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We’ve said before that plaintiff lawyers do a better job of putting together bench-bar conferences than the defense side does. It mirrors to a certain extent what goes on in the courtroom. The plaintiff side is better at showmanship. It is not just us saying that. Last week, we were at a bench-bar conference focused on Multidistrict Litigations (MDLs), and a state court judge told us the same thing. He had more fun at the plaintiff-run conferences. That judge was just one of many important judges (from state courts, including the Texas Business Court, as well as federal district and circuit courts) who came together to discuss the latest doings in MDLs, which have become the 64,000 pound gorilla of the American civil docket. Also in attendance were luminaries of the plaintiff bar, the usual suspects among defense hackery, and, increasingly important, tech vendors (more about artificial intelligence (AI) in a bit) and a banker (more about third party litigation funding (TPLF) in a bit.

The Chatham House Rule (note the singular – most people refer to the Chatham House Rules, but that plurality is a mistake) applied to the conference, which means that statements should not be attributed to any specific parties or affiliations. Therefore, anything we say about the conference will be like a plaintiff’s ultra-processed food complaint: broad, vague, and occasionally incoherent. 

We were on a panel moderated by an esteemed law professor. Also on the panel was a federal judge who had terrified us in a particular case. A long, long time ago, that judge had been a student of the professor’s, and it was interesting, surprising, and even a bit touching to see how the judge deferred to the professor. The panel was subjected to the Socratic method. We look forward to frequent anxiety dreams over the next couple of months. The main issue at hand was TPLF. There are draft bills in Congress on that topic, and there is a federal judiciary committee looking into it. As a card-carrying defense hack, it is obligatory for us to favor disclosure of TPLF, and a new Fed. R. Civ. P. modelled on Rule 26(a)(1)(A)(iv) — which mandates disclosure of a defendant’s insurance coverage — would suit us right down to the ground. The plaintiff lawyers were equally predictable in their opposition to such disclosure. Their argument was that such information is not relevant, it implicates work product concerns, and, anyway, there is no empirical evidence that such disclosure is needed. We waggled a finger at the professor. Unlike law school, where we were happy as a clam to, well, clam-up, we decided it was our duty to point out that absence of empirical evidence might be a function of absence of transparency. Moreover, some TPLF agreements have surfaced that, while cleverly disclaiming general control by the funder over the litigation, then go on to assert such control by dictating choice of lawyers, approval of settlements, and even client appearances. Some funding agreements require payments to the funders that include monetization of equitable relief. How does that work? As for more empirical evidence, what about Elizabeth Burch’s book, The Pain Brokers,  which documents a sleazy scheme that involved vaginal mesh litigation funding, unnecessary surgeries at inflated prices, and plaintiffs who emerged from the TPLF maw with scars and dissatisfaction?

At that point, a plaintiff lawyer who had worked on the vaginal mesh litigation expressed indignation that anyone would challenge the bona fides of that MDL. The illusion of harmony was dispelled for a moment. Not all was peaceable in the bench-bar kingdom. Should we respond? Galileo said “and yet it moves,” referring to the earth, after being criticized (an overly gentle way of putting it – Galileo was shown the implements of torture) for his heliocentric theory of the solar system. The scam afoot in The Pain Brokers might have been an aberration, but it happened. Sorry to veer from kumbaya. Go ahead, plaintiff bar, and defend the undefendable. And yet it reeks.

Maybe we should have reverted to law school form and just said “Pass.”

To be sure, we do not believe that the unhappy plaintiff lawyer or his firm had anything to do with anything inappropriate in the mesh litigation. But there are bad actors out there, and one reason that rules are necessary is to address the mischief wrought by such bad actors. That being said, the bad actors are not usually the folks who show up at bench-bar conferences. What puzzles us is why a good plaintiff lawyer would feel the need to protect the bottom-feeders. We do not mean to be unfair. There were several instances during the conference when plaintiff lawyers spoke in favor of early vetting of MDL cases. The good lawyers vet their own cases and make an effort at separating the wheat from the chaff before filing. We know who those lawyers are, and their inventories command much more respect from our clients.  Those lawyers actually embrace new Fed. R. Civ. P. 16.1, which lays out early vetting opportunities in MDLs. Rule 16.1 implements, at least in a hortatory tone, procedures that many MDL courts have improvised and deployed over recent years to, for example, require early showings of usage and injury. We heard from one judge who implemented state-of-the-art procedures to encourage early vetting. This was a judge who had learned from a prior MDL how messy things could get. It made us think of Irving Kristol’s quip that a neoconservative was “a liberal who had been mugged by reality.”

We heard from judges who were or had been on the Joint Panel for Multidistrict Litigation (JPML). Perhaps the best practice pointer of the conference came from one of those judges: when you are arguing for a particular location for an MDL, do not linger on the quality of the airport. The judges do not care about that infrastructure point very much, if at all. Much more crucial is what is the center of the litigation, in terms of witnesses, documents, etc.  In addition, before you launch into your one-two minute JPML argument, have in mind second and third choices for the transferee court. There might be reasons (e.g., a judge indicating no interest/availability in handling an MDL) why your first choice is a no-go.  

Too many MDL transferee courts assume from the jump that the affair must end in settlement.  That is bad enough. Still worse is when the transferee court designs everything in the MDL to drive the parties toward settlement. In the worst instances, that means bad rulings or, more typically, non-rulings. As is usual at these conferences, it was an in-house lawyer who had the temerity to challenge the initial, reflexive assumption that an MDL must pave a road to settlement. Sure, most of the MDLs do culminate in settlement one way or the other. But the process is not helped when one side sees the process as warped. Suspicion breeds resistance. In any event, settlement uber alles stinks. It needed to be said. It always does. 

There is a plaintiff lawyer out there (many of you know him) who is aggressive and effective at everything he does. We have personally been murdered by him in court during discovery squabbles. We saw him slice and dice one of our experts at trial. With all that mayhem, you might think we would get hives whenever we are in the same room with this plaintiff lawyer. But no, he is brilliant, funny, and fundamentally kind. That he clobbers us every once in a while is part of the deal. (Think Hyman Roth in Godfather 2 – this is the business we have chosen.) One thing about this particular plaintiff lawyer is that when he predicts that something is going to happen in this business, he is invariably right. Our ears perked up when he discussed medical devices approved through the de novo process – in between premarket approval (PMA) and 510(k). If there is no predicate device for 510(k) purposes — something that happens more and more as time goes on and new technology is invented – the device is probably destined for Class III/PMA treatment. But maybe the device is not implanted or the risks are moderate, so the manufacturer proposes it be treated as a Class II device. Through the de novo process, the manufacturer can submit an application with a ton of data – basically as much as a PMA –  about why the device is safe/effective and can be safely regulated without PMA.  If FDA agrees, it promulgates specific rules for that particular type of device.  The device that goes through the de novo process becomes the “predicate device” and then all future devices of that type can 510(k) off of that predicate. What does that de novo process mean with respect to preemption? The plaintiff lawyer opined that de novo devices were going to be more and more important and would raise interesting legal issues. Mark it down.  

Inevitably, AI was a featured player at the conference.  AI’s application in the legal field is already significant. That significance seems to be increasing exponentially just over the past couple of months. Anthropic’s Claude and other recently released products have supplied lawyers of all stripes with powerful tools. Judges also now have access to powerful tools, including some that enable them and their staff to identify hallucinated cases hiding in briefs. Be careful out there. The fact that judges are becoming more conversant with AI means that they will expect lawyers to do much more much faster. AI is making things much easier when it comes to analyzing medical records, comparing medical literature, drafting cross examinations, and- ta da!  – early case vetting. 

At the same time, AI lays traps for the unwary. What about deep fakes? Might we see fraudulent medical records? Might early vetting become a playground for AI mistakes – or worse? Did you know that it is possible to insert instructions into documents, via white ink and marginalia, that will force a reviewing AI program to veer away from its earlier instructions? Imagine the chaos that trick could cause. Anyone who would do such a thing would need to value their bar card cheaply, and the penalties for such abuse should be severe. But first it would need to be detected.  Finally, if you are suing a company that develops AI products, would responses to inquiries posed to that AI product constitute party admissions?

Our usual test for any bench-bar conference is whether we learned at least one worthwhile thing per day. By that measure, this MDL bench-bar conference gets a high grade. We learned a lot from important sources about things that are happening, or will happen, in our occupational neck of the woods. And then, of course, there is the hackneyed but true observation that the most important things are the people you encounter along the way. We encountered judges who have devoted enormous blocks of time to trying to improve our system of justice. (Let’s face it: the judiciary is the only part of our government that is doing its job with skill and honor.) We encountered a defense lawyer who is at the very top of her field, and has been for many years, and who now is absolutely heroic and inspiring. We encountered plaintiff lawyers who are brilliant, conscientious, and infuriatingly magical.  

We remember an episode of the sit-com Seinfeld in which one of the characters, Kramer, advises that one should get near a proctologist at parties because they tell the best stories.  Our advice for bench-bar conferences is to get near lawyers and judges from Louisiana. At conferences we like to plop down at tables with people we do not know, just to make new acquaintances. By chance, a couple of times we ended up sitting with judges, plaintiff lawyers, and consultants from Louisiana. Whether the topic was bizarre lawsuits (trading of alligator hides), lawyers (like the late Danny Becnel) who could have been characters in a Mark Twain story,  or what’ll you have to drink (one lawyer was gripping what had to have been a triple whiskey), people from the Pelican State are more colorful than their colleagues. Let the good times roll, indeed.

After the conference terminated, a group of us, both sides of the v as well as a couple of judges, headed for the hotel bar to watch game 2 of the NBA finals between the San Antonio Spurs and New York Knicks. None of us was from San Antonio and, for whatever reason, we were all rooting for the Knicks. (That came especially easy for us – the Drug and Device Law Son attended Villanova University, and the current iteration of the Knicks is essentially a Villanova squad that moved up the Jersey Turnpike to Madison Square Garden.) We cheered on the Knicks as they built a substantial lead, as they frittered away such lead, and as they ended up triumphing improbably in the last frantic seconds of the game. We swapped tall tales. We commiserated. During an hour or so of conviviality, we were all on the same side.

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A few weeks ago, we found ourselves underwhelmed by the court’s Rule 702 rulings in the Covidien Hernia Mesh MDL. Today, we can say much the same thing about its summary judgment decision. In In re: Covidien Hernia Mesh Products Liability Litigation No. II, 2026 WL 1555914 (D. Mass. June 2, 2026), the court largely denied summary judgment in a bellwether case governed by Alabama law. In fact, every claim survived except for design defect, on which the court reserved judgment pending a ruling on whether plaintiff may rely on a new alternative-design opinion offered only after his original expert opinions were excluded.

While we have concerns with several aspects of the decision, the court’s treatment of comment k is the most troubling.

Comment k to the Restatement recognizes that some products are “unavoidably unsafe” and therefore should not be subject to design defect liability. The Alabama Supreme Court has repeatedly applied comment k categorically to prescription drugs. The question presented here was whether the same rule applies to prescription medical devices.

The answer should not have been difficult. Alabama courts have never held that medical devices should be treated differently than prescription drugs under comment k. Indeed, the one Alabama federal court to squarely address the issue applied the same categorical approach to both. More broadly, our research has shown that states overwhelmingly apply the same comment k framework to prescription drugs and prescription medical devices, whether that framework is categorical or case-by-case.

But the Covidien Mesh MDL court charted a different course (an unfortunate recent MDL trend). Rather than follow Alabama precedent treating prescription products similarly, or the overwhelming authority from other jurisdictions that do the same, the court relied on what is essentially an outlier decision from Utah that distinguished between drugs and devices for comment k purposes. The result was a prediction that Alabama would apply comment k to medical devices on a case-by-case basis, even though no Alabama appellate court has ever done so. Id. at *6-7. 

That prediction is particularly difficult to square with the Erie doctrine. Federal courts sitting in diversity are not supposed to innovate or expand state law. Their task is to predict what the state’s highest court would do. Here, the court reasoned that because many states employ a case-by-case comment k analysis, Alabama would likely do the same for medical devices. Id. at *7. But that is not how Erie works. The relevant question is not what most states do. The question is what Alabama would do. And the best evidence of that answer is Alabama’s own precedent, which consistently applies comment k categorically to prescription drugs and has never suggested medical devices should be treated differently. If anything, applying a rule of “sameness” to medical devices would have been the more conservative prediction and the one less likely to expand state tort liability beyond existing precedent.

For now, the practical effect of the ruling remains uncertain. The court reserved final judgment on the design defect claim because plaintiff’s original alternative-design opinions were excluded under Rule 702. Plaintiff has since attempted to fill that gap with a new expert affidavit offering a different alternative design. Whether that late-breaking effort survives remains to be seen.

The rest of the decision is similarly generous to plaintiff.

Plaintiff’s failure-to-warn claim focused on the device’s collagen barrier, which is intended to reduce adhesions during the healing process. Plaintiff contended that defendant failed to warn that the barrier could degrade within seven days. The problem with that argument is that the Instructions for Use expressly warned about the very complications plaintiff allegedly suffered–adhesions, bowel obstruction, and hernia recurrence.  Id. at *8. The court nevertheless found a jury question because the warnings did not address the alleged “degree of danger.” Id. at *9. We are struggling to understand how a warning can be deemed inadequate when it warns physicians of the precise injuries that allegedly occurred. If a manufacturer identifies the relevant risks and the warned-of complications occur, one would think the warning accomplished exactly what it was supposed to do.

It also seems to support a finding that prescription medical devices, like prescription drugs, are unavoidably unsafe. There is no guarantee that every surgery will be 100% effective. So, manufacturers warn about the risks. Surgeons assess those risks, using their independent medical knowledge and their knowledge of the patient, and make treatment decisions.  When the risk that occurs is one that is warned about there can be neither design or warning defect liability.

The court’s causation analysis is equally difficult to follow. The implanting surgeon testified that he never read the IFU and would not have changed his decision to use the mesh. Id. at *10. Under Alabama’s learned intermediary doctrine, that testimony should ordinarily end the failure-to-warn claim because an unread warning cannot have affected the physician’s decision-making. Not here. The court concluded that causation could instead be established through alleged, but unidentified, statements by defendant’s sales representatives regarding the longevity of the collagen barrier. The evidentiary basis for this theory came from yet another late-filed declaration, this time from the implanting surgeon himself. Even then, the surgeon did not recall any representative actually making the alleged misstatement. Rather, the court held that a jury could infer the statements were made because sales representatives had been trained that the barrier could last up to thirty days. Id. at *10. 

That is a remarkable chain of inferences. Representatives were trained on a topic, therefore they must have communicated it to this surgeon, therefore the surgeon must have relied on it, despite not specifically recalling the communication. Yet those inferences were enough not only to preserve the failure-to-warn claim, but also plaintiff’s fraud and punitive damages claims. Id. at *11, *13.

Finally, the decision contains a cautionary tale about MDL case-management agreements. Alabama’s implied-warranty statute requires notice. Here, the court held that an email adding plaintiff to an MDL tolling agreement satisfied that statutory requirement. Id. at *12. Defendants often enter into MDL-wide agreements for practical reasons and to streamline litigation. This ruling serves as a reminder that such agreements can sometimes reappear later in entirely unexpected contexts.

Taken together, the opinion reflects a recurring theme. At multiple junctures, the court was willing to make Erie predictions that expanded state law, draw inferences unsupported by direct evidence, and overlook evidentiary shortcomings that ordinarily would doom a claim. Perhaps some of those rulings will ultimately prove academic if plaintiff cannot supply admissible evidence of a safer alternative design. But for now, this bellwether decision stands as another example of an MDL court finding a way to keep virtually every claim alive for another day.

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The Blog has always been interested in off-label use issues.  We hope our readers are as well.  Here are a couple of recent developments that have nothing in common except that they involve off-label issues.

The first is regulatory.  On May 12, 2023, the FDA actually did something smart, a relative rarity for the current regime.  Maybe Makary’s exit is already paying quick dividends.  It’s entitled “Drug Repurposing for Unmet Medical Needs; Request for Information,” and may be found at 91 Fed. Reg. 25897 (FDA May 12, 2026).  It doesn’t use the term “off-label use,” but that is what the “repurposing” is all about.

Drug repurposing refers to the identification of potential new uses of FDA-approved drugs, for which the new uses would be supported by safety and effectiveness data.  Because drug repurposing takes into account existing knowledge of approved drugs (e.g., safety profiles) when considering the benefits and risks of potential new uses, it can be an important approach for identifying potential treatments for diseases, conditions, or populations that currently lack adequate approved therapies.

Id. at 25897.  “New uses of FDA-approved drugs” is off-label use.

Bexis’ off-label use article, “Off-Label Use in the Twenty-First Century:  Most Myths & Misconceptions Mitigated,” 54 UIC J. Marshall L. Rev. 1 (2021), addressed one of the most significant economic reasons for off-label use:

Economic realities can also keep uses off the label.  Because of the time and expense of obtaining FDA approval of new uses for an already approved drug, drug manufacturers frequently do not voluntarily request FDA approval for a new use unless the change in the labeling will pay for itself in increased profits.

Id. at 28 (footnote omitted).

Here’s a concrete example.  For over 20 years a drug, methotrexate, that has been around forever (i.e., it’s generic), has been recognized as the safest first-line treatment for juvenile dermatomyositis, a rare (and potentially crippling) autoimmune disease.

Here, we report use of MTX [methotrexate] as first-line therapy for DM, along with aggressively tapered corticosteroids, in an attempt to reduce treatment-related side effects.. . . .  

Conclusion: Use of MTX in conjunction with an aggressively tapered course of prednisone may be as effective as traditional long-term corticosteroid therapy for children with DM, while decreasing the cumulative dose of corticosteroids.

Ramanan, et al., “The Effectiveness of Treating Juvenile Dermatomyositis with Methotrexate & Aggressively Tapered Corticosteroids,” 52(11) Arth. & Rheum’y 3570-3578 (Nov. 2005) (at abstract).  That article (and others like it) was published more than 20 years ago, but this treatment still does not appear on the FDA-approved label for the drug.  Why?  Because, first the disease is rare (3 in 1 million children), and second it’s a generic drug, and generic manufacturers are not equipped to perform the sort of clinical testing that the FDA regulatory process demands for label changes.

But the FDA’s recent “information request” may be about to change all that.  It focuses “on FDA-approved drugs for which there appears to be no commercial interest in adding a new use through a supplement to a new drug application.”  91 Fed. Reg. at 25897.  The FDA is looking for “cases where there are compelling data but potentially no commercial interest in submitting a supplemental application.”  Id. at 25898.  Now, after spending decades trying to interfere with information about off-label use, the FDA wants to collect it and to “use other complementary approaches supported by existing legislation and regulatory pathways to encourage labeling updates with new uses for drugs.”  Id.

Take the methotrexate example.  The FDA request for information invokes 21 U.S.C. §353d – added after Bexis’ article – which allows the agency to “identify covered drugs for which labeling updates would provide a public health benefit,” covered drugs being generic drugs:

for which − there is new scientific evidence available pertaining to new or existing conditions of use that is not reflected in the approved labeling; . . . or there is a relevant accepted use in clinical practice that is not reflected in the approved labeling; and updating the approved labeling would benefit the public health.

Id. §353d(a)(1)(C) (further subheadings removed).  That sounds like it would cover methotrexate, but there’s more.

Aside from statutory powers, FDA has been quietly:

initiating systematic analyses of publicly available scientific literature, and upon determining that the information supports findings that could result in labeling changes, subsequently publishing Federal Register Notices to facilitate these changes by encouraging the filing of supplemental applications

91 Fed. Reg. at 25898.  In other words FDA has started proactively looking for accepted off-label uses that could be brought onto drug labels, and this request seeks to broaden that initiative.

We strongly encourage our readers who may have information about medically accepted off-label uses to provide that information to the FDA during the comment period, which is open through June 11, 2026.

Here are the “criteria” for what kinds of off-label uses the FDA is seeking to add to drug (but apparently not device) labels.

(1) There is compelling scientific evidence to support the effectiveness of the drug for the new use, (2) the dosage form(s) and route(s) of administration for the new use are the same as for an approved indication, and (3) there is a comparable safety profile for the patient populations for the new use and approved  indications.  FDA is also seeking input on potential candidates for drug repurposing that may not meet all of the above criteria but have preliminary promising data that might address an unmet need.

Id. at 25899.  These are the medical conditions that the FDA currently views as “priority areas”

metabolic diseases, neurodegenerative conditions, women’s health conditions (e.g., conditions related to menopause), men’s health conditions (e.g., testosterone deficiency), and substance use disorders, as well as rare diseases.

Id.  The FDA request also identifies three “scenarios” based on the amount of existing data that is available:

  • Candidates for which sufficient evidence may already exist to demonstrate their safety and effectiveness for a potential new use.
  • Candidates for which there are preliminary signals from clinical data, but sufficient evidence does not yet exist to demonstrate their safety and effectiveness for a new use.
  • Candidates for which there are preliminary signals from preclinical data, but no clinical evidence yet exists to demonstrate their safety and effectiveness for a new use.

Id. (emphasis added).

However, given our stance on truthful off-label speech, we would not mind seeing our readers publicize to the medical community the data that they are submitting to the FDA in response to the agency’s request for information.  We find it hard to see how that could possibly be “illegal,” but we’re not the FDA, and we don’t know how the FDA would view that.

And now for something off-label, but completely different.

Bexis’ law review article cited exactly one medical malpractice case, ever, that involved an allegation “premised on a physician’s failure to prescribe off-label.”  54 UIC J. Marshall L. Rev. at 30 n. 140.  Now there is even more bizarre case – a claim that it was malpractice not to treat the plaintiffs’ decedent with not just an off-label use, but with a drug that had no FDA approval at all.  Maybe we should call that an “off-off-label” use.

Last month, DeMizio v. Johns Hopkins Health System Corp., 2026 WL 1265362 (Md. Spec. App. May 8, 2026) (unpublished), affirmed a defense verdict in a case where the plaintiff’s, and her expert’s, theory was:

Regarding the drug . . ., over objections, [plaintiffs’ expert] said there were studies conducted . . . showing [its] effectiveness, and these studies were “known and available . . . in the United States.”  During that time period, the drug was approved in the European Union and Japan for the treatment of [the relevant condition].  Meaning that patients could travel abroad and receive treatment with [the drug] if they had the means.  The FDA did not approve the drug in the United States until 2019.  Even prior to the FDA’s approval, [plaintiff’s expert] said [the drug] was “known to be out there.”  To be prescribed [the drug] in the United States, there were . . . centers across the county where the drug could be prescribed off-label.

Id. at *3.

Not surprisingly this theory – that the medical standard of care in Maryland purportedly required treatment with a drug that the FDA had not yet approved for anything – failed miserably.  The expert “did not provide any peer reviewed or published literature to support his conclusion,” and the opinion was “an unjustified extrapolation where during the relevant treatment period the treatment with [that drug] was not FDA-approved for any purpose.”  Id. at *4.

On appeal, the plaintiffs lost again.

“Extrapolation” is one of the various factors relevant to Maryland’s quasi-Daubert-based approach to expert testimony.  The appellate court agreed that this “ipse dixit” opinion that use of a totally unapproved drug that was not available in the United States was somehow the “standard of care” flunked that test:

[W]hether there was an unjustified extrapolation from an accepted premise to an unfounded conclusion . . . is related to the concept of an “analytical gap”. . . .  An expert’s opinion has an analytical gap when the expert fails to bridge the gap between his or her opinion and the empirical foundation on which the opinion was derived.  A trial court is not required to admit an opinion that is connected to existing data only by the ipse dixit of the expert.  Here, [the expert’s] opinion that using [the drug] was the standard of care, when the drug was not yet FDA-approved for any purpose and [the expert] did not point to other evidence supporting his conclusion beyond his own testimony, had too wide of an analytical gap between the empirical foundation and the opinion. . . .  At the hearing, [the expert] failed to present sufficient evidence to support the reliability of his conclusion on [the drug].  Instead, [his] testimony on this issue was precisely the kind of ipse dixit opinion that Maryland courts have said is not sufficiently reliable for admission.

Id. at *9.

We think that DeMizio’s conclusion was absolutely correct.  That notion − that treatment with a totally unapproved drug (or device, for that matter) could nonetheless be the medical standard of care − is one of the most bizarre expert “opinions” we’ve ever come across in the context of prescription medical products.

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Today’s post is not from the Reed Smith side of the blog.

We remember a time years ago when the phrase “Lone Pine order” was not widely understood. That has long since changed, and now it’s tough to imagine anyone who practices in mass torts not being familiar with it. Indeed, we’ve posted repeatedly about courts entering Lone Pine orders in certain litigation.  We also have a cheat sheet of favorable Lone Pine orders. But as we posted a year ago, the term “Lone Pine” carries a lot of baggage, and we suggested it might be time to stop using the name of a 1986 New Jersey case to refer to a case management procedure for requiring plaintiffs to establish the factual bases for their claims. Terms like “Threshold Evidence Orders” or “Case Vetting Orders” seem more appropriate, and dropping the Lone Pine description might generate less resistance from plaintiffs’ counsel and courts.   

Continue Reading Case Vetting Order in the Thalidomide Litigation
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For about 18 months now, we’ve been feeling a bit like Chicken Little (or Henny Penny for those in Europe). 

We have been posting about the dangers hidden in the impending implementation of the European Union’s Product Liability Directive (“EU PLD”), and bending the ear of any in house lawyer in reach about taking precautionary steps regarding supply chain risks, insurance coverage, contract terms with component part suppliers and distributors, company communications and other sources of data, and regulatory compliance.

People are starting to pay attention.  (One example:  an inaugural product liability conference in Brussels later this month, at which we are speaking).  But the effective date of the EU PLD is still a few months away, other deadlines press, and how bad will it really be?

We agree that Europe will not be awash in product liability lawsuits by December 31, 2026.  Not all member countries within the EU have completed the process of transposing the Directive into national law as yet, and the EU PLD’s standards only will “apply to products placed on the market or put into service after 8 December 2026.”

But we invite you to read the EU PLD and decide for yourself:  Directive (EU) 2024/2853 of the European Parliament and of the Council of 23 October 2024 on liability for defective products and repealing Council Directive 85/374/EEC (Nov. 18, 2024).

To our eye, the EU PLD actively, affirmatively, perhaps even aggressively, encourages more product liability litigation.  

First, it significantly eases the burdens of proof on those who would bring such lawsuits in the EU. Claimants get presumptions of defectiveness, causation, or both, for a host of reasons, including:  

  • Because “it would be excessively difficult for the claimant, in particular due to the technical or scientific complexity of the case, to prove the defectiveness or the causal link, or both”;
  • Because there was an “obvious malfunction”;
  • Because the product “belongs to the same production series as a product already proven to be defective”; and/or
  • Because the product was established to be defective, and “the kind of damage that occurred” is typical of the damage seen in other lawsuits.

Second, it expands the definition of a “product” to include most software and things like electricity, expands the amount of recoverable damages, expands the concept of product defect into areas like cybersecurity vulnerabilities and the failure to supply software updates, and expands the statute of limitations and statute of repose.

Third, it creates new disclosure (i.e., discovery) rules for product liability litigation in EU member countries, many of which never required anything like it before.  Yet at the same time, the EU PLD does not require EU member countries to recognize attorney-client privilege or attorney work-product protections for disclosed materials, and most member countries do not recognize such privileges.

Fourth, it allows courts to impose a duty on defendants to make their disclosed materials understandable to claimants.  It says:  

Taking into consideration the complexity of certain types of evidence, for example evidence relating to digital products, it should be possible for national courts to require such evidence to be presented in an easily accessible and easily understandable manner, subject to certain conditions.

Fifth, the EU adopted its own unique collective action law a few years back—the EU Representative Actions Directive (Directive (EU) 2020/1828) –and there does not seem to be any prohibition on resolving EU PLD claims through collective actions.  By contrast, in the U.S., the Supreme Court’s Amchem Products, Inc. v. Windsor, 521 U.S. 591 (1997), and Ortiz v. Fibreboard Corp., 527 U.S. 815 (1999), opinions prevent product liability and other personal injury claims from receiving the class action treatment.  

Many U.S. in house and defense lawyers may be holding on to hope that “loser pays” rules—rules that saddle unsuccessful claimants with reimbursing defense attorneys’ fees and costs—will stand as a bulwark against waves of new EU product liability litigation.  

Loser pays rules do certainly help tamp down frivolous litigation, but they are not uniformly in place across all countries within the EU, and the laws that exist vary in their terms.  In some countries, the loser pays only small, standardized amounts regardless of the actual costs of the defense and these are not a significant deterrent.  In other countries with loser pay rules, courts retain discretion to limit penalties in the interest of fairness.  

Thus, we do not think that loser pays rules will save the day.  Moreover, litigation funding can be available to tort claimants in the EU, and such arrangements may lessen the sting of loser pays rules even when litigation is unsuccessful.  

There also is no EU-wide restriction on third party litigation funding (“TPLF”), no EU-wide requirement regarding the disclosure of litigation funding, and no immediate plans for an EU litigation funding directive.  Don’t expect EU TPLF regulation to help keep a lid on post-December 2026 product liability litigation either.  

In fact, there was a recent report on TPLF in Europe (which we discussed here), but apparently momentum has paused on promulgating a litigation funding rule in favor of another study, about how things are going with the EU Representative Actions Directive (Directive (EU) 2020/1828).  And note that the Representative Actions Directive itself requires some such actions to be funded publicly or through said litigation funders.  

We are not going to say the sky is falling.  But we don’t see many rays of sunshine either.

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The more the merrier is not always true.  Ask any defendant in a trial that consolidates the claims of multiple plaintiffs.  The existence of multiple plaintiffs can conjure up an inference of guilt. If you are accused of hurting more than one person, that seems to increase the chance that the factfinder will conclude that you did something wrong. Surely there are studies that document this psychological effect. But everyday experience confirms it as much as anything else.  

So does not-so-everyday experience. We have been called for jury duty in Chester County, Pennsylvania on several occasions.  Once we actually served on a jury in a medical malpractice case and returned a verdict. (We wrote about that experience here). Another time, we lingered on the venire for most of a day in a criminal case. The voir dire was extensive and ended just before the lawyers would have gotten to us.  Thus, we remained gloriously mute and were sent on our way back to the juror assembly room. Presumably, enough jurors had escaped for-cause challenges and there were enough after taking into account peremptories.  We were eventually released for the day and found out that evening that our jury service for that year had been fulfilled.  That was good news.  But we had grown interested in the case. The defendant was accused of rape. Obviously, any juror on the case would be instructed not to perform any research, internet or otherwise, on the case.  But that no longer would apply to us. After one simple Google search, we learned that the defendant had been arrested for several rapes and was facing several separate trials.  Yikes. We could not help but wonder what would be the result if one of the impaneled jurors had violated the court order, entered keystrokes similar to ours, and discovered the fact of the defendant’s multiple arrests. It would have been enormously prejudicial. Maybe some unfortunate soul could be erroneously accused of one rape, but with two accusations the case starts to look compelling.  One might even think that the burden of proof was now shifted to the defendant to show he did not do it.  That would be wrong, of course, but many years of human evolution have linked our survival to pattern recognition and pessimism.  Good for survival of the fittest, but not good for someone facing multiple accusations of malfeasance. The law is designed to protect against unfair inferences. 

The law did protect against such unfair inferences in DLP Conemaugh Memorial Center, LLC et al. v. Jane BR 1 Doe, et al., 2026 WL 1465908 (Pa. Superior Ct. May 26, 2026). DLP Conemaugh is a  Pennsylvania Superior Court decision that is extremely favorable to defendants seeking to fend off consolidation of personal injury cases for trial.  Bexis wishes this case had been on the books when he was a mid-level associate in the Cretaceous Period, so that he would not have been stuck trying asbestos cases in groups of up to ten in the Philadelphia Court of Common Pleas.  But as we write this, Bexis is on vacation in a glorious location, so things have not turned out too badly.  

DLP Conemaugh is not a product liability case. Rather, it involved a Pennsylvania version of an MDL (Rule 213.1) with allegations of sexual abuse of minors at the hands of a now imprisoned pediatrician.  (So DLP Conemaugh really does remind us of that near-miss criminal trial.) The 140 plaintiffs sued various solvent medical care providers who had some sort of relationship with the imprisoned doctor.  The master complaint alleged the same causes of action by all plaintiffs: childhood sexual abuse and vicarious liability, negligence – hiring/retention, negligent supervision, negligent misrepresentation, intentional infliction of emotional distress, civil conspiracy to protect reputation and finances, medical negligence, violations of Title IX, and corporate negligence. The judge entered an order “directing that four bellwether cases be ‘combined and … tried together.’” The cases involved different solvent defendants, and different types and durations of alleged sexual abuse over a multi-year period.  

The defendants, understandably, objected to the consolidated trial. The judge stuck to his guns, stating that “it was the court’s intention to select a broad assortment of cases that would provide the court and parties the opportunity to resolve a variety of issues that would arise by way of motion practice and allow them to develop a procedure to move the remaining cases more effectively towards resolution.” One does not need any special skill at reading between the lines to see that “resolve” and “resolution” as an expression of the court’s fervent desire that the parties settle the cases. So much — too much — gets sacrificed on the altar of settlement. One thing that got sacrificed by the court’s ruling was any consideration of whether the defendants would be prejudiced by consolidation. The trial court simply did not address that issue.

Some defendants moved for reconsideration of the consolidation order. The judge denied reconsideration, then the judge recused himself from this case. (We do not know why.) Then that same judge certified the consolidation issue for interlocutory appeal.  (Yes, the order of things is confusing and counter-intuitive, but it ended up not mattering.)

The issue raised on appeal was “Whether the trial court abused its discretion in ordering the consolidation for joint trial of the four cases of Plaintiffs BR1, TS 11, AS67, and AP78, where the cases do not involve common parties or common questions of fact and law, and where consolidation will result in unfair prejudice to [DLP and LPA]?”

The Superior Court started where it must, with Pennsylvania Rule of Civil Procedure 213(a), which governs consolidation of actions pending in the same county.  It provides: “In actions pending in a county which involve a common question of law or fact or which arises from the same transaction or occurrence, the court on its own or on the motion of any party may order a joint hearing or trial of any matter in issue in the actions, may order the actions consolidated, and may make orders that avoid unnecessary cost or delay.” Comments and case law explain that consolidation can possibly benefit both sides of the v, can prevent inconsistent verdicts, and can reduce delays and expenses.

Were there common issues of law in the various sexual abuse cases? Maybe. After all, the complaints stated the same causes of action. Were there common issues of fact? Not really. “The four actions here do not arise from the same transaction or occurrence; they arose at different times and places over a period of sixteen years.” What prompted the Superior Court to vacate the consolidation order were the risks of prejudice and jury confusion. There was no way a four-plaintiff trial could not have prejudiced the defendants.  Trying four cases at once would risk “guilt by association” and that the jury would confuse what evidence applied to which defendant. Who knew what when (about the pediatrician) would be key issues for each defendant, and the different facts and time periods would be hard for the jury to keep straight. The trial court also “admitted that the four bellwether cases ‘include stronger and weaker fact patterns against some or all of the Defendants.’” Some defendant was likely going to pay a price by being grouped in with others.   

Further, a “proposed special verdict form under this scenario may necessarily be long and extraordinarily complex.” Nor would limiting instructions alleviate the potential for prejudice.  Consequently, “[a]ll of these factors counsel against consolidation in the manner contemplated by the trial court.” The trial court’s utter failure even to address the prejudice issue was particularly damning. The Superior Court held that “[i]n sum, the prejudice and confusion that consolidation will cause leads us to conclude that the order of consolidation constitutes an abuse of discretion by the trial court.”

The problems of prejudice and confusion from consolidation identified by the DLP Conemaugh court are much the same problems that plague all forms of personal injury consolidation, as we discussed here.  Having this precedential case on the books in Pennsylvania will greatly assist our clients in opposing similar consolidations. 

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Medical device sales representatives are many things. They know their product lines inside and out. They can tell a surgeon exactly where to find a particular screw, rod, or connector in a tray containing dozens of components. They can help ensure the requested hardware is available when needed. What they cannot do is scrub in, take over a surgery, or overrule a surgeon’s medical judgment. But that is essentially the duty plaintiff sought to impose in Spink v. Harms, 2026 Ga. State LEXIS 1133 (Ga. Super. Ct. Apr. 3, 2026).

Plaintiff underwent spinal fusion surgery during which her surgeon implanted bone screws manufactured by defendants. Present during the surgery were two representatives of the manufacturer. Their role was a familiar one in orthopedic and spinal procedures. Because spinal hardware systems contain numerous components in varying sizes and configurations, the representatives were there to help locate and provide the equipment requested by the surgeon. Id. at *2.

The facts regarding their involvement were undisputed. Neither representative was a physician. Neither was a surgeon. They did not scrub in. They did not enter the sterile field. They did not select hardware. They did not advise the surgeon on technique. They did not make treatment decisions. Rather, they monitored the procedure on a nearby screen and assisted the surgical team by identifying and locating the specific components requested by the surgeon. Id.  Most importantly, the surgeon testified that all relevant medical decisions were his and his alone. Id. at *3.

A few days after surgery, plaintiff reported nerve deficits. Her claim in the lawsuit was that the deficits were caused by improperly placed screws. Id. Notably absent from the lawsuit was any allegation that the screws themselves were defective. This was not a products liability case. The hardware was not accused of malfunctioning. Plaintiff’s complaint was that the surgeon allegedly put the screws in the wrong place. Id. But she sued the manufacturer and its representatives.

That left plaintiff searching for a theory under which those defendants could nevertheless be held liable. Plaintiff settled on ordinary negligence– not professional negligence, not medical malpractice–just negligence.  Which means plaintiff had to establish that defendants owed her a duty of ordinary care. So, plaintiff argued that the manufacturer’s representatives were obligated to “step in and say something” when they allegedly observed the surgeon incorrectly placing the screws. Id. at *5.

The court had little difficulty rejecting that theory. Under Georgia law, a defendant generally has “no duty to rescue” another from a perilous situation the defendant did not create. Id.  Here, defendants did not place the screws. They did not direct the placement of the screws. They did not make any surgical decisions. Therefore, the court found no basis for imposing an affirmative duty on the representatives to intervene in the surgeon’s conduct.

Recognizing that problem, plaintiff turned to the voluntary-undertaking doctrine. Under Georgia law, when someone voluntarily undertakes an act that he otherwise has no duty to perform, and another reasonably relies on that undertaking, the act must generally be performed with ordinary or reasonable care. Id. at *5-6. But that doctrine requires an actual undertaking. The representatives never undertook to perform surgery. They never undertook to monitor the surgeon’s technique. They never undertook to evaluate screw placement. They never undertook to act as an independent safety check on the surgeon’s medical judgment. The only thing they undertook to do was assist in providing the hardware requested by the surgeon. Id. at *6. What plaintiff was really arguing was that the representatives should have stepped beyond their limited role and assumed responsibilities they never accepted in the first place. The voluntary-undertaking doctrine does not impose liability for failing to take on additional responsibilities beyond those actually undertaken.

Further, the voluntary-undertaking doctrine only applies when a defendant’s affirmative conduct increases the risk of harm. It does not create liability because someone failed to reduce a risk created by another person. As the court recognized, the representatives’ alleged inaction did not transform properly placed screws into improperly placed screws. Whatever risk existed was created by the alleged surgical error, not by anything the representatives did or failed to do. Id. at *6-7. Their failure to intervene did not increase the risk of harm; at most, plaintiff argued they failed to decrease it. That distinction proved dispositive.

Plaintiff made one final attempt to save her claims by offering an expert in medical device management who opined that the representatives should have intervened. But expert testimony could not bridge the gap. Whether a legal duty exists is a question of law for the court, not a question that can be answered by an expert witness. Id. at *7. An expert may explain industry practices. An expert may describe standards of conduct. What an expert cannot do is create a legal duty where none exists.

The Georgia state court’s decision is a welcome reminder that negligence law still requires an actual duty. Plaintiff’s theory would have transformed non-physician device representatives into de facto surgical supervisors, obligated to second-guess surgeons during procedures and potentially challenge medical decisions they neither made nor controlled. That may be a creative attempt to expand the pool of defendants, but it is not the law. 

Medical device representatives may know where every screw, rod, and connector is located in the tray. What they do not have is a legal duty to take over the surgeon’s job.

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Here at the Blog, we love the learned intermediary rule.  We’ve chronicled the rule’s steady expansion as it now has precedential support in all fifty states.  “Every state in the country, along with the District of Columbia and Puerto Rico, has adopted the learned intermediary doctrine in some iteration.”  Dearinger v. Eli Lilly & Co., 510 P.3d 326, 329 (Wash. 2022). We’ve discussed how it applies to all types of prescription medical products (specifically, medical devices as well as drugs).  We’ve pointed out that it protects pharmacies as well as product manufacturers.  We have headcounts and 50-state surveys.  In fact, it’s gotten to the point that we’ve discussed the learned intermediary rule so many times from so many angles, that there are probably too many places to look efficiently.

We’re hoping to address the problem of too much information in too many places with this post.  Here, we’re combining in one place the jurisdictional information about the rule from our headcounts with the substantive information from our 50-state surveys.  This post, on a state-by state basis, not only provides the decisions from highest-level courts to adopt the learned intermediary rule itself, but also the best precedents for its application to medical devices, biologics (fewer cases after the Vaccine Act), and pharmacists.

One final note before getting to the meat of this quite long (81+ pages in Word) post − obviously, we believe the rationale for the rule would support its application in all of these contexts, even if a particular state doesn’t have authority in each area, so don’t let lack of directly on-point precedent in any particular state stop you from arguing for the learned intermediary rule.  This post is intended to help defense counsel do just that.  So, fill in those holes.

What we’re doing initially is what the Blog did with the failure to report 50-state survey, which was of similar length.  We’re going to break it into three posts over three weeks, so people who want to read them can do so without spending all day.  When that’s done, behind the scenes, we will add the three pieces back together so that our users can find everything in one place – our original goal.

Here goes.  Part 3.  After this we will consolidate the three together, under what is now Part 1.

North Dakota

The North Dakota Supreme Court has never adjudicated a learned intermediary case.  In the federal courts, Ehlis v. Shire Richwood, Inc., 367 F.3d 1013, 1017 (8th Cir. 2004), predicted that North Dakota, like its sister states, would follow the rule.

[T]he district court noted an overwhelming majority of jurisdictions have adopted the learned intermediary doctrine. . . .  Because the precedent is truly overwhelming and the policy enunciated by the learned intermediary doctrine is sound, we conclude the district court correctly ruled the North Dakota Supreme Court would adopt the learned intermediary doctrine.

Id. at 1017 (citation omitted).  Accord Harris v. McNeil Pharmaceutical, 2000 WL 33339657, at *4 n.4 (D.N.D. Sept. 5, 2000) (noting that the drug in question, “because it is only available by prescription, is an ethical drug.  It is well recognized that the duty an ethical drug manufacturer owes to the consumer is to warn only physicians or others permitted to dispense prescription drugs of any risks or contraindications associated with that drug.”) (citation omitted).  In State v. Purdue Pharma L.P., 2019 WL 2245743 (N.D. Dist. May 10, 2019), the “learned intermediary doctrine” was one reason for rejecting the plaintiff’s causation theory as “attenuated” because they did not “account for the independent actor (i.e. doctors) who stands between [defendant’s] alleged conduct and the alleged harm.”  Id. at *10.

We know of no North Dakota precedent on the learned intermediary rule in the pharmacy, medical device, or biologic contexts.

Ohio

In Ohio, a statute applies the learned intermediary rule to drugs.

An ethical drug is not defective due to inadequate warning or instruction if its manufacturer provides otherwise adequate warning and instruction to the physician or other legally authorized person who prescribes or dispenses that ethical drug for a claimant in question and if the federal food and drug administration has not provided that warning or instruction relative to that ethical drug is to be given directly to the ultimate user of it.

Ohio Rev. Code §2307.76(c).  The statute codified existing Ohio law.  See Howland v. Purdue Pharma, L.P., 821 N.E.2d 141, 146 (Ohio 2004) (“The learned-intermediary doctrine has been adopted and applied by this court.”) (citation omitted); Wagner v. Roche Laboratories, 671 N.E.2d 252, 256 (Ohio 1996) (“A manufacturer of an unavoidably unsafe ethical (prescription) drug is not strictly liable in tort to a consumer who has suffered injury as a result of ingesting that drug where the manufacturer has provided adequate warning to the medical profession.”); Tracy v. Merrell Dow Pharmaceuticals, Inc., 569 N.E.2d 875, 878 (Ohio 1991) (“Where a prescription drug has been prescribed for a patient by the patient’s physician, the manufacturer has been held to discharge its duty to warn if the manufacturer adequately warns the physician.”) (citations omitted); Seley v. G.D. Searle & Co., 423 N.E.2d 831, 839-40 (Ohio 1981) (“It has become a well established rule in such [prescription drug] cases that the manufacturer satisfies his duty to warn of dangers associated with use of the product by providing adequate *203 warnings to the medical profession, and not the ultimate user.”).

The learned intermediary rule applies to medical devices as a matter of Ohio common law.  Vaccariello v. Smith & Nephew Richards, Inc., 763 N.E.2d 160, 164 (Ohio 2002), rejected an argument that the statute’s omission of medical devices meant that the learned intermediary rule did not apply.

[Section] 2307.76(c) . . . does not thereby abrogate the common law. . . .  [T]he Revised Code does not contain a clear statement that the learned intermediary doctrine, a creature of the common law, cannot apply to prescription medical devices.  We stated in Tracy that “[t]he rationale behind [the learned intermediary doctrine] is that the physician stands between the manufacturer and the patient as a learned intermediary. . . .”  This rationale applies equally to prescription medical devices.  Accordingly, we hold that the learned intermediary doctrine applies to prescription medical devices.

Id. at 164 (citations and quotation marks omitted).

White v. Wyeth Laboratories, Inc., 533 N.E.2d 748, 755 (Ohio 1988), applied the Seley rule to a vaccine/biologic.

In Seley, . . . [w]e further held that the manufacturer of a prescription drug satisfies its duty to warn of risks associated with the use of the product by providing adequate warnings to the medical profession and not to the ultimate user.

Id. at 755 (quotation marks omitted).

In the only Ohio case involving pharmacists and the learned intermediary rule, Estate of Mehrer v. Walgreens Specialty Pharmacy, 218 N.E.3d 301 (Ohio App. 2023), the appellate court did not itself apply learned intermediary rule, but “instructed [the trial court] to consider” it on remand.  Id. at 311.

Oklahoma

The Oklahoma Supreme Court has applied the learned intermediary rule to prescription drugs, Edwards v. Basel Pharmaceuticals, 933 P.2d 298 (Okla. 1997), vaccines, Cunningham v. Charles Pfizer & Co., 532 P.2d 1377 (Okla. 1974), and medical devices, Tansy v. Dacomed Corp., 890 P.2d 881, 886 (Okla. 1994), and McKee v. Moore, 648 P.2d 21 (Okla. 1982).

Cunningham recognized the “general rule . . . that in cases involving prescription drugs the drug manufacturer has only a duty to warn the prescribing physician,” but applied the “mass immunization” exception.  Id. at 1381.  McKee rejected an attempt to distinguish medical devices:

[I]n cases involving prescription drugs, the manufacturer has a duty to warn only the prescribing physician.  Appellants contend that the rule is inapplicable because even though an [product] is sold by prescription it is a device rather than a drug.  We are not persuaded by this argument. . . .  The manufacturer’s duty is to warn the physician, who acts as a learned intermediary between the manufacturer and the consumer, because he is in the best position to evaluate the patient’s needs, assess the benefits and risks of a particular therapy, and to supervise its use. . . .  The manufacturer’s duty to warn the ultimate consumer of prescription drugs, or devices, as distinguished from those sold directly to the consumer, is limited to advising the prescribing or treating physician of the drug’s or device’s potential dangers. . . .  Once the physician is warned, the choice of treatment and the duty to explain the risk is incumbent on the physician.

(footnotes and block quotation omitted).  Accord Tansy, 890 P.2d at 886 (holding, in a device case, that “for the warning requirement, . . . Oklahoma has adopted the learned intermediary doctrine”).

Edwards recognized the learned intermediary rule as applicable to prescription drugs.

[T]he “learned intermediary doctrine” . . . Oklahoma has recognized as applicable in prescription drug cases. . . .  The doctrine operates as an exception to the manufacturer’s duty to warn the ultimate consumer, and shields manufacturers of prescription drugs from liability if the manufacturer adequately warns the prescribing physicians of the dangers of the drug.  The reasoning behind this rule is that the doctor acts as a learned intermediary between the patient and the prescription drug manufacturer by assessing the medical risks in light of the patient’s needs. . . .  The doctrine extends to prescription drugs because, unlike over the counter medications, the patient may obtain the drug only through a physician’s prescription, and the use of prescription drugs is generally monitored by a physician.

Id. at 300-01 (citations and block quotation omitted).

Carista v. Valuck, 394 P.3d 253, 259 (Okla. Civ. App. 2016), held that “the duty of [a p]harmacy . . . is limited by the principles and exceptions to the learned intermediary doctrine.”  Id. at 259.

[The p]harmacy argued that this [learned intermediary] principle places sole responsibility with the physician to communicate any matter covered by the learned intermediary doctrine, and not with a pharmacist.  No published Oklahoma case has applied this doctrine in a case involving a pharmacist.  Many other states . . . have adopted the doctrine, with limited exceptions, to shield pharmacists from being required to “second guess” a physician’s medical decisions embodied in an otherwise authorized and legally made prescription.

Id. at 256.  This precedent “conform[ed] to Oklahoma law.  Id. at 257.

Based on the scope of a pharmacist’s practice, it is clear the responsibility of prescribing medication to a patient does not lie with a pharmacist.  Rather, the determination of whether a particular medication is medically necessary for a patient lies with the treating physician or other appropriate individual.

Id. (citation and quotation marks omitted).

Oregon

Oregon was an early adopter of the learned intermediary rule.  In McEwen v. Ortho Pharmaceutical Corp., 528 P.2d 522, 528 (Or. 1974), the court held:

It is well settled . . . that the manufacturer of ethical drugs bears the additional duty of making timely and adequate warnings to the medical profession of any dangerous side effects produced by its drugs of which it knows, or has reason to know. . . .  Although the duty of the ethical drug manufacturer is to warn the doctor, rather than the patient, the manufacturer is directly liable to the patient for a breach of such duty.  The manufacturer’s compliance with this duty enables the prescribing physician to balance the risk of possible harm against the benefits to be gained by the patient’s use of that drug.

Id. at 385-87 (citations and footnote omitted).  Accord Oakeshott v. Lederle Laboratories, 656 P.2d 293, 297 (Or. 1982) (recognizing that “as a prescription drug manufacturer, defendant had an obligation to warn physicians . . . of possible harmful effects of its prescription medicines”) (citation omitted); Vaughn v. G.D. Searle & Co., 536 P.2d 1247, 1248 (Or. 1975) (reaffirming “the duty of a drug manufacturer to provide timely and adequate warnings to the medical profession” in a contraceptive drug case).

However, Oregon passed a product liability statute, effective in 1980, that adopted Restatement §402A and its comments.  Griffith v. Blatt, 51 P.3d 1256, 1260-61 (Or. 2002) (discussing Or. Rev. Stat. §30.920(3)).  Because the learned intermediary rule does not appear in the Second Restatement (although it does in the Third, see, Products Liability §6(c)), the Oregon Supreme Court in Griffith held that “Oregon’s product liability statute does not create a defense to strict liability based on the learned intermediary doctrine.”  Id. at 1262.  Thus, Oregon draws a unique distinction between negligence – where the rule applies – and strict liability – where it does not.

No Oregon appellate court has applied the learned intermediary rule in a medical device case, but several trial courts applying Oregon law have.  Pearson v. Ethicon, Inc., 2021 WL 4498562, at *7 (Mag. D. Or. Aug. 16, 2021) (applying learned intermediary rule to medical device to extent allowed by Griffith), adopted in pertinent part, 2021 WL 4494188 (D. Or. Sept. 30, 2021); Johnson v. Medtronic Inc., 2021 WL 2669560, at *4 (Mag. D. Or. June 10, 2021) (“Defendants had a duty to warn [the surgeon] of the known risks associated with their [device]”), adopted, 2021 WL 2668793 (D. Or. June 29, 2021); Allen v. G.D. Searle & Co., 708 F. Supp. 1142, 1147-48 (D. Or. 1989) (“This court will . . . apply the learned intermediary doctrine in this case” involving an IUD); Jennings v. Baxter Healthcare Corp., 1995 WL 17815190 (Or. Cir. Nov. 6, 1995) (“Implants by definition are placed in the human body by licensed physicians.  There is no reason treat breast implants any differently than other medical devices which require a prescription.”).  The oldest decision still has the most cogent reasoning:

There is no reason to believe that this [learned intermediary] concept applies with any less force to a case like plaintiff’s which involves the use of a prescription device. . . .  The devices are available only through a physician’s prescription  The physician performs an individualized balancing of the benefits and risks to the patient before prescribing the device. . . .  The doctor who prescribes an IUD is no less a “learned intermediary” between manufacturer and patient than was the physician in McEwen. . . .  For this reason I am convinced that Oregon courts would . . . hold . . . that the manufacturer of an IUD has a duty to warn physicians, not patients, of any possible dangers associated with its use.

Steinmetz v. A.H. Robins Co., 1981 WL 768631, at *2 (D. Or. Aug. 27, 1981) (citations omitted).

We are unaware of any Oregon law decision addressing the learned intermediary rule in either a biologic or pharmacy situation).

Pennsylvania

Pennsylvania is another early adopter of the learned intermediary rule.  In Incollingo v. Ewing, 282 A.2d 206, 220 & n.8 (Pa. 1971), a prescription drug case, the Pennsylvania Supreme Court held:

Since the drug was available only upon prescription of a duly licensed physician, the warning required is not to the general public or to the patient, but to the prescribing doctor.  The question, therefore, in this case is whether the warning that was given to the prescribing doctors was proper and adequate.

Id. at 220 (citation omitted).  Accord Baldino v. Castagna, 478 A.2d 807, 812 (Pa. 1984) (“where such drugs are available by prescription only, ‘the warning required is not to the general public or to the patient, but to the prescribing doctor.’”) (quoting Incollingo).  Cf. Lance v. Wyeth, 85 A.3d 434, 457 (Pa. 2014) (“not consider[ing] the wisdom of modifications or exceptions to the [learned intermediary] doctrine” in drug warning cases).

The learned intermediary rule was applied in the pharmacy context in Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1385 (Pa. 1991) (applied to pharmacists):

Since . . . this Court decided Incollingo v. Ewing, it has been clear that when a drug “is available only upon prescription of a duly licensed physician, the warning required is not to the general public or to the patient, but to the prescribing doctor”. . . .  

In arguing that pharmacists have an independent duty to warn of allegedly dangerous characteristics of prescription drugs they dispense, the appellants give scant attention to the rule of Incollingo or its rationale.  Under that rule, information about the risks of medicines is provided to the person who most needs and can best evaluate it − the physician − to be shared with and explained to the patient in the context of his or her individual medical circumstances.  If the manufacturer has no duty to directly warn patients of the risks of drugs, it would indeed be incongruous to hold pharmacists to such a duty in the dispensing of drugs. . . .  Pharmacists, as suppliers, do not freely choose which “products” they will make available to consumers in any given instance, and patients, as consumers, do not freely choose which “product” to buy.  Physicians exercising sound medical judgment act as intermediaries in the chain of distribution, preempting, as it were, the exercise of discretion by the supplier-pharmacist, and, within limits, by the patient-consumer. . . .  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.

Id. at 1385-86 (block quote omitted).  See Makripodis v. Merrell Dow Pharmaceuticals, Inc., 523 A.2d 374, 378 (Pa. Super. 1987) (applying learned intermediary rule to pharmacists pre-Coyle).

As for medical devices, Pennsylvania’s intermediate courts have applied the rule to these products several times. 

Under the learned intermediary doctrine . . . a manufacturer will be held liable only where it fails to exercise reasonable care to inform the one for whose use the product is supplied of the facts which make the product likely to be dangerous.  The intended “user” in a case involving a prescription drug or device is, of course, the prescribing physician.

Rosci v. AcroMed, Inc., 669 A.2d 959, 969 (Pa. Super. 1995) (citations omitted). 

[Plaintiffs’] argument presents only a facile conclusion that because existing cases have not applied the learned intermediary doctrine in that context, there exists no basis for its application here.  We find this rationale unsubstantiated and unconvincing.  To the extent that our court’s have previously applied the doctrine in relation to prescription drugs, we find no compelling reason why it may no be so applied here.

Creazzo v. Medtronic, Inc., 903 A.2d 24, 32 (Pa. Super. 2006).  Accord Brecher v. Cutler, 578 A.2d 481, 485 (Pa. Super. 1990) (IUD case; “A manufacturer will be held liable only if he fails to exercise reasonable care to inform the one for whose use the product is supplied of the facts which make it likely to be dangerous.”) (citation omitted).

The Third Circuit applied Pennsylvania’s learned intermediary rule to a vaccine/biologic in Mazur v. Merck & Co., 964 F.2d 1348, 1355-57 (3d Cir. 1992) (also holding that a nurse can be a learned intermediary).  See Lennon v. Wyeth-Ayerst Laboratories, Inc., 2001 WL 755944, at *2 (Pa. Super. June 14, 2001) (“the learned intermediary rule exists specifically because certain drugs are available only upon prescription, which only a licensed physician may provide, or, as in the case of the vaccine, upon administration by a health care professional at a doctor’s direction”) (non-precedential).

Puerto Rico

We could not find (at least in the English translations) any Puerto Rico territorial/commonwealth court decisions involving the learned intermediary rule.  Federal court cases applying Puerto Rico law have adopted the learned intermediary rule.  Guevara v. Dorsey Laboratories, Division of Sandoz, Inc., 845 F.2d 364 (1st Cir. 1988), held

The duty to warn in general is limited to hazards not commonly known to the relevant public. . . .  The courts have recognized this principle in their description of the scope of a drug manufacturer’s duty to warn: The warning should be sufficient to appraise a general practitioner as well as the unusually sophisticated medical man of the dangerous propensities of the drug.

Id. at 367 (citation and quotation marks omitted).

The rule has also been applied in Mendez Montes De Oca v. Aventis Pharma, 579 F. Supp.2d 222, 227 (D.P.R. 2008) (“This rule is known as the ‘learned intermediary doctrine’ whereby a prescription drug manufacturer has no duty to warn consumers directly of dangers or risks posed by the use of its product.  Rather, this duty extends exclusively to the prescribing physicians.”) (biologic); Rivera-Adams v. Wyeth, 2010 WL 5072541, at *3 (D.P.R. Dec. 8, 2010) (“[w]hen the product at issue is a prescription drug, the manufacturer’s duty to warn does not run to the user of the drugs directly; instead, the manufacturer has a duty to adequately warn prescribing physicians”) (prescription drug); Pierluisi v. E.R. Squibb & Sons, Inc., 440 F. Supp. 691, 694-95 (D.P.R. 1977) (“the duty of adequate warning by the manufacturer of an ethical drug is discharged by its warning of hazards to doctors”) (prescription drug).  We did not find any medical device or pharmacy learned intermediary cases from Puerto Rico.

Rhode Island

While the Rhode Island Supreme Court has yet to consider the learned intermediary rule, federal courts have consistently predicted that it will adopt the rule.  Greaves v. Eli Lilly & Co., 503 F. Appx. 70, 71 (2d Cir. 2012) (“[W]e conclude that the Rhode Island Supreme Court would likely adopt the learned intermediary doctrine if faced with the question of whether to do so under circumstances similar to these”) (applying Rhode Island law).  Accord Hogan v. Novartis Pharmaceuticals Corp., 2011 WL 1533467, at *10 (E.D.N.Y. April 24, 2011) (“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.”) (applying Rhode Island law).

The same is true of medical devices.  Costa v. Johnson & Johnson, 2023 WL 2662903, at *3 (D.R.I. March 28, 2023), held:

The Rhode Island Supreme Court has not expressly adopted the learned intermediary doctrine. . . .  Here, a number of factors counsel in favor of predicting that the Rhode Island Supreme Court would adopt the learned intermediary doctrine.  First, the Rhode Island Supreme Court has implicitly referenced the doctrine when describing the proximate cause element of a failure to warn claim.  In addition, the Rhode Island Supreme Court frequently relies on the Second and Third Restatements of Torts as a basis for the state’s product liability law.  The learned intermediary doctrine is defined in §388 of the Second Restatement, which the Rhode Island Supreme Court has cited with approval in other contexts.  The doctrine is also defined in §6 of the Third Restatement of Torts: Products Liability, other provisions of which the Rhode Island Supreme Court has cited with approval. . . .  Finally, the Court follows the lead of other federal courts that have predicted that the Rhode Island Supreme Court would likely adopt the learned intermediary doctrine.

Id. at *3 (citations and quotation marks omitted).  Accord Franks v. Coopersurgical, Inc., 722 F. Supp.3d 63 (D.R.I. 2024) (“the Rhode Island Supreme Court would likely adopt the [learned intermediary] doctrine, if given the opportunity, considering its reliance on the Second and Third Restatements of Torts as the basis for the state’s product liability law”) (following Costa).

We found no Rhode Island biologic or pharmacy cases involving the learned intermediary rule.

South Carolina

The South Carolina Supreme Court adopted the learned intermediary rule in Madison v. American Home Products Corp., 595 S.E.2d 493 (S.C. 2004), a “case present[ing] the purely legal issue of whether a pharmacy may be held strictly liable for properly filling a prescription drug in accordance with a physician’s orders.  Id. at 494.  Madison said no:

In addition to the theory that filling a prescription is more of a service than a sale, courts have found no basis to impose strict liability on pharmacists because . . . strict liability is inconsistent with the learned intermediary doctrine, which places the duty to warn on the prescribing physicians, and not pharmacists; the imposition of such duties would force pharmacists to refuse to stock necessary drugs because of risks involved, refuse to use less expensive generic drugs, or second guess the judgment of prescribing physicians.

Id. at 496 (citation and quotation marks omitted).

The Fourth Circuit has consistently applied South Carolina’s learned intermediary rule to prescription drugs and medical devices.  The earliest decisions involved medical devices.  Brooks v. Medtronic Inc., 750 F.2d 1227, 1231 (4th Cir. 1984), determined that, “[a]lthough the South Carolina Supreme Court has not addressed the issue, we conclude it would adopt the [learned intermediary] rule, generally accepted and supported by sound policy, restricting the manufacturer’s duty to warn to the prescribing physician.”  Id. at 1231.  This “drug exception,” id., was equally applicable to prescription medical devices.  “[T]he decision to prescribe [this device] involves precisely the sort of individualized medical balancing contemplated by the drug exception.”  Id. at 1232.  

It is plain that [plaintiff’s] claim is governed by the “learned intermediary” doctrine.  Under this doctrine, the manufacturer’s duty to warn extends only to the prescribing physician, who then assumes responsibility for advising the individual patient of risks associated with the drug or device.

Odom v. G.D. Searle & Co., 979 F.2d 1001, 1003 (4th Cir. 1992) (Brooks citation omitted).

But the Fourth Circuit has applied the rule to prescription drugs as well:

[T]he traditional view [is] that manufacturers of drugs and medical devices can discharge their common law duty by giving warnings directed to health-care providers and not to patients.  These healthcare providers act as “learned intermediaries,” using their knowledge, training, and experience to provide the patient with such information as is deemed appropriate under the circumstances so that the patient can make an informed choice as to therapy.  Often, the “learned intermediary” is the patient’s prescribing physician.

Bean v. Upsher-Smith Pharmaceuticals, Inc., 765 F. Appx. 934, 936 (4th Cir. 2019) (citations and quotation marks omitted).

Stratton v. Merck & Co., 2021 WL 5416705 (D.S.C. Nov. 17, 2021), applied the learned intermediary rule in the context of a biologic product.  Id. at *4 (treating defendant’s vaccine as equivalent to a drug for learned intermediary purposes). 

South Dakota

While the South Dakota Supreme Court has not addressed the learned intermediary rule, federal courts have applied it to South Dakota law:

To survive summary judgment, [plaintiffs] must establish a genuine issue of material fact whether an adequate warning would have altered [their prescriber’s] decision to prescribe [the drug].  The learned intermediary doctrine states that adequate warnings to prescribing physicians obviate the need for manufacturers of prescription products to warn ultimate consumers directly.

Schilf v. Eli Lilly & Co., 687 F.3d 947, 949 (8th Cir. 2012) (citations and quotation marks omitted).  Accord McElhaney v. Eli Lilly & Co., 575 F. Supp. 228, 231 (D.S.D. 1983) (“In cases involving prescription drugs the manufacturer must warn the physician, not the patient.”) (citation and quotation marks omitted), aff’d, 739 F.2d 340 (8th Cir. 1984); Yarrow v. Sterling Drug, Inc., 263 F. Supp. 159, 162 (D.S.D. 1967) (“In situations such as this, where the drug is a prescription drug, the manufacturer has a duty to properly warn the doctor of the dangers involved.”) (citations omitted), aff’d, 408 F.2d 978 (8th Cir. 1969).

Sluis v. Ethicon, Inc., 529 F. Supp.3d 1004 (D.S.D. 2021), applied the learned intermediary rule to a medical device.

Under [the learned intermediary] doctrine, a manufacturer of medical devices or pharmaceuticals satisfies its duty to warn by providing the appropriate information to the treating physician.  The treating physician then acts as a learned intermediary between the manufacturer and the patient, obviating the need for the manufacturer to warn the patient directly. . . .  Although [prior decisions] involved a drug manufacturer, [the] reasons for predicting that the Supreme Court of South Dakota would follow the learned intermediary doctrine apply with equal force here.  Thus, this Court predicts that the Supreme Court of South Dakota would follow the learned intermediary doctrine in cases against a designer and manufacturer of medical devices.

Id. at 1010 (discussion of Schilf omitted).  Accord Foster v. Ethicon, Inc., 529 F. Supp.3d 992, 997-98 (D.S.D. 2021) (identical discussion).

We have not seen any South Dakota law decisions that considered the learned intermediary rule in the context of pharmacies or biologics).

Tennessee

The Tennessee Supreme Court adopted the learned intermediary rule in Pittman v. Upjohn Co., 890 S.W.2d 425, 429 (Tenn. 1994).

Under the “learned intermediary doctrine,” makers of unavoidably unsafe products who have a duty to give warnings may reasonably rely on intermediaries to transmit their warnings and instructions.  Physicians are such intermediaries because of the pivotal role they play in the unique system used to distribute prescription drugs. . . .  However, physicians can be learned intermediaries only when they have received adequate warnings.  Thus, the learned intermediary doctrine does not shield a drug manufacturer from liability for inadequate warnings to the physician.

Id. at 429 (citations omitted).

Tennessee’s learned intermediary rule applies to medical devices as well as drugs.

The defendant relied on the defense of learned intermediary.  Under this doctrine, manufacturers of certain medical products may reasonably rely on intermediaries to transmit their warnings and instructions.  This defense is based upon the pivotal role that physicians play in the distribution of prescription products. . . .  Under this doctrine, physicians are the “consumers” who must be warned.

Harden v. Danek Medical, Inc., 985 S.W.2d 449, 451 (Tenn. App. 1998) (citations and quotation marks omitted).  Accord King v. Danek Medical, Inc., 37 S.W.3d 429, 453 (Tenn. App. 2000) (following Harden; “Accordingly, the learned intermediary doctrine applied to the plaintiffs’ allegation of failure to warn, and summary judgment was properly granted.”).

In Laws v. Johnson, 799 S.W.2d 249 (Tenn. App. 1990), the court applied learned intermediary rule principles to an action against a pharmacist, and affirmed summary judgment.

In considering the issue at bar it is necessary to recognize there is one body of the law relating to “proprietary or patent medicine” and the other relating to “ethical drugs” dispensed only by prescription.  In dispensing “proprietary or patent” medicine all warnings relating to the use of the drug must be given to the consumer of the drug.  In dispensing “ethical or prescription” drugs all warnings relating to the use of the drug must be given to the doctor or physician prescribing the drug.

Id. at 251 (citation omitted).  Significantly, the Tennessee Supreme Court in Pittman quoted and adopted as its own Laws’ statement of the learned intermediary rule.  890 S.W.2d at 429.  Cf. Johnson v. Settle, 2001 WL 585093, at *8 (Tenn. App. June 1, 2001) (learned intermediary rule protects medical supply company in suit over delivery correctly-labeled medical product).

We found no Tennessee learned intermediary decisions involving biologic products.

Texas

The Texas Supreme Court emphatically endorsed the learned intermediary rule in Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012), a prescription drug case.  Centocor summarized its holdings here:

Under the learned intermediary doctrine, the manufacturer of a pharmaceutical product satisfies its duty to warn the end user of its product’s potential risks by providing an adequate warning to a “learned intermediary,” who then assumes the duty to pass on the necessary warnings to the end user.  In this case, we consider the applicability of the learned intermediary doctrine to a patient’s claims against a prescription drug manufacturer. . . .  We hold that the doctrine generally applies within the context of a physician-patient relationship and allows a prescription drug manufacturer to fulfill its duty to warn end users of its product’s potential risks by providing an adequate warning to the prescribing physician. . . .  Although the patient alleged various common law causes of action, all of the patient’s claims turn on the prescription drug manufacturer’s failure to warn. Therefore, the learned intermediary doctrine applies to all of the patient’s claims.

Id. at 142-43.  See also Id. at 154-59, 164-66, 168-69 (detailed discussion of these issues).  Cf. Humble Sand & Gravel, Inc. v. Gomez, 146 S.W.3d 170, 190-91 (Tex. 2004) (applying learned intermediary rule in non-medical context); Alm v. Aluminum Co. of America, 717 S.W.2d 588, 590-92 (Tex. 1986) (same).

Texas appellate courts have routinely applied the learned intermediary rule in the medical context.  Verticor, Ltd. v. Wood, 509 S.W.3d 488, 495 (Tex. App. 2015) (“the ‘learned intermediary’ doctrine may limit the duty of a manufacturer or seller of prescription drugs or medical devices to warn end users of the product’s dangerous propensities”); Seifried v. Hygenic Corp., 410 S.W.3d 427, 432 (Tex. App. 2013) (“The prescribing doctor stands as a learned intermediary between the manufacturer and the consumer.”); Ethicon Endo-Surgery, Inc. v. Meyer, 249 S.W.3d 513, 516 (Tex. App. 2007) (applying learned intermediary causation, as the “independent knowledge doctrine,” in medical device case); Guzman v. Synthes (USA), 20 S.W.3d 717, 720 n.2 (Tex. App. 1999) (“where, as here, the product is meant only for administration by a physician, the physician is integrally involved in deciding what type of medical device to use on the patient, and the physician is in a better position than the patient to understand the dangers and propensities of the possible devices, the supplier satisfies its duty by warning and instructing the treating physician”) (citation omitted); Bean v. Baxter Healthcare Corp., 965 S.W.2d 656, 663 (Tex. App. 1998) (“we see no basis for distinguishing [prescription devices] from prescription drugs for purposes of applying the doctrine; in both instances, the product is manufactured for administration only by a physician or other authorized person.”; “The doctor stands as a learned intermediary between the manufacturer and the consumer.”); In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, 888 F.3d 753, 774 (5th Cir. 2018) (“[u]nder the learned-intermediary . . . doctrine, which Texas applies in medical products liability actions, the manufacturer  satisfies its duty to warn the end user of its product’s potential risks by providing an adequate warning to a ‘learned intermediary’”) (quotation marks and footnote omitted); Porterfield v. Ethicon, Inc., 183 F.3d 464, 467-68 (5th Cir. 1999) (“The learned intermediary doctrine applies in medical products liability actions in Texas.”) (citation omitted); In re Norplant Contraceptive Products Litigation, 165 F.3d 374, 379 (5th Cir. 1999) (“as long as a physician-patient relationship exists, the learned intermediary doctrine applies”).

Morgan v. Wal-Mart Stores, Inc., 30 S.W.3d 455, 467 (Tex. App. 2000), applied the learned intermediary rule to shield pharmacists from an independent duty to warn of dangers associated with prescription drugs.

[I]n light of the learned intermediary doctrine, which we find applicable to the relationship among physician, patient, and pharmacist, we hold that pharmacists have no generalized duty to warn patients of potential adverse reactions to prescription drugs absent some special circumstances not present here.  We do not imply that pharmacists may not warn patients of potential adverse reactions or dangerous side effects; we merely hold that pharmacists are not legally obligated to do so.

Id. at 469.

The learned intermediary rule also applies to Texas prescription biologic cases.  Hurley v. Lederle Laboratories, 863 F.2d 1173 (5th Cir. 1988), applied it to a vaccine.

Next we consider whether the doctrine of the learned intermediary applies in this case.  It is clear that this doctrine applies when a patient receives a drug or vaccination through a doctor who weighs the risks and benefits, and makes the decision to administer it.  In such a case, the fact that the manufacturer has adequately warned the prescribing physician will protect it from liability to the patient for failure to warn.

Id. at 1178.  A prior vaccine case under Texas law likewise recognized the learned intermediary rule.  Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1276 (5th Cir. 1974) (“in selling prescription drugs [defendants] are required to warn only the prescribing physician, who acts as a ‘learned intermediary’ between manufacturer and consumer”) (footnote omitted).  Reyes, however, held that an exception to the rule applied.  Id. at 1277.

Utah

The Utah Supreme Court first recognized the learned intermediary rule in Barson v. E.R. Squibb & Sons, Inc., 682 P.2d 832 (Utah 1984), holding that “[t]he manufacturer of ethical drugs has the duty of making timely and adequate warnings to the medical profession of any dangerous side effects produced by its drugs of which it knows or has reason to know.  The manufacturer is directly liable to the patient for the breach of such duty.”  Id. at 835 (footnotes omitted).

Utah’s highest court has also applied the learned intermediary rule twice in pharmacy cases. 

Under this rule, manufacturers of prescription drugs have a duty to warn only the physician prescribing the drug, not the end user or patient. . . .  It is the physician who is best situated to weigh the potential risks associated with a prescription drug against the possible benefits of the drug and the unique needs and susceptibilities of each patient.  The physician thus has the ability to combine medical knowledge and training with an individualized understanding of the patient’s needs, and is the best conduit for any warnings that are deemed necessary.  Many courts extend the learned intermediary rule to exempt pharmacists from strict products liability under a failure to warn theory.

Schaerrer v Stewart’s Plaza Pharmacy, Inc., 79 P.3d 922, 928-29 (Utah 2003) (citations omitted).

We [have] adopted the learned intermediary rule for purposes of exempting pharmacists from strict products liability, noting the classic concerns that the rule is intended to address.  We also made it clear, however, that the rule made sense in the context of a highly regulated distribution system for prescription drugs:  So long as a pharmacist’s ability to distribute prescription drugs is limited by the highly restricted, FDA-regulated drug distribution system in this country, and a pharmacist cannot supply a patient with prescription drugs without an intervening physician’s prescription, we will not impose a duty upon the pharmacist to warn of the risks associated with the use of prescription drugs.

Downing v. Hyland Pharmacy, 194 P.3d 944, 946 (Utah 2008) (Schaerrer citation and quotation marks omitted).  In Jensen v. Walgreen Co., 579 P.3d 305 (Utah 2025), the court reiterated the general applicability of the learned intermediary rule to pharmacists, id. at 311, but identified exceptions for “patient-specific risk[s] or . . . obvious error[s] on the face of the prescription.”  Id. at 313,

A nonprecedential federal appellate decision reference Utah’s learned intermediary rule in a medical device case in Tingey v. Radionics, 193 F. Appx. 747, 757 n.4 (10th Cir. 2006) (“Utah follows the ‘learned intermediary doctrine,’ whereby it is the manufacturer’s duty to warn the doctor of the dangers associated with a dangerous drug, rather than the patient.  Courts have applied this doctrine to claims involving medical devices, and we assume Utah would do so as well.”) (citations omitted).  So have several trial courts.  See In re Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation, 2020 WL 5223363, at *16 (S.D. Ohio Sept. 1, 2020) (“this Court will apply the learned intermediary doctrine to Plaintiff’s failure to warn claims”); In re Wright Medical Technology, Inc., Conserve Hip Implant Products Liability Litigation, 127 F. Supp.3d 1306 (N.D. Ga. 2015) (“the person who receives a medical device or to whom it is applied, is prescribed the device by a physician . . ., and it is the physician upon whom the user, or patient, relies to advise of warnings and risks.  It is from this practical reality in the doctor-patient relationship that the learned intermediary doctrine developed.”) (applying Utah law); Flandro v. Boston Scientific Corp., 2015 WL 5842823, at *5 (S.D.W. Va. Oct. 6, 2015); (“Utah courts adhere to the learned intermediary doctrine”; “Utah courts would likewise apply the learned intermediary doctrine to failure to warn claims arising out of the use of medical devices.”) (all applying Utah law).

Christison v. Biogen Idec Inc., 199 F. Supp. 3d 1315, 1320 (D. Utah 2016) , applied the learned intermediary rule to a biologic medication.

The learned intermediary doctrine has been adopted in Utah. . . .  [B]ecause the physician is in the best position to combine medical knowledge and training with an individualized understanding of the patient’s needs[,] . . . under Utah law, a drug manufacturer’s duty is to give timely, adequate, complete, and appropriate warnings to the prescribing physician such that the physician can understand possible side effects and prepare a suitable prescription program for a patient.

Id. at 1319-20 (quotation marks and footnotes omitted); accord Christison v. Biogen Idec Inc., 2014 WL 7261300 (D. Utah Dec. 18, 2014):

These allegations that Defendants had a duty to provide warnings directly to the patient . . . are incorrect and therefore they are stricken.  While it is true that under the learned intermediary doctrine a drug manufacturer may be liable directly to a patient if the manufacturer fails to adequately warn the prescribing physician, the manufacturer has no duty to directly warn a patient.

Id. at *7 (footnote omitted).

Vermont

Vermont lacks any appellate authority addressing the learned intermediary rule.  Several trial courts have applied the rule to Vermont law in various contexts.  In a pharmacy case, Baker v. University of Vermont, 2005 WL 6280644 (Vt. Super. May 5, 2005), held:

While apparently never explicitly treated by our Supreme Court, we consider the so-called “learned intermediary doctrine” adopted in a majority of jurisdictions to be of significant dispositive effect in determining the present claims.  The learned intermediary doctrine, first recognized in 1966, initially stood for the proposition that a prescription drug manufacturer had a had a duty to warn of possible side effects in some patients only to a purchasing doctor, the learned intermediary between the manufacturer and patient, and not directly to the patient.  The majority of jurisdictions have expanded this approach to cover pharmacists as well. . . .  [A] pharmacist has no duty to warn patients or doctors under the circumstances presented here.

Id. at ?? (citations omitted).

The same is true in federal court.  Leavitt v. Ethicon, Inc., 524 F. Supp.3d 360 (D. Vt. 2021), a medical device case, “predict[ed that the Vermont Supreme Court is likely to adopt the learned intermediary doctrine for three reasons”:

First, where Vermont law is undeveloped, the Vermont Supreme Court frequently looks to the Restatement for guidance . . ., and the restatement “has adopted the learned intermediary doctrine.”. . . .  Second, forty-eight states have adopted, or a federal court has predicted the state’s highest court would adopt, the learned intermediary doctrine. . . .  and third, the learned intermediary doctrine reflects the realities of patient consultations and identifies the best source of information regarding the risks and benefits of a particular device or procedure for a particular patient.

Id. at 368-69 (footnotes omitted).  A couple of other Vermont decisions discussed the learned intermediary rule at some length, but avoided deciding the issue.  See Drake v. Allergan, Inc., 63 F. Supp.3d 382, 390 (D. Vt. 2014); Kellogg v. Wyeth, 762 F. Supp.2d 694, 700 (D. Vt. 2010) (both prescription drug cases).

Virginia

The Virginia Supreme Court recognized the learned intermediary rule in Pfizer, Inc. v. Jones, as an “elementary principle[] of law.”  272 S.E.2d 43, 44 (Va. 1980).  “[I]t is the general rule that the duty of the drug manufacturer is to warn the physician who prescribes the drug in question.”  Id. (citation omitted).  Accord Stanback v. Parke, Davis & Co., 657 F.2d 642, 644 (4th Cir.1981) (“the well-settled rule is that the duty an ethical drug manufacturer owes to the consumer is to warn only physicians (or other medical personnel permitted by state law to prescribe drugs) of any risks or contraindications associated with that drug”; “we assume that the Virginia Supreme Court would follow the general rule”) (citations omitted).

The Fourth Circuit agreed in a medical device case.  Talley v. Danek Medical, Inc., 179 F.3d 154, 162-63 (4th Cir. 1999). 

The learned intermediary doctrine provides an exception to the general rule imposing a duty on manufacturers to warn consumers about the risks of their products.  For products requiring prescription or application by physicians, the doctrine holds that a manufacturer need only warn doctors and not consumers. The doctrine is based on sound policy considerations. . . .  For physician-prescribed drugs and medical devices, the physician is in the best position to understand the patient’s needs and assess the risks and benefits of a particular course of treatment. . . .  In addition, practical realities support the learned intermediary doctrine because it is virtually impossible in many cases for a manufacturer to directly warn each patient. . . .

Accordingly, in circumstances where (1) ethical drugs or medical devices that can be prescribed or installed only by a physician are involved and (2) a physician prescribes the drug or installs the medical device after having evaluated the patient, the manufacturer of the drug or device owes the patient only the duty to warn the physician and to provide the physician with adequate product instructions.

Id. at 162-63 (citations and quotation marks omitted). 

Similarly, the Fourth Circuit applied the learned intermediary rule in a Virginia vaccine/biologic case − holding, in Abbot v. American Cyanamid Co., 844 F.2d 1108 (4th Cir. 1988), that “[w]ith prescription drugs, . . . the duty is to warn the physician administering the drug.”  Id. at 1115 (citing Stanback).

A Virginia federal court applied it to a veterinary drug in Knapp v. Zoetis Inc., 2022 WL 989015, at *6 (E.D. Va. March 31, 2022).  We know of no pharmacy cases that have considered the learned intermediary rule under Virginia law.

Washington

Washington is another learned intermediary rule early (and often) adopter, starting with Terhune v. A.H. Robbins Co., 577 P.2d 975, 978 (Wash. 1978).  In Terhune, a medical device decision, the Washington Supreme Court held:

[I]t has become a well-established rule that in such cases, the duty of the manufacturer to warn of dangers involved in use of a product is satisfied if he gives adequate warning to the physician who prescribes it.  The reasons for this rule should be obvious.  Where a product is available only on prescription or through the services of a physician, the physician acts as a “learned intermediary” between the manufacturer or seller and the patient. It is his duty to inform himself of the qualities and characteristics of those products which he prescribes for or administers to or uses on his patients, and to exercise an independent judgment, taking into account his knowledge of the patient as well as the product.

Id. at 978 (citations omitted).  And, yes, the rule applied to prescription devices as well as drugs:

While recognizing the efficacy of this rule as applied to prescription drugs, the plaintiffs question its applicability to devices. . . .  We do not see this as a significant distinction. . . .  Certainly the insertion of the [device] requires a physician’s services, his knowledge and his skill. While the physician does not make the final choice but leaves that to the patient, he advises the patient with respect to the advantages and disadvantages of various choices, as was done in this case, and it is he who supplies and inserts the device. . . .  The fact that the patient makes the final choice . . . does not constitute a distinction which makes the general rule inapplicable. . . .  In any such situation which may come to mind, the patient is expected to look to the physician for guidance and not to the manufacturer of the products which he may use or prescribe in the course of treatment.

Id.  Taylor v. Intuitive Surgical, Inc., 389 P.3d 517, 525 (Wash. 2017), held “although the manufacturer has a duty to warn patients of product risks, it can satisfy this duty by warning the doctor (the learned intermediary), who then takes on the responsibility of communicating those warnings to the patient”) (citation omitted).  Cf. Accord Rublee v. Carrier Corp., 428 P.3d 1207, 1216-17 (Wash. 2018) (“[I]n the pharmaceutical or medical device context . . . the ’learned intermediary’ doctrine applies.  Under the learned intermediary doctrine, a manufacturer of certain medical products, obtainable solely through the services of a physician, fulfills its duty to warn when it gives adequate warning to the physician who must prescribe the product.”).

In McKee v. American Home Products Corp., 782 P.2d 1045 (Wash. 1989), the Washington high court applied the rule to pharmacists.  The learned intermediary rule was “closely related” to pharmacy warning liability.  Id. at 1049.

The relationship between the physician-patient-manufacturer applies equally to the relationship between the physician-patient and pharmacist. In both circumstances the patient must look to the physician, for it is only the physician who can relate the propensities of the drug to the physical idiosyncrasies of the patient. . . . 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.  In deciding whether to use a prescription drug, the patient relies primarily on the expertise and judgment of the physician. . . .  The physician is not required to disclose all risks associated with a drug, only those that are material.  It is apparent that a pharmacist would not be qualified to make such a judgment as to materiality. . . .  Requiring 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.  We believe that duty, and any liability arising therefrom, is best left with the physician.  A majority of other jurisdictions that have addressed the issue have likewise refused to impose a duty to warn on the pharmacist.

Id. at 1050 (citations omitted).  Further, mandating non-physicians to provide direct warning duties would be disruptive and dangerous.

A physician may often have valid reasons for deviating from the drug manufacturer’s recommendations based on a patient’s unique condition.  The duty which [plaintiff] urges would result in the pharmacist second guessing numerous prescriptions to avoid liability.  This would not only place an undue burden on pharmacists, but would likely create antagonistic relations between pharmacists and physicians. . . .  Moreover, unnecessary warnings to the patient could cause unfounded fear and mistrust of the physician’s judgment, jeopardizing the physician-patient relationship and hindering treatment.

Id. at 1053-54 (block quotation omitted).

The Washington Supreme Court has gotten around to applying the learned intermediary rule in prescription drug cases as well.  First, in Washington State Physicians Insurance Exchange & Ass’n v. Fisons Corp., 858 P.2d 1054, 1061 (Wash. 1993).

[I]n examining the nature of the relationship between a drug manufacturer, a prescribing physician and a patient, it is the physician who compares different products, selects the particular drug for the ultimate consumer and uses it as a tool of his or her professional trade.  Under the learned intermediary doctrine, a drug company fulfills its duty by giving warnings regarding prescription drugs to the physician rather than to the patient.  This unique relationship results in the physician being comparable to the ordinary consumer in other settings.

Id. at 1061 (footnote omitted).

Most recently, the rule received a ringing endorsement in Dearinger v. Eli Lilly & Co., 510 P.3d 326 (Wash. 2022):

In the context of prescription drugs, the learned intermediary doctrine provides the manufacturer satisfies its duty to warn the patient of the risks of its product where it properly warns the prescribing physician.  In other words, the manufacturer’s duty to provide warnings to patients transfers to the doctor, who is in a better position to communicate them to the patient.

The learned intermediary doctrine has been a fixed part of Washington law since this court adopted it in Terhune in 1978. Courts applying the learned intermediary doctrine have done so without recognizing an exception.  Indeed, we have consistently reiterated [the] central principle that a manufacturer satisfies its duty to warn patients of product risks by warning the prescribing physician, who then takes on the responsibility of communicating those warnings to the patient.. . . .  [N]ot only is the learned intermediary doctrine a fixed part of Washington law, it is also universally followed across the country.

Id. at 329 (citations and quotation marks omitted).  Accord Young v. Key Pharmaceuticals, Inc., 922 P.2d 59, 63 (Wash. 1996) (“while a manufacturer has a duty to warn about unavoidably unsafe products, where the product can be sold only under prescription, the duty to warn runs only to the physician, not to the ultimate consumer”) (citation omitted).

Finally, the learned intermediary rule was extended to biologics in Rogers v. Miles Laboratories, Inc., 802 P.2d 1346, 1353 (Wash. 1991) (quoting and following Terhune and McKee in blood product case).

West Virginia

West Virginia has the dubious distinction of being the only state where the learned intermediary rule was initially rejected by that state’s highest court.  See Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899, 913-14 (W. Va. 2007).  Karl was never applied to medical device cases.  E.g., Smallridge v. Johnson & Johnson, 2022 WL 1417313, at *3 (N.D.W. Va. Jan. 31, 2022) (Karl does not foreclose the application of the learned intermediary doctrine in cases involving a medical device rather than a drug” (citation and quotation marks omitted); accord Sutphin v. Ethicon Inc., 2020 WL 2517237, at *3 (S.D.W. Va. May 15, 2020) (same).

Shortly thereafter, the West Virginia legislature acted, and reversed Karl. 

(a) A manufacturer or seller of a prescription drug or medical device may not be held liable in a product liability action for a claim based upon inadequate warning or instruction unless the claimant proves, among other elements, that:

(1) The manufacturer or seller of a prescription drug or medical device acted unreasonably in failing to provide reasonable instructions or warnings regarding foreseeable risks of harm to prescribing or other health care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings; and

(2) Failure to provide reasonable instructions or warnings was a proximate cause of harm.

(b) It is the intention of the Legislature in enacting this section to adopt and allow the development of a learned intermediary doctrine as a defense in cases based upon claims of inadequate warning or instruction for prescription drugs or medical devices.

W. Va. Stat. §55-7-30 (emphasis added).

The Supreme Court of Appeals of West Virginia has recognized the legislature’s adoption of the learned intermediary rule.  McNair v. Johnson & Johnson, 818 S.E.2d 852, 865 (W. Va. 2018); J.C. v. Pfizer, Inc., 814 S.E.2d 234, 238 n.9 (W. Va. 2018).  The statute was effective May 17, 2016 and is not retroactive.  J.C., 814 S.E.2d at 238 n.9.

While there have been no West Virginia pharmacy cases since the statute was enacted, the statute reflects the state’s “long-standing restriction of products liability to the manufacturer and seller of the allegedly injury-causing product.”  McNair, 818 S.E.2d at 866.  Thus, the learned intermediary rule has been applied under West Virginia law as a “barrier to imposing a duty [against other third-party warning claims] where the independent medical practitioners assumed ultimate responsibility for advising patient.”  City of Charleston v. Joint Comm’n, 473 F. Supp. 3d 596, 624 (S.D.W. Va. 2020) (barring suit against medical accreditation organization).

We have not found any West Virginia law decision addressing the learned intermediary rule in the context of a biologic product.

Wisconsin

Two Wisconsin intermediate appellate decisions have mentioned, but not addressed, the applicability of the learned intermediary rule.  Kurer v. Parke, Davis & Co., 679 N.W.2d 867, 879 (Wis. App. 2004) (“Although the parties debate how the learned intermediary doctrine affects this appeal, we need not make that determination); Rennick v. Teleflex Medical, Inc., 2022 WL 1016686, at *4 (Wis. App. April 5, 2022) (“We need not address the adoption of this doctrine in Wisconsin”) (unpublished, non-citable), aff’d by equally divided court, 988 N.W.2d 680 (Wis. 2023).

In a medical device case, the Seventh Circuit predicted that Wisconsin would follow the learned intermediary rule.  In re Zimmer Nexgen Knee Implant Products Liability Litigation, 884 F.3d 746 (7th Cir. 2018).

The justification for adopting the learned-intermediary doctrine in cases involving prescription drugs applies even more forcefully in cases involving surgical implants. . . .  [P]atients could conceivably gain access to prescription drugs without their doctor’s assistance, but it is not reasonably conceivable that an individual could obtain and implant a device that requires a trained surgeon without the intervention of a physician.

In short, there is good reason to think that given the opportunity, the Wisconsin Supreme Court would join the vast majority of state supreme courts and adopt the learned-intermediary doctrine for use in defective-warning cases like this one involving a surgical implant.  We predict that the state high court would do so.

Id. at 752 (citation and quotation marks omitted).

Both federal and state trial courts in Wisconsin have followed the learned intermediary rule in prescription drug cases.  Lukaszewicz v. Ortho Pharmaceutical Corp., 510 F. Supp. 961, 963 (D. Wis. 1981) (“As a general rule the courts of this country universally hold that in the case of prescription drugs, the provision of proper warnings to a physician will satisfy the manufacturer’s duty to warn since the patient cannot obtain the drug except through the physician.”) (citations omitted), modified on other grounds, 523 F. Supp. 206 (D. Wis. 1981); Straub v. Berg, 2003 WL 26468454, at *6 (Wis. Cir. Jan. 6, 2003) (“Although Wisconsin courts have not addressed the application of the learned intermediary doctrine, courts of numerous other jurisdictions almost universally hold that in the case of prescription drugs, a manufacturer’s provision of proper warnings to a prescribing physician will satisfy the manufacturer’s duty to warn since the patient cannot obtain the drug except through the physician.”) (citation omitted).  Likewise, a Pennsylvania appellate court applied the rule under Wisconsin law.  Stange v. Janssen Pharmaceuticals Inc., 179 A.3d 45, 57 & n.4 (Pa. Super. 2018).

We have found no Wisconsin pharmacy or biologic cases addressing the learned intermediary rule.

Wyoming

In Rohde v. Smiths Medical, 165 P.3d 433, 438 (Wyo. 2007), the Wyoming Supreme Court noted the applicability of the learned intermediary rule in a medical device case. 

The “learned intermediary” principle generally states that a manufacturer has a duty to adequately warn medical professionals about risks associated with use of healthcare products.  So long as it complies with that obligation, the manufacturer may rely on medical professionals, as learned intermediaries, to properly warn their patients of the risks.

Id. at 436 n.5 (citation omitted).

Federal courts under Wyoming law have applied the rule to drugs.  Thom v. Bristol-Myers Squibb Co., 353 F.3d 848, 851-53 (10th Cir. 2003), pointed out:

Known as the “learned intermediary doctrine,” this doctrine shields manufacturers of prescription drugs from liability where the manufacturer adequately warns a patient’s prescribing physician of the potential risks inherent in the use of the product. . . .  The learned intermediary doctrine derives from §402A of the Restatement (Second) of Torts, which the Wyoming Supreme Court has adopted in its entirety. . . .  [Many] other jurisdictions have adopted the learned intermediary doctrine in prescription medicine cases.

Id. at 851-52 (citations omitted).  Accord Haste v. American Home Products Corp., 577 F.2d 1122, 1125 (10th Cir. 1978) (“the defendant discharged its duty to plaintiffs by the warnings to the veterinarians”) (veterinary drug); Van Dyke v. SmithKline, 2009 WL 10672280, at *6 (D. Wyo. March 27, 2009) (“the Wyoming Supreme Court would likely adopt the ‘learned intermediary’ doctrine”); Van Dyke v. Glaxo SmithKline, 2009 WL 10672277, at *2 (D. Wyo. April 8, 2009) (same); Jacobs v. Dista Products Co., 693 F. Supp. 1029, 1036 (D. Wyo. 1988) (“Defendants communicated adequate warnings to plaintiff’s prescribing physician. . . .  The drug manufacturer’s liability to plaintiff ended when it imparted adequate warnings to the physician.”).

There aren’t any Wyoming biologic or pharmacy cases that we know of.

*          *          *          *

And now for some statistics.  First, as to the learned intermediary rule generally, it has been applied by the highest courts, or by statute, in 40 American jurisdictions.  Those states are:  Alabama, Alaska, Arizona, Arkansas, California, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawai’i, Idaho (non-prescription medical product), Illinois, Kansas, Kentucky, Maryland, Massachusetts, Michigan (sort of), Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon (negligence only), Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, and Wyoming.  It has been applied by intermediate state appellate courts in another 4-5 jurisdictions:  Colorado, Indiana, Louisiana, Michigan (definitely), and New Mexico.  The rule’s adoption has been predicted by federal appellate courts in another eight jurisdictions:  Iowa, Maine, New Hampshire, North Dakota, Puerto Rico, Rhode Island, South Dakota, and Wisconsin.  In Vermont – the only jurisdiction without appellate authority – it has been adopted at the trial court level.  Thus, the learned intermediary rule is recognized by precedent in all fifty states, the District of Columbia, and Puerto Rico.

Second, as to prescription medical devices specifically, the learned intermediary rule has been applied by the highest courts, or by statute, in sixteen American jurisdictions, those being:  Alabama, Arizona, California, Connecticut, Delaware, Georgia, Hawai’i, Kansas, Mississippi, New Jersey, Ohio, Oklahoma, Oregon (negligence only), Washington, West Virginia, and Wyoming.  It has been applied by intermediate state appellate courts in another nine jurisdictions:  Colorado, Florida, Louisiana, Michigan, New Mexico, New York, Pennsylvania, Tennessee, and Texas.  Federal appellate courts have applied the learned intermediary rule in another ten jurisdictions:  Indiana, Kentucky, Maine, Massachusetts, Missouri, Nebraska, South Carolina, Utah, Virginia, and Wisconsin.  Trial court decisions in another fifteen jurisdictions also apply the rule to medical devices:  Arkansas, District of Columbia, Idaho, Iowa, Maryland, Minnesota, Montana, Nevada, New Hampshire, North Carolina, North Dakota, Oregon, Rhode Island, South Dakota and Vermont.  That’s a total of 50 jurisdictions (everything except Alaska and Puerto Rico).

Third, the learned intermediary rule has been applied to preclude generalized pharmacy warning duties by the highest courts, or by statute, in thirteen American jurisdictions:  Alabama, Arizona, California, Florida, Illinois, Maryland, Massachusetts, Nevada, Pennsylvania, South Carolina, Utah, and Washington.  Intermediate state appellate courts have applied the rule in another thirteen jurisdictions:  Arizona, Georgia, Indiana, Kansas, Louisiana, Michigan, New Jersey, New York, North Carolina, Ohio, Oklahoma, Tennessee, and Texas.  Federal district courts in another four jurisdictions have applied the rule to pharmacists:  Connecticut, District of Columbia, Kentucky, and Maine.  That comes to 30 jurisdictions.

Fourth, and finally, the learned intermediary rule has applied to biological products (vaccines, blood/tissue, and certain other FDA-approved biologics), with other developments – the federal Vaccine Act (which enforces the learned intermediary rule nationwide), and state blood shield statutes – cutting down on the number of cases.  For biologics, the learned intermediary rule has been applied by the highest courts in eight jurisdictions, specifically Florida, Kansas, Mississippi, Nevada, New Jersey, New Mexico, Ohio, Oklahoma, and Washington.  Another four states’ intermediate courts apply the rule to biologics:  Illinois, Michigan, Missouri, and New Mexico.  Federal appellate courts add seven more states to the count:  California, Idaho, Iowa, Maryland, Pennsylvania, Texas, and Virginia.  Finally, trial courts in another nine jurisdictions have enforced the learned intermediary rule in litigation involving biologics:  Indiana, Kentucky, Massachusetts, Nebraska, New York, North Carolina, Puerto Rico, South Carolina, and Utah.  Despite alternative statutory bases for dismissing biologic cases, that makes a total of 28 jurisdictions with such precedent.

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Is there a difference between a product manufacturer and a product seller when it comes to product liability?  There is in Georgia, and the Georgia Court of Appeals’ recent opinion in Taylor v. Mood Rite, LLC, 2026 Ga. App. LEXIS 240 (Ga. Ct. App. May 15, 2026), underscores that point.  An entity that merely packages and labels a product and places it into the stream of commerce is not a “manufacturer” and is not subject to strict product liability under Georgia law. 

The plaintiffs sued following the death of their 27-year-old son, who died of acute mitragynine toxicity.  If you are unfamiliar with that condition (as we were), mitragynine is the primary psychoactive alkaloid found in the leaves of Mitragyna speciosa, a tropical evergreen tree native to Southeast Asia.  The alkaloid is found in kratom, an herbal supplement derived from the leaves of the tree.  Kratom is unregulated and not FDA approved, but it is widely used nonetheless under the questionable belief that it can boost energy and relieve chronic pain and anxiety.  The Georgia Legislature classified kratom as a controlled substance in 2019.

The defendant was a kratom seller called Mood Rite, which purchased kratom in powder and capsule form and packaged the kratom into bags and plastic containers.  It then applied its own labeling, which included a warning that the product was not FDA approved and that the FDA considered kratom not fit for human consumption.  The labeling contained no directions for use.

The plaintiffs alleged strict liability and negligence, specifically alleging that the defendant failed to warn consumers that ingesting kratom could cause death.  A Georgia trial court granted summary judgment for the seller because the defendant was not a “manufacturer” under Georgia law and because the defendant did not know that kratom could cause death. 

The Georgia Court of Appeals affirmed.  Under Georgia’s strict liability framework, a manufacturer is liable in tort for injuries caused by a product that was not merchantable and not reasonably suited to its intended use when sold.  The Georgia statute, however, distinguishes between “manufacturers” and “product sellers.”  A “seller” is an entity that blends, packages, labels, markets, or assembles products pursuant to a manufacturer’s specifications, or otherwise places a product in the stream of commerce. 

Critically, a product seller is not a manufacturer for purposes of strict liability. 

The plaintiffs argued that because Mood Rite assembled, packaged, and labeled the kratom, a jury should decide whether the company was “actively involved” in the conception, design, or specification of the product—i.e., whether Mood Rite was a “manufacturer” subject to strict liability.  The Georgia Court of Appeals, however, rejected this argument.  The defendant purchased kratom in powder and capsule form and made no changes to the kratom product itself.  That was dispositive, as “an entity which merely repackages and labels a product is not a manufacturer.”  Id. at *7. The court further noted that the plaintiffs’ position amounted to an “ostensible manufacturer” argument that had been rejected since the enactment of Georgia’s 1987 tort reform act.

The Georgia Court of Appeal also rejected a negligence-based failure to warn because the defendant had no actual or constructive knowledge that ingesting kratom could cause death.  Under Georgia law, a seller is required to warn consumers of dangers of which it has actual or constructive knowledge.  Here, the plaintiffs cited FDA alerts, product complaints, publications reporting kratom poisoning, and a 2017 news article about a kratom-attributed death.  But this evidence did not raise a triable issue of material fact.  For one thing, many of the documents that the plaintiffs cited were not in the record, and clicking on hyperlinks in the plaintiffs’ briefs returned error messages.  The court thus admonished that “the parties’ briefs are not evidence” and “we can only consider hyperlinks to document which were properly admitted in the record below.”  Id. at *13.  More to the point, the evidence did not give rise to a duty to warn.  Reports of kratom-related deaths appeared to be localized and not widely publicized or available such that Mood Rite should have been aware of them through reasonable diligence. 

This opinion reinforces Georgia’s distinction between product manufacturers and product sellers in the strict liability context.  It confirms that entities engaged solely in repackaging and relabeling products obtained from third-party manufacturers cannot be held strictly liable as manufacturers.  The decision also underscores the evidentiary burden facing plaintiffs in negligence-based failure-to-warn claims, particularly that the dangerous condition be sufficiently well-established in the relevant field to impose a duty on sellers.  The opinion also serves as a pointed reminder—relevant in every court in every jurisdiction—that litigants ought not play fast and loose with the evidence.  The result for these plaintiffs was an error message: 404 Not Found. 

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The now well-known requirement from the TwIqbal cases that a complaint contains factual allegations that establish that relief is plausible derives from Rule 8(a)(2) requirement that each pleading contain “a short and plain statement of the claim showing that the pleader is entitled to relief.”  One recurring point of contention in drug and device litigation is when a defense has to be addressed in a complaint.  Plaintiffs, of course, would like a very low bar to pleadings, increasing the chances that they can force a settlement in the time following the denial of motion to dismiss.  Defenses, they usually say, do not have to be addressed in the complaint filed before defenses have been asserted formally by defendants.  A recent decision on a motion to dismiss in a drug case made us take another look at some of Federal Rules of Civil Procedure on pleadings for guidance on this issue.

Working backwards, under Rule 12(b), a motion to dismiss can be made on specified procedural/jurisdictional grounds or for the rather vague catchall “failure to state claim upon which relief can be granted.”  The authorization for a motion for judgment on the pleadings under 12(c), which is decided under the same standards as a 12(b) motion, is also broad:  “After the pleadings are closed—but early enough not to delay trial—a party may move for judgment on the pleadings.”  In the typical product liability case, there will be no pleading from the plaintiff responding to the defenses asserted in an answer, so pleadings close with the answer.  We know that both 12(b)(6) and 12(c) motions are used to raise not just whether the complaint includes factual allegations supporting each element of a cognizable cause of action but also various common product liability defenses such as preemption, statute of repose, and statute of limitations.  (This is different than a plaintiff trying to apply TwIqbal to an answer.)  Under 8(c)(1), answers “must affirmatively state any avoidance or affirmative defense, including” SOL and a number of other examples.  We say “examples” because there are clearly other affirmative defenses and that is what “including” means when used as it is in 8(c)(1).  It is also clear that not everything a defendant raises in an answer is an affirmative defense, meaning something on which it would have the burden at trial.  A plaintiff’s failure to carry her burden as to a cause of action is not a defense at all.  The tricky issue is when a defense has recognized exceptions.  A number of those defenses are predicated on fraud, which implicates heightened pleading under 9(b)—which does not limit itself to claims.  Bluntly, these rules allow either side to argue its position on what defenses need to be addressed in product liability complaints.  We also considered whether Rule 11 could require a complaint to address obvious defenses preemptively.  It is hard to say 11(b)(1)’s requirement that the filer certify that it “is not being presented for any improper purpose, such as to harass, cause unnecessary delay, or needlessly increase the cost of litigation.”

Irrespective of our Rules dive, Iqbal requires that “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.”  This is decidedly broader because liability means that the plaintiff got past any defenses raised, affirmative or otherwise.  It is with this context that we finally turn to Owens v. Johnson & Johnson Co., No. 25-cv-11129-REL, 2026 WL 1388701 (N.D. Cal. May 18, 2026).  In Owens, plaintiffs claimed that their mother died from breast cancer she allegedly contracted from her use of defendant’s prescription antipsychotic and generic versions of same.  Plaintiffs’ complaint was apparently—the court omitted details with a disclaimer that it “assumes the reader is familiar with the facts of the case”—quite sloppy, vague, and conclusory.  In other words, it was like many complaints plaintiffs file against manufacturers of FDA-approved/cleared medical products.  Predictably, defendants moved to dismiss and, predictably, plaintiffs will get another chance to plead plausible claims before the case is dismissed with prejudice.  The noteworthy part, at least to us, is that the plaintiffs’ failure to address defenses was the primary culprit.

Taking the issues in the opposite order of Owens, the “Complaint raises preemption on its face” and all of its independent counts were preempted.  Id. at *3.  The key turning point was that the court followed the Second Circuit’s Gibbons decision (here and listed as our second-best in 2019 here) and cases in the Ninth Circuit following it (such as the affirmance of this messy case) rather than the line of cases that punt on preemption at the pleadings stage.  Id.  Specifically for a suit against the NDA-holder of a branded prescription drug, it is clear from Albrecht and even cases like the otherwise horrible Holley that the path to a non-preempted warnings claim requires newly discovered evidence that would have allowed the defendant to use the CBE mechanism to change its label to add the warning plaintiff proposed post hoc.  The complaint in Owens did not identify studies that defendants allegedly knew but FDA did not at the time the decedent was prescribed the medication.  It certainly did not articulate how any unspecified newly acquired information required a warning that would have impacted the decedent’s prescription and use of the medication.  “Plaintiffs’ claims do not plausibly allege liability without further allegations supporting the conclusion that FDA regulation did not prohibit Defendants from issuing a stronger warning to Stacy Owens.”  Id.  That is not the exact formulation of what plaintiffs actually had to prove, in part because California follows the learned intermediary doctrine, but it was good enough.  Plaintiffs’ failure to test “general negligence” claim and fraud on the FDA claim were similarly barebones and preempted.

The other defense apparent from the face of the complaint was California’s two year statute of limitations.  Plaintiffs sued in 2025, their mother allegedly died in 2016, and she was allegedly diagnosed with breast cancer in 2012.  In response to the motion to dismiss, plaintiffs contended that their very late claims could be solved by the discovery rule and fraudulent concealment, even though neither was discussed in the complaint.  California state law required plaintiffs to include the allegations support either or both exceptions to the statute of limitations affirmative defense as long as their claims were otherwise time-barred “on the face” of the complaint.  Id. at *1-2 (citing Fox v. Ethicon Endo-Surgery, Inc., 110 P.3d 914 (Cal. 2005); Johnson v. Glock, Inc., No. 20-cv-08807-WHO, 2021 WL 1966692 (N.D. Cal. May 17, 2021)).  None of the elements of either was asserted; as to the latter, heightened pleading standards also applied.  So, the entire case was dismissed without prejudice, with plaintiff getting three weeks to assert facts establishing the plausibility of at least one cognizable, non-preempted, timely claim out of their original six.  Id. at *4.  We understand why plaintiffs will get another chance, using the court’s ruling as a roadmap, but it seems likely the plaintiffs cannot fix the complaint’s failings that without making up things—something Rule 11 definitely prohibits.

As much as the Blog has raised issues with various MDL practices, we do think there is a lesson to learn from the use of Master Complaints and Short Form Complaints.  MDLs and state coordinated proceedings often have Master Complaints that have general anti-SOL sections and Short Form Complaints that allow plaintiffs to adopt counts for fraudulent concealment, the discovery rule, tolling, etc., that do not assert causes of action.  The individual plaintiffs may even be invited to allege additional facts supporting the application of these exceptions to their case.  We wonder if courts—most logically those facing a bunch of related cases—could take it a step further.  They could require plaintiffs to state all facts pertaining to the timeliness of their claims under both SOLs and statutes of repose—Owens would have been barred by most states’ SORs also.  Too often, plaintiffs have some flexibility to change the facts set out in their complaint to save untimely claims.  The same goes for preemption.  Given the number of Supreme Court decisions on preemption of product liability claims against the manufacturers of medical products, about the only way that some aspect of preemption will not be apparent from the face of the complaint is if the complaint omits basic facts about the product’s regulatory status and history.  Those facts, or at least plaintiff’s version of them, should be included in a complaint asserting product liability claims as to FDA-regulated medical products.  (Rule 12(c) provides for a motion for more definite statement in such a situation.)  While it is true that the defendant may raise a novel or particularly technical preemption argument that plaintiff could not address up front, it is not too much to ask that these plaintiffs include factual assertions that, if true, would make it plausible that their claims can get past preemption to establish liability.  Other defenses, such as in pari delicto or contributory negligence, may also be apparent from the complaint. In the context of in forma pauperis, federal courts have explicit authority to do a sua sponte review to weed our frivolous claims at the pleading stage.  Under Rule 56(f)(2)-(3), a court can grant summary judgment “on grounds not raised by a party” or even “consider summary judgment on its own after identifying for the parties material facts that may not be genuinely in dispute.”  It might be more efficient for everyone if courts took a similar approach even before the defendant filed its initial responsive pleading. 

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