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States cannot take over enforcement of federal requirements when Congress has entrusted that enforcement exclusively to the FDA.  In Iowans for Alternatives to Smoking & Tobacco, Inc. v. Iowa Department of Revenue, No. 4:24-cv-00448, 2025 U.S. Dist. LEXIS 85732 (S.D. Iowa May 2, 2025), the state of Iowa enacted a law imposing penalties on manufacturers and sellers of vaping products that have not received marketing authorization from the FDA.  In addition, the law makes the shipping or receiving of non-compliant vaping products a violation of Iowa’s consumer fraud law and requires the appointment of an agent for service of process, thus serving up violators to the plaintiffs’ bar on a silver platter.  The law also benefited two large tobacco companies because it would have allowed the sale of their vaping products while simultaneously hindering unauthorized competition.  What again do they say about politics making strange bedfellows?

Here’s the rub.  Most vaping products on the market today are not authorized for marketing by the FDA, but the FDA allows them to remain on the market anyway.  That is because the FDA has exercised its enforcement discretion to recognize that immediately forcing most vaping products off the market could result in vape users reverting to more harmful products—i.e., traditional cigarettes.  That would be bad. 

It also means that if Iowa were allowed to enforce its new law, it would be penalizing the sale of unauthorized vaping products when federal regulators have allowed the sale of those same products.  That would be preemption—implied obstacle preemption to be precise.  That is the form of implied conflict preemption that occurs when state law “stands as an obstacle to the accomplishment and execution of the full purposes of Congress.”  Iowans for Alternatives to Smoking, at *11-*12.

To stop the Iowa law, a group of manufacturers, sellers, and users of unauthorized vaping products sued, claiming that the Iowa law violated the Supremacy Clause (implied preemption) and equal protection.  The district court ruled in their favor. 

At the outset, you might be wondering how this group had standing to sue.  If they were selling and using products that were unauthorized by federal law—i.e., they had no legal right to sell and use the products in the first place—what legal right did they possess that allowed adjudication in a court of law?  The district court ruled that this is the wrong question.  “The appropriate inquiry focuses not on whether the Plaintiffs’ activities fully comply with federal law, but on whether they have alleged a concrete injury that could be redressed by a favorable decision.”  Id. at *19.  Here, the FDA’s enforcement discretion created a “regulatory environment” under which market participants developed legitimate business interests that Iowa’s law placed at risk.  That is a “judicially cognizable interest” sufficient to confer standing.

On the merits, Congress placed the regulation of vaping products under the Food, Drug, and Cosmetic Act, and Section 337(a) of the FDCA “states unambiguously that all proceedings to enforce or restrain violations of the FDCA ‘shall be by and in the name of the United States.’”  Id. at *24-*25.  The Supreme Court’s Buckman opinion, moreover, recognizes Section 337(a) as clear evidence that Congress intended the federal government to be the exclusive enforcer of the FDCA.  Id. at *25. 

That is not to say that states lack any enforcement authority over vaping products.  The Tobacco Control Act reserves to the states the power to regulate the sale and possession of tobacco products, and some jurisdictions have, for example, permissibly banned all vaping products or all flavored products.  The Iowa law, however, goes beyond establishing general requirements for tobacco product sales.  “Rather, it creates a registration regime that explicitly incorporates federal premarket review standards as the determinative factor for market access.”  Id. at *33.  In other words, Iowa was asserting enforcement authority that belonged exclusively to the FDA: 

The statutory scheme effectively allows Iowa to bring enforcement actions in its own name against manufacturers and retailers based on compliance with the [Tobacco Control Act’s premarket tobacco product application] process—a federal requirement that Congress entrusted exclusively to FDA enforcement. . . .  The law’s operative effect is to create a state-level enforcement regime for federal premarket authorization requirements, with Iowa substituting its enforcement discretion for that of the FDA.

Id. at *33-*34.  The Iowa law therefore was “parasitic on the FDCA.”  And, while the Tobacco Control Act preserved significant state authority over tobacco regulation, Buckman reminds us that “savings clauses do not affect the ordinary working of conflict preemption principles.”  Id. at *35.  Implied preemption is, after all, grounded in the Supremacy Clause of the U.S. Constitution, not a federal statute. 

The Iowa law had to give way.  States cannot enforce the FDCA, and a scheme that conditions sales based on FDA authorization status “impermissibly intrudes on upon federal authority and contravenes congressional intent to centralize FDCA enforcement in the federal government.”  Id. at *38.  The district court thus preliminarily enjoined the implementation of the Iowa law. 

The court rejected the plaintiffs’ equal protection arguments, since the government presented rational bases for the various distinctions drawn by the statute.  But an equal protection challenge under rational basis review was always a longshot.  The story here is preemption.  Iowa and the vaping statute’s other supporters may be unhappy with the FDA’s enforcement discretion, but that is how Congress wrote it.  Thanks to Jim Fraser at Thompson Hine for bringing this order to our attention and getting this great result. 

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We weren’t expecting to find anything bloggable when we reviewed the Supreme Court’s recent unanimous decision in Smith & Wesson Brands, Inc. v. Estados Unidos Mexicanos, ___ U.S. ___, 2025 WL 1583281 (U.S. June 5, 2025).  But we were struck by the familiarity of the allegations of illegal marketing that the Court in S&W held could not be passed off as “aiding and abetting.”  These were the same tired and repetitive allegations of purported “illegal marketing” by independent actors in the distribution chain that we have seen in so many drug/device cases – sometimes masquerading as “public nuisance.”

We think our clients can use S&W against such allegations, at least by analogy.

Continue Reading Unanimous Supreme Court Slaps Down Familiar Sounding Marketing Allegations In Landmark Gun Decision
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On the internet, “because reasons” is the default when you don’t have the time or energy to explain why something is correct, but you are sticking with your viewpoint nonetheless.

It is the opposite of what our profession expects from lawyers and the courts:  We all are supposed to explain, with crystalline clarity, why our conclusion is exactly right.  If precedent sets out a multi-factor test for analyzing an issue, we all are supposed to march dutifully through those factors, applying law to the circumstances of our case with sound reasoning and thorough arguments, and only then arriving at our desired destination/outcome.

But haven’t you noticed that sometimes a particular hoary multi-factor test analyzed in every motion or opinion on a topic is not necessarily ideal?  The factors draw too fine a distinction, such that the discussion of one factor hardly varies from the others.  Some factors don’t matter at all, and so are hardly addressed and never outcome-determinative.  Maybe some of the factors fail to get to the root of the real, motivating concern for the test.  Or maybe there are too many factors, more than really needed to explain why a given outcome makes sense.  (Yes, we are looking at you, class certification.)

Anyway, a good multi-factor test ensures the parties and the courts don’t brush over important concerns, and articulate sound rationales at each step.  A bad multi-factor test is long, muddled, and results in a string of arguments that sound suspiciously like “because reasons”.

We thought about the problems that can crop up with multi-factor tests when writing our recent post about the Lone Pine factorial analysis in Conklin v. Corteva, 2025 U.S. Dist. LEXIS 92028, 2025 WL 1402696 (E.D.N.C. May 14, 2025).  It was a good outcome, and the analysis was commendable—but the points made by the court did not necessarily tie up with the Lone Pine factor headings they came under.

That got us thinking:  Are the Lone Pine factors most often listed the right ones?  Is there a better test?  

In fact, we probably should get away from talking about “Lone Pine orders” altogether.  The name is triggering for some, and the judicial remedies needed to cure frivolous litigation have long outstripped the one solution crafted by that one New Jersey state court judge in that one case, Lore v. Lone Pine Corp., 1986 NJ Super. LEXIS 1626, 1986 WL 637507 (N.J. Super. Ct. Nov. 18, 1986).  How about “Early Vetting Orders”? 

Let’s start with the purpose of this type of case management/early vetting order:

A Lone Pine order is designed to assist in the management of complex issues and potential burdens on defendants and the court in mass tort litigation, essentially requiring plaintiffs to produce a measure of evidence to support their claims at the outset.

In re Digitek Prod. Liab. Litig., 264 F.R.D. 249, 255 (S.D. W. Va. 2010). 

But that is not the only role of such case management orders.  For one, there are burdens on defendants in every litigation, although they most certainly weigh heaviest in mass torts.  But even in single plaintiff cases those burdens can be disproportionate where there is a threshold factual issue or two and reason to doubt that the plaintiff has the evidentiary support for them that Fed. R. Civ. Proc. 11 requires.  For another, in MDLs and other mass torts, sometimes there are burdens that could be addressed even at the pleading stage, when dodgy plaintiffs’ lawyers hide under “master complaints” without ever needing to specify that the relevant product was used or a plausible injury occurred.

As to commonly listed Lone Pine factors, these are:

(1) the posture of the action,

(2) the peculiar case management needs presented,

(3) external agency decisions impacting the merits of the case,

(4) the availability and use of other procedures explicitly sanctioned by federal rule or statute, and

(5) the type of injury alleged by plaintiffs and its cause.

See In re Digitek Prod. Liab. Litig., 264 F.R.D. 249, 256 (S.D. W. Va. 2010).  Not all of these clearly and directly speak to the stated goals for such case management orders, and the purpose of some of these factors is facially opaque.

If we were writing on a blank slate—which we can, because this is our (collective) blog—how would we frame the purpose of case management orders to weed out frivolous litigation, and what factors would make up an improved test?

Better yet, we understand the Federal Judicial Center is working on a Fifth Edition to the Manual for Complex Litigation last updated in 2004.  Wouldn’t it be great to have some guidance in there on this topic?  How about something like this:

Particularly in product liability MDLs, but in any civil action where threshold fact issues determine the viability of a claim or defense, the court should consider entering a pretrial case management order implementing procedures that will confirm the plausibility of the allegations and ensure the discovery burdens on the respective parties remain balanced throughout the litigation. 

For example, in a product liability MDL, consideration should be give to entering a pretrial order requiring plaintiffs to establish the factual basis for their claim, such as order requiring plaintiffs to produce evidence they took or used the product in question before any other discovery is propounded, or an order requiring plaintiffs to submit a limited expert report supporting the allegation that the product caused the plaintiff’s alleged injury well before other expert discovery takes place. 

Factors to be considered in entering this type of pretrial order include, but are not limited to:

  1. The requirements of Rule 11 when signing a complaint;The burdens imposed on the parties and the court if a complaint turns out to lack evidentiary support for basic and foundational factual contentions;
  2. The type of pretrial order that would be most appropriate given the posture of the action; 
  3. The relative burden on the plaintiff(s) of such an order, and the burden to the court and the parties of allowing an unvetted case to proceed that later is revealed to lack basic and foundational evidentiary support; and
  4. The likelihood that unsubstantiated claims have been filed, considering the prevalence of attorney advertising for claims of the type at issue, the involvement of litigation funders, scientific debate about the evidence of causation, and similar issues.

While we are dreaming, what about a change to the Federal Rules of Civil Procedure?  One issue commonly raised by plaintiffs in opposing requests for case management orders designed to weed out the mass tort wheat from the chaff is the absence of explicit authority in the Federal Rules of Civil Procedure for something called a Lone Pine order.  We are with the courts that say the broadly worded Rule 16 already provides federal judges with enough flexible authority to suffice.  But express language in the rules would convert such orders from relative rarities to commonplace occurrences.

For example, Rule 11(b) currently states that by signing a complaint, plaintiffs’ lawyers are “certif[ying] that to the best of [their] knowledge, information, and belief, formed after an inquiry reasonable under the circumstances” that “the factual contentions have evidentiary support or, if specifically so identified, will likely have evidentiary support after a reasonable opportunity for further investigation or discovery.” 

Yet Rule 11’s enforcement mechanism (found in Rule 11(c)) is clunky and little used because it involves imposing sanctions—something courts are loathe to do, even when appropriate.  So how about a new Rule 11(e) that authorizes orders designed to make a party “put up or shut up” with regard to the Rule 11(b) obligations?  It could provide something to the effect of:

The court may, and where doubt has been raised should, issue a case management order for the purpose of confirming a party’s compliance with Rule 11(b).  This provision operates independently of Rule 11(c) and is unrelated to the issue of whether sanctions should be imposed.

Add a few Advisory Committee notes explaining that this new subsection is about proactively weeding out unsubstantiated claims early on—unrelated to whether a given lawyer should be sanctioned for their deficient pleadings—and that its use it to be encouraged as a case management tool, and we would be off to the races.

Or maybe add Lone Pine considerations to the list of issues to be addressed at a Pretrial Conference pursuant to Rule 16(c)(2), such that an amended version could read, in relevant part (with our suggested addition underlined):

At any pretrial conference, the court may consider and take appropriate action on the following matters:

(A) formulating and simplifying the issues, and eliminating frivolous claims or defenses, including ordering parties to adduce prima facie evidence of essential facts;

* * *

(C) obtaining admissions and stipulations about facts and documents to avoid unnecessary proof, and ruling in advance on the admissibility of evidence;

* * *

(F) controlling and scheduling discovery, including orders affecting disclosures and discovery under Rule 26 and Rules 29 through 37;

* * *

(L) adopting special procedures for managing potentially difficult or protracted actions that may involve complex issues, multiple parties, difficult legal questions, or unusual proof problems;

* * *; and

(P) facilitating in other ways the just, speedy, and inexpensive disposition of the action.

For this hypothetical change to Rule 16, Advisory Committee notes also could explain that Rule 16(c)(2)(A)’s new language is well suited to situations where, for example, a plaintiff’s claim turns on whether he or she in fact took a given pharmaceutical product, and was diagnosed with a particular medical condition.  Requiring that plaintiff to come forward with some preliminary proof—a prescription or pharmacy record for the drug in question, and one measly medical record reflecting the diagnosis—should not be a big ask, and it might well clear out unmeritorious cases well before the parties and court slog through expensive discovery and summary judgment.

In federal courts, MDLs are where most of the bad cases hide out, so the forthcoming MDL Rule, Rule 16.1, is another opportunity for courts to consider proactive case vetting orders. 

Rule 16.1(a) already requires the assigned MDL judge to hold  “an initial management conference to develop an initial plan for orderly pretrial activity in the MDL proceedings” and Rule 16.1(b)(3) requires the parties’ report in preparation for that initial conference to cover topics that overlap with Lone Pine concerns, including “how and when the parties will exchange information about the factual bases for their claims and defenses” [Rule 16.1(b)(3)(B)] and “the principal factual and legal issues likely to be presented” [Rule 16.1(b)(3)(G)]. 

Rule 16.1 then contemplates entry of “an initial management order” addressing such concerns that will “control[ ] the court of the proceedings unless the court modifies it.”  Rule 16.1(c).  Given Rule 16.1’s terms, there should be no doubt that MDL courts can and should proactively consider what early vetting requirements are needed and implement them from the outset in the initial MDL management order.

Drug and Device Law Blog hive mind, what are your thoughts?  What other factors should a Lone Pine test involve?  Is “Early Vetting Order” a better name?  How else can the defense bar push courts to more regularly screen cases?

Frankly, we would take any approach that leads to the issuance of early, frequent, and even minimal Lone Pine-type orders.  The just, speedy, and inexpensive resolution of civil litigation certainly would be improved as a result.  Because reasons.

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Today we offer a peek at A. Twerski, “A Quarter Century after the Products Liability Restatement: Reflections,” 90 Brooklyn L. Rev. 1027 (Summer 2025).  The “Restatement” under discussion is the Restatement (Third), Products Liability, and the “A. Twerski” is, of course, Aaron Twerski, the sole surviving reporter for that Restatement. Professor Twerski has written this retrospective law review article, and it is well worth our attention. 

We dwell in a jurisdiction (Pennsylvania) where the Third Restatement has not quite gotten the traction that was expected by most and hoped for by some. But by Twerski’s account, the Third Restatement has had significant influence on the law. Twerski offers a nice distillation of what Restatements do:

“Restatements are a conglomeration of past, present, and future. Some issues have been well decided and are not controversial. A restatement may clarify them and shake out some cobwebs that have crept into the case law. For these noncontroversial rules, a restatement may set forth elements of a doctrine in a manner to make it easier for a court to apply. Other issues are the topic of some current controversy in the courts. An objective observer may well conclude that the law is moving in one direction and, for justifiable reasons, take sides on the issue. Still, other issues are the subject of great chaos and confusion in the courts.  A restatement may help in crystallizing the issues and in suggesting a new rule.”

Indeed.  Sometimes we defense hacks like the suggested new rules. Sometimes we do not. 

The article is short and focuses on areas of controversy and areas that might “benefit from additional clarity.”  Some interest us not at all, such as Section 16 on apportionment of damages in crashworthiness litigation. Some are interesting almost to the point of inspiring dread. For example, Section 3 permits plaintiffs to “draw a res ipsa-like inference of defect without proving a specific defect.”  Some might crop up in situations where our clients could be on either side of the issue, such as Section 12 successor liability and Section 13 post-sale failure to warn. Section 5 brings some clarity with respect to imposing liability on component part sellers where they have substantially participated in the integration of the component into other design of the product. 

The article addresses the significant controversy swirling around Section 2(B) Design Defect and the extent to which plaintiffs must show a reasonable alternative design (RAD). Most states require a RAD. (Pennsylvania does for negligence, but not for strict liability.) Even those allowing recovery based on disappointed consumer expectations have read that test narrowly. According to Twerski (and it does not get any more authoritative than that), “The Restatement’s position that one cannot warn oneself out of a design defect claim is now the rule in almost all jurisdictions. A manufacturer must maximize its product with a RAD, and only when risks cannot be ‘designed out’ of the product are warnings called for.”

For we Drug and Device Law drudges, Twerski’s discussion of §6, regarding drugs, is particularly interesting and relevant to what we do.  That “we” refers both to honorable defense hacks and predatory plaintiff lawyers.  

Here are a dozen key points regarding Section 6:

1. The learned intermediary rule (yes, Professor Twerski calls it a “rule,” as we do – it is not a “doctrine” or “defense”) is close to unanimous. We and the article cast a grim side-eye across the river at New Jersey. Twerski also notes that a “few jurisdictions will impose liability for not adequately warning the consumer directly when the Food and Drug Administration (FDA) requires that a warning be given in a pamphlet when the drug is dispensed.”

2. Comment k was a mess.  At least eight different interpretations were propounded. The state of the law “was simply incomprehensible.”  Thus, the Third Restatement did not try to restate it. 

3. Allegations of reasonable alternative design are “unwise and irrational” in light of the extensive FDA approval process.  Here, Twerski shows a keen understanding of the challenges and expense of drug development. “Scholars agree that basing a cause of action on a RAD is beyond the competence of courts.”  (Think about what this means for the execrable Gilead duty-to-innovate theory.)

4. “For an expert to state that the alternative drug that he or she proposes would attain FDA approval is sheer sophistry. Drugs are simply different.”

5. An alternative safer drug already approved could be meritorious, but “few if any drugs will meet that standard,” since competing drugs treating the same condition have different risk/benefit profiles.  

6. Pure risk/benefit balancing is beyond the competence of the courts and should be left to the FDA.  

7. Design defect claims involving drugs are mostly attempts to salvage cases barred by the learned intermediary rule.  

8. The Restatement exception for drugs too dangerous for “any class” of patients is narrow and should be.  (Should this be an exception at all, given FDA approval?)

9. “Defective design is, for the most part, not a workable theory for drugs.”  

10. A post-sale design defect based on a claim that a drug should have been redesigned is preempted.(But Twerski agrees with the dissent’s reading of New Hampshire law in the SCOTUS Bartlett case. Ugh.)

11. Pre-sale design defect claims are entirely speculative, given FDA approval requirements.  

12. Levine was a failure to warn case, and it does not apply to design defect claims.

The Twerski article is short and clear.  Even if you find yourself disagreeing with parts of it, you will have to consider the possibility that, given who the author is, you might be wrong.  In any event, you will be better informed for having read the article. 

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This is not the first time we have posted about Gallego v. Tandem Diabetes Care, Inc.  About six weeks ago we told you all about the excellent preemption decision that dismissed the entire case with prejudice except for a piece of the negligent design claim.  On that, plaintiff was given thirty days to file an amended complaint that sufficiently alleged both an FDA requirement and facts supporting a violation of that requirement.  On day twenty-eight, plaintiff moved for “pre-answer discovery” and an extension of the filing deadline.  Gallego, 2025 U.S. Dist. LEXIS 103545, *2 (E.D.N.Y. May 31, 2025). What plaintiff was actually asking for was “pre-complaint” discovery.  What the court said was: No.

Rather than file the more specific amended complaint the court ordered, plaintiff asked the court to compel defendant to produce no less than thirteen categories of documents ranging from broad policies and procedures to complaint reports to testing documents to the complete design files. Id. at * 4-5.  Perhaps putting the cart before the horse is too narrow an analogy.  This plaintiff was looking to fling open the corral doors and let all the horses run wild.  The scope of this “pre-complaint” discovery was virtually every type of document you would except a plaintiff to request after they pass TwIqbal—certainly not before. 

But scope barely factored into the court’s decision.  That is because it is a solidly established legal principle that “a plaintiff must allege facts supporting a plausible claim before being entitled to discovery.” Id. at *8 (citing numerous cases for this proposition).  Plaintiff’s complaint was dismissed for failure to state a plausible claim; therefore, he is not entitled to discovery unless and until that failure is remedied. While plaintiff claimed he could not “fully articulate” a claim without access to defendant’s documents, he cited no legal authority that circumvents the plausible pleading before discovery rule. 

While plaintiff tried to base his motion on “inconsistencies” in publicly available information, he neither specified the inconsistencies nor offered any explanation for why he believed the requested materials would resolve them.  Id. at *10-11.  He also argued there was information omitted from public reports, but again offered the court no specifics as to what was omitted or how it would aid in re-pleading his design defect claim.  Id. at *11.   In other words, plaintiff’s motion for “pre-complaint” discovery was just as vague as his original complaint. 

And yes, even if plaintiff had mustered a colorable argument for why discovery should be permitted, the proposed broad document requests were hardly tailored to be proportional to the needs of the case.  Id.  Indeed, it is difficult to understand how a court could apply the Federal Rules relevance and proportionality standards without a pending claim to know what the discovery is relevant and proportional to.

Plaintiff’s discovery requests were denied and he was given two weeks to file the amended complaint.  That two weeks is up soon. So, stay tuned to see if we have Gallego Part III.

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We have blogged several times before about the litigation misadventures of MSP Recovery, Inc., known for bringing Medicare recovery actions of questionable merit based on assignments of questionable validity that they obtain from various Medicare Advantage Plans looking for free money.  Occasionally, MSP has branched also filed RICO claims of an equally dubious nature.

In Series 17-03-615 v. Teva Pharmaceuticals USA, Inc., 2025 WL 1257677 (D. Kan. April 30, 2025), this would-be Medicare troll got trolled again, in yet another purported RICO class action.  Five defendants filed five motions to dismiss – and they were all granted.  Id. at *1.  On most issues, the five motions raised similar grounds:  lack of standing, lack of personal jurisdiction, and failure to state a claim.  Id. at *12. That led to the plaintiffs’ monumental procedural mistake.  Rather than bother to file separate responses to the five defendants’ motions, plaintiffs filed responsive papers that merely incorporated their responses to other defendants’ arguments by reference.  “[P]laintiffs filed responses to each of the five motions to dismiss” but “aggregated their responses to similar arguments which multiple defendants raised.”  Id.

Continue Reading Would-Be Litigation Troll Trolled Again
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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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