Learned intermediary doctrine faces challenges.

• Position: Pharmaceutical industry duty to warn

Writing in the January newsletter of the Drug, Device and Biotech Committee, Michael J. Farrell of Farrell, Farrell, Farrell & Farrell, Huntington, West Virginia, describes recent learned intermediary cases:

Challenges to the learned intermediary doctrine continued in 1997 in the United States in both federal and state courts--and with mixed results. Let's look at several of these cases and highlight the arguments advanced by plaintiffs in their efforts to abolish or weaken its application.

What is it?

The learned intermediary doctrine provides that when a drug manufacturer properly warns the prescribing physician of dangerous propensities of its product, the manufacturer is excused from its common law duty to warn directly each patient to whom the drug is prescribed. The need for this doctrine was summarized in Comment k to Section 402A of the Restatement (Second) of Torts.

Comment k acknowledged the societal need for unreasonably unsafe pharmaceutical products. A manufacturer of such products is generally constrained from direct distribution of these products to users by federal law and regulation. As a consequence, the pharmaceutical manufacturer's duty to warn extends, in most cases, to the prescribing physician. The scope of the manufacturer's duty is to provide an adequate warming of inherent dangers not within the knowledge of or obvious to the average learned intermediary. McGowan v. Mehta, 1997 WL 159519 (E.D. La. 1997), not reported in F.Supp., quoting Willet v. Baxter International Inc., 929 F.2d 1094, 1098 (5th Cir. 1991).

An alternative formulation of the doctrine provides that the warning to the learned intermediary be "reasonable, but `not the best possible warning.'" Pfizer Inc. v. Jones, 272 S.E.2d 43, 45 (Va. 1980).

As in all other warning causes of action, a plaintiff must establish that the failure to warn the physician of the risk associated with the use of the product was not known to the prescribing physician and that the failure to warn was both a cause in fact and a proximate cause of plaintiff's injury. Willet, 929 F.2d at 1098.

But there are exceptions

Historically, two exceptions to application of the doctrine have been recognized.

First, mass immunization programs for polio and swine flu explained that manufacturers could not invoke the doctrine since there was no opportunity for an interface between the patient and a prescribing physician. See Plummer v. Lederle Laboratories, 819 F.2d 349 (2d Cir. 1987), cert. denied, 484 U.S. 898 (1987); National Childhood Vaccine Injury Act, 42 U.S.C. [subsections] 300aa-1 through 300aa-34.

The second exception arose in connection with the selection and ingestion of contraceptive medications and devices. See MacDonald v. Ortho Pharmaceutical Corp., 475 N.E.2d 65 (Mass. 1985); Hill v. Searle Laboratories, 884 F.2d 1064 (8th Cir. 1989); and Odgers v. Ortho Pharmaceutical Corp., 609 F.Supp 867 (E.D. Mich. 1985). But see West v. Searle & Co., 806 S.W.2d 608, 614 (Ark. 1991); Reaves v. Ortho Pharmaceutical Corp., 765 F.Supp. 1287, 1291 (E.D. Mich. 1991). The rationale for this exception developed because of the active role of the patient in the decision to use the products, the alleged passive role of the physician, and the reality that the products invited use for an extended period of time without medical assessment or monitoring. The continuing viability of the contraceptive exception outside of Massachusetts is questionable in light of the pronouncements by the Arkansas Supreme Court in West and the federal district court in Reaves.

Scorecard looks good

Against this backdrop, many courts addressed application of the doctrine in 1997. The scorecard reflects favorable outcomes for the pharmaceutical industry and its defense counsel, with only one major decision that weakened its application.

Plaintiffs advanced a recurrent theme that involved scrutiny of the informational efforts of pharmaceutical companies to reach the consumer. Magazine articles and advertisements, cable and network television, billboards, direct mail and physician handouts were used by the industry to "educate" the consuming public. Plaintiffs sought to label these activities as inadequate and misleading promotional marketing. They argued that the industry had voluntarily undertaken to warn the consumers directly and therefore would have to do so in conformance with the traditional standards for an effective warning. Since the industry intentionally had not included all the known risks, hazards or contraindications in these informational messages, it forcefully argued that the learned intermediary doctrine applied and that it had no obligation to litigate the consumer warning issue.

The first major battleground in 1997 was the Norplant MDL litigation in Texas.

Norplant MDL litigation

Norplant is a contraceptive implant that has spawned significant federal litigation, which has been placed in MDL status in the U.S. District Court for the Eastern District of Texas at Beaumont. In In Re Norplant Contraceptive Products Liability Litigation., 955 F.Supp 700 (E.D. Texas 1997), the plaintiffs alleged that American Home Products was liable because it failed to warn both the physician and the ultimate user of the product about side effects associated with use of the product. The side effects included prolonged menstrual bleeding, headaches, mood changes, depression, weight gain, hair loss, arm pain, dizziness anti nausea.

Jurisdiction was obtained through diversity of citizenship, with the court applying the substantive law of Texas for the legal theories advanced by plaintiffs, which included strict liability, negligence, misrepresentation, implied warranty and claims under the Texas Deceptive Trade Practices Act. Texas law provided that, in pharmaceutical cases, the manufacturer would remain liable to the ultimate user if the warning to the physician intermediary was determined to be inadequate or misleading and the failure to warn proximately caused the physician to prescribe the implant and the resulting injury.

Judge Schell defined the causation issue fairly and precisely by focusing on the physician's, not patient's, state of mind:

In order to establish producing cause in a prescription drug failure-to-warn case, plaintiffs must demonstrate that a "proper warning would have changed the decision of the treating physician, i.e., that but for the inadequate warning, the treating physician would not have used or prescribed the product." [955 F.Supp. at 710.] The court granted summary judgment in the defendants' favor on all theories relating to the bellwether plaintiffs, since they failed to meet their burden of proof that a different warning would have changed the decision of the treating physicians.

"Mere conduit" argument

The plaintiffs attempted two approaches. First, they claimed that the informational distribution conduct of the manufacturer effectively displaced the physician's role as learned intermediary. The second approach focused on the product and urged the court to recognize an exception to the doctrine whenever a contraceptive was involved. The court rejected both approaches.

Unlike the polio vaccine cases typified by Reyes, the implantation of Norplant always required the active conduct of a physician in a traditional physician-patient relationship. As a consequence, each physician, prior to implanting the Norplant device, had a legal duty to warn the patient and obtain her informed consent. The Reyes court had limited its holding to those situations in which the physician-patient relationship was non-existent.

Judge Schell rejected the contention that physicians who had implanted Norplant had become mere "conduits" for distribution of the product by reaffirming the duty of the physicians to make disclosures:

Moreover, if any physician allowed himself to become a mere conduit for Wyeth's materials, then it is the physician who is responsible. By the same token, Wyeth cannot remove a physician from the decision making process, only the physician can do that by avoiding his responsibility to make an individualized balancing of the risks and benefits associated with a drug and to advise the patient of possible adverse reactions. [955 F.Supp. at 706.] "Active/passive physician"

The court rejected the "active/passive physician" argument by pointing out that no jurisdiction had followed the MacDonald rationale during the 12 years since its publication. Moreover, the patient's participation in the selection of a contraceptive does not diminish the physician's professional responsibility to...