SARAY PEREZ, CHERYL BAILEY, KIMBERLY BARTLETT, ANNA CESAREO AND SORAYA
ARIAS, PLAINTIFFS-APPELLANTS, v. WYETH LABORATORIES INC., A SUBSIDIARY OF
AMERICAN HOME PRODUCTS CORPORATION; AMERICAN HOME PRODUCTS CORPORATION;
WYETH-AYERST LABORATORIES DIVISION OF AMERICAN HOME PRODUCTS CORPORATION;
WYETH-AYERST INTERNATIONAL INC.; WYETH-AYERST LABORATORIES COMPANY AND DOW
CORNING FRANCE, S.A., DEFENDANTS-RESPONDENTS.
A-16 September Term 1998
SUPREME COURT OF NEW JERSEY
161 N.J. 1; 734 A.2d 1245; 1999 N.J.
LEXIS 1000; CCH Prod. Liab. Rep. P15,809
March 2, 1999, Argued
August 9, 1999, DecidedPRIOR HISTORY:
[***1] On certification to the Superior Court, Appellate
Division, whose opinion is reported at 313 N.J. Super. 511, 713 A.2d 520
(This syllabus is not part of
the opinion of the Court. It has been prepared by the Office of the Clerk for
the convenience of the reader. It has been neither reviewed nor approved by the
Supreme Court. Please note that, in the interests of brevity, portions of any
opinion may not have been summarized). Saray Perez, et al. v. Wyeth Laboratories, Inc., et al.
Argued March 2, 1999 -- Decided August
9, 1999 O'HERN, J., writing for a majority
of the Court.
This appeal concerns Norplant,
a Food and Drug Administration (FDA)-approved, reversible contraceptive that
prevents pregnancy for up to five years.
Norplant contraceptive employs six thin, flexible, closed capsules that contain
a synthetic hormone, levonorgestrel. The capsules are implanted under the skin
of a woman's upper arm during an in-office surgical procedure characterized by
the manufacturer as minor. A low, continuous dosage [***2] of the
hormone diffuses through the capsule walls and into the woman's bloodstream.
Removal occurs during an in-office procedure, similar to the insertion
Wyeth began a massive advertising
campaign for Norplant in 1991, which it directed at women rather than at their
doctors. Wyeth advertised on television and in women's magazines, such as
, and Cosmopolitan
. None of the
advertisements warned of any dangers or side effects associated with Norplant,
but rather praised its convenience and simplicity. Wyeth also sent a letter to
physicians advising that it was about to launch a national advertising program
in magazines that the physicians' patients may read.
In 1995, several women began to file lawsuits in various New Jersey
counties claiming injuries that resulted from their use of Norplant. Their
principal claim was that Wyeth, distributors of Norplant in the United States,
failed to warn adequately about the side effects associated with the
contraceptive, including weight gain, headaches, dizziness, nausea, diarrhea,
acne, vomiting, fatigue, facial hair growth, numbness in the arms and legs,
irregular menstruation, hair loss, leg [***3] cramps, anxiety and
nervousness, vision problems, anemia, mood swings and depression, high blood
pressure, and removal complications that resulted in scarring.
Class action certification was denied and all New
Jersey cases involving Norplant were consolidated in Middlesex County. Following
a case management conference, Perez's counsel sought a determination of whether
the "learned intermediary" doctrine applied. The "learned intermediary" doctrine
generally relieves a pharmaceutical manufacturer of an independent duty to warn
the ultimate user of prescription drugs, so long as it has supplied the
physician with information about a drug's dangerous propensities. Five
representative plaintiffs, including Perez, were selected to challenge Wyeth's
motion for summary judgment concerning the "learned intermediary" doctrine.
Subsequently, the trial court dismissed those plaintiffs' complaints, concluding
that even when a manufacturer advertises directly to the public, and a woman is
influenced by the advertising campaign, a physician nevertheless retains the
duty to weigh the benefits and risks associated with a drug before deciding
whether the drug is appropriate for the patient. Thus, [***4] the
trial court held the "learned intermediary" doctrine applicable to plaintiffs'
The trial court was not concerned with
the effect that a warning had on the consumer plaintiffs because the Products
Liability Act, N.J.S.A.
2A:58C-1 to -11, measures the adequacy of a
warning based on the knowledge and characteristics of the health-care provider
and not the ultimate consumer. The trial court further found that Perez and the
other representative plaintiffs had failed to provide expert testimony to rebut
the statutory presumption under the Products Liability Act that the
manufacturer's warning is adequate when it has been approved by the FDA.
Finally, the trial court determined that Perez failed to establish that her
injuries were proximately caused by any failure on the manufacturer's part.
On appeal, Perez and the other representative
plaintiffs challenged the trial court's failure to hear expert testimony on the
adequacy of the warnings and the decision concerning proximate cause,
maintaining that "it [had been] specifically agreed that the production of
expert testimony would await the outcome of the decision on the issue of the
learned intermediary doctrine. [***5] " The Appellate Division
affirmed the trial court's grant of summary judgment and its determination that
the learned intermediary doctrine applied. The Appellate Division further noted
that Section 6(d)(2) of the Restatement (Third) of Torts: Products
) may require a warning when the
physician or health-care provider has a "diminished role as an evaluator or
decision maker," in which case the manufacturer would have a duty to warn
patients directly. However, the court agreed with the trial court that if the
warning was legislatively deemed adequate and has been given to the proper
party, then no warning defect existed under the Products Liability Law.
The Supreme Court granted Perez's petition for
The "learned intermediary"
doctrine does not apply to the direct marketing of drugs to consumers;
prescription drug manufacturers that market their products directly to consumers
should be subject to claims by consumers if their advertising fails to provide
an adequate warning of the product's dangerous propensities.
1. The Court has specifically declined to hold as a
matter of law and policy that all prescription drugs [***6] that are
unsafe are unavoidably so; there are circumstances in which the manufacturer
should not be relieved of the duty to warn. (pp. 11-14)
2. Direct-to-consumer advertising has become an essential part of
pharmaceutical manufacturers' marketing plans and have been extremely
successful. However, given the constraints of modern advertising mediums such as
television, pharmaceutical ads often contain warnings of a general nature, which
often do not give the consumer a sufficient understanding of the risks inherent
in the use of the product. (pp. 14-19)
has left the issue of a drug manufacturer's duty to warn the
consumer directly of the risks associated with the product use to developing
case law. (pp. 19-20)
4. Although the New Jersey
Products Liability Act sets forth a physician-based standard for determining the
adequacy of the warning due to a physician, it does not legislate the boundaries
of the "learned intermediary" doctrine. The Senate Judiciary Committee Statement
that accompanied the proposed Act identifies the physician as the party to whom
the warning is owed only because, at that point, pharmaceuticals were marketed
primarily, if [***7] not exclusively to physicians. (pp. 21-23)
5. The "learned intermediary" doctrine is based on
four premises: (1) reluctance to undermine the doctor-patient relationship; (2)
absence of need for the patient's informed consent; (3) inability of drug
manufacturer to communicate with patients; and (4) complexity of the subject.
However, consumer-directed advertising of pharmaceuticals belies each of these
premises. (pp. 23-27)
6. New Jersey has long
recognized the informed role of the patient in health-care decisions. Thus, a
patient must be informed of material risks associated with a drug when the
patient would likely attach significance to a risk or cluster of risks in
deciding whether to forego the proposed therapy or to submit to it. In the
context of "life-style" drugs or elective treatments that may cause significant
and incurable side effects, increased consumer protection becomes imperative
because such drugs, by definition, are not medically necessary. (pp. 28-30)
7. Had Wyeth simply supplied the physician with the
information about Norplant and not advertised directly to patients, then Wyeth
would have had no independent duty to warn patients, as opposed to physicians.
[***8] (pp. 30-31)
drug manufacturers that market their products directly to consumers should be
subject to claims by consumers if their advertising fails to provide an adequate
warning of the product's dangerous propensities. In determining whether those
warnings are adequate, drug manufacturers should be entitled to the rebuttable
presumption that they have satisfied their duty to warn ultimate consumers about
the potential harmful side effects of its product if their warnings comply with
FDA regulations. (pp. 31-37)
9. In the area of
direct marketing of pharmaceuticals, the intervention of the physician does not
necessarily break the chain of causation. Rather, neither the manufacturer nor
the physician should be relieved of their respective duties to warn. Thus,
manufacturers may seek contribution, indemnity or exoneration because of the
physician's deficient role in prescribing a drug. In each case, a jury must
resolve the close questions of whether a breach of duty has been a proximate
cause of harm and how that harm may be apportioned among culpable defendants.
10. The direct marketing of drugs to
consumers generates a corresponding duty requiring [***9]
manufacturers to warn of defects in the product. It is fair to reinforce the
comprehensive FDA regulatory scheme by allowing patients deprived of reliable
medical information to establish that the misinformation was a substantial
factor contributing to their use of a defective pharmaceutical product. (pp.
Judgment of the Appellate Division is
and the matter is REMANDED
to the Law Division for
further proceedings. JUSTICE POLLOCK
filed a separate dissenting opinion. Justice Pollock believes that the New
Jersey Products Liability Law clearly adopts the "learned intermediary" doctrine
and that the Court's holding in this case ignores the Legislature's clear
legislative expression and intent of that Act. CHIEF JUSTICE PORITZ and JUSTICES HANDLER, STEIN and COLEMAN join in
JUSTICE O'HERN's opinion. JUSTICE POLLOCK has filed a separate dissenting
opinion in which JUSTICE GARIBALDI joins. COUNSEL: Richard Galex,
argued the cause for appellants
(Galex, Tortoreti & Tomes,
attorneys). John W. Vardaman,
a member of the District of Columbia bar,
argued the cause for respondents (Porzio, Bromberg & Newman,
attorneys; Anita R. Hotchkiss, [***10] Lauren E. Handler, Connie
and Linda Pissott Reig,
on the brief). John F. Brenner,
submitted a brief on behalf
of amicus curiae,
Pharmaceutical Research and Manufacturers of America
(McCarter & English,
attorneys; Mr. Brenner
and Jerry P.
on the brief).JUDGES:
of the Court was delivered by O'HERN, J. POLLOCK, J., dissenting. GARIBALDI, J.,
joins in this dissent. Chief Justice PORITZ and Justices HANDLER, STEIN and
COLEMAN join in Justice O'HERN's opinion.OPINION
[**1246] The opinion of the Court was delivered by
[*4] O'HERN, J.
jurisprudence is based on images of health care that no longer exist. At an
earlier time, medical advice [**1247] was received in the doctor's
office from a physician who most likely made house calls if needed. The patient
usually paid a small sum of money to the doctor. Neighborhood pharmacists
compounded prescribed medicines. Without being pejorative, it is safe to say
that the prevailing attitude of law and medicine was that the "doctor knows
best." Logan v. Greenwich Hosp. Ass'n
, 191 Conn. 282, 465 A.2d 294, 299
never [***11] advertised their products to patients, but rather
directed all sales efforts at physicians. In this comforting setting, the law
created an exception to the traditional duty of manufacturers to warn consumers
directly of risks associated with the product as long as they warned health-care
providers of those risks.
For good or ill, that has all
changed. Medical services are in large measure provided by managed care
organizations. Medicines are purchased in the pharmacy department of
supermarkets and often paid for by third-party providers. Drug manufacturers now
directly advertise products to consumers on the radio, television, the Internet,
billboards on public transportation, and in magazines. For example, a recent
magazine advertisement for a seasonal allergy medicine in which a person is
standing in a pastoral field filled with grass and goldenrod, attests that to
"TAKE [THE PRODUCT]" is to "TAKE CLEAR CONTROL." Another recent ad features a
former presidential candidate, encouraging the consumer to "take a little
courage" to speak with "your physician." The first ad features major side
effects, encourages the reader to "talk to your doctor," and lists a brief
summary of risks [***12] and contraindications on the opposite page.
The second ad provides a phone number and the name of the pharmaceutical
company, but does not provide the name of the drug.
question in this case, broadly stated, is whether our law should follow these
changes in the marketplace or reflect the [*5] images of the past.
We believe that when mass marketing of prescription drugs seeks to influence a
patient's choice of a drug, a pharmaceutical manufacturer that makes direct
claims to consumers for the efficacy of its product should not be unqualifiedly
relieved of a duty to provide proper warnings of the dangers or side effects of
This appeal concerns Norplant, a Food
and Drug Administration (FDA)-approved, reversible contraceptive that prevents
pregnancy for up to five years. The Norplant contraceptive employs six thin,
flexible, closed capsules that contain a synthetic hormone, levonorgestrel. n1
The capsules are implanted under the skin of a woman's upper arm during an
in-office surgical procedure characterized by the manufacturer as minor. A low,
continuous dosage of the hormone diffuses through the capsule walls and into the
bloodstream. [***13] Although the capsules are not usually visible
under the skin, the outline of the fan-like pattern can be felt under the skin.
Removal occurs during an in-office procedure, similar to the insertion
- - - - - - - - - - - - - - Footnotes - - - -
- - - - - - - - - - -
n1 The Norplant
System was made available for marketing in the United States by Wyeth-Ayerst
Laboratories (Wyeth) in 1990. The "Wyeth" defendants include Wyeth Laboratories,
Inc., a subsidiary of American Home Products Corporation; American Home Products
Corporation; Wyeth-Ayerst Laboratories Division of American Home Products
Corporation; Wyeth-Ayerst International Inc.; and Wyeth-Ayerst Laboratories
Company. The complaint against Dow Corning France, S.A., was dismissed for lack
of personal jurisdiction in January 1996.
- - - - - - - - - - - - End Footnotes- - - - - - - - - - - - - -
We have no doubt of the profound public interest in
developing new products for reproductive services. We intend no disparagement of
the product when we recite plaintiffs' claims concerning the efficacy of
Norplant. The procedural posture that brings this case before us requires that
we accept [***14] as true plaintiffs' version of
the [**1248] facts. The motion to dismiss was in the nature of a
motion for judgment on the pleadings.
According to plaintiffs, Wyeth began a massive advertising campaign for Norplant
in 1991, which it directed at women rather than at their doctors. Wyeth
advertised on television and in women's magazines such as Glamour,
According to plaintiffs, none of the
advertisements warned of any inherent danger posed by Norplant; rather, all
praised its simplicity and convenience. None warned of side effects including
pain and permanent scarring attendant to removal of the implants. Wyeth also
sent a letter to physicians advising them that it was about to launch a national
advertising program in magazines that the physicians' patients may read.
Plaintiffs cite several studies published in medical
journals that have found Norplant removal to be difficult and painful. One study
found that thirty-three percent of women had removal difficulty and forty
percent experienced pain. Another study found that fifty-two percent of
physicians reported complications during removal. Medical journals have
catalogued the need [***15] for advanced medical technicians in
addition to general surgeons for Norplant removal. Plaintiffs assert that none
of this information was provided to consumers.
plaintiffs began to file lawsuits in several New Jersey counties claiming
injuries that resulted from their use of Norplant. Plaintiffs' principal claim
alleged that Wyeth, distributors of Norplant in the United States, failed to
warn adequately about side effects associated with the contraceptive. Side
effects complained of by plaintiffs included weight gain, headaches, dizziness,
nausea, diarrhea, acne, vomiting, fatigue, facial hair growth, numbness in the
arms and legs, irregular menstruation, hair loss, leg cramps, anxiety and
nervousness, vision problems, anemia, mood swings and depression, high blood
pressure, and removal complications that resulted in scarring.
Class action certification was denied. All New Jersey Norplant cases
were consolidated in Middlesex County. Eventually, twenty-five New Jersey
Norplant cases involving approximately fifty [*7] Norplant users
were pending in the Superior Court in Middlesex County.
After a case management conference, plaintiffs' counsel sought a
determination of whether [***16] the learned intermediary doctrine
applied. Pursuant to that conference, five bellwether plaintiffs n2 were
selected to challenge defendant's motion for summary judgment concerning the
learned intermediary doctrine. See Perez v.
Wyeth Labs., Inc.
, 313 N.J. Super. 646, 650, 713 A.2d 588 (Law Div.1997).
The trial court dismissed plaintiffs' complaints, concluding that even when a
manufacturer advertises directly to the public, and a woman is influenced by the
advertising campaign, "a physician is not simply relegated to the role of
prescribing the drug according to the woman's wishes." Id.
at 658, 713
A.2d 588. Consequently, the court held that the learned intermediary doctrine
[*8] applied. Ibid.
According to the court, the physician
retains the duty to weigh the benefits and risks associated with a drug before
deciding whether the drug is appropriate for the patient. Ibid.
2A:58C-4 of the Products Liability Act, N.J.S.A.
to -11, measures warning adequacy based on the knowledge and characteristics of
the health-care provider, the court was not "concerned with the effect that a
warning had on the . . . consumer-plaintiff." Id.
at 659, 713 A.2d
588. [***17] The court found, however, that plaintiffs failed to
provide expert testimony to rebut the statutory presumption under
2A:58C-4, that the manufacturer's warning is adequate when it
has been approved by the FDA, as is the case here. The court found that
plaintiffs failed to rebut the presumption by demonstrating that the
manufacturer's warnings to the physicians were inadequate or that a warning as
to the difficulty of removal would have altered the health-care providers'
decisions to implant Norplant. Id
. at 659-60, 713 A.2d 588. Although the
trial court listed pain and scarring associated with removal among plaintiffs'
. at 650-52, 713 A.2d 588, when addressing proximate cause
the court subsequently stated that "none of the bellwether plaintiffs complained
of difficult removals or that they have significant scarring." Id.
n. 5, 713 A.2d 588. Consequently, the court concluded that plaintiffs had failed
to prove failure to warn and proximate cause, and dismissed plaintiffs'
at 660, 713 A.2d 588.
- - - - -
- - - - - - - - - Footnotes - - - - - - - - - - - - - - -
N2 Bellwether plaintiffs are not created pursuant to any
formal rule. As explained by the Fifth Circuit in In re Chevron, U.S.A.,
, 109 F.3d 1016, 1019-20 (1997):
The term bellwether is derived from the
ancient practice of belling a wether (a male sheep) selected to lead his
flock. The ultimate success of the wether selected to wear the bell was
determined by whether the flock had confidence that the wether would not lead
them astray, and so it is in the mass tort context.
The notion that the trial of some members of a large group of
claimants may provide a basis for enhancing prospects of settlement or for
resolving common issues or claims is a sound one that has achieved general
acceptance by both bench and bar. References to bellwether trials have long
been included in the Manual for Complex Litigation. See MANUAL FOR COMPLEX
LITIGATION § 33.27-.28 (3d ed. 1995). . . . If a representative group of
claimants are tried to verdict, the results of such trials can be beneficial
for litigants who desire to settle such claims by providing information on the
value of the cases as reflected by the jury verdicts. Common issues or even
general liability may also be resolved. . . .
. . .
[B]efore a trial court may utilize results
from a bellwether trial for a purpose that extends beyond the individual cases
tried, it must, prior to any extrapolation, find that the cases tried are
representative of the larger group of cases or claims from which they are
selected[,] . . . based on competent, scientific, statistical evidence . . . .
so as to permit a finding that there is a sufficient level of confidence that
the results obtained reflect results that would be obtained from trials of the
whole. . . .
- - - - -
- - - - - - - End Footnotes- - - - - - - - - - - - - - [***18]
Plaintiffs appealed. Plaintiffs challenged the court's
failure to hear expert testimony on the adequacy of the warnings and the
decision concerning proximate cause because "it was specifically agreed that the
production of expert testimony would await the outcome of the decision on the
issue of the learned intermediary doctrine." The Appellate Division affirmed the
trial court's grant of summary judgment in favor of defendants and its
determination that the learned intermediary doctrine applied. 313 N.J. Super.
511, 713 A.2d 520 (1998). The court supplemented the trial court's opinion,
comparing Section 6d of the Restatement (Third) of Torts: Products
) to N.J.S.A.
[*9] the similar provision of New Jersey's Products Liability Act.
Section 6(d) of the Restatement
(d) A prescription drug or medical
device is not reasonably safe due to inadequate instructions or warnings if
reasonable instructions or warnings regarding foreseeable risks of harm are
not provided to:
(1) prescribing and other
health-care providers who are in a position to reduce the risks of harm in
accordance with the instructions or warnings; or
(2) the patient [***19] when the manufacturer knows or
has reason to know that health-care providers will not be in a position to
reduce the risks of harm in accordance with the instructions or
As noted by the
Appellate Division, the new Restatement
is similar to N.J.S.A.
2A:58C-4, which defines an adequate warning as
one that a reasonably prudent
person in the same or similar circumstances would have provided with respect
to the danger and that communicates adequate information on the dangers and
safe use of the product, . . . in the case of prescription drugs, taking into
account the characteristics of, and the ordinary knowledge common to, the
The court noted that Section 6(d)(2) of the Restatement
require a warning when [**1250] the physician or health-care provider
has a "diminished role as an evaluator or decision maker," in which case the
manufacturer would have a duty to warn patients directly. 313 N.J. Super. at
515, 713 A.2d 520 (citing Restatement (Third),
§ 6d comment b). n3
Consequently, the court agreed with the trial court that if the warning was
"legislatively deemed adequate and has been given to the proper party," no
warning defect under N.J.S.A.
2A:58C-4 [***20] had been
- - - - - - - - - - - - - -
Footnotes - - - - - - - - - - - - - - -
Although the New Jersey statute refers only to a prescribing "physician," the
court assumed that other health-care providers such as dentists, optometrists,
podiatrists, nurse practitioners, home health care service firms and physician's
assistants, or other professionals licensed to prescribe or administer drugs,
would be included. Perez
, 313 N.J. Super. at 515-16, 713
- - - - - - - - - - - -
End Footnotes- - - - - - - - - - - - - -
plaintiffs' petition for certification. 156 N.J. 410, 719 A.2d 642 (1998).
Feldman v. Lederle Laboratories, Inc.
, 97 N.J. 429, 479 A.2d 374, (1984)
), we considered the relationship between principles of
products liability law and pharmaceutical products. In Feldman I,
declined to "hold as a matter of law and policy that all prescription drugs that
are unsafe are unavoidably so." Id.
at 447, 479 A.2d 374. We explained:
Drugs, like any other products,
may contain defects that could have been avoided by better manufacturing
or [***21] design. Whether a drug is unavoidably unsafe should be
decided on a case-by-case basis; we perceive no justification for giving all
prescription drug manufacturers a blanket immunity from strict liability
manufacturing and design defect claims under [Restatement (Second)
Torts § 402A] comment k [(1965)].
if a prescription drug were unavoidably unsafe, the comment k immunity would
not eliminate strict liability for failure to provide a proper warning. As
Justice Pollock stated in O'Brien [v. Muskin Corp., 94 N.J. 169, 183,
463 A.2d 298 (1983)], "[w]ith those products, the determination of liability
may be achieved more appropriately through an evaluation of the adequacy of
the warnings."  Thus, a manufacturer who knows or should know of the danger
or side effects of a product is not relieved of its duty to warn. Rather, as
the comment expressly states, it is only the unavoidably unsafe product
"accompanied by proper * * * warning" that is not defective. (Emphasis
As explained in Niemiera by
Niemiera v. Schneider
, 114 N.J. 550, 559, 555 A.2d 1112 (1989):
In New Jersey, [***22] as
elsewhere, we accept the proposition that a pharmaceutical manufacturer
generally discharges its duty to warn the ultimate user of prescription drugs
by supplying physicians with information about the drug's dangerous
propensities. See, e.g., Bacardi v. Holzman, 182 N.J. Super.
422, 442 A.2d 617 (App.Div.1981). This concept is known as the "learned
intermediary" rule because the physician acts as the intermediary between the
manufacturer and the consumer. The phrase appears to have been coined in the
case of Sterling Drug, Inc. v. Cornish, 370 F.2d 82, 85 (8th
that there were circumstances, such as in Davis v. Wyeth Laboratories,
, 399 F.2d 121 (9th Cir.1968), in which the manufacturer should not be
relieved of a duty to warn. Niemiera
, 114 N.J. at 559, 555
A.2d 1112. In Davis
, the manufacturer of a polio vaccine was held
to have an independent duty to warn the consumer because in mass immunization
clinics such as where the plaintiff received a polio vaccine, there was "no
physician [*11] present to weigh the risks and benefits of the drug
therapy for each patient." Ibid.
(quoting Reyes v. Wyeth Labs.,
, 498 F.2d 1264 [***23] (5th Cir.), cert. denied,
U.S. 1096, 95 S. Ct. 687, 42 L. Ed. 2d 688 (1974); see also Stephens
v. G.D. Searle & Co.
, 602 F. Supp. 379 [**1251]
(E.D.Mich.1985) (manufacturer of oral contraceptive has duty to warn consumers
directly of risks and side effects); Samuels v. American Cyanamid Co.
130 Misc. 2d 175, 495 N.Y.S.2d 1006 (Sup.Ct.1985) (pharmaceutical company had
duty to warn recipient of "travel" vaccines when company knew vaccines were
ordinarily given without meaningful balancing of risks and benefits by informed
We were satisfied in Niemiera
, that sufficient reasons existed with respect to the DPT vaccine
(for diphtheria, pertussis and tetanus) to conclude that the "'learned
intermediary' doctrine should apply." Id
. at 560, 555 A.2d 1112. The
question in this appeal is whether sufficient reasons exist to warrant its
application under these facts. Norplant appears to be a hybrid prescription
medical device exhibiting characteristics both of a medical device implanted in
the body and of a drug. For convenience, most of our discussion will use the
terminology relevant to prescription drugs, the context [***24] in
which most such claims may arise.
paradoxical that so pedestrian a concern as male-pattern baldness should have
signaled the beginning of direct-to-consumer marketing of prescription drugs.
Upjohn Company became the first drug manufacturer to advertise directly to
consumers when it advertised for Rogaine, a hair-loss treatment. Jon D. Hanson
& Douglas A. Kysar, Taking Behavioralism Seriously: Some Evidence of
, 112 Harv. L. Rev. 1420, 1456 (1999). The ad targeted
male consumers by posing the question, "Can an emerging bald spot . . . damage
your ability to get along with others, influence your chance of obtaining a job
or date or even interfere with your job performance?" Ibid.
omitted). [*12] A related ad featured an attractive woman asserting
suggestively, "I know that a man who can afford Rogaine is a man who can afford
Rogaine was the tip of the iceberg. Since drug manufacturers began marketing
directly to consumers for products such as prescription drugs in the 1980s,
"almost all pharmaceutical companies have engaged in this [***25]
direct marketing practice." Ibid.
(footnote omitted). Consider the
A hot-air balloon floats lazily across
the backdrop of a beautiful, cloudless, sunny sky. Cole Porter sings in the
background, "Blue skies smiling at me[.] Nothing but blue skies do I see." A
kind voice instructs the viewer to "see your doctor about Claritin (R)"
because a "clear answer is out there." This advertisement for Claritin (R), a
nondrowsy prescription antihistamine, aired prior to the . . . (FDA's) release
of new direct-to-consumer (DTC) broadcast advertising guidelines in August
1997. The viewer often was bewildered because the "clear answer" about what
Claritin (R) treated was not in the otherwise well-produced thirty-second
[Kelly N. Reeves,
Direct-to-Consumer Broadcast Advertising: Empowering the Consumer or
Manipulating a Vulnerable Population?, 53 Food & Drug L.J. 661, 661
(1998) (footnotes omitted).]
These campaigns "bring to 'bear all the slick pressure of which Madison
Avenue is capable'." Hanson & Kysar, supra,
112 Harv. L.Rev. at 1456
Pressure on consumers is an
integral part of drug manufacturers' [***26] marketing strategy. From
1995 to 1996, drug companies increased advertising directed to consumers by
ninety percent. Bob Van Voris, Drug Ads Could Spell Legal Trouble[.] Consumer
Campaigns May Result in Greater Liability, Nat'l L.J.,
July 21, 1997, at B1.
In 1997, advertising costs of pharmaceutical products surpassed the half-billion
dollar mark for the first time, "easily outpacing promotional efforts directed
to physicians." Lars Noah, Advertising Prescription Drugs to Consumers:
Assessing [**1252] the Regulatory and Liability Issues
, 32 Ga.
L. Rev. 141, 141 (1997) (footnote omitted). "John F. Kamp, senior vice president
of the American Association of Advertising Agencies, said that prescription drug
companies spent $ 1.3 billion on print and broadcast advertising aimed at
consumers last year, up from $ 843 million in 1997 . . . ." Robert Pear, Drug
Companies Getting [*13] F.D.A. Reprimands for False or Misleading
N.Y. Times, Mar. 28, 1999, at 28. These efforts are not just an
essential part of manufacturers' marketing plans; they are an extremely
successful one. As of December 1998, "because of its testimonials" in print and
broadcast media by renowned [***27] personalities, sales of a product
that treats male impotence had increased to $ 788 million, with approximately
7.5 million prescriptions having been written. Jay P. Speivack, Direct Ads
May Create Liability Dangers. Consumer Advertising by Drug Manufacturers Has
Reopened the Issue of Expanded Liability
, Nat'l L.J., Mar. 15, 1999, at B7
Without vouching for every decimal point in the
discussion, the following is a summary of changes in pharmaceutical marketing.
[Significant technological] advances in
[medical] treatment have been accompanied by significant increases in the cost
of health care. It is estimated that in 1996, Americans spent more than $ 1
trillion on health care products and services. Health care is the single
largest business in the United States, representing 14% of the gross domestic
product. Health care expenses comprise the largest single area of
Corresponding with the
financial burdens attendant to our modern health care system, a fundamental
change has taken place in the way Americans pay for their health care [from
individually-funded to third-party-funded health care]. . . . These
fundamental changes have drastically [***28] altered the delivery
of health care services.
. . . .
As [pharmaceutical] manufacturers attempt to appropriately position
their products in the chain of delivery, new techniques are often employed to
supplement traditional marketing efforts which have historically consisted of
direct physician education, information provided in medical references,
educational seminars, and research grants. . . .
Among the most controversial of the new marketing techniques employed
by pharmaceutical manufacturers is direct-to-consumer prescription advertising
in a variety of formats and media. Pharmaceutical remedies for varied problems
such as allergies, nail fungus, hypertension, hair loss, and depression are
placed directly before the consumer in magazines, television, and via the
Internet. The utilization of direct consumer marketing raises questions and
issues addressing manufacturer liability for failure to adequately warn of
risks possibly associated with pharmaceutical use.
[*14] . . . .
Medical Association (AMA) has long maintained a policy in opposition to
product-specific prescription ads aimed at consumers. A 1992 study by the
Annals of Internal Medicine reports that a peer [***29] review of
109 prescription ads found 92 per cent of the advertisements lacking in some
[Michael C. Allen, Medicine Goes
Madison Avenue: An Evaluation of the Effect of Direct-to-Consumer
Pharmaceutical Advertising on the Learned Intermediary Doctrine, 20
Campbell L. Rev. 113, 113-116 (1997) (footnotes omitted).]
The difficulties that accompany this [type of advertising] practice
are manifest. "The marketing gimmick used by the drug manufacturer often
provides the consumer with a diluted variation of the risks associated with
the drug product." [**1253] Even without such manipulation,
"[t]elevision spots lasting 30 or 60 seconds are not conducive to 'fair
balance' [in presentation of risks]." Given such constraints, pharmaceutical
ads often contain warnings of a general nature. However, "[r]esearch indicates
that general warnings (for example, see your doctor) in [direct-to-consumer]
advertisements do not give the consumer a sufficient understanding of the
risks inherent in product use." Consumers often interpret such warnings as a
"general reassurance" that their condition can be treated, rather than as a
requirement that "specific vigilance" is needed to protect [***30]
them from product risks.
[Hanson & Kysar,
supra, 112 Harv. L.Rev. at 1456.]
How Has the Law Responded to These Changes?
A. The new Restatement (Third) of Torts has left the issue
to "developing case law."
Parallel to the
developments in drug marketing, the American Law Institute was in the process of
adopting the Restatement (Third) of Torts: Products Liability
comment to Section 6 explains that subsection (d)(1) sets forth the traditional
rule of the learned intermediary that drug and medical device manufacturers are
liable for failing to warn of a drug's risks only when the manufacturer fails to
warn the health-care provider of risks attendant to a specific drug.
§ 6(d) comment a. That same comment also notes
that subsection (d)(2) reflects decisional law and provides limited exceptions
to the traditional rule by requiring manufacturers to warn patients in certain
Because situations may exist when the health-care
provider assumes a "much-diminished role as an evaluator or decisionmaker," it
is appropriate to impose a duty on [*15] the manufacturer to warn
the patient directly. Id.
[***31] at § 6d comment b. Despite
the early effort to provide an exception to the doctrine in the case of direct
marketing of pharmaceuticals to consumers, the drafters left the resolution of
that issue to "developing case law." Id.
at § 6d comment e. One
commentator described the Restatement's
approach as a "tepid endorsement"
of the learned intermediary doctrine. Charles J. Walsh et al., The Learned
Intermediary Doctrine: The Correct Prescription for Drug Labeling,
Rutgers L. Rev. 821, 869 (1994). Thus, under the new Restatement,
"warnings may have to be provided to a health-care provider or even to the
patient," depending on the circumstances. William A. Dreier, The Restatement
(Third) of Torts: Products Liability and the New Jersey Law--Not Quite Perfect
50 Rutgers L.J.
2059, 2097 (1998). This is an entirely
appropriate resolution. Judge Cardozo, a shaper of both the common law and of
of law drafted by the American Law Institute, saw each
role as complementary:
Cardozo saw the Institute as continuing his own work as a common
law judge: to show that new decisions that modernized law had their roots
in [***32] ancient notions of the purpose of law to accomplish
justice through an ongoing reformulation of the governing rules.
[Andrew L. Kaufman, Cardozo 174 (1998).]
B. The New Jersey Products Liability Act does not
legislate the boundaries of the learned intermediary doctrine.
As noted, the New Jersey Products Liability Act provides:
An adequate product warning or instruction is one that a
reasonably prudent person in the same or similar circumstances would have
provided with respect to the danger and that communicates adequate information
on the dangers and safe use of the product, taking into
account [**1254] the characteristics of, and the ordinary knowledge
common to, the persons by whom the product is intended to be used, or in the
case of prescription drugs, taking into account the characteristics of, and
the ordinary knowledge common to, the prescribing physician. If the warning or
instruction given in connection with a drug or device or food or food additive
has been approved or prescribed by the federal Food and Drug Administration
under the "Federal Food, Drug, and Cosmetic Act," 52 Stat. 1040, 21
U.S.C. § 301 et seq., . . . a rebuttable presumption shall
arise [***33] that the warning or instruction is adequate. . . .
[*16] The Senate Judiciary Committee Statement that
. 197 recites: "The subsection contains a
general definition of an adequate warning and a special definition for warnings
that accompany prescription drugs, since, in the case of prescription drugs,
the warning is owed to the physician
." See N.J.S.A.
(providing the Committee Statement) (emphasis added). At oral argument, counsel
for Wyeth was candid to acknowledge that he could not "point to a sentence in
the statute" that would make the learned intermediary doctrine applicable to the
manufacturers' direct marketing of drugs, but rather relied on the Committee
Statement. Although the statute provides a physician-based standard for
determining the adequacy of the warning due to a physician, the statute does not
legislate the boundaries of the doctrine. For example, the Act does not purport
to repeal a holding such as Davis v. Wyeth Labs
required that manufacturers directly warn patients in mass inoculation cases.
Rather, the statute governs the content of an "adequate product warning,"
when [***34] required. As noted, supra
at 11-12, 734 A.2d at
1251, in 1987, direct-to-consumer marketing of prescription drugs was in its
beginning stages. The Committee Statement observes that "the warning is owed to
the physician" because drugs were then marketed to the physician. We believe
that the part of the provision establishing "a presumption that a warning or
instruction is adequate on drug or food products if the warning has been
approved or prescribed by the Food and Drug Administration," Committee
, will provide the benchmark for this decision.
Our dissenting member suggests that we should await
legislative action before deciding that issue. As we explained in Kelly v.
[t]his Court has decided many
significant issues without any prior legislative study. In any event, if the
Legislature differs with us on issues of this kind, it has a clear remedy. . .
We are satisfied that our decision today is well
within the competence of the judiciary. Defining the scope of tort liability
has traditionally been accepted as the responsibility of the courts.
[*17] [96 N.J. 538,
555-56, 476 A.2d 1219 (1984) (footnote and internal citations
If [***35] we decline to resolve the question, we are making
the substantive determination that the learned intermediary doctrine applies to
the direct marketing of drugs, an issue recently debated but left unanswered by
the drafters of the Restatement.
Either course, then, requires us to
adopt a principle of law. The question is which is the better principle.
C. Direct advertising of drugs to consumers alters the calculus of
the learned intermediary doctrine.
, the respected Judge John Minor Wisdom explained the
rationale behind the learned intermediary doctrine. His perspective reflects the
then-prevalent attitude about doctor-patient relationships:
This special standard for
prescription drugs is an understandable exception to the Restatement's general
rule that one who markets goods must warn foreseeable ultimate users of
dangers inherent in [the] products. . . . 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
the drug, as well as the susceptibilities of [the]
patient. [**1255] [The physician's] task [is to weigh]
[***36] the benefits of any medication against its potential
dangers. The choice [the physician] makes is an informed one, an
individualized medical judgment bottomed on a knowledge of both patient and
palliative. Pharmaceutical companies then, who must warn ultimate purchasers
of dangers inherent in patent drugs sold over the counter, in selling
prescription drugs are required to warn only the prescribing physician, who
acts as a "learned intermediary" between manufacturer and consumer.
[498 F.2d at 1276 (footnote and citation
A more recent review summarized
the theoretical bases for the doctrine as based on four considerations.
First, courts do not wish to intrude upon the doctor-patient
relationship. From this perspective, warnings that contradict information
supplied by the physician will undermine the patient's trust in the
physician's judgment. Second, physicians may be in a superior position to
convey meaningful information to their patients, as they must do to satisfy
their duty to secure informed consent. Third, drug manufacturers lack
effective means to communicate directly with patients, making it necessary to
rely on physicians to convey the relevant [***37] information.
Unlike [over the counter products], pharmacists usually dispense prescription
drugs from bulk containers rather than as unit-of-use packages in which the
manufacturer may have enclosed labeling. Finally, because of the complexity of
risk information about prescription drugs, comprehension problems would
complicate any effort by manufacturers [*18] to translate
physician labeling for lay patients. For this reason, even critics of the rule
do not suggest that pharmaceutical companies should provide warnings only to
patients and have no tort duty to warn physicians.
[Noah, supra, 32 Ga. L.Rev. at 157-59 (footnotes
These premises: (1) reluctance
to undermine the doctor patient-relationship; (2) absence in the era of "doctor
knows best" of need for the patient's informed consent; (3) inability of drug
manufacturer to communicate with patients; and (4) complexity of the subject;
are all (with the possible exception of the last) absent in the
direct-to-consumer advertising of prescription drugs.
First, with rare and wonderful exceptions, the "'Norman Rockwell' image
of the family doctor no longer exists." Id.
at 180 n. 78
(citing [***38] Paul D. Rheingold, The Expanding Liability of the
Drug Manufacturer to the Consumer,
40 Food Drug Cosm. L.J.
(1985)). Informed consent requires a patient-based decision rather than the
paternalistic approach of the 1970s. See Largey v. Rothman
N.J. 204, 206, 540 A.2d 504 (1988) (discussing Canterbury v. Spence
U.S. App. D.C. 263, 464 F.2d 772 (D.C.Cir.), cert. denied,
409 U.S. 1064,
93 S. Ct. 560, 34 L. Ed. 2d 518 (1972)). The decision to take a drug is "not
exclusively a matter for medical judgment." See
Teresa Moran Schwartz,
Consumer-Directed Prescription Drug Advertising and the Learned Intermediary
46 Food Drug Cosm. L.J.
829, 831 (1991) (citing Margaret
Gilhooley, Learned Intermediaries, Prescription Drugs, and Patient
30 St. Louis. U. L.J.
633, 652 (1986)).
Second, because managed care has reduced the time allotted per patient,
physicians have considerably less time to inform patients of the risks and
benefits of a drug. Sheryl Gay Stolberg, Faulty Warning Labels Add to Risk in
N.Y. Times, June 4, 1999, at [***39] A27. "In
a 1997 survey of 1,000 patients, the F.D.A. found that only one-third had
received information from their doctors about the dangerous side effects of
drugs they were taking." Ibid.
spent $ 1.3 billion on advertising in 1998, supra
at 12-13, 734 A.2d at
1251-52, drug manufacturers can hardly be said to "lack effective means to
communicate [**1256] directly with patients," [*19] Noah,
32 Ga. L.Rev.
at 158, when their advertising campaigns can
pay off in close to billions in dividends.
Consumer-directed advertising of pharmaceuticals thus belies each of
the premises on which the learned intermediary doctrine rests.
First, the fact that manufacturers are advertising their drugs and
devices to consumers suggests that consumers are active participants in their
health care decisions, invalidating the concept that it is the doctor, not the
patient, who decides whether a drug or device should be used. Second, it is
illogical that requiring manufacturers to provide direct warnings to a
consumer will undermine the patient-physician relationship, when, by its very
nature, consumer-directed advertising encroaches on that relationship by
encouraging consumers [***40] to ask for advertised products by
name. Finally, consumer-directed advertising rebuts the notion that
prescription drugs and devices and their potential adverse effects are too
complex to be effectively communicated to lay consumers. Because the FDA
requires that prescription drug and device advertising carry warnings, the
consumer may reasonably presume that the advertiser guarantees the adequacy of
its warnings. Thus, the common law duty to warn the ultimate consumer should
[Susan A. Casey, Comment,
Laying an Old Doctrine to Rest: Challenging the Wisdom of the Learned
Intermediary Doctrine, 19 Wm. Mitchell L. Rev. 931, 956 (1993)
all of its premises are absent, as when direct warnings to consumers are
mandatory, the learned intermediary doctrine, "itself an exception to the
manufacturer's traditional duty to warn consumers directly of the risk
associated with any product, simply drops out of the calculus, leaving the duty
of the manufacturer to be determined in accordance with general principles of
tort law." Edwards v. Basel Pharms.
, 116 F.3d 1341, 1343 (10th Cir.1997)
(discussing question of adequacy of [***41] nicotine patch warning
under Texas law certified in Edwards v. Basel Pharms.
, 1997 OK 22, 933
P.2d 298 (1997)). We acknowledge that the Fifth Circuit recently held that under
Texas law, the learned intermediary doctrine does apply in the context of
Norplant. In re Norplant Contraceptive Prod. Liab. Litig. v. American Home
, 165 F.3d 374, 379-80 (1999). Nonetheless, we agree with the
Tenth Circuit's approach.
Concerns regarding patients'
communication with and access to physicians are magnified in the context of
medicines and medical devices furnished to women for reproductive decisions. In
[*20] v. Ortho Pharmaceutical Corp.
Mass. 131, 475 N.E.2d 65 , cert. denied,
474 U.S. 920, 106 S. Ct. 250, 88
L. Ed. 2d 258 (1985), the plaintiff's use of oral contraceptives allegedly
resulted in a stroke. The Massachusetts Supreme Court explained several reasons
why contraceptives differ from other prescription drugs and thus "warrant the
imposition of a common law duty on the manufacturer to warn users directly of
associated risks." Id
. at 136-37, 475 N.E.2d 65. For example, after the
patient receives [***42] the prescription, she consults with the
physician to receive a prescription annually, leaving her an infrequent
opportunity to "explore her questions and concerns about the medication with the
prescribing physician." Id
. at 137, 475 N.E.2d 65. Consequently, the
limited participation of the physician leads to a real possibility that their
communication during the annual checkup is insufficient. Id
. at 138, 475
N.E.2d 65. The court also explained that because oral contraceptives are drugs
personally selected by the patient, a prescription is often not the result of a
physician's skilled balancing of individual benefits and risks but originates,
instead, as a product of patient choice. Id
. at 137, 475 N.E.2d 65. Thus,
"the physician is relegated to a . . . passive role." Ibid.
[**1257] Patient choice is an increasingly
important part of our medical-legal jurisprudence. New Jersey has long since
abandoned the "professional standard" in favor of the
objectively-prudent-patient rule, recognizing the informed role of the patient
in health-care decisions. Largey
, 110 N.J. at 212, 540 A.2d
504. Accordingly, a patient must be informed of material risks, which exist
"when a reasonable patient, [***43] in what the physician knows or
should know to be the patient's position, would be 'likely to attach
significance to the risk or cluster of risks' in deciding whether to forego the
proposed therapy or to submit to it." Id
. at 211-12, 540 A.2d 504
, 464 F.2d at 787). When a patient is
the target of direct marketing, one would think, at a minimum, that the law
would require that the patient not be misinformed about the product. It is one
thing not to inform a patient about the potential side effects of a product; it
is another [*21] thing to misinform the patient by deliberately
withholding potential side effects while marketing the product as an efficacious
solution to a serious health problem. Further, when one considers that many of
these "life-style" drugs or elective treatments cause significant side effects
without any curative effect, increased consumer protection becomes imperative,
because these drugs are, by definition, not medically necessary.
In the development of products liability law, the role of advertising
has been a significant factor in defining the duties of sellers.
An early, but important, example
is Henningsen v. Bloomfield Motors Inc., [32 N.J. 358, 161 A.2d 69
(1960)] [***44] the seminal case marking "the date of the fall of
the citadel of privity," in which the Court recognized the "advent of large
scale advertising by manufacturers" as a basis for reconsidering the
long-standing privity rule in warranty cases. The general principle recognized
in Henningsen--that a manufacturer's duty runs directly to the consumer
when it markets its products directly to the consumer--is as applicable today
to prescription drug manufacturers who advertise their products as it was to
automobile manufacturers three decades ago in Henningsen.
[Schwartz, supra, 46 Food Drug Cosm. L.J.
at 840-41 (footnotes omitted).]
the learned intermediary doctrine applies when its predicates are present. "In
New Jersey, as elsewhere, we accept the proposition that a pharmaceutical
manufacturer generally discharges its duty to warn the ultimate users of
prescription drugs by supplying physicians with information about the drug's
dangerous propensities." Niemiera
, 114 N.J. at 559, 555
A.2d 1112. Had Wyeth done just that, simply supplied the physician with
information about the product, and not advertised directly to the patients,
plaintiffs would [***45] have no claim against Wyeth based on an
independent duty to warn patients. The question is whether the absence of an
independent duty to warn patients gives the manufacturer the right to
misrepresent to the public the product's safety.
D. Prescription drug manufacturers that market their products
directly to consumers should be subject to claims by consumers if their
advertising fails to provide an adequate warning of the product's dangerous
In reaching the conclusion
that the learned intermediary doctrine does not apply to the direct marketing of
drugs to consumers, we must necessarily consider that when prescription drugs
[*22] are marketed and labeled in accordance with FDA
specifications, the pharmaceutical manufacturers should not have to confront
"state tort liability premised on theories of design defect or warning
inadequacy." Note, A Question of Competence: The Judicial Role in the
Regulation of Pharmaceuticals,
103 Harv. L. Rev. 773, 773 (1990). We draw
much of this summary concerning the specifics of FDA
pharmaceutical [**1258] regulation from the brief of amicus
the Pharmaceutical Research and Manufacturers of America. Because
such regulations [***46] may change from day to day, our commentary
concerning the current regulations may soon become moot.
The FDA is authorized to regulate advertisements for prescription drugs
pursuant to 21 U.S.C.A.
Section 352(n) of the Food, Drug and Cosmetic
Act, 21 U.S.C.A.
Sections 301-397. Advertisements subject to Section
352(n) include "advertisements in published journals, magazines, other
periodicals, and newspapers, and advertisements broadcast though media such as
radio, television, and telephone communication systems." 21 C.F.R.
)(1). Although the FDA has regulated drug advertising since 1963,
those regulations initially addressed only advertising directed at health-care
providers. Noah, supra,
32 Ga. L.Rev.
at 142-43. Aware of the
potential threat to consumers when pharmaceutical companies first sought to
advertise to non-health-care professionals, the FDA, in the early 1980s
initially imposed a [voluntary] moratorium on such advertising so
that it could study the issue more carefully; but, in 1985, it lifted the
moratorium, content to apply its existing regulations to this new practice.
Perhaps spurred by the rapid [***47] growth of direct consumer
advertising and the inherent shortcomings of rules designed to control
advertising to physicians, coupled with the emergence of brand new media such
as the Internet for disseminating promotional messages, the Agency has now
proposed to modify its approach.
Section 352(n) of the Act
contains the "brief summary requirement," which is a misnomer considering that
the summary is anything but brief. Accordingly, all advertisements must include
a description of "side effects, contraindications, and effectiveness as shall be
required in regulations. . . ." 21 U.S.C.A.
[*23] The regulations addressing prescription drugs also require
that the brief summary provide "all the risk-related information in a product's
approved package labeling," which is usually a package insert or product package
insert. 62 Fed. Reg.
43,171 (Aug. 12, 1997) (citing 21 C.F.R.
202.1(e)(1) and (e)(3)(iii)). As noted by amicus curiae,
"[r]egulations are exhaustive, addressing issues as broad as the requirement
that ads be fairly balanced (21 C.F.R.
§ 202.1(e)(6)) and as narrow as
how graphs must be [***48] labeled (21 C.F.R.
202.1(e)(7)(iv)) and the type size used to set forth a medicine's established
name (21 C.F.R.
In August 1997,
the FDA released a Draft Guidance, which specifically addresses
consumer-directed broadcast advertisements such as radio, television and
telephone communications. 21 Fed. Reg.
43,172 (Aug. 12, 1997). Broadcast
advertisements must contain a "major statement" of the major risks of the drug.
Instead of presenting a brief summary with the broadcast, which is
not as feasible as in the print media, the Guidance proposes an alternative
requirement known as the "adequate provision" requirement. Ibid.
provision provides that the manufacturer "may make adequate provision for the
dissemination of the approved package labeling in connection with the broadcast
presentation (§ 202.1(e)(1))." Ibid.
The Guidance explains that four
components must be present to meet the "adequate provision" requirement in
broadcasts--a toll-free number that provides information concerning where
consumers might find information about package labeling; an alternative
mechanism for obtaining package labeling information for
consumers [***49] who do not have access to technology such as the
Internet; a statement directing consumers to pharmacists and/or physicians; and
an Internet web-page address. See Guidance for Industry:
Consumer-Directed Broadcast Advertisements
(visited June 14, 1999)
<http://www.fda.gov/cder/guidance/index.htm>. Within two years of the
release of the Guidance, the FDA "intends [**1259] to evaluate the
effects of the guidance . . . ." 62 Fed. Reg.
43,172. These FDA actions
indicate that the agency views direct-to-consumer advertising [*24]
as a means of providing consumers with improved access to important information
about prescription drugs. n4
- - - - - - - - - - - - -
- Footnotes - - - - - - - - - - - - - - -
n4 But see
Robert Cohen, Regulation on Drugs Unraveling on
Star-Ledger, July 6, 1999, at 1 (noting that although prescription
"drug bazaars" on the Internet "are undermining federal drug safety laws,
tearing apart the doctor-patient relationship and breaking state pharmacy and
medical regulations," federal officials are uncertain how to "get control of the
latest e-commerce phenomenon.").
- - - - - - - - - - End Footnotes- - - - - - - - - - - - -
FDA regulations are pertinent in
determining the nature and extent of any duty of care that should be imposed on
pharmaceutical manufacturers with respect to direct-to-consumer advertising.
. Alloway v. Bradlees, Inc.
, 157 N.J. 221, 236, 723 A.2d 960
(1999) (discussing relevance of federal OSHA standards in determining duty of
care to impose on general contractor for injuries incurred by subcontractor's
employee on worksite). Presently, any duty to warn physicians about prescription
drug dangers is presumptively met by compliance with federal labeling.
2C:58-4. That presumption is not absolute. See,
, Feldman v. Lederle Labs., Inc.
, 125 N.J. 117, 156-7, 592 A.2d
1176 (1991) (Feldman II
) (concluding that under unique circumstances of
case, compliance with FDA determination not to require drug warning due to lack
of "unequivocal factual evidence of adverse reaction in man," despite evidence
of adequacy of product labeling, did not create conclusive presumption that
labeling contained adequate warning) cert. denied,
505 U.S. 1219, 112 S.
Ct. 3027, 120 L. Ed. 2d 898 (1992). Nevertheless, FDA regulations
serve [***51] as compelling evidence that a manufacturer satisfied
its duty to warn the physician about potentially harmful side effects of its
We believe that in the area of
direct-to-consumer advertising of pharmaceuticals, the same rebuttable
presumption should apply when a manufacturer complies with FDA advertising,
labeling and warning requirements. That approach harmonizes the manufacturer's
duty to doctors and to the public when it chooses to directly advertise its
products, and simultaneously recognizes the public interest in informing
patients about new pharmaceutical [*25] developments. Moreover, a
rebuttable presumption that the duty to consumers is met by compliance with FDA
regulations helps to ensure that manufacturers are not made guarantors against
remotely possible, but not scientifically-verifiable, side-effects of
prescription drugs, a result that could have a "significant antiutilitarian
effect." See Feldman II
, 125 N.J. at 162, 592 A.2d
1176 (Garibaldi, J., dissenting); see also
Michael D. Green, Statutory
Compliance and Tort Liability: Examining the Strongest Case,
30 U. Mich.
J.L. Ref. 461, 466-67 (1997) (noting that over deterrence in drug
advertising [***52] context could impede and delay manufacturers from
research and development of new and effective drugs, force beneficial drugs from
market, lead to shortages in supplies and suppliers of pharmaceuticals, and
create unnecessary administrative costs).
that this standard is fair and balanced. For all practical purposes, absent
deliberate concealment or nondisclosure of after-acquired knowledge of harmful
effects, compliance with FDA standards should be virtually dispositive of such
claims. By definition, the advertising will have been "fairly balanced." This
presumptive effect is in accordance with legislative intent that we discern from
the punitive damages provision of the Products Liability Act. See L.
. 142, § 5(c). That provision prohibits, in the case of the sale
of pharmaceutical products, an award of punitive damages if there has been
compliance with FDA labeling and pre-marketing requirements, impliedly reserving
compensatory damages for those rare cases when the presumption is overcome.
The final issues in this case concern proximate cause,
that is, whether misinformation actually affected these patients and, if so,
whether the [***53] intervention of the physician (without whom the
product may not reach the patient) breaks the chain of causation.
Concerning the first issue, defendants argue that we
should refrain from deciding whether the learned intermediary doctrine
[*26] applies because these plaintiffs did not say that they had
been influenced by defective advertising of Norplant. We decline to do so for
two reasons. First, plaintiffs claim to have been lulled into the view that the
only issue for decision at this phase of the case was the application of the
learned intermediary doctrine. Moreover, were we to decline to resolve the
application of the learned intermediary doctrine, the remainder of the fold
would have to relitigate the issue even if their bellwethers were no longer
available to lead them. n5 See supra
at 7 n. 2, 734 A.2d at 1248 n. 2. We
believe it best to resolve the threshold issue of whether the learned
intermediary doctrine applies in the case of direct-to-consumer marketing of
pharmaceutical goods and to remand the matter for further proceedings. The issue
on remand will be whether, on a summary judgment motion, there is sufficient
evidence for a reasonable jury to determine in the cases of [***54]
the bellwether plaintiffs, or any remaining plaintiffs, that the absence of
information or presence of misinformation in Norplant advertising was in
violation of FDA requirements and whether such violations, if any, were a
substantial factor in bringing about the harm suffered.
- - - - - - - - - - - - - - Footnotes - - - - - - - - - - - - - - -
n5 Several of the bellwether plaintiffs
submitted supplemental affidavits concerning exposure to advertising of
- - - - - - - - - - - -
End Footnotes- - - - - - - - - - - - - -
difficult question is whether the role of the physician breaks the chain of
causation. Although the physician writes the prescription, the physician's role
in deciding which prescription drug is selected has been altered. With the
arrival of direct-to-consumer advertising, patients now enter physicians'
offices with "preconceived expectations about treatment because of information
obtained from DTC [direct-to-consumer] advertisements." Tamar V. Terzian,
Directr-to-Consumer Prescription Drug Advertising,
25 Am. J.L. & Med.
149, 157 (1999). Consequently,
[p]hysicians may relent to patient [***55] pressure,
even if it is not in the best interest of the patient. In fact, physicians
state that they are increasingly asked and pressured by their patients to
prescribe drugs that the patient has seen advertised. [*27] For
example, the diet drug combinations known as fen-phen was prescribed despite
little hard scientific evidence of its potential side-effects. Physicians are
under attack for prescribing the pills too often and too readily to
inappropriate patients. Physicians argue that it is not their fault; rather,
they claim pushy patients, prodded by DTC advertisements, pressed, wheedled,
begged and berated them for quick treatments. This scenario comes at a time
when physicians cannot afford to lose patients, because their income is
already strained by managed care cost cutting. Physicians complain that it is
impossible to compete with pharmaceutical companies' massive advertising
budgets, and resign themselves to the fact that if consumers make enough
noise, they will eventually relent to patient pressure.
[Id. at 157-58 (footnotes omitted).]
We disagree that these "ads change the physician
into 'simply a functionary, filling out prescriptions[,]'" but
we [***56] must examine whether the changed relationship affects the
finding of proximate cause. See
Van Voris, supra, Nat'l L.J.,
B1 (quoting Michael Traynor, adviser to the Restatement
[**1261] We have described proximate cause as
an expression as much of policy as it is an expression of the effect of
sequential events. A proximate cause need not be the sole cause of harm. It
suffices if it is a substantial contributing factor to the harm suffered.
"Proximate or legal causation is
that combination of 'logic, common sense, justice, policy and precedent' that
fixes a point in a chain of events, some foreseeable and some unforeseeable,
beyond which the law will bar recovery." People Express Airlines, Inc. v.
Consolidated Rail Corp., 100 N.J. 246, 264, 495 A.2d 107 (1985) (quoting
Caputzal v. Lindsay Co., 48 N.J. 69, 77-78, 222 A.2d 513 (1966); see
also Kuzmicz v. Ivy Hill Park Apartments, Inc., 147 N.J. 510,
540-41, 688 A.2d 1018 (1997) (Stein, J., dissenting) (same); Contey v. New
Jersey Bell Tel. Co., 136 N.J. 582, 587, 643 A.2d 1005 (1994) ("We have .
. . defined the limits of proximate cause as an instrument [***57]
of fairness and policy.") (internal quotation omitted); Brown v. United
States Stove Co., 98 N.J. 155, 173, 484 A.2d 1234 (1984) ("The assessment
as to whether conduct can be considered sufficiently causally connected to
accidental harm so as to justify the imposition of liability also implicates
concerns for overall fairness and sound public policy."); Rappaport v.
Nichols, 31 N.J. 188, 205, 156 A.2d 1 (1959) ("We are fully mindful that
policy considerations and the balancing of the conflicting interests are the
truly vital factors in the molding and application of the common law
principles of negligence and proximate causation.").
Ordinarily, issues of proximate cause are considered to be jury
questions. See Martin v. Bengue, Inc., 25 N.J. 359, 374 136 A.2d
626 (1957). However, in unique cases our courts have rejected the imposition
of liability as a matter of law for highly extraordinary consequences . . . .
v. Township of Middletown, 154 N.J. 282, 307-308, 712 A.2d 1101 (1998)
(Stein, J., concurring).]
a matter of policy then, we could hold that even if deceptive advertising were a
substantial contributing [***58] factor influencing a patient's
choice of a medicine, the intervening role of the physician should insulate the
manufacturer who has engaged in deceptive trade practices. In other contexts, we
have not insulated manufacturers when another might have given better warning.
Freund v. Cellofilm Properties, Inc.
, 87 N.J. 229, 245, 432 A.2d 925
(1981); see also Campos v. Firestone Tire & Rubber Co.
N.J. 198, 208, 485 A.2d 305 (1984), citing Bexiga v. Havir Mfg. Corp.
N.J. 402, 410, 290 A.2d 281 (1972) (holding that manufacturer may be responsible
for failing to include safety precautions on its machine despite its expectation
that someone would install these safety devices, because public interest
required that duty of assuring such installation should not be left to others);
and Davis supra
, 399 F.2d at 131 (holding that prescription drug
manufacturer may have duty to see that warnings of drug's risks, distributed to
medical profession, in fact reached drug's ultimate consumers).
Furthermore, a manufacturer who fails to
warn the medical community of a particular risk may nonetheless be relieved of
liability under [***59] the learned intermediary doctrine if the
prescribing physician either did not read the warning at all, and thus did not
rely on any information from the manufacturer in prescribing the product, or
if the physician was aware of the risk from other sources and considered the
risk in prescribing the product. Under these circumstances, the learned
intermediary's conduct is deemed to be the superseding or intervening cause
that breaks the chain of liability between the manufacturer and the user.
[Richard J. Heafey & Don M. Kennedy, Products Liability:
Winning Strategies and Techniques § 10.03 (1999) (footnotes
because it is based on the familiar tort concept that a tortfeasor is liable
only for the injuries that he or she proximately causes. Despite its appeal,
one problem with using the causation rationale is the inherent difficulty of
establishing causation in failure-to-warn cases as compared with other product
liability claims. In a typical defective design case, a plaintiff points to
the existence of a viable alternative design and asserts that the
manufacturer's failure to use that design proximately caused the
plaintiff's [***60] injury. Failure-to-warn claims, however, entail
a different sort of showing. A plaintiff suing under a failure-to-warn theory
must presumably establish that she would have heeded an adequate warning if
one were given. Due to the individualized nature of the inquiry into what
warning [*29] would have caused the plaintiff to alter her
behavior, Professors Henderson and Twerski suggest that predicting how
additional information would have affected any given individual may be well
[Lloyd C. Chatfield II,
Medical Implant Litigation and Failure to Warn: A New Extension for the
Learned Intermediary Rule, 82 Ky. L.J. 575, 582-83 (1993-94) (footnotes
On balance, we believe that the patient's interest in reliable
information predominates over a policy interest that would insulate
manufacturers. "Products liability law is based on concepts of fairness,
feasibility, practicality and functional responsibility. We have always stressed
the public's interest in motivating individuals and commercial entities to
invest in safety to protect workers." Zaza v. Marquess and Nell, Inc.
144 N.J. 34, 64, 675 A.2d 620 (1996). Within bounds, that [***61]
policy extends to consumers of pharmaceuticals.
Obviously, the physician is almost always the essential link between
the patient and the pharmaceutical. Most ads for drugs caution the patient to
consult with a physician. Because of that essential link, under the learned
intermediary rule drug manufacturers were found not liable even if they did not
provide an adequate warning to those physicians who eventually prescribed a
drug, to inform them of the risk. n6
Courts have differed in their
application of the learned intermediary doctrine in cases in which the
defendant claimed that the prescribing physician knew of the risk that the
manufacturer [***62] did not warn about. Some courts have applied a
presumption that the physician would not have prescribed the product if an
adequate warning had been given. The defendant may then rebut the presumption
with evidence that the physician's decision would not have been affected by
such a warning. Other courts have refused to create such a presumption, and
have required the plaintiff to prove that an adequate warning would actually
have changed the physician's decision. The courts have also differed in the
quantum of proof a defendant must establish to show that the physician would
have prescribed the drug even if the manufacturer had warned of the risk.
[Heafey & Kennedy, supra, at § 10.03
[*30] However, we must consider as well a case in which a
diabetic patient might have been influenced by advertising to request a drug
from a physician without being warned by the manufacturer or the physician of
the special dangers posed to a diabetic taking the drug. If an overburdened
physician does not inquire whether the patient is a diabetic, the question
remains whether the manufacturer should be relieved entirely of responsibility.
In the case of direct marketing of [***63] drugs, we believe that
neither the physician nor the [**1263] manufacturer should be
entirely relieved of their respective duties to warn. Pharmaceutical
manufacturers may seek contribution, indemnity or exoneration because of the
physician's deficient role in prescribing that drug. In each case, a jury must
resolve the close questions of whether a breach of duty has been a proximate
cause of harm, Cowan v. Doering
, 111 N.J. 451, 545 A.2d 159 (1988), and
how that causative harm, if found, may be apportioned among culpable defendants.
In our experience, jurors are extremely skilled at sorting out the justly and
legally responsible parties. See Estate of Chin v. St. Barnabas Med'l
, 160 N.J. 454, 734 A.2d 778 (1999) (explaining how jury assessed
evidence to determine relative fault of physician and attending nurses when
medical device manufacturer was relieved of liability). As our dissenting member
observes, it is still the physician in whom the patient reposes the greatest
trust for health-care decisions. Post
at 36, 734 A.2d at 1236. We are
certain that today's ruling will not alter the existing fair balance of trust
and responsibility for patient health [***64] care as between
physician and pharmaceutical manufacturer.
- - - - - -
- - - - - - - - Footnotes - - - - - - - - - - - - - - -
n6 The sale of pharmaceuticals is changing even faster
than the manufacturers themselves might have anticipated. Doctors in
"cyberspace" write prescriptions for patients whom they have never seen.
Sometimes the "learned intermediary" owns the pharmacy. Sheryl Gay Stolberg,
Internet Prescriptions Boom in the 'Wild West' of the Web,
June 27, 1999, at A1.
- - - - - - -
- - - - - End Footnotes- - - - - - - - - - - - - -
To sum up, the dramatic shift in
pharmaceutical marketing to consumers is based in large part on significant
changes in the health-care system from fee-for-service to managed care. Managed
care companies negotiate directly with pharmaceutical companies and then inform
prescribers which medications are covered by the respective plans. Because
managed care has made it more difficult for pharmaceutical companies to
communicate with prescribers, [*31] the manufacturers have developed
a different strategy, marketing to consumers.
Pharmaceutical companies have a right to communicate with the
public. These companies hope to increase their market share by making their
product well known to both patients and physicians. Pharmaceutical executives,
aware of the high levels of spending on DTC efforts, are trying to determine
how to best spend their funds to obtain the highest return on their
investment. Since the FDA Guidance was released, pharmaceutical companies have
taken consumer advertising crash courses. Pharmaceutical companies are already
seeing results in strong sales growth, due to DTC advertising.
[Terzian, supra, 25 Am. J.L. & Med. at 160-61.]
The direct marketing
of drugs to consumers generates a corresponding duty requiring manufacturers to
warn of defects in the product. The FDA has established a comprehensive
regulatory scheme for direct-to-consumer marketing of pharmaceutical products.
Given the presumptive defense that is afforded to pharmaceutical manufacturers
that comply with FDA requirements, we believe that it is fair to reinforce the
regulatory scheme by allowing, in the case of direct-to-consumer marketing of
drugs, patients deprived of reliable medical information to establish that the
misinformation was a substantial factor contributing to their use of a defective
Before concluding, we
acknowledge that the procedural posture of this case casts defendant's product
in an unfair light. Because the case arises on a motion for summary judgment, we
are obliged to view the issues in the light most favorable to the claimants. We
have no doubt that substantial proofs will be marshaled to show that Norplant is
a safe and efficacious product and that Wyeth's advertising, if any, was fairly
balanced. An agreed statement of facts submitted to the trial court suggested as
much. And Norplant probably [***66] does not afford the best context
in which to address the general question whether direct-to-consumer marketers of
pharmaceutical products are unqualifiedly relieved of a duty to warn consumers
of the dangerous propensities of a product. After all, in the case of Norplant,
the role of the physician can never be insubstantial because only a physician
may implant the [**1264] device. Just as it is difficult to legislate
a rule for every foreseeable [*32] circumstance, so too it is
difficult to create a special rule of law for a hybrid product such as
We are called upon, however, to resolve a
question of law that will apply equally as well to an unprincipled marketer of
pharmaceutical products as to a principled marketer. To place the issue in
context, consider if prescription diet drugs were heavily advertised without
warning of a known potential for heart damage.
Health hazards associated with prescription diet treatments in the
1990s . . . provide a modern example of the continuing threat posed by the
premature approval of drugs. This threat is exacerbated by unprecedented
access to information for an increasing number of patients. With access to
more and more information about new drugs, [***67] consumers not
only become empowered to direct their own treatment, but often become
demanding as well, pressuring physicians to prescribe drugs that are expensive
and sometimes ineffective at best, and harmful or even deadly at worst.
[Steven R. Salbu, The FDA and
Public Access to New Drugs: Appropriate Levels of Scrutiny in the Wake of
HIV, AIDS, and the Diet Drug Debacle, 79 B.U. L. Rev. 93, 98-99 (1999)
the normative situation for which we must decide if a pharmaceutical
manufacturer is free to engage in deceptive advertising to consumers. We believe
that the answer in such a case should be no. Any question of fairness in
imposing on the direct marketer of a product such as Norplant a duty to warn the
targeted consumers will be resolved in the proximate cause analysis.
Finally, we return briefly to the main theme of the
at 35-36, 734 A.2d at 1266, that our decision is
inconsistent with legislative mandate. We are certain that legislative
codification of the learned intermediary doctrine--which generally relieves a
pharmaceutical manufacturer of an independent duty to warn the ultimate user of
prescription [***68] drugs, as long as it has supplied the physician
with information about a drug's dangerous propensities--does not confer on
pharmaceutical manufacturers a license to mislead or deceive consumers when
those manufacturers elect to exercise their right to advertise their product
directly to such consumers.
judgment of the Appellate Division is reversed and the matter is remanded to the
Law Division for further proceedings.DISSENT
With disarming understatement, the majority
opinion raises profound questions about the purpose of judicial opinions, the
role of courts, and the separation of powers. In raising those questions, the
majority rejects the Legislature's endorsement of the learned intermediary
doctrine as set forth in N.J.S.A.
2A:58C-4. The majority opinion sustains
itself only by ignoring the plain language of an unambiguous statute, the New
Jersey Products Liability Act, N.J.S.A.
2A:58C-1 to -7 (NJPLA), and by
substituting its own policy [***69] preference for that of the
Legislature. Contrary to the majority opinion, the point of this dissent is not
that the Court should await legislative action. Ante
at 16, 734 A.2d at
1254. Rather, the point is that the Legislature has already acted. Believing
that the Court is bound by the NJPLA, I respectfully dissent.
Initially, the Law Division held that the duty of defendants Wyeth
Laboratories Inc., American Home Products Corporation, Wyeth-Ayerst Laboratories
Division of American Home Products Corporation, Wyeth-Ayerst International Inc.,
and Wyeth-Ayerst Laboratories Company ("defendants" or "Wyeth") extended not to
plaintiffs, but to their physicians or other health-care professionals. 313 N.J.
Super. 646, 658, 713 A.2d 588 (1997). The Appellate Division affirmed. 313 N.J.
Super. 511, 516, 713 A.2d 520 (1998).
On a related
issue, the Law Division held that defendants adequately
warned [**1265] the bellwether plaintiffs' physicians or other
health-care professionals of the risks associated with Norplant. 313 N.J. Super.
at 658, 713 A.2d 588. The Appellate Division likewise affirmed that holding. 313
N.J. Super. at 518, 713 A.2d 520.
reverses the judgment of the Appellate Division. I would [***70]
[*34] To place the issue in
perspective, a brief summary of relevant principles of products liability law
may be helpful. At common law, a manufacturer is strictly liable for a defective
product. Feldman v. Lederle Lab., Inc.
, 97 N.J. 429, 441-42, 479 A.2d 374
(1984) (Feldman I
). The manufacturer, however, is not liable if the
product is "unavoidably unsafe" and is "accompanied by proper warning."
at 447, 479 A.2d 374. In general, the manufacturer must communicate
this warning directly to the consumer. Niemiera v. Schneider
, 114 N.J.
550, 559, 555 A.2d 1112 (1989). With prescription drugs, the "manufacturer
generally discharges its duty to warn the ultimate user . . . by supplying
physicians with information about the drug's dangerous propensities."
This rule, known as the learned intermediary doctrine, reflects the
common law's awareness of the unique role that physicians serve in warning their
patients of the risks associated with prescription drugs. See Sterling
Drug, Inc. v. Cornish
, 370 F.2d 82, 85 (8th Cir.1966). New Jersey courts
consistently have recognized the vitality of the learned
intermediary [***71] doctrine. See, e.g.
, Bacardi v.
, 182 N.J. Super. 422, 442 A.2d 617 (App.Div.1981); Torsiello v.
, 165 N.J. Super. 311, 322-23, 398 A.2d 132 (App.Div.)
("[W]hile it is the customer who is entitled to the warning in respect of
nonprescription drugs, only the prescribing physician need be warned as to the
risks involved in a prescription drug."), certif. denied,
81 N.J. 50, 404
A.2d 1150 (1979). In 1987, the Legislature codified the learned intermediary
doctrine in the NJPLA. L.
. 197, § 4 (effective July 22,
1987). Thus, although the learned intermediary doctrine remains a common-law
rule in most states, it is now a statutory rule in New Jersey.
Before the enactment of the NJPLA, this Court had issued numerous
products liability opinions based primarily on the common law. In those
opinions, we emphasized the rights of injured persons and consumers in a
mass-marketing economy. New Jersey manufacturers, including pharmaceutical
companies, thought we had gone too far. The Legislature agreed and enacted
[*35] the NJPLA. As the passed bill memorandum to Governor Kean
The New Jersey manufacturers that have
lobbied [***72] heavily for the enactment of this bill argue that
in certain areas the New Jersey Supreme Court has gone beyond the laws of
other states. These groups state that this bill will "bring New Jersey back
into the mainstream" of product liability law. New Jersey manufacturers argue
that because certain areas of New Jersey product liability law provide more
protection for the consumer than other states, injured consumers from
out-of-state are likely to bring a lawsuit against the New Jersey
manufacturers in New Jersey. Thus, to the extent this bill conforms the New
Jersey product liability law to the law of the majority of states, New Jersey
will no longer be a "favorable forum" to out-of-state injured parties.
[Passed Bill Memorandum to Governor Thomas H. Kean on
S-2805, at 3 (July 10, 1987).]
Of special interest to the pharmaceutical companies
and the Legislature was the learned intermediary doctrine.
Analysis of the status of the learned intermediary doctrine thus
depends on the intent of the Legislature. Merin v. Maglaki
, 126 N.J. 430,
435, 599 A.2d 1256 (1992). When a statute is clear, a court need not look beyond
the statutory language to discover [***73] the legislative intent.
State v. Kittrell
, 145 N.J. 112, 123, 678 A.2d 209 (1996). The language
of the NJPLA is clear.
[**1266] The NJPLA
states that a manufacturer has a duty to include an "adequate warning or
instruction" with a product. Otherwise, the product may be considered defective.
According to the statute, an "adequate warning" is
one that a reasonably prudent person in the same or similar
circumstances would have provided with respect to the danger and that
communicates adequate information on the dangers and safe use of the product,
taking into account the characteristics of, and the ordinary knowledge common
to, the persons by whom the product is intended to be used, or in the case
of prescription drugs, taking into account the characteristics of, and the
ordinary knowledge common to, the prescribing physician.
[N.J.S.A. 2A:58C-4 (emphasis added).]
The majority finds ambiguity in the NJPLA, stating that
"[a]lthough the statute provides a physician-based standard for determining the
adequacy of the warning due to a physician, the statute does not legislate the
boundaries of the doctrine." Ante
at 16, 734 A.2d at 1254. According to
the Senate [***74] Committee statement [*36] accompanying
the NJPLA, however, a drug manufacturer's duty to warn is owed to the physician,
not the consumer:
[A] manufacturer or seller is not liable
in a warning-defect case if an adequate warning is given when the product has
left the control of the manufacturer or seller . . . . The subsection contains
a general definition of an adequate warning and a special definition for
warnings that accompany prescription drugs, since, in the case of
prescription drugs, the warning is owed to the physician.
[Senate Judiciary Committee, Statement to Senate Bill No.
2805 (L. 1987, c. 197), N.J.S.A. 2A:58C-1a (emphasis
The NJPLA provides
that "committee statements that may be adopted or included in the legislative
history of this act shall be consulted in the interpretation and construction of
this act." N.J.S.A.
2A:58C-1a; Roberts v. Rich Foods Inc.
N.J. 365, 374, 654 A.2d 1365 (1995). Through that extraordinary mandate, the
Legislature sought to preclude judicial circumvention of the plain meaning of
Today's decision demonstrates that the
Legislature's efforts were unavailing. The majority has
mischaracterized [***75] both the statute and the rationale for the
learned intermediary doctrine. Contrary to the majority opinion, the statute
directs that the warning is owed to the physician not "because drugs were then
marketed to the physician," Ante
at 16, 734 A.2d at 1254, but because the
physician is in the best position to make an individualized evaluation of the
risks of drugs and warn the patient of those risks. The patient, moreover,
cannot obtain the drugs without a prescription written by a physician.
Underlying the majority opinion is the assumption that the
Legislature in 1987 could not have anticipated the mass-marketing of
prescription drugs. That assumption, however, has no basis in the record. In
fact, the drug companies and the Legislature, like the Federal Food and Drug
Administration (FDA), were aware of such marketing. See Direct-to-Consumer
Advertising of Prescription Drugs,
50 Fed. Reg.
(commenting that "the public discussion on direct-to-consumer advertising of
prescription drugs has provided interested individuals and organizations ample
opportunity to consider and express opinions on the issue"). As
[*37] the majority opinion states: "Aware [***76] of the
potential threat to consumers when pharmaceutical companies first sought to
advertise to non-health-care professionals, the FDA, in the early 1980s
'initially imposed a [voluntary] moratorium on such advertising so that it could
study the issue more carefully; but in 1985, it lifted the moratorium, content
to apply its existing regulations to this new practice.'" Ante
at 22, 734
A.2d at 1258 (quoting Lars Noah, Advertising Prescription Drugs to Consumers:
Assessing the Regulatory and Liability Issues,
32 Ga. L. Rev. 141, 142-43
[**1267] The majority's imposition
of expanded duties on drug manufacturers contravenes the legislative history of
the NJPLA. That history demonstrates that the statute was intended to strengthen
the protections afforded manufacturers:
It is important to recognize that this
bill not only conforms New Jersey product liability law to the law of the
majority of states but, in some instances, changes New Jersey law in favor of
the manufacturer in a way that is not currently recognized by the law of the
majority of states. Thus, the effect of the enactment of this bill would be to
shift the status of the law of New Jersey [***77] on certain issues
from its current position of being more favorable to the injured consumer than
the majority of states to being more favorable to the manufacturer than the
majority of states.
[Passed Bill Memorandum to Governor Thomas H. Kean on S-2805,
supra, at 3.]
Judges, although they may disagree with a legislative policy, are bound
to respect it. In adapting the common law to society's needs, this Court may not
have favored manufacturers, including pharmaceutical companies, as
enthusiastically as has the Legislature. The issue, however, is not whether the
Court shares the Legislature's enthusiasm or even whether the majority would
prefer to amend the common-law learned intermediary doctrine. Because of the
enactment of the NJPLA, the issue is whether the majority should respect the
learned intermediary doctrine as declared by the Legislature.
As the majority recognizes, the modern law of product liability began
with Justice Francis's opinion in Henningsen v. Bloomfield Motors Inc.
32 N.J. 358, 161 A.2d 69 (1960), ante
at 21, 734 A.2d [*38] at
1257; see Prosser & Keeton on Torts
§ 97 (5th ed.1984) (describing
as "the most rapid [***78] and altogether
spectacular overturn of an established rule in the entire history of the law of
torts"). Given the prominence of that opinion, written by Justice Francis while
serving on this Court with Chief Justice Joseph Weintraub, Justice Francis's
eulogy at the proceedings before this Court in memory of Chief Justice Weintraub
is worth recalling. Justice Francis eloquently described the distinction that
the late Chief Justice drew between respecting the will of the Legislature and
adapting the common law to the needs of the time. Speaking of Chief Justice
Weintraub, Justice Francis stated:
Throughout his years on the Court, he
remained acutely aware of the line of demarcation between the judicial and
legislative branches of government, and of the duty of the judicial branch to
refrain from encroaching on the area of operation of the legislative branch.
So if a statutory rule or doctrine were in question before the Court, even if
it appeared to be inadequate to serve the needs of the times, he would declare
that the remedy was in the hands of the Legislature, and the Courts should not
[72 N.J. XIX, XXVIII-XXIX
That demarcation remains
valid today. [***79]
Given the statutory
basis for the learned intermediary doctrine in New Jersey, recourse to the
Restatement (Third) of Torts: Products Liability
§ 6 (1998)
) is gratuitous. Furthermore, the Restatement
generally endorses the traditional rule that a drug manufacturer's duty to warn
is owed to the health-care provider, not the consumer. Id.
§ 6(d)(1). The
suggests, however, that it may be appropriate to impose a
duty to warn the patient directly "when the manufacturer knows or has reason to
know that health-care providers will not be in a position to reduce the risks of
harm in accordance with the instructions or warnings." Id.
Here, the Restatement
does not apply for two reasons. First, as
prestigious as any Restatement
may be, it cannot supersede a governing
statute. Second, the surgical implantation of Norplant requires the significant
involvement of a health-care provider who must make an individualized evaluation
of the risk to the patient. Such involvement stands in
contrast [**1268] to [*39] the "diminished role as an
evaluator or decision maker" that is a predicate for liability under the
. See id
. § [***80] 6(d) comment a. That
involvement also distinguishes the implantation of Norplant from the
administration of mass inoculations, see ante
at 10-11, 734 A.2d
at 1250-51, which proceed without an individualized evaluation of the risks to
Contrary to the majority opinion, the
question is not "whether the absence of an independent duty to warn patients
gives the manufacturer the right to misrepresent to the public the product's
at 21, 734 A.2d at 1257. No defendant claims such a right.
Neither does the FDA, which regulates prescription drug advertising, allow it.
For example, FDA regulations require that print and broadcast advertisements
promoting prescription drugs be "balanced." 21 C.F.R.
Additionally, the FDA has issued a Draft Guidance that requires prescription
drug broadcast advertisements to include a thorough "major statement" in
"consumer-friendly" language about a drug's major risks. 62 Fed. Reg.
43,171; see also Guidance for Industry: Consumer-Directed Broadcast
(visited July 14, 1999)
the facts, moreover, Norplant is a poor [***81] vehicle to import so
momentous a change. Unlike other drugs that concern the majority, the record
reveals that Norplant cannot be purchased in a supermarket, see
at 4, 734 A.2d at 1247, is not promoted by health maintenance
organizations, see ante
at 18, 734 A.2d at 1255, approved by
compliant physicians to placate overbearing patients, see ante
20, 734 A.2d at 1257, or implanted over the Internet, ante
at 4, 29 n. 6,
734 A.2d at 1257, 1262. Through the incorporation of presumed facts, the
majority has created a phantom record to support the creation of its exception
to the learned intermediary doctrine. That exercise has led the majority to
wander from the confines of the present case.
is not an over-the-counter drug; it can be obtained only with a doctor's
prescription. To insert Norplant, a physician or other health-care professional
anesthetizes an area in a patient's [*40] upper arm, makes a
one-eighth-inch incision, and implants six capsules just below the patient's
skin. Similar surgery is required to remove the capsules.
The use of Norplant thus requires the significant involvement of the
prescribing physician. Even Norman Rockwell, [***82] see
at 18, 734 A.2d at 1255, would recognize the procedure as one
performed in accordance with the traditional physician-patient relationship.
Presumably, Wyeth's mass-marketing campaign has increased the demand for
Norplant and led many women to request it by name. In some contexts, the extent
to which pharmaceutical companies seek to influence consumers, like the extent
to which they seek to influence physicians, may be disturbing. Here, however,
the mass-marketing campaign apparently was ineffectual; none of the bellwether
plaintiffs saw any advertising about Norplant. The invasiveness of the Norplant
procedure, moreover, would give any patient pause and a physician cause to
evaluate the risks. As the Law Division stated, "a physician is not simply
relegated to the role of prescribing the drug according to the woman's wishes."
313 N.J. Super. 646, 648, 713 A.2d 588 (Law Div.1997).
Earlier this year, the Fifth Circuit Court of Appeals held, in a case
involving Norplant, that "as long as a physician-patient relationship exists,
the learned intermediary doctrine applies." In re Norplant Contraceptive
Prods. Liab. Litig.
, 165 F.3d 374, 379 (5th Cir.1999). [***83]
The court rejected the creation of an exception to the learned intermediary
doctrine for mass-marketed drugs. Specifically, the court stated that "Norplant
is nevertheless a prescription drug . . . [and] physicians play a significant
role in prescribing Norplant and in educating their patients about the benefits
and disadvantages to using it." Ibid.
[**1269] The majority identifies four premises underlying
the learned intermediary doctrine that it asserts are inapplicable when a
manufacturer advertises the drug directly to consumers: "(1) reluctance to
undermine the doctor-patient relationship; (2) absence in the era of 'doctor
knows best' of need for the patient's [*41] informed consent; (3)
inability of drug manufacturer to communicate with patients; and (4) complexity
of the subject." Ante
at 18, 734 A.2d at 1255. Contrary to the majority,
at 18-19, 734 A.2d at 1255-56, those four considerations remain
relevant to the implantation of Norplant.
Norplant System must be implanted surgically. Implicit in the performance of a
surgical procedure is respect for the physician-patient relationship. "[T]he
physician is in the best position to take into account the [***84]
propensities of the drug and the susceptibilities of the patient, and to give a
highly individualized warning to the ultimate user based on the physician's
specialized knowledge." Spychala v. G.D. Searle & Co.
, 705 F. Supp.
1024, 1031-32 (D.N.J.1988). Second, the physician is the only person who can
communicate with the patient to obtain the patient's informed consent to the
procedure. Third, a pharmaceutical company, such as Wyeth, cannot provide an
adequate warning to each individual consumer about the potential side-effects
and risks associated with the device. Each patient has individualized risks
associated with surgical procedures. Lastly, the Norplant implant, far more than
other birth control devices, is a complex contraceptive system that requires
detailed instructions and warnings.
To soften the
impact of its opinion, the majority creates a rebuttable presumption that a
warning is adequate if it complies with FDA regulations. Ante
at 5, 734
A.2d at 1259. Regrettably, the Court has not granted the parties the opportunity
to address the creation, nature, or sufficiency of such a presumption. To the
extent that such a presumption is essential to [***85] the majority's
rationale, the parties should have been given that opportunity. See
Office of Employee Relations v. Communication Workers
, 154 N.J. 98, 108,
711 A.2d 300 (1998); see also Canesi v. Wilson
, 158 N.J. 490,
539-41, 730 A.2d 805 (1999) (Pollock, J., dissenting). Similarly, the parties
should have been accorded the opportunity to address the issue of proximate
cause, see ante
at 25, 734 A.2d at 1260, as well as that of
contribution and indemnity from physicians, [*42] see
at 30, 734 A.2d at 1262-63. In a judicial proceeding, the test of a
hypothesis through the adversary process serves as a safeguard when addressing
issues of broad public concern, such as those introduced by the majority.
To conclude, when enacting the NJPLA, the Legislature
chose to confine the expansion of product liability law. The majority's
preference for a different policy does not justify ignoring the one chosen by
GARIBALDI, J., joins in this dissent.