liability landscape is one we generally like.  Here, the decedent’s estate sued the manufacturer for negligence (N.C. does not recognize strict liability) and breach of the implied warranty of merchantability.

After the trial court granted summary judgment, finding the decedent’s contributory negligence barred recovery under N.C. Gen. Stat. § 99B-4, the North Carolina Court of Appeals agreed that the decedent’s own negligence was clear and affirmed.

N.C. Gen. Stat. § 99B-4—a most useful statute—provides that a manufacturer or seller is not liable in a product liability action if:

(1) The use of the product giving rise to the product liability action was contrary to any express and adequate instructions or warnings delivered with, appearing on, or attached to the product or on its original container or wrapping, if the user knew or with the exercise of reasonable and diligent care should have known of such instructions or warnings; or

(2) The user knew of or discovered a defect or dangerous condition of the product that was inconsistent with the safe use of the product, and then unreasonably and voluntarily exposed himself or herself to the danger, and was injured by or caused injury with that product; or

(3) The claimant failed to exercise reasonable care under the circumstances in the use of the product, and such failure was a proximate cause of the occurrence that caused the injury or damage complained of.

The court rejected the plaintiff’s argument that this statute requires a determination of whether the decedent exercised reasonable care under the circumstances and whether the warning was adequate, because the statute pretty clearly uses the disjunctive or between its prongs. 

It also distinguished prior pharmacy cases that had chipped away at the statute (based on allegations the plaintiff was given the wrong product, or there were extenuating circumstances, or there were individualized warnings from a pharmacist).

The evidence established that both the decedent and her boyfriend either knew or should have known of the product’s express warnings, and in not reading them failed to exercise the care an ordinarily prudent person would have under similar circumstances, barring both the negligence claim and the implied warranty claim.

This conclusion tracks.  But even without the North Carolina statute, should a claim based on facts like these pass muster?  If the claim is for failure to warn, absolutely not. 

The idea behind a failure to warn claim is that if only the manufacturer had given a different, stronger, more adequate warning, then the harm never would have occurred—the prescription product never would have been prescribed or, with an OTC product, the consumer would have not taken the product or they would have followed the labeling. 

But on the facts of Saulsby, the flaw in that theory of liability is that it did not matter what the warnings said, because the decision-makers never read them.  In other words, the plaintiff cannot prove that the allegedly defective warning caused the harm, because the allegedly defective warning had no effect whatsoever.  (We have a comprehensive post on failure to read warnings and causation.)

Facts like those in Saulsby are one of the reasons we think the “heeding presumption” is nonsense.  Plenty of consumers take OTC medicines without much thought, after a quick trip to the store and maybe a cursory scan of the products on the shelves or an out-of-context question posed to someone behind the pharmacy counter.  These are the type of events that are entirely commonplace.  Maybe these are not the actions of an ordinarily prudent person when it comes to medications, but they are not rare.  States that use the heeding presumption tip the scales in plaintiffs’ favor by presuming (absent contrary evidence) that everyone always will read and heed a product label.  But we know people don’t, so the law should not ignore real life and presume that they will.

Anyway, this court came out the right way.  We just would like to think that failure to read facts like these would end in summary judgment even in states without North Carolina’s sensible contributory negligence statute.

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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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