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Here is a question the First Circuit has now answered the wrong way — can a scientific paper published before the FDA approved a drug nonetheless qualify as “newly acquired information” that triggers a duty to change the warnings under the Changes Being Effected regulation? The Fifth Circuit said no last year in Hickey. The Fourth Circuit said no in Knight. The First Circuit’s own prior panel in Celexa said no. And now, in Warner v. Amgen Inc., — F.4th —-, 2026 WL 3033704 (1st Cir. Oct. 9, 2026), the First Circuit has said — maybe yes.

Warner is a hard case. A young man with a history of seizures and cerebrovascular disease died at twenty-five from cerebrovascular complications after taking a single dose of Aimovig, the defendant’s CGRP-receptor antagonist for migraine prevention. Id. at *1. There is no way to write about this one lightly, and we’re not going to try. But the law does not change because the facts are tragic, and the law the First Circuit announced here is, at least in part, a problem.

One quick regulatory note. Aimovig is a biologic, so FDA approval runs through a Biologics License Application (BLA), the biologics counterpart to an NDA. For our purposes the preemption and CBE frameworks are materially the same as on the drug side — there is no express preemption clause for either — and nothing in the analysis below turns on the drug/biologic distinction.

Here is the good news first. Plaintiff originally pleaded a garden-variety pre-approval failure-to-warn claim arguing that the FDA-approved label should have disclosed that clinical trials excluded anyone who had ever had seizures or cerebrovascular disease, and should have warned of the complications that befell her son. Id. at *4. The defendant moved to dismiss on impossibility preemption, pointing out that it was legally required to use the label the FDA approved, and had no unilateral power to change it. Id. The district court agreed, and so did the First Circuit.

The court held, as a matter of law, that a manufacturer’s ability to ask the FDA to include different label language is not the unilateral authority required to defeat an impossibility defense — and that this principle, long established post-approval under Wyeth, Mensing, and Albrecht, applies equally to pre-approval submissions, because a BLA (or NDA) is “by its nature, a request for agency approval.” Id. at *6. That is exactly right, and it is a useful statement of circuit law to have on the books.

The court then added belt to suspenders. The FDA plainly knew the trials excluded people with any history of seizure disorders or significant neurological conditions, and in fact considered and rejected a proposed cerebrovascular warning finding “insufficient evidence to include th[e] theoretical risk in labeling.” Id. at *7. So, the final approved label — with its particular description of the twelve-month exclusion and its silence about the lifetime exclusion — was itself the agency’s “determination” that the label was adequate, and “when the FDA formally approves a label stating one thing with full and obvious notice of the directly contrary position, one can read the approval as rejecting the contrary position.” Id. at *9 (quoting In re Zofran (Ondansetron) Prods. Liab. Litig., 57 F.4th 327, 343 (1st Cir. 2023)).

That is a clean, defense-friendly recitation of the pre-approval preemption rules. We’ll take it. Here is where the opinion starts to drift.

After the hearing on the motion to dismiss, plaintiff changed theories. In a supplemental brief, she submitted nine studies and literature reviews — most of them published before FDA approval — and argued that they were “newly acquired information” that would have allowed the defendant to invoke the Changes Being Effected procedure to unilaterally add a warning after approval but before her son was prescribed the drug. Id. at *5. The district court saw this for what it was and denied leave to amend as futile. The First Circuit reversed. Id. at *17. That alone is a disappointment; but the reasoning is worse.

First, the opinion treats pre-approval publication dates as largely irrelevant. “A study published prior to the approval of a drug or biologic’s label may still qualify as newly acquired information if it had not been ‘previously submitted’ to the FDA.” Id. at *15. Publication dates, the court said, are “not dispositive.” Id.

Compare that with where the rest of the field has landed on the same question. In Hickey v. Hospira, Inc., 102 F.4th 748 (5th Cir. 2024), the Fifth Circuit went the other way. The point there — the point that matters here — is that the pre-approval scientific literature is the baseline. It is what the FDA already had, or was obligated to have, when it made its labeling decision; by definition, it is not “newly” anything. The Fifth Circuit put the proposition in a footnote directly on point, flatly “reject[ing]” the argument “that an individual study that defendant was required to submit to the FDA before approval of Defendants’ drugs independently constitutes ‘newly acquired information.’” Id. at 759 n.8.

The Fourth Circuit got there first, and arguably further. In Knight v. Boehringer Ingelheim Pharmaceuticals, Inc., 984 F.3d 329 (4th Cir. 2021), the court held that information “could not have been ‘newly acquired’ because the FDA already knew about it.” Id. at 340 n.10. The Fourth Circuit specifically concluded that a document the plaintiffs cited “was not ‘newly acquired information’” because “it was submitted to the FDA before it approved Pradaxa.” Id. And even for information not formally submitted, the court held that an association “the FDA already knew of” when it approved the drug — “and nonetheless did not require the defendants specifically to warn of it in the label” — does not qualify as “newly acquired information.” Id. at 338-39. The animating principle is deference. Once something is in the public scientific literature, the agency with the specialized expertise and the statutory charge to evaluate that literature is presumed to have done its job. The question is not whether the defendant physically waved any particular paper in front of the FDA reviewers; the agency — not the manufacturer, and not a court on a motion to dismiss — owns the pre-approval record.

And here is the awkward part for the First Circuit — it had already said the same thing. In In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34, 41 (1st Cir. 2015) — which the Warner panel itself quotes — the court explained that the “newly acquired information” requirement “lets the FDA be the exclusive judge of safety and efficacy based on information available at the commencement of marketing, while allowing the states to reach contrary conclusions when new information not considered by the FDA develops.” Warner, 2026 WL 3033704, at *10 (quoting Celexa) (emphasis added). It is hard to square “exclusive judge of safety and efficacy based on information available at the commencement of marketing” with a rule that pre-approval publications are “newly acquired” whenever the record is silent on whether the agency saw them.

Second — and this is where it starts to sound like something else by another name — the court repeatedly leaned on the absence of record evidence that the FDA had seen the articles plaintiff relied on. “We also find no evidence in the record as it now stands that the [four studies] were brought to the FDA’s attention.” Id. at *15. Translation — at the pleading stage, we assume the FDA didn’t see this stuff, and the defendant has to come forward later to prove otherwise. That is a backdoor fraud-on-the-FDA theory, only without the discipline Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), would impose. Buckman, notably, is nowhere in the opinion. And that is the whole point of Buckman. Deciding whether the FDA was properly informed — whether it was fully in the loop or somehow hoodwinked — is the FDA’s job, not a federal court’s. Treating a plaintiff’s bare assertion that studies were not “brought to the FDA’s attention” as enough to defeat preemption at the pleading stage runs headlong into that principle.

Third, the First Circuit opened the door to animal studies as “newly acquired information.” The court was “not certain that the [animal] study fails to qualify as newly acquired information,” reasoning that FDA guidance permits “theoretical warnings ‘if the animal data raises substantial concern about the potential for … adverse reaction in humans.’” Id. at *16. We understand the hook — Aimovig was a first-in-class biologic and the FDA itself relied on animal data in approving it. Id. But using that fact to justify forcing manufacturers to chase every rodent paper into the CBE process is going to produce exactly the overwarning the agency keeps telling us it doesn’t want. The court even acknowledged earlier in the opinion that the FDA aims to “prevent overwarning,” including “theoretical hazards not well-grounded in scientific evidence [that] can cause meaningful risk information to lose its significance.” Id. at *2 (citations omitted). The two halves of the opinion do not entirely talk to each other.

Fourth, the causal-association prong took a hit. The court held that the regulatory definition of an adverse reaction does not “require[] that the inclusion of an adverse reaction in labeling be based solely on clinical studies of the drug itself,” id. at *18, and credited plaintiff’s theory that the newly acquired studies showed Aimovig was associated not with causing seizures, but with worsening the outcomes of seizures by weakening the blood-brain barrier. Id. at *17. That is a notably loose formulation of causal association for a motion-to-dismiss standard. The CBE regulation’s two causal thresholds — “reasonable evidence of a causal association” for warnings and precautions, and “some basis to believe there is a causal relationship” for adverse reactions, id. at *17 — were already generous. They are now even more so in the First Circuit.

Finally, we note what the opinion does not decide. The court flagged the “clear evidence” defense — that even if the four surviving studies had been submitted, the FDA would still have rejected the proposed label change — but observed that the defendant had “chosen not to rely on such an argument” at this stage, so the court didn’t reach it. Id. at *19. That defense remains fully available on remand, and given how specifically the FDA engaged with CGRP antagonism and the “world’s literature” on the subject, we would expect it to feature prominently on summary judgment.

The scorecard isn’t exactly even. Dismissal of the original pre-approval theory affirmed. Good. Clear circuit-level statement that a BLA/NDA submission is a request for agency action and cannot defeat impossibility preemption. Better. A ruling that pre-approval studies can be “newly acquired information,” that single animal studies may qualify, and that the required causal association does not need to involve the drug itself. Not good. And the whole thing is wrapped in a pleading-stage “we cannot say with certitude” posture that puts the manufacturer in the position of having to disprove, later, what plaintiffs barely alleged in the first place.

The bright spot is that this is a remand, not a verdict. The court itself noted that it was “inclined to read the record as the district court did” on the newly-acquired-information issue, and reversed only because, without expert testimony, it could not get all the way to “certitude.” Id. at *14. Plaintiff gets to replead. Based on what she has put on the table so far, we would not bet the farm on where she ends up.

But the broader doctrinal footprint is the thing to watch. The Fourth Circuit in Knight and the Fifth Circuit in Hickey — and, before them, the First Circuit’s own panel in Celexa — had put the field on reasonably firm ground that information already in the FDA’s hands (or in the public scientific literature) at the time of approval is not “newly acquired” when a plaintiff later rediscovers it. Warner nudges that ground. If a published-but-not-formally-submitted study predating approval can still ground a CBE claim, “the exclusive judge of safety and efficacy” is no longer the agency — it is the lawyer with the better literature search. We hope the First Circuit, or the next panel to grapple with this on a fuller record, reels this one back in.

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Last year we posted about the “Frontal Assault” on the constitutionality of the False Claims Act (“FCA”), mounted in United States ex rel. Zafirov v. Florida Medical Associates, LLC, 751 F. Supp.3d 1293 (M.D. Fla. 2024).  We pointed out that the district court in Zafirov had adjudicated one of the constitutional questions raised by three Supreme Court justices in their concurring and dissenting opinions in United States ex rel. Polansky v. Executive Health Resources, Inc., 599 U.S. 419 (2023).  The district court agreed with the concurring justices.

Now we report, somewhat belatedly by Blog standards, that on appeal the Eleventh Circuit did not agree and reversed.  United States v. Florida Medical Assocs., LLC, ___ F.4th ___, 2026 WL 2581886 (11th Cir. Sept. 1, 2026) (“Zafirov”).  The district court had held that FCA “relators” were irregularly appointed “federal officers” under Article II’s Appointment Clause.  The Eleventh Circuit “disagree[d] and h[e]ld that relators are not officers of the United States because they do not occupy a continuing position established by law.”  Id. at *1.

The appellate court reasoned that status of a private plaintiff as “relator” was not “continuing” because:

  • “[A] relator’s tenure is occasional and temporary because it lasts the length of one case”;
  • Once that case is over, “the relator has no remaining duties”;
  • “[T]he overall length of” time that an individual case is pending does not matter, since a relator has no “tenure”;
  • The “one-time” contingent fee that a successful relator obtains under the FCA “is not continuing”;
  • The relator’s recovery is “a portion of the judgment, if any, not through any regular appropriation.”
  • “A relator occupies a personal role, not one where his duties continue, though the person be changed.”
  • Unless the government intervenes in an FCA case, a relator’s “role in the case cannot be assumed by anybody else.”

Zafirov, 2026 WL 2581886, at *4-5 (citations and quotation marks omitted).

Zafirov rejected any analogy to the roles of federal independent counsel because, although such appointments were “temporary” and “single task,” it was not “personal,” since a successor could pick up where the prior independent counsel left off, and independent counsel were also on the “public payroll.”  Id. at *6.  So, even if some temporary personnel could be considered “federal officers,” FCA relators were not among them, according to Zafirov.  The opinion also declared that, despite the qui tam provisions of the FCA, there was no “office of relator” waiting for any random person claiming inside information to fill it.  Id.

That was as far as the Eleventh Circuit went in Zafirov, because that was all the district court had decided.  The Eleventh Circuit “remand[ed] for the district court to evaluate the defendants’ Take Care Clause and Vesting Clause arguments.”  Frankly, we have always thought that the Take Care argument was the best one, because what the FCA does – arguably unconstitutionally – is for the Legislative Branch to seize a portion of the Executive Branch’s power to “take care that the laws are faithfully executed” and to turn it over to anybody in the country who claims to have some inside knowledge of some sort of wrongdoing that produces “false” claims.”  Or, as the dissenting opinion in Polansky put it, more elegantly:

There are substantial arguments that the qui tam device is inconsistent with Article II and that private relators may not represent the interests of the United States in litigation. Because the entire “executive Power” belongs to the President alone, it can only be exercised by the President and those acting under him.  And, as a lawsuit is the ultimate remedy for a breach of the law, . . . conducting civil litigation  for vindicating public rights of the United States is an executive function that “may be discharged only by persons who are “Officers of the United States”. . . .  It thus appears to follow that Congress cannot authorize a private relator to wield executive authority to represent the United States’ interests in civil litigation.

599 U.S. at 449 (citations and quotation marks omitted).

Whether someone is a federal “officer” is, as Zafirov demonstrates, subject to a lot of technicalities.  However, the more fundamental separation-of-powers issue of whether Congress has the power to delegate enforcement of the laws of the United States to non-executive personnel is not.  Thus, the constitutionality of the FCA’s qui tam provisions is far from settled.

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As we head into the busy final stretch of the year, many of us are focused on wrapping up projects, planning for 2027, and preparing for the holiday season. Around here, that also means it’s almost time for the blog’s annual review of the best and worst cases of the year. Before we get there, however, consider adding discounted registration to ACI’s Drug and Medical Device Litigation Conference, coming up December 2-3, to your list. As we’ve mentioned, the good people at ACI asked the blog to be a media sponsor once again and are offering a special registration discount for the conference for the blog’s readers. If you use the code D10-999-DDLB27 when you register, you’ll save 10% off your conference registration. Best rates expire October 30th.

A number of bloggers will be present. Steven McConnell will be speaking as part of the In-House Roundtable Series on December 2 at 11:15 a.m. Later that day, at 3:00 p.m., Eric Alexander will be speaking on The Future of Products Liability: Failure to Warn, Duty to Innovate, and Other Novel Legal Theories. Lisa Baird will be presenting Putting the Offense in the Preemption Defense on December 3 at 11:30 a.m. We look forward to the insightful presentations from the consistently outstanding faculty of in-house counsel, top defense firms, and seasoned jurists.

If you want to register, you can do so here. We look forward to seeing you in New York!

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Sometimes we get a little tired of plaintiffs’ antics in bringing multi-plaintiff complaints to defeat diversity jurisdiction or tilt the scales in their favor at trial.  Federal courts are generally wise to this maneuver (see our prior posts here, here and here), but there’s a never ending battle to avoid multi-plaintiff actions in some of the familiar state court haunts (St. Louis and Philly come to mind). So, when we see a state trial court decision shooting down a multi-plaintiff complaint at the outset, we get excited.

Palmer v. Pfizer, Inc., 2026 WL 300105 (Conn. Super. Oct. 9, 2026), involves claims by four plaintiffs who filed a lawsuit together claiming that their use of an injectable contraceptive caused them to develop meningioma (a type of brain tumor). The four plaintiffs were from different states (New York, Kentucky, Louisiana and Connecticut), they received their injections at different times, and the injections they received were different combinations of brand and generic versions. The defendant moved to strike the complaint based on improper joinder.  The defendant argued both that (1) the plaintiffs themselves were improperly joined, and (2) that the plaintiffs’ claims were improperly joined.

The court started its analysis by noting that the Connecticut Supreme Court has historically “taken a liberal approach to permissive joinder.” Id. at *3. The court then looked to Connecticut law to determine the proper inquiry for addressing defendant’s misjoinder arguments. To determine whether plaintiffs are misjoined, Connecticut law requires a three-part inquiry:

  1. Do the plaintiffs have any “right of relief” “arising out of the same transaction or series of transactions” that are alleged?
  2. If the plaintiffs brought separate actions, would “any common question of law or fact” arise? and
  3. Would joinder “embarrass or delay the trial”?

Id. (quoting Conn. Gen. Stat. § 52-104). After concluding that Connecticut courts take a broad view of what constitutes a “transaction” and that courts should consider the interests of judicial economy in evaluating the statute, the court noted a paucity of caselaw in Connecticut determining whether different plaintiffs’ rights of relief arose from the same “transaction” in the context of pharmaceutical cases. The court then reviewed a number of federal decisions that rejected joinder of multiple plaintiffs in a single complaint:

  • In re Zantac (Ranitidine) Products Liability Litigation, 343 F.R.D. 347, 351 (S.D. Fla. Feb. 7, 2023) (denying a motion to permit multi-plaintiff complaints where “the Plaintiffs, each with unique physiology, consumed a drug created by different manufacturers, using different supply chains, at different times, in different places, with varying levels of exposure”).
  • In re Orthopedic Bone Screw Products Liability Litigation, 1995 WL 428683 (E.D. Pa. July 15, 1995) (“joinder based on the belief that the same occurrence or transaction is satisfied by the fact that claimants have the same or similar device of a defendant manufacturer implanted in or about their spine is . . . not a proper joinder”).
  • In re Propecia (Finasteride) Product Liability Litigation, 2013 WL 3729570 (E.D.N.Y. May 17, 2013) (54 plaintiffs who ingested a prescription product and suffered injuries had not alleged claims that arose from the same transaction or occurrence because their claims differed as to the product, dosage amounts and frequency, dates of ingestion, duration of ingestion and location of purchase and ingestion).
  • McNaughton v. Merck & Co., Inc., 2004 WL 5180726 (S.D.N.Y. Dec. 17, 2024) (plaintiffs alleging improper warnings about a medicine raised common issues but their claims did not arise from the same transaction or occurrence).

Id. at *6-7. While recognizing that these cases showed a clear trend against joinder of plaintiffs in cases involving drugs or medical devices, the court flagged the limitations imposed on it at the motion to strike stage:

Notably, the federal cases that have considered whether the plaintiffs’ exposure to pharmaceuticals or medical devices were not decided under the narrow rules that apply to motions to strike in Connecticut state courts. Most of them were considering defendants’ motions to sever plaintiffs’ claims or plaintiffs’ motions to remand to state court for lack of diversity jurisdiction. This court is limited to the facts alleged in the . . . complaint, which it must construe in the manner most favorable to sustaining its legal sufficiency.

Id. at *8. In other words, in considering only the allegations in the complaint, the court couldn’t inject a dose of reality (pun intended) by recognizing the variables highlighted in the federal cases that weighed against joinder. With that important caveat, the court concluded the allegations in the complaint sufficiently alleged the same “transaction.” The court also concluded that the allegations in the complaint sufficiently alleged claims from which “common questions of law or fact would arise.” Id. at *9.

But, plaintiffs couldn’t get past the third element of the court’s inquiry—whether joinder would “embarrass or delay the trial.” Applying that part of the inquiry, the court held:

The use of the somewhat archaic word “embarrass” in the statute and rule could mean “to hamper or impede the movement” of the trial. The differences among the plaintiffs’ facts, particularly as to treatment and injuries, are enough that combining them all into one case (1) would increase the amount of discovery to be undertaken (including discovery outside of Connecticut for three of the plaintiffs), (2) could raise different issues for summary judgment, (3) delay the trial date, and (4) create jury confusion at trial. Although it might be convenient to hear some issues such as general causation together in preliminary hearings . . . it would not be convenient to combine the causes of action into one trial.

Id. at *12. So even under Connecticut’s restrictive standard at the motion to strike phase, the court held that the plaintiffs were misjoined. The court also held that the plaintiffs’ claims were misjoined based on it being inconvenient for the court to hear the causes of action together.  The court’s rejection of multi-plaintiff joinder at the outset of this case is an encouraging sign of the growing recognition of the confusion, delay, complexity and unfairness posed by multi-plaintiff drug and device cases.

Readers of this space know we pay close attention to how courts handle preemption in product cases.  This week, we stumbled across a new-to-us variation, by virtue of the federal Poison Prevention Packaging Act (“PPPA”), 15 U.S.C. § 1471, et seq. and its implementing regulations, 16 C.F.R. Part 1700, et seq. 

The PPPA authorizes the Consumer Product Safety Commission (CPSC) to set “standards for the special packaging of any household substance if it finds that–

(1) the degree or nature of the hazard to children in the availability of such substance, by reason of its packaging, is such that special packaging is required to protect children from serious personal injury or serious illness resulting from handling, using, or ingesting such substance; and

(2) the special packaging to be required by such standard is technically feasible, practicable, and appropriate for such substance.”

Foods, drugs, and cosmetics are expressly covered.  16 C.F.R. Part 1700.1(b)(2)(ii).  The regulatory scheme apparently works pretty well:  The CPSC notes that since it took effect, “there have been remarkable declines in reported deaths from ingestions by children of toxic household products including medications.” 

In H.H. an Infant by Parent and Natural Guardian, Robert Avallone v. L.N.K. International, Inc., No. 613433/2026, 2026 WL 3079412 (N.Y. Sup. Ct. Oct. 6, 2026), the plaintiff asserted strict liability and negligence claims after an eight-year-old child was able to open a bottle of acetaminophen and take some.

The PPPA, however, only specifies that covered products must be in packaging that is “significantly difficult for children under five years of age to open…within a reasonable time.”  15 U.S.C. § 1471(4).  Thus, the plaintiff’s allegations sought to impose a higher degree of child resistance than the PPPA requires—namely, that the packaging not only be significantly difficult for a five-year-old, but that it actually prevent access by an eight-year-old.  The age difference is significant–it’s the difference between Bluey and Avatar: The Last Airbender. So is the degree of child-proofing.

The PPPA’s express preemption provision states that:

no State or political subdivision thereof shall have any authority either to establish or continue in effect, with respect to such household substance, any standard for special packaging … which is not identical to the standard established under [the PPPA].

15 U.S.C. § 1476(a).

Because the strict liability claim depended on a packaging standard “not identical to” the PPPA’s “under five years of age” requirement, it failed to state a cognizable claim under New York law and was dismissed with prejudice.

The plaintiff’s second cause of action sounded in negligence, and alleged the bottle was defectively manufactured.  This claim also was dismissed with prejudice.

First, there was no specific defect alleged.  While the complaint had the words “defective manufacture” and “defective condition,” it did not actually identify what supposedly was wrong with the bottle or its closure system that allowed it to be opened by the child.

Second, the complaint alleged no specific duty that was violated.  The complaint had a lot of generalized words—design, assembly, inspection, testing, quality control, packaging, labeling, marketing, distribution, and so on.   But it did not spell out what specific duty, grounded in law or regulation, the defendant allegedly had breached.

Had the complaint done so, the negligence claim likely would have run into preemption as well, as the court noted that these areas are “controlled by the Federal Statute,” the PPPA.

HH is a useful, albeit brief, illustration of (1) how the PPPA can provide an express preemption defense to state-law product claims in cases related to drug packaging, and (2) the pleading rigor New York courts (sometimes) impose on defect and duty allegations.

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No harm, no foul. And no case. That is the lesson of Klosowski v. FPG Labs, LLC, 2025 WL 2532500 (D. Del. Sept. 3, 2025).  (Yes, the case is over a year old.  But this bundle of joy just popped up on our Lexis doorstep this week.)

Klosowski was a putative class action against fertility clinics over genetic testing of embryos.  The clinics offered preimplantation testing to screen embryos for chromosomal abnormalities.  The defendants promised that the testing was “98% accurate, increases the chance of pregnancy, decreases the chance of miscarriage, leads to a higher chance of a healthy pregnancy, and reduces the time in pregnancy.”  The nine plaintiffs in Klosowski cited studies they said put the lie to the defendants’ claims. That meant, according to the plaintiffs, that they had overpaid for the testing. To put a finer point on it, the plaintiffs claimed they had been deprived of the benefit of the bargain. That could conceivably be a viable harm, but not in this case. 

The plaintiffs filed a class action complaint asserting 13 claims for violations of state consumer protection statutes, common law fraud, breach of warranty, and unjust enrichment. The complaint was brought on behalf of the nine named plaintiffs, a nationwide class, and five subclasses from California, Louisiana, Nevada, North Carolina, and Texas. 

The defendants moved to dismiss the case for lack of standing and failure to state a claim. They were right to do so, because what we have in Klosowski is yet another economic loss (no personal injury) only claim.  

The would-be class representatives could not show any actual injury to themselves and thus did not have standing. To have standing to sue, plaintiffs must have “(1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the defendant, and (3) that is likely to be redressed by a favorable judicial decision.” The plaintiffs bear the burden of showing all three components of standing, and they could not do so here. Third Circuit law is clear that allegations that a product is flawed as to others are not relevant to determining whether named plaintiffs have standing themselves.  While attacking the scientific validity of the defendant’s tests in general, the Klosowski plaintiffs did not allege that anything bad actually happened to them. There were no allegations (because, of course, they would create individualized issues) that any of the putative class representatives failed to become pregnant, suffered a miscarriage, or experienced a medically compromised pregnancy.  Indeed, the complaint contains no mention of harm to the plaintiffs at all.  There were general references to possible harms, but the plaintiffs’ “conclusory assertions of harm are all the more implausible here given that some of these adverse outcomes are directly in conflict with and mutually exclusive of one another.”  

Comsequently, the Klosowski court dismissed the class action complaint. The court did afford the opportunity to amend, except for the claims under the Louisiana Unfair Trade Practices Act, where even the plaintiffs recognized they were irretrievably sunk.  

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Johnny Cash sang about ghost riders in the sky. In a federal courtroom in Las Vegas earlier this month, we got the litigation version: ghost writers in the sky — specifically, in three different expert reports that all somehow said the same thing in the same words about the same data, from experts in different fields who, strangely, all seem to share a prose style. And a vocabulary. And a conclusion. Spooky. Just in time for Halloween.

The case is Barton v. Sunbeam Products, Inc., 2026 WL 3036047 (D. Nev. Oct. 9, 2026), and we are the first to admit it is not one of ours in the usual sense. This is not a prescription-drug or medical-device case. The plaintiff was burned using a heating pad while visiting her daughter, and she sued the manufacturer, affiliated entities, and the retailer under Nevada strict liability and negligence law. So why are we writing about it? Because the court’s rulings on (1) ghostwritten expert reports and (2) failure-to-warn causation when nobody read the warning are directly transportable to our clients’ litigation. Plaintiff tried to pull a trick and instead, the court gave us a treat.

The plaintiff retained three experts: a burn surgeon, an electrical engineer, and a product safety manager. Id. at *2. Three different experts, three different disciplines, three separate reports. You would expect, oh, three different ways of looking at the problem.

You would be wrong.

All three experts reached the identical conclusion that the pad was “unreasonably dangerous” because the temperatures it was designed to reach were “excessive, unnecessary and provided no extra therapeutic benefit.” Id. at *5. All three considered the same data and summarized that data in nearly identical prose. Id. We’re not talking about a shared paragraph or a shared turn of phrase. We’re talking about side-by-side charts of word-for-word identical passages across the reports. Id. at *6.

Defendants moved to exclude under Federal Rule of Civil Procedure 26(a)(2)(B). That Rule requires every retained expert’s disclosure to be “accompanied by a written report” that is “prepared and signed by the witness,” setting out “a complete statement of all opinions the witness will express and the basis and reasons for them.” Id. at *3. And Rule 37(c)(1) provides the “automatic sanction” of exclusion when a party fails to disclose as Rule 26(a) requires. Id.

Plaintiff ran the familiar line we see every time this comes up — the Advisory Committee Notes let counsel “assist” an expert, so what are we even arguing about? A lot, actually.

Looking to the plain meaning of “prepare,” the court held that an expert must decide what information is responsive to subsections (i) through (vi) of Rule 26(a)(2)(B) and ensure that the information is memorialized in the written report. Id. at *4. The drafters could have said “written,” but they said “prepared” — meaning the expert need not personally put pen to paper, but the expert must be the one who decides what is in the report. Id.

The Advisory Committee Notes did not save the plaintiff; they sank her. The court made the point that “assistance” cannot possibly mean what plaintiff said it means, because on plaintiff’s reading “an attorney could tell his expert to consider only certain data or to reach a particular conclusion,” which the court flatly rejected as an “unreasonable result” that would “all but eliminate the need for expert disclosures as an attorney could just draft an ‘expert report’ and have their retained expert sign it.” Id. Correct. That is the whole game, and the court saw it.

What “assistance” does mean, the court explained, is tasks performed at the expert’s request, such as sending the expert documents produced in discovery, or reviewing the finished report to make sure none of the Rule 26 content is missing. Id. What assistance does not mean is the attorney telling the expert what data to rely on or what conclusion to reach. “[I]f the attorney is making that decision, it is the attorney’s report, not the expert’s.” Id.

Which brings us back to the three experts who all said the same thing in the same words about the same data. Their deposition testimony is a connoisseur’s gallery of walking it back. The burn surgeon testified he “went back and forth … on the phone … discussing the language,” presumably with counsel, before “writ[ing]” it into his report. Id. at *5. The electrical engineer, who in a different case had used substantially the same language, allowed that counsel “may have provided him with that language” and that he and counsel “did go back and forth on it.” Id. at *6. And the product safety manager, who insisted “no one gave [him] that wording,” had testified in that other case that counsel “gave [him] those sentences and [he] said, okay, [he] c[ould] incorporate them because [he] believe[d] them.” Id. Three experts, one script.

The court was unamused. All three experts considered the same sources (seemingly given to them by counsel) to reach the same conclusion using the same phrasing; nothing in the record showed any independent review or research by any expert to form or even confirm the conclusion. Id. It followed, the court held, that “it was Barton’s counsel — not the experts — that decided to include the sources of information and the conclusion [defendant] challenges.” Id.

The automatic sanction was exclusion. And because plaintiff did not argue substantial justification, did not argue harmlessness, and did not even ask for lesser sanctions, she could not escape the “harshness” of exclusion. Id.

This is the main event, and it is a gift to any defendant staring down a coven of plaintiff-side experts who all somehow found their way to the same magic words. The next time you depose a plaintiff’s expert and the “independent” opinion starts to look like a mimeograph, Barton is the opinion you want in your appendix. Three disciplines, one voice. Three signatures, one author. One Rule 26, one result.

The second ruling is on causation, and it’s been added to our failure-to-read 50-state survey. On the failure-to-warn claim, the manufacturer argued that even if the warning on the heating pad’s electrical cord were somehow inadequate, plaintiff could not show causation because she admitted she never saw the warnings — and neither did her daughter, who was the one who actually placed the pad on plaintiff’s back. The court agreed. Both the plaintiff and her daughter “stated that they had not seen the warnings that came with the heating pad,” and plaintiff pointed to no record evidence that either of them had. Id. at *11.

That’s not an evidentiary close call. It’s a legal one, and reasonable minds can only draw one conclusion from it:

Reasonable minds could not differ in concluding that a different warning would not have prevented [plaintiff’s] injuries when neither [the plaintiff] nor her daughter saw the warnings.

Id.

And, the line of the opinion: the warning

could have read, ‘[Plaintiff], do not use this heating pad because it is certain to burn you and will result in thousands of dollars in medical bills,’ and [plaintiff] would have been none the wiser.

Id.

The court granted summary judgment on failure to warn.

In a learned-intermediary case, substitute “prescriber” for “user and user’s daughter,” and the analysis is the same — if the person whose decision would be influenced by the warning never read it, a different warning would not have changed the outcome, and causation fails as a matter of law.

So today we tip our pointy hats to the District of Nevada — and we add two more spells to the spellbook. The next time plaintiff’s counsel passes off his own words as three different experts’ opinions, we know what to call it. And we know who you gonna call — Barton. Even in October, the ghosts have to put their names on their own work.

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There is still a lot of 2026 left, and the Blog has already published two posts discussing (among other things) informed consent claims brought against manufacturers of prescription medical products.  The first post reviewed Graw v. Eli Lilly & Co., 821 F. Supp.3d 981 (E.D. Mo. 2026), where the plaintiff unsuccessfully brought such a claim against the manufacturer sponsor of a clinical trial involving an investigational drug.

[Plaintiff] has not shown that [the manufacturer/clinical trial sponsor] is a “medical practitioner” as defined by [state] law.  To adequately plead lack of informed consent, a plaintiff must plausibly allege whether a reasonable person in plaintiff’s position would have consented to the procedure had the treating medical practitioner made the proper disclosures of the risks and alternatives. . . .  Moreover, [plaintiff] fails to plausibly allege why [the manufacturer], as opposed to [actual healthcare providers], would have been responsible for disclosing the information.  As [the manufacturer] points out, in the clinical trial context, the investigator is typically responsible for obtaining the participants’ informed consent. . . .  [Plaintiff] has not sufficiently alleged why she should be able to sustain a lack of informed consent claim against [the manufacturer].

Id. at 994-95 (citation and quotation marks omitted) (emphasis original).  The second post did the same with Petty v. Schwartz, 2026 WL 2806936 (N.Y. Sup. Sept. 1, 2026), which rejected informed consent as a viable theory against the manufacturer of an implantable medical device.

Plaintiff concedes that . . . manufacturers were not medical practitioners and that the decedent was not their patient for [New York law]. . . .  [T]he complaint does not state causes of action based upon [the manufacturer’s] alleged failure to warn [the implanting surgeon] and the wider medical community of the risks associated with the implant of which it knew, or, in the exercise of reasonable care, should have known to exist.  [Defendant], as the manufacturer of the implant, cannot be held liable for lack of informed consent.

Id. at *3 (citations omitted).

We reviewed our nearly two decades of blogposts and determined that we have never comprehensively researched precedent on this question – informed consent claims against manufacturers of prescription medical products.  Rather, our research posts on informed consent have focused on judicial rejection of informed consent claims against healthcare providers in off-label use cases concerning FDA regulatory status.  So rather than beat that very dead horse, we decided to research informed consent precedent involving manufacturers.  In that regard, Graw and Petty are very much in the judicial mainstream.

We start with Moore v. Regents of University of California, 793 P.2d 479 (Cal. 1990).  Most lawyers, if they’re familiar with Moore, know it as a case that expanded physician informed consent obligations, but in Moore, the plaintiff also sued several non-physician defendants, including a drug company involved in developing a “cell line” derived from the plaintiff’s tissue.  Id. at 482.  Plaintiff sought to assert the informed consent claims against all of the defendants, but Moore said no.  Against anyone other than treating doctors, the California Supreme Court held that informed consent was not a viable cause of action.  “The [other defendants], and [the drug company] are not physicians. . . .  [N]one of these defendants stood in a fiduciary relationship with [plaintiff] or had the duty to obtain [plaintiff’s] informed consent to medical procedures.”  Id. at 486.

That’s one.  Several federal courts of appeals agree.  “[I]t is not the manufacturer’s job to ensure the patient gave ‘informed consent’ to a medical procedure when a learned intermediary is involved.”  Cates v. Zeltiq Aesthetics, Inc., 73 F.4th 1342, 1350 (11th Cir. 2023) (applying Florida law).  Informed consent claims “have little merit against” an investigational drug manufacturer because “under the FDA’s regulatory scheme it is not the pharmaceutical companies that are charged with ensuring trial participants’ well being.”  Abney v. Amgen, Inc., 443 F.3d 540, 551 (6th Cir. 2006) (applying Kentucky law).  “[T]he predicate of a claim for informed consent addresses the duty of the physician, not the manufacturer, to the patient.”  Gile v. Optical Radiation Corp., 22 F.3d 540, 551 (3d Cir. 1994) (citation omitted) (applying New Jersey law).  See also Anderson v. George H. Lanier Memorial Hospital, 982 F.2d 1513, 1516, 1520 (11th Cir. 1993) (holding that the district court’s determination “federal law did not impose a duty upon [a manufacturer/sponsor] to ensure that its ‘investigators’ obtained informed consent from each subject of the study” was “without an error of law”) (applying Alabama law).  As these appellate cases demonstrate, informed consent claims against prescription medical product manufacturers arise as often in the investigational context as they do with products that the FDA has decided can be generally prescribed.

For similar reasons, Lewis v. Intermedics Intraocular, Inc., 56 F.3d 703 (5th Cir. 1995) (applying pre-LPLA Louisiana law), rejected an informed consent claim against a device manufacturer – but on statutory grounds, since Louisiana doesn’t recognize common law in this area:

Louisiana, being a Civil Law state, would not recognize a common law duty on the part of a manufacturer to obtain informed consent. . . .  The Louisiana Uniform Consent Law clearly does not apply to manufacturers. . . .  [O]nly a physician or health care provider who will actually perform the procedure is required to obtain informed consent. . . .  Moreover, we also note that Gile provides support for our determination that an informed consent claim does not automatically flow from an assertion of negligence. . . .  Although Gile did not arise in Louisiana, it is illustrative of the concept that a general tort duty not to be negligent is not enough to bring a manufacturer within the purview of an informed consent claim.  Based upon the above, we conclude that Louisiana law does not recognize plaintiffs’ state claims against [the manufacturer] for failure to obtain informed consent.

Id. at 707-08 (citations omitted).  Lewis has been followed as an accurate statement of Louisiana law.  Touchet v. Ace Medical Co., 1998 WL 531887, at *8 (E.D. La. Aug. 24, 1998) (plaintiff’s informed consent claim “does not implicate [the manufacturer/sponsor’s] wrongdoing, but questions her doctors’ judgment”); Borskey v. Medtronics, 1998 WL 122602, at *4 (E.D. La. March 18, 1998) (“The LPLA clearly preclude[s] plaintiffs’ cause of action against the manufacturer for failure to obtain informed consent, because the LPLA contains no provision for such a cause of action.”); McMurtrie v. Iolab Corp., 914 F. Supp. 1372, 1374 (E.D. La. 1995) (applying Louisiana law) (“Louisiana law does not recognize a cause of action against a manufacturer for failure to obtain informed consent”).

The only other state appellate decision on point is Salva v. Blum, 716 N.Y.S.2d 527, 528 (N.Y. App. Div. 2000), finding “lack of viability of the cause of action for lack of informed consent against [manufacturer] defendants.”  Id. at  528 (citations omitted).

Lack of informed consent is not a theory of liability upon which an injured person may sue the manufacturer of a defective product.  Defendants are not medical practitioners, nor was decedent their patient.

Id.  See also Wholey v. Amgen, Inc., 86 N.Y.S.3d 16, 17 (N.Y. App. Div. 2018) (holding generally that, “[a]s the sponsors of a clinical trial, [sponsor] defendants owed no duty to . . . an enrollee in the trial”; not specifically mentioning informed consent).  Thus, the result in Petty under New York law was hardly a surprise.

Several other New York decisions agree, including Chandler v. Janssen Pharmaceuticals, Inc., 322 F. Supp.3d 314 (E.D.N.Y. 2018).

[T]hat Plaintiff’s guardian, according to her affirmation, would not have consented to the [drug] prescription had [her physician] advised her of the risk . . . is irrelevant to Plaintiff’s claims against Defendants.  [citing Salva]  A failure to obtain informed consent might be a viable theory of liability against the physician or the hospital where the operation was performed.  However, neither . . . is a party to this lawsuit.

Id. at 329.  Accord Gioia v. Janssen Pharmaceuticals, 2021 WL 602683, at *2 (E.D.N.Y. Feb. 16, 2021) (“a failure to obtain informed consent might be a viable theory of liability against the physician who prescribed the medication, however, it is not a sufficient basis to hold a manufacturer liable”) (citations omitted); Fleming v. Endo International PLC, 2019 WL 4378964, at *4 (S.D.N.Y. Aug. 27, 2019) (informed consent allegations insufficient under learned intermediary rule to state warning claim against drug manufacturer); Tomaselli v. Zimmer, Inc., 2017 WL 2820065, at *5 (Mag. S.D.N.Y. Jan. 20, 2017) (plaintiff’s “affirmation that she would not have consented to the surgery had [her surgeon’ advised her of the [relevant] risk is irrelevant to her claims against the defendant manufacturer”), adopted, 2017 WL 1011492 (S.D.N.Y. March 15, 2017), aff’d, 728 F. Appx. 41 (2d Cir. 2018); Greenwood v. Tehrani, 2017 WL 4083099, at *3 (N.Y. Sup. Sept. 15, 2017) (“Lack of informed consent is not a theory of liability upon which an injured person may sue the manufacturer of a defective product.”) (quoting Salva).

A number of other federal and state trial courts have also considered informed consent claims asserted against prescription medical product manufacturers and likewise concluded that they are legally impermissible.  Kernke v. The Menninger Clinic, Inc., 173 F. Supp.2d 1117 (D. Kan. 2001), considered an informed consent claim arising in the investigational drug context, and held informed consent “duties do not rest with” the manufacturer/sponsor of the clinical trial.  Id. at 1124.

All of the duties alleged by plaintiffs in this case fall within the purview of the [health care provider] defendants as the investigator conducting the . . . study; the duties do not rest with [the manufacturer/sponsor]. . . .  [I]nformed consent is the duty of the physician and not the manufacturer. . . .  For that reason, the court grants summary judgment to [the manufacturer] on plaintiffs’ negligence claim.

Id. (following Gile and Anderson, other citations omitted).

Otis-Wisher v. Fletcher Allen Health Care, Inc., 951 F. Supp.2d 592, 602 (D. Vt. 2013), aff’d, 616 F. Appx. 433 (2d Cir. 2015), rejected an informed consent claim purportedly about a physician’s financial ties with the manufacturer.

[The manufacturer], however, is a different question.  Vermont law defines lack of informed consent as the failure to disclose to the patient such alternatives thereto and the reasonably foreseeable risks and benefits involved in the professional treatment.  Plaintiff’s claim regarding the relationship between her doctor and [the manufacturer] fails to state a viable claim for lack of informed consent because it does not concern alternatives, risks or benefits of the treatment.

Id. at 602 (citations omitted).

Guinan v. A.I. duPont Hospital for Children, 597 F. Supp.2d 485 (E.D. Pa. 2009), rev’d on other grounds, 393 F. Appx. 884 (3d Cir. 2010), decided under Delaware law, reached the same result.  The Delaware informed consent statute “place[d] the burden of obtaining informed consent on health care providers, not manufacturers.”  Since the defendant manufacturer was “not a health care provider[, t]herefore [it] had no duty to obtain informed consent from Plaintiff.”  Id. at 501 (statutory citations omitted).  See Gobin v. Eli Lilly & Co., 2026 WL 1728155, at *1 (S.D. Ind. May 27, 2026) (“inadequate-informed-consent component” of plaintiff’s complaint dismissed because there is “no Indiana authority that imposes a duty of care on a clinical study sponsor, which is what [defendant] is”); Cantwell v. De La Garza, 2019 WL 2166541, at *3 (W.D. Okla. May 17, 2019) (informed consent claim dismissed against device manufacturer; manufacturer “had no duty to obtain her informed consent to the procedure”); Mink v. Smith & Nephew, Inc., 145 F. Supp.3d 1208, 1217 (S.D. Fla. 2015) (“federal post-approval study requirements . . . obligate the physician ‘investigator,’ not the manufacturer, to obtain the patient’s informed consent”), aff’d in part & rev’d in part on other grounds, 860 F.3d 1319 (11th Cir. 2017); Sykes v. United States, 2011 WL 3739017, at *17 (Mag. S.D. Ohio July 22, 2011) (informed consent “claims fail as a matter of law because the pharmaceutical defendants owed no legal duty to the decedent under” Ohio law because the “tort of lack of informed consent applies only to physicians and hospitals”) (citation and quotation marks omitted), adopted, 2011 WL 3739306 (S.D. Ohio Aug. 24, 2011), aff’d, 507 F. Appx. 455, 462 (6th Cir. 2012) (quoting and following Abney); Dyer v. Danek Medical, Inc., 115 F. Supp.2d 732, 742 (N.D. Tex. 2000) (“The informed consent standard, however, applies to negligence actions against physicians, rather than failure to warn actions against product manufacturers and suppliers.) (citation omitted); cf. Knoth v. Apollo Endosurgery US, Inc., 425 F. Supp.3d 678, 688 (S.D. Miss. 2019) (when brought against a product manufacturer, an informed consent claim is subsumed by Mississippi’s product liability statute).  See also Dare v. Isner, 2005 WL 6000374, at ??? (Mass. Super. Nov. 15, 2005) (clinical trial “sponsor[] did not directly owe specific duties to” study participant, such as “obtaining the informed consent of each human subject”).

We found only two contrary cases, which we are not citing because we don’t believe in doing the other side’s research for them.

If any reader is currently litigating an informed consent claim against a prescription medical product manufacturer, here’s what can beat it.  Otherwise, just keep this research handy – because you never know when you might encounter such a case.

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A recent order from the Northern District of Illinois shows just how far public entities will go in trying to spread blame for opioid use and abuse, and in Baltimore City Board of School Commissioners v. Publicis Health, LLC, the district court found that a group of school districts reached too far.  No. 24 CV 11435, 2026 WL 2935336 (N.D. Ill. Sept 30, 2026).  The plaintiffs were twelve school districts seeking special education and related costs tied to Neonatal Opioid Withdrawal Syndrome, and while most opioid litigation has been waged against defendants that sold prescription medicine, these plaintiffs took a different tack.  They sued three companies that allegedly helped to market opioids: an advertising agency, an electronic health records vendor, and a sales consultant. 

Similar to other public entities, the plaintiff school districts purported to allege that consulting around the marketing of prescription opioids constituted a public nuisance.  As we have said before, this is a square peg in a round hole, but these plaintiffs tried anyway. 

It did not work.  The district court had already dismissed the districts’ RICO claims, ruling that the complaint did not allege a direct relationship between the allegedly wrongful conduct and the alleged injury.  That was because the physicians, pharmacists, and parents stood between the defendants’ conduct and the school districts’ alleged additional costs.  The amended complaint repled the case under state law, asserting public nuisance, negligence, gross negligence, civil conspiracy, and aiding and abetting on behalf of seven statewide classes.  As the court put it, the motions to dismiss were “fundamentally about whether the downstream effects of the opioid epidemic give the districts claims against these defendants.”  Id. at *1.

Preliminarily, one of the defendants had already settled with the Attorneys General of all the states where the school districts were located, and that defendant justifiably argued that the plaintiff school districts could not accept the benefit of those public settlements and also sue on their own.  The court rejected that argument, reasoning that the AGs did not purport to represent the school districts and that the consent judgments did not purport to release the school districts’ claims.

On the merits, though, the defendants prevailed on all claims.  On public nuisance, the school districts did not allege a “special injury.”  A public nuisance is “an unreasonable interference with a right common to the general public.”  Id. at *6 (citing Restatement (Second) of Torts § 821B(1)).  A private party may sue only if it “suffered harm of a kind different from that suffered by other members of the public exercising the right common to the general public that was the subject of interference.”  Baltimore City, at *6.  This is the “special injury” requirement. 

On this score, the school districts’ claims were similar to a hospital’s claims for the alleged costs of treating opioid-affected patients:  Such alleged harms are no different in kind from the public’s injury and cannot be special injuries sufficient to support public nuisance.  As another district judge observed in another opioid-related proceeding, “[I]f everyone’s injury is special, no one’s is.”  Id.  Moreover, there is no exception for governmental entities.  A plaintiff suing for the public needs authority “to represent the state,” and the school districts did not have it.  In some ways, the school districts were talking out of both sides of their mouths.  On the one hand, they disavowed their representative capacity to evade the AG settlements, but then purported to drape themselves in a governmental mantle in claiming public nuisance.  This doublespeak left them holding a losing bag. 

The school districts’ other state-law claims failed, too.  On negligence, the school districts effectively abandoned any argument that the defendants owed them a direct duty, which forfeited the point.  In any event, courts consistently decline to find that a consultant owes a duty to strangers allegedly injured by a client’s use of its advice.  The client’s Corporate Integrity Agreement similarly created no tort duty for vendors, and the plaintiffs did not cite any legal provision enacted to protect institutions that bear the cost of drug misuse.

The court’s causation analysis is especially notable.  It distinguished its RICO ruling, explaining that state common law turns on foreseeability, so the number of intervening actors is not alone a reason to dismiss.  Even so, the school districts’ alleged loss is purely economic and derivative of injuries to third parties too remote to support liability.  As the court stated, “[T]he school districts’ injury is not physical harm to their persons or property but the cost of serving people harmed by someone else—economic loss that is wholly derivative of injuries to third parties.  That kind of loss is too remote to be recovered in tort by the party who absorbs it, whatever its foreseeability.”  Id. at *9. 

Finally, the school districts could not hold the defendants liable for the alleged torts of prescription opioid manufacturers under conspiracy and aiding and abetting theories.  Civil conspiracy and aiding and abetting are not standalone claims, and each requires an underlying tort committed against the plaintiff.  The complaint never alleged what duty any manufacturer owed a school district, or under which state’s law.  And, the federal Controlled Substances Act protects individuals, not institutional payors, so it could not supply a negligence per se predicate, either.  In the end, “Without a tort committed against them, there is nothing for defendants to have conspired in or aided.”  Id. at *12. 

To remove all doubt, the court further ruled that the plaintiffs’ negligence-based claims were time barred, except for the plaintiffs located in Maine.  Two of the plaintiffs sued prescription opioid manufacturers in 2019, and the plaintiff school districts did not dispute that they knew of their alleged injuries by that time.  The plaintiffs also knew or could have known the identity of these marketing-related defendants then or shortly thereafter.  Only Maine’s longer, six-year statute of limitations could accommodate the plaintiffs’ claims. 

The court denied leave to amend because its rulings were legal in nature, and the plaintiffs had already had multiple opportunities to amend.  We will return to our square-peg-in-a-round-hole analogy.  Public nuisance claims should not be based on the legal sale of products, including prescription drugs.  That is especially true here, where school districts attempted to recover from actors too far removed any alleged harms and for alleged injuries derived from harm to others.

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As if our reputation as curmudgeonly and heartless defense lawyers needed burnishing, our post today gripes about how the Fifth Circuit affirmed the dismissal of two related cases brought by a decedent’s estate.  This griping arguably ignores the sage advice we have received from a few trial judges to sit down and stop arguing after we have won some contested issue.  Still we persist.  Our non-heroic querulous efforts here are directed to a different sort of equality than those of more storied persistence—the equality of the parties in civil litigation in the eyes of the law.  In literature, television, and film, the plucky little-guy plaintiff recovers against the big-guy corporate defendant despite the system being stacked against him.  In our experience over the last three decades, many things favor the product liability plaintiff, especially when her case proceeds in a plaintiff-friendly jurisdiction against a deep-pocket medical product manufacturer from somewhere else.  One of the least sensational and tangible of these factors is that judges tend to sympathize with injured plaintiffs.  Relatedly, in our experience, they are very hesitant to hold the mistakes of the plaintiff lawyers—even those made quite consciously—against the plaintiffs.

“Hey, grump, what is wrong with having some sympathy or even a little empathy?” you may be asking.  Nothing, we would say.  These are fine qualities for humans to exhibit.  (“Empathy” was even a pangram on Spelling BeeTM earlier this week.)  They just are not supposed to play a role in who wins a motion or trial.  While we are not so naive as to believe all juries push aside their sympathies in the face of relentless emotional overtures from the plaintiff lawyers, model civil jury instructions advise them to do so.  In California, for instance, both the preliminary instructions and the ones about the duties of the judge and jury are emphatic:  “Do not let bias, sympathy, prejudice, or public opinion influence your verdict” and “You must not let bias, sympathy, prejudice, or public opinion influence your decision.”  Federal Rule of Evidence 403 and state equivalents also empower judges to exclude relevant evidence based on its risk of “unfair prejudice, confusing the issues, misleading the jury, undue delay, wasting time, or needlessly presenting cumulative evidence.”  The notes of the federal rule from back in 1932 link “unfair prejudice” to playing on a jury’s sympathy:  “These circumstances entail risks which range all the way from inducing decision on a purely emotional basis, at one extreme, to nothing more harmful than merely wasting time, at the other extreme” and “‘Unfair prejudice’ within its context means an undue tendency to suggest decision on an improper basis, commonly, though not necessarily, an emotional one.”

Judges are also urged not to let sympathy and emotional appeal enter their decision making.  The United States Courts issue something called the Code of Conduct for United States Judges.  We find a number of its provisions interesting and relevant to several decisions we have panned over the last year or so, but the one most relevant here is Canon 3A(1), which provides “A judge should be faithful to, and maintain professional competence in, the law and should not be swayed by partisan interests, public clamor, or fear of criticism.”  Relatedly, “The duty under Canon 2 to act in a manner that promotes public confidence in the integrity and impartiality of the judiciary applies to all the judge’s activities, including the discharge of the judge’s adjudicative and administrative responsibilities.”  Just as a judge should clearly not offer in an opinion that claims about failure to warn with prescription drugs tend to be bogus, statements of sympathy for the extent of injuries allegedly suffered by plaintiffs run contrary to these precepts even if sympathy actually plays no role in the judge’s ultimate decision.  After all, Canon 2 referenced in the second quote is “A Judge Should Avoid Impropriety and the Appearance of Impropriety in All Activities.”  Superfluous statements of sympathy are avoidable and may support the appearance of impropriety depending on how the court rules.

In Phillips v. Ethicon Endo-Surgery, Inc., — F.4th –, 2026 WL 2969090 (5th Cir. Oct. 2, 2026), an estate brought two separate suits for implied warranty, neither of which satisfied the well-known and easily met requirement of pre-suit notice for such claims in Texas.  Plaintiff then acceded to having a final judgment entered in defendants’ favor in the first suit, which precluded her claims in the second suit.  The overall record below was even worse for plaintiff than the thumbnail sketch here suggests, yet the conclusion of the Fifth Circuit’s decision affirming defendants’ judgment in both cases was apologetic:

Our sympathies are with Plaintiffs, who have suffered a horrible loss. Given Plaintiffs’ concessions and forfeiture, we find that they have not shown any reversible error in Phillips I or Phillips II.

Id. at *5.  We have never seen a court write something akin to “we regret that we cannot exclude plaintiff’s general causation testimony that is utterly unsupported and unreliable” or “the law requires us to grant summary judgment to the defendant given plaintiff’s failure to come forward with admissible evidence to support any of her claims, but our sympathies demand that we rule otherwise.”  Part of the issue here is that a court’s ruling on a Rule 12(b)(6), 56, or 702 motion should not depend on whether the plaintiff has suffered a “horrible loss” or is suing over a “tragic death,” as the first paragraph of Phillips writes.  A plaintiff with modest injuries or whose decedent’s death was not tragic—if there is such a thing—has the same burdens.  Pleading standards and state law prerequisites for warranty claims do not change based on the extent of sympathy for the plaintiff, just as they do not change based on whether the plaintiff has some immutable characteristic. 

We have noted a number of times that an opinion’s description of plaintiff’s injuries and why the prescription medical product was used in the case can be indicators for how a court will rule.  In Phillips, the court notes that the prescription surgical stapler was used in connection with the reapproximation of the decedent’s bowel after a length was resected, but it does not say why he had the surgery, which is relevant in a case where a bowel perforation led to sepsis.  A more noteworthy omission from the opinion, however, is any criticism of plaintiff’s counsel.  (There is criticism of defense counsel.)  The first case against the manufacturer defendants was brought in federal court almost two years after the decedent’s injury began, yet plaintiff’s counsel never bothered to provide the required pre-suit notice on the two implied warranty claims asserted along with a design defect claim.  After defendants raised the lack of notice in a motion to dismiss the first complaint, plaintiff merely filed an amended complaint that dropped the design defect claim without fixing the other issues.  Id. at *1.  This was at a point within the statute of limitations for implied warranty claims.  Ultimately, a magistrate recommended that a motion to dismiss the second complaint be granted with prejudice as to a patently inapplicably claim for warranty of fitness for a particular purpose and without prejudice as to a claim for implied warranty of merchantability, which lacked sufficient factual allegations and pre-suit notice.  Id. at *2.  With dismissal on the horizon, plaintiff filed a new state court case against the hospital where the surgery occurred and a slightly different mix of manufacturer defendants.  Then, in sequence, plaintiff did not oppose the adoption of the magistrate report and recommendation, the second case was removed to federal court, the judge in the first case adopted the report and recommendation but made it all with prejudice, the defendants moved to dismiss the second case, the magistrate recommended dismissal based on the prior judgment, and the court adopted it.  Id. at *2-3.  Along the way, plaintiff offered nothing suggesting a further amended complaint could fix the issues with the first two complaints, did not tell the federal court about the second case, and did not seek a voluntary dismissal to provide pre-suit notice or make sure the proper manufacturer entities had been sued.  Plaintiff’s counsel even had “additional relevant facts” asserted in the second case that were not asserted in the first.  Id. at *5.

In affirming the various decisions of the district court, the Fifth Circuit offered no rebuke to the plaintiff’s counsel for their various choices and gaffes.  Surely, filing a second case in state court while the first is still pending in federal court and not informing the federal court could have been called out in starker terms, such as by invoking the duty of candor to a tribunal.  It may be that losing two cases and a published appeal will provide some deterrence for plaintiff-lawyering like this.  As outsiders, we can both express sympathy for the death of plaintiff’s decedent and decry the waste of judicial resources in the two cases she brought and lost.  Courts have their own canons, though.

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