Journal of Refractive Surgery

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Legal Perspectives 

Patient Testimonials and Radial Keratotomy Marketing-Effective, But Beware

Alan E Reider; Michael Eaton, JD

Abstract

In many areas of the United States, you cannot turn on the radio or read a newspaper without encountering ads containing patient testimonials, such as, "RK is the best thing that happened to me since I met my husband," or "I was able to throw my glasses away after RK." Aggressive mass-marketing campaigns have spread across the country to appeal to the millions of prospective refractive surgery candidates in the United States. Although effective, these ads are often criticized. As noted in a recent New York Times article (by Jane Brody, June 1, 1994):

Rather than going into the surgery with both eyes open, literally and figuratively, many patients are so swayed by personal and professional testimonials that they ignore the very real risks of the procedure....

While ophthalmology has been in the forefront of recognizing the possible benefits of truthful patient testimonials in advertising, this form of marketing is highly regulated. Thus, refractive surgeons who consider marketing programs which include patient testimonials must be sensitive to various legal and regulatory issues.

The focus of this article will be on the limitations imposed by the Federal Trade Commission (FTC), state regulation of physician advertising, and ethical standards. We will save for another day the broader issues presented by the FTC's recent initiation of a sweeping investigation into radial keratotomy advertising claims. That effort, by the FTC's Boston Regional Office, does not specifically target testimonials, but it does demand that radial keratotomy advertisers provide their substantiation for a number of specific claims, including any claim that radial keratotomy eliminates the need for glasses or corrective lenses.

REGUUDION BY THE FEDERAL TRADE COMMISSION

The FTC views endorsements and testimonials in advertising as an area with significant potential for deception. Consequently, the FTC has issued regulations providing specific guidelines on the permissible use of endorsements and testimonials which apply to all advertisers, including physicians or medical practices. The FTC standard for a testimonial is that:

LaJn advertisement employing an endorsement reflecting the experience of an individual or group of consumers Lie, patients] on a central or key attribute of the product or service will be interpreted as representing that the endorser's experience is representative of what consumers will generally achieve...! 16 C.F.R. §255.2(a)]

Furthermore, advertisements presenting endorsements by persons purporting to be consumers (ie, patients), must be actual patients [16 C.F.R. §255. 2(b)]. Statements made in testimonials (including verbal statements, demonstrations, or depictions of the name or likeness of an individual) must be truthful, nondeceptive, representative of the typical experience of other patients, and able to be substantiated by data from the physician's actual practice. The FTC has recently challenged a number of testimonials, especially for weight loss programs, because the experience portrayed was not that of a typical patient. If a radial keratotomy testimonial contains a statement from a patient whose experience was atypical - as to visual acuity after the procedure, pain, recovery time, resumption of normal activities, or any other material fact - the atypical nature of that patient's experience should be clearly disclosed.

STATE REGULATION

Virtually all states, either through their medical practice acts or consumer protection laws, regulate physician advertising. Thus, physicians need to understand the marketing practices which are allowed in their state. For example, some states (such as Illinois, New York, and Texas) specifically prohibit all use of patient testimonials. Although the constitutionality of those broad prohibitions is questionable, physicians in those states must be wary of such restrictive laws.

ETHICAL STANDARDS

Physicians should also be cautious about the use of testimonials due to ethical concerns. Patient testimonials require special attention because they can be misleading…

In many areas of the United States, you cannot turn on the radio or read a newspaper without encountering ads containing patient testimonials, such as, "RK is the best thing that happened to me since I met my husband," or "I was able to throw my glasses away after RK." Aggressive mass-marketing campaigns have spread across the country to appeal to the millions of prospective refractive surgery candidates in the United States. Although effective, these ads are often criticized. As noted in a recent New York Times article (by Jane Brody, June 1, 1994):

Rather than going into the surgery with both eyes open, literally and figuratively, many patients are so swayed by personal and professional testimonials that they ignore the very real risks of the procedure....

While ophthalmology has been in the forefront of recognizing the possible benefits of truthful patient testimonials in advertising, this form of marketing is highly regulated. Thus, refractive surgeons who consider marketing programs which include patient testimonials must be sensitive to various legal and regulatory issues.

The focus of this article will be on the limitations imposed by the Federal Trade Commission (FTC), state regulation of physician advertising, and ethical standards. We will save for another day the broader issues presented by the FTC's recent initiation of a sweeping investigation into radial keratotomy advertising claims. That effort, by the FTC's Boston Regional Office, does not specifically target testimonials, but it does demand that radial keratotomy advertisers provide their substantiation for a number of specific claims, including any claim that radial keratotomy eliminates the need for glasses or corrective lenses.

REGUUDION BY THE FEDERAL TRADE COMMISSION

The FTC views endorsements and testimonials in advertising as an area with significant potential for deception. Consequently, the FTC has issued regulations providing specific guidelines on the permissible use of endorsements and testimonials which apply to all advertisers, including physicians or medical practices. The FTC standard for a testimonial is that:

LaJn advertisement employing an endorsement reflecting the experience of an individual or group of consumers Lie, patients] on a central or key attribute of the product or service will be interpreted as representing that the endorser's experience is representative of what consumers will generally achieve...! 16 C.F.R. §255.2(a)]

Furthermore, advertisements presenting endorsements by persons purporting to be consumers (ie, patients), must be actual patients [16 C.F.R. §255. 2(b)]. Statements made in testimonials (including verbal statements, demonstrations, or depictions of the name or likeness of an individual) must be truthful, nondeceptive, representative of the typical experience of other patients, and able to be substantiated by data from the physician's actual practice. The FTC has recently challenged a number of testimonials, especially for weight loss programs, because the experience portrayed was not that of a typical patient. If a radial keratotomy testimonial contains a statement from a patient whose experience was atypical - as to visual acuity after the procedure, pain, recovery time, resumption of normal activities, or any other material fact - the atypical nature of that patient's experience should be clearly disclosed.

STATE REGULATION

Virtually all states, either through their medical practice acts or consumer protection laws, regulate physician advertising. Thus, physicians need to understand the marketing practices which are allowed in their state. For example, some states (such as Illinois, New York, and Texas) specifically prohibit all use of patient testimonials. Although the constitutionality of those broad prohibitions is questionable, physicians in those states must be wary of such restrictive laws.

ETHICAL STANDARDS

Physicians should also be cautious about the use of testimonials due to ethical concerns. Patient testimonials require special attention because they can be misleading or misinterpreted. As explained by the American Medical Association (AMA), in its Code of Medical Ethics, Standard 5.02, Advertising and Publicity:

...Nothing in this opinion is intended to discourage or to limit advertising and representations which are not false or deceptive within the meaning of Section 5 of the Federal Trade Commission Act. At the same time, however, physicians are advised that certain types of communications have a significant potential for deception and should, therefore, receive special attention. For example, testimonials of patients as to the physician's skill or the quality of the physician's professional services tend to be deceptive when they do not reflect the results that patients with conditions comparable to the testimoniant's condition generally

The same caution is expressed by the American Society of Cataract and Refractive Surgery (ASCRS), in its Guidelines for Advertising Cataract and Refractive Surgery:

Patient testimonials. Advertising· that includes patient testimonials about an ophthalmologist should be actual and should reflect only representative results in the ophthalmologists practice.

In some states, even if the use of patient testimonials is not specifically prohibited, the state medical practice act (for example, Va. Code Ann. § 54.1-291419]) may state that it is grounds for disciplinary action if a physician violates an ethical standard. In such states, the use of unrepresentative patient testimonials could be considered professional misconduct based on noncompliance with ethical standards of the AMA.

An additional consideration is that compliance with national ethical standards, such as those promulgated by the AMA, may be required by local hospital bylaws. Thus, if a hospital has such a provision in its bylaws, a physician could lose his or her staff privileges for using a patient testimonial which does not comply with the ethical standards discussed above.

MALPRACTICE LIABILITY

The requirement that all testimonial statements reflect the general experience of the physician's patient population is important, not only to avoid allegations with respect to deceptive advertising, but also to decrease liability exposure (ie, malpractice or lack of informed consent). All testimonial information must be viewed from the perspective of its effect on a "reasonable person." All statements in a testimonial must be consistent with the information which is provided to a patient in the informed consent procedure and not subject to contrary interpretation. Statements made in testimonials cannot undermine or minimize the risks or complications associated with the surgical procedure. For example, if a testimoniant states that there was "no pain" with the procedure, a potential malpractice plaintiff could claim that he or she relied upon this statement in the decision to undergo the surgery and was misinformed.

While patient testimonials may be effective and are often included in packaged marketing materials distributed by advertising firms, testimonials should be used with caution. The text of such marketing materials needs to be reviewed carefully for compliance with federal and state requirements.

10.3928/1081-597X-19950101-06

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