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Back in the bad old days of the Bone Screw litigation, we had to fight our way through a thicket of scurrilous allegations about how our clients supposedly promoted off-label use through continuing medical education seminars that the Bone Screw plaintiffs claimed were used to reward surgeons who regularly used our clients’ products with excessive speaker fees.  Back then – in the mid 1990s – the plaintiffs’ preferred avenues for asserting such allegations were state-law based:  negligence per se, fraud on the FDA, and conspiracy.  By the time that the infamous Franklin False Claims Act (“FCA”) decisions came down (United States ex rel. Franklin v. Parke-Davis,147 F. Supp.2d 39 (D. Mass. 2001), and United States  ex rel. Franklin v. Parke-Davis, 2003 WL 22048255 (D. Mass. Aug. 22, 2003)), we had won Buckman (and a lot of other things), so Bone Screw-related promotion allegations were never the subject of FCA litigation.

But the Bone Screw promotional allegations were close enough to what has been subsequently alleged ad nauseum in FCA litigation that we’ve followed similar FCA litigation ever since.  Today’s case, United States v. Gilead Sciences, Inc., 2025 WL 2627686 (E.D. Pa. Sept. 11, 2025), does not involve off-label use, but does involve allegations of kickbacks – through speaker programs and donations to charitable organizations.  We’re happy to say that the entire action was dismissed – on both sets of facts.  We’re even happier to recommend the discussion in Gilead as providing useful guidance for how pharmaceutical companies can manage both types of programs in compliance with applicable law.

Continue Reading FCA Dismissal Illustrates Pharmaceutical Promotion Done Right
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We’ve blogged a lot recently about preemption and the dismissal of complaints alleging that certain over the counter products, including acne medications, sunscreens, antiperspirants, expectorants, and shampoos contain benzene.  Almost a year ago we blogged about the dismissal of an OTC case involving medicated shampoo that allowed plaintiff leave to amend. Today’s decision, Pineda v. Lake Consumer Products, Inc., 2025 WL 2698991 (E.D. Pa. Sept. 22, 2025), is a mixed bag that addresses plaintiff’s amended complaint. It’s about coal-tar shampoos, which are known to include benzene and are subject to an FDA monograph that recognizes the naturally occurring presence of benzene in coal tar. Yet, shockingly, plaintiff filed a class action claiming she would not have purchased the shampoos had she known they contained benzene.

Continue Reading OTC Preemption Letdown in the Eastern District of Pennsylvania
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This post is from the non-Dechert and non-RS side of the Blog.

Depending on the time, issue, and players, the supposed epithets of “judicial activism” or “activist judge” can be thrown in just about every juridical direction.  If we were to try to parse out the most common reason for the use of these terms, we might identify a judge or panel of judges establishing law that should have resulted from legislation.  There is also the variant where the judge or judges establish new law that really should come from another court, such as the highest court of the relevant state.  While we recognize that many decisions from courts could be said to “establish new law” whenever a non-rote issue is being decided, there is a difference between interpreting existing law in connection with deciding a live issue in a particular case and establishing new law.  Under the principle of stare decisis, controlling precedent is to be respected with logical applications of the precedent to novel sets of facts, which can lead to “extensions” or “corollaries” of existing law.  (Obviously, stare decisis does not prevent the Supreme Court or state supreme courts from reversing decades of established law, like Brown v. Board of Ed. undoing Plessy v. Ferguson or Dobbs undoing Roe.)  When a federal court sits in diversity and has to utilize Erie restraint in applying state law, these dynamics become more than mere semantics.

In a federal diversity case where the highest court of the state whose law is being applied has not ruled on the specific issue in the case, in which direction does restraint pull?  As lawyers defending companies that get sued, our first thought on this is that federal courts sitting in diversity should not establish new state law causes of actions.  We concede that they also should not establish new state law defenses to causes of action.  In many cases, however, the fight is about whether a broad or vaguely defined state law cause of action encompasses the relief plaintiff seeks for the defendant’s allegedly culpable conduct.  For instance, a state’s recognition of a cause of action for negligence does not cover conduct as to which the state imposes no duties.  Reporting to a federal agency, such as FDA, would be an example.  Also, if the state’s product liability law has recognized distinct theories for strict liability failure to warn, design defect, and manufacturing defect, then making up a hybrid theory to fit the plaintiff’s needs in the particular case would be an expansion.

In City of Huntington v. AmerisourceBergen Drug Corp., 609 F. Supp. 3d 408 (S.D. W. Va. 2022), the district court presented its Findings of Fact and Conclusions of Law after a long bench trial.  The trial court found that plaintiffs had failed to carry their burdens on a number of the elements of their public nuisance claims asserted against the three main U.S. prescription drug distributors related to the purported connection between their distribution of prescription opioids and the local impacts of abuse of prescription opioids and various illegal drugs of abuse.  This defense win in a marquee opioid litigation trial—the plaintiff jurisdictions were considered some of the strongest plaintiffs because of the volume of prescriptions dispensed in them compared to their populations and the extent of the local problem—garnered quite a bit of attention.  Predictably, it also garnered an appeal.  Last week, the Fourth Circuit reversed.  City of Huntington v. AmerisourceBergen Drug Corp., — F. 4th –, 2025 WL 3009526 (4th Cir. Oct. 28, 2025).  Our introduction was not subtle in signaling that we think one of these courts got it wrong in large part because of not following Erie.

We have made no secret of our view that public nuisance should not be extended to the sale or distribution of products, especially prescription medical products.  We have been saying this since long before the Restatement (Third) of Torts: Liability for Economic Harm § 8 cmt. g (A.L.I. 2020), stated that “the common law of public nuisance is an inapt vehicle for addressing” alleged harms related to products.  We also think the municipal cost recovery rule is a problem for the opioid litigation claims, as they are premised on shifting the increased costs of government functions to purported tortfeasors/lawbreakers.  Part of the issue with the proposed expansions of public nuisance is that the tort of nuisance—since its roots in thirteenth century England—has always been focused on the use or enjoyment of real property.  As private nuisance expanded to public nuisance, both through common law and statute, the connection to real property has become somewhat more opaque but is still present.  The remedy has always been abatement, an equitable remedy, not monetary damages for past injury.  Even the term “abatement” derives from the term for cutting down a tree, which definitely relates to property.  Before opioid litigation pushed the limits of public nuisance to try to encompass liability for marketing, selling, and distributing products, perhaps the most famous litigation seeking to impose broad liability for a purported public nuisance was the Rhode Island lead paint litigation.  While that had a much closer link to real property rights—the allegedly harmful paint was on the walls of residences where children lived and consumed paint chips—it still fell in the Rhode Island Supreme Court because there was an insufficient connection between the defendants’ sale of their products and the creation of a dangerous condition at a specific location that affected an indivisible public resource.  As the Rhode Island Supreme Court said there, “Expanding the definition of public right based on the allegations in the complaint would be antithetical to the common law and would lead to a widespread expansion of public nuisance law that never was intended[.]”  State v. Lead Indus. Ass’n, 951 A.2d 428, 453 (R.I. 2008).  By any measure, using public nuisance as a vehicle for governmental entities to obtain damages related to the marketing, distribution, or sale of a product would be an expansion of public nuisance, not a failure to restrict it.

This brings us back to the issue of Erie restraint.  The Huntington district court, at the start of its analysis of West Virginia law on public nuisance, wrote:

This court should “‘respond conservatively when asked to discern governing principles of state law’ and take care to avoid interpreting that law in a manner that ‘has not been approved’” by the West Virginia Supreme Court of Appeals.

609 F. Supp. 3d at 472.  This sentence cited Knibbs v. Momphard, 30 F.4th 200, 213 (4th Cir. 2002), and its own quotation of Rhodes v. E.I. du Pont de Nemours & Co., 636 F.3d 88, 96 (4th Cir. 2011).  The Fourth Circuit echoed the same exact Knibbs and Rhodes citations after the following sentence, but without any hint of the need for restraint or a conservative response:  “Because there is an absence of controlling state law, we are charged with predicting what the State Supreme Court would conclude based on that state’s existing law.”  2025 WL 3009526, *10.  The actual cited/quoted language from Knibbs and Rhodes (in order below without citation) supports the district court’s approach:

We “respond conservatively when asked to discern governing principles of state law” and take care to avoid interpreting that law in a manner that “has not been approved” by the Supreme Court of North Carolina.

            * * *

In the absence of such action by the highest state court in West Virginia, our role in the exercise of our diversity jurisdiction is limited. A federal court acting under its diversity jurisdiction should respond conservatively when asked to discern governing principles of state law. See Day Zimmermann, Inc. v. Challoner, 423 U.S. 3, 4, 96 S. Ct. 167, 46 L. Ed. 2d 3 (1975) (per curiam). Therefore, in a diversity case, a federal court should not interpret state law in a manner that may appear desirable to the federal court, but has not been approved by the state whose law is at issue. See id. Mindful of this principle, we decline the plaintiffs’ invitation to predict that the West Virginia Supreme Court of Appeals would adopt the specific provisions of the Restatement advanced by the plaintiffs.

While both the Huntington district and appellate court recognized that the West Virginia Supreme Court had not ruled on the direct issue of whether West Virginia public nuisance law covered damages (not just traditional abatement) for harms allegedly caused by the distributors’ distribution of prescription opioids to pharmacies in the plaintiff jurisdictions, they came down on opposite sides of these issues.  It is clear to us that the district court applied the proper restraint against expansion counseled by the Supreme Court and prior Fourth Circuit decisions—both as to the scope of conduct and the scope of remedies.  The Fourth Circuit, which repeatedly framed its approach as refusing to restrict West Virginia’s common law on public nuisance, did not.  The rest of the decision reversing and remanding the case for further proceedings was essentially a foregone conclusion.

Mind you, the Fourth Circuit had done the right thing by referring a certified question to the West Virginia Supreme Court and was put in an unusual, awkward position when the West Virginia Supreme Court denied its request on the grounds that it could not give an advisory opinion.  That meant that an Erie prediction—with proper restraint, hopefully—was back on the Fourth Circuit’s plate.  Of course, had it answered the question, the West Virginia Supreme Court very well could have expanded public nuisance to the extent needed to help out the case brought by a West Virginia county and city against out-of-state companies.  After all, this is the same court that adopted medical monitoring without present injury in Bower v. Westinghouse Electric Co., 522 S.E.2d 424, 427 (1999), and rejected the learned intermediary doctrine for prescription drug product liability cases State ex rel. Johnson & Johnson v. Karl, 647 S.E.2d 899 (W. Va. 2007).  The political pressure to provide such novel remedies in Huntington would surely have been substantial.  But the Fourth Circuit, in its role on a diversity case, should not have “interpret[ed] state law in a manner that may appear desirable to the federal court, but has not been approved by the state whose law is at issue,” which was clearly the case here.

We could walk through the rest of the Fourth Circuit’s decision to highlight instances of questionable conclusions and suspect analysis throughout.  Surely, others will, including on the likely cert. petition to the Supreme Court.  Rather than do that, we will focus briefly on two interrelated recurring issues. 

First, the district court, after recounting lots of evidence and many findings from bench trial, went ahead and addressed whether plaintiffs carried their burden as to the elements of public nuisance, assuming it encompassed products and monetary damages.  The district court’s decisions, as factfinder, established layers of alternative grounds for affirming even if the Fourth Circuit disagreed on the scope of public nuisance.  It was obvious from the opinion below that each factual determination that the Fourth Circuit revisited was supported by substantial evidence in the record.

Second, although questions of fact are supposed to be reviewed on a clear error standard, 2025 WL 3009526, *9 (“[T]his is a deferential standard, and we will not disturb the district court’s factual findings if they are plausible in light of the record reviewed in its entirety.”) (citation omitted), the Fourth Circuit appeared to undertake a de novo review of some of the district court’s many factual determinations.  The Fourth Circuit held that a number of these factual determinations, such as the existence of multiple, fatal holes in plaintiff’s proximate cause case, “were based, at least in part” or “rested, in part” on purported legal errors in interpreting the distributors’ duties under the federal Controlled Substances Act.  Even if the district court was wrong on that issue—it relied on plaintiffs’ witnesses’ testimony on those federal duties—this holding was quite a stretch.  The Fourth Circuit did not identify improperly excluded evidence, hold that any factual determinations were not supported by substantial evidence in the record or were contrary to the weight of the evidence, or explain how there could be proximate cause given the many undisturbed factual determination on causation.  For instance, this finding from the district court seems untouched by the Fourth Circuit’s criticisms and negates causation under the causation theory it resurrected:

Plaintiffs rely on a breach of a no-shipping duty to prove diversion and creation of an opioid epidemic. To the extent they also rely on the reporting requirement, plaintiffs failed to show that any alleged violations based upon a failure to report suspicious orders by defendants contributed to the volume of opioids distributed in Cabell/Huntington. Put another way, plaintiffs did not show that had defendants reported more suspicious orders that the DEA would have closed any of the pharmacies that defendants serviced in Cabell/Huntington.

609 F. Supp. 3d at 449 n.5.  There are more examples, but we will leave it there.

Whether this goes to the Supreme Court or goes to the district court to redo its Findings of Fact and Conclusions of Law in light of the Fourth Circuit’s expansion of West Virginia public nuisance law, it is still far from a foregone conclusion that plaintiffs will win this case with the obvious holes in the evidence they offered at trial.  As John Adams famously said, and some plaintiff lawyers like to quote:

Facts are stubborn things; and whatever may be our wishes, our inclinations, or the dictates of our passions, they cannot alter the state of facts and evidence.

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Today’s case, Clayton v. Zimmer United States, Inc., 2025 U.S. Dist. LEXIS 213345 (S.D. Ohio Oct. 29, 2025), marks two weeks in a row where we discuss good (for the defense) court decisions coming out of Ohio.  Meanwhile, in our non-blogging-but-actually-paying part of our job, we’re on something like our fifth week in a row fighting against plaintiffs in several cases who are doing everything possible to stay out of federal courts.  Why do some plaintiff lawyers shun the wisdom, life-tenure, non-elected, well-resourced majesty of federal courts?  We don’t mean to be unkind, but we take this fear of the federal to say nothing good about those lawyers or their cases.

In Clayton, the plaintiff was an Ohio citizen who claimed that an implanted knee device fractured and caused her serious injuries. She filed suit in Ohio state court under the Ohio Products Liability Act (the OPLA) against the manufacturing companies (not Ohio citizens) and a local supplier called Mid-Ohio which was – you guessed it – an Ohio citizen.  The defendants removed the case to federal court, invoking diversity jurisdiction. Obviously, at first blush it looked like Mid-Ohio’s presence defeated diversity. But the defendants argued that the federal court should retain jurisdiction over the case because Mid-Ohio was fraudulently joined. The plaintiff’s response was that Mid-Ohio was legitimately in the case because it was derivatively liable as a supplier of the device implanted into her knee.

The federal court began its analysis by reminding us that fraudulent joinder is a pretty tough test for defendants to meet.  There must be “no colorable cause of action” against the non-diverse party. It helps the removing party that it “can present evidence beyond the pleadings to make this showing,” but it hurts the removing party that the standard for fraudulent joinder is “akin to that of a Rule 12(b)(6) motion to dismiss,” with perhaps even more deference to the plaintiff. 

As we have seen more than once, Ohio’s substantive product liability law, the OPLA, is remarkably sane. Under that law, the plaintiff’s claim against the local supplier could not survive, even under the loose fraudulent joinder standard. Ohio’s product liability statute limits “derivative” liability to when “the supplier in question is owned, or when it supplied that product, was owned, in whole or in part, by the manufacturer of that product[.]” Ohio Rev. Code § 2307.78(B)(4). No such ownership interest existed here, so the fraudulent joinder standard was met and, given this quirk of Ohio law, removal to federal court was successful.  

The plaintiff tried to support her claim against the local supplier by alleging that her surgeon spoke to a “local Zimmer representative” about the device and that Mid-Ohio is listed on the Zimmer website. But Mid-Ohio submitted undisputed evidence that it “does not own, is not owned by, nor has it ever been owned by Zimmer US, Inc., Zimmer Biomet Holdings, Inc., or Zimmer, Inc.” Accordingly, the federal court found that the plaintiff failed to assert a colorable claim against Mid-Ohio and that Mid-Ohio was fraudulently joined in this action.

In our eyes, the OPLA is just as undefeated as the Ohio State Buckeye football team.

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In the 1980s, when a wave of complicated, expensive, and hard to prove lawsuits against the vaccine industry threatened to drive many manufacturers out of the market and subsequently cause a public health crisis, Congress stepped in and enacted the Vaccine Act which created the National Vaccine Injury Compensation Program. It is designed to strike a balance. It keeps vaccines available by shielding manufacturers from constant litigation and provides an accessible, less adversarial way for injured individuals to be compensated. Claimants don’t have to prove fault like in regular tort cases, and even if they lose, they can sometimes get their attorneys’ fees paid as long as their claim was brought in good faith and on a reasonable basis.

But here’s the catch: “reasonable basis” has to actually mean something. If you’re going to bring a claim in the Vaccine Court, you need some evidence to back it up—medical records, a doctor’s note, a little something beyond “I just feel like it was the vaccine.” That was the issue the court had to deal with in Stratton v. Secretary of Health and Human Services, 2025 WL 2955287 (Fed. Cl. Ct. Aug. 22, 2025).

Plaintiff filed her Vaccine Act petition alleging that her HPV vaccine caused her to develop POTS and autonomic dysfunction. The petition “acknowledged outright” that she only filed the petition because she was statutorily compelled to do so before she could pursue litigation against the manufacturer. Id. at *4. Not surprisingly then, plaintiff did a minimal amount of work and then immediately withdrew her claim at the 240-day mark—the deadline by which if a claim is not resolved, the claimant can withdraw it and move forward in federal court. However, even when a claim is withdrawn, plaintiff can file a motion for attorney’s fees and costs for work performed up to the time of withdraw. Here the claim was for almost $11,000. Notably, this is just one of over 300 HPV vaccine claims initiated and then withdrawn by the same counsel, so Stratton has broader implications.

Attorney’s fees should not be handed out like participation trophies.  Even though “[r]easonable basis is an extremely lenient standard,” it is not non-existent. It requires objective evidence. Id. at *6. Here, the plaintiff’s medical records detail multiple symptoms of POTS experienced by plaintiff long before receiving the vaccine and “no contemporaneous evidence that she experienced a close-in-time reaction or worsening of her pre-vaccination symptoms.” Id. at *8. Moreover, the Vaccine Program has a long history of rejecting contentions that the HPV vaccine is capable of causing POTS.  The opinion cites to a series of rulings issued before plaintiff’s claim was filed that should have put her counsel on notice of the weakness of the claim. Id. at *9. Allowing attorneys to get paid in cases like these would send the wrong message: that the Vaccine Court is an ATM for anyone willing to type “vaccine injury” into a form.

There is also a fundamental problem with plaintiffs using the Vaccine Act program as nothing more than a waiting room; a place to kill time until they can march off to federal court and start the “real” lawsuit. That’s missing the whole point. The Vaccine Act wasn’t designed as a bureaucratic obstacle course before you can sue the government. It was meant to resolve disputes efficiently—give claimants compensation when it’s deserved and protect vaccine manufacturers (and the vaccination system itself) from endless litigation. If you just sit back and let the 240 days tick by without engaging, you’re not participating in that process—you’re gaming it (as we discussed here).

And worse, if people keep doing this, it turns the Vaccine Court into a rubber stamp. The system depends on claimants actually trying to resolve their cases there. When people skip that step, it wastes time, money, and judicial resources. So yes, if a claimant does nothing during those 240 days—or flat-out says, “I’m only here because I have to be”—they shouldn’t get to turn around and say, “Okay, my time’s up, let’s go to federal court!” The Vaccine Act isn’t a formality; it’s a process with a purpose. If you want to use the Vaccine Act, use it. If not, don’t pretend you did.

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Not long ago we published a blogpost, “New California Ranitidine Litigation Order Makes A Huge Mess Of Everything” about a California trial court decision that created, out of whole cloth, what it called a “hybrid theory” of strict liability that jumbled together elements of the long-established – and long separate – concepts of design and manufacturing defect, while sprinkling in the negligence concept of intent.  See In re Rantidine Cases, 2025 WL 2796831 (Cal. Super. Sept. 15, 2025).  As a result, the court allowed a “manufacturing” defect that was uniform across all units of the product, because it construed plaintiffs’ attack on the defendants’ manufacturing processes as a manufacturing defect.

In this post we will attempt to describe just how far out of bounds this “hybrid theory” really is.

Continue Reading California Design vs. Manufacturing Defects – Neer the Twain Shall Meet
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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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