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We’ve written a lot about the recent amendment to Federal Rule of Evidence 702.  As noted here, the amendment (1) mandates that the court must determine the admissibility of evidence before presenting it to the jury, (2) integrates the preponderance of evidence standard—requiring the proponent of expert testimony to prove that it is more likely than not that all of Rule 702’s requirements are met, and (3) reinforces that each expert opinion must reliably apply the expert’s principles and methods to the facts of the case. These changes were driven by the fact that “many courts have held that the critical questions of the sufficiency of an expert’s basis, and the application of the expert’s methodology, are questions of weight and not admissibility.”  Fed. R. Evid. 702 Advisory Committee’s Note to 2023 Amendment.  The changes to Rule 702 are intended to prevent such erroneous “weight vs. admissibility” findings.  We’re also fans of the Don’t Say Daubert movement that reminds lawyers that Rule 702 itself – not the Daubert decision – defines the applicable standard for the admission of expert testimony. 

Continue Reading Rule 702 Gatekeeping by En Banc Panel of the Federal Circuit
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For the decades that we have been handling drug and medical device product liability cases, it has been a given that we wanted to make it clear that our clients did not provide medical care or healthcare directly to patients.  For one thing, unauthorized practice of medicine would be bad.  Also, when dealing with prescription medical products, we do want the learned intermediary doctrine to apply.  In addition, in part because FDA does not regulate the practice of medicine, preemption based on the FDCA is not going to succeed as to claims based on the defendant’s provision of medical care.  There are other reasons why drug and device manufacturer defendants typically shout from the litigation mountaintops that they are not healthcare providers.  Not just in litigation, either.  There are plenty of venues for manufacturers to disclaim that they are not healthcare providers, not providing medical care, not providing medical advice, etc.  This applies to marketed products, as well as clinical trials that the manufacturer sponsors.

In Irwin v. Zoll Lab, Servs., LLC, — F. Supp. 3d –, 2025 WL 1249370 (S.D. Iowa Apr. 30, 2025), the plaintiff alleged that the device manufacturer defendant was a healthcare provider liable for medical malpractice.  For reasons peculiar to the case, the defendant admitted it was a healthcare provider that had taken an “active role” in monitoring and interpreting plaintiff’s cardiac data as part of her clinical care.  This allowed defendant to move for summary judgment or judgment on the pleadings when plaintiff missed the deadline for a certificate of merit affidavit required for med mal proceedings against providers.  As no discovery had yet occurred, this motion was properly treated as being for judgment on the pleadings, and plaintiff’s well-pleaded factual allegations were accepted as true.  The basic allegations were that plaintiff was prescribed a medical device to monitor her drug-induced tachycardia, the serial numbers on the device and its packaging did not match, defendant was supposed to use her device to monitor and report her heart rate and rhythm, but reported on another patient’s data, which resulted in medical decisions by her doctors to perform unnecessary surgeries to implant and later explant a pacemaker. 2025 WL 1249370, *1-2.  The decision is not terribly precise—it does not even identify the device by name—but it appears that plaintiff’s complaint characterized the defendant manufacturer as a healthcare provider in an attempt to frame her claims as being for medical malpractice rather than product liability.  When she failed to serve a certificate of merit affidavit sixty days after the defendant’s answer, the defendant leapt.

It might seem to be a relatively straightforward analysis:  plaintiff alleged that the defendant was a healthcare provider who provided healthcare to plaintiff, plaintiff based her claims on those allegations, defendant admitted those allegations, and plaintiff served no affidavit.  However, in responding to the motion, plaintiff was permitted to take the position that defendant was not a health care provider for purposes of the Iowa med mal statute that required an affidavit—and under which she had sued.  The court analyzed this reversal as one of waiver based on what defendant put in its answer.  Id. at *4-5.  To us, that does not seem like the right way to analyze the issue.  Even if the plaintiff should not be judicially estopped from taking a position contrary to his complaint—as far as we can tell, she had not won anything based on the position that defendant was a healthcare provider who provided her healthcare—then she cannot defeat a motion for summary judgment or a motion for judgment on the pleadings by contradicting her own pleadings.  These allegations appear to have been central to her claims and were not stated in the alternative or hedged as being on information and belief.  And the Iowa statute makes the timely service of a certificate of merits affidavit a predicate to proceeding, not an affirmative defense.  So, plaintiff should have had to lie in the bed she made.

But the Irwin court let plaintiff take a contrary position to her complaint in an attempt to keep her case alive.  In its merits analysis, the court did recognize that its job sitting in diversity was to predict what the Iowa Supreme Court would do absent controlling authority.  Id. at *3.  While it did not mention Erie deference, the pertinent issue was not really about expanding or contracting a claim or defense.  Instead, the issue was statutory interpretation of whether the pleadings established the defendant manufacturer as a health care provider under the catchall provision of “any other person who is licensed, certified, or otherwise authorized or permitted by the law in this state to administer health care in the ordinary course of business or in the practice of a profession.”  Id. at *5.  Even under the allegations and admissions from the pleadings, it was not.  The analysis largely turned on the decision that, as used in the statute, “authorized or permitted” meant there had to be “affirmative permission from a regulatory agency or similar oversight authority.”  Id. at *6.  The defendant “has no ‘license,’ ‘certification,’ or similar permission to administer health care in Iowa, nor is it subject to ongoing regulatory oversight under state law,” referring to some terms applicable to types of healthcare providers subject state licensure statutes.  Id. at *7.  The court rejected the defendant’s argument that its accreditation by CMS, which Iowa allows to suffice as an inspection for purposes of seeking state hospital licensure, was good enough, because the defendant was not a licensed hospital in Iowa.  Id. at *8.

We wonder if the court will accept all the implications of its ruling that defendant is not a health care provider for purposes of the Iowa med mal statute.  If it is not, then it cannot be liable under that statute and plaintiff’s claims should be dismissed.  Irwin implicitly recognized as much when it explained the rationale of requiring a certificate of merit application in cases against entities that provide medical care:  “It follows that if a plaintiff alleges a breach of the standard of care, it must establish at an early stage that there is a legitimate basis for that allegation.”  Id. at *9.  It also follows that a defendant cannot be liable for breaching a standard of care that does not apply to it.  Iowa has a Good Samaritan law, which should not provide a basis for liability here either.  So, plaintiff will probably have to assert product liability claims against the device manufacturer, something she chose not to do in the first place.  That makes sense because device companies are not healthcare providers.  Right?

(We have used both “healthcare” and “health care” in this post.  The Iowa statute uses the latter.  The pleadings seemed to use the former.  When describing a case where the complaint and answer agreed that defendant was a healthcare provider and the court disagreed, we did not think foolish consistency would matter.)

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Franco v. Chobani, LLC, 2025 WL 1530996 (N.D. Ill. May 29, 2025) is a  relatively rare preemption win in a court controlled by occasionally iffy Seventh Circuit law. It is also a food case, not a drug or device case. There is a lot of food-specific discussion (about different molecular structures of “sugar”). That being said, the decision makes points that are useful to drug/device defendants.  So sit down to your Justice Souter-esque lunch of yogurt and an apple (including the core!), and read our summary of this appetizing opinion.


This is usually the moment when we offer a brief recital of the fundamental facts and claims in the case. But it is hard to improve on the Franco court’s introduction: “When plaintiffs … purchased Chobani’s sugar-free yogurt, they thought they were getting a sweet deal.  But the deal, it turns out, was sweeter than they anticipated – four grains of allulose per serving sweeter.”  The plaintiffs claimed that the presence of allulose rendered the “sugar-free” label a lie.  They sued for violations of “a whole host of laws.” Those laws included consumer protection statutes in 37 states.  The complaint was brought on behalf of a nationwide class and several state-specific sub-classes. Besides penalties associated with the consumer protection statutes, the complaint sought a declaratory judgment, recovery for unjust enrichment, and the imposition of a constructive trust. 


The defendant moved to dismiss the complaint, arguing lack of subject matter and personal jurisdiction, as well as preemption. 

We will mostly skip the discussion of subject matter jurisdiction.  The issue was whether named plaintiffs could bring claims under various state laws for which no concrete injuries were alleged in the complaint.  The court essentially punted on this issue, believing it a “matter left for class certification.” Anyway, given the disposition of the case, the issue was of no consequence. On whichever side of the v you dwell, you will want to follow the best piece of advice from season two of the Andor series and “calibrate your enthusiasm” as far as subject matter jurisdiction goes in this case.


The personal jurisdiction issue was more interesting.  The defendant argued that there were no grounds for general personal jurisdiction because the defendant was neither incorporated in nor had its principal place of business in the court’s jurisdiction.  The plaintiffs cited the execrable Mallory decision in response, arguing that, as in Mallory, doing business in Illinois constitutes consent to personal jurisdiction.  But the Franco court correctly held that Mallory applies only to benighted states, such as Pennsylvania, that enact statutes expressly allowing personal jurisdiction by consent. Mallory does not impair the overwhelming majority rule that corporate registration is not inferred from statutes (such as the one in Illinois) that are silent.  As for specific personal jurisdiction, the Franco court threw out some claims and kept others in the case. The reasons for that might entertain jurisdiction nerds, but nobody else.


The plaintiffs also attempted to establish general jurisdiction by pointing to the defendant’s status as an LLC rather than a corporation.  According to the plaintiffs, an LLC is at home wherever it has members.  The Franco court expressed skepticism about this approach, but ended up avoiding the issue on the simple basis that the plaintiffs had not identified any LLC members in Illinois. 


Now we get to preemption. The plaintiffs’ main argument was they were looking for a jury verdict that would enforce, not conflict with, federal law. The pertinent federal regulation defined total sugars in food to be the “sum of all free mono- and disaccharides (such as glucose, fructose, lactose, and sucrose).” Allulose, which everyone agrees was in the yogurt, is a monosaccharide, even though it was not listed in the “such as” clause. So do things look sour for the defendant?  No, because the Food and Drug Administration (FDA) had issued a guidance document laying out its “enforcement discretion” determination that allulose (for particularized reasons that made scientific and nutritional sense) would not be counted as “sugar” in determining compliance with the agency’s food labeling requirements.  The plaintiffs contended that the guidance should not count for preemption purposes, because it was “not binding on [the] FDA or the public.”  That much is true.  But while guidances do not always have the force of law, here the guidance is “controlling” for preemption purposes  “unless plainly erroneous or inconsistent with” the regulation “or there is any other reason to doubt that [it] reflect[s] the FDA’s fair and considered judgment.” The Franco court quoted our old friend, PLIVA v. Mensing.  Here, there was no reason to question the FDA’s judgment. The guidance was supported by applicable science, and giving it preemptive force makes practical sense since once the FDA has expressly exercised its enforcement discretion, it is difficult to believe it would have allowed private litigation doing the same thing.  Who needs that sort of chaos?

The plaintiffs pushed back against the Franco’s application of the FDA guidance, pointing to a Ninth Circuit case (Reid), which held a FDA guidance to lack preemptive effect.  But that guidance was couched in language “in tentative and non-committal terms.”  According to the Franco court, “Reid is distinguishable, not dispositive, and consistent with PLIVA. The Allulose Guidance has binding effect.” Thus, the Franco court concluded that the Allulose Guidance explicitly authorized the defendant’s “sugar-free” statements in the label.  The case was dismissed.  The Franco court did not need to reach the defendant’s primary jurisdiction argument.   

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Admittedly, we sometimes feel like a broken record playing the same song over and over. But doesn’t everyone have that favorite album that they can put on a loop and never get tired of?  (Prince’s Purple Rain; The Beatles 1967-1970; Elton John’s Two Rooms). For the DDL blog, that album would be preemption because it is just so full of unforgettable hits – Buckman, Riegel, Mensing.  The list goes on and on.

And we can’t help that plaintiffs themselves are stuck on replay.  They seem to be playing their OTC products album a lot recently and their favorite track–benzene.  But to plaintiffs’ ears decisions on alleged benzene contamination in OTC products, like in acne medications and sunscreen, should sound more like dirges than ditties. Birdsong v. Walgreen’s Inc., 2025 WL 1446400 (N.D. Ill. May 20, 2025), beats that familiar refrain, only this time plaintiffs were a proposed class of purchasers of generic extended-release mucous relief medications.

Unlike many of the prior benzene cases, Birdsong is not based on “independent testing” (ha) by Valisure laboratories.  Rather, extended-release medications can be created with an ingredient called carbomer, which is sometimes produced using benzene as a solvent.  As a result, traces of benzene may remain in the carbomer and thus in the medication.  Id. at *1.

While the decision does not come right out and say so, it appears that the use of benzene in the production of carbomer is known and permitted by the FDA.  Id.  So, it really isn’t surprising that Birdsong joins the many proposed OTC class actions dismissed based on express preemption. 

But before we get to that, we’ll acknowledge that the court did not agree with defendant’s standing argument which was based on plaintiffs’ failure to identify which of defendant’s extended-release mucous relief medications they used and defendant’s contention that not all of those medications include a carbomer made with benzene.  However, that is not what plaintiffs alleged. Their complaint alleged that all of defendant’s products in this category used “benzene containing components” and therefore all are contaminated.  Accepting that allegation as true, the court found plaintiffs had stated a plausible claim for which they had standing.  Id.

That turned out to be a hollow victory.  For OTC drugs, the Food, Drug, and Cosmetic Act (“FDCA”) expressly preempts state law requirements that are “different from or in addition, to, or that [are] otherwise not identical with” the federal requirements under the FDCA.  Id. at *2 (quoting 21 U.S.C. § 379r).  Plaintiffs advanced two theories to support their claim that under state law defendant breached its duty to notify consumers about the risk of benzene in its products.

First plaintiffs alleged that defendant failed to include benzene as an ingredient on the label.  The FDCA provides that only “active ingredients” and “inactive ingredients” may be listed on the labeling.  Looking at how the FDA defines those terms, the court concluded that benzene is neither because it is not an “intended” component.  Therefore, any claim that benzene should have been included is different from federal requirements and preempted.  Id. 

Second, plaintiffs alleged that defendant “made affirmative misrepresentations about product safety” in its marketing.  But plaintiffs’ alleged affirmative misrepresentations were solely based on defendant’s failure to disclose the presence of benzene:

Plaintiffs and consumers do not know, and did not have a reason to know, that [the mucus medication products they] purchased were contaminated with Benzene.

Id. Thus, plaintiffs’ “affirmative” claims were “not factually different” from their non-disclosure claims.  Making them preempted as well.    Id. at *3.

Cue up the preemption/benzene soundtrack—it’s not new but it’s music to our ears.

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Almost ten years ago Bexis argued that the Federal Rules were technologically out-of-date and proposed a number of topics that would benefit from rules-based codification.  One of those topics involved machine learning – specifically use of predictive coding in ediscovery.

That didn’t go anywhere, but on May 2, 2025, the Advisory Committee on Evidence Rules proposed language for a new rule – Fed. R. Evid. 707 – addressed to the impact of artificial-intelligence-generated evidence in the courtroom.  Here’s the proposed language:

Rule 707. Machine-Generated Evidence

When machine-generated evidence is offered without an expert witness and would be subject to Rule 702 if testified to by a witness, the court may admit the evidence only it if satisfies the requirements of Rule 702 (a)-(d).  This rule does not apply to the output of basic scientific instruments.

Committee on Rules of Practice and Procedure, Agenda Book, at Appendix B, page 75 of 486 (June 10, 2025).  This proposal is the product of three years of research and investigation.  Id.

Continue Reading Federal Judicial Conference Evidence Rules Committee Releases Possible New Rule Pertaining to Artificial Intelligence
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The Avandia MDL has been a long, winding, and ultimately meritless road.  The FDA approved the drug to treat Type II diabetes in 1999, and the MDL got going in 2007, after a widely publicized, but ultimately disproven meta-analysis purported to show that Avandia presented an increased risk of heart attacks. 

That was 18 years ago.  In that time, the FDA asked the manufacturer to add a black box warning on myocardial ischemia—only to remove it six years later when it determined that the science did not support it.  The FDA likewise imposed a REMS program that significantly restricted access to the product—only to end the program after long-term study results dispelled any increased risk.  In the meantime, the parties and the courts have expended a tremendous amount of public and private resources, and patients were deprived of a therapeutic option that undoubtedly would have benefited many. 

All because of a cardiac risk that the FDA has determined did not exist.  Heck, just last November, Bexis published a blogpost entitled, “Avandia Litigation – Is This Finally the End?” 

Well, it is not quite the end.  At least not yet.  The personal injury claims have long been resolved—either settled or dismissed (for example, here, here, and here).  But third party payers still have RICO and consumer fraud claims asserting that they paid for more Avandia prescriptions than they would have had the manufacturer accurately disclosed information on cardiac risks in real time.  We have serious doubts about the merits of these claims:  The payers got exactly what they paid for, and they do not allege that any patient was actually harmed.  Moreover, any price impact would have been dwarfed by the FDA’s requirement, and then removal, of the ultimately unnecessary boxed warning. 

Regardless, the district court has now certified a TPP class and is allowing them to proceed in a collective manner. In In re Avandia Marketing, Sales Practices, and Products Liability Litigation, No. 07-md-1871, 2025 U.S. Dist. Lexis 97465 (E.D. Pa. May 22, 2025), the district court certified a class of TPPs who purchased Avandia from January 1, 2005 through August 14, 2007.  The TPPs’ theory of liability has shifted over time, but it appears they have settled on arguing that the manufacturer marketed the drug as having better cardiovascular outcomes, but had data showing that was not true as early as 2005.  The truth allegedly came out, according to the TPPs, when the aforementioned meta-analysis was published in 2007.  (Although the court does not explain it, these allegations appear to frame the beginning and end of the class period.) 

In urging class certification, the TPPs argued that the manufacturer’s “marketing fraud” was a standardized campaign directed at the entire healthcare community with “market-wide impact,” thus making it susceptible to class-wide proof.  The manufacturer disagreed, mainly on the ground that that leads to denial of most TPP economic harm class actions—causation.  We see the manufacturer’s point.  To link the alleged wrongdoing to the alleged harm, the TPPs have to prove that the manufacturer misrepresented the benefits of Avandia, that a prescribing physician relied on those representations in prescribing Avandia, that the prescriber would not have prescribed the product but for the representations, and the prescriber would instead have prescribed a cheaper medicine or nothing at all.  These elements require individualized proof, especially reliance.  There are, after all, many reasons why physicians prescribed Avandia, and they may or may not have even seen or heard the alleged “marketing,” let alone relied on it.

Despite this, the court found that the TPPs could prove causation on a class-wide basis.  First, the court determined that it could infer reliance on the manufacturer’s marketing, and it distinguished cases holding otherwise on the basis that “every provider’s goal when considering whether to prescribe Avandia is largely the same—to treat a patient’s diabetes without otherwise causing harm.”  Id. at *20.  Based on this (oversimplified) view of prescribing decisions, the court concluded that “even though the decision to prescribe Avandia is not ‘one-dimensional,’ it is not so subjective that a provider’s reliance cannot be inferred.”  Id. at *20-*21. 

Second, the court found that the TPPs could prove class-wide reliance through statistical econometric models, even though the court already excluded the plaintiffs’ expert’s regression analysis purporting to show causation.  In its place, the court accepted the plaintiffs’ offer of the manufacturer’s own internal studies of how its marketing impacted sales and other “generalized” proof, such as “papers, internal corporate studies, and communications.”  Id. at *21-*22. 

The court therefore found that common issues predominated over the element of reliance.  That is not the correct outcome.  It was undisputed that providers prescribed Avandia for many reasons, and the manufacturer submitted testimony from individual providers contesting that they relied on the manufacturer’s marketing.  The court, however, ruled that this individualized evidence was minimal by comparison and that it would not engage in conjecture on what other evidence the manufacturer would be able to marshal at trial. 

The manufacturer offered other reasons why individual issues would swamp common issues.  RICO claims require proof of concrete financial loses, yet there were multiple scenarios under which putative class members suffered no aggregate loss at all.  Determining this element—which relates to liability, and not only damages—could be determined only be examining each class member.  The court, however, ruled that each TPP’s harm occurred at the time of each Avandia purchase, which means that any TPP who paid for even one Avandia prescription suffered an injury.  That logic erases individualized issues, but it clears the way for class-wide recovery for a class whose members may not have lost any money, or may even have come out ahead.  Indeed, the plaintiffs’ own expert concluded that 26 percent to 33 percent of TPPs in one dataset had “zero or negative damages.”  Id. at *28. 

The manufacturer also cited the plaintiffs’ reliance on oral statements, which by nature are inappropriate for class treatment.  The court rejected this argument too, on the basis that the manufacturers’ marketing messages and tactics did not vary by region and that “the oral component of the fraudulent sales presentations did not vary appreciably” from provider to provider. 

Finally, the court found that the class was ascertainable.  Under the TPPs’ proposal, they would use vendors to compile a list of every TPP, then each potential class member would submit sworn affidavits as claim forms following judgment.  The court accepted this method, relying on Third Circuit authority allowing “some level of verification” during the claims administration process.  The devil, however, is in the details, and when starting with an overly broad list of every TPP, the contemplated affidavits will be much more than mere “verification.” Moreover, the facts asserted will not be subject to cross-examination. The class members would essentially be expected to prove their claims on an individual basis after the fact, which is not what class actions should be. 

In certifying a TPP class, this order is in the distinct minority, and the difference is that these plaintiffs will be allowed to round over the edges of individualized inquires using “common” proof at trial.  If we are searching for a silver lining, we would point to the limited, two-and-a-half-year class period.  But that’s not saying much given the overall result.  We would not be surprised if the manufacturer seeks an interlocutory appeal, and the manufacturer also has a motion for summary judgment pending.  This may not be our last word on Avandia. 

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In our legal world, Lone Pine is not a small California town near the majestic Mt. Whitney and the sobering Manzanar National Historic Site.  It is an order directing plaintiffs to come forward with some evidence that they took, or were exposed to, the product they are suing over, and some evidence about their alleged injury (that it exists, and maybe even that it was connected to the product).

To those who don’t live in our legal world:  Yes, lawsuits are filed all the time on behalf of people who never took the drug, had the device, used the product, were exposed to the chemical.  And yes, lawsuits are filed all the time on behalf of people who have no injury from that drug, device, product, or chemical.  And no, it is not so easy to get rid of such cases—it can take years of expensive discovery and motion practice for the truth to out, particularly if the bad lawsuit apples are hiding out amongst several hundred bushels in an MDL or mass tort.  

We now have a PFAS case, Conklin v. Corteva, 2025 U.S. Dist. LEXIS 92028, 2025 WL 1402696 (E.D.N.C. May 14, 2025), to add to our Lone Pine Cheat Sheet, which these days is getting slightly more populated.

In Conklin, after the Eastern District of North Carolina partially denied a motion to dismiss and allowed some claims to proceed toward discovery, the defendants requested a Lone Pine order.  The defendants asked for entry of a case management order directing the plaintiffs (60 in all, across 8 related cases) to come forward with expert declarations confirming they each had the injuries they allege, and that those injuries were proximately caused by their exposure to PFAS. 

The court thought that requiring a “‘measure of evidence’” near the outset of the cases might help it “‘identify and cull potentially meritless claims and streamline litigation.’”  Id. at *3 (quoting In re Digitek Prod. Liab. Litig., 264 F.R.D. 249, 255 (S.D.W. Va. 2010) and In re Vioxx Prod. Liab. Litig., 557 F. Supp. 2d 741, 743 (E.D. La. 2008)).  So, it went through the Lone Pine factorial test.

Factor 1:  What is the posture of the litigation? 

A pre-discovery Lone Pine order can be appropriate where “the requested information is the kind that plaintiffs should have had in their possession before filing the lawsuit pursuant to Fed. R. Civ. P. 11.”  This was true in Conklin.  Plaintiffs had full access to their own medical records and would eventually need to produce supporting expert testimony anyway.  In fact, by the time the Lone Pine order was requested, their lawsuits already had been on file for two years, so this wasn’t even a particularly early Lone Pine request.  This procedural posture favored a Lone Pine order, and would not impose undue burdens. 

Factor 2:  What are the peculiar case management needs of the litigation?

Although the plaintiffs argued that the litigation involved too few cases to warrant a Lone Pine order, the court—juggling 60 plaintiffs across 8 lawsuits—disagreed.  A Lone Pine order would help with case management.

Factor 3:  Have questions been raised about the plaintiffs’ medical and scientific evidence?

The parties traded arguments about EPA findings regarding what levels of exposure to PFAS could cause harmful effects as well as university research about the defendant’s PFAS use.  Safe to say, questions had been raised, and the fact that there was debate was the point.  Although plaintiffs could not be faulted for filing suit without waiting for full scientific clarity, they had to “accept that ongoing research concerning PFAS compounds [would] affect the viability of their claims.”

Factor 4:  Would other procedures accomplish the same goals?

Federal procedure, of course, allows for the usual forms of discovery (depositions, interrogatories, independent medical exams, requests for documents), and motions for summary judgment are another procedure that requires a plaintiff to come forward with some evidence in support of his or her claim.  But unlike a Lone Pine order, these usual discovery tools and usual forms of motion practice are just not very efficient and take too long, and they thus would be “insufficient to address the issues at hand.”

Factor 5:  What are the injuries alleged, and their alleged cause?

Lone Pine orders are well suited for environmental contamination matters, and plaintiffs’ PFAS allegations fit that paradigm.  (Although we would hasten to add, Lone Pine orders are well suited to pharmaceutical and medical device product liability litigation as well.)

All the factors in Conklin thus favored a Lone Pine order “requiring plaintiffs to submit expert declarations confirming their injuries and proximate causation.”  This was basic evidence they were supposed to have before filing a lawsuit, and eventually would need to produce anyway to prevail at trial. 

In short, another good Lone Pine decision.  Maybe someday we will have a whole pine forest.

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Cordero v. Olson Assocs. P.C., 2025 U.S. Dist. LEXIS 91994, 2025 WL1383217 (D. Utah May 13, 2025), is just another FDCA case. Except it is not the Food, Drug and Cosmetic Act that is in controversy, but, rather, the Fair Debt Collection Act. The plaintiff sued several defendants, including law firms, for allegedly unlawful debt collection practices. She claimed that those debt collection practices caused emotional distress and physical injuries. 

So what is a debt collection case doing on the DDL Blog?  We owe an explanation. 

Cordero ends up being interesting for how the court (a magistrate judge) handled the plaintiff’s lawyer, who seems to have been something of a “Rambo litigator” — and most of you have had the misfortune of encountering representatives of that unpleasant species. To be fair, this was a Rambo in the sense of words, not deeds.  As far as we know, the lawyer did not do last minute document dumps or commit fraud or anything like that.  Instead, it appears that the lawyer hurled a lot of useless, silly invectives.  But after a certain point, name-calling can be irksome enough to move a court to action. 

At issue in this decision were the plaintiff’s medical records and various disputes related to her deposition topics and location.  The plaintiff filed a motion for a protective order and the defendants filed competing motions to open up certain avenues of discovery. The plaintiff wanted to prevent sharing of her records among the defendant law firms. She also wanted to limit questioning about her medical or financial condition that she deemed irrelevant or overly intrusive.  This type of skirmishing is typical in American litigation, and the issues are seldom novel or intriguing. The plaintiff won a couple of her arguments, and lost a few more. 

But Cordero highlighted a couple of points that are either instructive or at least a source of solid schadenfreude. 

First, on substance, the defendant was entitled to take the plaintiff’s deposition in person at the offices of defense counsel.  It was the plaintiff, after all, who brought the suit. She was obviously a key witness. Her injury claims placed her credibility at the center of the case. The plaintiff resisted a personal appearance at the defense law firm on grounds of inconvenience and burden, but these arguments did not impress the court. The noticer of a deposition chooses the location, and the default form of deposition remains in-person, face to face.  The plaintiff could not force the defendants to take a remote deposition. 

If any of this arrives as a surprise to you, count yourself instructed. You’re welcome.  

Now for the moment of schadenfreude. The court admonished plaintiff’s counsel on “professionalism” for the purple prose he deployed in his briefs, which the court considered to be a series of personal attacks on opposing counsel.  The plaintiff’s briefing characterized defense arguments as being “disingenuous,” “nonsense,” “meaningless,” “callous,” “intellectually dishonest,” “baseless,” “blatantly untrue,” etc. etc.  You get the idea. It appears that the plaintiff briefing devoted as much ink to impugning the other side’s motives as to addressing the logic of the arguments.  That is not a good or smart. When we edit a brief and see this sort of thing (the word “disingenuous” is always a giveaway) we wince, and then we delete. Heat is a poor substitute for light. 

(We can recall with precision the first time we encountered the word “disingenuous.” We were in an undergraduate course on the history of the Supreme Court. The teacher was Archibald Cox. One session was devoted to FDR’s 1937 court-packing plan. SCOTUS had invalidated several New Deal initiatives. FDR’s purported rationale for adding Justices to the Court had nothing to do with the High Court’s rulings. Instead, FDR expressed concern that SCOTUS was filled with “aged or infirm Justices.” The plan failed. Critics called FDR’s stated reason “disingenuous.” The word means dishonest — an innocent-sounding cover for something devious.)

In Cordero, the court expressed displeasure with the plaintiff lawyer’s “hostile, discourteous, and uncivil” conduct.  Such judicial disappointment would hurt enough. But the Cordero court went as far as imposing a sanction against the plaintiff counsel, apparently sua sponte. (From the opinion we learn that the plaintiff lawyer asked for sanctions against the defense, but we read nothing about the defense asking for sanctions.  How’s that for comeuppance?) The court ordered the plaintiff lawyer to read the Utah Standards of Professionalism, certify to having done so, and certify that he will comply with those standards “in both letter and spirit.”  The court clearly had enough, and warned of further sanctions and referral to the disciplinary board for any future unprofessional conduct.  

It is probably a good thing for judges to take actions against lawyers who make the occupation more nasty than it needs to be. But while we used the word schadenfreude to signal our approval of the Cordero decision, we did so fully aware that poison pens exist on both sides of the v.  (Yes, maybe even occasionally on this blog. Yes, mostly the author of this post.  Yes, we grieve over this fact during dark evenings of the soul.) We defense hacks can do better. And that is not mere moralizing. Judges hate it when lawyers challenge the honesty of their opponents. (A couple of weeks ago, Justice Gorsuch dressed down perhaps the finest current SCOTUS advocate during oral argument for labeling her “friends on the other side” as liars.) The best way to get sanctions against the other side is to make sure that your own side does not stray into incivility. Make the contrast clear for the court. Tamp down the name-calling, avoid ad hominem attacks, and clobber the other side on the facts and law. 

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We have learned, through repeated harsh experience (e.g., Mallory, Wullschleger, Harrington) that while the current Supreme Court can be described as “conservative,” that hardly means that it is pro-business.  Indeed, it appears that when the issue is p-side forum-shopping, the Notorious RBG (opponent of all things preemption) was far more “pro-business” than justices bearing the “ultra-conservative” label.

With that in mind, we turn to the Court’s latest certiorari grant in a plaintiff forum-shopping case − Palmquist v. Hain Celestial Group, Inc., 103 F.4th 294 (5th Cir. 2024).  Palmquist is a food case, and the plaintiffs sued − in addition to the targeted manufacturer  − a local grocery store in a transparent effort to destroy diversity and thereby keep the case in state court.  The manufacturer removed, claiming that joinder of the intermediate seller was fraudulent under a state (Texas) statute that, with some exceptions, immunized such sellers from suit.  After abandoning their initial complaint in favor of an amended complaint that attempted to plead around the statute, plaintiffs sought remand.  They lost, and the district court retained jurisdiction.  See Id. at 299-300 (describing procedural history).  That was in 2021.  The suit, now between completely diverse parties, was litigated in federal court over the next two years until, during a jury trial, the defendant successfully moved for judgment as a matter of law on grounds that the plaintiffs presented “no evidence of general causation” since they had no expert witness.  Id. at 300.

On appeal the Fifth Circuit never reached the slam-dunk reason why the defense won on the merits.  Instead, it found – under the extremely low pleading bar that plaintiffs enjoy when they engage in fraudulent joinder − that even the original complaint (which plaintiffs abandoned) had successfully evaded the Texas statute that the legislature enacted to stop precisely what the plaintiffs in  Palmquist did:

The language in the as-removed complaint was broad enough to encompass both breach of express and implied warranties claims.  The paragraph was entitled “Breach of Warranties,” which could include both express and implied claims.  Although the language in the as-removed complaint generally discussed [the intermediate seller’s] implied warranties, it also discussed [its] express representations regarding [the manufacturer’s] products.  We therefore hold that the district court erred in concluding that the [plaintiffs] added a new breach of express warranty claim in their second amended complaint.

103 F.4th at 302.  Under the “no possibility of recovery” fraudulent joinder standard, the plaintiffs’ threadbare pleading sufficed.  Id. at 304.  “As the [plaintiffs] argue, the [intermediate seller’s] business model depends on [its] reputation and customers’ willingness to a pay a premium for products that [it] advertises as healthy and high quality.”  Id. at 307.

Finding a non-waivable subject-matter-jurisdiction defect, the Fifth Circuit threw two years of litigation between the diverse parties out the window and let the plaintiffs have a do-over in state court.  Standing in the way was a Supreme Court decision in a prior case involving improper removal, where the Supreme Court had refused to jettison the results of that litigation, holding:

[Plaintiffs’] arguments are hardly meritless, but they run up against an overriding consideration.  Once a diversity case has been tried in federal court, with rules of decision supplied by state law. . ., considerations of finality, efficiency, and economy become overwhelming.

Caterpillar Inc. v. Lewis, 519 U.S. 61, 75 (1996) (citation omitted).

Palmquist, however, distinguished Caterpillar.  According to Palmquist, the Caterpillar plaintiffs had surrendered their jurisdictional argument by “cur[ing]” it themselves.  103 F.4th at 307.  Those plaintiffs had settled with the non-diverse defendant, thus eliminating any lack of jurisdiction, whereas in Palmquist the plaintiffs had not.

Unlike Caterpillar, complete diversity did not exist at the time judgment was entered because the [plaintiffs] alleged non-fraudulent claims against a non-diverse defendant. . . .  Where a jurisdictional defect lingers (i.e., lack of subject matter jurisdiction) through judgment in the district court, the case must be remanded because the federal court lacked jurisdiction.

103 F.4th at 308 (citation omitted).

What this “conservative” Fifth Circuit panel did in Palmquist was to convert fraudulent joinder – or any other means of involuntarily eliminating a non-diverse defendant – into a free shot for plaintiffs.

If the plaintiff ultimately wins, or settles, in federal court, then the plaintiff would simply forget about jurisdiction – a winning or settling plaintiff would have no reason to appeal and to challenge subject-matter jurisdiction.  For their part, defendants in such a situation would face judicial estoppel if they contested their loss by raising lack of subject matter jurisdiction, since they had initially removed the case to federal court.  E.g., American Fire & Casualty Co. v. Finn, 341 U.S. 6, 17 (1951).

But now, under the Fifth Circuit’s Palmquist decision, whenever plaintiffs lose in a case removed to federal court, they get a free shot at a do-over if, on appeal, they can convince a federal court of appeals that the diversity-destroying defendant should not have been dismissed, and that the case should have been remanded to state court.  This makes fraudulent joinder far more risky for defendants, because even if they win, they can still lose on appeal – with the penalty being that everything done in federal court was for naught, and that plaintiffs get a second bite at the apple (with the advantage everything they learned about a defendant’s case) back in state court.

To the Fifth Circuit in Palmquist, it was of no moment that the parties before it, who had actually litigated the case to a final judgment, were fully diverse, or that there was no other error aside from the jurisdictional defect.  Nor was any mention made of the plaintiff taking any steps to pursue any claim in state court against the defendant dismissed as fraudulently joined.

Now, the Supreme Court granted certiorari on the following question:

Whether a district court’s final judgment as to completely diverse parties must be vacated when an appellate court later determines that it erred by dismissing a non-diverse party at the time of removal.

Hain Celestial Group, Inc. v. Palmquist, 2025 WL 1211787 (U.S. April 28, 2025); Petition for Certiorari, at i (filed March 25, 2025).

You wouldn’t know it from the Fifth Circuit’s opinion, but this is hardly the first time that plaintiffs have sought this kind of free shot.  The petition cited Junk v. Terminix International Co., 628 F.3d 439 (8th Cir. 2010), so we checked out that decision, which turned out to be anything but eponymous.  Junk held that the later dismissal of plaintiff’s claims against the non-diverse defendant cured the jurisdictional defect:

[Plaintiff] urges that the erroneous denial of remand should void the court’s subsequent rulings in favor of [the diverse defendants], but “a district court’s error in failing to remand a case improperly removed is not fatal to the ensuing adjudication if federal jurisdictional requirements are met at the time judgment is entered.” Upon [the non-diverse defendant’s] dismissal, the court’s diversity jurisdiction was perfected and the litigation could proceed as to [the diverse defendants].

Id. at 447 (quoting and following Caterpillar; other citation omitted).

The petition also relied on Gould v. Mutual Life Insurance Co., 790 F.2d 769, 774 (9th Cir. 1986), which held essentially the same thing prior to Caterpillar:

When final judgment was entered, only a diverse defendant remained because the nondiverse defendants had been dismissed by summary judgment. . . .  Essentially, the rule requires an appellant to have a remand issue certified for interlocutory review. . . .  Under the [Supreme Court’s] rule, the court below had subject matter jurisdiction.  The nondiverse defendants had been dismissed by the state trial court and that dismissal had not yet been overturned on appeal.  The only parties before the court were diverse.  Although application of this rule puts an appellant to a choice, it promotes finality and judicial efficiency.

Id. at 774 (citations omitted).

The Fourth Circuit is also on the other side of the circuit split.  Moffitt v. Residential Funding Co., LLC, 604 F.3d 156 (4th Cir. 2010), also rejected the sort of mandatory nullification rule that the Fifth Circuit adopted in Palmquist.  “[E]xcus[ing] jurisdictional defects at the time of removal” “is grounded not only in the interest of ‘finality’ but also in larger considerations of ‘judicial economy.’”  Id. at 160 (quoting Able v. Upjohn Co., 829 F.2d 1330, 1334 (4th Cir. 1987), overruled on other grounds in Caterpillar).  “[I]t would be a waste of judicial resources to remand these cases on the basis of an antecedent violation of the removal statute now that jurisdiction has been established.”  Id.

Here, judicial economy and finality require that the district court’s judgment be allowed to stand.  Where a matter has proceeded to judgment on the merits and principles of federal jurisdiction and fairness to parties remain uncompromised, to disturb the judgment on the basis of a defect in the initial removal would be a waste of judicial resources.

Able, 829 F.2d at 1334 (citation omitted).

On the other hand, the petition concedes that the Eleventh Circuit has the same rule as the Fifth – that when a district court errs by dismissing a nondiverse party as fraudulently joined, any final judgment it later issues against the remaining completely diverse parties that remain must be overturned for lack of subject matter jurisdiction.  Petition at 19 (citing and discussing Henderson v. Washington National Insurance Co., 454 F.3d 1278, 1284 (11th Cir. 2006)).

The plaintiffs’ opposing brief in Hain v. Palmquist, claimed that any circuit split was “stale and non-recurring.”  Id. at 8.  Anybody who regularly litigates in this space knows that this is not true.  Plaintiffs appeal all the time trying to nullify adverse results due to claims of purported jurisdictional defects.  Most of the time they lose on the jurisdictional issue, but the threat of nullification is always there.  Otherwise, the plaintiff-respondents:  (1) distinguished Caterpillar in the same way the Fifth Circuit did, id. at 7-8; (2) attacked the petitioning defendant’s reading of circuit split cases for a variety of reasons, id. at 10-19; (3) relied on a post-Caterpillar case, Grupo Dataflux v. Atlas Global Group, L.P., 541 U.S. 567 (2004), holding that a defendant could not cure a jurisdictional defect by changing its own citizenship in the middle of the litigation, id. at 19-21; and (4) relied on Royal Canin U.S.A., Inc. v. Wullschleger, 604 U.S. 22 (2025), id. at 22, which we discussed here.   Royal Canin has no bearing on the nullification issue, as it allowed plaintiffs to amend their complaints to add diversity-destroying new defendants.  Since such amendments must be made promptly, they implicate none of the “overwhelming” “considerations of finality, efficiency, and economy” that carried the day in Caterpillar.  Grupo Dataflux seems distinguishable because the defendant, not the plaintiff, had sought to change jurisdictional facts after the fact.

In reply, the defendant-petitioner reiterated that the circuit split was real and “intractable.”  Id. at 2-7.  It pointed out that the main ground plaintiffs raised to minimize the circuit split was an issue that  Caterpillar did decide – that failure to take an immediate interlocutory appeal following denial of remand did not constitute a waiver on the part of a plaintiff.  Id. at 5-6.  They argued that one of the arguments plaintiffs made further demonstrated the wrong-headedness of the Fifth Circuit’s rule of absolute nullification whenever a jurisdictional defect existed at the beginning of the case.  Id. at 7-9 (it’s esoteric, but you can read it here).  Finally, the reply reiterated both the common-place nature of the issue, and the judicial economy reasons that counsel against the Fifth Circuit’s nullification ruling.  Id. at 9-10.

Now the Court has taken the case.

Will the defense prevail, or will the recent trend continue of this “conservative” Court now being more sympathetic to p-side forum shopping than when former Justice Ginsburg still sat?  We don’t know, but we do know that the decision in Hain Celestial will be a big deal, given the frequency with which plaintiffs join non-diverse plaintiffs on fanciful claims that they never intend to pursue once defendants are trapped in state court following expiration of the 1-year period for diversity-based removals.  We don’t think that every successful fraudulent joinder removal should create a looming background threat of everything that happens thereafter being for naught.

If that were to happen, we would be in favor of either universal application of the minimal diversity model currently found in the Class Action Fairness Act, a requirement that the plaintiff have diligently pursued a state-court claim against the dismissed non-diverse defendant, or failing either of those, giving plaintiffs an immediate and mandatory interlocutory appeal as of right from any denial of remand based on fraudulent joinder.  It’s crazy to waste that much time and effort., both for the parties and of the courts.  We hope that the Supreme Court agrees.

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Today we address two more cooked-up—literally—Valisure cases, Bodunde v. Walgreens Boots Alliance, Inc., No. 1:24-CV-00985-JLT-SAB, 2025 WL 1411306 (E.D. Cal. May 15, 2025), and Navarro v. Walgreens Boots Alliance, Inc., No. 1:24-CV-00290-JLT-SAB, 2025 WL 1411406 (E.D. Cal. May 15, 2025).

These two cases involve legally identical magistrate recommendations that Defendant’s motions to dismiss be granted.  The cases are part of a putative consumer fraud class action regarding the sale of Walgreens’s over-the-counter benzol peroxide (“BPO”) acne treatment drug products. The complaint incorporated allegations in an FDA citizen petition filed by Valisure, an entity well known to readers of the Blog by now (see here, here, and here, to name a few), stating that it had tested the BPO products and found high levels of benzene when stored at above-ambient temperatures.  Valisure reached this result by “incubating” the products at 122 degrees Fahrenheit for 18 days.  Earlier this year, we discussed the FDA’s response to that petition.  In short, the FDA was not impressed.  FDA tested 95 BPO-containing acne products, and more than 90% of tested products had undetectable or extremely low levels of benzene; FDA initiated a limited number of voluntary recalls for the small number of products with elevated benzene levels, and even in those, only specific lot numbers.  Undeterred, Plaintiffs here brought claims under various consumer fraud and deceptive trade practices statutes, unjust enrichment, and breach of implied warranty of merchantability.  Walgreens moved to dismiss for lack of standing and failure to state a claim.

Standing

Walgreens asserted that Plaintiffs lacked Article III standing because they did not allege that the BPO products they purchased actually contained benzene; therefore, there was no injury-in-fact.  

The court held this argument was disposed of by the Ninth Circuit’s recent decision in Bowen v. Energizer Holdings, Inc., 118 F.4th 1134 (9th Cir. 2024).  In Bowen—a case involving allegations of benzene in sunscreen—the court held that under a theory of economic harm, a plaintiff must only prove that he or she “paid more for the product than she otherwise would have paid or bought it when she otherwise would not have done so” absent the alleged false representation or non-disclosure.  Id. at 1147 (cleaned up).  The court concluded that standard was met by the plaintiffs’ allegations.  Bodunde, 2025 WL 1411306 at * 9; Navarro, 2025 WL 1411406 at *8.

Preemption

Walgreens also argued that the claims were expressly and impliedly preempted by the FDCA.

With respect to OTC drugs like the BPO products, the FDCA has a broad express preemption prohibiting any state requirement “(1) that relates to the regulation of a [nonprescription drug]; and (2) that is different from or in addition to, or that is otherwise not identical with, a requirement under” the FDCA. 21 U.S.C. § 379r(a). OTC acne products are governed by a comprehensive set of FDA regulations called a monograph that contains specific requirements for labeling and expressly permits BPO in these products in an amount from 2.5-10%. Under the regulations, if a product complies with the monograph it “is generally recognized as safe and effective and is not misbranded.” Id. at § 333.301.

However, the express preemption provision does not bar state law claims that impose identical or “parallel” requirements to FDA regulations. Bodunde, 2025 WL 1411306 at * 11; Navarro, 2025 WL 1411406 at *10 (citing Riegel v. Medtronic, 552 U.S. 312, 330 (2008)).  The claim here was that the BPO products were misbranded by omission: they did not disclose or warn that the products contain or might contain benzene.  The court correctly concluded that “federal labeling regulations do not require such a statement, so Plaintiffs’ claims, insofar as they grounded on this basis, are expressly preempted.”  Bodunde, 2025 WL 1411306 at *12; Navarro, 2025 WL 1411406 at *11.  The acne monograph specifically lists BPO as a permissible active ingredient and does not require manufacturers to include any warning about benzene.  Any added warning about benzene would be an “additional” requirement of state law and is expressly preempted.  Id.

The court also rejected the claim that benzene should have been listed as an inactive ingredient.  Inactive ingredients are “any component other than an active ingredient.” 21 C.F.R. § 201.66(b)(8).  Benzene would not qualify as a component because it was not “intended for use in the manufacture of a drug product.” 21 C.F.R. § 210.3(b)(3).  “[B]ecause Walgreens did not intend for benzene to end up in its BPO products, claims based on this theory are preempted.”  Bodunde, 2025 WL 1411306 at *12; Navarro, 2025 WL 1411406, *12.

The court then considered a parallel claim based on violation of  “Current Good Manufacturing Practice” regulations, which concern manufacturing processes and operations.  This is where the court went awry.  Without much discussion, the court found that “to the extent Plaintiffs’ state law claims are parallel claims brought for violations of CGMPs, those claims are not categorically preempted.”  Bodunde, 2025 WL 1411306 at *14; Navarro, 2025 WL 1411406 at *14.  These allegations were based on the vaguest cCGMPs possible (having “written procedures” for “process controls”).  In part, the court relied on the Ninth Circuit’s Davidson decision, which we lamented here, which allows FDCA enforcement laundered through state laws.  In this case, those state laws were state consumer or “little FDCA” statutes, even though it’s not clear here what actionable facts could support such a claim.

In Bodunde, Walgreens also argued that Plaintiffs’ claim was barred by the Illinois consumer fraud statute’s “safe harbor” provision.  The court declined to apply this exception, holding that the fact that federal law allows for the omission of benzene warnings does not make it “specifically authorized.”  Bodunde, 2025 WL 1411306 at *14.

Fraud

Walgreens also attacked Plaintiffs’ fraud claim as not alleging the “when,” “where,” and “how” as required by Rule 9(b).  Although the court found that the “when” and “where” were there, it agreed with Walgreens that the complaints lacked allegations of the “how.”  “While Plaintiffs have listed at least 22 CGMPs that Walgreens purportedly violated, the Court finds that Plaintiffs have not alleged facts that either establish that Walgreens allegedly violated the subject CGMPs, or even if Walgreens did violate the CGMPs, how those violations ultimately deceived Plaintiffs.”  Bodunde, 2025 WL 1411306 at *15; Navarro, 2025 WL 1411406 at *15.  Plaintiffs improperly used a circular reasoning that just because benzene was found in product in the United States, there must necessarily have been a CGMP violation by Walgreens.  This type of “res ipsa loquitor” theory is not sufficient.

Primary jurisdiction and injunctive relief

Finally, the court addressed primary jurisdiction and injunctive relief.  It rejected the argument that the court should stay or dismiss the action based on the FDA’s primary jurisdiction, and it held that the argument that equitable relief is not available where there is an adequate remedy of law was premature given the failure to state a claim.

The court granted the motions to dismiss but with leave to amend in the entirety.  Right result, some wrong reasoning, which we hope the magistrate or the district judge will fix on the next round.

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