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Preemption Can Buttress the Learned Intermediary Rule

James M Beck


  • The learned intermediary rule, directing warnings for prescription medical products to medical professionals rather than patients, is widely recognized in mass torts, supported by precedent in all 50 states.
  • Exceptions to the rule exist, such as Oregon's interpretation of its product liability statute and New Jersey's exception for drugs advertised directly to consumers, but these are rare.
  • The rule is harmonized with FDA regulations, as prescription drugs and devices are exempt from providing patient-directed warnings, reinforcing the responsibility of professionals in the distribution and use of such products.
  • FDA regulations preempt state laws that conflict with the learned intermediary rule, barring requirements for direct-to-patient warnings where federal exemptions apply.
Preemption Can Buttress the Learned Intermediary Rule
Javier Zayas via Getty Images

The learned intermediary rule—that warnings concerning prescription medical products are properly directed to the medical community, not lay patients—is one of the most universally recognized legal doctrines in mass torts, with supportive precedent in all 50 states. This rule is supported by state statutes or high court precedent from 38 states and the District of Columbia, intermediate state appellate decisions from 4 more states, and federal appellate predictions of state law governing 7 additional states and Puerto Rico. In 2024, only 3 states lack binding appellate precedent following the learned intermediary rule: Rhode Island, South Dakota, and Vermont. Those states all have pro-rule federal district court precedent, and Rhode Island has unpublished federal appellate authority in addition.

Nonetheless, there are exceptions. The State of Oregon was an early adopter of the learned intermediary rule, see McEwen v. Ortho Pharmaceutical. Corp., 528 P.2d 522, 528 (Or. 1974), but a subsequent decision construed an Oregon product liability statute (enacted three years after McEwen and that essentially adopted Restatement section 402A in toto) as precluding the rule in strict liability cases because section 402A did not reference the rule. Griffith v. Blatt, 51 P.3d 1256, 1262 (Or. 2002) (interpreting Or. Rev. Stat. §§ 30.900 et seq.). Applying New Jersey law, Perez v. Wyeth Laboratories, Inc., 734 A.2d 1245, 1263–64 (N.J. 1999), uniquely created an exception to the learned intermediary rule for drugs promoted by means of direct-to-consumer advertising. However, in the ensuing quarter century, no other state has followed Perez.

Thus, the learned intermediary rule will apply, as a matter of state law, in the vast majority of prescription medical product liability litigation cases, but some common-law loopholes exist. For those cases, however, a backup argument exists—implied federal preemption of such loopholes by the “prescription only” requirements of the Food and Drug Administration (FDA) for prescription medical products. Indeed, in deciding to adopt the learned intermediary rule, courts applying state law have frequently pointed out that the rule keeps the common law in harmony with “the unique system used to distribute prescription drugs” imposed by the FDA under federal law. Pittman v. Upjohn Co., 890 S.W.2d 425, 429 (Tenn. 1994).

One reason the rule makes sense is that “patients can obtain prescription drugs only through their prescribing physician or another authorized intermediary.” Watts v. Medicis Pharm. Corp., 365 P.3d 944, 950 (Ariz. 2016) (quoting Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 159 (Tex. 2012)). Other state high courts have further explained:

[A] prescription drug [is] a product whose distribution is limited precisely because its benefits and risks are to be assessed only by licensed physicians acting on behalf of particular patients whose individual physical condition and circumstances are known to them.

Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1387 (Pa. 1991).

The entire system of drug distribution in America is set up so as to place the responsibility of distribution and use upon professional people. The laws and regulations prevent prescription type drugs from being purchased by individuals without the advice, guidance and consent of licensed physicians and pharmacists.

Larkin v. Pfizer, Inc., 153 S.W.3d 758, 763 (Ky. 2004) (citation and quotation marks omitted).

“[T]he role of the federal government through the [FDA]” is a “unique feature” of prescription-only products. Thus, “the [FDA’s] approval process involves a complex and often ad hoc balancing of imponderable and incommensurate factors related to danger and utility” with the result that “[t]he producer’s basic responsibility in this area is to provide adequate warnings to physicians.” In re Zyprexa Prods. Liab. Litig., 489 F. Supp. 2d 230, 265 (E.D.N.Y. 2007) (Weinstein, J.) (quoting Prosser & Keeton, The Law of Torts, 688 (5th ed. 1984)) (applying Florida law). Given that “[b]y law, a prescription drug manufacturer cannot sell its products to the consumer without the physician’s approval . . . , [a] patient must rely on the physician.” Oksenholt v. Lederle Labs., 656 P.2d 293, 297 (Or. 1982).

But what the learned intermediary rule harmonizes with FDA regulations as a matter of common-law policy implied conflict preemption can enforce as a matter of the supremacy of federal law. Where, as in the Oregon and New Jersey examples, state law would allow a claim for lack of patient-directed warnings while the FDA does not, preemption precludes such deviations.

For both prescription drugs and medical devices, FDA regulations provide that direct-to-patient warnings—called “adequate directions for use”—are not necessary for drugs or devices that are available only with a physician’s prescription. For drugs, the relevant regulation is 21 C.F.R. § 201.100(a)–(c). That regulation provides that a prescription-only drug—one that can be obtained only through “a practitioner licensed by law to administer or prescribe such drugs” bearing “[t]he statement ‘Rx only’”—is “exempt” from requirements to provide adequate directions for use to patients. Id. § 201.100(a)–(b). Those directions instead go to physicians:

Labeling on or within the package from which the drug is to be dispensed bears adequate information for its use, including indications, effects, dosages, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which practitioners licensed by law to administer the drug can use the drug safely and for the purposes for which it is intended. . . .

Id. § 201.100(c)(1) (emphasis added).

The corresponding regulation for medical devices is 21 C.F.R. § 801.109, which exempts manufacturers of prescription-only devices from providing “adequate directions for use” to patients where the manufacturer is required to provide physician warnings for a prescription-only device.

Any labeling . . . [must contain] adequate information for such use, including indications, effects, routes, methods, and frequency and duration of administration and any relevant hazards, contraindications, side effects, and precautions, under which practitioners licensed by law to employ the device can use the device safely and for the purposes for which it is intended. . . .

Id. § 801.109(d) (emphasis added). See Ellis v. C.R. Bard, Inc., 311 F.3d 1272, 1285 (11th Cir. 2002) (detailing how “§ 801.109 expressly exempts a prescription device” from having to provide “adequate directions for use” to patients) (applying Georgia law).

Often, if not always, the approval letter (or Risk Evaluation and Mitigation Strategy (REMS)) for FDA-regulated prescription drugs or the “special controls” for FDA-regulated medical devices will specify that a product can be marketed only for prescription use and is thus exempt from providing “adequate directions for use” to lay patients. Such FDA requirements are preemptive. E.g., GenBioPro, Inc. v. Sorsaia, 2023 WL 5490179, at *10 (S.D. W. Va. Aug. 24, 2023) (discussing preemption and REMS); 76 Fed. Reg. 6551, 6553 (FDA Feb. 7, 2011) (discussing medical device preemption). Applicable FDA regulations thus mandate that “adequate directions for use” need not be provided directly to patients whenever a drug or device is (a) prescription-only and (b) those directions are provided instead to the prescribing physician. The issue is unlikely to arise very often. See Holloway v. AbbVie, Inc., 2024 WL 477523, at *3 (M.D. La. Feb. 7, 2024) (Mag.) (unnecessary to decide preemption where the learned intermediary rule reaches same result as section 801.109).

However, any purported state law requirement for direct-to-patient warnings where the above FDA regulations expressly exempt the product from that type of requirement should be barred by conflict preemption. Were a state to impose directly an over-the-counter drug warning requirement on a prescription drug, implied conflict preemption would almost surely be preclusive. A tort claim phrasing the same sort of requirement in terms of the inapplicability of the learned intermediary rule should be no different. State law cannot require direct-to-patient warnings where applicable federal law provides an exemption from such requirements.