The Learned Intermediary Doctrine and

 Direct-to-Consumer Advertising of Prescription Drugs

 

 

Timothy A. Pratt

John F. Kuckelman

 

 

I.

 

Introduction

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.