(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).
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.
The 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 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 process.
Because of the procedural posture of this case, the Supreme Court was required to accept plaintiffs' version of the facts as
true. 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, Mademoiselle, 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 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, the trial court held the “learned intermediary” doctrine applicable to plaintiffs' actions.
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.” 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
Liability (1997) (Restatement) 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 review.
HELD: 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 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)
3. The Restatement 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 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. (pp. 30-31)
8. 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. 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. (pp. 37-46)
10. The direct marketing of drugs to consumers generates a corresponding duty requiring 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. 46-49)
Judgment of the Appellate Division is REVERSED and the matter is REMANDED to the Law Division for further
proceedings.
JUSTICE POLLOCK has 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.
SUPREME COURT OF NEW JERSEY
A-
16 September Term 1998
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.
Argued March 2, 1999 -- Decided August 9, 1999
On certification to the Superior Court,
Appellate Division, whose opinion is reported
at
313 N.J. Super. 511 (1998).
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, Lauren E.
Handler, Connie A. Matteo 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. Sattin,
on the brief).
The opinion of the Court was delivered by
O'HERN, J.
Our medical-legal jurisprudence is based on images of health
care that no longer exist. At an earlier time, medical advice
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,
465 A.2d 294, 299 (Conn. 1983).
Pharmaceutical manufacturers never 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 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.
The question in this case, broadly stated, is whether our
law should follow these changes in the marketplace or reflect the
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 the product.
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 as true plaintiffs' version of the 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, Mademoiselle and Cosmopolitan. 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 for advanced medical technicians in addition to general surgeons for Norplant removal. Plaintiffs assert that none of this information was provided to consumers.
In 1995, 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 Norplant users were pending in the Superior Court in Middlesex County.
After a case management conference, plaintiffs' counsel sought a determination of whether the learned intermediary doctrine applied. Pursuant to that conference, five bellwether plaintiffsSee footnote 22 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 (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. Consequently, the court held that the learned intermediary doctrine 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. Because N.J.S.A. 2A:58C-4 of the Products Liability Act, N.J.S.A. 2A:58C-1 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. The court found, however, that plaintiffs failed to provide expert testimony to rebut the statutory presumption under N.J.S.A. 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. Although the trial court listed pain and scarring associated with removal among plaintiffs' complaints, id. at 650-52, 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. at 660 n.5. Consequently, the court concluded that plaintiffs had failed to prove failure to warn and proximate cause, and dismissed plaintiffs' complaints. Id. at 660.
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 (1998). The court supplemented the trial court's opinion, comparing Section 6d of the Restatement (Third) of Torts: Products Liability (1997) (Restatement) to N.J.S.A. 2A:58C-4, the similar provision of New Jersey's Products Liability Act. Section 6(d) of the Restatement provides:
(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 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.
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 prescribing physician.
The court noted that Section 6(d)(2) of the Restatement 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. 313 N.J. Super. at 515 (citing Restatement (Third), §
6d comment b).See footnote 33 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 had been established. Ibid.
We granted plaintiffs' petition for certification.
156 N.J. 410 (1998).
In Feldman v. Lederle Laboratories, Inc., 97 N.J. 429, (1984) (Feldman I), we considered the relationship between principles of products liability law and pharmaceutical products. In Feldman I, we declined to "hold as a matter of law and policy that all prescription drugs that are unsafe are unavoidably so." Id. at 447. We explained:
Drugs, like any other products, may contain defects that could have been avoided by better manufacturing or 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)].
Moreover, even 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 (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 added.)
[Ibid. (citations omitted).]
As explained in Niemiera by Niemiera v. Schneider, 114 N.J. 550, 559 (1989):
In New Jersey, 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 Cir. 1966).
We observed that there were circumstances, such as in Davis v. Wyeth Laboratories, Inc., 399 F.2d 121 (9th Cir. 1968), in which the manufacturer should not be relieved of a duty to warn. Niemiera, supra, 114 N.J. at 559. 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 present to weigh the risks and benefits of the drug therapy for each patient.” Ibid. (quoting Reyes v. Wyeth Labs., Inc., 498 F.2d 1264 (5th Cir.), cert. denied, 419 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 (E.D. Mich. 1985) (manufacturer of oral contraceptive has duty to warn consumers directly of risks and side effects); Samuels v. American Cyanamid Co., 495 N.Y.S.2d 1006 (N.Y. 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 intermediary).
We were satisfied in Niemiera, supra, 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. 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 in which most such claims may arise.
Direct-to-Consumer Advertising
Advertising for 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 direct marketing practice." Ibid. (footnote omitted). Consider the following example:
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 television advertisement.
[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 (footnote omitted).
Pressure on consumers is an integral part of drug manufacturers' 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 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 F.D.A. Reprimands for False or Misleading Advertising, 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 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 n.1.
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 non government spending.
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 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.
. . . .
The American 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 review of 109 prescription ads found 92 per cent of the advertisements lacking in some manner.
[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." 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 them from product
risks.
[Hanson & Kysar, supra,
112 Harv.
L. Rev. at 1456.]
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 (1997). The 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.
Restatement, supra, § 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 circumstances. Ibid.
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 the
manufacturer to warn the patient directly. Id. 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,
48 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 Together,
50 Rutgers L.J. 2059, 2097 (1998). This is an
entirely appropriate resolution. Judge Cardozo, a shaper of both
the common law and of the Restatements 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 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 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 that the warning or instruction
is adequate . . . .
The Senate Judiciary Committee Statement that accompanied L.
1987, c. 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. 2A:58C-1 (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, supra,
which required that manufacturers directly warn patients in mass
inoculation cases. Rather, the statute governs the content of an
“adequate product warning,” when required. As noted, supra at
___ (slip op. at 15), 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 Statement, supra, 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. Gwinnell,
[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.
[
96 N.J. 538, 555-56 (1984) (footnote and
internal citations omitted).]
If 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.
In Reyes, supra, 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. [The
physician's] task [is to weigh] 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
omitted).]
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
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 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 omitted).]
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 Paul D. Rheingold, The Expanding Liability of
the Drug Manufacturer to the Consumer, 40 Food Drug Cosm. L.J.
135, 136 (1985)). Informed consent requires a patient-based
decision rather than the paternalistic approach of the 1970s.
See Largey v. Rothman,
110 N.J. 204, 206 (1988) (discussing
Canterbury v. Spence,
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 Rule,
46 Food Drug Cosm. L.J. 829, 831 (1991) (citing Margaret
Gilhooley, Learned Intermediaries, Prescription Drugs, and
Patient Information,
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 Prescription
Drugs, N.Y. Times, June 4, 1999, at 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.
Third, having spent $1.3 billion on advertising in 1998,
supra at ___ (slip op. at 16-17), drug manufacturers can hardly
be said to “lack effective means to communicate directly with
patients,” Noah, supra,
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 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 warm the ultimate consumer should
apply.
[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) (footnotes
omitted).]
When 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
nicotine patch warning under Texas law certified in Edwards v.
Basel Pharms.,
933 P.2d 298 (Okla. 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
Prods. Corp.,
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 MacDonald v. Ortho Pharmaceutical Corp.,
475 N.E.2d 65
(Mass.), 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. For example, after the patient receives 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. Consequently, the limited
participation of the physician leads to a real possibility that
their communication during the annual checkup is insufficient.
Id. at 138. 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. Thus, “the
physician is relegated to a . . . passive role.” Ibid.
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, supra, 110 N.J. at 212.
Accordingly, a patient must be informed of material risks, which
exist “when a reasonable patient, 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 (quoting Canterbury, supra, 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 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 (1960)] 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).]
Obviously, 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, supra, 114 N.J. at
559. Had Wyeth done just that, simply supplied the physician
with information about the product, and not advertised directly
to the patients, plaintiffs would 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
propensities.
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 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 regulation from
the brief of amicus curiae, the Pharmaceutical Research and
Manufacturers of America. Because such regulations 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. § 202.1(l)(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 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.
§352(n)(3). 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, the FDA
“[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 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. § 202.1(b)(2)).”
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.
Ibid. 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. That 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 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 to evaluate the
effects of the guidance. . . .”
62 Fed. Reg. 43,172. These FDA
actions indicate that the agency views direct-to-consumer
advertising as a means of providing consumers with improved
access to important information about prescription drugs.See footnote 44
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. Cf. Alloway v. Bradlees, Inc.,
157 N.J. 221, 236
(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.
See N.J.S.A. 2C:58-4. That presumption is not absolute. See,
e.g., Feldman v. Lederle Labs., Inc.,
125 N.J. 117, 156-7 (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 as compelling
evidence that a manufacturer satisfied its duty to warn the
physician about potentially harmful side effects of its product.
We believe that in the area of