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Benzene-based consumer class actions are becoming almost routine. So are their dismissals on preemption grounds. It takes something a little different to make one stand out. The plaintiff in Leonard v. CVS Pharmacy, 2026 WL 986311 (N.D. Cal. Apr. 13, 2026), tried just that, invoking a res ipsa loquitur–type theory to plead “parallel” CGMP violations. That move may sound familiar to those who follow medical device litigation, where it has been tried—and rejected—before. But as far as we know, this is the first time plaintiffs have attempted to import that playbook into the growing wave of benzene cases.

It didn’t work here either.

We probably shouldn’t be surprised. This was already plaintiff’s second attempt to bring her consumer protection claims against the manufacturers of generic Mucinex. The court previously dismissed her claims as expressly preempted after concluding that the FDA’s approval of the drug’s ANDA, which disclosed that its manufacturing process involved a carbomer that could introduce benzene, necessarily determined the product complied with the FDCA. Claims that the product was “adulterated” or “misbranded” because it contained benzene imposed requirements different from federal law and were therefore preempted. Id. at *1. Plaintiff was given leave to amend. She did—but not successfully.

Round two swaps out express preemption arguments for a “parallel violation” theory grounded in CGMPs. Plaintiff alleged that defendants violated those regulations and that the violations resulted in benzene contamination. But as the court quickly recognized, the theory had a glaring problem: it was entirely unsupported by facts. Indeed, “the only fact Plaintiff alleges to support her allegations that Defendants violated the cGMPs, is the presence of benzene itself.” Id. at *2. But that’s just circular reasoning.

Start with the basics. CGMPs do not regulate the presence of benzene. In fact, the FDA approved the product with the condition that it could contain benzene below a certain threshold (2 ppm). Id. at *3. So, the mere presence of benzene does not establish a CGMP violation. And if plaintiff’s position is that any benzene violates CGMPs, that would put her theory squarely at odds with the FDA’s approval—creating the very conflict that preemption forbids.

So, plaintiff tried a different tack suggesting that maybe the levels were too high. But here again, the complaint comes up empty. There are no factual allegations about the benzene levels in the product plaintiff actually purchased—only the assertion that benzene levels can be “astronomically high.” Id. But saying something can happen is not the same as alleging that it did happen. Saying a product can contain high levels of benzene is like saying a lottery ticket can be a winner. True—but most aren’t. Plaintiff needs “more than a sheer possibility” to satisfy TwIqbal. She didn’t get there.

Plaintiff also attempted to anchor her claims by listing various CGMPs—written procedures, laboratory controls, recordkeeping obligations. But again, the complaint offered no facts explaining how any of those requirements were actually violated. A laundry list of regulatory provisions, untethered to factual allegations, likewise does not satisfy federal pleadings standards. Again, plaintiff relied exclusively on the presence of benzene as purported proof that defendants violated the CGMPs. But the court was unwilling to take the leap plaintiff invited–to infer that the failure to keep written procedures, laboratory controls, or laboratory records caused the presence of benzene. Id.

That’s where the res ipsa theory ultimately collapses. The premise is that benzene should not be present unless something went wrong, so the court should infer a CGMP violation. But as courts have already recognized in the device context, complex medical products and complex regulatory schemes do not lend themselves to that kind of shortcut. Without factual allegations connecting the dots, there is no “parallel” claim—just speculation dressed up as doctrine.

This time, because plaintiff advanced a new theory, she gets one more chance to try to plead it. But stepping back, the broader takeaway is becoming hard to ignore. Plaintiffs keep looking for a way into these benzene class actions—and keep running headfirst into preemption. Express preemption has blocked one path. Implied preemption has closed off another. And now, even repackaging the claim as a res ipsa-style “parallel violation” theory meets the same fate.

At some point, the pattern matters. Plaintiff may get another opportunity to re-plead in this case, but it is difficult to see what avenue remains. Without facts showing an actual, non-preempted violation tied to her product, simply relabeling the theory is not going to get her over the hump. So far, every path leads back to the same place: dismissal.

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The learned intermediary rule – that prescription medical product warnings are directed to (and written to be understood by) the professional medical personnel who prescribe them – is as close to unanimous as any tort doctrine that we know of.  We keep a running tab on the 50 states, and the rule has support in every state, including 37 highest courts (or statutory adoption).  The learned intermediary rule is so widespread because the policies supporting it are likewise universally recognized.  There are several such supportive policies, but one of the most important is to preserve the institution of the physician-patient relationship.

Direct-to-patient warnings from manufacturers and others in the chain of distribution of prescription medical products would inevitably complicate and disrupt the physician-patient relationship.  Unlike physicians, who tailor their informed consent process to the medical needs of particular patients, remote manufacturers could only provide generalized information – and none at all about off-label uses.  If the law were to require persons other than prescribing physicians to send generalized information directly to patients (assuming that it is even practical to do so, another reason for the rule), that information would inevitably conflict with the patient-specific medical advice that the prescribers themselves are legally and ethically required to provide their patients.

Again, that conflict would inevitably occur with off-label uses, given FDA restrictions on what regulated entities are required to say.  Off-label use remains a significant part of medical practice.  In his 2021 off-label use law review article Bexis reported:

More recent estimates indicate the prevalence of off-label use remains notoriously high among some patient populations.  An estimated twenty-one to fifty percent of all prescriptions are for off-label indications and in some patient groups, this number may exceed eighty percent.  Off-label use is particularly prevalent in oncology and in pediatrics.

James Beck, “Off-Label Use in the Twenty-First Century: Most Myths & Misconceptions Mitigated,” 54 UIC J. Marshall L. Rev. 1, 25-26 (2021) (footnotes and quotation marks omitted).  Two years later a Congressional Research Service report reached essentially the same conclusion. 

In a 2006 study of drug prescribing by office-based physicians, 21% of prescriptions were written for off-label uses.  Of those off-label prescriptions, the study’s authors found that 27% were backed by strong scientific support. . . .  An econometric model from the National Ambulatory Medical Care Survey estimated a 38% rate of off-label use.

Research has shown that more than half of oncology drug use is off-label.  A 2018 study examined 43 FDA-approved cancer drugs and compared their 99 labeled uses with the acceptable uses published by a national compendium Medicare relies on to make coverage decisions.  Of the 451 compendium-accepted uses, 56% were off-label. Of the off-label uses, the authors deemed 91% as “well-accepted off-label use.”

Hassan Sheikh, “Off-Label Use of Prescription Drugs,” at 2-3 (2023) (Canadian information and footnotes omitted).  That’s a lot of physician prescriptions that, but for the learned intermediary rule, would be disrupted by extraneous, but legally required information from FDA-regulated product manufacturers.  And the disruption to the physician-patient relationship that the learned intermediary rule prevents goes far beyond just off-label use situations.

Thus, it’s hardly a surprise that courts have repeatedly referenced damage to the physician-patient relationship as a basis for the learned intermediary rule.  Washington adopted the learned intermediary “primarily for public policy reasons focused on preserving the physician-patient relationship,” Rublee v. Carrier Corp., 428 P.3d 1207, 1217 (Wash. 2018), and that state’s highest court discussed the need for the rule to protect the physician-patient relationship at length in Dearinger v. Eli Lilly & Co., 510 P.3d 326 (Wash. 2022):

Physicians comprehend this complex information in a way the average lay person cannot.  Indeed, the FDA has recognized the information on the prescribers’ label is of “questionable” value when provided directly to patients and “relatively inaccessible to consumers. . . .”  [P]hysicians can give personally tailored warnings to patients in a way manufacturers cannot.  A physician can personalize warnings to a patient based on that patient’s medical history and needs.  “[I]t is only the physician who can relate the propensities of the drug to the physical idiosyncrasies of the patient.”  “A physician possesses the medical training to assess adverse health effects of a medical product and to tailor that assessment to a particular patient.”  Conversely, drug manufacturers cannot create individualized warnings because they do not know consumers’ medical information.  Thus, manufacturers issue broad, complex warnings that must be simplified by a learned intermediary − the physician − before being given to patients.

Dearinger v. Eli Lilly & Co., 510 P.3d 326 (Wash. 2022) (quoting McKee v. American Home Products, Corp., 782 P.2d 1045, 1051 (Wash. 1989), and Ruiz-Guzman v. Amvac Chemical Corp., 7 P.3d 795, 802 (Wash. 2000)) (regulatory citation omitted).  McKee also observed that mandating manufacturer warnings “may confuse and frighten the patient.”  782 P.2d at 1055.

Another state high court discussed the learned intermediary rule’s function to protect the physician-patient relationship extensively in Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012):

Despite the intricate web of modern healthcare providers and treatments, the bedrock of our healthcare system is the physician-patient relationship, and the ultimate decision for any treatment rests with the prescribing physician and the patient.  As a matter of both necessity and practicality, the duty to warn the patient of the potential risks and possible alternatives to any prescribed course of action rests with the prescribing physician. . . .  [Generalized information from a manufacturer] cannot explain the complex intricacies of the human body or supplant the detailed, interconnected nature of the practice of medicine, which necessitates that an informed intermediary help determine the best course of treatment for a patient’s particular symptoms.  To hold that each healthcare provider owes a separate and individual duty to warn each patient of all possible risks associated with a treatment prescribed by any doctor would . . . undermine the prescribing doctor’s physician-patient relationship. . . .  In most prescription drug contexts, the learned intermediary doctrine applies and the duty to warn the patient rests solely with the prescribing physician.

Id. at 166-67 (citations and footnote omitted).

“[I]mposition of a duty to warn the user directly would interfere with the relationship between the doctor and the patient.”  West v. Searle & Co., 806 S.W.2d 608, 613 (Ark. 1991) (citation omitted).  Plainly, “the highly personal doctor-patient relationship” is one of the “safeguards in place under the learned intermediary doctrine.”  Vitanza v. Upjohn Co., 778 A.2d 829, 845 (Conn. 2001).

When a patient consults with a physician seeking a prescription drug or restricted device, the patient also expects the physician to use his informed independent judgment to advise the patient and to prescribe the most appropriate use of the drug or device, based on his professional judgment.

Lacy v. G.D. Searle & Co., 567 A.2d 398, 400 (Del. 1989).  The “reasons” for the learned intermediary rule are “obvious” – patients “place primary reliance upon [physician] judgment,” and necessarily “[t]he physician decides what facts should be told to the patient.”  Wooderson v. Ortho Pharmaceutical Corp., 681 P.2d 1038, 1052 (Kan. 1984).  Only doctors know exactly how a drug is being prescribed, and can tailor the informed consent discussion to the relevant risks:

[I]mposing a duty to warn upon the manufacturer would unduly interfere with the physician-patient relationship. . . .  []Since the typical manufacturer’s warning provides a list with scores of potential side effects, no matter how minute the possibility of occurrence, the lay consumer might overreact to such warnings and forego beneficial, or even vital, medical treatment.

Larkin v. Pfizer, Inc., 153 S.W.3d 758, 764 (Ky. 2004) (citations omitted).  See Perez v. Wyeth Laboratories, Inc., 734 A.2d 1245, 1255 (N.J. 1999) (“courts do not wish to intrude upon the doctor-patient relationship”; “warnings that contradict information supplied by the physician will undermine the patient’s trust in the physician’s judgment”) (citation and quotation marks omitted).

The same is true for the learned intermediary rule in cases where plaintiffs seek to impose general duties on pharmacists to provide information direction to patients.  Several state high courts have made this crystal clear, the first being Pennsylvania (in a decision Bexis briefed). 

While the patient is entitled to know, and a doctor has a duty to inform the patient, of any dangers or side effects associated with a drug recommended for treatment, we see no sound reason for imposing on pharmacists the duty to supply information about the risks of drugs that have already been prescribed.  On the contrary, such a rule would have the effect of undermining the physician-patient relationship by engendering fear, doubt, and second-guessing.

Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1386 (Pa. 1991).  Massachusetts was next in line:

Physicians, after considering the history and needs of their patients and the qualities of the drug, are required to inform their patients of those side effects they determine are necessary and relevant for patients to know in making an informed decision.  Requiring the manufacturer to provide warnings directly to the consumer would interfere with the doctor-patient relationship.

Cottam v. CVS Pharmacy, 764 N.E.2d 814, 820 (Mass. 2002) (citations omitted).  Other states have followed:

Because the decision to prescribe a specific drug involves an analysis of the patient’s unique condition and a balancing of the risks and benefits of a given drug, the cases extending the learned intermediary to pharmacists reason that imposing a duty to warn on the pharmacist would intrude on the doctor-patient relationship and would force the pharmacist to practice medicine without a license.

Walls v. Alpharma USPD, Inc., 887 So.2d 881, 885 (Ala. 2004) (citation omitted).  Accord Kowalski v. Rose Drugs of Dardanelle, Inc., 378 S.W.3d 109, 120 (Ark. 2011) (“the underlying rationale for applying the learned-intermediary doctrine is to protect the patient-physician relationship by preventing pharmacists from second-guessing the physicians or otherwise interfering with the patient-physician relationship”); Nail v. Publix Super Markets, Inc., 72 So.3d 608, 615 (Ala. 2011) (the learned intermediary rule “sought to prevent, asking the pharmacist to intrude himself or herself into the physician-patient relationship”).

In addition to these high court decisions, numerous other state and federal courts have also recognized preservation of the physician-patient relationship as a key policy behind the learned intermediary rule.  The reasoning in Swayze v. McNeil Laboratories, Inc., 807 F.2d 464 (5th Cir. 1987) (applying Mississippi law), rejecting abandonment of the learned intermediary rule because doctors, allegedly, were not doing their jobs, remains valid today and almost universally applicable:

[W]hat would patients do with this information [a direct to patient warning]?  It might prompt would-be patients to put pressure on their physicians to better supervise, but physicians hardly need more incentive to be non-negligent.  In all likelihood, such warnings would only lead to confusion, and perhaps undermine the physician-patient relationship.  When the physician-patient relationship does exist, as here, we hesitate to encourage, much less require, a drug manufacturer to intervene in it. . . .  A special relationship, between physician and patient . . . receives special protection in law, and, at the same time, creates a great responsibility for every physician. . . .  [I]t is the physicians who have undertaken the responsibility of [performing the relevant medical procedures], and that responsibility cannot be shunted onto, or shared with, drug manufacturers.

Id. at 471.  Many other courts, applying the laws of many other jurisdictions, have recognized the essential role that the learned intermediary rule is intended to play in preserving the physician-patient relationship.

Alabama:  Lansdell v. American Home Products Corp., 1999 WL 33548541, at *5 (N.D. Ala. Oct. 26, 1999), held:

Neither manufacturer nor pharmacist has the medical education or knowledge of the medical history of the patient which would justify a judicial imposition of a duty to intrude into the physician-patient relationship.  Moreover, to hold otherwise, would require the pharmacist to question the physician’s judgment regarding the appropriateness of each customer’s prescription.  Such a policy, inevitably, would wedge the pharmacist into the relationship between a physician and her or his patient and, thereby, interfere with ongoing treatment.

Id. at *5 (citations and quotation marks omitted).  Accord Orr v. Wyeth-Ayerst Laboratories Co., 1999 WL 33548162, at *2 (Ala. Cir. Aug. 2, 1999) (direct-to-patient warnings are an “interference in the patient-physician relationship [that] can only do more harm than good).

Arkansas:  Bell v. Pfizer, Inc., 716 F.3d 1087, 1097 (8th Cir. 2013) (“[A] duty to warn the user directly would interfere with the relationship between the doctor and the patient.  With respect to the relationship between the patient, the physician, and the pharmaceutical manufacturer, the patient must look to the physician, for it is only the physician who can relate the propensities of the drug to the physical idiosyncracies of the patient.”) (citations and quotation marks omitted) (applying Arkansas law); Kendrick v. Wright Medical Technology, Inc., 2021 WL 3516663, at *6 (E.D. Ark. Aug. 10, 2021) (“imposing such a duty to warn on [the manufacturer] would interfere with the relationship between [plaintiff’s surgeon] and [plaintiff]”) (citation and quotation marks omitted); Stube v. Pfizer Inc., 446 F. Supp. 3d 424, 440 (W.D. Ark. 2020) (following West; “requiring drug manufacturers to directly warn the ultimate drug consumer would interfere with the doctor/patient relationship because patients rely on their doctors’ expertise in selecting and using drugs”); Kohl v. American Home Products Corp., 78 F. Supp. 2d 885, 890 (W.D. Ark. 1999) (courts “have been cautious in placing a duty to warn of potential side effects on a pharmacy because such a duty would interfere with the physician-patient relationship”).

California:  Plenger v. Alza Corp., 13 Cal. Rptr. 2d 811, 819 n.6 (Cal. App. 1992):

The rationale of the [learned intermediary] rule is:  [that] The doctor is intended to be an intervening party in the full sense of the word.  Medical ethics as well as medical practice dictate independent judgment, unaffected by the manufacturer’s control, on the part of the doctor. . . .  Were the patient to be given the complete and highly technical information on the adverse possibility associated with the use of the drug, he would have no way to evaluate it, and in his limited understanding he might actually object to the use of the drug, thereby jeopardizing his life.

(quoting Carmichael v. Reitz, 95 Cal. Rptr. 381, 400 (Cal. App. 1971)); Saavedra v. Eli Lilly & Co., 2013 WL 3148923, at *2 (C.D. Cal. June 13, 2013) (“Requiring the manufacturer to provide warnings directly to the consumer would interfere with the doctor-patient relationship.”) (applying California, Massachusetts and Missouri law); Regwan v. Reagan, 2020 WL 7862818, at *4 (Cal. Super. Nov. 5, 2020) (“Plaintiff’s allegations that a device manufacturer owes a duty to supervise and intervene in the provision of medical care cannot be reconciled with California’s licensing scheme or the learned intermediary doctrine and its underlying rationale.  To impose such a duty would place a medical device manufacturer in the middle of the doctor-patient relationship.”); Russo v. Safeway, Inc., 2006 WL 4114000 (Cal. Super. Jan. 3, 2006) (“[T]he rationale for applying the doctrine to pharmacists is compelling.  To impose such a duty to warn on the pharmacist would be to place the pharmacist in the middle of the doctor-patient relationship”.) (footnote omitted).

Connecticut:  DiVincenzo v. Molinaro, 2022 WL 17102332, at *2 (Conn. Super. Nov. 2, 2022) (“To impose a duty to warn on the pharmacist, however, would be to place the pharmacist between the physician who, having prescribed the drug presumably knows the patient’s present condition as well as his or her complete medical history, and the patient. Such interference in the patient-physician relationship can only do more harm than good.”) (citation and quotation marks omitted); Lynch v. State, 2018 WL 2207813, at *4 (Conn. Super. April 17, 2018). (analogizing sperm bank to pharmacist; “physicians have more knowledge than pharmacists about their patients’ needs and proclivities.  Holding otherwise would put pharmacists between the physician-patient relationship.”); Deed v. Walgreen Co., 927 A.2d 1001. 1004 (Conn. Super. 2007) (“To impose a duty to warn on the pharmacist would be to place the pharmacist in the middle of the doctor-patient relationship, without the physician’s knowledge of the patient.”) (citation and quotation marks omitted) (emphasis original).

Florida:  Buckner v. Allergan Pharmaceuticals, Inc., 400 So.2d 820, 823-24 (Fla. App. 1981) (purported physician failures to warn do not affect the learned intermediary rule; “extent of disclosure is a matter of medical judgment”; “failure to do so in a particular instance should not give rise to a duty in the manufacturer”); Pringle v. Johnson & Johnson, 2020 WL 4501834, at *3 n.5 (S.D. Fla. Jan. 30, 2020) (“[w]arnings directly from the manufacturer to the patient can undermine the doctor-patient relationship”); Labzda v. Purdue Pharma, L.P., 292 F. Supp.2d 1346, 1355 (S.D. Fla. 2003) (“Florida law does not impose a duty on the defendants to interfere with the physician-patient relationship”).

Georgia: Williams v. American Medical Systems, 548 S.E.2d 371, 375 (Ga. App. 2001) (“any information supplied to [plaintiff] by [the manufacturer] regarding dangers associated with the device could compromise the doctor-patient relationship”); Lance v. American Edwards Laboratories, 452 S.E.2d 185, 187 (Ga. App. 1994) (“any information supplied to [plaintiff] by defendants regarding dangers associated with use of the [device] may have compromised the doctor-patient relationship and thus impaired the best medical treatment for [plaintiff’s] chronic condition”); Walker v. Jack Eckerd Corp., 434 S.E.2d 63, 67 (Ga. App. 1993) (learned intermediary rule reflects “the need for preserving, without interference of third parties, a trusted physician-patient relationship”); Ellis v. C.R. Bard, Inc., 311 F.3d 1272, 1280 (11th Cir. 2002) (quoting and following Lance); Ingram v. Mylan Pharmaceuticals, Inc., 2009 WL 10665022, at *4 (N.D. Ga. Nov. 12, 2009). (“Considering the reality and practicality of the doctor and patient relationship, the learned intermediary doctrine developed in Georgia.”).

Illinois:  Urbaniak v. American Drug Stores, LLC, 126 N.E.3d 561, 567 (Ill. App. 2019) (“the learned intermediary doctrine dictates that pharmacists stay out of the physician-patient relationship”).  The same court made same point at greater length in Kennedy v. Medtronic, Inc., 851 N.E.2d 778 (Ill. App. 2006):

[A] central aspect of the learned intermediary doctrine . . . is that a licensed physician . . . has the knowledge of his patient’s medical history and background, and, therefore, he is in a better position, utilizing his medical judgment, to determine a patient’s needs and what medical care should be provided.  It would be unreasonable, and potentially harmful, to require a [device manufacturer’s representative] to delay or prevent a medical procedure simply because she believes the setting is not appropriate or the doctor is unqualified.  To hold otherwise would place a medical device manufacturer . . . in the middle of the doctor-patient relationship.

Id. at 786.  The same reasoning was also made, as to a pharmacist, in Fakhouri v. Taylor, 618 N.E.2d 518 (Ill. App. 1993):

Determining which medication is to be utilized in any given case requires an individualized medical judgment, which, in our opinion, only the patient’s physician can provide.  That physician, having prescribed the drug, presumably knows the patient’s current condition, as well as the patient’s complete medical history.  To impose a duty to warn on the pharmacist would be to place the pharmacist in the middle of the doctor-patient relationship, without the physician’s knowledge of the patient.

Id. at 521; accord Eldridge v. Eli Lilly & Co., 485 N.E.2d 551, 553 (Ill. App. 1985) (without the learned intermediary rule, “the pharmacist would have to interject himself into the doctor-patient relationship and practice medicine without a license”); In re Depo-Provera (Depot Medroxyprogesterone Acetate) Products Liability Litigation, 2025 WL 2711592, at *3 (N.D. Fla. Sept. 22, 2025) (following Fakhouri) (applying Illinois law); In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation, 692 F. Supp.2d 1025, 1033 (S.D. Ill. 2010) (policy “reasons” supporting learned intermediary rule include avoiding “[i]nterference with the doctor-patient relationship”); In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation, 692 F. Supp.2d 1012, 1018 (S.D. Ill. 2010) (same); Stephens v. CVS Pharmacy, 2009 WL 1916402, at *3 (N.D. Ill. June 11, 2009) (following Fakhouri); Jones v. Irvin, 602 F. Supp. 399, 402 (S.D. Ill. 1985) (“Placing these duties to warn on the pharmacist would only serve to compel the pharmacist to second guess every prescription a doctor orders in an attempt to escape liability.”).

Indiana:  Ingram v. Hook’s Drugs, Inc., 476 N.E.2d 881 (Ind. App. 1985):

The decision of weighing the benefits of a medication against potential dangers that are associated with it requires an individualized medical judgment.  This individualized treatment is available in the context of a physician-patient relationship which has the benefits of medical history and extensive medical examinations. . . .  The injection of a third-party in the form of a pharmacist into the physician-patient relationship could undercut the effectiveness of the ongoing medical treatment.

Id. at 886-87 (footnote omitted).

Iowa: Madsen v. American Home Products Corp., 477 F. Supp.2d 1025, 1033 (E.D. Mo. 2007) (“states want to preserve the doctor-patient relationship which could be undermined if patients received warnings from drug manufacturers that differed from doctor’s warnings”) (applying Iowa law).

Kansas:  Nichols v. Central Merchandise, Inc., 817 P.2d 1131, 1133 (Kan. App. 1991) (imposing a duty to warn on the pharmacist would intrude on the doctor-patient relationship and would force the pharmacist to practice medicine without a license”).

Maine:  Tardy v. Eli Lilly & Co., 2004 WL 1925536, at *2 (Me. Super. Aug. 3, 2004) (“The injection of a third party . . . into the physician/patient relationship could undercut the effectiveness of the ongoing medical treatment by the physician. . . .  [T]he patient would be receiving information about the risks of medication . . . from someone unfamiliar with the patient’s medical condition, after those risks had already been weighed by a physician having specific knowledge of the patient’s medical needs.”).

Massachusetts:  Yout v. Biogen Idec, Inc., 2015 WL 13697200, at *4 (Mass. Super. Oct. 15, 2015) (“Requiring the manufacturer to provide warnings directly to the consumer would interfere with the doctor-patient relationship.”).

Michigan:  Mowery v. Crittenton Hospital, 400 N.W.2d 633, 637 (Mich. App. 1986) (“a duty to warn the user directly would cause undue interference with the relationship between doctor and patient”) (citations omitted); Nichols v. McNeilab, Inc., 850 F. Supp. 562, 570 (E.D. Mich. 1993) (“The rationale behind the [learned intermediary rule] has been stated as avoiding the confusion and unnecessary interference with the doctor/patient relationship which might result if drug manufacturers were required to warn patients directly of their drug’s possible side effects.”); Hickey v. Tennessee Gas Pipeline Co., 1992 WL 236915, at *3 (E.D. Pa. Sept. 9, 1992) (“A warning to the patient under these circumstances could potentially cause undue interference with the doctor-patient relationship, cause patient confusion, and result in a hampering of the healing process.”) (quoting and following Mowery) (applying Michigan law); Reaves v. Ortho Pharmaceutical Corp., 765 F. Supp. 1287, 1289 (E.D. Mich. 1991) (“[t]he learned intermediary doctrine protects the physician-patient relationship”).

Missouri:  Puricelli v. Genetech, Inc., 2011 WL 1576779, at *2 n.2 (E.D. Mo. April 26, 2011) (“states want to preserve the doctor-patient relationship which could be undermined if patients received warnings from drug manufacturers that differed from doctor’s warnings”) (citation and quotation marks omitted).

New Jersey:  Jones v. Synthes USA Sales, LLC, 2010 WL 3311840, at *4 n.3 (D.N.J. Aug. 19, 2010) (the learned intermediary rule has a rationale which . . . prevents the court from intruding upon the doctor-patient relationship”); Simineri v. LifeCell Corp., 2015 WL 3384588, at *8 (N.J. Super. Law Div. May 8, 2015) (“To require [defendant] to communicate directly with the patient would unnecessarily intrude on the doctor-patient relationship.).

New York:  In a pharmacy case, Abrams v. Bute, 27 N.Y.S.3d 58 (N.Y. App. Div. 2016), held:

Courts have been reluctant to impose a standard of care on pharmacists that would . . . require pharmacists to exercise their own professional judgment in a manner that could conflict with that of the prescribing physician. . . .  Accordingly, a rule that requires a pharmacist to independently evaluate the propriety of a physician’s prescription would not only place an undue burden on pharmacists, but would likely create antagonistic relations between pharmacists and physicians and interfere with the patient-physician relationship.

Id. at 66-67 (citations and quotation marks omitted).  Accord Brumaghim v. Eckel, 944 N.Y.S.2d 329, 332 (N.Y. App. Div. 2012)  (imposing “duties to warn on the pharmacist would only serve to compel the pharmacist to second guess every prescription a doctor orders in an attempt to escape liability”); Bee v. Novartis Pharmaceuticals Corp., 18 F. Supp.3d 268, 295 (E.D.N.Y. 2014) (quoting and following Hogan); Hogan v. Novartis Pharmaceuticals Corp., 2011 WL 1533467, at *10 (E.D.N.Y. April 24, 2011) (“Broadly speaking, the learned intermediary rule seeks to preserve the doctor-patient relationship and allows the doctor to interpret the dangers involved in taking a drug; a warning to the patient, the rationale suggests, even if practical, could be detrimental as the patient may not properly weigh the drug’s risks against its benefits.”).

Oklahoma:  Carista v. Valuck, 394 P.3d 253, 259 (Okla. App. 2016) (rejecting “broad expansion to the duties of pharmacists” that would “second-guess the judgment of a doctor in prescribing drugs” and “would result in pharmacists acting as a form of second medical opinion, and certainly could enmesh pharmacists in the practice of medicine.”  Rather pharmacist duties are “limited by the principles and exceptions to the learned intermediary doctrine”) (footnote omitted).

Pennsylvania:  Makripodis v. Merrell-Dow Pharmaceuticals, Inc., 523 A.2d 374, 378 (Pa. Super. 1987) (“A requirement that a pharmacist provide to the consumer the same warnings that the drug manufacturer must supply to prescribing physicians would intrude upon the doctor-patient relationship.”); Polt v. Sandoz, Inc., 462 F. Supp.3d 557, 570 & n.18 (E.D. Pa. 2020) (quoting and following Coyle; “the physician, not the manufacturer, decides whether to prescribe drugs and explains the risks to consumers”); Ramirez v. Richardson-Merrell, Inc., 628 F. Supp. 85, 88 (E.D. Pa. 1986) (“To impose a duty to warn on the pharmacist, however, would be to place the pharmacist between the physician who, having prescribed the drug presumably knows the patient’s present condition as well as his or her complete medical history, and the patient. Such interference in the patient-physician relationship can only do more harm than good.”).

Rhode Island: Franks v. Coopersurgical, Inc., 722 F. Supp.3d 63, 91 (D.R.I. 2024) (the learned intermediary rule “puts the onus on a patient’s physician to inform her of the risks associated with a particular medical device because the physician is in a better position to understand the risks, and inform the patient of those risks by virtue of their doctor-patient relationship”) (citation omitted).

South Carolina:  Brooks v. Medtronic, Inc., 750 F.2d 1227, 1232 (4th Cir. 1984) (“[T]otal disclosure by a manufacturer would not be in the patient’s best interest.  One in a serious medical condition faces unwanted, unsettling and potentially harmful risks if advice, almost inevitably involved and longwinded, from non-physicians, contrary to what the doctor of his choice has decided should be done, must be supplied to him during the already stressful period shortly before his trip to the operating room.”).

Tennessee:  Laws v. Johnson, 799 S.W.2d 249, 254 (Tenn. App. 1990) (quoting and following Brooks, see South Carolina); Dunkin v. Syntex Laboratories, Inc., 443 F. Supp. 121, 123 (W.D. Tenn. 1977) (“attempts to give detailed warnings to patients could mislead patients and might also tend to interfere with the physician/patient relationship”).

Texas:  Butler v. Juno Therapeutics, Inc., 541 F. Supp. 3d 774, 786 (S.D. Tex. 2021) (“Texas law does not tie the [learned intermediary rule’s] protection to the specific conduct of the physician.  Rather, the protection is triggered by the presence of a physician-patient relationship.”); McKay v. Novartis Pharmaceuticals Corp., 934 F. Supp.2d 898, 910 n.90 (W.D. Tex. 2013) (multiple warnings from different sources would “undermine the prescribing doctor’s physician-patient relationship”), aff’d, 751 F.3d 694 (5th Cir. 2014); Solomon v. Bristol-Myers Squibb Co., 916 F. Supp.2d 556, 563 (D.N.J. 2013) (“Recognizing the doctor-patient relationship, the [learned intermediary rule] excuses a drug manufacturer from warning each patient who receives the product when the manufacturer properly warns the prescribing physician of the product’s dangers.”) (citation and quotation marks omitted) (applying Texas law).

Vermont:  Baker v. University of Vermont, 2005 WL 6280644 (Vt. Super. May 4, 2005) (“[R]equiring the pharmacist to warn of potential risks associated with a drug would interject the pharmacist into the physician-patient relationship and interfere with ongoing treatment.”) (citation and quotation marks omitted).

Washington:  Long v. Rite Aid Headquarters Corp., 2019 WL 1370442, at *3 (Wash. App. (March 25, 2019) (“The duty to warn about potential adverse side effects must be the sole obligation of the prescribing physician because the physician may often have valid reasons for deviating from the drug manufacturer’s recommendations based on a patient’s unique condition.”; “excessive warnings . . . could cause unfounded fear and mistrust of the physician’s judgment, jeopardizing the physician-patient relationship and hindering treatment”) (quotation marks and footnotes omitted).

West Virginia:  City of Charleston v. Joint Commission, 473 F. Supp. 3d 596, 625 (S.D.W. Va. 2020) (The learned intermediary rule reflects both “the concern that direct warnings to ultimate users would interfere with doctor/patient relationships” and “the corollary principle that physicians exercise their independent clinical judgment in patient evaluations”) (citation and quotation marks omitted); Ashworth v. Albers Medical, Inc., 395 F. Supp.2d 395, 407 (S.D.W. Va. 2005) (the learned intermediary rule “arises from the recognition of the primary role of the patient’s physician in diagnosing a particular condition or ailment and prescribing a course of treatment and from the reluctance to place a duty on a manufacturer that may interfere with the physician-patient relationship”).

Based on this survey of the law – including decisions from 29 different jurisdictions as recent as 2024 and 2025, and as old as 1971 −  it should be unmistakable that protection of the physician-patient relationship and prevention of that relationship being undermined by overly expansive warning duties concerning prescription medical products are at the core of the universally applicable learned intermediary rule.  This is not some tangential concern that only governs a small subset of learned intermediary cases.  No.  Preservation of the physician-patient relationship from disruption by third-party sources of generalized medical information, be they manufacturers, distributors, pharmacists, or whatever, is at the heart of the learned intermediary rule.

That’s why we are disturbed by the rationale of the recent decision in Himes v. Somatics, LLC, 549 P.3d 916, 926 (Cal. 2024) (discussed here).  Himes embraced a pernicious theory of warning causation that is fundamentally at odds with the learned intermediary rule’s purpose of protecting the physician-patient relationship from damage by product liability litigation.  Here’s why – it allows plaintiffs to get to the jury with otherwise hopeless causation evidence by testifying that had they known of some prescription-product-related risk they would have rejected their physician’s recommendation to use the product in question.  Forget possibly divergent warnings from different sources, we can think of nothing more corrosive of the physician-patient relationship than the prospect of liability turning on patient non-compliance with medical recommendations.

Here’s how things happened in Himes:  The plaintiff had previously been “prescribed at least nine different antipsychotics and antidepressants to treat depression, but her condition worsened,” and plaintiff “was hospitalized several times for severe depression or suicidal ideation.”  549 P.3d at 921.  As a last resort, one of her physicians treated plaintiff with electroshock therapy using the defendant’s device.  Id.  She was warned that the therapy “could cause short-term memory loss” but claimed that the defendant’s label did not disclose “permanent” brain damage and amnesia.  Id.  The doctor testified, however, “that he still would have recommended [the therapy] even if he had been informed of th[ose] risk[s].”  Id. at 922.  That additional information would not have changed a prescribing physician’s treatment is a well-established basis for severing causation as a matter of law in learned intermediary rule cases.

But Himes held that the plaintiff could overcome this testimony with evidence that “the [prescribing] physician would have communicated the stronger warning” to the plaintiff, and further that “an objectively prudent person in the patient’s position would have thereafter declined the treatment notwithstanding the physician’s continued recommendation of the treatment.”  Id. at 921 (emphasis added).

That formulation is totally at odds with all the above precedent establishing that preservation of the relationship of trust represented by the physician-patient relationship is a fundamental goal of the learned intermediary rule.  Even though there was significant California law favoring the preservation of the physician-patient relationship (see above), neither that precedent (be it from California or elsewhere), nor the relationship itself was mentioned in Himes.  Instead, Himes analogized to informed consent. “Implicit in our informed consent rule is the recognition that patients will sometimes opt out of the medical treatments their physicians recommend, as is their right.”  Id. at 926.  We agree with that statement as far as it goes, but we don’t think that a patient’s right to act contrary to medical advice should be weaponized into a cause of action – nor has any other court that we know of.

Moreover, the sort of evidence that Himes envisioned is not just plaintiffs with dollar signs in their eyes testifying that “if they had only known,” of course they would never have consented to the recommended drug/device/vaccine.  We’re not talking about Taxotere plaintiffs claiming that they, personally, would have refused to take a life-saving cancer drug because of hair loss or crying excessive tears.  See Id. at 932 (“If a subjective test were used, a plaintiff could simply offer self-serving testimony asserting that he or she would have declined the recommended treatment after being informed of the risks.”).

No, this formulation is more pernicious than a plaintiff relying on his or her own obviously biased testimony.  Himes demands purportedly “objective” testimony.  This test potentially requires rummaging through the entire physician-patient relationship in search of a basis for a jury to conclude that the physician’s judgment was so incorrect that an “objectively prudent patient” would have refused to comply:

[R]elevant factors that should be considered in determining whether an objectively prudent patient would have declined physician-recommended treatment include, but are not necessarily limited to, whether the physician weighed and assessed the risks and benefits of the treatment and, after discussing those risks and benefits with the patient, continued to recommend the treatment; whether the treatment was novel or was instead an established method for addressing the patient’s condition; the availability and utility of alternative treatments and the degree to which they have previously been tried in an effort to address the patient’s condition; the severity of the patient’s condition; and the likelihood that the treatment would have resulted in more than marginal benefits to the patient.

Id. at 931.

Thus, Himes has authorized plaintiffs – and eventually, juries, to second-guess essentially every aspect of medical decision-making – the quality of the doctor’s initial prescription decision; the quality of the discussion between the physician and the patient; whether the treatment was “novel” or “established”; alternative treatments; and the extent of both the medical risks and benefits.  Basically, under the guise of proving “causation,” Himes has imported into California prescription product liability litigation the entire range of proof normally seen in informed consent cases where the plaintiff sues his or her physician.  The plaintiff is thus encouraged to attack every aspect of the physician’s decision-making.  Such proof is necessarily destructive of the physician-patient relationship and thus directly at odds with one of the nationally accepted pillars of the learned intermediary rule.

We also point out that Himes is fundamentally different from another adverse learned intermediary rule decision, Blackburn v. Shire U.S., Inc., 380 So.3d 354 (Ala. 2022) (discussed here), that we have often criticized in the same breath for dumbing down learned intermediary rule-related causation requirements.  While Blackburn did indeed liberalize warning causation in Alabama, it did so in a way that did not require attacks on the functioning of the physician-patient relationship.  Rather, Blackburn was dependent on the physician’s own conduct, as testified to by the physician.  Blackburn involved instructions on how to monitor the development of adverse reactions.  Thus, a major question was “whether information provided by a prescription-drug manufacturer would have changed how a physician chose to monitor a patient.”  Id. at 368 (emphasis original).  The physician testified in Blackburn that if the defendant’s warnings had included more monitoring, “he ‘would have followed those protocols.’”  Id. at  357.  The plaintiff in Blackburn was not incentivized to attack the prescriber’s actions.  We think Blackburn was wrongheaded for other reasons – such as ignoring the undisputed fact that the plaintiff failed to keep subsequent medical appointments, and thus could not have been monitored at all.  Blackburn v. Shire U.S., Inc., 2020 WL 2840089, at *5 (N.D. Al. June 1, 2020).  But as bad as Blackburn was, at least it did not encourage patients to claim they would have disregarded medical device as a means to prove causation.

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Can states compel prescription drug manufacturers to deliver steeply discounted medicines to unlimited numbers of pharmacies?  That is the issue that has been kicking around federal courts for a few years now, and the Fourth Circuit has now weighed in by answering “no.” 

We are talking here about drugs purchased under the federal government’s 340B Drug Pricing Program, and the Fourth Circuit’s recent opinion is significant for a couple of reasons.  First, the stakes are extremely high: Eligible purchasers bought $81.4 billion in covered outpatient drugs under the 340B program in 2024, and that figure is rising rapidly year by year.  Second, the Fourth Circuit’s opinion creates a circuit split on an issue that has generated intense interest from healthcare providers and pharmaceutical manufacturers alike.  In other words, the odds of the Supreme Court stepping in have increased.

The case is Pharmaceutical Research and Manufacturers of America v. McCuskey, No. 25-1054, 2026 WL 898259 (4th Cir. Mar. 31, 2026) (to be published in F.4th), and the opinion addresses whether states can prevent pharmaceutical manufacturers from limiting delivery of 340B-discounted drugs to so-called “contract pharmacies.” 

In a nutshell, if drug manufacturers want to participate in Medicare and Medicaid, they have to offer their drugs at a discount to certain healthcare providers—called “covered entities”—which typically care for low-income and rural populations.  When Congress first created the 340B program in 1992, few covered entities had in-house pharmacies, so HHS issued a guidance allowing each covered entity to use one external contract pharmacy where the covered entity’s patients could fill their prescriptions.

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

States therefore have stepped in and passed their own laws prohibiting manufacturers from limiting the numbers of contract pharmacies, or even requesting that covered entities and pharmacies submit claims data supporting eligibility for the discounted prices.  Drug manufacturers predictably have challenged these laws in multiple courts (see our latest report on those cases here).  Most courts have ruled against the manufacturers, including the Fifth and Eighth Circuits.  See AbbVie, Inc. v. Murrill, 166 F.4th 528 (5th Cir. 2026); Pharmaceutical Research Mfrs. v. McClain, 95 F.4th 1136 (8th Cir. 2024). 

The Fourth Circuit has gone the other way.  Like other states, West Virginia passed a contract pharmacy law that prohibits manufacturers from limiting the acquisition of 340B-discounted drugs or requesting claims data to verify eligibility.  The Fourth Circuit held that federal law preempted West Virginia’s law because the state law specially targeted participants in the federal 340B program (drug manufacturers) and altered the bargain that Congress struck with manufacturers when it created the program. 

The key issue is this: While other courts have characterized state contract pharmacy laws as merely regulating delivery of medicines, which is purportedly outside the scope of the federal 340B statute, the Fourth Circuit recognized that West Virginia was really regulating price, which is what the federal 340B statute is all about.  As the Fourth Circuit put it,

West Virginia . . . imposes conditions on drug manufacturers by virtue of their participation in the 340B program.  The result is that more drugs will be sold at bargain prices.

McCuskey, 2026 WL 2026 WL 898259, at *1 (emphasis added).  Price versus delivery.  That’s probably the most simplistic way to see this controversy.  States can regulate health and safety, and they ostensibly can regulate how covered entities have discounted drugs delivered to pharmacies, and by extension to their patients. 

But does that really make a difference?  The Fourth Circuit didn’t think so.  Government programs grounded in Congress’s spending power operate based on consent.  For the 340B program, that is true in a constitutional sense and also literally—the manufacturers participate in the 340B program under a Pharmaceutical Pricing Agreement executed with HHS.  Contract pharmacy laws like West Virginia’s interfere with that agreement. 

For one thing, the state law facially targets a federal domain and “springs obligations on manufacturers specifically by virtue of their participation in a federal program.”  Id. at *7.  Moreover, in conceiving the 340B program, Congress leveraged its spending power to forge a bargain, offering federal funds (Medicare and Medicaid spending) in exchange for compliance with certain conditions (offering drugs to covered entities at steep discounts).  West Virginia’s law seeks to “add conditions, uninvited,” thus disrupting the bargain.  Id. at *7-*8. 

The result is federal preemption.  The law directly purported to change the terms of the federal 340B program, where Congress “did not merely set a floor to which States may add additional obligations.”  Id. at *9.  Approving West Virginia’s law would upset the bargain that Congress struck, and it would also allow states to enact additional and unique obligations whenever they are unhappy with federal requirements. 

There were more specific problems with the statute.  The law intruded on HHS’s enforcement authority in numerous ways.  And it likewise interfered with audits by prohibiting manufacturers from requesting claims data.  Thus, “[t]he substantive provisions interfere at a high level with Congress’s exercise of its spending power and at an operational level with HHS’s enforcement authority and specific enforcement activities.  No possible construction of [West Virginia’s law] avoids this result.  As such, it is likely preempted.”  Id. at *12.

The PhRMA v.McCuskey opinion does not stand alone.  As we were writing this blogpost, the Fourth Circuit filed an unpublished opinion holding that Maryland’s contract pharmacy law was also likely preempted.  See Abbvie, Inc. v. Brown, No. 24-1939, 2026 U.S. App. LEXIS 10581 (4th Cir. Apr. 14, 2026).  One judge dissented from both opinions, with a long dissent in McCuskey that echoed points made in the Fifth Circuit and Eighth Circuit opinions—mainly that the West Virginia statute “regulates delivery.”  We understand that point, but as noted above, the difference between regulating “delivery” and regulating “price” is difficult to articulate.  The pharmacies are purchasing the medicines no matter what.  The only question is what price they will pay for them.  Surely a cert petition is coming, if not filed already. 

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We typed the following question into a simple AI prompt:  “What is the difference between admonish and deter?”  The response started with “The primary difference between admonish and deter lies in their intent and timing:  admonishing is form of active, often verbal correction or warning regarding past or present behavior, while deterring is an act of preventing a future action from happening in the first place.”  We did this, not because of existential dread about training our new Newfie puppy, but because we read an otherwise routine denial of a motion to vacate a conditional transfer order.  For people who do not play in the MDL sandbox, once an MDL is established by the Judicial Panel on Multidistrict Litigation (“JPML”), a new case filed in (or removed to) any federal district court can be tagged by any party, the JPML, or the MDL, which results in the entry of a Conditional Transfer Order that, absent a motion to vacate, loses its conditional status after a period of time.  The JPML decides those motions to vacate and almost always denies them.  Using the rubric of a product liability MDL, cases involving the product or products at issue in the MDL and generally the same factual issues as led the JPML to create an MDL in the first place are going to get transferred as long as the MDL is still accepting cases for pretrial centralization.  In In re Philips Recalled CPAP Bi-Level PAP & Mechanical Ventilator Prods. Liab. Litig., MDL No. 3014, 2026 WL 926016 (J.P.M.L. Apr. 6, 2026) (“Gravelyn”), that is what happened, notwithstanding plaintiff’s arguments about the seriousness of his injuries, the Northern District of California being more convenient, and the path to trial being longer with transfer.  As expected, those arguments were all rejected.  That is not why we are discussing our musings on the decision, though.

This is yet another case where a party submitted made-up citations and holdings.  In a recent post, we offered our own modest proposal (that did not involve cannibalism) for deterring such nonsense, but we also linked a website that does a really good job of tracking “hallucinations” in legal briefs from around the world.  More on those later.  In Gravelyn, the plaintiff lawyer started things off by misfiling her brief with phony citations to two purported JPML decisions allegedly supporting vacatur.  The misfiled brief was replaced with a brief with two different bogus citations—the only JPML decisions it purported to cite.  One cite was wrong, but both decisions held the opposite of what plaintiff claimed in his brief.  Minus footnotes, this is what the panel said about the plaintiff’s gobbledygook:

Before concluding, we must raise an additional issue, given our serious concerns about the integrity of the record in this matter. Plaintiff’s brief cites only two Panel decisions, but these two citations are inaccurate and misrepresent the holdings in the underlying cases. The nature of the misrepresentations suggests that counsel may have used generative artificial intelligence to draft plaintiff’s brief without checking the accuracy of the information produced, though it is possible counsel used some other unreliable source. Regardless, plaintiff improperly submitted a brief with false legal representations. We admonish plaintiff and his counsel for fabricating and misrepresenting legal authorities. This is an abuse of the judicial process, and one which we do not take lightly. Parties have a duty to ensure that citations are, in fact, real. See In re Snowflake, Inc., Data Sec. Breach Litig., MDL No. 3126, ___ F. Supp. 3d ___, 2025 WL 4007421, at *2 (J.P.M.L. Aug. 7, 2025). Any further non-compliant submissions from plaintiff may be stricken or result in additional appropriate corrective action.

2026 WL 926016, *2.  We do not find this admonishment enough in light of the “serious concerns,” “false legal representations,” “abuse of the judicial process,” and vow to not take it lightly.  The threat of striking future “non-compliant submissions from plaintiff” also rings empty.

Part of the problem in Gravelyn is the nature of the JPML practice.  The plaintiff and his counsel were not before the JPML for more than a few weeks.  The plaintiff is unlikely ever to be back.  His counsel might be back on some other case, although this firm seems to be a local Texas immigration firm operating out of its depth.  Even if the future sanction for more citation to hallucinated cases is that this firm’s motion to vacate in a future case involving transfer to the same or another MDL is stricken for similar false citations, then the result would be the transfer of a tagged case to an active MDL as happens in the vast majority of cases where transfer is opposed.  Overall, we see little chance that this admonishment will deter this plaintiff, his lawyer, or other plaintiff lawyers who do not file with the JPML regularly from continuing to save time and money by letting A.I. write their briefs without human oversight.

There are tools available beyond the proverbial finger wag, though.  When a lawyer hears that a brief was submitted with “false legal representations,” the first thought is usually Fed. R. Civ. P. 11.  It clearly covers this situation, regardless of whether A.I. was utilized (poorly):

By presenting to the court a pleading, written motion, or other paper—whether by signing, filing, submitting, or later advocating it—an attorney or unrepresented party certifies that to the best of the person’s knowledge, information, and belief, formed after an inquiry reasonable under the circumstances:

(1) it is not being presented for any improper purpose, such as to harass, cause unnecessary delay, or needlessly increase the cost of litigation;

(2) the claims, defenses, and other legal contentions are warranted by existing law or by a nonfrivolous argument for extending, modifying, or reversing existing law or for establishing new law;

Fed. R. Civ. P. 11(b)(1)-(2).  There are a few drawbacks to using Rule 11 as the primary tool of deterrence, though.  First, making the defendants police this recurring plaintiff behavior is unfair absent cost-shifting.  Second, the procedure under Rule 11 means that the motion for sanctions cannot be filed until 21 days after it is first served on the plaintiff to afford time to withdraw or correct the filing.  Even if that timing worked in the context of a motion to vacate a CTO, there will be no consequence if the plaintiff files a new brief without the fake stuff.  Third, the court’s authority to order the plaintiff to show cause under Rule 11(c)(3) is unlikely to be utilized by the JPML unless it catches the problem early and/or holds onto the case long enough to sanction the plaintiff.  Fifth, monetary sanctions may not be awarded against a represented party—but can be against a pro se party—for violating Rule 11(b)(2), which means the court would need to find that the “improper purpose” language applied.  Fed. R. Civ. P. 11(c)(5).  The purpose of any sanction is to “deter repetition of the conduct or comparable conduct by others similarly situated.”  Fed. R. Civ. P. 11(c)(4).  Taking monetary sanctions off the table certainly limits the deterrence value.

When Rule 11 is not enough, courts can look to their inherent authority and various rules of professional conduct as empowering them to act to deter bad conduct.  In Gravelyn, the court noted its uncertainty about whether “counsel may have used generative artificial intelligence to draft plaintiff’s brief without checking the accuracy of the information produced” or “counsel used some other unreliable source.”  The JPML surely could have directed plaintiff’s counsel to explain what happened.  We have seen sanctions hearings where the plaintiff’s counsel dug a deeper hole.  The plaintiff lawyer in an auto accident case we wrote about last year got plenty of chances to avoid sanctions for contradictory jurisdictional allegations,   In the end, the $7500 fine was not as impactful as the formal reprimand for “[f]ailing to comply with the duties of an attorney by filing pleadings containing false representations and legally unsupportable contentions” that would have to be reported in connection with any application for admission. His firm caught shrapnel with the judge’s finding that, “based on the many [of the firm’s] cases that have come before me and my colleagues, I am persuaded that the facially obvious errors found in this case reflect a cultural norm at [the firm] to prioritize volume at the expense of accuracy.”  (This is the same court where sanctions-related proceedings are still going on a decade after the plaintiff lawyers’ non-A.I. hallucinations and other misconduct discussed here.)

We keep saying “plaintiff” and “plaintiff’s counsel” because that is who seems to be engaging in the sanctionable conduct when it comes to made up citations and made-up facts.  The website we mentioned earlier shows that hallucinations in U.S. cases overwhelmingly come from pro se litigants and plaintiff lawyers.  An occasional criminal defense lawyer too, but very rarely from lawyers representing a tort defendant.  Because the list of cases addressing A.I. hallucinations grows longer just about every day, it is apparent that the bad actors are not being deterred by what most courts have been doing.  There are some courts taking an aggressing approach to out and deter the behavior, though.  Focusing on sanctions against lawyers for citing bogus cases, two very recent decisions stood out to us in terms of the courts doing something more to deter continuing or similar behavior.  (By the way, we read the decisions and did not just rely on a website’s summary.)  In a case called Heimkes v. Fairhope Motorcoach Resort Condominium Owners Association, Inc., the Southern District of Alabama ordered the plaintiff lawyer to pay $55,597 to the defense counsel “for their time spent addressing [plaintiff lawyer’s] misstatements of law.”  In addition, the plaintiff lawyer was required to file the court’s order on the open docket in each of his pending cases and any new ones over the next year.  Within three days, he had to certify that he sent the order to wherever he was licensed.  The court sent the order to the state bar with a recommendation that the plaintiff’s lawyer “be found incompetent to practice law.”  For good measure, all the judges in the district and the chief judges of the three federal districts in the state would get a copy, and it would be submitted for publication in the Federal Supplement.  That should get someone’s attention. 

In an unpublished decision from the Sixth Circuit in a case called U.S. v. Farris, the lawyer appointed to represent an indigent criminal defendant on appeal got hammered for his hallucinations.  This decision is also pertinent to our musings about Gravelyn because the current JPML chair is a judge from the Eastern District of Kentucky, within the Sixth Circuit and where Farris was tried.  The Sixth Circuit kicked the lawyer off the case and took away any fees to which he would have been entitled under the Criminal Justice Act.  He was referred for disciplinary proceedings with the Sixth Circuit and his state bar.  The opinion was also sent to the Chief Judge and Clerk of the Eastern District of Kentucky.  While perhaps not quite the tar-and-feathering of Heimkes, this decision should be a cautionary take for anyone who thinks less effort can got into an appointed representation.

By contrast, we have seen any number of MDL decisions where the plaintiff lawyers have not been sanctioned for false representations in filings and other misconduct.  This seems to be the case even when the lawyers are before the court on multiple cases.  Such as here.

That brings us back to our prior proposal.  We suggested the following:

After due prior publicity – bar associations should punish attorneys caught with their hand in the AI cookie jar with suspensions from the practice of law.  We think that a first offense should warrant a suspension of one week for each fraudulent citation, quotation, or misrepresentation of a judicial opinion.  Second offenses should be punished at the rate of a month apiece.  If that’s not a sufficient deterrent, then the licensed miscreant is probably not fit to practice law.

The policing entity in this Bexian world is a bar association and the initial stick is a suspension.  Maybe this would work, but it seems like courts need to play a more active role.  We are not sure than suspension alone will do the job, especially if law firm partners can continue to share profits while on these mini-sabbaticals (and bar associations probably do not have a say on that).  Fee shifting directly from the miscreant to the other side also makes sense and courts have plenty of authority to do it. If sunlight makes the best disinfectant, then circulating decisions to people and entities that should care, including recipients of pro hac applications, should help.  We are sensitive to the suggestion that an accusation is not proof, as well as the reality that some mistakes really are innocent.  After all, our day job involves representing defendants who never do anything wrong.  However, just like punitive damages are intended to deter bad conduct, not just admonish it, there needs to be consistent action from courts to deter bad conduct from hallucinating lawyers.  Features of the rule of law, such as notice, opportunity, and appellate review, also have a place for severe sanctions, but there has to at least be the possibility of severe sanctions to begin to prevent patterns of prevarication.  Perhaps.

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Emile Bove’s nomination to the Third Circuit was controversial. We do not know enough about that controversy to offer an opinion, but we know it was about politics, and there is little reason for you to care about our political opinions. As we reflect back over the years, we calculate that our political opinions have been wrong at least 30% of the time.

We’d like to think our batting average when it comes to legal analysis has been better than that. United States v. Anderson, No. 4:21-cr-00204-001 (3d Cir. March 26, 2026), is the first opinion written by Judge Bove that we have read. Here is the beginning of his Anderson opinion:  “If you dislike jargon, buckle up. The focus of this appeal is the reliability of probabilistic genotyping software in forensic DNA identification under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993) and Rule 702 of the Federal Rules of Evidence.” Anderson is a criminal case, not a drug or device tort case, but any analysis of Rule 702 by the Third Circuit (our home circuit) will be of more than a little interest to us. 

Rule 702 is the same for criminal and civil cases, but we cannot help but think that the criminal vs. civil context matters. How does it matter? We are thinking of Sarah Isgur’s rule of Bad Man Stays in Jail.  With most judges, close calls usually do not benefit criminal defendants who seem like especially bad people. The defendant in Anderson was charged with being a convicted felon in possession of a gun, a violation of 18 U.S.C. section 922(g)(1).  While executing a search warrant, Pennsylvania State Police seized a gun from a bag that also contained Anderson’s identification and two loaded magazines.  Anderson was in the same bedroom as the bag at the time of the search. He was on parole for a state-law offense at the time.  On that evidence alone, we would bet on a conviction. But the prosecution had more evidence.  The police swabbed DNA evidence from the gun. They compared it to known DNA evidence taken from the defendant.  The Pennsylvania State Police laboratory found several sources of DNA on the gun, but could not state within a degree of reasonable scientific certainty whether there was a match with Anderson. Law enforcement then sent the DNA evidence to Pittsburgh-based Cybergenetics, Corp., which used TrueAllele software and advanced computing power to perform probabilistic genotyping. Comparison of the DNA profiles via a sophisticated algorithm led to a conclusion that a match between some of the DNA from the gun and Anderson’s DNA was “11.5 trillion times more probable than a coincidental match” between the evidentiary sample and a random person’s DNA. The defendant challenged the admissibility of that evidence under Rule 702 and lost.  Anderson then pleaded guilty, but preserved his ability to appeal the admissibility of the DNA evidence. 

The Third Circuit reviewed the admissibility of the evidence for abuse of discretion. From the first two sentences of Judge Bove’s opinion, which we recited above, we had two immediate responses: (1) Judge Bove is a good, clear writer; and (2) he clearly does not follow our rule of don’t say Daubert. As most of you readers know, this blog prefers to refer to Rule 702 – as amended – and to leave the Daubert label behind, because too many courts shirked their gatekeeping duties and watered Daubert down with all sorts of weight-not-admissibility nonsense.  The result is that the very name Daubert now comes freighted with a lot of sloppy law, which the recent 702 amendment was intended to correct. To our eyes, the deployment of the Daubert case name amplifies the possibility of error (and trauma to defense hacks).

So were we worried a bit at the outset of Anderson? Yes we were. Even more worrisome, when the Anderson opinion goes through the usual throat-clearing announcement of Rule 702’s standards, it discusses cases that predate the 2023 amendment to Rule 702, which makes clear that the party proffering the expert witness bears the burden of proof, and that the expert’s opinion must be a reliable application of principles and methods to the facts of the case. The Anderson opinion itself never mentions the Rule 702 amendment. Ugh.  Nevertheless, the Anderson opinion does point out that “the proponent of the evidence must establish admissibility by a preponderance under Rule 104(a).” Maybe Judge Bove falls into the camp of those who consider the 2023 amendment as a mere clarification of what was always required.

We should mention that also on the Anderson panel was Judge Bibas, who is one of the smartest judges anywhere, particularly when it comes to criminal law and criminal procedure. Let’s face it: it is harder for a judge to screw things up when that judge is on a three-judge panel. By contrast, a crazy trial judge can perpetrate enormous mischief. That is not to say that Judge Bove is crazy or that he screws anything up in the Anderson case. But, as you will see, we do harbor at least a little doubt about the outcome.

The Anderson opinion correctly states that “[r]eliability is the issue here.” Some of the factors “bearing on reliability are testability, peer review, error rates, existence of standards, and general acceptance of the method.” So far so good. And then that fine point is at least slightly ruined by this: “These are just guideposts. The list is not exhaustive. Determining reliability is not a check-the-box exercise, and we give trial courts significant autonomy to do the necessary work.” That little chestnut is all fine and good unless that “significant autonomy” translates into the court acting as a matador, waving the bull by. Some trial judges do not want to do the work — the whole point of going to law school was to avoid math and science — and will seize upon any basis to send sketchy science to the jury to sort out however they see fit. Again, we are mostly fretting about things that could happen but did not happen.  In Anderson, Judge Bove delves fairly deeply into science behind the TrueAllele evidence. He covers the method’s testability, support in peer reviewed literature, error rates, existence of standards, and general acceptance of the method. We daresay that most of the plaintiff expert opinions we see in drug, device, toxic tort, or asbestos litigation would not satisfy the type of analysis that Judge Bove applies in Anderson. If you ask most plaintiff experts what their error rate is, they will indignantly reject the question, exclaiming that their error rate is precisely zero. What that really means is that their science is not science at all, but a litigation-driven article of faith. Also, good luck finding peer reviewed support for the plaintiff expert’s methodology and conclusion. At best, you’ll hear about bogus extrapolations or ginned-up articles replete with fraud.

For the most part, the Anderson opinion is sound. The court upheld the trial court’s admission of the probabilistic genotyping. TrueAllele does look more like science than voodoo. Bad man will, indeed, stay in jail. The one issue that gives us pause was the defendant’s argument “on appeal that he should have been granted access to TrueAllele’s source code so that he could test that too.” The lower and appellate courts concluded that because “the issue was whether TrueAllele is capable of being tested based on objective criteria, Cybergenetics was not required to let the defense under TrueAllele’s hood by disclosing the source code.” The source code was the programmer syntax that implements the algorithm, and the defense had access to the actual algorithm. For the court, that access was enough. “Daubert is not a criminal discovery device.” We suppose there might be some proprietary concerns for Cybergenetics, though a confidentiality/protective order could address those concerns. Moreover, the defense could run its own tests and “try to show that TrueAllele does not function in the manner that the government’s expert described.” But showing a different test result is not necessarily the best or only way of undermining the inculpatory test result.   The Anderson court talks about not authorizing “a fishing expedition through TrueAllele’s source code under the auspices of Daubert” and how the defendant was not entitled to go “under the hood.” But then what is left is a black box supporting the government’s expert testimony. Maybe, in context, that black box in Anderson was enough to pass Rule 702 muster. Still, we can think of plenty of cases where the expert’s entire opinion is a giant black box wrapped in ipse dixit.

Anderson also challenged the TrueAllele evidence because it involved mere likelihoods and was subject to “potential errors by software operators and problems lurking in TrueAllele’s source code.” That argument went nowhere fast. There are other areas of expert testimony where discretion and judgment play a not insubstantial role. Fingerprint identification methodology , for example, involves “an unspecified, subjective, sliding scale” and human judgment calls relating to the quality and level of detail in a fingerprint.” Handwriting comparisons are even more subjective, yet judges every day admit such evidence.  (When we worked in the U.S. Attorney’s office in Los Angeles a long time ago, there was one rogue judge who excluded fingerprint and handwriting experts, reasoning that jurors were capable of making the comparisons themselves. That view was not shared by any colleagues and was not smiled upon by the Ninth Circuit.)

Anderson is worth reading if you are looking at potential Rule 702 admissibility issues in the Third Circuit.  It applies rigorous analysis that should weed out the worst of the worst junk science on offer. But it might also contain enough squishiness to let some frail expert testimony through.

The opinion also rejected the defendant’s argument that section 922(g) violated the Second Amendment. That is a fairly obvious and uninteresting result, unless you want to dive into a political debate — which we do not.       

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Artificial intelligence isn’t going anywhere. Experts use it. Opposing counsel use it. Clients use it – and want their lawyers to use it too. It is becoming an increasingly standard legal research, drafting, and case strategy tool. But as a couple of our recent posts (here and here) have pointed out—AI is far from perfect. And modest fines and court-imposed sanctions are proving wholly insufficient to combat the accelerated frequency of AI hallucinations in litigation filings. We’ve suggested some harsher sanctions (if anyone is listening). But it also made us curious to see if anything else was being done. Turns out, courts across the country are moving beyond reactive sanctions imposed after problematic filings, toward a proactive enforcement posture.  Some courts now impose disclosure obligations and verification standards as threshold filing requirements.   

The standing orders vary in scope and consequence, and we have not undertaken a 50-state or all jurisdiction review. So, this should not be considered comprehensive, but more of an FYI and a heads up to check your local rules and judge-specific standing orders.

For example, in the Southern District of New York, Judge Broderick’s Civil Rules provide that any party must disclose the use of GenAI when the GenAI tool is used to prepare any filings with the Court.  Rule 4(J); see Bonsignore v. N.Y. Dep’t. Tax’n & Fin., No. 25-CV-6324, 2025 WL 3468041 (S.D.N.Y. Dec. 3, 2025); see also Brian NG v. Amguard Ins. Co., 25 CIV. 806 (VSB) (GS), 2025 WL 3754555, at *7 (S.D.N.Y. Dec. 29, 2025) (warning a party against submitting fake citations and noting that Judge Broderick’s certification rules apply to all parties, regardless of pro se status). More importantly, the party must certify that it has independently reviewed and verified the accuracy of any portion of the filing generated by GenAI, and that the filing complies with Rule 11 obligations or else face penalties. In the Southern District of Texas, Judge Olvera’s Local Rules similarly require all parties at the outset of a case to file a certificate attesting

either that no portion of any filing will be drafted by [GenAI] or that any language drafted by [GenAI] will be checked for accuracy, using print reporters or traditional legal databases, by a person.

Rule 8(C)(1) (emphasis added).

It’s a little scary that courts need to have “check your work or else” orders. But as Judge Matthew J. Kacsmaryk (N.D. Tex.) explains in his Mandatory Certification Regarding Generative Artificial Intelligence:

[GenAI] platforms are incredibly powerful and have many uses in the law . . . But legal briefing is not one of them. Here’s why. These platforms in their current states are prone to hallucinations and bias. On hallucinations, they make stuff up—even quotes and citations. Another issue is reliability or bias. While attorneys swear an oath to set aside their personal prejudices, biases, and beliefs to faithfully uphold the law and represent their clients, [GenAI] is the product of programming devised by humans who did not have to swear such an oath. As such, these systems hold no allegiance to any client, the rule of law, or the laws and Constitution of the United States (or, as addressed above, the truth). Unbound by any sense of duty, honor, or justice, such programs act according to computer code rather than conviction, based on programming rather than principle. Any party believing a platform has the requisite accuracy and reliability for legal briefing may move for leave and explain why.

In other words, the use of GenAI in court filings raises real ethical and practical concerns. And judges should not accept “sorry, ChatGPT threw that cite in there” any more than they accept “I’m just here covering for another attorney.”

Here are additional orders we found requiring certification that a human being has reviewed AI generated material:  IAS Rules (Judge Peter Weinmann, NY Sup. Ct., Erie Cnty.) (requiring certification that the filing has been verified and reviewed by a human being); Use of Generative AI (Magistrate Judge Phillip Caraballo, M.D. Pa.) (requiring parties to certify that they have “checked the accuracy of any portion of the document generated by AI, including all citations and legal authority”); Standing Order, Rule 5(c) (Judge Blumenfeld, C.D. Cal.) (requiring certification that “filer has reviewed the source material and verified the [AI] generated content is accurate”); Standing Order, Rule E(5) (Judge Hwang, C.D. Cal.) (same); Standing Order, Rule 10 (Magistrate Judge Susan van Keulen, N.D. Cal.) (imputing any GenAI related hallucinations and corresponding sanctions to the signature of the attorney or party on the filing, because the signature indicates that counsel has personally confirmed the accuracy of the content generated by GenAI tools); Individual Rules and Practices, Rule 2(E) (Judge Cronan, S.D.N.Y.) (requiring certification that “litigant personally reviewed the filing for accuracy of cited legal authorities and factual assertions and . . . describing in detail the steps taken to verify the accuracy of all legal authorities and factual assertions generated by the AI tool” or else face sanctions).

One of the most comprehensive standing orders we found on AI use comes from the Northern District of California’s Magistrate Judge Kang. His Standing Order issues guidelines in three broad categories: filings with the Court, evidence, and confidentiality. Rule VII(C). For filings with the Court, any party must identify the GenAI tools used for drafting the text in its title, caption, a table preceding the body text, or by a separate contemporaneous notice and must also maintain records of these portions of text should the Court request it. Any GenAI generated evidentiary material must be identified in discovery by a notice and declaration verifying authenticity and may not contain “uncorroboratable” or “fictitious” statements of fact or evidence. Regarding confidentiality, counsel must comply with all protective order obligations while interacting with such tools and must maintain records of all prompts or inquiries submitted to these tools to establish compliance with this standing order. Further, Judge Kang repeatedly admonishes that parties should only use AI tools “with competent training, knowledge, and understanding of the limitations and risks of such automated tools.” The order stops short of requiring certification of human proof reading, it makes clear that the court expects as much in accordance with all ethical and professional standards.

While the above are all judge-specific orders, the Northern District of Texas, has adopted a Local Civil Rule mandating that a brief must disclose GenAI use on “the first page under the heading ‘Use of Generative Artificial Intelligence’ [and] [i]f the presiding judge so directs, the party filing the brief must disclose the specific parts prepared using [GenAI].”  Rule 7.2(f)(1).     

Finally, some courts outright prohibit the use of artificial intelligence in court filings.  The Western District of North Carolina, for instance, based on a “concern regarding the reliability and accuracy of filings” using AI, has issued an Order requiring that all court filings be accompanied by a certification that stipulates that no artificial intelligence was used in research for the preparation of the document, except for AI embedded in traditional legal research tools, and verifies that every statement and citation has been checked by an attorney or paralegal.  Judge Newman’s Standing Order, in the Southern District of Ohio, prohibits the use of any AI in the preparation of any filing to the court, with exceptions for information gathered from legal search engines, internet search engines, or Microsoft suite products. Rule VI. A violation of the AI ban may result in “sanctions including, inter alia, striking the pleading from the record, the imposition of economic sanctions or contempt, and dismissal of the lawsuit. See also Standing Order (Judge Boyko, N.D. Ohio) (same). In the Northern District of Illinois, Judge Coleman’s Case Procedures prohibit the use of AI to draft memoranda or as authority to support a party’s motion.

Paralleling the growth of AI and the uncertainty it generates, the proliferation of judge-specific standing orders rather than uniform district- or circuit-wide rules has created a patchwork that is increasingly difficult to navigate. But one thing is clear—courts are not waiting to deal with AI problems after the fact. They are shifting the burden to counsel at the outset. Disclose it, verify it, stand behind it.

And that shift has consequences. These disclosure, certification, and outright ban orders are not just compliance hurdles—they are litigation tools. They provide a roadmap to challenge opposing counsel’s filings, probe the reliability of their submissions, and tee up Rule 11 motions. So yes, check your local rules. But also read your opponent’s certifications carefully. Because in a court where AI disclosure is mandatory, what is said about how a filing was created may matter just as much as what the filing says. 

Much thanks to Dechert law clerk, Nimisha Noronha, for digging in on this research.

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As we have discussed more times than we like, the plaintiffs’ class action cabal, in conjunction with their running-dog Valisure “if it doesn’t have it, we’ll cook it until it does” “testing” laboratory, has targeted various products supposedly containing benzene contaminants.  The result has been a plethora of no-injury class actions by plaintiffs who used these products without incident, but purportedly want their money back.

As is evident from our prior posts, most of them have been dismissed.

Here’s another one:  Navarro v. Walgreens Boots Alliance, Inc., 2025 WL 1411406 (Mag. E.D. Cal. May 15, 2025), adopted, 2025 WL 3485004 (E.D. Cal. Dec. 4, 2025).  The targets of opportunity in Navarro were several “acne treatment drug products.”  Id. at *1.  After keeping some of these products at ridiculously high temperatures (between 99 and 158°F) for extended periods of time (18 days), Valisure was able to detect “high levels of benzene” in some of the samples.  Id. at *2.  Citing those tests, a couple of plaintiffs (from California and Massachusetts) sued, bringing consumer protection, warranty, and unjust enrichment claims under the laws of various states – including states in which they neither lived nor purchased any products.  Id. at *5.

The magistrate judge threw out the entire kit and kaboodle, holding that while the plaintiffs had standing (at least in their states of residence) the claims were either preempted or failed to state a claim.  Unfortunately, Ninth Circuit standing precedents are woefully lax, allowing plaintiffs to sue whenever they allege that they “paid more for [the product] than [they] otherwise would have paid, or bought it when [they] otherwise would not have done so,” but for a defendant’s actionable statements or omissions.  Id. at  *8 (citation and quotation marks omitted).  So the plaintiffs got a pass on standing.

These anti-acne products are OTC drugs, and as we have discussed many times, the OTC section of the FDCA has a strong preemption clause – albeit with an exception for “product liability” that does not protect economic loss claims from preemption. That clause prohibits enforcement of state-law requirements “different from or in addition to, or . . . otherwise not identical with” FDA requirements.  Id. at *10 (quoting 21 U.S.C. §379r(a)).  Plaintiffs, of course, claimed that the various states’ laws required benzene-related warnings that the FDA had not required in its “monograph” governing these products.  Since the federal labeling requirements for these OTC products did not require any reference to benzene, those claims “are expressly preempted.”  Id. at *11.  Nor could plaintiffs evade preemption by claiming “misbranding.”  “The upshot of the regulations and the anti-acne monograph, described above, is that a drug that complies with all monograph requirements is not misbranded.”  Id. (citation omitted).  An applicable monograph “cannot be used as the basis to force a company to go above and beyond what that monograph prescribes because that is expressly preempted.”  Id.

Nor was benzene either an “inactive ingredient” or a “component” of these products.

There are no allegations that [defendant] intended to directly combine benzene into [these] products; rather, the allegations are that [they] can and do[] degrade into benzene.  Based on the forgoing, the Court concludes that benzene is not an inactive ingredient, and [defendant] was therefore not required to list it on its . . . labels. Plaintiffs have not pointed the Court to any authority to the contrary.

Id. at *13.

Navarro did not, however, extend preemption to purported “parallel” claims involving allegations of violations of FDA CGMPs – at least not yet.  Disturbingly, the decision imported the rationale in Davidson v. Sprout Foods, Inc., 106 F.4th 842 (9th Cir. 2024), a food case, into the OTC drug context, without even acknowledging the difference between the two.  Navarro, 2025 WL 1411406, at *13-14.  Even though that claim was an afterthought, with CGMPs never mentioned in the complaint, Navarro found these purported “parallel” claims sufficiently pleaded.  Id.

But parallel claims didn’t get these plaintiffs very far, because the state-law claims they brought all sounded in fraud, and plaintiffs “failed to allege how they were deceived.”  Id. at *14.

Plaintiffs have argued throughout their opposition (and alleged in their complaint) that [defendant] has potentially violated regulations or cGMPs.  Even with this reasonable inference, the Court finds that Plaintiffs have not alleged facts that either establish that [defendant] violated cGMPs, or even if [it] did violate the cGMPs, how those violations ultimately deceived Plaintiffs.

Id. at *15.  Vague allegations of “omissions” were not enough.  Id.  Therefore, the entire action was dismissed.

Plaintiffs predictably objected to the magistrate’s findings.  They lost again.  Navarro v. Walgreens Boots Alliance, Inc., 2025 WL 3485004 (E.D. Cal. Dec. 4, 2025), did more than just adopt the magistrate’s decision.  First, the district judge agreed that “claims based on a theory of failure to warn/disclose BPO degradation risk are categorically preempted by the [FDCA].”  Id. at *1.  On the adequacy of the pleadings, however, the judge went further.  Plaintiffs failed even to allege any purchase of purportedly benzene-contaminated products:

Plaintiffs assert parallel state duties and third-party free speech rights that assume benzene adulteration.  However, Plaintiffs have not made a colorable showing the product they purchased from Defendant contained benzene due to a failure to follow cGMP or otherwise.

Id.  Thus, this Valisure molehill will not become a class action mountain.

Good riddance.

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On April 28, Dechert will host its 3rd Annual Life Sciences Day, a half-day program for in-house counsel, executives, and investors. Featuring speakers from leading pharmaceutical and biotech companies, the program will deliver sharp insights on the legal, regulatory, and business challenges shaping the industry. Hear directly from practitioners on how to manage risk and stay ahead in a rapidly evolving landscape.

The topics will include:

  • Health Apps in the Cross Hairs: Winning the First Big Tech Privacy Class Action and What It Means for Your Business
  • Active and Engaged: What Government Enforcers Want Life Sciences Companies to Know
  • Antitrust R&D: What’s in the Pipeline?
  • The Life Sciences Executive: The New Rules for Leadership

Click here to register.

Detailed agenda and additional speaker announcements will be shared soon. We hope to see you there!

Event Details:

Location: Dechert LLP, Cira Centre, 2929 Arch Street, Philadelphia, PA 19104

Date: Tuesday, April 28, 2026

1:30 p.m. | Registration

2:00 p.m. | Program

5:30 p.m. | Networking Reception

CLE Information:

CLE credit for this program is pending for California, Connecticut, Illinois, New Jersey, New York, North Carolina, Pennsylvania and Texas.

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It’s hard to think of any recent litigation where plaintiffs didn’t seek overblown discovery about adverse event reports and then have their experts rely on those reports in an effort to establish causation.  But as we’ve blogged about repeatedly, reports from the FDA’s Adverse Event Reporting System (“FAERS”) do not establish causation (and, for good measure, they don’t constitute newly acquired information). Today’s decision, Taylor v. Dixon, 2026 WL 865183 (M.D. Fla. Mar. 30, 2026), is a little different since it involves a federal habeas petition.  But we couldn’t resist blogging about it given the court’s comprehensive take-down of the attempted use of an adverse event report to show causation. 

Continue Reading Adverse Event Reports May Not Be Used to Establish Causation
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The latest medical device express preemption decision, Wieder v. Advanced Bionics LLC, 2026 U.S. Dist. LEXIS 70645, 2026 WL 880370 (S.D.N.Y. Mar. 31, 2026), comes out of the Southern District of New York and involves a Class III, PMA‑approved cochlear implant. 

Fluid allegedly worked its way into the device and caused a short‑circuit and device failure.  Then, a replacement surgery only partially succeeded because of scarring attributed to the original device, allegedly leading to permanent impairment of the infant patient’s ability to hear, speak, and learn.

In this opinion, the District Court adopted almost all of a solid Report and Recommendation by Magistrate Judge Gorenstein, and the result is that all the classic product‑liability theories—manufacturing defect, design defect, implied warranty, consumer protection, fraud, and failure to warn—were dismissed, largely on preemption grounds, while three negligence‑based counts and derivative loss‑of‑services claims live on.

The court followed the familiar Riegel v. Medtronic, Inc. framework:  For PMA‑approved Class III devices, state‑law claims are expressly preempted if they would impose requirements “different from, or in addition to” the federal requirements.  To escape preemption, plaintiffs must plead a “parallel” claim: a traditional state‑law duty that mirrors a federal requirement applicable to the device without imposing anything more or different.  (We realize the parallel terminology is de rigueur, but would not mind if more courts adopt the “mirror and ceiling” framework instead.)

We heartily approve of some themes that run through the opinion:

  • It is plaintiffs’ burden to allege a specific deviation from applicable FDA requirements.
  • General references to Current Good Manufacturing Practice regulations (or “CGMPs”) do not supply the needed specificity.
  • Voluntary recalls, alleged high failure rates, and alleged under‑reporting to FDA also are not, without more, enough either.

As to strict liability manufacturing defect, the plaintiffs did not merely regurgitate the elements in a conclusory way.  They at least added some alleged facts to the mix—that the manufacturing defect resulted from hand-application of a silicone sealant around the implant’s electrode, which allegedly was not subject to proper quality control, as the CGMPs allegedly require and as a voluntary recall and high failure-rate study allegedly established.

While that perhaps would be enough to state an ordinary manufacturing defect claim for a regular product, it was not enough to plead and adequate, non-preempted one for a PMA medical device.  The complaint did not allege any specific  CGMP violation, it wasn’t clear that hand application was a CGMP violation, and asserting “no quality control” is too conclusory to withstand our old friend Twiqbal.

In objecting to the Magistrate Judge’s Report and Recommendation, Plaintiffs did raise a specific alleged CGMP violation for the first time (21 C.F.R. § 820.70(a) regarding process validation and reproducibility), but the District Court refused to consider arguments not presented to the magistrate judge. 

Nevertheless, we will raise another CGMP argument of our own here for the first time in response.  PMA applications “are required to include” descriptions of their compliance with Current Good Manufacturing Practices (“CGMP”) requirements, which are promulgated in the Quality System Regulation (“QSR”), and “approval of a PMA application for a device can be denied if a manufacturer does not conform to the QS regulation requirements.”   See FDA’s Compliance Program Guidance Manual related to Medical Device PMA Preapproval and PMA Postmarket Inspections, at Part I, p. 1-2.

Putting it another way, the FDA reviewed and approved the hand-painted silicone step and the quality control procedures as part of the PMA process.  Therefore, a plaintiff claiming that the quality control process didn’t measure up, or that the manufacturer’s systems did not satisfy 21 C.F.R. § 820.70(a)’s process validation and reproducibility requirements, necessarily is using a state law claim to second-guess the FDA’s grant of premarket approval and inherent determination that the manufacturer’s processes were appropriate.  Preemption should result regardless.

Anyway, next up was the design‑defect claim, and that was quickly dispatched.  State‑law design‑defect claims challenging the safety or efficacy of the PMA‑approved design are categorically preempted because they would impose different design requirements than those the FDA approved.  Even though a plaintiff lacks access to confidential PMA documents at the motion to dismiss phase, those practical difficulties do not excuse plaintiffs from meeting their burden of alleging a specific deviation from PMA requirements. 

The New York implied warranty of merchantability claim went the same way.  Such claims also necessarily second‑guess the FDA’s safety and effectiveness determination by asserting the product was not “merchantable” (i.e., not fit for its ordinary purpose) despite being approved.

Plaintiffs’ New York consumer protection and fraud claims, and part of their failure to warn claim, targeted the device’s labeling, marketing, or promotional materials as deceptive and misleading.  But those materials were FDA‑approved, so these theories were preempted.  (Plaintiffs also failed to identify the allegedly fraudulent statements, which itself is always a problem.)

Weider also addressed a failure to warn claim premised on an alleged failure to report adverse events to the FDA.  The Magistrate Judge, quite correctly, recommended dismissal of this claim because New York law does not recognize a state law duty to report adverse events to FDA. 

The District Court unfortunately disagreed on this point, concluding that New York law might allow this theory in some circumstances.  In particular, because the learned intermediary doctrine requires manufacturers to take “adequate steps” to alert prescribing or implanting physicians to device risks, those steps may include notifying the FDA of adverse events, which the FDA may then disseminate to the universe. 

That allowance did not save plaintiffs’ claim here, however, because these plaintiffs alleged that the FDA received “multitudes of adverse event reports,” undermining the whole “there was a failure to report” idea.  

The claims that made it through were narrower negligence and loss of consortium-type claims that the manufacturer did not attack with preemption. 

The District Court’s order smartly closed the door on further amended complaints, and directed the parties to get to work on a discovery and case management plan for the case as narrowed. 

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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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