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We reported two years ago on a Third Circuit opinion holding that the federal government did not have the authority to require drug manufacturers to deliver 340B-discounted drugs to an unlimited number of pharmacies.  The D.C. Circuit came to the same conclusion a year later.  See Sanofi Aventis U.S. LLC v. HHS, 58 F.4th 696 (3d Cir. 2023); Novartis Pharm. Corp. v. Johnson, 102 F.4th 452 (D.C. Cir. 2024).  These opinions are important because the sale of prescription drugs at steep 340B discounts has exploded over the last 15 years, making it significant that the 340B statute itself allows manufacturers to set limits on the delivery of these discounted products. 

The federal government thus has backed down, but that is by no means the end of the story.  About twenty states have stepped in to pass laws prohibiting manufacturers from limiting the number so-called “contract pharmacies” that can receive delivery of drugs supplied at 340B-discounted prices.  In other words, states are passing laws to accomplish what the federal government cannot.  Can states do that? 

We don’t think so, but the preliminary results have been mixed.  You can read a more-complete description of the 340B program in our earlier post, but in a nutshell, if drug manufacturers want to participate in Medicare and Medicaid, they have to offer their drugs at a discount to certain healthcare providers—called “covered entities”—which typically care for low-income and rural populations.  The required discounts are steep, but they are not always passed on to patients.  Instead, covered entities can claim reimbursement at full price, for example from insurance carriers, allowing them an opportunity to turn a greater profit. 

One problem (among others) is the tremendous expansion of the use of contract pharmacies.  When Congress first created the 340B program in 1992, few covered entities had in-house pharmacies, so HHS issued a guidance allowing each covered entity to use one external “contract pharmacy” where the covered entity’s patients could fill their prescriptions. 

But then, in a guidance issued concurrently with the passage of the Affordable Care Act in 2010, HHS said that covered entities could use an unlimited number of contract pharmacies, which caused the use of contract pharmacies to increase twentyfold.  This is a problem and increases the risk of abuse through duplicate discounts and drug diversion.  Several drug manufacturers therefore imposed their own pharmacy limits, which federal law allows them to do.

The issue now is whether states can prohibit manufacturers from imposing these limits, and the latest word that we know of is an order from about a month ago.  In Novartis Pharmaceuticals Corp. v. Frey, No. 1:25-cv-00407, 2025 U.S. Dist. LEXIS 198943 (D. Me. Sept. 23, 2025), the district court denied a preliminary injunction sought by drug manufacturers against Maine’s new law prohibiting them from “interfering” with delivery of 340B drugs or requiring the submission of claims data.  Id. at *15-*17.  Provisions like these are common in the various states’ laws, and you might call them a double whammy: Drug manufacturers are allowed neither to limit deliveries to contract pharmacies nor request information establishing eligibility under the 340B program in the first place. 

In denying the preliminary injunction, the district court was not writing on a clean slate.  In PhRMA v. McClain, 95 F.4th 1136 (8th Cir. 2024), the Eight Circuit ruled that federal law did not preempt Arkansas’s contract pharmacy law; and the Fifth Circuit more recently rejected federal preemption of Mississippi’s contract pharmacy law in AbbVie v. Fitch, No. 24-60375, 2025 U.S. App. LEXIS 23952 (5th Cir. Sept. 12, 2025) (unpublished). 

A district court in West Virginia went the other way.  In PhRMA v. Morrisey, 760 F. Supp. 439 (S.D. W. Va. 2024), the district court granted a preliminary injunction over West Virginia’s contract pharmacy law on the basis of implied preemption.  First, the West Virginia law, like other states’ laws, prohibited manufacturers from requesting claims data supporting eligibility for 340B discounts.  The 340B program, however, includes a dispute resolution system that a manufacturer can use only after first conducting an audit.  By disabling a manufacturer’s ability to gather information (i.e., conduct an audit), the West Virginia law stood as an obstacle to the federal process.  Id. at 450-53.  Second, the West Virginia law allowed enforcement by state authorities and under general unfair trade practices laws.  That conflicted with federal law granting enforcement power to the federal government, including exclusive control over price.  The state argued that West Virginia’s law was about delivery of drugs, not price.  But the district court correctly found delivery and price to be inseparable.  Under any circumstances, the pharmacies were receiving the products.  The only issue was what price—340B or otherwise—the manufacturer could charge.  Id. at 453-60. 

Back then to the recent order in Novartis v. Frey, where the district court rejected preemption and addressed a number of additional constitutional issues.  Invoking the “presumption of preemption,” the district court in Maine rejected field preemption because the 340B statute was silent on where and how drugs should be delivered.  The statute requires manufacturers to “offer” drugs to covered entities at or below the cap prices, but beyond that, the federal statute did not preclude state involvement on such issues as where the purchased drugs would be delivered.  The court also rejected conflict preemption because the use of multiple contract pharmacies (and the resulting dramatic increase in sales under 340B discounts) was not inconsistent with the objectives of the 340B program.  The court also found that claims data was not necessary to audit covered entities and that the proof necessary to obtain an audit was not “onerous.” 

The flaw in this conclusion is that the district court is assuming that the contract pharmacies are acting as mere agents of the covered entities, who are the real purchasers of the products.  That is a myth.  In reality, contract pharmacies fill prescriptions for covered entity patients from their general stock, and then place orders for drugs at 340B-discounted prices based on a retrospective review of dispensing data.  The newly purchased drugs are then co-mingled back into the general inventory.  This “replenishment model” is the prevailing system, and it reinforces that the issue here is price.  Like the district court in PhRMA v. Morrisey, we don’t see how states should be allowed to interfere. 

The manufacturers in Novartis v. Frey raised a number of additional constitutional issues, all of which the district court rejected.  First, Maine’s contract pharmacy law did not run afoul of the Dormant Commerce Clause because it did not discriminate between substantially similar entities in the same market.  The statute discriminated against out-of-state prescription drug manufacturers for the benefit of in-state pharmacies, but those are different businesses.  Second, the statute did not enact a taking forbidden by the Fifth Amendment because participation in the 340B program is voluntary.  Third, the statute was not impermissibly vague under due process because, although the word “interfere” could be vague, it provided sufficiently reasonable guidance within context and when aimed at professional, sophisticated parties.  In addition, a method existed for drug manufacturers to obtain government clarification before facing penalties, and courts are less likely to find a state statute unconstitutionally vague in a pre-enforcement context and where only civil penalties were at stake, not criminal.  Finally, facial pre-enforcement vagueness challenges are generally disfavored, except in the First Amendment context. 

We could say much more about these issues, but one thing is certain—this litigation will continue.  States continue to enact contract pharmacy laws, and multiple orders are on appeal.  Moreover, there is a lot at stake, as spending under the 340B program has increased more than tenfold since 2010, reaching an estimated $66 billion in 2024, or more by some estimates.  That is why we keep writing about it. 

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Is it really an opposition to a motion to compel if the brief does not bemoan the plaintiff’s discovery “fishing expedition”? 

We don’t think so.  A license to practice law seems to mandate that the holder must use the fishing expedition metaphor whenever discovery is the topic.  As a result, we were a little amused by In re Glucagon-Like Peptide-1 Receptor Agonists GLP-1 Ras Prods. Liab. Litig., 24-md-3094, 2025 U.S. Dist. LEXIS 208548 (ED Pa. Oct. 23, 2025) (“In re GLP-1”), which described the MDL discovery at issue as a “snipe hunt.”

In addition to staking out its bold “fishing expedition=nah/snipe hunt=yeah” stand, In re GLP-1 confirms that even in an MDL, discovery requests can go too far, require too much, and impose more burdens than they are worth.  The juice ain’t worth the squeeze, if you will permit us yet another metaphor.

In In re GLP-1, the United States District Court for the Eastern District of Pennsylvania addressed whether MDL plaintiffs were entitled to obtain animal histopathology slides from 22 preclinical studies conducted by two pharmaceutical manufacturers, implicating thousands of slides per defendant.  Adopting the recommendation of the MDL special discovery master, the court denied the motion to compel, finding the slides’ minimal relevance and the disproportionate burdens that production would entail outweighed any potential benefit.

Or, in the language of Federal Rule of Civil Procedure 26(b)(1), the discovery was not sufficiently relevant and proportional to the needs of the case.

The court was generous in concluding that the animal histopathology slides weren’t entirely irrelevant, although that was only so because they potentially might bear on what defendants knew and reported to the FDA regarding preclinical findings, but this relevance was marginal at best.  The defendants already had produced extensive discovery, including the study reports they submitted to the FDA based on the slides themselves.  Not to mention literally millions of pages of safety data spanning over two decades, plus their various study protocols, appendices, backup, and regulatory communications.  

The court emphasized that the plaintiffs’ speculation—that the slides theoretically might reveal information withheld from the FDA—was unfounded.  There was nothing suggesting study information was withheld from the agency or misrepresented to it.  Plaintiffs failed to identify any specific studies or prior instances suggesting that the study reports were inaccurate or incomplete.  In other words, plaintiffs were proposing to drag themselves, the defendants, and the court all off on a long, expensive, complicated trip to hunt hypothetical and mythical discovery snipe—and to foist the cost of that fool’s journey off on the defendants.  (We would also add that fraud-on-the-FDA claims are preempted under Buckman.)

Fortunately, the court was not having any of it.

The court first recognized that the burden of the production of the underlying animal histopathology slides would be substantial.  Locating, reviewing, and producing thousands of physical slides would require significant resources, including specialized handling, imaging, and protocol negotiations about preserving specimen integrity. The whole process would be time- and resource-intensive, particularly given the volume of slides requested. 

Next, the court recognized that this was not first-tier evidence.  (Frankly, it wasn’t even second- or third- or fourth-tier evidence.)  Had these slides really been essential evidence, plaintiffs would have sought them earlier in discovery, they would have been able to credibly articulate the evidentiary value of the slides, and they would have diligently pursued them throughout.  Instead, plaintiffs’ demand for the slides came up late in discovery, was intermittently discussed by the parties, and then resulted in the motion to compel only after plaintiffs left the issue languishing for several months. 

Weighing the minimal probative value of the animal histopathology slides against the significant burden and expense of production, the court concluded that the request was not proportional to the needs of “the case”—even though that “case” was an entire MDL.  

Proportionality in discovery matters, even in complex MDL proceedings where voluminous discovery is the norm.  Although the scope of discovery allowed under Rule 26 is broad, it is not limitless. 

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It feels like 20 years ago when we were doing almost monthly fen-phen diet drug trials in the Philadelphia Court of Common Pleas. The old timey-air-conditioning units in City Hall, along with subways rumbling underfoot, occasionally drowned out the testimony of plaintiff experts taking both scientific studies and internal company documents out of context. That is to say, bad infrastructure was more reliable than Philly CCP rulings in keeping junk science away from the jurors’ ears.

These were cases where the plaintiffs opted out from a huge, matrix settlement.  By and large, in those cases plaintiffs claimed that the diet drugs caused heart valve damage, resulting in shortness of breath and the risk of open-heart valve replacement surgery. City Hall courtrooms rung out with the clickety-clack of cowboy-booted Texas plaintiff lawyers strutting around lecterns as they represented women (mostly, it seemed, from Utah) who bemoaned their reduced abilities to snowmobile and hunt elk. You could watch in real time vast indifference pass across the faces of Philly jurors. To be sure, in some of those trials the juries banged the defendant with large dollar verdicts, but more often there were either defense verdicts or, in some ways more satisfying from the perspectives of appellate prospects and sheer comedy, whimpering verdicts awarding plaintiffs under ten thousand dollars.  Our guess was that the jury was calculating expenditures for dental antibiotics for the rest of the plaintiffs’ lives.  After those sorts of minimal verdicts, our chief legal strategist would gleefully calculate how the plaintiff expert hotel bills alone dwarfed such “awards.”  

Good times (mostly). 

Anyway, we thought fen-phen litigation was firmly in our rear view mirror.  It’s over, right?

Wrong. 

Today’s case, Anderson v. Wyeth LLC, 2025 U.S. Dist. LEXIS 208332 (S.D.N.Y. Oct. 22, 2025), is a leftover fen-phen case.  In Anderson, unlike the heart valve cases, the plaintiff alleged that her use of diet drugs caused her to suffer primary pulmonary hypertension (PPH). PPH is a serious lung disease. We heard a plaintiff expert explain that if he had to make a list of ways to die, PPH would be on the bad end of the list.  He called it slow motion suffocation. Most of those cases settled. 

In Anderson, the plaintiff was alleging PPH almost 30 years after ingestion.  The plaintiff took the diet drugs back in 1996, when she was 18 years old.  Talk about latency! Fenfluramine (the “fen” half of fen-phen) was withdrawn from the market in 1997. The settlement was in 2000. Anderson is an outlier. 

The defendants moved to dismiss the complaint on multiple grounds, all of which, according to the court, had “merit.”  Although the plaintiffs (the wife and her husband, who claimed loss of consortium) were no longer living in Ohio, that was where the drug was allegedly prescribed and consumed, so that state’s law applied to this case. Let us take a moment to explain.  New York, as the forum state, supplied the choice of law rule. There was an actual conflict of law among the four possibilities: Ohio (where the allegedly tortious acts occurred), Idaho (where the plaintiffs currently resided), New York (where the corporate defendants were citizens), and New Jersey (where one corporate defendant had its principal place of business). Under New York choice of law, the location of the tort was key, so Ohio law governed. 

That choice of law mattered quite a bit in this case, because it meant that the complaint had to travel under the Ohio Product Liability Act (OPLA).  The OPLA furnishes the exclusive remedy. But the plaintiffs’ complaint did not even mention the statute. That omission does not mean that a federal court is free to transmogrify the causes of action into Ohio law; it means they must be dismissed. Both Ohio state and federal courts “have held that a complaint pleading a claim pursuant to the OPLA must in fact make reference to the applicable provision of the OPLA.”  If we were handing out practice pointers to plaintiff lawyers … but we’re not. 

Several claims in the complaint were precluded by the OPLA, which abolished all common-law causes of action, and therefore were dismissed by the court. All that being said, the court dismissed these claims without prejudice, permitting the plaintiff to take a shot at repleading in a statutorily appropriate fashion. 

The court also dismissed the punitive damages claim. The reason for such dismissal was that under “Ohio law, punitive damages are not recoverable in pharmaceutical product liability actions unless the FDA has made such an express finding of fraud by the defendant in connection with the marketing of the drugs at issue.” The complaint in Anderson pleaded no such finding. The court seems to come oh-so-close to dismissing punitive damages with prejudice, because it doubted that the FDA ever made the requisite fraud finding, but ended up “assum[ing] that, when they file their amended complaint, the Plaintiffs will either plead the requisite FDA finding or refrain from releasing their request for relief in the form of punitive damages.” 

This is not the first time this blog has addressed the OPLA’s abrogation of common law causes of action. See here, for example.

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We have seen a recent plague of purported class actions against various FDA-regulated OTC products that include allegations of contamination (usually benzene) that are purportedly supported by “independent laboratory” testing. Fortunately, we have also seen these cases dismissed one after another for a variety of reasons, including lack of standing. Today’s case is a great example of how vague allegations about testing are not enough to confer standing. Although Lurenz v. The Coca-Cola Company, 2025 WL 2773188 (S.D.N.Y Sep. 29, 2025) is about purported food contamination rather than drugs or devices, everything that this case holds is equally applicable to them.

Plaintiff filed the purported class action in December 2022 and filed two amended complaints over the next year and a half. The most recent amendment included allegations that plaintiff had the at issue products (juices) tested as follows: samples collected in July 2022 tested in February 2023; additional samples tested in February 2023; and additional testing in July 2024, including two products purchased by plaintiff. Id. at *1. The complaint claims those tests show the samples contained PFAs. But plaintiff’s allegations about that sample testing were not enough to demonstrate that the products tested were either the actual products plaintiff purchased or that the court should extrapolate the test results to the broader product line.

Overall plaintiff’s allegations about the “independent testing” were just too vague for the court to draw any reasonable conclusions that would support standing. As to the first two sample sets, plaintiff made no allegations that he actually purchased any of the products tested. As to the third set, plaintiff’s allegations were unclear as to whether the samples were from his own purchased products or whether he simply had purchased products from the product lines tested. The court was also concerned about the seven-month gap between collection of the samples and testing because the products could have been PFAs-free when collected and then contaminated “through no fault of Defendants.” Id. at *4. Moreover, plaintiffs did not allege anything about how many products were tested, how many tests were run, what percentage of the products/tests detected PFAs. “Absent specific facts concerning the various tests, the Court cannot conclude the presence of PFAs in the test Products was anything more than a “sheer possibility.” Id. at *5.

The court also took issue with the timing of the testing. If plaintiff was alleging that the July 2024 testing was of actual product he purchased around the time of the testing, that put those purchases nineteen months after he filed the lawsuit—nineteen months too late for plaintiff to claim to have been misled.  “A plaintiff that self-inflicts his alleged injury solely to manufacture standing for litigation does not have standing.” Id.

Not being able to show that the testing was done on any product plaintiff actually purchased, he also tried to argue that the court should draw a “plausible inference” that the contamination was so widespread that plaintiff must have purchased at least once mislabeled product. Here the court considered a variety of factors. First, was the testing “reasonably near in time” to plaintiff’s purchases? Between the 7-month gap between purchase and testing for the first sample set and the lack of any allegations of when the products for the other samples sets were purchased, plaintiff could not establish this factor. Second, did plaintiff “regularly purchase” the product? Id.  Plaintiff’s claim that he bought the products “numerous times” was not enough to establish “regular” purchases. Third, did the testing involve “more than a small number” of samples and what was the “geographic proximity of the testing to plaintiff’s purchases?” Id. Plaintiff failed to provide any details about where the tested product was purchased, when it was purchased, how much was purchased, or any methodology used to conduct the testing. Plaintiff did not provide SKU numbers of lot codes that would show where the tested products were purchased. Overall, the plaintiff failed to establish a “meaningful link” between the products tested and the products he actually purchased. Allegations “describing general and unspecific results of testing [are] insufficient to sustain Article III standing.” Id. at *6. 

Striking out on the testing, plaintiff also argued he had standing to pursue a “benefit of the bargain” theory of injury—that he received a product worth less than what he paid for it. But regardless of the “all-natural” claim on the label, “plaintiff paid for fruit juice and received fruit juice, which he consumed without suffering any harm,” (otherwise he would have brought a personal injury claim, not an economic injury claim). Id. at *7.  In other words, he did get the benefit of the bargain. He didn’t get a rock in a bottle or an IOU. The benefit of the bargain was a functional, drinkable juice, not a moral victory in the war on marketing buzzwords.

Finally, since this was plaintiff’s second amended complaint and he still failed to allege sufficient facts to confer standing, the case was dismissed with prejudice.

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Not long ago we discussed Somerlot v. Jung, ___ A.3d ___, 2025 WL 2157391 (Pa. Super. July 30, 2025), as providing a potential antidote to some Mallory-inspired forum shopping.  However, as we pointed out, Somerlot’s advantages were limited, because:  (1) they required the pro-active use of forum selection clauses in advance of any litigation, and (2) would only be available to defendants who had the sort of relationship (directly or through distributors or doctors) with a plaintiff that would provide the opportunity to require such a clause.  Thus, the Somerlot solution was not available to all, or even most, prescription medical product liability litigation.

However, over the last couple of months, Pennsylvania appellate decisions involving the more traditional concepts of forum non conveniens and venue have materially changed applicable law for the better, in terms of their availability as tools to combat post-Mallory forum shopping.  Since Pennsylvania remains the only large state to allow general jurisdiction by consent in prescription medical product liability litigation, Pennsylvania law remains by far the most important for dealing with post-Mallory forum shopping.

Continue Reading Recent Pennsylvania Appellate Decisions Can Combat Post-Mallory Forum Shopping
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If you’re an in-house counsel working in the pharmaceutical, biotech, medical device, or digital health space (and still looking to complete CLE hours before year-end) we invite you to join Reed Smith’s annual Virtual Life Sciences CLE Week, taking place November 3–7, 2025.

This week-long event will feature a series of live webinars on the most current legal and regulatory developments impacting the life sciences industry. Several of your favorite Reed Smith bloggers will be presenting throughout the week.

Topics this year will cover a range of timely and critical issues including artificial intelligence, fraud and abuse enforcement, drug pricing, vaccine liability, ethical considerations in litigation, women’s health, and more.

Check out the session lineup and register here.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Drug & Device Resources

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