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The Intersection of Madison Avenue and the Learned Intermediary Doctrine

 
By David J. Cooner of McCarter & English, LLP

INTRODUCTION

The learned intermediary doctrine emerged from the development of strict product liability law, including the recognition of a cause of action for failure to warn. At its core, the doctrine is pragmatic: it recognizes that the warnings and instructions which accompany medicines and medical devices are directed not to ultimate consumers or the end users of those products, but to the physicians who prescribe them and who are in the best position to evaluate the risks associated with their use. As a matter of practical reality, patients rely on their physicians, not manufacturers, to determine the appropriateness of prescription products.

The doctrine has proven to be a valuable defense for pharmaceutical and medical device manufacturers. It allows those companies to discharge their duty to warn by supplying adequate information about the dangerous propensities of their products directly to prescribing physicians, as opposed to consumers. Since the doctrine was first recognized some fifty years ago, it has been adopted by most state and federal courts.

Over the years, however, the doctrine has seen its share of challenges, and a few exceptions have been recognized, chiefly in the contexts of mass immunizations and family planning, areas where physicians arguably have a somewhat lesser role in connection with the prescription. Recently, with the exponential growth of direct-to-consumer advertising on television and in the print media, the doctrine has been challenged by plaintiffs' lawyers, arguing that the doctrine should be abolished (or at least modified) in cases where the industry directs its marketing effort toward patients, not merely prescribing physicians. And this past August, the New Jersey Supreme Court became the first state supreme court to address the impact of direct-to-consumer advertising on the learned intermediary doctrine, concluding that "the doctrine does not apply to the direct marketing of drugs." In so doing, the New Jersey Supreme Court overturned the opinions of the trial and intermediate appellate courts, and broke rank with the Federal District Court in Texas and the Fifth Circuit, the only other courts to squarely address the issue.

Direct-to-consumer advertising has become the fastest growing segment of pharmaceutical advertising. In the late 1990's, pharmaceutical companies have spent billions of dollars on such advertising, and today ads for pharmaceutical products are commonplace on television and radio, and in lay magazines and newspapers.

This manuscript is intended to provide an overview of (1) the learned intermediary doctrine, (2) the regulations governing direct-to-consumer advertising, (3) the emergence of direct-to-consumer advertising as a front line marketing tool, and (4) the challenges posed by the increasingly common presence of patient-directed advertisements on television and radio, and in the popular press.

The Learned Intermediary Doctrine

The Doctrine

Simply put, the learned intermediary doctrine allows manufacturers of medicines and medical devices to discharge their duty to warn by adequately advising physicians of the potential risks associated with the use of their products. The physician effectively serves as an intermediary between the manufacturer and the ultimate consumer (the patient). So long as the warning conveys adequate information to the physician concerning the product's risks and indications, the product is not defective. In short, it is not necessary for the manufacturer to warn the patient directly. See e.g., Niemiera v. Schneider, 114 N.J. 550, 559 (1989) ("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"); Alm v. Aluminum Co. of America, 717 S.W.2d 588, 592 (Tex. 1986) ("when a drug manufacturer properly warns a prescribing physician of the dangerous propensities of its product, the manufacturer is excused from warning each patient who receives the drug"). See also Kane, Construction and Application of Learned Intermediary Doctrine, 57 ALR 5th 1 (1998).

Its Rationale

The learned intermediary doctrine is premised upon the recognition that physicians are in the best position to balance the risks posed by medicines and medical devices against the susceptibilities of their patients.

By training, the physician has acquired the specialized knowledge and expertise to accord him a unique role in the delivery of medicines to consumers. He or she must determine whether the medicine is appropriate for the patient. This involves diagnosing the condition, knowing what therapies may treat the condition, understanding the risks and benefits of each of the available therapies, assessing the overall condition of the patient, determining whether the patient is an appropriate candidate for a particular treatment, and selecting the therapy the physician believes is applicable after weighing all the circumstances. Thus, the learned intermediary doctrine is based on the principle that the physician is in the best position to know both the medicine and the patient, and the duty of the manufacturer of the medicine is to provide the physician with accurate and complete information so that the physician can do his/her job.

With respect to prescription medicines, Judge Wisdom's rationale in support of the doctrine is frequently cited by courts when discussing the doctrine:

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 the patient and the palliative.

Reyes v. Wyeth Lab., 498 F.2d 1264, 1276 (5th Cir.), cert. denied, 419 U.S. 1096 (1974) (cited with approval, for example, in Torsiello v. Whitehall Lab., 165 N.J. Super. 311 (App. Div. 1979)). See also Niemiera by Niemiera v. Schneider, 114 N.J. 550, 552 (1998) ("the role of the physician with respect to DPT requires an exercise in medical judgment concerning when and under what circumstances the vaccine shall be administered"); Calabrese v. Trenton State College, 162 N.J. Super. 145, 154 (App. Div. 1978), aff'd, 82 N.J. 321 (1980) ("These drugs were manufactured for administration only by a physician or other authorized person. Generally speaking, only a physician would understand the propensities and dangers involved. The doctor is a learned intermediary between the manufacturer and the ultimate consumer."); Spychala v. G.D. Searle & Co., 705 F. Supp. 1024, 1031-32 (D.N.J. 1988) ("Because prescription drugs are often complex in formula and effect, the physician is in the best position to take into account the propensities of the drug and the susceptibilities of the patient, and to give a highly individualized warning to the ultimate user based on the physician's specialized knowledge.")

Its Early Recognition

The concept of what has become the learned intermediary doctrine was probably first articulated in Marcus v. Specific Pharmaceuticals, Inc., 77 N.Y.S.2d 508 (N.Y. Sup. Ct. 1948). There, the court recognized that the warnings accompanying a medicine were directed to physicians and held that there was no liability for the manufacturer's failure to warn consumers about a risk (potential overdose) associated with the product (a suppository).

It is difficult to see on what basis this defendant can be liable to plaintiff: It made no representation to plaintiff, nor did it hold out its product to plaintiff as having any properties whatsoever. To physicians it did make representations. . . . The sole claim is not misrepresentation or even concealment, but a negligent failure to give adequate information, and in some instances a failure to use adequate means to call attention to the information given. It may be safely conceded that these allegations would be sufficient if the product were sold to the public generally as a drug for which no physician's prescription was necessary. The situation alleged is materially different. There is no reason to believe that a physician would care to disregard his own knowledge of the effects of drugs and hence of the quantity to be administered, and substitute for his own judgment that of a drug manufacturer. Nor is there any reason to expect that if a doctor did choose to rely on the information given by the manufacturer he would prescribe without knowing what that information was. In the absence of any such grounds for belief there would be no negligence.

77 N.Y.S.2d at 509-10 (emphasis added). In short, since the warnings were not issued to the ultimate consumers, there would be no basis for liability against a manufacturer which allegedly failed to warn the patient.

Some twenty years later, the term "learned intermediary doctrine" was coined as the Eighth Circuit observed that the physician stood as a "learned intermediary" between the manufacturer and the patient:

We are dealing with a prescription drug rather than a normal consumer item. In such a case, the purchaser's doctor is a learned intermediary between the purchaser and the manufacturer. If the doctor is properly warned of the possibility of a side effect in some patients and has advised of the symptoms normally accompanying the side effect, there is an excellent chance the injury to a patient can be avoided.

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

Its Broad Acceptance

Most states have expressly or implicitly recognized the doctrine. See generally Kane, Construction and Application of Learned Intermediary Doctrine, 57 ALR 5th 1 (1998) (citing cases and identifying jurisdictions embracing the doctrine). In addition to prescription medicines, the doctrine has been applied in scores of cases involving medical devices, including catheters, pacemakers, breast implants, bone plates and screws, etc. Id. at 73-77 (citing cases).

The Creation of Limited Exceptions

The learned intermediary doctrine has been challenged, and its breadth has been limited (albeit slightly) in some jurisdictions in some contexts. The limitations typically come into play when the physician is not involved with (or has a very limited role in connection with) the dispensing of a prescription medicine. In such circumstances, the manufacturer may have a duty to warn the patient directly.

Mass Immunizations: An exception to the doctrine has been recognized in connection with mass immunizations. In such cases, the physician cannot provide individualized balancing of the risks posed by a vaccine, especially where the medicine is provided to most anyone who requests it. See Davis v. Wyeth Lab., Inc., 399 F.2d 121, 131 (9th Cir. 1968). See also Edwards v. Basel Pharmaceuticals, 933 P.2d 198, 301 (Okla. 1997).

(This exception is abrogated somewhat, at least in part, by the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. 300aa-14(a), which established a no fault recovery system.)

Oral Contraceptives: An exception to the doctrine has also been recognized in connection with oral contraceptives. In McDonald v. Ortho Pharmaceutical Corp., 475 N.E.2d 65, 72 (Mass.), cert. denied, 474 U.S. 920 (1985), the court held that a manufacturer of oral contraceptives owes a duty to consumers to warn of the product's dangers. Id. 475 N.E.2d at 68. The court determined that oral contraceptives are different from other prescription medicines because the patient is more actively involved in the decision-making process. Id. at 69. Moreover, women tend to take oral contraceptives over long periods of time, often without contact with their physicians. The court reasoned that physicians perform a "relatively passive role" in connection with the prescription of oral contraceptives, as opposed to the role taken with respect to most other prescription medicines. Id.

The oral contraceptive exception has also been recognized by a Federal District Court in Michigan; however, the opinions were issued in the absense of controlling state law. See Odgers v. Ortho Pharmaceutical Corp. 609 F.Supp. 867 (E.D. Mich. 1985) (manufacturer has a duty to warn user of potential side effects); Stephens v. G.D. Searle & Co., 602 F.Supp. 379 (E.D. Mich. 1985) (same).

The oral contraceptive exception was also recognized by a Federal District Court in Wisconsin in Lukaszewic v. Ortho Pharmaceutical Corp., 510 F.Supp. 961 (E.D. Wisc. 1981). But that case was atypical, both in terms of its rationale and the facts upon which it was premised, i.e., plaintiff did not receive a package insert with her oral contraceptives, which in itself violates federal regulations. The court held that the failure constituted negligence.

(Most jurisdictions have refused to exempt oral contraceptives from the learned intermediary doctrine. See e.g., Spychala v. G.D. Searle & Co., 705 F. Supp. 1024, 1031-33 (D.N.J. 1988) (applying New Jersey law); MacPherson v. G.D. Searle & Co., 775 F. Supp. 417, 425 (D.D.C. 1991) (applying District of Columbia law); Reaves v. Ortho Pharm. Corp., 765 F. Supp. 1287, 1290-91 (E.D. Mich. 1991) (applying Michigan law); Zanzuri v. G.D. Searle & Co., 748 F. Supp. 1511, 1514-15 (S.D. Fla. 1990) (applying Florida law); Stafford v. Nipp, 502 So. 2d 702, 704 (Ala. 1987); West v. Searle & Co., 806 S.W.2d 608, 613-14 (Ark. 1991). See also Kane, Construction and Application of Learned Intermediary Doctrine, 57 ALR 5th 1, 27 (1998) ("most of the courts confronted with the issue have reasoned that birth control pills are sufficiently similar to traditional prescription drugs as to warrant application of the [learned intermediary] doctrine").)

Intrauterine Devices: Also in connection with family planning, an exception to the learned intermediary doctrine was recognized by the Eighth Circuit in a case involving an intrauterine device. In Hill v. Searle Laboratories, 884 F.2d 1064 (8th Cir. 1989) the court analogized IUDs to other forms of birth control, and observed that the physician generally does not make an individualized medical decision about the suitability of the product for a particular patient. Relying upon the rationale underpinning the mass immunization and oral contraceptive exceptions, the court noted the highly private nature of the decision to choose a particular method of birth control, the fact that IUDs are often given in clinic-conditions, the fact that the Food and Drug Administration (FDA) requires patients to receive more information from the manufacturer, and the lack of on-going contact between the patient who is receiving the IUD and her doctor. Id. at 1071. Notably, that court also stated that the manufacturer had conducted "mass advertising and merchandising" in marketing the product directly to consumer, which made it "difficult for consumers to fully understand the risks with using an IUD." Id. at 1070.

* * *

Direct-to-Consumer Advertising: While the subject of direct-to-consumer advertising is discussed at length below, it is addressed initially here in the contexts of exceptions to the learned doctrine. As noted, the New Jersey Supreme Court has limited the breadth of the doctrine, holding that it is inapplicable in cases where pharmaceuticals have been directly marketed to consumers. Perez v. Wyeth Laboratories, 161 N.J. 1, 21 (1999). Other courts have considered the same issue, and have reached a different conclusion, while still others have suggested that the issue should await consideration.

For example, a Federal District Court in Massachusetts has questioned, in dicta, whether, in an appropriate case, "the advertising of a prescription drug to the consuming public may constitute a third exception to the learned intermediary rule." Garside v. Osco Drug, Inc. 764 F.Supp. 208, 211 n.4 (D. Mass. 1991), rev'd on other grounds, 976 F.2d 77 (1st Cir. 1992). In addition, the Oklahoma Supreme Court held that the learned intermediary doctrine did not apply in a failure-to-warn action brought against a nicotine-patch, reasoning that FDA regulations required patch manufacturers to provide certain warnings directly to consumers. Edwards v. Basel Pharmaceuticals, 933 P.2d 298 (Okla. 1997). Those and other cases, including the New Jersey Supreme Court's opinion, are discussed further below.

Its Incorporation Into The Restatement

The Restatement (Third) of the Law of Torts recognizes the viability of the learned intermediary doctrine, even in an era of direct-to-consumer advertising. The Restatement, however, notes that there may be occasions when pharmaceutical and medical device manufacturers must issue warning directly to consumers.

Under the Restatement, a prescription medicine or medical device may be found defective because of inadequate instructions or warnings if:

Reasonable instructions or warnings regarding foreseeable risks of harm are not provided to:

  1. prescribing and other healthcare 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 healthcare providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings.

The Restatement, therefore, expressly recognizes the doctrine by requiring that the warning be directed to the healthcare providers. But it goes on to recognize an exception, which would require direct patient warnings if the healthcare provider is not "in a position to reduce the risks of harm in accordance with the instructions or warnings." Thus, on its face, the Restatement suggests that a manufacturer may be held liable even if adequate warnings were given to the prescribing physician (or healthcare provider).

The commentary to Section 6 suggests that the (d)(2) exception may apply only "in certain limited therapeutic relationships [where] the physician or other healthcare provider has a much-diminished role as an evaluator or decision-maker. In these instances it may be appropriate to impose on the manufacturer the duty to warn the patient directly." See Comment b. By way of an example, the commentators note that direct patient warnings may be necessary in the mass immunization context:

In such programs, healthcare providers are not in a position to evaluate the risks attendant upon use of the drug or device or to relate them to patients. When a manufacturer supplies prescription drugs for distribution to patients in this type of unsupervised environment, if a direct warning to patients is feasible and can be effective, the law requires measure to that effect. Id.

In short, while the Section 6(d)(2) exception suggests that a manufacturer may be held liable even if adequate warnings were given the prescribing physician, the commentary suggests that it simply codifies the mass immunization exception recognized in case law and discussed above.

Direct-to-consumer advertising is specifically addressed in Comment e. The drafters, however, refused to address whether there should be such an exception to the learned intermediary doctrine. After discussing the competing points of view, they left it "to developing case law" to determine whether such an exception should be adopted. Id.

The Regulatory Framework Governing Direct-to-Consumer Advertising

As part of the 1962 amendments to the Food, Drug and Cosmetic Act, Congress granted the Food and Drug Administration express authority to regulate prescription drug advertising. See Drug Amendments of 1962, Pub. L. No. 87-781, 76 Stat. 780. Pursuant to regulations implementing those amendments, a prescription drug can be "misbranded" -- subjecting its manufacturer to criminal and other penalties -- if its advertising is false or misleading, fails to reveal material facts, or fails to present a fair balance of information. 21 C.F.R. § 202.1(e)(5) (1997). The FDA has broad jurisdiction over all manner of advertising, including that "in published journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication systems." 21 C.F.R. § 202.1(l)(1).

Since securing jurisdiction over prescription drug advertising over 35 years ago, the FDA has aggressively regulated the area. A special division within the FDA -- the Division of Drug Marketing, Advertising and Communications ("DDMAC") -- is charged with policing the advertising of prescription medicines. Through 1997, the FDA had issued dozens of "Guidance For Industry" documents, interpreting the multitude of regulations governing various facets of prescription drug advertising. See Prescription Drug Advertising and Promotional Labeling, 62 Fed. Reg. 14,912 (1997) (setting forth list).

The regulations governing prescription drug advertising are fairly extensive and comprehensive. Pharmaceutical manufacturers have little leeway in presenting advertisements for their products. The regulations prescribe certain information that must appear in every ad, and proscribe use of a wide array of information in any ad. Format, as well as content, is regulated.

The following overview of the applicable regulations shows how different prescription drug advertising is from that for other products.

Regulations Applicable to All Prescription Medicine Advertising

Historically, the FDA's regulations controlling prescription drug advertising have not differentiated between communications directed principally to physicians, and those directed to lay audiences. All advertising, irrespective of its target audience, must generally comply with the extensive requirements set forth at Part 202 of the Code of Federal Regulations. The CFR regulations 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)). A list of just some of Part 202's requirements and prohibitions underscores the unique regulatory environment in which manufacturers wishing to advertise prescription drugs must operate:

  • Prescription drug advertisements must set forth the same listing of ingredients as they appear on the product's label, but "the advertisement shall not employ a fanciful proprietary name for the drug or any ingredient in such a manner as to imply that the drug or ingredient has some unique effectiveness or composition . . . ." § 202.1(a)(3);

  • "The advertisement shall not feature inert or inactive ingredients in a manner that creates an impression of value greater than their true functional role in the formulation." § 202.1(a)(4);

  • Advertisements may not designate a drug or ingredient by a proprietary name that "may be confused with the proprietary name or the established name of a different drug or ingredient." § 202.1(a)(5);

  • Manufacturers must follow precise rules regarding size and placement of a drug's established and proprietary names. § 202.1(b)(1) and (2);

  • Each advertisement must contain a "true statement of information in brief summary relating to side effects, contraindications, and effectiveness." § 202.1(e). The so-called "brief summary" requirement is, as one commentator has observed, "inaptly named."[1] The "brief summary" requirement has caused prescription drug manufacturers to include with advertisements the lengthy and detailed list of side effects, contraindications, warnings, precautions and the like that are included in the product information supplied to physicians. The "brief summary" (that accompanies print advertisements of prescription drugs) is sometimes much longer than the ads themselves. Until very recently, this requirement has been the major impediment to television and other broadcast media-based advertising of prescription drugs directly to consumers;

  • Prescription drug advertisements must present information "in fair balance." § 202.1(e)(6). This requirement imposes significant restrictions on what may, and may not, be contained in a prescription drug advertisement.

The foregoing are but a sampling of a much longer list of requirements contained in Part 202.

Special Regulations Applicable to Consumer-Directed Broadcasts

Until 1997, Part 202's requirements effectively precluded the use of consumer-directed prescription drug ads on television and radio. Section 202.1(e)(1) required that broadcast media-based ads contain the "brief summary" -- which, as discussed above, is not "brief" at all -- of side effects and contraindications, unless "adequate provision is made for dissemination of the approved or permitted package labeling." 21 C.F.R. § 202.1(e). Since, as a practical matter, there was no way to include the lengthy and detailed information regarding side effects in a television or radio advertisement, such ads were not undertaken.[2] In the words of one commentator, "the brief summary requirement makes non-print advertising nearly impossible. . . ." Lars Noah, Advertising Prescription Drugs to Consumers: Assessing the Regulatory and Liability Issues, 32 Ga. L. Rev. 141, 148 (1997).

In August 1997, the FDA disseminated a draft "Guidance For Industry" that created special guidelines for manufacturers seeking to advertise prescription drugs through broadcast media. More particularly, the FDA presented methods for broadcast advertisers to comply with the requirement that they make "adequate provision" for dissemination of the approved package labeling. Under the guidelines, a prescription drug maker wishing to advertise on television or radio must:

  1. include in the advertisement a thorough "major statement" conveying all of the product's most important risk information. Information relevant to the product's indication must be communicated "in consumer-friendly language" and the ad must not be otherwise false or misleading.

  2. provide acceptable means for meeting the "adequate provision" requirement. That requirement may be met by providing all of the following:

    1. toll-free telephone number for consumers to call for the approved product information;

    2. "a mechanism to obtain package labeling for consumers with restricted access to sophisticated technology, such as the Internet, as well as those who are not active information seekers." This could include a statement in the broadcast advertisement that additional product information is provided with print advertisements;

    3. a statement that pharmacists and physicians are available to provide additional product information;

    4. an Internet web page address that provides access to the product information.

Draft Guidance for Industry: Consumer-Directed Broadcast Advertisements, 62 Fed. Reg. 43,171 (1997).

As with all drug advertising, broadcast-media ads must not be misleading, must present information in fair balance, and must otherwise comply with Part 202's restrictions.

In addition to promulgating these guidelines, the FDA set a two-year period in which it would collect data and evaluate the impact of the Guidance, as well as broader issues relating to direct-to-consumer advertising. 62 Fed. Reg. 43,172.

* * *

In short, prescription pharmaceutical ads are not like other advertising. Pharmaceutical makers who wish to advertise their products to consumers work under tight constraints set by the FDA.

The Proliferation of Direct-To-Consumer Advertising

Following the relaxation of FDA regulations concerning direct-to-consumer advertising, pharmaceutical manufacturers have poured billions of dollars into television, radio and print ads. In so doing, the industry has employed a wide array of patient-directed promotion more commonly associated with consumer products. Jingles, coupons, money back guarantees and celebrity endorsements now play a role in the marketing of prescription medicines. (Of course, the ads are not quite the same as those for consumer products, as they must comply with FDA regulations, including those discussed previously.)

The ads have become ubiquitous. It is rare to pick up a magazine or watch television in the evening without confronting direct-to-consumer advertising. In 1998, manufacturers spent more than $100 million per month on consumer advertising. See "Influencing Doctor's Orders," New York Times, Nov. 17, 1998 at C1. See also "Healthcare's Future in Baby-Boomers' Hands," Orange County Reporter, January 11, 1999 at B5 (noting that consumer-directed advertising of prescription products more than doubled from $600 million in 1997 to $1.3 billion in 1998).

The ads have paid dividends for manufacturers, as sales growth has followed the marketing effort. The ads have been particularly common and effective with respect to allergy treatments. "Influencing Doctor's Orders," New York Times, Nov. 17, 1998 at C1. Sales have soared for allergy medicines such as Claritin, Allegra and Zyrtec, which are advertised on television and in magazines. Joan Lunden, the former host of ABC's "Good Morning America," is a spokesperson for Claritin and has appeared in television and print advertising for the medicine. Another Claritin ad uses the song "Walking on Sunshine" as a bed for actors frolicking, allergy-free, in a commercial that is somewhat similar to a music video.

Not all advertising is directly product specific. For example, Bob Dole, who acknowledged taking an anti-impotence medicine after undergoing prostate surgery, participated in a public service-like announcement concerning erectile dysfunction. In the spot, Mr. Dole says, "It may take a little courage to ask your doctor about erectile dysfunction, but everything worthwhile usually does." The campaign was sponsored by Pfizer, the manufacturer of the medicine that Mr. Dole took following his surgery. See "A Dose of Madison Avenue," The Kansas Star, March 28, 1999 at F1.

A recent Louis Harris Survey found that nearly 30% of patients who had taken a prescription medicine said that they had spoken with their physician about a medicine they had seen advertised. See "Influencing Doctor's Orders, New York Times, November 17, 1998 at C10.

Manufacturers claim that direct-to-consumer advertising enhances the physician patient relationship, results in better informed patients, and encourages patients to seek treatment for treatable conditions. Moreover, of course, before any medicine can be dispensed, a prescription is required; as a result, physicians still stand as gatekeepers between the patient and the product, thereby ensuring that a specific determination is made as to the appropriateness of the medicine.

Despite the foregoing, as direct-to-consumer advertising has become commonplace, some manufacturers have been criticized. For example, Sidney Wolfe, M.D., Director of Public Citizen's Research Group, calls the ads "a major step backward for the health of people in this country."

There have been reports of the FDA having to reprimand manufacturers concerning their direct-to-consumer advertising. See e.g., "FDA Scold Drugmakers for Misleading Ads," Product Liability Law and Strategy, Volume XVII, No. 10 at 6 (April, 1999); Terzin, Diret-To-Consumer Advertising, 25 Am. J.L. & Med. 149 (1999) ("FDA has already warned many pharmaceutical companies that their advertisements do not fully comply with [Guidance for Industry: Consumer-Directed Broadcast Advertisements] regulations").

And David Kessler, M.D., the former Commissioner of the FDA, recently warned manufacturers that the proliferation of such advertising will inevitably lead to litigation. "One day in a courtroom," Dr. Kessler said, "I assure you, one of you is going to have your [direct-to-consumer] ads played." David Kessler, M.D. "Drug Makers Warned of Risky TV Ads," The Star Ledger, June 11, 1998 at 39. While the day about which Dr. Kessler warned has yet to come, the courts have addressed the issue of direct-to-consumer advertising.

The Challenges Posed By Direct-to-Consumer Advertising

The learned intermediary doctrine has proven to be a valuable defense for pharmaceutical and medical device manufacturers. To date, the exceptions to the doctrine clearly represent minority positions. Nevertheless, it is clear that the protection afforded by the doctrine is not absolute. And the growth of direct-to-consumer advertising presents new and potentially significant challenges to the doctrine. As the Restatement commentators observe, the continued viability of the doctrine in the face of direct-to-consumer advertising will be left to developing case law.

Several courts have had an opportunity to consider the effect on the learned intermediary doctrine in the context of direct-to-consumer advertising, both before and after the Restatement, but to date, none except for the New Jersey Supreme Court has taken action to revoke or limit the doctrine. Other courts, however, have commented upon its continued viability (and its possible abrogation).

Prior to the New Jersey Supreme Court's decision in Perez, several courts have foreshadowed the challenges posed by direct-to-consumer advertising upon the learned intermediary doctrine. The following representative cases have discussed the learned intermediary issue in the context of consumer-directed advertising and other consumer-directed promotion of prescription medicines.

Squarely Foreshadowing The Challenge

Garside v. Osco Drug, Inc., 764 F. Supp. 208 (D. Mass. 1991), rev'd on other grounds, 976 F.2d 77 (1st Cir. 1992).

The Federal District Court in Massachusetts stated, in dicta, that in an appropriate case, the advertising of a prescription medicine to the public may give rise to an exception to the learned intermediary rule:

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." Id. at 211 n4 (emphasis added).

(Since, however, there was no advertising directly to the consumer in this case, the Garside court commented that such an exception would not apply in any event.)

Shanks v. Upjohn Co., 835 P.2d 1189 (Alaska 1992).

In a case alleging that plaintiff's decedent committed suicide because of a defective prescription medicine, the court, in a footnote, questioned whether a medicine marketed directly to the public may give rise to a duty to warn patients directly:

With certain types of prescription drugs, the role of the doctor in the decision to use a specific product is significantly reduced. Examples of such atypical prescription products include contraceptives, where the patient initiates and directs the usage, drugs typically administered in a clinical setting with little or no physician involvement, or drugs marketed under a strategy to appeal directly to the consuming public. These are areas where courts have held the manufacturers have a duty to warn patients directly. Id. 1195, n. 7 (emphasis supplied).

Foreshadowing the Challenge In Related Settings

Edwards v. Basel Pharmaceuticals, 933 P.2d 298 (Okla. 1997) (examining learned intermediary doctrine in context of FDA-mandated patient warnings).

In this case, the Tenth Circuit certified to the Oklahoma Supreme Court a question concerning the applicability of the learned intermediary doctrine in a case involving a prescription nicotine patch. The court held that the learned intermediary doctrine was inapplicable in a wrongful death action stemming from a death allegedly caused by overuse of the patch.

The manufacturer argued that the learned intermediary doctrine relieved it of liability because the physician-directed literature was adequate and contained a warning on point. However, the FDA-mandated and approved direct-to-patient warnings did not include the warning directly on point. The Oklahoma Supreme Court held that the doctrine did not apply:

When direct warnings to the user of a prescription drug have been mandated by a safety regulation promulgated for the protection of the user, an exception of the learned intermediary doctrine exists, and failure on the part of the manufacturer to warn the consumer can render the drug unreasonably dangerous. 933 P.2d at 301.

The Court concluded as follows:

We hold that when the FDA requires warnings be given directly to the patient with a prescribed drug, an exception to the learned intermediary doctrine has occurred and the manufacturer is not automatically shielded from any liability by properly warning the prescribing physician. When this happens the manufacturer's duty to warn the consumer is not necessarily satisfied by compliance with FDA minimum warning requirements. The required warnings must not be misleading and must be adequate to explain to the user the possible danger associated with the product. Whether that duty has been satisfied is governed by the common law of the state, not the regulations of the FDA and necessarily implicates a fact-finding process, something beyond our assignment in response to this certified question. Id. at 303 (emphasis added).

(Even though this case does not address the issue of direct-to-consumer advertising per se, the court's reasoning may be used to support the relaxation or abrogation of the learned intermediary doctrine in some circumstances.)

Polley v. Ciba-Geigy Corporation., 658 F.Supp. 420 (D.Alaska 1987) (examining learned intermediary doctrine in context of a patient brochure).

In this case, the manufacturer claimed that "patient brochures" were irrelevant to a manufacturer's duty to warn because, pursuant to the learned intermediary doctrine, warnings were owed to the prescribing physician alone. The Federal District Court upheld the learned intermediary doctrine, agreeing with a previous state court order that the plaintiff would be precluded from arguing or presenting evidence in support of the proposition that the defendant had a duty to warn plaintiff directly of the dangers associated with using its product. 658 F. Supp. at 422. In so doing, however, the court held that the brochures would be relevant and could be admissible if they "shed[] light on whether or not the manufacturer fulfilled its duty to warn physicians." Id.

The court also declined to certify the issue of whether direct patient warnings abrogated the learned intermediary doctrine, observing that "every single court which has considered the issue in the context of prescription medicines -- except for oral contraceptives or mass immunization, situations in which the physician's traditional role as a learned intermediary is minimized -- has concluded that there is no duty on the part of the manufacturer to warn the patient directly of risks inherent in the prescription medicine." Id. at 422-23.

(This case would be helpful in the defense of the doctrine as the court's analysis focuses how the literature is relevant to the manufacturer's duty to warn the physician.)

Presto v. Sandoz Pharmaceuticals Corporation, 487 S.E.2d 70 (Ga. App. 1997) (examining learned intermediary doctrine in the context of a voluntarily provided patient-directed pamphlet).

In this case the court refused to invalidate the learned intermediary doctrine in a case where the manufacturer of an anti-psychotic medicine provided a pamphlet proving product information directly to consumers. The plaintiff abruptly stopped taking the medicine and died. Plaintiffs argued that since the manufacturer undertook, voluntarily, the duty to provide the pamphlet, it should have warned that one should gradually reduce the dose before one stops taking the medicine. The court disagreed, concluding that, while the pamphlet did give some information, the plaintiff could not, as a matter of law, have reasonably relied on the pamphlet for warnings concerning the dangers of discontinuing the use of the medicine. The court explained its reasoning as follows: "The pamphlet does not constitute an effort to inform patients of all the dangers of [the medicine] and does not purport to do so. The booklet states that it 'provides answers to many questions about [the medicine]' but cautions the reader 'if there are other questions about [the medicine], be sure to ask the doctor, nurse or pharmacist'." Id. at 549.

(This case would be helpful in the defense of the doctrine as the court's analysis focuses how the literature in question was intended only to answer frequently asked questions about the medicine, not supplant physician-directed materials. In addition, it advised users to consult with their providers.)

Squarely Facing the Challenge

To date, courts in two jurisdictions (Texas (federal court) and New Jersey (state court)) have squarely faced the issue of direct-to-consumer advertising and its affect, if any, upon the learned intermediary doctrine. The issue was first confronted in the Federal District Court in Texas, and then in the Fifth Circuit, where the courts preserved the doctrine as it stood for the past few decades. Then, the same result was reached as the issue was considered by the trial and intermediate appellate courts New Jersey. Those decisions were reversed by the New Jersey Supreme Court in . Perez v. Wyeth Laboratories, 161 N.J. 1, 21 (1999).

Texas
In re Norplant Contraceptive Prod. Liab. Litig., 165 F.3d 374 (5th Cir. 1999), aff'g 955 F. Supp. 700 (E.D. Tex. 1997).
The Federal District Court in Texas held that defendant's marketing campaign with respect to Norplant prescription contraceptives, including direct-to-consumer advertising of the product, did not affect the learned intermediary because plaintiffs never saw any advertising prior to the implant of Norplant. 955 F. Supp. 705-07. The court commented that "whether a drug manufacturer's use of direct-to-consumer advertising is ever grounds for creating an exception to the learned intermediary doctrine remains to be seen." Id. At 708 (emphasis added). The court held that the issue "should be resolved by the Texas Supreme Court." Id.

On appeal to the Fifth Circuit, plaintiff argued, inter alia, that defendant engaged in aggressive marketing, and therefore should not be afforded the protection of the learned intermediary doctrine. The court rejected the argument, ruling that none of the plaintiffs had relied on any marketing materials in selecting the Norplant device. 165 F.3d at 379. The court further stated, "It seems clear, however, that even if the facts were in [the plaintiff's] favor, [the plaintiff] would still lose." Id. The court reasoned that, under Texas law, "as long as a physician-patient relationship exists, the learned intermediary doctrine applies." Id.

New Jersey
Perez v. Wyeth Labs., Inc., 161 N.J. 1, rev'g, 313 N.J. Super. 511 (App. Div. 1998), aff'g 313 N.J. Super. 646 (Law Div. 1997).
In this Norplant case, plaintiffs relied upon, among other things, the dicta in Garside v. Osco Drug, Inc., supra, arguing that the learned intermediary doctrine should not apply when a manufacturer has advertised directly to the general public. They contended that the manufacturer's advertising campaign caused women to ask their physicians to prescribe and implant Norplant to the exclusion of other methods of birth control.

The trial court rejected the plaintiffs' contentions, stating that "[e]ven though a woman may investigate various methods of contraception and be influenced by a manufacturer's advertising campaign, a physician is not simply relegated to the role of prescribing the drug according to the woman's wishes." 313 N.J. Super. at 658. The court further observed that the physician must still determine whether the product is appropriate after weighing its risks and benefits. The court concluded as follows:

Thus, although a manufacturer may directly advertise to the consuming public, it is still protected by the learned intermediary doctrine when it adequately warns the physician or other qualified healthcare worker. Id.

On appeal, the Appellate Division affirmed, in large part on the strength of the "comprehensive decision" of the trial court. The court "specifically agree[d]" that no "relaxation of the learned intermediary doctrine governing prescription drugs" was warranted, even where the product had been "advertised directly to consumers." 313 N.J. Super. at 516. The New Jersey Supreme Court granted certification. 156 N.J. 410 (granting certification). Oral argument was heard in April, and the court's opinion was issued on August 9, 1999: it reversed the opinions of the lower courts and became the first state high court to address the impact of direct-to-consumer advertising on the learned intermediary doctrine.

The supreme court's opinion was somewhat fractious. The justices split 5-2, with the majority holding that "the learned intermediary doctrine does not apply to the direct marketing of drugs to consumers." 161 N.J. at 21. The Court appeared determined to reach that result, as it largely ignored (or dismissed with only limited analysis) such thorny problems as the fact that none of the plaintiffs in the case ever saw any Norplant ads, and New Jersey's Product Liability Act specifically directs that a pharmaceutical manufacturer's duty is to warn the physician, not the patient. Justice Pollock raised these issues in a pointed dissent, in which, among other things, he accused the majority of violating the prerogatives of the Legislature, overstepping its authority, and creating a "phantom record" to support its decision.

CONCLUSION

The learned intermediary doctrine had become a bedrock principle of pharmaceutical and medical device products liability law over the past few decades. Efforts to limit the doctrine have not generally been successful. And while some courts have crafted exceptions to the doctrine, they have been limited to unique contexts and have not been universally embraced.

The doctrine as we now know it, however, has been threatened. The traditions upon which it was premised are changing. HMO's have transformed the physician-patient relationship. The Internet has fueled the public's growing demand for information about all sorts of products and services, including information about their own medical care. And the competitive marketplace, including competition from generic manufacturers, has made pharmaceutical manufacturers even more covetous of market share and brand recognition. Efforts in that regard now include sophisticated direct-to-consumer marketing.

Such advertising, of course, does not afford carte blanche access to manufacturers' prescription products, but evidence shows that advertising fuels demand. Even so, consumer-directed advertising does not diminish one of the most important considerations underlying the doctrine: to purchase a medicine, a person must go to his physician and obtain a prescription. The physician has legal and ethical obligations to assess the risks, benefits and appropriateness of the use of any product in the treatment of an individual patient.

Nevertheless, the dynamic is changing. Some commentators and courts have questioned the continued viability of the doctrine. And the Restatement, while recognizing the doctrine, states that there may be some contexts when warnings must be directed to the patient. Beyond that, the New Jersey Supreme Court, concerned to some degree that pharmaceutical advertising may mislead consumers, struck a recent blow to the doctrine, limiting its application in cases where products are advertised directly to the public.

The bright line protection once afforded by the doctrine may be eroding.. Manufacturers which use direct-to-consumer ads may face additional litigation, and they may find it somewhat more difficult to extricate themselves from failure to warn claims. Also, they may find challenges to the meaning of "direct-to-consumer" in the context of the advertising of prescription medicines, especially in an age where anyone with a computer and internet access can obtain a wealth of information concerning a wide range of products available only by prescription.

The contours of the doctrine are likely to change in the coming years.

ACKNOWLEDGEMENTS

I would like to thank John F. Brenner, Jerry P. Sattin and Eric R. Fish of McCarter & English, LLP, and Lawrence J. Myers of Smith, Helms, Mulliss & Moore, LLP, for their input in connection with this manuscript.




[1] Lars Noah, Advertising Prescription Drugs to Consumers: Assessing the Regulatory and Liability Issues, 32 Ga. L. Rev. 141, 148 (1997).

[2] The regulations did not prohibit so-called "reminder" ads on radio or television. These are advertisements that call attention to the name of a drug, but provide no information about its indications or dosage. 21 C.F.R. § 202.1(e)(2)(i).






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