Norplant litigation: creating an exception to the learned intermediary doctrine.

As of 1994, about 900,000 women in the United States had been implanted with the Norplant System.(1) Six matchstick-sized capsules, implanted under the skin of a woman's arm, slowly release levonorgestrel into the body for birth control. Levonorgestrel is a synthetic hormone that prevents pregnancy by suppressing the ovulation cycle and thickening the cervical mucus. Once implanted, Norplant incrementally releases levonorgestrel for about five years.(2)

Unfortunately, some users are encountering health problems they believe arc caused by the system.(3) These include menstrual disruptions, hormone imbalance, headaches, mood swings, appetite and weight changes, enlargement of the ovaries or fallopian tubes, and cyst formation. More serious complications may include stroke, pseudotumor cerebri, blindness, pulmonary embolism, myocardial infarction, and other possibly fatal pulmonary and cardiac injuries.

Other common problems include infection, numbness, or pain at the implantation site and numbness or pain in the arm or hand. The capsules may also rupture or migrate, making removal difficult and resulting in nerve damage and scarring.

In response to their injuries, women are suing the manufacturer/distributor, Wyeth-Ayerst Laboratories, and its parent, American Home Products Corp., under theories of strict products liability, negligence, breach of warranty, fraud, misrepresentation, and violation of deceptive trade practices acts.(4)

In defense, Wyeth-Ayerst has raised the learned intermediary doctrine. It provides that when a prescription drug manufacturer sells a drug "properly prepared and accompanied by proper directions and warnings" to a learned intermediary (the physician), the drug is not viewed as "defective" or "unreasonably dangerous" and the manufacturer is not liable for resulting damages.(5) The doctrine assumes physicians will use their expertise to decide which warnings to pass on to patients.(6)

The rationale underlying the doctrine is that regardless of precautions in prescribing, drugs may cause foreseeable injuries. Notwithstanding these, the societal benefits of treating health problems with "unavoidably unsafe" drugs outweighs the risk of injury. This rationale collapses, however, when science creates a nontherapeutic product whose use is not mandated by health considerations.

Recognizing this, courts have created exceptions to the doctrine for vaccines administered in mass immunizations,(7) oral contraceptives,(8) and intrauterine devices (IUDS).(9) This article examines the doctrine and its exceptions and shows why they should be expanded to include Norplant.

Vaccines

The first major inroad against the doctrine arose in Davis v. Wyeth Laboratories, Inc.(10) There, the plaintiff sued a polio vaccine manufacturer for massive health problems sustained after receiving the vaccine. A clinic had dispensed the vaccine without a physician's assessment of the risks involved to each individual. The Ninth Circuit rejected the manufacturer's claim of learned intermediary protection, determining that "without an individualized balancing by a physician of the risks involved ... it is the responsibility of the manufacturer to see that warnings reach the consumer, either by giving warning itself or by obligating the purchaser to give warning."(11)

Six years after Davis, the Fifth Circuit also adopted the individualized balancing rule in Reyes v. Wyeth Laboratories.(12)

A New York trial court adopted this exception in Samuels v. American Cyanamid Co.(13) The plaintiff sued the defendant for injuries received from immunizations taken before international travel. The court formulated the decisive question as "whether an informed intermediary could reasonably be expected to have made an individualized assessment of the risks and potential side effects of the vaccine which the patient could then rely upon."(14)

In other words, when a manufacturer of an unavoidably unsafe vaccine knows or should know that it will be supplied without a physician's individual assessment of the patient, the manufacturer cannot protect itself with the learned intermediary doctrine and, thus, has a duty to warn the patient directly. This exception is limited to vaccines used in settings where the manufacturer knows the doctor will not be able to give individual warnings about the medication's potential danger to each patient.(15)

Oral Contraceptives

Seventeen years after the first vaccine exception, the Massachusetts Supreme Court, in MacDonald v. Ortho Pharmaceutical Corp., created the oral contraceptive exception.(16) The plaintiff began taking Ortho birth control plus when she was 26. Three years later, she suffered a debilitating stroke. Her pill dispenser included a warning that the drug could cause blood clotting that "may threaten life if the clots break loose."

The jury found the defendant had been negligent for failing to give the plaintiff "sufficient warning" of the dangers associated with the birth control pills despite its warning the physician. Pivotal to the decision was that the word "stroke" was not included on the dispenser warning or in brochures Ortho distributed to patients.

Upholding the jury's verdict for the plaintiffs and reversing the trial court's judgment n.o.v., the Massachusetts Supreme Court detailed three "peculiar characteristics" that distinguished oral contraceptives from other products protected by the doctrine. First, the normal active-passive roles of physician and patient are reversed: The healthy, young consumer is usually actively involved in the decision to use the contraceptive, and the prescribing physician is relegated to a relatively passive role.

Second, unlike other prescription drugs whose uses end upon remedy, oral contraceptives may be used for extended periods of time with minimal physician monitoring - generally yearly examinations. Consequently, users most likely will have difficulty recalling their physicians' detailed warnings.

Third, the FDA regulates oral contraceptives to ensure users make an informed choice based on knowledge of the potential side effects.(17) The court cited the FDA's determination that oral contraceptives are taken as a matter of choice and entail a relatively high incidence of serious illness and that "in the absence of direct written warnings, many potential users of `the pill' do not receive the needed information in an organized, comprehensive, understandable, and handy-for-future-reference form."(18) In summary, the court determined that the manufacturer has a duty to warn the ultimate user.

The court said this encompassed a duty to communicate "reasonable notice" of the side effects and their likelihood. The court also made it clear that compliance with FDA requirements, "though admissible to demonstrate lack of negligence, is not conclusive on this issue of failure to warn, just as violation of FDA requirements is evidence, but not conclusive evidence, of negligence."(19)

Coinciding with MacDonald were two similar Michigan federal cases, Odgers v. Ortho Pharmaceutical Corp.(20) and Stephens v. G.D. Searle & Co.(21) In Odgers, the plaintiff sued for damages sustained from a blood clot caused by the defendant's oral contraceptive. Despite the jury's decision for the plaintiff, the court granted the defendant's motion for a new trial and certified to the Michigan Supreme Court the question of whether the manufacturer of an oral contraceptive has a duty to warn users directly. The result was a four-to-three decision in which the majority declined to decide the issue.(22)

The dissent offered four reasons why it supported imposing a duty to warn patients directly. First, the patient, not the doctor, generally decides to use an oral contraceptive; the "threshold question" of medical need has already been decided by the patient when she visits the physician.(23)

Second, Ortho's advertising, directed at women, prompted patients to request the pill but did not explain the potential risks involved. The dissent pointed to Ortho's unique and successful advertising as a way the manufacturer bypassed physicians to create an increased demand for its product.(24)

Third, the dissent reasoned that imposing a duty to warn patients directly would not frustrate the physician-patient relationship or unduly burden the pill's manufacturer.

The dissent recognized the desirability of the physician filtering warnings to the patient in most circumstances, because the patient relies on the physician's judgment and does not have sufficient knowledge to balance potential bad side effects against the risks of not taking the drug. However, this rationale does not apply to oral contraceptives because these drugs are an optional and nontherapeutic medication.(25)

Neither did the dissent believe that it would be "impossible" for manufacturers to directly warn patients, citing current FDA regulations requiring manufacturers of oral contraceptives to provide package inserts warning of the drug's risks.

Fourth, the dissent - like the court in MacDonald - cited extended periods of use with minimal physician monitoring as a reason why the doctrine should not apply.

Finding the reasons advanced by the dissent persuasive, the federal judge in Odgers concluded that the Michigan Supreme Court was unwilling to adopt the learned intermediary doctrine. Thus, the court found as a rule of law that the manufacturer of oral contraceptives had a duty to warn the user of potential risks.(26)

In Stephens, the plaintiff sued for damages resulting from a stroke caused by the manufacturer-defendant's oral contraceptives. As in Odgers, the court followed the dissent's rationale in In re Certified Questions to deny the defendant's summary judgment motion based primarily on the learned intermediary doctrine. In its conclusion, the Michigan court imposed on the manufacturer a duty to warn users of oral contraceptives directly.

Intrauterine Devices

This exception is set forth in Hill v. Searle Laboratories.(27) The plaintiff sued the manufacturer of an IUD for damages sustained from the IUD's perforating her uterus and embedding in her intestine. The plaintiff claimed the device was defectively designed and the defendant had failed to warn of the risk of uterine penetration.

Reversing the trial court's grant of summary judgment for the defendant based on the learned intermediary doctrine, the court offered four reasons justifying its holding.

First, as with oral contraceptives, the patient independently decides to use an IUD and receives only limited input from the prescribing physician. Second, because there is decreased physician supervision and increased responsibility for patient self-monitoring, direct manufacturer-to-patient warnings will decrease injuries. Third, the manufacturer's marketing strategy has intentionally bypassed physicians to persuade potential users to choose its IUD over competing products. Fourth, some IUDs are implanted in clinic-type settings where there is limited physician-patient contact.

The court ultimately held that because the patient makes the final choice regarding the IUD, she must be provided with direct warnings to enable her to make an informed decision.(28)

Norplant Exception

Norplant uses the same medical technologies as oral contraceptives - its active ingredient, levonorgestrel, is the same one used in Nordette-21, Wyeth-Ayerst's "mini pill"(29) - and it shares other common characteristics with oral contraceptives and the IUD. Thus, courts accepting the decisions above should logically create another exception for Norplant. Lawyers handling a Norplant case should check the law in their jurisdictions to see if the reasoning of these courts has been accepted.

There are four reasons why Norplant should be excepted from the doctrine. First, it is an elective prescription drug. As noted above, a crucial distinction between prescription drugs and birth control products is that the former arc vital and therapeutic, while the latter are primarily elective and nontherapeutic. This distinction is significant because the failure to take an elective drug will not result in an injury to the patient, while the failure to take a therapeutic drug is likely to cause a patient's condition to deteriorate. A rationale for the learned intermediary doctrine - to protect patients from injuring themselves by failing to take needed drugs - does not apply in the case of elective drugs.

Second, the patient is actively involved in deciding to use Norplant, while the physician assumes a passive role. How a user obtains her prescription mirrors the MacDonald court's description of the typical oral contraceptive user. She examines the available products; chooses a contraceptive; and seeks out a physician, who then acts in accordance with her decision.(30)

Third, as with oral contraceptives and IUDs, patients use Norplant for extended periods without medical supervision. The complete system is inserted during a single hospital visit and is intended to last five years, with yearly examinations to check the patient's health.(31)

As the Massachusetts Supreme Court noted in MacDonald, it is unrealistic to expect a long-term prescription birth control user to recall multiple warnings from a yearly conversation with her physician. If the manufacturer directly warns patients in writing, injuries can be avoided by giving patients a means to refresh their memory about die physician's warnings and a handy reference if problems develop.

The argument that distributing warnings would be impossible is invalidated by FDA regulations that force oral contraceptive and IUD manufacturers to have warning inserts packaged with their birth control products. Norplant is also required by FDA regulations to provide these inserts, proving it is feasible to directly warn patients.

Fourth, Norplant's manufacturer/distributor has undertaken an extensive advertising campaign directed toward consumers. In a "Dear Doctor" letter, Wyeth-Ayerst states, "[W]e are about to launch a national advertising program in many of the magazines your patients may read."(32) The rest of the letter says the "exciting [advertising] program" will lead to patient inquiries about Norplant.

The campaign, launched in the United States in 1991, included advertisements in nationally circulated magazines such as Glamour, Mademoiselle, and Cosmopolitan. The campaign also included brochures, pamphlets, and a video to be placed in doctors' offices and clinics.

Like all consumer-driven advertising, the advertisements extol Norplant's simplicity and convenience. However, the campaign was not balanced by a comparable disclosure of Norplant's inherent dangers.(33)

In addition to the lack of adequate disclosure, the advertising goes against many of the learned intermediary doctrine's principles. Advertising Norplant directly to consumers establishes that they have a significant role in their medical choices with respect to birth control, undermining the argument that physicians need to decide what information concerning risks should be presented to their patients.(34)

Moreover, it is illogical to argue that requiring direct warnings will undermine the patient-physician relationship. Consumer-directed advertising, by its very nature, encroaches on that relationship by encouraging consumers to ask for advertised products by name.

Finally, bypassing physicians to create increased patient demand for Norplant refutes the argument that Norplant's side effects are too complex to be effectively conveyed to patients. If advertisements can communicate the benefits of Norplant, then those same ads can be used to disclose Norplant's side effects.

Logical Restriction

Norplant's unique similarities to oral contraceptives and IUDs - its elective nature, prescription process, extended unmonitored use, and the marketing strategy used to promote it - make it a logical exception to the learned intermediary doctrine.

A Norplant exception will further limit uncritical adherence to the doctrine by restricting it to only those drugs where it is necessary. This restriction will result in fewer individual injuries and the advancement of individual autonomy.

Notes

(1) Letter from Wyeth-Ayerst Laboratories to "Healthcare Provider," July 1994. (2) Sec PHYSICIANS' DESK REFERENCE 2760 (50th ed. 1996). (3) In 1990, the University of California conducted a study of 205 women using Norplant. Of the 110 women who completed die testing, 46 percent dropped out because of side effects; 14 percent, because of concern about decreased effectiveness; 10 percent, because of "medical problems"; and 6 percent, because they desired pregnancy. P.D. Darney, Acceptance and Perceptions of NOR-PLANT Among Users in San Francisco, 21 STUD. FAM. PLAN. 152 (1990). (4) In re Norplant Contraceptive Prods. Liab. Litig., MDL No. 1038 (E.D. Tex. Feb. 24, 1995). (5) RESTATEMENT (SECOND) OF TORTS [sections] 402A cmt. (1965). See also Lloyd C. Chatfield, Medical Implant Litigation and Failure to Warn: A New Extension for the Learned Intermediary Rule? 82 KY. L. J. 5 75 (1993-94); Alan R. Styles, Prescription Drugs and the Duty to Warn: An Argument for Patient Package Inserts, 39 CLEV. ST. L. REV. 110 (1991). (6) See generally JOHN W. WADE, PROSSER, WADE AND SCHWARTZ'S CASE AND MATERIALS ON TORTS 761 (9th ed. 1994); West v. Searle & Co., 806 S.W.2d 608, 613-14 (Ark. 1991) (health care provider is best assessor of relevant risks and benefits). (7) See Davis v. Wyeth Lab., 399 F.2d 121 (9th Cir. 1968). See also Reyes v. Wyeth Lab., 498 F.2d 1264 (5th Cir.), cert. denied, 419 U.S. 1096 (1974). (8) MacDonald v. Ortho Pharmaceutical Corp., 475 N.E.2d 65 (Mass.), cert. denied, 474 U.S. 920 (1985). (9) Hill v. Searle Lab., 884 F.2d 1064 (8th Cir. 1989). (10) 399 F.2d 121. (11) Id. at 131 (emphasis added). (12) 498 F.2d 1264. (13) 495 N.Y.S.2d 1006 (Sup. Ct. 1985). (14) Id. at 1013. (15) Davis, 399 F.2d 121, 131 (polio vaccine given as part of "mass immunization"); Reyes, 498 F.2d 1264, 1276 (oral vaccine administered in "clinic type" setting); Mazur v. Merck & Co., 964 F.2d 1348, 1361-62 (3d Cir.) (measles vaccination at public school amounted to "mass immunization"), cert. denied, 113 S. Ct. 463 (1992). (16) 475 N.E.2d 65. (17) Id. at 69-70. Reference is to 43 Fed. Reg. 4,215 (1978), requiting that labels warn of the risks of blood clots, circulatory problems, cancer, and the effects on unborn children associated with the use of oral contraceptives. (18) Id. (quoting 43 Fed. Reg. 4,215 (1971) and 35 Fed. Reg. 9,002 (1970), which mandates that a brochure disclosing the dangers be given to doctors for dissemination to patients, md that the oral contraceptive container remind patients of the information doctors have given concerning the prescription). (19) Id. at 70-71. (20) 609 F. Supp. 867 (E.D. Mich. 1985). (21) 602 F. Supp. 379 (E.D. Mich. 1985). (22) In re Certified Questions, 358 N.W.2d 873 (Mich. 1984). (23) Id. at 879 (Boyle, J., dissenting). (24) Id. at 884-85. A report on the Gallup survey mentioned by the dissent is found in Poll on the Pill - 18 Percent of U.S. Users Have Recently Quit, NEWSWEEK, Feb. 9,1970. (25) Id. at 882-85. See Margaret Gilhooley, Learned Intermediaries, Prescription Drugs, and Patient Information, 30 ST. LOUIS U. L.J. 633, 644-45 (1986). (26) 609 F. Supp. 867, 879. (27) 884 F.2d 1064 (8th Cir. 1989). (28) Id. at 1071. See also Susan A. Casey, Laying an Old Doctrine to Rest: Challenging the Wisdom of the Learned Intermediary: Doctrine, 19 WM. MITCHELL L. REV. 931, 945 (1993). (29) See PHYSICIANS' DESK REFERENCE, supra note 2, at 2755. (30) 475 N.E.2d 65; see also Tim S. Hall, Bypassing the Learned Intermediary: Potential Liability for Failure to Warn in Direct-to-Consumer Prescription Drug Advertising, 2 CORNELL J.L. & PUB. POL'Y 449 (1993). (31) See PHYSICIANS' DESK REFERENCE, supra note 2, at 2761. "A complete ... physical examination should be taken prior to implantation ... of the Norplant System capsules and at least annually during its use." (32) Letter from Wyeth-Ayerst Laboratories to "Healthcare Provider," Nov. 1992. (33) Plaintiffs' fraud allegations in In re Norplant Contraceptive Prods. Liab. Litig. (MDL No. 1038) claim the manufacturers misrepresented or otherwise misled readers about certain tests concerning Norplant. Other advertising falsely implied women in U.S. clinical trials discontinued Norplant only because of menstrual irregularities or the desire to become pregnant. (34) See Casey, supra note 28, at 956, citing Teresa Moran Schwartz, Consumer-Directed Prescription Drug Advertising and the Learned Intermediary Rule, 46 FOOD DRUG COSM. L.J. 829 (1991).