Indiana Law Review


Oral Contraceptives: Heading Into an Era of

Unpredictability, Unlimited Liability, and Unavailability?

I. Introduction

Technological advances have placed modern man in a precarious
position. Now, more than ever, man is capable of creating and producing
materials suited to solve the problems of the world, yet these beneficial

products frequently bear concomitant hazards which cannot be avoided;

that is, **some products ... are quite incapable of being made safe for
their intended and ordinary use.'" However, general tort principles

indicate that manufacturers of such products will bear no liability if

their product is properly manufactured and accompanied by adequate

directions and warnings.^ Consequently, the manufacturer of any product

it knows or should know is dangerous bears an unquestioned duty to
warn the product's consumer of its potential hazards or adverse effects.^

Yet, as with many across-the-board rules, this common law duty to
warn has its exceptions. For instance, when a manufacturer sells products
that are generally used under the supervision of engineers or technicians,

the manufacturer fulfills its duty to warn when it supplies adequate

warnings and instructions to the supervisory engineers or technicians,

rather than the actual user.'* Similarly, when a manufacturer supplies a
product to members of a trade or profession, it bears no duty to warn

of hazards generally known to that trade or profession.^ Nowhere
have there been more exceptions to the duty to warn the user than in

the area of pharmaceuticals. Beginning in the mid-1960s, courts have

almost universally held that manufacturers of prescription drugs have a

'Restatement (Second) of Torts § 402A, comment k (1965).
^Id. This Restatement comment goes on to emphasize:

[T]he seller of such products, again with the qualification that they are properly

prepared and marketed, and proper warning is given, where the situation calls

for it, is not to be held to strict liability for unfortunate consequences attending

their use, merely because he has undertaken to supply the public with an

apparently useful and desirable product, attended with a known but apparently
reasonable risk.

Id.

'See, e.g., Illinois State Trust Co. v. Walker Mfg. Co., 73 111. App. 3d 585, 589,

392 N.E.2d 70, 73 (1978); Craven v. Niagara Mach. and Tool Works, Inc., 417 N.E.2d

1165, 1169 (Ind. Ct. App. 1981), rev'd on rehearing on other grounds, 425 N.E.2d 654

(Ind. Ct. App. 1981); H.P. Hood v. Ford Motor Co., 370 Mass. 69, 75, 345 N.E.2d
683, 688 (1976).

^See Jacobsen v. Colorado Fuel and Iron Corp., 409 F.2d 1263, 1273 (9th Cir.

1969). See also Hopkins v. E.I. DuPont de Nemours & Co., 212 F.2d 623, 626 (3d Cir.),
cert, denied, 348 U.S. 872 (1954).

'See Shawver v. Roberts Corp., 90 Wis. 2d 672, 686, 280 N.W.2d 226, 233 (1979).

615



616 INDIANA LAW REVIEW [Vol. 19:615

duty to warn the user's physician, who in turn is required to warn the
patient, the user of the drug, of potential adverse effects^ under the

theory of informed consent.^ This exception to the common law duty
to warn is premised on the doctrine of the learned intermediary.* Ac-

cording to the learned intermediary doctrine, the physician is viewed as

a knowledgeable liaison whose role is to translate warnings provided by

the drug's manufacturer into meaningful advice for his patient,^ the

drug's ultimate consumer. However, limitations on the above-cited ex-

ceptions to the common law duty to warn the consumer directly were
forewarned in the Restatement (Second) of Torts section 388, comment
n, which states:

Giving to the third person through whom the [product] is supplied
all the information necessary to its safe use is not in all cases

sufficient to relieve the supplier from liability .... The question

remains whether this method gives reasonable assurance that the

information will reach those whose safety depends on their having

it
'«

/

"See Canterbury v. Spence, 464 F.2d 772, 780 (D.C. Cir.), cert, denied, 409 U.S.

1064 (1972), where the court first cited Schloendorff v. Society of New York Hospital,
211 N.Y. 125, 129-30, 105 N.E. 92, 93 (1914), overruled in Bing v. Thunig, 2 N.Y.2d

656, 143 N.E.2d 3 (1957), for the proposition: '* 'Every human being of adult years and
sound mind has a right to determine what shall be done with his own body ....'" A/.

The Canterbury court interpreted "informed consent" in the following way:
True consent to what happens to one's self is the informed exercise of a choice,

and that entails an opportunity to evaluate knowledgeably the options available

and the risks attendant upon each. The average patient has little or no under-

standing of the medical arts, and ordinarily has only his physician to whom he
can look for enlightenment with which to reach an intelligent decision. From
these almost axiomatic considerations springs the need, and in turn the require-

ment, of a reasonable divulgence by physician to patient to make such a decision

possible.

Canterbury, 464 F.2d at 780. See also Cobbs v. Grant, 8 Cal. 3d 229, 243, 502 P.2d 1,

9, 104 Cal. Rptr. 505, 513 (1972); Wilkinson v. Vesey, 110 R.I. 606, 624, 295 A.2d 676,

685 (1972). For additional commentary on the development and scope of the "informed

consent" doctrine, see Riskin, Informed Consent: Looking for the Action, 1975 U. III.

L.F. 580 (1975); Waltz and Scheuneman, Informed Consent to Therapy, 64 Nw. U.L.
Rev. 628 (1970); Comment, The Evolution of the Doctrine of Informed Consent, 12 Ga.
L. Rev. 581 (1978).

"See Sterling Drug, Inc. v. Cornish, 370 F.2d 82, 85 (8th Cir. 1966).

"Id.

'""Restatement (Second) of Torts § 388, comment n (1965), continues:
Many such articles can be made to carry their own message to the understanding
of those who are likely to use them ... by a label or other device, indicating
with substantial sufficiency their dangerous character. Where the danger involved
in the ignorant use of their true quality is great and such means of disclosure

are practicable and not unduly burdensome, it may well be that the supplier should
be required to adopt them.

Id. (emphasis added).



1986] ORAL CONTRACEPTIVES 617

Accordingly, courts confronted with factual situations in which a

manufacturer's warnings to the physician were predictably relayed to the

patient-consumer in an **inadequate way"" have side-stepped the doctrine

of the learned intermediary to impose liability on the manufacturer for

its failure to warn the consumer directly.'^

Judicial reluctance to give recognition to the learned intermediary

doctrine, which originally evolved in the area of vaccines,'^ has most

recently extended to oral contraceptives."* This reaffirmation of the

common law duty to warn the consumer directly is not viewed as
surprising given the Food and Drug Administration's (*TDA")'^ current

requirement of patient package inserts for oral contraceptives.'^ However,

in MacDonald v. Ortho Pharmaceutical Corporation^'' and two similar
cases,'* the manufacturer of oral contraceptives was held liable for its

failure adequately to warn the consumer directly in spite of its compliance

with FDA packaging/labeling requirements.'^ These cases present a puz-
zling question as to how manufacturers are to satisfy their duty to warn
the consumer directly in the case of oral contraceptives distributed

nationwide in light of the fact that each court held that the adequacy

of any given warning must be determined against state negligence law

as interpreted by a jury. Yet, because sucTi adequacy standards are never

concretely fashioned prior to user injury and have the potential to vary
from state to state, oral contraceptive manufacturers held to these stand-

ards embark upon an era of certain unpredictability and probable un-

limited liability. In addition, an analysis of the reasoning used in these

"In this context, "inadequate way" describes the situation in which a manufacturer's

warnings to the physician about a product's potential adverse effects were not, in turn,

passed on to the patient in an understandable manner by the physician after an individualized

assessment of the risks and benefits. See Reyes v. Wyeth Laboratories, 498 F.2d 1264,

1277 (5th Cir.), cert, denied, 419 U.S. 1096 (1974).

'-See Givens v. Lederle, 556 F.2d 1341 (5th Cir. 1977); Reyes v. Wyeth Laboratories,

498 F.2d 1264 (5th Cir.), cert, denied, 419 U.S. 1096 (1974); Davis v. Wyeth Laboratories,

Inc., 399 F.2d 121 (9th Cir. 1968); Odgers v. Ortho Pharmaceutical Corp., 609 F. Supp.

867 (E.D. Mich. 1985); 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, 106 S. Ct. 250 (1985).

"See Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir.), cert, denied, 419 U.S.

1096 (1974); Davis v. Wyeth Laboratories, Inc., 399 F.2d 121 (9th Cir. 1968).

''See Odgers v. Ortho Pharmaceutical Corp., 609 F. Supp. 867 (E.D. Mich. 1985);

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, 106 S. Ct. 250

(1985).

'The Food and Drug Administration is the agency of the federal government charged

with protecting the public from impure and unsafe drugs.

'"See 21 C.F.R. § 310.501 (1985).
'^394 Mass. 131, 475 N.E.2d 65 (1985).

'^Odgers, 609 F. Supp. 867; Stephens, 602 F. Supp. 379.

"'See 21 C.F.R. 310.501 (1985).



618 INDIANA LAW REVIEW [Vol. 19:615

recent cases causes one to ponder the future of the doctrine of the

learned intermediary in relation to other prescription drugs.

This Note will initially trace the development of the doctrine of the

learned intermediary and the limitations on this doctrine as they first
appeared in the area of vaccines. In addition, it will briefly discuss the

emergence of the oral contraceptive industry and the public's call for

FDA intervention in the labeling of its products. Next, this Note will
consider the application of the learned intermediary doctrine in early

oral contraceptive cases and its apparent inapplicability in three recent

oral contraceptive cases — McDonald, Odgers, and Stephens. Finally,
the Note will explore the potential effects of these latest holdings on
the manufacturers of oral contraceptives and the expansion of the

MacDonald holding to other prescription drugs.

II. The Emergence of the Learned Intermediary Doctrine and
Its Early Limitation: The Vaccine Cases

Today it is well established that a prescription drug manufacturer

discharges its duty to warn of its product's risks and hazards when it
supplies physicians with adequate information about the drug's associated

side effects.^^ This general tort principle, now commonly referred to as
the doctrine of the learned intermediary, was originally conceived in the

case of Love v. Wolf.^^
In Love, the California Court of Appeals held that the manufacturer

of chloromycitin, an antibiotic used in the treatment of minor ailments,

had no specific duty to warn the patient directly.^^ Instead, the man-

ufacturer's common law duty to warn could be discharged through

'''See Reyes, 498 F.2d 1264, 1276 (5th Cir.) cert, denied, 419 U.S. 1096 (1974), where

a prescription drug manufacturer's duty to warn was explained as follows:

[W]here prescription drugs are concerned, the manufacturer's duty to warn is

limited to an obligation to advise the prescribing physician of any potential

dangers that may result from the drug's use .... Prescription drugs are likely
to be complex medicines, esoteric in formula and varied in effect. As a medical

expert, the prescribing physician can take into account the propensities of his

patient. His is the task of weighing the benefits of any medication against its

potential dangers. The choice he makes is an informed one, an individualized
medical judgment bottomed on a knowledge of both patient and palliative.

Id. (emphasis in original). See also Mauldin v. Upjohn Co., 697 F.2d 644, 647 (5th Cir.),

cert, denied, 464 U.S. 848 (1983) (manufacturer of antibiotics not required to warn patient

directly if physician adequately warned); Dyer v. Best Pharmaceutical, 118 Ariz. 465, 468,

577 P.2d 1084, 1087 (1978) (manufacturer of pharmaceutical used for anorexiant purposes

was under duty to warn the physician only); McKee v. Moore, 648 P.2d 21, 24 (Okla.
Sup. Ct. 1982) (lUD manufacturer required to warn physician); Terhune v. A.H. Robins

Co., 90 Wash. 2d 9, 13, 577 P.2d 975, 979 (1978) (manufacturer not required to warn

lUD wearers directly); Prosser and Keeton, Torts 688 (5th ed. 1984).
^'226 Cal. App. 2d 378, 38 Cal. Rptr. 183 (1964).
"/^. at 395, 38 Cal. Rptr. at 193.



1986] ORAL CONTRACEPTIVES 619

adequate warning given to either the physician or the patient.^^ Implicit

in the Love decision was the court's reluctance to impose a direct duty

to warn the patient-consumer on manufacturers, which normally have

only minimal contact with the ultimate users of the drugs. ^'^ This mere

reluctance of the Love court planted the seed that ultimately grew into

the learned intermediary doctrine. The term "learned intermediary'* was

first coined in Sterling Drugs, Inc. v. Cornish,^^ when it was applied
descriptively to denote the special liaison-like role the physician plays

between patient and drug manufacturer. In Cornish, the primary issue

on review for the Eighth Circuit Court of Appeals was whether the

defendant-drug manufacturer had a duty to warn the prescribing physician

of recently-discovered side effects of its product, Aralen, an anti-arthritic

agent. Affirming the judgment below in favor of a plaintiff who suffered
chloroquine retinopathy, a degenerative disease of the eye resulting from

ingesting Aralen, the Eighth Circuit Court of Appeals emphatically held

that the drug manufacturer did have a duty to warn the physician, a

measure which, in the court's opinion, would minimize the number of
patients injured by adverse effects.^^ Although the court's discussion of

the learned intermediary doctrine was limited to one paragraph, this

single phrase became authority for subsequent judicial rulings that a

drug manufacturer has a duty to warn only the physician.^^

From this relatively unnoticed beginning, the doctrine of the learned
intermediary emerged as a general tort principle that has been given

credence either directly or indirectly in nearly every case in which a

plaintiff brought a warning-related action against a prescription drug

manufacturer.^* Although this doctrine has been summarized in almost

"/</. Specifically, Presiding Justice Pierce wrote:

In the case of a drug it has been held there is a duty to exercise reasonable

care to warn of potential dangers from use even though the percentage of users

who will be injured is not large [citation omitted]. But if adequate warning of
potential dangers of a drug has been given to doctors, there is no duty by the

drug manufacturers to insure that the warning reaches the doctor's patient for

whom the drug is prescribed [citation omitted].
Id.

Id.

»Id. at 394, 38 Cal. Rptr. at 192.

"370 F.2d 82, 85 (1966).

-^Id. In particular, the court described the patient-physician relationship as follows:

... we are dealing with a prescription drug rather than a normal consumer
item. In such a case, the purchaser's doctor is a learned intermediary between

the purchaser and the manufacturer. If the doctor is properly warned of the

possibility of a side effect in some patients, and is advised of the symptoms
normally accompanying the side effect, there is an excellent chance that injury

to the patient can be avoided. This is particularly true if the injury takes place

slowly ....

-^See supra note 20.

''Id.



620 INDIANA LAW REVIEW [Vol. 19:615

as many different ways as the number of courts that have discussed it,
the reasons for the learned intermediary doctrine's soundness and broad

acceptance are three-fold.^^

The primary argument in support of limiting a prescription drug

manufacturer's duty to warn so as to require only the warning of

physicians springs logically from the framework of the patient-physician

relationship. When an individual chooses to seek medical care, it is
reasonable to assume that he places a great deal of trust in the skill

and expertise of his physician.^^ This reliance readily translates into

unquestioned compliance with **doctor's orders"; that is, the patient

takes the medication the physician selects.^' Based on this observation

of human behavior, proponents of the learned intermediary doctrine
view direct warnings to the patient as extraneous materials. Instead, the

manufacturer's resources are best directed to the physician, who balances
a given medication's risks against its potential benefits to the patient in

selecting the optimal drug. In addition, the learned intermediary doctrine

is frequently justified on the basis that direct warnings to patients may,

in fact, compromise the patient-physician relationship and thereby actually

endanger the patient's health." A patient's first opportunity to read the
manufacturer's information detailing a given drug's adverse effects might

well occur outside the supervision of the prescribing physician. Intimi-

dated by potential unpleasant consequences and perhaps confused by

technical terminology, some patients might forego treatment but avoid

informing the prescribing physician in an attempt to bypass an imagined

confrontation. As a result, the patient could go for months without
receiving any therapy for an ailment which otherwise could be treated

virtually risk-free."

'"See Carmichael v. Reitz, 17 Cal. App. 3d 958, 989, 95 Cal. Rptr. 381, 399 (1971);

Terhune v. A.H. Robins Co., 90 Wash. 2d 9, 14, 577 P.2d 975, 978 (1978).

«'See Carmichael v. Reitz, 17 Cal. App. 3d 958, 989, 95 Cal. Rptr. 381, 399 (1971);

Seley v. G.D. Searle & Co., 67 Ohio St. 2d 192, 203, 423 N.E.2d 831, 840 (1981); Terhune
V. A.H. Robins Co., 90 Wash. 2d 9, 14, 577 P.2d 975, 978 (1978).

''See Carmichael, 17 Cal. App. 3d at 989, 95 Cal. Rptr. at 399; Seley, 67 Ohio St.

2d at 203, 423 N.E.2d at 840; Terhune, 90 Wash. 2d at 14, 577 P.2d at 978.

"Carmichael v. Reitz, 17 Cal. App. 3d 958, 989, 95 Cal. Rptr. 381, 400; Curran,

Package Inserts for Patients: Informed Consent in the 1980's, 305 New Eng. Med. J.
1564, 1570 (1981); Rheingold, Products Liability — The Ethical Drug Manufacturer's
Liability, 18 Rutgers L. Rev. 947, 987 (1964).

"Carmichael, 17 Cal. App. 3d at 989, 95 Cal. Rptr. at 400. In Carmichael, the

plaintiff suffered both pulmonary embolisms and thrombophlebitis as a result of ingesting

Enovid, a product of defendant Searle, for a period of approximately one year. At trial,

the treating physician testified that he had informed the plaintiff that ''breakthrough

bleeding, nausea and vomiting" were potential side effects of Enovid, but no warning of

risk of thromboembolic disease was ever given. Id. at 972, 95 Cal. Rptr. at 388. In fact,

the physician testified that although he had read product literature on Enovid, he was

unaware of a causal relationship between thromboembolic disease and the use of Enovid.

Id. at 973, 95 Cal. Rptr. at 388-89.



1986] ORAL CONTRACEPTIVES 621

Lastly, the learned intermediary doctrine is often supported by an

argument based purely on logistics. It has been asserted that direct

communication between drug manufacturer and patient is **difficult if

not virtually impossible.'*^"* This argument is premised on the fact that,

at the time of the learned intermediary doctrine's inception, a one-on-

one contact between manufacturer and the ultimate consumer was limited.

At this time, magazines and television had yet to assume their function

as disseminators of medical information.'^

Although the learned intermediary doctrine has been widely accepted,

it is not without its limitations. In fact, only two years after the court

in Sterling Drug, Inc. v. Cornish first articulated the phrase *iearned

intermediary,"^* the Ninth Circuit Court of Appeals in Davis v. Wyeth

Laboratories^^ determined that certain circumstances surrounding a pre-

scription drug's administration could bar application of the doctrine.

In Davis, the plaintiff appealed a jury's verdict in favor of the

defendant-manufacturer in a suit brought after he contracted polio as

a result of vaccination with the manufacturer's product at a mass im-

munization clinic.'* A representative of the manufacturer had supplied
detailed instructions and warnings to those in charge of the immunization

program, yet no materials concerning adverse effects reached either the

vaccines' actual administrator or those who received the vaccines.'^ On
the contrary, the plaintiff testified that those materials provided implied

'Hhat it was his civic duty to participate.'"**^

After noting that **[o]rdinarily in the case of prescription drugs

warning to the prescribing physician is sufficient," the Ninth Circuit

Court of Appeals held that, because of the particular circumstances

surrounding mass immunization programs, the judicially-created learned

intermediary doctrine was clearly inapplicable to that case."*' Therefore,

the court revitalized the common law duty to warn the consumer directly.

"Rheingold, Products Liability — The Ethical Drug Manufacturer's Liability, 18
Rutgers L. Rev. 947, 987 (1964). See also Carmichael, 17 Cal. App. 3d at 989, 95 Cal.

Rptr. at 400 (quoting Rheingold); Terhune, 90 Wash. 2d at 14, 577 P.2d at 978.

"See Hayes, Consumer Advertising of Prescription Drugs, Pai- Med., Dec, 1983,

at 50; Direct to Consumer Advertising of Prescription Drugs, Am. Pharmacy, Feb., 1984,
at 20; Advertising and Ethics: Prescription Drugs on TV, Hosp. Prac, Oct., 1983, at
13.

'"370 F.2d at 85.

"399 F.2d 121 (9th Cir. 1968), cert, denied, 419 U.S. 1096 (1974).

''Id. at 122.

'Vflf. at 125.

'"Id.

*^Id. at 130. Specifically, the Davis court said:

[A]lthough the drug [polio vaccine] was denominated as a prescription drug, it

was not dispensed as such. It was dispensed to all comers ... (as in the case

of over-the-counter sales of non-prescription drugs) ....

Id. at 131 (footnote omitted).



622 INDIANA LAW REVIEW [Vol. 19:615

Two factors — the lack of a physician's individualized analysis of the
vaccine's risks/benefits for each recipient and the decrease in the phy-

sician's role in the choice of whether to vaccinate or not'*^ — appeared
to be paramount in the court's ultimate decision.

Similarly, six years later, the learned intermediary doctrine was ruled

inapplicable in Reyes v. Wyeth Laboratories,"^^ another immunization

case. Like Davis, the injured party, the eight-month-old daughter of the

plaintiff, had contracted polio after receiving the defendant-manufac-

turer's product at a local department of health clinic.'*^ In Reyes, the

vaccine had been administered by a registered nurse; no doctors were

present.*' Each ten-dose package contained a circular provided by Wyeth

which was intended to warn doctors, hospitals, or other purchasers of

potential dangers in ingesting the vaccine, but the consent form signed

by the patient's mother immediately prior to vaccination contained **no

warning of any sort.'"*^

While the Reyes court readily recognized the drug manufacturer's

duty to warn only physicians in customary prescription drug cases,'*^ it

cited Davis v. Wyeth Laboratories and imposed a duty to warn the

consumer directly when the manufacturer's product is **dispensed without

the sort of individualized medical balancing of the risks to the vaccinee

that is contemplated by the prescription drug exception.'"** Of primary
importance to the Reyes court was the fact that Wyeth Laboratories
knew or should have known that its vaccines were frequently administered
in mass immunization settings or at rural health departments, environ-

ments where patients would receive the product without the individualized

care of a physician.'*^ Once a manufacturer possessed such knowledge,

either actually or constructively, it could no longer rely on warnings

given to the physician. At that point, the manufacturer would have to

warn all foreseeable users or make certain that such users are warned
by the vaccines' administrators.^"

Subsequent to Davis and Reyes, the learned intermediary doctrine

was frequently held to be inapplicable in immunization cases even when

the vaccine was given in a private physician's office rather than in a

mass setting.^' The applicability of the learned intermediary doctrine

''Id.

^M98 F.2d 1264 (5th Cir. 1974).

''Id. at 1270.

''Id.

"Id.

"Id. at 1276.

""Id. at 1277.

"'Id.

'"Id.

''E.g., Givens v. Lederle, 556 F.2d 1341 (5th Cir. 1979); Williams v. Lederle Lab-

oratories, 591 F. Supp. 381 (S.D. Ohio 1984).



19861 ORAL CONTRACEPTIVES 623

underwent constant refinement in the area of immunizations until the

question most recently determinative of this issue was ** whether the drug

is commonly administered without individualized balancing by a physician
of the risks involved and the individual's needs and circumstances.""
However, such a test had never been applied to manufacturers of pre-
scription drugs outside the class of immunizations.

III. The Public's Demand for FDA Intervention in the Area of
Oral Contraceptives and the FDA's Response

While battles over the manufacturer's duty to warn the consumer

directly were waged on the immunization front, other segments of the

pharmaceutical industry were preparing to produce **The Pill."" G.D.

Searle & Company became the first manufacturer to receive FDA approval
for the marketing of an oral contraceptive, Enovid, in June, 1960.^'*

Almost immediately after Enovid hit the marketplace, the FDA began
receiving reports of increased incidence of thromboembolic disease in

patients ingesting this oral contraceptive.^^ Sparked by increasing concern

within the public sector, the FDA sponsored a committee to research
the link between the use of Enovid and thromboembolic disease. ^^ In

1963, this link was reported to be insignificant. ^^

In April, 1965, the FDA approved the marketing of two sequential
birth control pills, a development that significantly sped up the nation's

race to get on the pill.^^ By 1965, the estimated number of oral con-

traceptive users tallied over five million women.^^ The numbers of new

"Williams, 591 F. Supp. at 389 (S.D. Ohio 1984).
"The term, "The Pill," has been freely used in a generic sense in societal conversation

to denote oral contraceptives.

^''Hearings on Present Status of Competition in the Pharmaceutical Industry Before

the Subcomm. on Monopoly of the Senate Comm. on Small Business, 91st Cong., 2d
Sess., 6787 (1970) [hereinafter referred to as the Nelson Comm. Hearings].

-^Id. at 6787, 7235, 7237. Thromboembolic disease is a generic classification for the

occlusion or obstruction of a blood vessel by blood clots dislodged from a vein. Stedman's

Medical Dictionary 1295 (22d ed. 1972).
^Nelson Committee Hearings, supra note 54, at 6787.

''Id.

-""Id. Sequential birth control pills consist of 15 tablets containing estrogen, followed

by five tablets containing a proportioned mixture of estrogen and a progesterone; such

a regiment is thought to simulate a woman's natural cycle. Davis & Fuoo, Drugs of Choice
618 (1968-69). It should be noted that sequential birth control pills are currently not marketed

in the United States. 43 Fed. Reg. 4218 (1978). Oral contraceptives frequently prescribed

today contain low doses of both estrogen and progesterone (50 micrograms estrogen and

less than 1.5 miligrams progesterone); such low-dose oral contraceptives are purported to

be as effective and safer than earlier preparations. Lia, Clinical Pharmacology and Com-
mon Minor Side Effects of Oral Contraceptives, 24 Clinical Obstetrics and Gynecology
879 (1981). Langone, At Last, Good News About The Pill, Discover, Feb. 16, 1985, at 8.

"Nelson Comm. Hearings, supra note 54, at 6787. This number had increased by
150% by 1969. Id.



624 INDIANA LAW REVIEW [Vol. 19:615

prescriptions mounted daily as women were induced to demand the pill
by manufacturers' overzealous marketing^ and comforting articles ap-

pearing in widely-read women's periodicals.^' Although no federal funds

were directly allocated to study reported side effects,^^ the FDA did
establish an Advisory Committee on Obstetrics and Gynecology to con-

sider all of the available evidence and provide the FDA with adequate
scientific evidence relating to the connection between oral contraceptives

and health problems. Once again, the government committee found no
association between the pill and reported ill effects." The committee

did, however, make strong recommendations for measures aimed at
keeping a closer surveillance on reports of thromboembolic disease among
pill users, expanding studies on the laboratory level, encouraging uniform

labeling of oral contraceptives, and expediting approval of low dosage

products.^

By early 1968, the recommended surveillance system was implemented

and the FDA was receiving mounting reports of thromboembolic incidents
among pill users.^^ Almost simultaneously, British epidemiological re-
searchers published the results of a study, the Vessey report, in which

an undeniable link between oral contraceptives and thromboembolic

disease had surfaced.^ Specifically, the Vessey report indicated that

women using oral contraceptives required hospitalization for throm-
boembolic disease nine times more frequently than women who did not
use the pill.^^ In light of the concrete evidence presented in the Vessey

report, the FDA was compelled to issue its first warning of potential
adverse effects from oral contraceptives in June, 1968.^*

As the number of oral contraceptive users increased, so did the
number of deaths and permanent disabilities resulting from the pill's

"'Id. at 6788.

'''See, e.g., Hellman, Doctor's View of Birth Control Pills, Redbook, April, 1969,

at 132; Langmyhr, How Safe is the PUP., Parent's Magazine, Oct., 1967, at 58.
"^See Mintz, 'The Pill": An Alarming Report 53 (1969).
"'Id.

"^Id.

*"Id.

**'See Vessey and Doll, Investigation of Relation Between Use of Oral Contraceptives

and Thromboembolic Disease, British Med. J., Apr. 27, 1968, at 199 [hereinafter referred

to as the Vessey Report].

'''Id. at 205.

"^Nelson Comm. Hearings, supra note 54, at 7022. This initial warning took the
form of a "Dear Doctor" letter. Id. "Dear Doctor" letters are mass-produced form letters

published by either a drug manufacturer or the FDA. "Dear Doctor" letters have generally
been scorned as an ineffective means of communicating warnings relating to adverse effects

because their use has not been restricted to this purpose; rather, they are also frequently

used as promotional materials. As a result, "Dear Doctor" letters run the risk of being
deficient in giving an adequate warning. Note, Liability of Birth Control Pill Manufacturers,

23 Hastings L.J. 1526, 1536 (1972).



1986] ORAL CONTRACEPTIVES 625

ingestion. ^^ During the period of July 1 to December 31, 1969, the FDA
surveillance system documented fifteen fatalities and twenty-eight non-

fatal thromboembolic incidents unquestionably attributable to the pill.^*^

By the close of 1969, over three hundred lawsuits had been filed against

oral contraceptive manufacturers.^' Nevertheless, a Gallup poll conducted

in February, 1970, revealed startling results: two thirds of the women
surveyed had *' never been told about possible hazards by their physi-

cians.*'^^

Intensification of the public's concern about the risk associated with

the use of oral contraceptives induced Senator Gaylord Nelson to hold

public hearings on the use and hazards of birth control pills. ^^ Shocked

by the inadequacy of information being given to oral contraceptive users,

the FDA announced on the last day of the Nelson hearings that in the
future it would require oral contraceptive manufacturers to include a

uniform-content leaflet in each package of the product manufactured.
^"^

The primary purpose of the leaflets was "to recall to the patient her

discussion with the physician when she made her decision to begin taking
oral contraceptives."^^ Although the original proposed text of these

leaflets consisted of a detailed 600-word statement discussing the hazards

related to oral contraceptive use in lay language,^^ when these leaflets
reached the marketplace, they had been reduced to a 155-word warning

that mentioned only an increased incidence of bloodclotting among pill
users. ^^ Even so, this leaflet did represent the FDA's initial response to
the public's demand for more adequate direct information. In an effort
to provide consumers with expanded labeling information about recent

reports on the risk of blood clots, other problems of the circulatory

system, cancer, and effects on the unborn child associated with the use
of oral contraceptives, this original warning leaflet was replaced in 1978

""^See Nelson Comm. Hearings, supra note 54, at 6789.
™/d. Additional reports of deaths and injuries had been received, but the FDA could

not clearly identify their epidemiological origin. Id.

''See Note, Products Liability and the Pill, 19 Clev. St. L. Rev. 468 (1970). It

should be noted that all 300 actions arose from injuries caused by adverse reactions from

the pill. None of these suits had been brought on a theory of breach of warranty by
plaintiffs who had conceived unexpectedly while on the pill. Id.

'^Nelson Comm. Hearings, supra note 54, at 6628. The complete results of the poll
were reported in Poll on the Pill, Newsweek, Feb. 9, 1970, at 52.

^'The complete text of Senator Nelson's hearings regarding oral contraceptives are

documented as Hearings on Present Status of Competition in the Pharmaceutical Industry

Before the Subcomm. on Monopoly of the Senate Comm. on Small Business, 91st Cong.,
2d Sess., 5921-7324 (1970).

'^See Nelson Comm. Hearings, supra note 54, at 6800.
''Id.

''•For original proposed text of leaflets, see Nelson Comm. Hearings, supra note 54,
at 6800-01.

"21 C.F.R. § 130.45(d)(1) (1971).



626 INDIANA LAW REVIEW [Vol. 19:615

by the current patient package insert program.^^ Presently, the FDA
requires oral contraceptive manufacturers to provide users of the pill

with two types of informational materials: (1) a brief summary containing
essential information to be included in each package as it is dispensed

to each user,^^ and (2) a longer, more detailed labeling device to be

included in or dispensed with each package as it is distributed. *° In the

preamble to the 1978 replacement, the FDA Commissioner, Charles
Edwards, responded to manufacturers* concerns focusing on the immense

difficulty of preparing understandable direct patient warnings that would

be considered legally adequate, and the consequential potential for adverse

jury determinations on the issue of adequacy.^' Commissioner Edwards

adamantly stated that the federal regulation of warning labels enacted

in 1978 would have no adverse effect on the standard of civil tort liability

imposed on the oral contraceptive industry.*^ Rather, Edwards stated

that the liability of oral contraceptive manufacturers for their products*

adverse effects would continue to be determined on a case-by-case basis,

taking into consideration the applicable state negligence law, which could

be altered to reflect state approval or disapproval of federally-imple-

mented patient package insert programs.*^

IV. The Judiciary's Answer to Plaintiffs Injured by the
Ingestion of Oral Contraceptives

Amid court battles against the manufacturers of vaccines and con-
flicting signals by the FDA concerning a manufacturer's duty to warn
oral contraceptive users of their products' associated risks, several oral

contraceptive users filed suit for injuries sustained as a result of ingesting

'"/</. In 1974, the FDA withdrew 21 C.F.R. § 130.45 and replaced it in its renumbered
version, 21 C.F.R. § 310.501. The text of the warning leaflet was unaltered. However,

as previously noted, this leaflet warning was totally replaced by new text in 1978. Since

its original passage in 1978, this text of the patient package insert has remained virtually

unchanged.
^''21 C.F.R. § 310.501(a)(1). For specific requirements of information to be included

within the brief summary, see 21 C.F.R. § 310.501(a)(2). Generally, brief summary must

include information on the drug's effectiveness, contraindications for use, the serious side

effects of contraceptive use, and the most common side effects of contraceptive use.
'*"21 C.F.R. § 310.501(a)(1). For specific requirements of information to be included

within the detailed patient labeling, see 21 C.F.R. § 310.501(a)(3). Generally, the detailed

patient labeling must include the same types of information as the brief summary; however,

the text of this information is to be more extensive and specific.
"'43 Fed. Reg. 4214 (1978).

"Ve/. Edwards believed that improved warning programs would bring reduced risk

of liability "due to improved patient compliance with physician directions and self-

monitoring of adverse effects, and a corresponding decrease in drug-induced injury." 43

Fed. Reg. 4214 (1978).



19861 ORAL CONTRACEPTIVES 627

the pill.*'* For the most part, manufacturers were relieved of any liability;

the courts applied the learned intermediary doctrine and held that where

the manufacturer had adequately warned the physician, either directly

or indirectly, no common law duty to warn the consumer existed.*' Thus,
the primary issue rarely involved to whom a warning was owed, but
whether the warning given the physician had been adequate.*^ Then in

1985, three surprising cases were decided that completely disregarded the

doctrine of the learned intermediary in the area of oral contraceptives

and imposed a duty on the manufacturer to warn the ultimate consumer,

the patient, directly.*
87

A. MacDonald v. Ortho Pharmaceutical Corporation

In MacDonald v. Ortho Pharmaceutical Corporation,^^ the Massa-
chusetts Supreme Court reviewed the propriety of an action brought by
a plaintiff who suffered a stroke with resultant permanent disabilities
after ingesting Ortho*s product, Ortho-Novum, for a period spanning
at least three years. *^ Unquestionably, the plaintiff had received both

the brief summary and detailed warning pamphlet as dictated by FDA
regulations.^ Both materials referred to abnormal blood clotting as a

potential side effect of Ortho-Novum, yet neither contained the specific
word **stroke.'*^' Accordingly, the plaintiff testified that she had never

""Brochu V. Ortho Pharmaceutical Corp., 642 F.2d 652 (1st Cir. 1981); Lindsay v.

Ortho Pharmaceutical Corp., 637 F.2d 87 (2d Cir. 1980); Skill v. Martinez, 91 F.R.D. 498

(D.N.J. 1981), aff'd, dll F.2d 368 (3d Cir. 1982); Goodson v. Searle Laboratories, 471

F. Supp. 546 (D. Conn. 1978); Dunkin v. Syntex Laboratories, Inc., 443 F. Supp. 121

(W.D. Tenn. 1977); Chambers v. G.D. Searle & Company, 441 F. Supp. 377 (D. Md. 1975),
affd, 567 F.2d 269 (4th Cir. 1977); Hamilton v. Hardy, 37 Colo. App. 375, 549

P.2d 1099 (1976); Mahr v. G.D. Searle & Company, 390 N.E.2d 1214 (111. 1979); Ortho
Pharmaceutical Corp. v. Chapman, 388 N.E.2d 541 (Ind. Ct. App. 1979); Cobb v. Syntex
Laboratories, 444 So. 2d 203 (La. Ct. App. 1983); Leibowitz v. Ortho Pharmaceutical

Corp., 224 Pa. Super. 418, 307 A.2d 449 (1973).

'^^See cases cited at supra note 84. But see Lukaszewicz v. Ortho Pharmaceutical

Corp., 510 F. Supp. 961 (E.D. Wis. 1981) (court held that manufacturer had a duty to

warn patient directly but compliance with FDA regulations would satisfy such duty). Id.
at 965.

^"But see McEwen v. Ortho Pharmaceutical Corp., 270 Or. 375, 528 P.2d 522 (1974)
in which the court recognized the learned intermediary doctrine but extended the duty to

warn to encompass treating physicians as well as prescribing physicians.

*'See Odgers v. Ortho Pharmaceutical Corp., 609 F. Supp. 867 (E.D. Mich. 1985);

Stephens v. G.D. Searle & Company, 602 F. Supp. 379 (E.D. Mich. 1985); MacDonald
V. Ortho Pharmaceutical Corp., 394 Mass. 131, 475 N.E.2d 65, cert, denied, 106 S. Ct.

250 (1985).

"394 Mass. at 132, 475 N.E.2d at 66, cert, denied, 106 S. Ct. 250 (1985).

»'/cf. The action in MacDonald vi2iS actually brought by two plaintiffs, the injured

user and her husband. M. at 131, 475 N.E.2d at 65.
'^Id. at 132-33, 475 N.E.2d at 66-67.

"^^Id. at 133, 475 N.E.2d at 67. Ortho's detailed warning pamphlet did contain the

following passage:



628 INDIANA LAW REVIEW [Vol. 19:615

realized that abnormal blood clotting included the possibility of stroke.^^

In reversing the lower court's final disposition of the case,^^ the

Massachusetts Supreme Court openly abandoned the learned intermediary

rule in cases involving injuries caused by oral contraceptives and imposed

on the defendant-manufacturer a duty to warn the consumer directly.^"*

Explaining the reasoning underlying its decision, the MacDonald court
stated that oral contraceptives and the circumstances under which they

are frequently prescribed necessitate the revitalization of the common
law duty of a manufacturer of a dangerous product to warn the user

directly of potential adverse effects.^^ Specifically, the court noted that

oral contraceptives are drugs not taken out of medical necessity; rather,

oral contraceptives are drugs personally selected by the patient amid a

myriad of other available birth control plans.'' Because the consumer

plays a significantly more active role in deciding to use the pill, the

physician's role as a learned intermediary between manufacturer and

consumer becomes nearly non-existent. A prescription for oral contra-
ceptives is not the result of a physician's skilled balancing of individual

benefits and risks, but rather originates as a product of patient demand.^^

In addition, the MacDonald court emphasized that oral contraceptives
are frequently prescribed for protracted periods of eleven or twelve

months in which the patient may ingest numerous doses without re-
examination or direct supervision by the prescribing physician.^^ Such a

setting is unlikely to favor the formation of a strong patient-physician

relationship. Therefore, the consumer may develop multiple concerns
and questions relating to her oral contraceptive regimen without ever

having the opportunity to present these to the prescribing physician.^

Finally, the MacDonald court referred to federal regulations imposed
on the manufacturers of oral contraceptives to support implicitly the

About blood clots:

Blood clots occasionally form in the blood vessels of the legs and the pelvis of

apparently healthy people and may threaten life if the clots break loose and

then lodge in the lung or if they form in other vital organs, such as the brain.

Id. at 133 n.4, 475 N.E.2d at 67 n.4.

'''Id. at 134, 475 N.E.2d at 67.

"'Id. at 135, 475 N.E.2d at 68. At the trial court level, the jury found that Ortho

had adequately warned the plaintiff's physician of risks inherent in the use of Ortho-

Novum, but had failed to provide the plaintiff with sufficient information. The jury

reasoned that this insufficiency had proximately caused the plaintiff's injury and that the

defendant-manufacturer was liable for the resultant damages. However, the trial court

judge granted Ortho's motion for judgment notwithstanding the verdict, basing his decision

on the applicability of the learned intermediary doctrine. Id. at 135, 475 N.E.2d at 68.

•^Id. at 135, 138-39, 475 N.E.2d at 68, 70.

"'Id. at 137, 475 N.E.2d at 69.

""Id.

"'Id.

"'Id.

""Id.



1986J ORAL CONTRACEPTIVES 629

imposition of a common law duty to warn.'^ Inferrable from the court's
reiteration of factors leading to the FDA's implementation of a direct
patient warning program, '*'' the court reasoned that these same factors

readily justified a judicial abandonment of the learned intermediary

doctrine in civil cases dealing with oral contraceptives.'^^ In addition,

oral contraceptive manufacturers' nationwide compliance wth FDA reg-
ulations proved that direct information provided to the patient-user was

a feasible, economical means of disseminating warnings of potential

adverse effects. '^^ Given all these considerations, the MacDonald court
had little or no difficulty in holding that the defendant-manufacturer

bore a duty to warn the patient-consumer directly.'^

Having made this decision as to the scope of Ortho's duty to warn,

the MacDonald court next examined the adequacy of the warning Ortho
had supplied directly to the plaintiff in an attempt to comply with FDA
requirements.'^^ The text of the warning received by the plaintiff in both

the brief summary and more detailed warning pamphlet had been ex-
plicitly approved by the FDA.'^ However, the MacDonald court initially
cited Commissioner Edwards' statement in the preamble to the FDA's

1978 replacement of section 310.501 of Title 21 of the Code of Federal

Regulations for the proposition that **the boundaries of civil tort liability

for failure to warn are controlled by applicable State law," rather than

by FDA labeling requirements.'"^ The MacDonald court joined with the
majority of jurisdictions to hold that federally-based requirements have

'""/</. at 137-38, 475 N.E.2d at 69-70.

""M In particular, the MacDonald court cited 43 Fed. Reg. 4215 (1978), at which
the FDA stated the primary reasons for implementation of 21 C.F.R. § 310.501 as follows:

Because oral contraceptives are ordinarily taken electively by healthy women
who have available to them alternative methods of treatment, and because of
the relatively high incidence of serious illnesses associated with their use, . . .

users of these drugs should, without exception, be furnished with written in-

formation telling them of the drug's benefits and risks.

43 Fed. Reg. 4215 (1978). In addition, the MacDonald court cited 35 Fed. Reg. 9002

(1970), for the FDA's reasoning supporting its earlier regulations codified at 21 C.F.R.

§ 130.45. The FDA considered direct patient warnings necessary because the use of oral
contraceptives is "too complex to expect the patient to remember everything told her by

the physician," and, as a result, patient users need information "in an organized, com-

prehensive, understandable, and handy-for-future-reference form." 35 Fed. Reg. 9002

(1970).

•"^394 Mass. at 137-38, 475 N.E.2d at 70.

'"The impracticability of a manufacturer's providing warnings directly to the consumer

concerning adverse effects had frequently been given as an argument in favor of the

learned intermediary doctrine. See, e.g., sources cited at supra note 34.

""j94 Mass. at 137-38, 475 N.E.2d at 68, 70.

""M. at 139, 475 N.E.2d at 70.

""M. (citing 43 Fed. Reg. 4214 (1978)).



630 INDIANA LAW REVIEW [Vol. 19:615

no preemptive effect on state tort law.'°* Although compliance with FDA
standards could be offered as evidence of due care, the MacDonald
court distinctly noted that, in the absence of the learned intermediary

doctrine's applicability, the common law required that warnings of a
product's adverse effects be provided in a manner **comprehensible to
the average user and . . . convey[ing] a fair indication of the nature and

extent of the danger to the mind of a reasonably prudent person.'""' In
the opinion of the MacDonald court, the jury could reasonably have
found that the omission of the specific word **stroke" from FDA-
approved warning materials minimized the warning's impact to render

the warning inadequate for the average consumer."^

In summary, Ortho's liability for failing to warn the consumer-

patient directly resulted from the combined effect of two factors. First,

the MacDonald court decided to void the applicability of the learned
intermediary doctrine in cases dealing with injuries induced by oral

contraceptives. Second, the jury determined as lay persons that the FDA-
approved warning given directly to the plaintiff by Ortho was inadequate

under the rigors of state negligence doctrine.

B. Odgers v. Ortho Pharmaceutical Corporation

While the MacDonald action was progressing through the Massa-
chusetts state court system, two similar actions were just beginning in

the federal district court of Michigan.'" In Odgers v. Ortho Pharma-

ceutical Corporation, ^^^ the plaintiff allegedly suffered partial paralysis

as a result of a blood clot induced by her ingestion of Ortho-Novum,

a product of the defendant-manufacturer."^ The oral contraceptive man-

"•"Se^, e.g., Brochu v. Ortho Pharmaceutical Corp., 642 F.2d 652, 658 (1st Cir. 1981);

Hubbard-Hall Chem. Co. v. Silverman, 340 F.2d 402, 405 (1st Cir. 1965); Ferebee v.

Chevron Chem. Co., 552 F. Supp. 1293, 1304 (D.D.C. 1982), aff'd, 736 F.2d 1529 (D.C.

Cir. 1984), cert, denied, 105 S. Ct. 545 (1984); Skill v. Martinez, 91 F.R.D. 498, 508

(D.N.J. 1981), aff'd, 611 F.2d 368 (3d Cir. 1982); Wooderson v. Ortho Pharmaceutical

Corp., 235 Kan. 387, 409, 681 P.2d 1038, 1055, cert, denied, 105 S. Ct. 365 (1984);

McEwen v. Ortho Pharmaceutical Corp., 270 Or. 375, 386, 528 P.2d 522, 534 (1974);
Stevens v. Parke, Davis & Co., 9 Cal. 3d 51, 64, 507 P.2d 653, 661, 107 Cal. Rptr. 45,
53 (1973).

'•'•'394 Mass. at 140, 475 N.E.2d at 71 (quoting Ortho Pharmaceutical Corp. v.

Chapman, 180 Ind. App. 33, 49, 388 N.E.2d 541, 552 (1979)). In addition, the MacDonald
court felt very strongly that the sufficiency of any given warning is always a question

for the jury. 394 Mass. at 140, 475 N.E.2d at 71. As a result, the liability of an oral

contraceptive manufacturer based on failure to warn the consumer adequately remains

unknown until the final poll of the jury.
""394 Mass. at 141, 475 N.E.2d at 71-72.

'''See Odgers v. Ortho Pharmaceutical Corp., 609 F. Supp. 867, Stephens v. CD.
Searle &. Company, 602 F. Supp. 379.

"^609 F. Supp. 867 (E.D. Mich. 1985).

'"Id. at 868.



1986] ORAL CONTRACEPTIVES 631

ufacturer had provided the plaintiff's physician with package inserts.'"*

The plaintiff had received her prescription only after careful examination

by her physician"^ and receipt of a brief summary of adverse effects

and a warning pamphlet, both prepared by Ortho in accordance with

the applicable FDA regulations."^ Despite these measures, the plaintiff
maintained that Ortho had failed to warn her adequately of its product's

potential side effects."^ In opposition, the drug manufacturer contended

that it had more than fulfilled its duty of due care, relying on its

compliance with FDA regulations and the learned intermediary doctrine
for support."^

Following a verdict for the plaintiff, the trial court granted Ortho's

motion for a new trial on the ground that the jury had been improperly
instructed on the scope of Ortho's duty to warn"^ and certified a question

concerning Ortho's duty to the Michigan Supreme Court in In re Certified

Questions.^^^ However, the majority of the Michigan Supreme Court

refused to decide whether Ortho had a duty to warn the consumer

directly of the dangers associated with the use of of oral contraceptives.'^'

The majority in In re Certified Questions maintained that to render

any decision on the issue of Ortho's duty would require

a choice between different systems for allocating between man-

ufacturers, physicians, and pharmacists the duty to warn patients

of the risks and potential side effects associated with the use

of prescription drugs. . . . [A]ny decision of this Court implicates

the obligations of members of professions who are involved in

''*See In re Certified Questions, 419 Mich. 686. 694, 358 N.W.2d 873, 875, reh'g denied,

421 Mich. 1201 (1984). In re Certified Questions is cited here to provide facts not discussed

in Odgers, 609 F. Supp. 867.

"M19 Mich, at 694, 358 N.W.2d at 876.
'"•21 C.F.R. § 310.501. It should be noted that not only were the brief summary

and warning pamphlet FDA approved, but the text of the brief summary had been drafted
by the FDA. In re Certified Questions, 419 Mich, at 694, 358 N.W.2d at 875.

'''Odgers, 609 F. Supp. at 868.

""/of. at 869, 877.

'"Specifically, the trial judge had instructed the Odgers jury that "Ortho owed her
[the plaintiff] the duty of reasonable care in the preparation of the booklet [warning

pamphlet] accompanying the drug that, under federal regulations, Ortho was required to

distribute." In re Certified Questions, 419 Mich, at 694, 358 N.W.2d at 876. Because the
trial judge cited to Smith v. E.R. Squibb & Sons, Inc., 405 Mich. 79, 90, 273 N.W.2d
476, 484, in determining that the above instruction was improper, it appears that a correct

jury instruction in Odgers would have called upon the jury to determine whether the

warnings actually given were reasonably adequate, not whether the manufacturer acted

reasonably. See generally Smith v. E.R. Squibb & Sons, Inc., 405 Mich. 79, 90, 273
N.W.2d 476, 483-84 (Mich. 1979) (discussion of proper jury instruction in products liability
action based on breach of duty to warn).

'-"419 Mich. 686, 358 N.W.2d 873.
'^'Id. at 692, 698, 358 N.W.2d at 874, 877-78.



632 INDIANA LAW REVIEW [Vol. 19:615

the distribution of prescription drugs but not represented in these

proceedings.'"

In fact, the majority in In re Certified Questions stated that to determine

judicially the scope of Ortho's duty to warn would be to assume a

function best left to state legislative bodies. '^^

On the other hand, three dissenting justices in In re Certified Ques-
tions had no difficulty in imposing a duty on Ortho to warn the users

of oral contraceptives directly."^'* The dissent's reasoning focused on the

absence of any of those arguments commonly used to validate the learned
intermediary exception to the common law duty to warn in oral con-
traceptive cases'" because the drugs were used solely for nontherapeutic

purposes. The dissent initially noted that, unlike other prescription drug

users, oral contraceptive users generally do not rely on their physician's

skill, but demand to have the pill.'^^ Direct-to-the-consumer warnings,
therefore, are less likely to damper patient use of the contraceptive

because it is the patient who choses the medication.
In addition, the In re Certified Questions dissent noted, like the

McDonald court, that oral contraceptives are frequently prescribed on a
long-term basis without intermittent examination and evaluation by the

physician. '^^ Thus, the original goal of the learned intermediary doctrine,

the reduction of patient injuries via physician monitoring, '^^ is most

likely unachievable in the oral contraceptive industry. '^^ Finally, the

dissent noted that the FDA regulations requiring direct warnings undercut
the argument that it is impossible for drug manufacturers to give these

warnings to consumers. '^^ Thus, in the absence of any reason previously

used to validate the application of the learned intermediary doctrine,

the dissent would not have hesitated to impose a duty on pill producers

to warn consumers directly.'^'

'''Id. at 697-98, 358 N.W.2d at 877.

'^'Specifically, the In re Certified Questions majority stated:

The allocation of the duty to warn patients is a public policy question involving

the marketing system and economics of a major industry and the everyday

practice of an essential profession. We believe that the Legislature is in a better
position to allocate those duties.

419 Mich, at 691-92, 358 N.W.2d at 874.
'''Id. at 716, 358 N.W.2d at 886 (Boyle, J., dissenting).

'''Id. at 711, 358 N.W.2d at 884-85.

'""Id. at 711, 358 N.W.2d at 884. Succinctly, the dissent stated that "patient choice

plays a much more prominent role [in oral contraceptive use] than in the case of drugs

prescribed for the treatment of illness or injury. The role of patient choice in this process

supports the need for a direct patient warning. Id. at 712, 358 N.W.2d at 884,

'"Id. at 714, 358 N.W.2d at 885.
'^"Sterling Drug, Inc. v. Cornish, 370 F.2d at 82, 85 (8th Cir. 1966).

'"//7 re Certified Questions, 419 Mich, at 714, 358 N.W.2d at 885.

"''Id. at 714, 358 N.W.2d 885-86.

'"Id. at 716, 358 N.W.2d 886.



1986] ORAL CONTRACEPTIVES 633

The certification's result still left the federal judge in Odgers v.

Ortho Pharmaceutical Corporation without any concrete statement of

an oral contraceptive manufacturer's duty to warn under Michigan law.

However, after fully justifying the ability of a federal judge to elucidate

unsettled matters of state substantive law,'^^ the Odgers court inferred

from the Michigan Supreme Court's reluctance to apply the learned

intermediary doctrine to oral contraceptives that Ortho had a duty to

warn the consumer directly in the case of oral contraceptives used for

nontherapeutic purposes.'" In support of its decision, the trial court

drew from the rationale of the dissent in In re Certified Questions. ^^"^

The Odgers court reasoned that none of the customary arguments in-

voking the learned intermediary exception applied when the prescription
drug in question was an oral contraceptive used for contraceptive pur-

poses.
'^^

C. Stephens v. G.D. Searle & Company

In the second Michigan federal case, Stephens v. G.D. Searle &
Company, ^-^^ which was decided after the ruling in In re Certified Ques-

tions but before Odgers, a similar duty was imposed.'" The Stephens

court was asked to rule on the oral contraceptive manufacturer's motion

for summary judgment in an action brought by a plaintiff alleged to
have suffered a stroke as a result of her ingestion of the defendant's

product. ''* In denying Searle's motion for summary judgment, which had
been based both on a predicted application of the learned intermediary

doctrine'^^ and Searle's compliance with FDA regulations concerning

'"The ability of a federal judge to decide matters of state substantive law are beyond

the scope of this Note. See Odgers v. Ortho Pharmaceutical Corp., 609 F. Supp. at 869-

70.

'''Odgers, 609 F. Supp. at 878.

'"/</. at 870-78. Specifically, the Odgers court relied heavily upon the language of

MacDonald, citing at length from its text. Id. at 874-75. The Odgers court then noted

that the rationale of the dissent in In re Certified Questions closely paralleled that of

MacDonald in the reasons that were espoused for imposing a duty to warn the consumer
directly:

use attributed to consumer demand rather than physician's advice, use for

extended periods without medical assessment, and FDA regulations requiring
direct warnings to patients.

609 F. Supp. at 875. In addition, the Odgers court noted the In re Certified Questions

dissent's emphasis on the fact that "consumers of oral contraceptives are subjected to

much laudatory publicity attributable to the manufacturers and aimed directly at con-
sumers." Id.

'''Id. at 875.

'%02 F. Supp. 379 (E.D. Mich. 1985).
'"Id. at 381.

"'Id. at 380.

'"'Id.



634 INDIANA LAW REVIEW [Vol. 19:615

patient warnings,"**^ the Stephens court relied heavily on the dissenting

opinion of In re Certified Questions to impose a duty to warn the

consumer directly on the manufacturer when its product had been used
solely for contraceptive purposes."*' In addition, the Stephens court, like

the MacDonald court, held that compliance with FDA standards did
not conclusively determine the issue of warning adequacy, a question

which is exclusively a matter of state negligence law."*^

In summary, all three cases — MacDonald, Ogders, and Stephens
— held that the doctrine of the learned intermediary simply is not
applicable to the distribution of the pill, at least in cases in which oral

contraceptives are used solely for contraceptive purposes. The basis of

these decisions rests primarily on the particular characteristics attendant

to the distribution and ingestion of the pill. Oral contraceptives are

readily chosen by healthy normal women, frequently as a result of product
advertising rather than reliance on the advice of their personal physician.

In addition, oral contraceptives are most often prescribed for significant

portions of a woman's childbearing years and ingested daily with only

intermittent, if any, medical supervision and assessment of the user's

condition. These two factors, combined with the apparent feasibility of

direct warnings as evidenced by the manufacturers' compliance with FDA
regulations, induced the courts to impose on the oral contraceptive

manufacturer a duty to warn the patient-consumer directly. Once such

a duty was found, the courts then applied the negligence law of their

particular jurisdiction and allowed the jury to determine whether the

manufacturer in question had met its duty. Thus, McDonald and its
progeny unquestionably unleashed a theory of liability to be used against

the prescription drug industry: a new duty to warn, the adequacy of
which can never be predicted until after the damage is done.

V. The Ramifications of MacDonald and Its Progeny: An Era of
Unpredictability, Unlimited Liability, and Unavailability?

For a short period in the development of products liability law, the

learned intermediary doctrine stood unquestioned as an exception to the

common law duty of every manufacturer to warn a product's user of
dangers inherent to its use."*^ Shortly thereafter, Davis^^ and Reyes^^^

created limitations on this doctrine that somewhat undermined its vitality.

Today MacDonald, Stephens, and Odgers appear to reject completely

'"7flf. at 382.

'*'Id. at 381.

'''Id. at 382.

'*^See supra note 20.

'''Davis, 399 F.2d at 131.
'^'498 F.2d at 1277.



1986] ORAL CONTRACEPTIVES 635

the application of the learned intermediary doctrine in oral contraceptive

cases by imposing a common law duty to warn the consumer directly.
This revitalization of a common law duty to warn the consumer and
the policies behind it bear serious ramifications for both society and the

pharmaceutical industry in terms of unpredictability, unlimited liability,

unavailability. The logical existence of these unpleasant ramifications is

readily supported by analogy to the initial limitation of the learned

intermediary doctrine in mass immunization cases and its resultant effect

on the vaccine sector of the drug industry. As originally espoused by
Davis and Reyes, the court-created limitations on the learned intermediary

doctrine applied only where vaccines, which are prescription drugs, were

'*not dispensed as such,""^ that is, where vaccines were administered

in mass immunization settings. Subsequently, the vaccine manufacturer's,

duty to warn the consumer directly was extended to encompass virtually

all immunization situations including those in which the manufacturer's

product was administered in a private physician's office."*^

Once the duty to provide direct warnings to consumers became firmly
entrenched as the rule in vaccine-related litigation, judicial focus then

turned to the adequacy of the manufacturer's warning. In almost every

case, the warning given the patient-consumer was determined to be

inadequate because the fact situation of the case allowed a jury to

**reasonably" find, under applicable state negligence law, that the man-
ufacturer's warning had not sufficiently alerted vaccinees of potential

risks."*" In the face of mounting liability based on inadequacy of warning

and other theories of liability,''*^ manufacturers producing diphtheria-

pertussis-tetanus (DPT) vaccines which bear inherent, but rare, serious
side effects are opting out of the marketplace or threatening to do so,

absent government intervention.'^^

DPT is a vaccine which is given to nearly every American child '^'

to combat three serious childhood diseases,'" yet it is estimated that

'''-Davis, 399 F.2d at 131.

'''See Givens v. Lederle, 556 F.2d 1341 (5th Cir. 1979); Williams v. Lederle Labo-

ratories, 591 F. Supp. 381 (S.D. Ohio 1984).

'''See Ezagui v. Dow Chemical Corp., 598 F.2d 727, 736 (2d Cir. 1979); Givens v.
Lederle, 556 F.2d at 1345.

""^Prevalent theories of liability in immunization cases frequently involve allegations

of failure to manufacture an optimum vaccine or failure to manufacture a vaccine which

is as safe as a competitor's product. See, e.g., Tomer v. Lederle Laboratories (No. 84-

3906, S.D. Idaho 1984), discussed in Nat'l L.J., Apr. 1, 1985, at 26, col. 2; Tom v. Wyeth
Laboratories (No. 82 L 17548, N.D. lUinois 1983), discussed in Nat'l L.J., Apr. 1, 1985,

at 27, col. 1.

'"Nat'l L.J., Apr. 1, 1985, at 27, col. 2.

'"Currently, 41 states require that every child be immunized with DPT vaccines prior
to entering school. Nat'l L.J., Apr. 1, 1985, at 1, col. 3.

'"DPT vaccines protect against diphtheria, pertussis ("whooping cough") and tetanus

("lock jaw").



636 INDIANA LAW REVIEW [Vol. 19:615

one child out of every 310,000 vaccinees will suffer serious injury, such

as brain damage.'" As a result of these injuries, nearly 150 lawsuits are

already on file against DPT producers, although defendant-manufacturers
claim that the vaccine is **as safe as medical science can make it.'"^"*

Following the vaccine's introduction into the marketplace, nearly a

dozen companies produced the vaccine, yet this number dwindled to

three in 1984 and one in 1985.'" The factor cited most often for

production withdrawal was the cost of defending DPT litigation. '^^ Today,
Lederle Laboratories remains as the sole producer of DPT vaccines.'"
However, even its days of production may be numbered. DPT-related
lawsuits currently pending against Lederle bear dollar demands amounting

to a sum two hundred times greater than Lederle* s gross sales of the
product in 1983.'^^ In an effort to continue supplying DPT, Lederle
urged Congress to pass legislation that would insulate it from the harsh

liability demands of plaintiffs injured by a vaccine, allegedly incapable

of safer production. '^^ Such legislation, however, has been slow to de-

velop. Time alone will determine whether an immunity program is passed

prior to Lederle's withdrawal from the marketplace. Although it may
be difficult to summon much sympathy for the liability woes of a multi-
million dollar pharmaceutical company whose product undeniably causes
injury, problems of the producer ultimately translate into problems for

the consumer. The increasing liability of DPT manufacturers and their
resultant withdrawal from production has led to an obvious decrease in

the availability of DPT vaccine materials.'^ In fact, the shortage of
these products resulted in an unprecedented request from the Centers for

Disease Control in Atlanta: **a request for physicians and other health

care providers to delay giving DPT booster shots in order to insure a
sufficient supply of the vaccine to immunize infants from these highly

contagious diseases.'*'^' In economic response to decreased supply, the

cost of DPT vaccines skyrocketed. In 1983, the average cost of a single

'"Nat'l L.J., Apr. .1, 1985, at 1, col. 3.

'''Id.

'''Id. at 27, col. 2.

"''Id.

'''Id.

'"Id.

'"The National Childhood Vaccine-Injury Compensation Act was introduced in the

Senate, but it never progressed beyond the hearing stage. Such legislation would establish

a "no-fault, national program to compensate children who are injured by a childhood
vaccine. S. 827, 99th Cong., 1st Sess., 131 Cong. Rec. S3844. Lederle is also in the

process of drafting a compensation program, but Lederle' s proposed program would be

privately funded. Nat'l L.J., Apr. 1, 1985, at 27, col. 3.

'^'See Notice, Diphtheria-Tetanus-Pertussis Vaccine Shortage, 34 Morbidity and Mor-
tality Weekly Report 103 (1985). See also 131 Cong. Rec. S3844 (daily ed. Apr. 2,
1985).

"•'S. 827, 99th Cong., 1st Sess., 131 Cong. Rec. S3844.



19861 ORAL CONTRACEPTIVES 637

dose was eleven cents; in April, 1985, the same dose cost $2.80.'^^

Decreased supply plus increased cost equals an increased incidence of

pertussis for the public in general. The number of reported cases of
pertussis, more commonly known as **whooping cough," increased by
nearly thirty-three percent between 1982 and 1983.'" Of these documented
cases, sixty-six percent of the children under six years old affected had

not received the full complement of three doses required to immunize

completely against the disease.'^ Given the current state of DPT vaccine
production, these numbers are likely to rise in the future. Thus, what

started as a judicial attempt to provide compensation for injury sustained

by a limited group of plaintiffs has actually acted to the detriment of

society as a whole, a detriment resulting from unavailability, increased

cost, and increased disease.

A similar result in the area of oral contraception is not beyond
imagination or logic. Just as Davis and Reyes opened a whole new
avenue of liability for the manufacturers of vaccines, MacDonald
and its progeny created a new theory of liability to be wielded against
the producers of the pill: the failure to warn the patient-consumer

directly and adequately. Given the ability of oral contraceptive manu-

facturers to comply with FDA warning regulations and given the fact
that direct patient warnings do enhance patient compliance, '^^ the im-

position of a duty to warn the patient-consumer is neither impractical

nor unbeneficial from the standpoint of both manufacturer and consumer.

However, the resolution of the adequacy issue on a case-by-case basis

must seriously be questioned, for it will inevitably lead the producers

of the pill down the well-trodden path once traveled by the manufacturers
of DPT vaccines. The courts' general denial of the determinative effect
of compliance with FDA patient package insert regulations may well
coincide with similar rulings in other areas of products liability law,'^^

yet it leaves the oral contraceptive manufacturer with no predictable

basis of liability. The adequacy of any given warning, even those approved

"•The total number of pertussis cases reported in 1982 was 1,895, while 2,463 cases

were reported in 1983. Current Trends, Pertussis-United States, 1982 and 1983, 33 Mor-

bidity AND Mortality Weekly Report 573 (1984).
"^/c^. Those cases reported for the age group of six years and under comprised

approximately 82<^o of all reported cases. Id. at 573-74.

^''^See generally The Meaning of Medications: Another Look at Compliance, 20 Soc.
Sci. Med. 29 (1985).

"*See, e.g., Howard v. McCrory Corp., 601 F.2d 133 (4th Cir. 1979) (flammability
of children's attire); LaGorga v. Kroger Co., 275 F. Supp. 373 (W.D. Pa. 1967), af/'d,
407 F.2d 671 (3d Cir. 1969) (flammability of children's attire); Buccery v. General Motors

Corp., 60 Cal. App. 3d 676, 132 Cal. Rptr. 605 (1976) (lack of headrest on vehicle);

Rumsey v. Freeway Manor Minimax, 423 S.W.2d 387 (Tex. Civ. App. 1968) (failure to
warn of absence of antidote to pesticides).



638 INDIANA LAW REVIEW [Vol. 19:615

by the FDA, will never be settled until after a user is injured and a
jury returns a verdict. The thought that a manufacturer will **know

better the next time'* can hardly be considered solace to either plaintiff

or defendant. Perhaps if one uniform, adequate set of warnings had

been available and complied with, both injury and liability could have

been avoided. The marketplace effect of this expanded manufacturer

liability on the oral contraceptive consumer is uncertain. Given both the

pill's widespread use'^^ and its presumably wide profit margin, oral

contraceptive manufacturers may well be able to weather the threatening
storm of increased liability. However, it is equally plausible that smaller

oral contraceptive manufacturers or the manufacturers of contraceptives

holding only a small percentage of the marketshare will simply close

shop rather than bear the risk of making large capital investments to

meet enhanced warning requirements, only to find out later that such

attempts were in vain within a particular jurisdiction. At the very least,

it is likely that oral contraceptive manufacturers may distribute their
products selectively rather than nationally in the future. Pill producers

may readily distribute their product in areas of previously **jury-estab-
lished" law or in jurisdictions that recognize the exculpatory effect of

compliance with FDA patient package insert regulations.'^* Yet those
same producers may simply refuse to distribute the pill in areas where
the law is "in flux'* or consistently ** anti-manufacturer." Thus, to-

morrow's population of American women may well face a scarcity of
oral contraceptives of the proportion currently being realized among
potential DPT vaccinees. Increased costs predictably accompany decreased
supply. Increased costs, in turn, may place oral contraceptives, once
heralded as the future of birth control, '^^ beyond the reach of poorer

segments of the American population and off the shelves of free university

facilities and federally-funded public clinics. Unavailability inevitably

leads to rising birth rates. In the litigation arena, the holdings of

MacDonald and its progeny bear a perversion for potential plaintiffs.
Jurisdiction-by-jurisdiction, jury determination of direct warning ade-

quacy will invariably lead to forum shopping on the part of injured pill
users. Current nationwide distribution of oral contraceptives by major

manufacturers subjects such producers to in personam jurisdiction na-

"^It is currently estimated that 10 million-plus women currently choose oral contra-
ceptives as their means of birth control. Lia, Clinical Pharmacology of Common Minor
Side Effects of Oral Contraceptives, 24 Clinical Obstetrics and Gynecology 879 (1981).

"*See 21 C.F.R. § 310.501 (1985). For a court's recognition of the general exculpatory

effect of FDA compliance, see Lukaszewicz v. Ortho Pharmaceutical Corp., 510 F. Supp.
961 (E.D. Wis. 1981).

^^'*See generally Brown, Nothing Will Affect Our Lives More, The Evening Bulletin,
Dec. 28. 1971, at 41, col. 7.



1986] ORAL CONTRACEPTIVES 639

tionwide.'^^ Thus, potential diversity plaintiffs could pick and chose

between federal jurisdictions to select one where relevant choice of law

leads to precedential jury-determinations most favorable to the circum-

stances surrounding their injury.

Having reflected upon the pitfalls resulting from the determination

of a given warning's adequacy by a jury, the issue becomes whether

the adequacy of a manufacturer's direct patient warning can ever be

effectively dictated by state negligence law as espoused by all three recent

oral contraceptive decisions. The question is likely to be answered in
the negative. The urgent need for uniform standards determining the
adequacy of oral contraceptive warnings transcends current state capa-

bilities. Possible state-based solutions to this need could focus on the

passage of legislation or codes by standing state legislatures or specially-

created commissions. However, three problems with such plans come
immediately to mind. The first of these drawbacks, cost, might appear
trivial, but the added cost of creating such standards is a burden which

must be borne by someone, most Hkely every taxpayer of a jurisdiction.

Second, one must question the wisdom of placing the dehcate task of
determining the adequacy of a warning describing the use and potential

side effects of oral contraceptives in the hands of a state political machine,

most members of which probably having little medical training and/or

exposure to the pill. Last, and most importantly, the determination of

patient-direct warning standards by state legislative or administrative

bodies may lend predictability to oral contraceptive manufacturers' li-
ability but would still result in a varying set of standards'^' which may
ultimately prove uneconomical and unpalatable to oral contraceptive

manufacturers. Assuming that every state jurisdiction immediately enacted

oral contraceptive patient warning standards, such a system could con-

ceivably leave pill producers facing compliance with fifty similar, but

distinguishable, standards. Compliance would entail the printing and

stocking of fifty state-dictated warning devices in addition to the brief

summaries and warning pamphlets currently mandated by FDA regu-
lations.'^^ Also, manufacturers would be confronted with increased prob-

""See Keeton v. Hustler Magazine, Inc., 465 U.S. 770 (1984), where the United States

Supreme Court stated:

[TJhe victim . . . may choose to bring suit in any forum with which the defendant
has "certain minimum contacts . . . such that the maintenance of the suit does
not offend 'traditional notions of fair play and substantial justice.'

"

Id. at 780-81 (quoting International Shoe Co. v. Washington, 326 U.S. 310, 316 (1945)).

'^'In the area of product safety, laws promulgated at the state and local level have

been described as a "hodge-podge of tragedy-inspired responses" and all generally char-

acterized by "narrow scope, diffuse jurisdiction, miniscule budgets, absence of enforcement,

mild sanctions, and casual administration." See Final Report, National Commission on

Product Safety 2, 81-88 (1970).
"^21 C.F.R. § 310.501 (1985).



640 INDIANA LAW REVIEW [Vol. 19:615

lems in product packaging and inventory control; a state-varied warning

system would demand considerable effort to make certain **the right
lots with the right warnings got to the right state/' Finally, as actions

premised on failure to warn adequately arose, as they inevitably would,

nationwide distributors would be faced with the costly task of tailoring

a defense viable within a given jurisdiction. Such complexity might lead

to the selective distribution of oral contraceptives or withdrawal from

the marketplace by pill producers. Practical, predictable state-based res-

olutions to the adequacy issue are non-existent. Consequently, renewed

reliance on uniform FDA regulations detailing the scope and extent of
direct patient warnings required of oral contraceptive manufacturers

surfaces as the best, though judicially-refused solution. It may well be
that current FDA mandates '^^ do not result in warnings which '*make
the nature of the risk reasonably comprehensible to the average con-

sumer. '"^"^ Yet such a faiUng warrants a revamping of the standards,

not a total disregard of their existence. The solution to the inadequacy

problem lies in the careful, thorough revision of section 310.501 of

Title 21 of the Code of Federal Regulations based on the input of
consumers, health care providers, and manufacturers alike, not its jux-

taposition by unpredictable state determinations. This realization, how-

ever, places an ethical burden on all parties involved. For the FDA,
necessary revision of current regulations requires the agency to remain

open and responsive to the demands and comprehension of the public

at large rather than the purse strings of expansive pharmaceutical con-

glomerates. Likewise, for oral contraceptive manufacturers, a call for

federal revamping of warning regulations necessitates a more brass-tacks
approach to the adequacy problem. In the future, manufacturers must

make a concerted effort to review the nature and extent of danger
conveyed by a brief summary or a warning pamphlet from the eyes of
a typical consumer. A stroke must be called a stroke, rather than
*

'abnormal blood clotting which can be fatal. '''^^ However, the greatest

burden will be borne by patient-consumers and health care providers.

This burden requires an awareness of current oral contraceptive warning

regulations, an assessment of the meaning and adequacy of them, and

the revelation of needed revisions to those who can effect changes:
manufacturers, consumer lobbyists, and the FDA itself. Finally, the
determination of inadequate warning cases based on revamped federal

'''Id.

''*MacDonald, 394 Mass. at 140, 475 N.E.2d at 71-72.

'"/c^. at 141, 475 N.E.2d at 71. It should be noted that subsequent to the events

surrounding the MacDonald case, the FDA did amend its warning requirements to include
specific reference to the word stroke. 394 Mass. at 134 n.6, 475 N.E.2d at 67 n.6 (citing

43 Fed. Reg. 4221 (1978)).



1986] ORAL CONTRACEPTIVES 641

regulations will impose a burden on the judiciary. Barring a clear Congres-

sional intent to preempt in the area of direct patient warnings federally,

federal and state judges must recognize that revised FDA standards
represent the ultimate product of consumer demands and medical/man-

ufacturing expertise and, as such, must be considered determinative of

the adequacy issue. Even the most comprehensive attempt to revamp

FDA warning standards based on consumer demand and understanding
will be thwarted unless judges accept compliance with such standards

as conclusive on the adequacy issue.

Undoubtedly changes in oral contraceptive warning regulations at
the federal level will be costly in terms of time, effort, and monetary

expenditures. In addition, some injured patient-users may be left without
compensation if the adequacy of a given patient warning is determined

against an evolving federal standard. Yet, when these costs are evaluated
against those potentially resulting from the courts' resolution of the

adequacy issue on a jurisdiction-by-jurisdiction poll of the jury basis,

risks of unpredictability, unlimited liability, and unavailability make a
federal regulation system the most economical and practical solution to

the warning problem.

VI. A Brief Look to the Future

The potential effect of MacDonald and its progeny on the prescription
drug industry in general is uncertain in light of the limited precedential

sphere of the courts in which those decisions were rendered. MacDonald
is the product of the supreme court of a single state, Massachusetts,

while Odgers and Stephens were both decided by a federal district court

interpreting the negligence law of Michigan alone. In addition, both

Odgers and Stephens appear to be self-limiting, imposing a duty to warn

the oral contraceptive user directly only where the pill is used for non-

therapeutic purposes.

MacDonald, Stephens, and Odgers do, however, represent a judicial
reaffirmation of the common law duty to warn a product's user directly.
Refusing to apply the learned intermediary doctrine, all three courts

emphasized the lack of individualized medical assessment of a prescription

drug's risks/benefits in reaching their ultimate decisions to impose a

duty to warn the oral contraceptive user directly. This same reasoning

was previously applied in the mass immunization cases, which emphasized

the increasing role of the patient in the drug choice. Certain societal

factors in America today forewarn that future courts may determine
that other prescription drugs warrant the imposition of a similar duty

on manufacturers of additional drug classes. Initially, it should be noted

that the American public is **trending-away" from the type of one-on-

one patient-physician relationship that was prevalent at the inception of



642 INDIANA LAW REVIEW [Vol. 19:615

the learned intermediary doctrine."^* Induced by life's fast pace and

mobility, the modern patient no longer places his complete reliance and

medical fate in the hands of one multi-talented, fatherly, family physician.

Instead, America appears to be buying its health care from a stock

selection of **fast-food'* medicine served up at walk-in medical facilities. '^^

A growing number of the population are procuring their prescriptions
from medical personnel manning locally-based emergency clinics, health

maintenance organizations, and university and employment health fa-

cilities.'^* In all of these situations, the physician is likely to be seen on

a chance basis and may well serve only as a figurehead to services
provided by nurses and other technical assistants. Thus, it is questionable

whether the modern patient establishes the type of patient-physician

relationship envisioned by the creators of the learned intermediary doc-

trine.

In addition, diet and exercise are being increasingly realized as

valuable in the treatment of common diseases. '^^ As diet and exercise
programs continue to develop, they may eventually displace to some
extent medication as standard treatment. In the future, an individual

ingesting a prescription drug might truly be doing so of his own reasoned
choice because alternative diet and exercise regimens are unsuitable for

his lifestyle. This situation is readily analogous to a woman's choice of
the pill among various other forms of birth control and could conse-
quently induce additional limitations on the learned intermediary doctrine.

Finally, increased feasibility of direct patient warnings is certain to

augment the growing list of prescription drugs requiring such information.

In the era which spawned the learned intermediary doctrine, prescription

drugs were most frequently shipped in bulk or as raw ingredients to be

counted out or compounded by the local pharmacist. '*° Today, however,
medication comes prepacked and sealed.'*' Thus, any warning label

'^"•See generally Katz, Free-Standing Treatment Centers, Postgraduate Med., Aug.,

1983, at 291.

'""Fast-food" medicine has generally been defined as the type of service a patient

receives at free-standing emergency clinics, ambulatory surgery clinics, and birthing centers.

Id. at 291. Basically, such a label denotes medical service received at facilities on a walk-

in, first-come-first-served basis.

""See Katz, Free-Standing Treatment Centers, Postgraduate Med., Aug., 1983, at

291; Mestarz, HMO's Contracting with EEC's, Hosp., July, 1984, at 36.
"'See, e.g., Harbcom, Therapeutic Value of Graded Aerobic Exercise Training in

Rheumatoid Arthritis, 28 Arthritis And Rheumatism 32 (1985); Diet and 20-Year Mortality
Rates in Coronary Heart Disease, 312 New Eng. J. Med. 811 (1985).

'""Parker and Kilsoonk, Drug Distribution: A Recap and Future Trends, 1 Topics
IN Hospital Pharmacy Management 47, 49 (1981); The Burger Opinion: What Pharmacists
Had to Say, NS16 Journal of American Pharmaceutical Association 492 (Sept., 1976);
Viewpoint: Hospital Pharmacy's Changing Roles, 1 Topics in Hospital Pharmacy Man-

agement 87, 88 (1981).
'•"Parker and Kilsoonk, Drug Distribution: a Recap and Future Trends, 1 Topics

AND Hospital Pharmacy Management 47, 49 (1981).



1986] ORAL CONTRACEPTIVES 643

affixed to the manufacturer's container could undoubtedly reach the

product's ultimate consumer, the patient. '^^ Such a deviation in distri-

bution from that prevalent at the onset of the learned intermediary

doctrine essentially eliminates one primary argument proffered in its

favor: the general impractibility of requiring direct patient warnings.

Thus, as new developments alter the complexion of medical care and
pharmaceutical distribution, society's expectations of and dependence on

the physician as learned intermediary are diminishing with a predictable

concomitant increase of judicial limitations on the doctrine, once created

to protect this almost sacrosanct patient-physician relationship. If such

limitations are accompanied in the future by a judicial rehance on state

negligence law as the determinative factor in deciding the adequacy of

a given direct patient warning, that development is likely to lead to

problems currently occurring in the vaccine industry: unpredictability

and unlimited liability for the manufacturer with resultant unavailability

for the consumer.

VII. Conclusion

The holdings of MacDonald, Stephens, and Odgers can generally be
divided into two components. First, the manufacturer of oral contraceptives

has a duty to warn the patient-consumer directly of risks inherent in

the use of its product. Second, compliance with FDA patient package
insert regulations is not determinative of a manufacturer's liability for

failure to warn adequately. Determination of adequacy is to be left to

the jury and based on concepts of state negligence law. The first of

these components, the imposition of a duty to warn the consumer directly,

represents a refusal to apply the doctrine of the learned intermediary,

which would impose on the prescription drug manufacturer a duty to

warn the consumer's physician only. Those reasons espoused by MacDonald
and its progeny, namely the enhanced role of the healthy user in the

choice of the pill, with a consequential reduction of the physician's role

as learned intermediary, and the common practice of prescribing the pill
for protracted periods of time, call for the revitalization of a common
law duty to warn the user directly. In this era of increased public

knowledge and concern regarding health, the imposition of a direct

patient warning is to be applauded. In addition, certain societal factors

forewarn that future courts may determine that other prescription drugs
warrant additional limitations to the learned intermediary doctrine. In-

deed, limitations may eventually swallow the rule, making the learned
intermediary doctrine an artifact of only historical interest.

The second component of the holding of MacDonald and its progeny,
the courts' refusal to determine a warning's adequacy based on com-

'"^See Perez, New Look to Prescription Drug Labeling, Am. Pharmacy, Feb., 1981,
at 39.



644 INDIANA LAW REVIEW [Vol. 19:615

piiance with FDA regulations, must be seriously questioned. The judi-
cially-espoused alternative requires determination of the warning's adequacy

based upon a jury's interpretation of applicable state negligence law.

Such a holding will lead to unpredictable and unlimited liability for the

manufacturers of oral contraceptives and other prescription drug man-
ufacturers if additional limitations on the learned intermediary doctrine

are pronounced in the future. Consequently, pill producers and others

may counter with selective distribution or withdrawal from the mar-
ketplace, actions which ultimately result in unavailability and increased

costs for the patient-consumer. A better solution would be to work
within the pre-existing regulatory framework, the FDA, to produce more
comprehensible, patient-oriented warnings for oral contraceptives.

Victoria J. Kincke