for making deceptive claims in their advertising.

Here's what you can do:

1. File a Private Attorney General Action for false or misleading advertising.

The definition of unfair business practices is very broad. If there is ANYTHING false or misleading in a doctor or laser center's advertising, ANYONE can bring a lawsuit against them.  You do not have to be their patient, and the action can be strictly in the name of protecting the general American public.

There are three ways that justice can be served in these cases:

1. Disgorgement of all profits from LASIK--everything they have profited can be taken away from them.

2. Restitution for what has wrongfully been taken.  This means restoring to the original condition.

3. Court-Compelled Notice- to invite ALL of a doctor/center's previous patients to assert a claim against them.  Every patient would be notified by the court.

The state-imposed limits on pain and suffering do not apply to consumer fraud, therefore caps such as MICRA in California are not imposed on judgments for fraudulent claims in advertising. Also, malpractice insurance does not typically cover this, so the doctor may find himself without any assistance from his insurance carrier.

If you have had LASIK or PRK and did not receive a Patient Information Booklet, it's going to be impossible for a doctor to defend himself against consumer fraud. No jury is going to forgive a doctor who intentionally withholds warnings from the patient.

2.  Report false or misleading advertising to the FDA and FTC.

These reports can be filed online by clicking on the following links:

FTC (Federal Trade Commission) 

"Use this form to submit a complaint to the Federal Trade Commission (FTC) Bureau of Consumer Protection about a particular company or organization. The information you provide is up to you. However, if you do not provide your name or other information, it may be impossible for us to refer, respond to, or investigate your complaint or request. To learn how we use the information you provide, please read our Privacy Policy. While the FTC does not resolve individual consumer problems, your complaint helps us investigate fraud, and can lead to law enforcement action. The FTC enters Internet, telemarketing, identity theft and other fraud-related complaints into Consumer Sentinel, a secure, online database available to hundreds of civil and criminal law enforcement agencies worldwide."

Report a Problem to the Federal Trade Commission 

FDA (Food & Drug Administration) 

http://www.fda.gov/cdrh/lasik/contact.htm

For comments about LASIK, LASIK advertising, complaints, etc. 

https://www.accessdata.fda.gov/scripts/medwatch/

"Our MedWatch Online form is available to you for the voluntary reporting of serious adverse events, potential and actual medical product errors, and product quality problems associated with the use of FDA-regulated drugs, biologics, devices, and dietary supplements. With the click of a button, you can complete, print, and submit the voluntary MedWatch Form (3500) online through the World Wide Web."

Canadian patients http://www.consumer.ca/laser.htm

Robert M. Portman, JD, MPP

 

As competition among LASIK (laser in situ keratomi-leusis) adopting aggressive marketing strategies to attract prospective patients. Claims of superior outcomes, statements such as "throw away your glasses" and "20/20 vision or your money back," and the use of celebrity and patienttestimonials are just some tactics LASIK practices are using to increase their volumes.

 

But this kind of advertising is not without risk. The Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) have been keeping a close eye on advertising pertaining to LASIK and photorefractive keratectomy (PRK). At the same time, each state has consumer protection and other laws to shield their citizens from false and deceptive advertising. Many states also have statutes specifically targeted at physician advertising, and some preclude testimonials. In addition, the American Society of Cataract and Refractive Surgery (ASCRS), American Academy of Ophthalmology (AAO), and other ophthalmic organizations have developed guidelines for marketing refractive surgery that are useful to both providers and patients. The failure to take heed of these laws and professional standards could land your practice in very hot water.

 

Federal Regulation
The FTC and the FDA share jurisdiction over refractive surgery advertising. In general, the FTC is responsible for protecting consumers against false or misleading advertising and other deceptive trade practices. The FDA regulates drugs and medical devices, including the advertising or labeling of devices such as the excimer laser. The agency has approved certain lasers as safe and effective for LASIK, PRK, and other specific uses. Thus far, the Summit, VISX, and Technolas 217 lasers have been approved for LASIK. For any other laser, LASIK is still considered an "off-label" use of the laser. Although the FDA does not regulate physicians' off-label uses of medical devices, it does have jurisdiction over physician advertising of such devices.

 

According to the FTC, an advertisement is deceptive under the Federal Trade Commission Act if it contains a material representation or omission of fact that is likely to mislead consumers acting reasonably under the circumstances. Advertisers are also responsible for claims that are reasonably implied from their statements. These rules apply to all advertisements, including consumer testimonials. In addition, advertisers must be able to substantiate all objective claims they make about a product or service.

The FTC has provided the following specific guidance about refractive surgery marketing:

 

Under FTC law, therefore, advertisements, promotional brochures, informational tapes, seminars and other forms of marketing of RK [radial keratotomy], PRK, or LASIK to consumers should not contain express or implied claims that are false or unsubstantiated, or omissions of material information. In particular, claims that convey an inaccurate impression about the safety, efficacy, success or other benefits of any form of refractive surgery would raise deception concerns. For example, an unqualified claim for PRK or LASIK that patients can "throw away their glasses" would be suspect. . . .

 

Even a more limited claim made for any of these surgeries, suggesting only that patients who are nearsighted, with no other refractive vision deficiencies, can "throw away their eyeglasses" may also be deceptive, without further qualification, if, after surgery, a significant number of patients require eyeglasses for best vision, for reading, or under particular circumstances, such as for night driving. . . .

 

Finally, representations about the safety or efficacy of RK [refractive keratectomy], PRK, or LASIK may, in certain circumstances, require disclosures of material information about health risks or limitations associated with surgery to prevent deception. For example an advertisement containing express or implied representations that surgery is safe may also need to contain information about any significant risks associated with surgery, and for PRK or LASIK, with the particular laser in use.1

The FTC further stated, "In the context of claims about the safety, efficacy, success or other benefits of [refractive surgery], substantiation will usually require competent and reliable scientific evidence sufficient to support the claim that is made."2

 

The FTC has also adopted guidelines concerning use of endorsements and testimonials in advertising.3 The FTC defines endorsements or testimonials as "any advertising message (including verbal statements, demonstrations, or depictions of the name, signature, likeness or other identifying personal characteristics of an individual or the name or seal of an organization) which consumers are likely to believe reflects the opinions, beliefs, findings, or experience of a party other than the sponsoring advertiser."4

 

In general, the FTC guidelines require that testimonials reflect the honest opinions, findings, beliefs, or experience of the endorser. Testimonials may not contain deceptive representations or representations that cannot be substantiated directly by the advertiser. For example, although the exact words of the endorser need not be used, statements must not be distorted or used out of context. If there is a connection between the endorser and the seller that might materially affect the credibility of a testimonial and the connection is not reasonably apparent or expected (e.g., if a patient is not a celebrity and is being paid for a testimonial), that fact must be disclosed. Further, if the advertisement represents that an endorser has used the product, the endorser must be a bona fide user of the product. Therefore, if an individual offers a testimonial related to his or her experience with refractive surgery, the individual must be a patient who has actually had the procedure.

 

Patient testimonials also must not be otherwise misleading and should be representative of the experiences of other refractive surgery patients treated by the advertising physician.

The FDA has also weighed in on the issue of refractive surgery marketing. In a joint letter from the FDA and the FTC in 1996, the agencies warned against manufacturers or practitioners promoting the excimer laser for off-label uses. A year later, an official from the FDA's Office of Ophthalmic Devices told ASCRS that physicians are free to describe the LASIK procedure and to call themselves LASIK surgeons in their advertising and marketing materials. They are also free to refer to their practices as "LASIK centers." However, the agency reiterated that surgeons may not advertise the laser for off-label uses.5

 

The FTC's primary remedy against false and misleading advertising is to seek injunctive relief.6 However, courts have forced some advertisers to pay civil penalties in cases in which they have been unjustly enriched by false advertising.7 The FDA cannot impose penalties against a physician who merely advertises his or her services, but can seek injunctive relief and civil or criminal penalties against a physician who advertises a medical device in a manner that is inconsistent with its FDA-approval status.8

 

State Law
Every state has general consumer protection laws that prevent deceptive trade practices. For example, Texas law provides that false, misleading, or deceptive acts or practices in the conduct of trade or commerce are unlawful.9 The statute cites the following activities, among others, as examples of deceptive practices: (1) causing confusion or misunderstanding as to the source, sponsorship, approval, or certification of goods or services,10 and (2) representing that goods or services have sponsorship, approval, or characteristics that they do not.11 Similarly, New York law provides that false advertising in the conduct of any business, trade, or commerce or in the furnishing of any service is unlawful.12 California law provides that it is unlawful to, among other things, make or disseminate untrue or misleading statements in any advertising material with the intent of selling goods or services.13

 

Many states also have specific laws that restrict physician advertising. Following are some examples:

In Maryland, advertisements by physicians may not contain (1) "[s]tatements intended to, or likely to, create false or unjustified expectations of favorable results," or (2) "[s]tatements containing representations or implications that in reasonable probability can be expected to cause an ordinary prudent person to misunderstand or to be deceived."14

Virginia's regulations of physicians provide that "[i]t shall be considered unprofessional conduct for a licensee of the board [of Medicine] to publish an advertisement which is false, misleading, or deceptive."15

 

The District of Columbia's regulations prohibit a health professional from making a communication that contains "material misrepresentations or omits to make a representation necessary to make the statement considered as a whole not misleading."16

 

Illinois law explicitly provides that "[i]t is unlawful for any [physician] licensed under this Act to use testimonials or claims of superior quality of care to entice the public."17 New York and Texas also preclude the use of testimonials by physicians.18

 

These regulations typically grant the relevant medical boards the power to take disciplinary action (including reprimand, suspension, or revocation of the physician's license) against a physician whose advertisements violate the applicable regulations.19 State attorneys general typically have the authority to seek injunctive relief and civil penalties against individuals who or entities that violate general consumer protection laws.

 

ASCRS/AAO Guidelines
In addition to federal and state law, ASCRS, AAO, and other ophthalmic organizations have issued guidelines intended to assist practitioners and consumers in avoiding or identifying confusing claims about refractive surgery that might run afoul of the FTC and FDA rules. These guidelines can be found on ASCRS' web site at http://www.ascrs.org/members/rkguidelines.html (see sidebar on page 38).

 

Comment
The temptation to make broad claims about the safety and effectiveness of current refractive surgery techniques, to brag about high success rates, and to use patient or celebrity testimonials is understandable given the growing competition in the refractive surgery market. But succumbing to this temptation could raise a legal risk for the surgeon and his or her practice.

 

Refractive surgery practices should exercise caution in developing their marketing strategies to ensure that all claims made are consistent with FTC, FDA, and industry guidelines and capable of substantiation by scientific and medical evidence. This means the practice must be diligent in monitoring the activities of outside marketing firms to ensure they understand and comply with these ground rules. The surgeon and his or her office administrator must review and approve all proposed advertisements and marketing materials before they hit the street or the airwaves. While they're at it, refractive surgeons should also make sure that their informed-consent process is thorough and consistent. For instance, patients should be told of the possible risks, complications, and side effects of LASIK and PRK, as well as any off-label aspects of their surgery.

Failure to take these precautions could result in a surprise visit from a federal or state official, fines, and possible disciplinary action against the surgeon's medical license. Exaggerated claims of safety and effectiveness can also increase the risk of being sued by patients whose outcomes do not match the representations that induced them to have the surgery in the first place. The surgeon can reduce these risks by following the guidelines discussed above and in the sidebar, by being personally involved in reviewing advertising copy and other marketing materials, and by resisting the temptation to adopt overly aggressive marketing strategies.

 

Advertising Guidelines
The ASCRS and AAO guidelines for marketing refractive surgery are divided into claims about effectiveness, safety, permanence and predictability, success rates, and painlessness. These guidelines provide a useful summary of some of the do's and don'ts of refractive surgery advertising.

 

1. Effectiveness. Claims such as "throw away your glasses" and "see naturally with refractive surgery" may be misleading because the data show that refractive surgery patients often still need glasses after the procedure, whether to fully correct remaining myopia or to address presbyopia ("aging eye"), which cannot be corrected yet by refractive surgery. Consumers should be informed of actual success rates and the potential risks, complications, and side effects of refractive surgery, including that the patient may need reading glasses sooner after LASIK or PRK than if they had not had the surgery.

 

2. Safety. Any suggestion that refractive surgery is "a safe and easy alternative to glasses" could raise deception concerns. As the FTC requires, any claims about safety should be substantiated by scientific and medical data and require disclosure of the risks, complications, and side effects of refractive surgery. The ASCRS and AAO guidelines also caution against references to the fact that LASIK and PRK do not involve knives without fully disclosing the invasive nature of the laser procedure. The ophthalmic groups warn that the Federal Food, Drug and Cosmetics Act does not permit advertisements to include references to the FDA approval status of any medical device.

 

3. Permanence and predictability. The FTC has objected to claims that refractive surgery results are permanent because of the lack of long-term studies to substantiate such statements. In addition, as with effectiveness claims, the suggestion that 20/20 visual acuity results are predictable in any given case are potentially deceptive unless there are scientific data confirming that such results have been achieved in virtually every case.

4. Success rates. Claims of specific success rates based on clinical studies are appropriate as long as the studies are scientifically reliable and the surgeon's own outcomes do not vary significantly from the reported results.

 

5. Painless procedure. Claims that PRK or LASIK are painless procedures should be avoided because many patients experience some pain or discomfort during the procedures and for a short time after.

<>


Robert M. Portman, JD, MPP, is a health care attorney and partner with the Washington, D.C., office of Jenner & Block. Telephone: 202-639-6000; facsimile: 202-639-6066; e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.; web site: www.jenner.com. Kevin M. Stack, also an attorney with Jenner & Block, contributed to the research for this article.
http://www.ascrs.org/publications/ao/ae92portman.html

by Ellen Dean Wilson Correspondent


Advertisements that credit a laser in-situ keratomileusis surgeon with a certain number of cases or promise a rate of visual acuity are ruining the industry, refractive pioneers say. And for the hapless patient, some ads are so misleading that they can cause the selection of the wrong doctor or procedure.

 

Daniel S. Durrie, MD, a member of the American Academy of Ophthalmology Executive Committee for Refractive Surgery, said ophthalmology organizations or the Federal Trade Commission should review certain types of LASIK ads.

 

He wondered why ads for medicines must have “a whole page of disclaimers,” but LASIK surgeons and centers are not required to. Patients are often not warned of possible results, such as halos at night, said Durrie, associate clinical professor, University of Kansas, Kansas City, who is in private practice at Hunkeler Eye Centers, Overland Park.

 

Stephen P. Ginsberg, MD, in private practice at Kensington Eye Center, Kensington, Md., said that the number of procedures is “kind of a Catch-22,” because better surgeons tend to take tougher cases.

 

Some center ads give statistics for all its surgeons together, including inexperienced ones, and some ads even list surgeons who do not practice in that area, he said. “Everyone is trying to out-experience the others,” he said.

 

“Anyone can claim they’re an expert,” said I. Howard Fine, MD, clinical associate professor, Oregon Health Sciences University, Portland, in private practice at Oregon Eye Associates, Eugene. “They can take a course, then claim they’re a LASIK expert.”

 

Paul Weber, risk manager at Ophthalmic Mutual Insurance Co., the AAO’s insurance plan, said he hasn’t heard of any legal cases focused on advertising. His organization reviews members’ ads before they are published, he said.

 

“Everyone claims he or she has done 10,000 cases, everyone has done it first, and everyone is the best,” said Frederic B. Kremer, MD, director of the Kremer Laser Eye Center, King of Prussia, Pa. “By ophthalmologists letting this get out of hand, it undermines the whole profession.”

 

Kremer takes action when he sees ads he thinks are misleading — he calls the surgeons or has an attorney contact them. “It usually works,” he said.

 

What spectacle wearer could resist a recent Laser Vision Institute ad? “98.7% of Dr. Tanchel’s patients enjoy 20/20 vision or better!” it says. Nancy A. Tanchel, MD, of Vienna, Va., told EyeWorld that that figure came from a survey of patients in the past several months. Although she agrees that her recent results have been excellent, she said, the survey for company officers “was not meant for publication.” It had not been analyzed and checked as she would have done for a formal study.

 

She said that she has no control over ad copy. “The people who write the ads are not medical,” said Tanchel, an assistant clinical instructor at University of South Florida.

 

She said that the percentage could be misleading to, for example, a –15–D patient who is less likely to reach 20/20.

 

Steve A. Arshinoff, MD, lecturer, University of Toronto, has had similar experiences. “I’m often arguing with the manager of my center,” he said. “The companies don’t like to deal with ethics, just cash flow.”

 

Arshinoff, who often sees post-LASIK problems, said most LASIK ads are “intentionally deceiving. The more the centers are run by management companies, the more deceptive the ads,” he said. “They sold hamburgers last week.”

 

Francis W. Price, MD, clinical instructor, Indiana University, Indianapolis, who is in private practice with Corneal Consultants of Indiana, Fort Wayne, said advertising that lists surgeons who actually work in another part of the country should be illegal. “One retinal guy in town says he’s done thousands of laser procedures,” but the procedures were not LASIK, he said.

 

“It’s a shame. I’ll lay it all on the government and the lawyers. They gave doctors the right to advertise,” Price said. He said that low-price LASIK advertisements do not explain that an inexperienced surgeon is often the only one who will work this cheaply, he said.

 

“They’re often comparing apples and oranges,” said Peter S. Hersh, MD, director of the Cornea and Laser Eye Institute at Hackensack University Medical Center and an ophthalmology professor at New Jersey Medical School.

 

“I don’t think the ‘20/20 or better’ or ‘20/40 or better’ are useful, because there’s no basis upon which they’re vetted,” said Hersh, of Teaneck, N.J.

 

Joe Krupa, corporate communications director at Icon Laser Eye Centers, said his firm does not use physicians in advertising. Instead, it tries to interest potential patients and get them to call its toll-free number, staffed by 80 well-trained workers.

 

He said that some patients are very concerned about physicians. If they ask about doctors, they are given a complete list of those at their local centers, not merely the best ones, he said.

 

“If they say they’re excellent surgeons, they’re held to a higher [legal] standard,” said Aaron M. Levine, JD, of Washington, D.C., chairman of the LASIK Malpractice Group of the American Trial Lawyers Association. “They could be implying a warranty.”

 

He said that no cases so far have been based on a breach of promise, although it is a possible tactic. “You need words” to litigate that type of case; the misrepresentation in some surgery offices is nonverbal, he said. “You walk into the doctor’s office and see a big basket of glasses people don’t need anymore, and a picture of Tiger Woods,” he said. TLC is the organization that snared Tiger Woods as a patient and spokesman.

 

Richard Abbott, senior ophthalmic practice secretary at the AAO, said ads that list a surgeon’s number of cases or a percentage of visual acuity achieved are “misleading and deceptive.” There is no “magic number” of cases, and percentages without the patients’ pretreatment acuities are worthless, he said.

 

Lee T. Nordan, MD, assistant clinical professor, University of California at Los Angeles Jules Stein Eye Institute, in private practice La Jolla, said, “Reputable people’s numbers are down due to this advertising,” He said ads cannot represent a surgeon’s skills accurately, because “you always end up lying by omission.”