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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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Last week we blogged about the Seventh Circuit’s affirmance of a dismissal of yet another case challenging a vaccine mandate. We predicted that our inbox would be visited by dissenters. We were not wrong. One reader rebuked us for our snarky tone. And that reader was not wrong. 

Look: to our mind, it is perfectly obvious that Jacobson is binding precedent, and employers and governments can take reasonable measures to protect people.  To our mind, following the medical consensus is reasonable. Frankly, we think the other side is mostly unreasonable. But, yes, our language was intemperate.  

We have a Joycean memory of a Thanksgiving dinner a couple of years ago when a political argument erupted and we found ourselves calling an uncle, who was a sweet, intelligent man, stupid.  Others at the table gasped.  We were rude and unkind. We do not mean to inflict that sort of unpleasantness on our readers, or anyone else. 

Still, most of the folks who insist on doing their own research are merely scrolling until they find something that is in accord with their predilections.  Reason scouts and spies for the passions. Tom Nichols wrote about the Death of Expertise, and he was on to something. Maybe it is due to the internet or political polarization, but there is profound skepticism about experts.  Any defense lawyer who files plenty of Rule 702 motions must acknowledge that experts can be wrong. But a medical consensus is more likely to be right than a keyboard warrior. So we plead guilty to deploying a dismissive tone when we consider vaccine cases.  To be fair, most courts are literally dismissive.  We cannot help it; we harbor doubts about the good faith and rationality of most of the challengers. But we have no such doubts about the reader who took the time to write to us. He has ample reserves of smarts and integrity.  We just disagree. And we agree with most of the courts that have wrestled with vaccine mandates. 

This week we find ourselves agreeing with Schmidt v. City of Pasadena, et al., 2026 WL 2980130 (9th Cir. Oct. 5, 2026). Schmidt counts as a major, published, appellate application of immunity under the Public Readiness and Emergency Preparedness (PREP) Act, this time against a plaintiff challenging governmental COVID vaccination requirements.  This decision should put an end to attacks on employment-related vaccination and related requirements, since they are barred by the PREP Act. Should, but probably won’t. 

The plaintiff in Schmidt was a forensic specialist with the Pasadena Police Department. Pasadena implemented a COVID-19 vaccination policy for its employees to “stem the rapid increase in Covid-19 transmission” resulting from the Delta variant of the virus. Employees who successfully invoked exemptions based on religion or sincere beliefs would then be subject to testing and masking requirements.  The plaintiff refused the Covid-19 vaccination, eventually complied with the alternative masking and testing requirements, but contended that those requirements created a “hostile work environment.” He sued, setting forth no fewer than 21 claims (some federal and some state) against the masking and testing requirements.  Both the district and circuit courts had little difficulty holding that all those claims were barred by the PREP Act preemption (state claims) or immunity (federal claims) provisions.  We should point out that the plaintiff also filed motions for recusal of the trial judge and for reconsideration.  (Maybe we are not alone in being intemperate on this topic.)

The PREP Act precludes liability against any “covered person” on “any claim for loss that has a causal relationship with the administration to or use by an individual of a covered countermeasure.”  The local government was a covered person under the Act since it was administering covered countermeasures and was a “program planner” for such countermeasures. So far, so good. 

Vaccination, masking, and testing are all covered countermeasures under applicable emergency use authorizations.  (The plaintiff argued that the saliva tests were particularly out of bounds, but the court disagreed.) “Both the PREP Act and the HHS Secretary’s Declaration plainly extend immunity for the administration of COVID-19 tests and masks.”

The plaintiff attempted to use Loper Bright to get the court to disregard the HHS Secretary’s definition of “covered countermeasure.” But the court held that even in the wake of Loper Bright the court “must respect when Congress has ‘expressly delegated to an agency the authority to give meaning to a particular statutory term.'” 

The Act’s causation language is exceedingly broad, and is satisfied by any of “caused by, arising out of, relating to, or resulting from” use of countermeasures.  The Act’s scope is not limited to any particular category of causes of action.  The plaintiff’s alleged emotional distress damages and purported “property interest” in his DNA are all “losses” under the Act and the claims are therefore preempted. 

The recusal motion was based on the district judge’s ownership of mutual funds. But ownership  in a mutual fund is not considered a “financial interest in such securities unless the judge participates in the management of the fund.”

Finally, the court considered the plaintiff’s motion for Rule 11 sanctions based on the defendants’ disparagement of the plaintiff’s expert for indulging in a “conspiracy theory” and other “outlandish conspiracies.”  The court held that such “word choice simply does not meet the criteria for being made without reasonable, competent inquiry.” 

The case was dismissed and the plaintiff’s sanctions request was denied. 

Is it churlish of us to feel doubly vindicated?

Or should we say triply vindicated? After the Ninth Circuit issued its opinion, the plaintiff filed an emergency motion to vacate the opinion “based on lies, misstatements, false statements, material omissions, and sophistry in the rendered opinion.”  Earlier we confessed to being intemperate.  But compared to this litigant, we look like Fred Rogers.  

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Every so often, the song nobody wanted turns out to be the one that lasts. Radiohead almost left “Creep” off their debut album because the band itself was embarrassed by it; it became their defining hit. Prince wrote “Nothing Compares 2 U” and gave it away as album filler for a side project he was producing, and it sat largely unnoticed for years before someone else’s cover turned it into a standard. Fleetwood Mac’s “Dreams” was reportedly written in about ten minutes, tucked in among songs the band thought were the real singles, and it ended up their only number one hit. Nobody plans for the afterthought to be the survivor. A Lap-Band preemption decision out of the Southern District of West Virginia this week tells a similar story, except in reverse — almost the entire album got cut, and the one track still standing was never much of a contender to begin with.

The Lap-Band is a Class III device that received premarket approval from the FDA in 2001. The defendant manufacturer acquired the device in 2006 and marketed it until at least 2015. Plaintiff had hers implanted in 2009. Fifteen years later, the device eroded into her stomach and bowel, requiring surgical removal. Plaintiff sued the manufacturer and a string of corporate successors and affiliates asserting failure to warn, design defect, negligence, gross negligence, a state consumer protection claim, negligent misrepresentation, and punitive damages — seven tracks on the album, so to speak. Defendants moved to dismiss on preemption and pleading-sufficiency grounds. The resulting decision in Branch v. Allergan, Inc., 2026 WL 2939572 (S.D.W. Va. Sept. 30, 2026), is a useful refresher on just how far PMA preemption reaches when a plaintiff tries to dress up a different-or-additional-requirements claim as something else.

Plaintiff’s warning claim argued that defendants should have disclosed higher erosion, removal, and failure rates than the FDA-approved labeling reflected. No matter how plaintiff tried to frame it — as a labeling problem or as a marketing-and-advertising problem — the court saw it for what it was — a demand for greater warnings than the FDA required, which is squarely preempted. Id. at *6. The court also found the claim independently inadequate under TwIqbal because plaintiff never pointed to specific facts showing how the advertising actually deviated from the PMA-approved conditions. Id. at *7. Conclusory allegations that advertising was “inconsistent” with the PMA approval do not cut it; a plaintiff has to identify an actual fact-based regulatory violation, not just assert one.

The design defect claim fared no better, and for a reason that should surprise nobody who has followed PMA preemption for more than five minutes. West Virginia requires a plaintiff asserting design defect to prove a feasible alternative design existed. But any alternative design is, by definition, a different design than the one the FDA approved through the PMA process. That is exactly the kind of “different from, or in addition to” federal requirement that Riegel v. Medtronic forecloses. Id. at *6–7. The court lined this ruling up with a chorus of sister-court authority holding the same thing — you cannot use state design-defect law to relitigate the FDA’s own risk-benefit calculus on a Class III device.

Negligence, gross negligence, and negligent misrepresentation got a partial reprieve — but only partial. Id. at *8. To the extent those claims were really failure-to-warn claims in a different costume, they were preempted for the same reasons as above. The one sliver that survives is any claim resting on affirmative misrepresentations about the device, as opposed to a failure to disclose more than the FDA required. The court was careful to note that a manufacturer does not violate federal law merely by saying its FDA-approved device is safe — that is the whole point of approval. It is only when a manufacturer makes other affirmative claims, like superiority over competing devices, that it steps outside the protected zone. Notably, the court never identifies any specific affirmative misrepresentation that plaintiff actually pled. Rather, this is a claim that survives the motion more on the theory that it could exist than on any specific factual allegation that it does.

The next part of the decision is West Virginia specific but noteworthy. The court held claims brought under the West Virginia Consumer Credit and Protection Act are barred for Class III medical devices. Id. at *8–9. This ruling extends the West Virginia Supreme Court’s decision in White v. Wyeth, 705 S.E.2d 828 (W. Va. 2010) — previously applied to prescription drugs — to a Class III device for the first time. Id. at *9. “White stands for the common-sense proposition that where there is a protective intermediate decision-making buffer[,] the patient-consumer is insulated from the wrongs the WVCCPA seeks to redress.” Branch, 2026 WL 2939572, at *10. Plaintiff argued that West Virginia’s high court had never extended White to medical devices and would not do so here. The court disagreed, reasoning that the plaintiff was never a consumer left to navigate a complex medical decision on her own. Id. at *10–11. In fact, she went through not one but two physicians before her Lap-Band was implanted. Class III devices are about as heavily regulated as products get and implanting surgeons are certainly decision-making buffers. Id.

Fifteen years is a long time, and corporate ownership of the Lap-Band changed hands more than once in that stretch. Plaintiff tried to rope all of the successors and affiliates in under a successor liability theory. The court was not having it. West Virginia only permits successor liability where there was an express or implied assumption of liability, a fraudulent transaction, or bad faith in the transaction — and plaintiff did not plead facts supporting any of those narrow grounds, except against one co-promoter. Id. at *11. Call it a one-hit wonder — of four corporate defendants targeted on a successor or affiliate theory, only one made the final cut.

There is really only one sour note in this decision. The negligent misrepresentation claim survives in theory, but the court never points to any specific affirmative misrepresentation that plaintiff actually pled, leaving the door open for defendants to revisit the issue on summary judgment. Seven tracks went into this motion, and only a fragment of one came out the other side still standing. Unlike “Creep” or “Dreams,” though, this survivor was not a hidden gem waiting to be discovered — it is an undeveloped claim that escaped the cutting room floor on a technicality, and it may well not make the final cut either once the record is actually developed. Most of this album got cut exactly where it should have — at the PMA preemption line.

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