Current Applications & Limitations on the Learned Intermediary Rule

What The Rule Is And How It Applies

To avoid liability, a manufacturer of a product has a duty to exercise reasonable care in giving adequate warnings to consumers of potential dangers from the use of its product. See Magee v. Wyeth Laboratories, Inc., 214 Cal.App.2d 340, 350, 29 Cal.Rptr. 322 (1963). In general, this duty to warn is owed to the consumer directly. However, a manufacturer of prescription drugs may fulfill the duty by providing adequate warnings to a physician who is prescribing the manufacturer's drugs to a patient. The prescribing physician is an "informed" or "learned" intermediary between the manufacturer and the patient. Love v. Wolf, 226 Cal.App.2d 378, 395, 38 Cal.Rptr. 183, 192 (1964); Hill v. Searle Laboratories, 884 F.2d 1064, 1070 (8th Cir. 1989).

The learned intermediary rule is a common law exception to liability. It applies when a pharmaceutical company informs prescribing physicians of any known or suspected risks associated with its product's use. Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1276 (5th Cir. 1974), cert. denied, 419 U.S. 1096 (1974). Thus, "if adequate warning of potential dangers of a drug has been given to doctors, there is no duty by the drug manufacturer to insure that the warning reaches the doctor's patient for whom the drug is prescribed." Love v. Wolf, supra, 38 Cal.Rptr. at 193. If the manufacturer meets this requirement, it cannot be held liable under a theory that it breached a duty to warn which it owed to the consumer. Swayze v. McNeil Laboratories, Inc., 807 F.2d 464, 469-70 (5th Cir. 1987).

In Desmarais v. Dow Corning Corp., 712 F.Supp.13,17 (D.Conn. 1989), a breast implant case, the district court described both the rule and the scope of its acceptance by the judiciary as follows:

Indeed, it is by virtue of the licensed physician's education, training, and experience that he or she is in the best position to make an individualized medical judgment as to which specific palliative to prescribe for a particular patient. See Mazur v. Merck & Co., 964 F.2d 1348, 1355-59 (3d Cir.1992); Windham v. Wyeth Laboratories, Inc., 786 F.Supp. 607, 611 (S.D.Miss. 1992).

In Mazur v. Merck, the court of appeals held that the nurse who supervised the administering of a vaccine at a school did not qualify as a learned intermediary because she had not undergone "the rigorous medical training necessary to become a licensed physician" and therefore was not capable of making the individualized medical judgment required under the rule. 964 F.2d at 1357-58. However, the Third Circuit did note that courts in other jurisdictions under limited circumstances have found a nurse to be a learned intermediary. Id. at 1356, 1360 n.18.

In part, the rationale behind an exception which allows a manufacturer to issue its warning to the physician instead of to the consumer is that "[a]s a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his patient." Reyes v. Wyeth, supra, 498 F.2d at 1276. In observing that it is the physician's task to weigh the benefits of any drug against its potential dangers, the Reyes court stated (id.):

One court has stated the following three reasons for the rule:

1. The doctor is intended to be an intervening party in the full sense of the word. Medical ethics as well as medical practice dictate independent judgment, unaffected by the manufacturer's control, on the part of the doctor.
2. Were the patient to be given the complete and highly technical information on the adverse possibility associated with the use of the drug, he would have no way to evaluate it, and in his limited understanding he might actually object to the use of the drug, thereby jeopardizing his life.
3. It would be virtually impossible for a manufacturer to comply with the duty of direct warning, as there is no sure way to reach the patient.

Carmichael v. Reitz, 17 Cal.App.3d 958, 989, 95 Cal.Rptr. 381, 400 (1971), quoting Rheingold, "Products Liability - The Ethical Drug Manufacturer's Liability," 18 Rutgers L.Rev. 947, 987 (1964). See Hill v. Searle Laboratories, supra, 884 F.2d at 1070.

The manufacturer's duty to inform learned intermediaries of the potential risks associated with the use of its prescription products does not extend to potential risks which may result from prescribing a drug for a nonindicated use. In Robak v. Abbott Laboratories, 797 F.Supp. 475, 476 (D.Md. 1992), the court held that where a physician prescribes a drug for a use that is not indicated on the product's label or the package insert, the manufacturer has no duty to warn of possible adverse reactions from misuse of the product. Thus far, the learned intermediary rule has been applied not only to pharmaceutical drugs, but also to some medical devices, such as pacemakers, heart catheters, and internal fixation devices.

A current question is whether the doctrine applies in the context of an optometrist prescribing contact lenses. In Bukowski v. Coopervision, Inc., 185 App.Div.2d 31, 592 N.Y.S.2d 807 (1993), the reviewing court affirmed the trial court's denial of the defendant contact lens manufacturer's motion for summary judgment that was predicated upon the learned intermediary doctrine. The court held that a triable issue of fact existed as to whether the relationship of the optometrist and the plaintiff was sufficiently similar to that of a physician and his patient to invoke the rule. One might ask whether an optometrist is merely dispensing as opposed to prescribing contact lenses; other courts have indicated that a pharmacist merely dispensing prescription drugs is not a learned intermediary. See Eldrige v. Eli Lilly & Co., 138 Ill.App.3d 124, 485 N.E.2d 551 (1985); Jones v. Irvin, 602 F.Supp. 399 (S.D.Ill. 1985).

Various courts have refused to apply the learned intermediary doctrine in cases where they have concluded that the rationale for shifting the duty to warn from the manufacturer to the physician does not apply. Illustrative examples include personal injury actions involving oral contraceptives, IUDs, and vaccines. In refusing to apply the learned intermediary rule, the courts have emphasized the defendant manufacturers' conduct in aggressively marketing their drugs to the public.

Excessive Promotion. The California Supreme Court has held that a pharmaceutical company's warnings to physicians of the potential dangers from the use of one of its prescription drugs does not protect it from liability if the manufacturer engages in aggressive promotion of that drug and thereby induces physicians to disregard the warnings. In such instance, the learned intermediary doctrine will not be applied and the manufacturer's duty to warn the consumer of possible hazards associated with the use of its products has not been met. Stevens v. Parke, Davis & Co., 9 Cal.3d 51, 65,107 Cal.Rptr. 45, 53 (1973); Love v. Wolf, supra, 38 Cal.Rptr. at 196; see also, Carmichael v. Reitz, supra.

In Stevens, a manufacturer of the prescription drug Chloromycetin included FDA-mandated warnings on the drug's labels and packages disclosing that certain blood disorders had been associated with use of the drug and cautioning against indiscriminate and unnecessary uses. At the same time, however, the manufacturer distributed calendars and other sales promotional "freebies" and placed ads in medical magazines touting the drug's alleged effectiveness without mentioning the associated dangers, 107 Cal.Rptr. at 54. The California Supreme Court upheld the jury's finding that the defendant negligently failed to provide an adequate warning as to the dangers of Chloromycetin "by so 'watering down' its warnings and so overpromoting such drug that members of the medical profession.....were caused to prescribe it when it was not justified." Id.

Oral Contraceptives. Some courts have held that the learned intermediary rule does not apply in cases involving injuries from the use of oral contraceptives. See, e.g., Stephens v. G.D. Searle & Co., 602 F.Supp. 379 (E.D.Mich. 1985); MacDonald v. Ortho Pharmaceutical Corp., 394 Mass. 131, 475 N.E.2d 65, cert. denied, 474 U.S. 920 (1985); Odgers v. Ortho Pharmaceutical Corp., 609 F.Supp. 867 (E.D.Mich. 1985). Relying on the MacDonald and Stephens decisions, the district court in Odgers reasoned that the rule should not apply in oral contraceptive cases because, unlike instances involving "therapeutic" drugs, (1) the patient — not the physician — assumes the rule of choosing a contraceptive, (2) there is usually little initial or follow-up contact between the patient and the prescribing physician, and (3) oral contraceptives are specifically subject to federal regulations intended to ensure an informed decision about their use, which weighs in favor of imposing a duty to provide direct warnings to the consumer. 609 F.Supp. at 874-75, 878-79.

Interestingly, in Reaves v. Ortho Pharmaceutical Corp., 765 F.Supp. 1287, 1290-91 (E.D.Mich. 1991), Judge Feikins disagreed with his brethren who authored the Stephens and Odgers opinions; he reasoned that oral contraceptives were not so different from other prescription drugs that the learned intermediary rule should apply to one but not the other. Thus, he applied the doctrine in Reaves.

Similarly, in West v. Searle & Co., 305 Ark. 33, 806 S.W.2d 608 (1991), the Supreme Court of Arkansas agreed that the learned intermediary rule is appropriate in the case of oral contraceptives. "The patient would normally make the initial choice about birth control but, after that, the physician would exercise his medical judgment concerning the best method of contraception for his patient." 806 S.W.2d at 614. The court noted that the physician chose the oral contraceptive for the plaintiff because it contained the proper estrogen dosage for that patient. The selection of the amount of estrogen was enough for the Arkansas court to conclude that the physician played an "intermediary" role and therefore, the manufacturer's warning only needed to be given to the physician. See also, Goodson v. Searle Laboratories, 471 F.Supp. 546 (E.Conn. 1978); Chambers v. G.D. Searle & Co., 441 F.Supp. 377 (D.Md. 1975), aff'd, 567 F.2d 269 (4th Cir. 1977).

IUDs. In Hill v. Searle Laboratories, 884 F.2d 1064 (8th Cir. 1989), the Eighth Circuit declined to apply the learned intermediary rule to an injury caused by the use of CU-7, an intrauterine device. "IUDs, like other forms of birth control, are atypical from most prescription drug products because the treating physician generally does not make an intervening, individualized medical judgment in the birth control decision." 884 F.2d at 1070. Rather, the decision as to whether to use a prescription drug for birth control and which one to use is a patient's independent decision "with only limited input from the prescribing physician." Id. at 1071.

The Hill court then recited the same factors as those outlined in the oral contraceptive cases, described above, to explain why the learned intermediary rule would not apply to IUD cases. For example, birth control decisions are private matters dependent on many non-medical related factors; following the initial treatment, little patient-physician contact exists.

The learned intermediary rule will probably not apply when the contraceptive product can be purchased directly by the patient, over the counter without a prescription. In Mitchell v. VLI Corp., 786 F.Supp. 966 (M.D.Fla.1992), the doctor merely gave a sample of the contraceptive sponge to the patient, apparently with minimal information about its use or dangers. Noting that the product was nonprescriptive in nature, the district court declined to apply the rule and denied the defendant manufacturer's motion for summary judgment. 786 F.Supp. at 970.

On the other hand, the Fourth and Sixth Circuits have applied the learned intermediary doctrine in IUD cases, apparently reasoning that IUDs are pharmaceutical products available only by prescription. Odom v. G.D. Searle & Co., 979 F.2d 1001 (4th Cir.1992); Beyette v. Ortho Pharmaceutical Corp., 823 F.2d 990 (6th Cir. 1987). In Allen v. G.D. Searle & Co., 708 F.Supp. 1142 (D.Or. 1989), the federal court followed Oregon law to apply the learned intermediary doctrine in an IUD case. The Supreme Court of Delaware, in Lacy v. G.D. Searle & Co., 567 A.2d 398, 401 (Del. 1989), concluded that "the rationale supporting the learned intermediary doctrine is even stronger when applied to the IUD, as opposed to an oral contraceptive." A federal court in Minnesota applied the doctrine in an IUD case, citing "[t]he overwhelming majority of decisions that have applied [it] to cases involving contraceptives." Kociemba v. G.D. Searle & Co., 680 F.Supp. 1293, 1305 (D.Minn. 1988).

Vaccines. Courts have also declined to apply the learned intermediary rule in cases involving vaccines. In Reyes v. Wyeth Laboratories, supra, the court applied the rationale of Davis v. Wyeth, infra, to hold that the learned intermediary doctrine did not apply to vaccines administered in clinics. 498 F.2d at 1276. It reasoned that in mass immunization programs, vaccines are dispensed at a clinic "without the sort of individualized medical balancing of the risks to the vaccinee that is contemplated by the prescription drug exception." Id. at 1277.

A contrary view is taken in Plummer v. Lederle Laboratories, 819 F.2d 349 (2d Cir.), cert. denied, 484 U.S. 898 (1987), where the Second Circuit, in applying the rule to an oral vaccine case, reversed a plaintiff's judgment against a manufacturer. Plaintiff contracted polio from contact with his infant granddaughter, who had been prescribed an oral polio vaccine which was administered by a physician at the physician's office. The Plummer court drew a distinction between the situation where a prescription drug is obtained in a "clinic-like setting" in which it would find the rule did not apply and the manufacturer would have a duty to warn the consumer directly, and the case where a physician sees the consumer and dispenses the drug, in which event the rule applies and the manufacturer need only warn the physician. 819 F.2d at 356. Likewise, in Hurley v. Lederle Laboratories, 863 F.2d 1173, 1178 (5th Cir. 1989), the Fifth Circuit held the doctrine applied in a DPT vaccine case where, unlike the mass immunization scenario, "there is no question whatsoever but that a patient-physician relationship existed before and at the time the immunization was given."

Absence of Individualized Attention. In instances in which a pharmaceutical product was administered in a mass clinic setting without individualized medical attention and judgment, some courts have refused to impose the learned intermediary doctrine and continue to require the manufacturer to warn the ultimate consumer.

In Davis v. Wyeth Laboratories, Inc., 399 F.2d 121 (9th Cir. 1968), a manufacturer supplied its vaccine to a mass immunization clinic where the vaccine was dispensed to everyone who came in, without an individualized balancing of benefits and risks by a physician. Because the manufacturer was aware that patients would not receive individualized medical attention, the court held that the manufacturer's duty to warn extended directly to the consumer, and not just to the physician. 399 F.2d at 131. Other courts have adopted this "mass immunization exception" to the learned intermediary rule: where a prescription drug is given in a "clinic-type" situation, the manufacturer has a duty to warn consumers directly because of the absence of a medical intermediary to counsel them and to inform them of any applicable warnings. See, e.g., Hill v. Searle, supra, 884 F.2d at 1071; Plummer v. Lederle, supra, 819 F.2d at 356.

One court has distinguished the mass immunization "clinictype" setting from a Veterans Administration clinic in which a physician saw a walk-in patient and prescribed an anti-inflammatory drug. It reasoned that the V.A. physician "assumed the burden of presiding over [the patient's] medical interests . . . ." Krasnopolsky v. Warner-Lambent Co., 799 F.Supp. 1342, 1347 (E.D.N.Y. 1992). Consequently, the court applied the learned intermediary rule and granted the pharmaceutical manufacturer's motion for summary judgment.

Thus, if you are not going to receive individualized medical attention and the manufacturers know or should anticipate that situation, then the learned intermediary doctrine will not apply. The reason seems to be that there is no medical intermediary to counsel patients individually.

One commentator has extended this reasoning to the dispensing of drugs in health maintenance organizations. Kennedy, "Risk Management for Drug & Medical Device Product Liability," p. B-22, DRI Drug & Medical Device Litigation Seminar (1992). Like patients in clinics, patients in HMOs do not always receive individualized medical attention. They can obtain drugs over the telephone without seeing or speaking with a physician or nurse. Consequently, it has been suggested that, where a drug manufacturer knows or should know that its products are being dispensed to patients who are members of HMOs without the individualized weighing of risks and benefits by a physician, the manufacturer has a duty to warn those consumers directly of any potential dangers from the use of the products, particularly when the potential risks and adverse effects are serious in nature.

With the rapid rise of HMOs in the last decade, and particularly in California, it is advisable that a manufacturer continue to warn consumers directly and not rely upon the application of the learned intermediary doctrine in the HMO context.

Drug Distributor's Responsibility. A pharmaceutical manufacturer may contractually avoid liability when selling its drugs to distributors as long as the latter agrees to provide warnings to consumers. In effect, the distributor obtains not only the drug, but also the duty to warn and the concomitant legal status as the learned intermediary. In Mazur v. Merck & Co., 964 F.2d 1348 (3d Cir. 1992), the district court had granted a vaccine manufacturer's motion for summary judgment. The court of appeals affirmed, holding that the manufacturer satisfied its duty to warn consumers by contractually obligating the purchaser of the drug, the Centers for Disease Control, to provide a warning either to a learned intermediary or directly to the consumer. Id. at 1364-65.

Mazur suggests an expansion of the learned intermediary doctrine beyond its "individualized medical attention" parameters. By contracting with a purchaser/distributor on whom it can reasonably rely to warn the ultimate users, a drug manufacturer can satisfy its duty to warn, whether or not the distributor plans to pass the warning on to each individual user. This contractual route may appeal to manufacturers, at least in the "mass immunization" situation.

However, the Mazur court limited its analysis to the reasonableness of contracting with the CDC to warn the ultimate users; in dicta, it stated that drug manufacturers who delegate to third parties their responsibility to warn the consumer will be held to a higher standard of care in their selection of a third party upon whom they will rely to provide the warnings. Id. at 1366-68. The court further emphasized that the manufacturer has a continuing duty to inform such third parties of any risks which it later discovers, or should reasonably have discovered, to be associated with the use of its products. Id. at 1366.

In the majority of jurisdictions, the learned intermediary rule can protect pharmaceutical manufacturers from liability for failing to warn the ultimate consumer of potential risks associated with the use of their products. That protection is dependent on the manufacturers providing physicians with adequate and updated warnings of potential adverse reactions and contraindications to the use of their pharmaceuticals. Moreover, some courts have expanded the rule to include medical devices.

Courts have declined to apply the learned intermediary rule in situations where the drug manufacturer overpromotes its product and thereby "waters down" the warnings it conveys to the learned intermediary. There is a split of authority on the question of whether the rule applies in cases involving oral contraceptives.

In view of the "mass immunization" exception to the doctrine, as well as the rapid proliferation of HMOs, a manufacturer of prescription drugs who has reason to believe that its products will be administered without the individualized medical judgment of a learned intermediary must take steps to ensure that the ultimate consumer is warned of the potential risks associated with the use of its products. Finally, manufacturers may consider contractually delegating to distributors and other third parties the responsibility for conveying such warnings to learned intermediaries or consumers. However, in deciding whether to pursue that option with a particular third party, the manufacturer should first conduct the necessary background investigation to satisfy itself that the third party will, in fact, dutifully convey the warnings.