The Learned
Intermediary Doctrine and
Direct-to-Consumer Advertising of Prescription
Drugs
I.
The learned intermediary doctrine is one of the
most important defenses available to manufacturers of medicines and medical
devices. Although it continues to be a
viable defense in many jurisdictions, at least one court has eroded that
defense in the context of direct-to-consumer (DTC) advertising. This article will discuss the history of the
learned intermediary defense and the current challenges to its continued
availability.
II.
Background and
Development
The term “learned intermediary” was first used in
1966 in an Eighth Circuit decision[1]
and since that time the doctrine has been adopted in “an overwhelming number of
jurisdictions.”[2] The learned intermediary doctrine provides
that manufacturers of prescription drugs and medical devices discharge their
duty of care to patients by providing warnings to the prescribing physicians.[3] The Fifth Circuit Court of Appeals stated the
policy behind the doctrine as follows:
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 his patient. His is
the task of weighing the benefits of any medication against its potential
dangers. The choice he makes is an
informed one, an individualized medical judgment bottomed on a knowledge of
both patient and palliative.
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.[4]
The justification for the learned intermediary
doctrine is grounded in the fact that consumers cannot buy prescription drugs
directly. Rather, they must first
consult with and receive the approval of a physician.[5] By providing adequate warnings to a
prescribing physician, who in turns provides appropriate patient-specific
warnings, the manufacturer discharges its warning responsibilities.[6]
III.
The Doctrine and the
Restatement (Third) of Torts
Although the learned intermediary doctrine is
not part of the Second Restatement of Torts, the Third Restatement, adopted in
1997, does explicitly include the learned intermediary doctrine. Section 6(d)
of the new Restatement provides:
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.[7]
This section basically states the current
learned intermediary doctrine as applied by the courts except that it extends
the duty to warn to “other health-care providers” in addition to prescribing
physicians. It has been suggested that
this provision, if adopted by courts, could substantially increase the burden
on drug manufacturers to provide warnings necessary to meet the requirements of
the learned intermediary rule. It is
unclear who is included in “other health care providers,” what type of warning
must be given to “other health care providers,” under what circumstances such
warnings must be given, or the appropriate type and method of warning.[8] It has been suggested that this may mean
manufacturers have to “determine on a drug-by-drug basis what group or class of
persons may constitute ‘other health-care providers who are in a position to
reduce the risks of harm.’”[9]
Section 6(d)(2) also incorporates another
exception to the learned intermediary doctrine.[10] The section states that a manufacturer should
provide warnings to “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.”[11] The exception has been applied in some cases,
such as mass inoculations, where a health-care provider is not in a position to
evaluate the risks of using the drug or to relate those risks to the patients.[12] In those cases, some courts have held that
the manufacturer must warn the patient directly.
Two other proposed exceptions to the learned
intermediary doctrine were in earlier drafts of the Third Restatement, but did
not make the final draft. These
proposals were mentioned, however, in Comment (e) to section 6.[13] One provided that when the Food & Drug
Administration (“FDA”) required that direct warnings be given to the patient,
the learned intermediary doctrine would not apply. The Oklahoma Supreme Court has recognized
that exception.[14]
The other proposed exception provided that when
a manufacturer of prescription drugs advertised directly to the consumer, the
learned intermediary doctrine would not shelter the manufacturer from failure to
warn claims.[15] The drafters of the Third Restatement did not
adopt this exception in the final draft.
This issue is particularly relevant when one considers the recent
increase in direct-to-consumer (DTC) advertising. Before discussing the effect of DTC
advertising on the learned intermediary doctrine, it is useful to first discuss
the history of DTC advertising in the prescription drug industry.
IV.
Direct to Consumer
Advertising: Background
Prior to the 1980's, drug manufacturers marketed
products solely to health care professionals.
Beginning approximately fifteen years ago, however, manufacturers began
limited marketing directly to the consumer.[16] Between the mid-1980's and 1997, DTC
advertising increased noticeably. It
skyrocketed beginning in August of 1997 with the FDA’s issuance of new draft
regulations liberalizing advertising requirements.[17]
When drug companies first began to use DTC
advertising, the FDA appeared to encourage the advertisements.[18] The FDA’s chief counsel at the time said the
FDA “should assure itself that the claims are true, then get out of the way,”
and that the advertisements would lead to “better informed” and “healthier
patients” who “will save money.”[19] By 1983, however, the FDA had asked drug
companies to refrain from using DTC advertising while the FDA studied the issue
and this resulted in a two-year moratorium.[20] After holding public meetings and conducting
research, the FDA decided that the regulations governing advertisements aimed
at health-care professionals would apply to DTC advertisements as well.[21] The regulations required advertisements to
include a “brief summary.”[22] The brief summary was required to be highly
inclusive, and the requirement was met in print advertisements by printing the
entire risk-related sections of the approved labeling.[23] That requirement made it almost impossible to
advertise using television or radio because of the inability to include all of
the required information in limited space and time.[24]
Nonetheless, advertising on television and radio
was possible through the use of so-called “reminder” advertisements and
“help-seeking” advertisements.[25] Reminder advertisements called attention to a
drug’s name, but did not state the condition it is used to treat.[26] The purpose of reminder advertisements was to
reinforce name recognition and brand loyalty.[27] Help-seeking advertisements, on the other
hand, did not mention the product by name, but discussed symptoms, conditions,
and diseases and encouraged consumers to see their doctors.[28] Help-seeking advertisements, while forbidden
from mentioning the product by name, could mention the manufacturer’s name.[29]
Despite the bizarre nature of DTC advertising
under the then-existing regulatory scheme, prescription drug-makers invested in
marketing directly to the consumer. By
1996, one year before the FDA relaxed advertising regulations, drug companies
were advertising directly to the consumer in the form of reminder and
help-seeking advertisements.[30]
V.
The 1997 Draft
Guidance: the FDA Changes the Rules
In August 1997, the FDA issued its “Draft
Guidance for Industry: Consumer-Directed Broadcast Advertisements,” which
greatly relaxed the DTC advertising regulatory environment. The FDA recently
finalized the new advertising guidance with few substantive changes.[31]
Although the requirement of including a brief
summary still applies to print advertisements, the burden has been lifted from
television and radio advertisements. The
“Guidance for Industry” provides that television and radio advertisements will
satisfy the requirements of the Act if the advertisements make “adequate
provision” for concerned persons to get the approved labeling.[32] To make “adequate provision,” a television or
radio advertisement must include a toll-free number for requesting information,
a web site address where such information is posted, a reference to a print ad
that includes the brief summary, and a referral to a physician or pharmacist
for additional information.[33] These requirements are designed to ensure
that those who need the information may receive it from a variety of sources,
but the information need not be included in the ad, thereby making it feasible
to actually use television and radio for prescription drug product promotion.
VI.
DTC Advertisements and
the Learned Intermediary Doctrine
As previously discussed, the drafters of the new
Restatement did not include an exception to the learned intermediary doctrine
for instances in which drug manufacturers advertise directly to consumers. The drafters did, however, mention in the
comments to the Restatement that there has been some argument that an exception
be created in the case of DTC advertising, but said “[t]he Institute leaves to
developing case law whether exceptions to the learned intermediary rule in these
or other situations should be recognized.”[34]
The New Jersey Supreme Court recently addressed
whether a “DTC” exception to the learned intermediary rule should be
recognized.[35] In Perez
v. Wyeth Laboratories, Inc., the court decided that the learned intermediary
doctrine does not apply when prescription drugs have been marketed directly to
the consumer under the circumstances of that case.[36] Perez
involved a suit by plaintiffs who had received Norplant implants. The plaintiffs argued that Wyeth’s 1991
advertising campaign for Norplant was directed at women rather than at their
doctors.[37] Because Norplant had been marketed directly
to consumers, the plaintiffs argued that the learned intermediary doctrine
should not apply.[38] The New Jersey Supreme Court agreed, becoming
the first state high court to create an exception to the learned intermediary
doctrine in the case of DTC advertising.
The New Jersey court based its holding in Perez on its finding that advertising
prescription drugs directly to consumers “alters the calculus of the learned
intermediary doctrine.”[39] It cited four justifications for the
doctrine, including the complexity of risk information about prescription
drugs, a physician’s superior capability to convey meaningful information to a
patient, drug manufacturers’ lack of effective means to communicate directly
with patients, and judicial reluctance to intrude on the physician-patient
relationship.[40] The court said that these justifications are
absent when drug companies advertise prescription drugs directly to consumers.[41]
In asserting that these factors no longer
support the application of the learned intermediary doctrine, the court focused
on the modern trend of more active patient involvement in health care decisions
and the effect that such increased involvement has had on the physician-patient
relationship. The court said that, after
seeing or hearing DTC advertisements, patients go to doctors’ offices with
preconceived expectations about treatment.[42] It expressed concern that, for instance, a
diabetic patient may request a drug from a doctor without being warned by the
manufacturer of the special dangers posed to a diabetic taking the drug.[43] The court also cited a need for increased
consumer protection in the area of elective treatments and lifestyle drugs,
such as drugs and devices women use in reproductive decisions.[44] In general, the Perez decision minimizes the importance of the physicians’
involvement in prescribing a drug.
Regardless of whether the court’s concerns about
a growing lack of involvement by physicians in prescribing drugs are valid, its
reasoning in creating an exception to the learned intermediary doctrine is
flawed. The justifications for the
doctrine are as valid today as they were when the learned intermediary doctrine
was first created. First, prescription
drugs remain complex and a physician must act as a learned intermediary in the
process of prescribing a drug. Only a physician can weigh the propensities of
the drug and susceptibilities of the patient in making a reasoned, educated
determination whether the drug should be prescribed. Second, physicians remain in a superior
position to convey meaningful information and warnings to individual patients. Only a physician may properly consider the
relevant factors in determining the effect a drug will have upon a patient,
many of which are patient-specific. A
physician can tailor warnings specifically to a patient, taking into
consideration all the factors relevant to that particular patient. Third, even though a manufacturer can
communicate with patients through advertising, a manufacturer cannot
effectively tailor warnings specifically for individual patients, taking into
consideration important patient-specific factors. Finally, requiring a manufacturer to warn a consumer
directly imposes the manufacturer into the physician-patient relationship. The decision to prescribe and the weighing of
risks for the particular patient are central to the physician-patient
relationship. Courts should not
undermine a patient’s trust in a physician’s judgment by placing the
manufacturer between physician and patient.
Although DTC advertising is now allowed, the physician-patient
relationship remains the most effective means for communicating the risks and
benefits of a particular drug for a particular patient.
The New Jersey decision does not leave drug
manufacturers completely exposed to liability for failure to warn. The court decided that, if the manufacturer
complied with FDA advertising, labeling, and warning requirements, the
manufacturer will be entitled to a rebuttable presumption that there was no
failure to warn.[45] The court said that such a presumption
ensures “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 anti-utilitarian effect.’”[46] Importantly, the court added: “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.”[47]
VII.
Conclusion
The learned intermediary doctrine should be
preserved. It requires that the
manufacturer provide an adequate warning to the trained professionals who
prescribe the products. It allows the
physician to make individualized medical judgments for particular
patients. It permits patients to obtain
reliable information from the very person who is in the best position to
provide effective warnings and answer questions -- the physician. Although DTC advertisements provide an
additional means for patients to obtain information, they in no way displace
the role of the prescribing physician.
ENDNOTES
[1] Sterling
Drug v. Cornish, 370 F.2d 82, 85 (8th Cir. 1966).
[2] Pumphrey
v. C.R. Bard, Inc., 906 F. Supp. 334, 338 (N.D.W.Va. 1995).
[3] Restatement (Third) of Torts: Products
Liability § 6 cmt. d, reporters’ note (1997).
[4] Reyes
v. Wyeth Labs., 498 F.2d 1264, 1276 (5th Cir. 1974).
[5] Karl
E. Seib Jr. & Andrew E. Miller, Courts
Should Rebuff Assault on ‘Learned Intermediary’ Rule, Andrews Pharmaceutical Litigation Reporter,
December 1997, at 12,515.
[6] Justin
T. Toth, Prescription Drugs and Medical
Devices: The Impending Impact of the Restatement (Third) of Torts in Texas,
Houston Lawyer, March/April 1998,
at 40, 41.
[7] Restatement (Third) of Torts: Products
Liability § 6(d).
[8] Id.
[9] Edward
W. Gerecke & Harvey L. Kaplan, The
Restatement (Third) of Torts and its Projected Impact Upon Manufacturers of
Prescription Drugs and Medical Devices, in Drug and Medical Device Litigation: Defense Perspectives, 2
DRI 70, 71 (1998).
[10] Restatement (Third) of Torts: Product
Liability § 6(d)(2).
[11] Id.
[12] Id. § 6 cmt. e.
[13] Id.
[14] Edwards
v. Basel Pharm., 933 P.2d 298 (Okla. 1997).
[15] Restatement (Third) of Torts: Products
Liability § 6 cmt. e.
[16] Draft
Guidance for the Industry; Consumer-Directed Broadcast Advertisements;
Availability, 62 Fed. Reg. 43171 (1997).
[17] Prescription Drug Advertising Soars Through
Third Quarter, Medical Marketing
& Media, February 1, 1999, at 22.
[18] Michael
F. Conlan, In-Your-Face Pharmacy, Drug Topics, July 8, 1996, at 98.
[19] Id.
[20] Id.
[21] Id.
[22] Warren
R. Ross, The Flood vs. The Ripples: An
Overview, Medical Marketing &
Media, November 1, 1998, at 45, 50.
[23] Draft
Guidance for the Industry; Consumer-Directed Broadcast Advertisements;
Availability, 62 Fed. Reg. 43171 (1997); Tamar Nordenberg, Direct to You: TV Drug Ads That Make Sense, FDA Consumer, January-February 1998, at 7, 9.
[24] Ross,
supra note 22, at 50.
[25] Nordenberg,
supra note 23, at 9.
[26] Id.
[27] Conlan,
supra note 18, at 98.
[28] Nordenberg,
supra note 23, at 9.
[29] Id.
[30] 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.
[31] Draft
Guidance for the Industry; Consumer-Directed Broadcast Advertisements;
Availability, 64 Fed. Reg. 43197 (1999).
[32] Id.
[33] Id.
[34] Restatement (Third) of Torts: Products
Liability § 6 cmt. e (1997).
[35] A
federal court in Massachusetts considered creating an exception, but the case
was not appropriate to rule on the issue.
The court said in a footnote:
In an appropriate case, the advertising of a prescription drug to the consuming public may constitute a third exception to the learned intermediary rule. By advertising directly to the consuming public, the manufacturer bypasses the traditional patient-physician relationship, thus lessening the role of the “learned intermediary.”
Garside v. Osco Drug, Inc., 764 F.Supp. 208, 211
n. 4 (D. Mass. 1991), rev’d, 976 F.2d
77 (1st Cir. 1992).
A
federal court in Texas has also addressed the issue. The court refused a plaintiff’s request for
an exception, saying that the FDA reviews DTC advertisements to ensure that the
advertisements are balanced and not unfair or misleading. In re
Norplant Contraceptive Products Liability Litigation, 955 F. Supp. 700, 704
(E.D. Tex. 1997). The court added that
whether such exception should ever be recognized is an issue which should
properly be resolved by the Texas Supreme Court. Id.
[36] 734
A.2d 1245 (N.J. 1999).
[37] Id. at 1248.
[38] Id. at
1248-49.
[39] Id. at 1254.
[40] Id. at
1255.
[41] Id.
[42] Id. at
1260.
[43] Id. at
1262.
[44] Id. at
1257.
[45] Id. at 1259.
[46] Id.
[47] Id.
(Authors’ bios)
Timothy
A. Pratt is a partner in the Pharmaceutical and Medical Device Litigation
Division of Shook, Hardy & Bacon L.L.P. He received his J.D. and graduated
Order of the Coif from Drake University Law School where he was editor-in-chief
of the Drake Law Review. Following
graduation Mr. Pratt was a law clerk for Hon. Floyd R. Gibson of the United
States Court of Appeals for the Eighth Circuit. He is a member of the
Federation of Insurance & Corporate Counsel and its Pharmaceutical
Litigation Section, the Defense Research Institute, the Missouri, Texas and
Iowa Bar Associations, as well as the Bars of the Fourth, Fifth, Sixth, Eighth,
Ninth and Tenth Circuit Courts of Appeal.
John
F. Kuckelman is an associate in the Pharmaceutical and Medical Device
Litigation Division of Shook, Hardy & Bacon L.L.P. He received his J.D.,
magna cum laude from Notre Dame Law School in 1999, where he was a member of
its national trial advocacy team. Mr. Kuckelman completed one year of graduate
studies as a 1995-96 Rotary Ambassadorial Scholar at Eberhard-Karls Universität
in Tübingen, in Tübingen Germany.
He is fluent in German.