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.
