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 Post subject: FTC Takes Issue with LASIK Eye Surgery Advertising
PostPosted: Fri Aug 25, 2006 11:32 pm 
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FTC Takes Issue with LASIK Eye Surgery Advertising

Robert M. Portman, JD, MPP Theresa A. Chmara, JD

For some time, the Federal Trade Commission (FTC) has warned that medical providers and companies must be cautious in making advertising claims about the efficacy and safety of the services they provide to consumers. Recently, the FTC took action against two large providers of laser in situ keratomileusis (LASIK): Laser Vision Institute, LLC (LVI) and LCA Vision, Inc. (LCA).1 The FTC alleged that both providers made false and unsubstantiated claims related to the efficacy of the surgery. In addition, the FTC charged that LVI made false claims about "free" consultations and that LCA made unsubstantiated safety claims about LASIK services.

In March 2003, both companies signed consent orders agreeing not to make similar claims in the future. Providers of LASIK services must take heed: The FTC is watching and is prepared to institute actions against advertisers that make claims considered to be false, deceptive, or misleading.

Federal and State Advertising Guidelines
In general, FTC rules and guidelines state that an advertiser may not make a material representation about its product or service that is false or that would deceive or mislead a reasonable consumer. The FTC will assess an advertisement in its entirety to determine its explicit and implicit messages. In its evaluation, the FTC will examine the general messages in the advertisement as well as consumer or expert testimonials. Moreover, the FTC will require objective, quantifiable claims to be supported by competent scientific studies. The FTC has made clear that "[a]necdotal evidence and consumer testimonials are not considered competent and scientific evidence."2

Testimonials, in general, must reflect the honest opinions, findings, beliefs, or experience of the endorserwhether a consumer or an expert. Claims made by a person providing a testimonial must be substantiated directly by the advertiser. Any material connection between the endorser and the seller must be disclosed if the connection is not readily apparent (e.g., the patient is a celebrity and it is apparent he or she would be paid for the endorsement). If representing that he or she has used the product or service, the endorser must be a bona fide user of the product. Moreover, statements in the testimonial about the endorser's experience with the product or service must be typical of other consumers' experience with the product.

Certain states, such as New York, Texas, and Illinois, prohibit physicians from using testimonial advertising.3 However, those laws have recently been called into question. For example, an intermediate appellate court in Illinois held that a blanket prohibition on physician testimonial advertising violates the First Amendment of the United States Constitution.4 The Illinois Department of Professional Regulation subsequently filed and then withdrew its appeal to the Illinois Supreme Court. The Attorney General of Texas issued an opinion letter stating that a similar statute in Texas would likely be found to violate the federal Constitution on First Amendment grounds if challenged in court.5 Nonetheless, advertisers must be very cautious when using testimonial claims and should avoid doing so entirely in New York.

In providing specific guidance to eyecare providers, the FTC states that "advertisements, promotional brochures, informational tapes, seminars and other forms of marketing of RK [radial keratotomy], PRK [photorefractive keratectomy], or LASIK [laser assisted in-situ keratomileusis] to consumers should not contain express or implied claims that are false or unsubstantiated, or omissions of material information."6 Moreover, the FTC cautions that "claims regarding success rates, long-term stability or predictability of outcome would also need to be substantiated by competent and reliable scientific evidence."7 Finally, the FTC has warned eyecare providers that "representations made about the safety or efficacy of RK, PRK, or LASIK may, in certain circumstances, require disclosures of material information about health risks or limitations associated with the surgery to prevent deception."8

Thus, advertisers of refractive eyecare surgery services must be vigilant in avoiding any material deception, must include any material information about their product or service, and are required to substantiate all objective claims, whether made through testimonials or other forms of advertising. In two recent instances, the FTC concluded that advertisers of refractive eyecare surgery services materially misled consumers by failing to adhere to these guidelines.

Laser Vision Institute
The FTC charged that LVI advertising made the following unsubstantiated claims regarding the efficacy of the services they offered: (1) LVI's LASIK services will eliminate the need for glasses and contacts for life; (2) LVI's LASIK services will eliminate the need for reading glasses; (3) LVI's LASIK services will eliminate the need for bifocals. The FTC argued that these false messages were conveyed by the following advertising claims:

? A testimonial from a surgeon urging consumers to "[e]liminate your need for reading glasses. . . . I did, and I do surgery with it."
? "Come see how this miraculous, effective, and simple procedure can eliminate a lifetime of dependence on glasses and contacts in a matter of seconds!"
? "You may never need contacts or glasses again!"
? "Imagine freedom from your ill-fitting, uncomfortable glasses that constantly fog up. Imagine life without the daily hassle of contact lenses that dry out or tear. Thanks to the Laser Vision Institute, you may say goodbye to glasses or contact lenses. . . ."9
The FTC complaint alleged these advertising claims were unsubstantiated. The agency focused specifically on the fact that "LASIK surgery does not eliminate most peoples' need for reading glasses."10 In its consent order with the FTC, LVI agreed not to make these claims without "competent and reliable scientific evidence that substantiates the representation."11

The FTC plainly concluded that claims that consumers could "eliminate" their need for glasses or bifocals, say "goodbye" to their glasses or contact lenses, and eliminate a "lifetime of dependence" on glasses imply the advertised surgery will last forever and remove the need for any type of glasses. Because the advertiser did not have competent, reliable scientific evidence to support this claim, the FTC took issue with the advertising.

The FTC also claimed that LVI made advertising claims that deceptively claimed the company offered a "free" consultation to determine the actual candidacy of a consumer for surgery. The FTC alleged this message was conveyed through advertising claims stating "call or come by anytime for a free consultation" and "book a free consultation."12 The advertising also referred specifically to the fact that "[a]t the Laser Vision Institute we will conduct a thorough evaluation to determine candidacy for LASIK." In fact, the FTC found that the claims regarding a "free" consultation were not truthful:

In truth and in fact, consumers do not receive a free consultation that determines their candidacy for LASIK. Indeed, consumers receive a free, initial meeting with an LVI representative. At this meeting, consumers receive a quoted price for the procedure based on their prescription and other desired services, and are required to pay a $300 deposit before the risks and limitations of LASIK are disclosed to them and their candidacy is determined by a health care professional at a future time. The $300 deposit is non-refundable if, after the consultation, consumers elect not to undergo the procedure. Consumers are refunded $200 of the deposit if they are later rejected as medical candidates.13

Advertisers must be extremely careful when claiming that an offer is "free" and explain exactly what is being offered. Advertisers must also be certain that there are no hidden costs that would transform a "free" offer into one that requires payment.

LCA-Vision, Inc. Doing Business as LasikPlus
The FTC charged that LCA advertising made the following unsubstantiated claims regarding the efficacy of the services they offered: (1) LCA's services will eliminate the need for glasses and contacts for life; (2) LCA's services pose significantly less risk to patients' eye health than wearing glasses or contacts; (3) LCA's services will eliminate the risk of glare and halos, a starburst effect around lights at night that can be caused by the LASIK procedure.14 The FTC argued that the false messages regarding efficacy were conveyed by the following advertising claims:

? An announcer statement that "now there's a way you could be free from your glasses or contacts forever. . . . You could enjoy a lifetime of better sight in just minutes with LasikPlus."
? A graphic stating, "A LIFETIME OF BETTER SIGHT . . . IN JUST MINUTES!"
? A newspaper print advertisement stating, "Now you can afford to get rid of your glasses and contacts for life! So many former eyeglass and contact lens wearers are celebrating the fact that Laser Vision Correction has improved their lives and released them from the on-going hassle and expense of glasses and contacts."
? Outside billboard advertisements stating, "Now you can afford to get rid of your corrective lenses for life!"
? Direct mail advertising stating, "Fed up with the ongoing expense and hassle of contacts? LasikPlus lets you throw away your lenses for life! . . . With LasikPlus laser vision correction, you could have a lifetime of better sight without lenses!"15
The many references to "forever," "a lifetime of better sight," and the ability to eliminate glasses or contacts "for life" contributed to the FTC's concern that consumers would be misled about the efficacy and long-term effects of the surgical procedure.

In addition, the FTC took issue with LCA's advertising claims regarding the safety of LASIK compared to that of wearing contact lenses. As support for its complaint, the FTC highlighted the claims that "[p]eople who wear contact lenses face many more risks from infection or corneal damage" and "laser vision correction can eliminate risks often associated with wearing contacts or glasses." The FTC concluded that LCA did not have competent scientific support for its claims that contact lenses are less safe than LASIK surgery.

Finally, the FTC charged LCA with falsely claiming that its procedure could correct the effect of glare and halos; LCA made the following claim:

Glare and halos at night are caused when the treatment area does not cover the total area of the dilated pupil. This may create a starburst effect around lights at night. Those providers who offer a choice of the latest FDA approved laser technology can customize the treatment area to accommodate almost any pupil size. This virtually eliminates the risk of glare or haloing.16

The FTC complaint alleged these advertising claims were unsubstantiated and that LCA did not have scientific support for its claim that its procedure was more effective than any other procedure in eliminating glare or halos. In its consent order with the FTC, LCA agreed not to make any of the challenged claims without "competent and reliable scientific evidence that substantiates the representation."17

Comment
These recent FTC actions and resulting consent decrees demonstrate that advertisers of refractive eye surgery must avoid aggressive marketing campaigns that tout the efficacy, safety, or benefits offered by a particular LASIK provider unless the claims can be substantiated by competent and reliable scientific evidence, including comparison studies when appropriate. Advertisers must also be very careful about making the claim that any part of the consultation is "free" and should be cautious about using testimonials that might be misleading to consumers.

The FTC's recent actions confirm that the federal agency is prepared to pursue LASIK providers that launch advertising campaigns without proper substantiation. In particular, without competent and reliable scientific studies, refractive surgery practices must do the following:

? Avoid claims that LASIK surgery will eliminate the need for glasses or contact lenses "forever" or "for life."
? Avoid claims about the superior effect of a particular refractive surgery practice (i.e., with respect to elimination of glare and halos) without competent, scientific, comparative studies.
? Avoid claims that consultations are "free" without adequately explaining the precise information that is offered in the "free" consultation.
In addition, Lasik providers must examine their advertising scrupulously to ensure that there are no false, deceptive, or misleading statements or implicit messages that might confuse or mislead consumers. Finally, advertisers should use only their own patients for testimonials and ensure that the person providing the testimonial speaks honestly only about his or her experience.

Robert M. Portman, JD, MPP, and Theresa A. Chmara, JD, are partners
in the Washington, D.C., office of Jenner & Block. Portman chairs the firms'
Health Care Practice Group.
E-mail: rportman@jenner.com or tchmara@jenner.com.

Footnotes
1. In the Matter of Laser Vision Institute, LLC, File Number 022-3053; In the Matter of LCA-Vision, Inc. d/b/a LasikPlus, File No. 022-3098

2. Federal Trade Commission, "Marketing of Refractive Eye Care Surgery: Guidance for Eye Care Providers," Dec. 1997 (http://www.ftc.gov/bcp/guides/eyecare2.htm)

3. See, e.g., 225 ILCS ? 60/26; NY Education Law ? 6530(27)(a)(iii); Texas Occupations Code ? 101.201(b)(4)

4. Snell v. Dept. of Professional Regulation of the State of Illinois, 318 Ill. App. 3d 972, 742 N.E.2d 1282, 252 Ill. Dec. 418 (Ill. App. Ct., 4th Dist.), appeal allowed, 195 Ill.2d 572, 754 N.E.2d 1292, 257 Ill. Dec. 897 (Ill. 2001)

5. Tex. Atty. Gen. Op. JC-0458, 2002 WL 199725 (Tex. A.G.)

6. Federal Trade Commission, "Marketing of Refractive Eye Care Surgery: Guidance for Eye Care Providers," Dec. 1997 (http://www.ftc.gov/bcp/guides/eyecare2.htm)

7. Ibid.

8. Ibid.

9. In the Matter of Laser Vision Institute, LLC, File Number 022-3053, Complaint ? 7

10. Ibid., Complaint, ? 10

11. In the Matter of Laser Vision Institute, LLC, File No. 022-3053, Agreement Containing Consent Order, Section I

12. In the Matter of Laser Vision Institute, LLC, File Number 022-3053, Complaint ? 7

13. Ibid., Complaint, at ? 12

14. In the Matter of LCA-Vision, Inc. d/b/a LasikPlus, File No. 022-3098,
Complaint, ? 5

15. Ibid., Complaint, ? 4

16. bid., Complaint, ? 4

17. In the Matter of LCA-Vision, Inc. d/b/a LasikPlus, File No. 022-3098, Agreement Containing Consent Order, Section I



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_________________
Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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