|Date: 04/02/2003 07:18 pm
From: "Michael Patterson" <redacted>
Subject: Comments on FTC agreements for file numbers 022 3098 and 022 3053
Dear Mr. Clark,
Please email me if additional information, separate comments or any other modification to this submission is required to comply with the commission's procedures.
Referring to file numbers 022 3098 and 022 3053, the following comments regard whether or Not the two recently announced agreements meet the FTC's own objectives pursuant to consideration of the provisions of Section 2.34 of the Commission's Rules and clarification of the meaning of these agreements as worded (seehttp://www.ftc.gov/os/2003/03/lcaagreement.pdf and http://www.ftc.gov/os/2003/03/lviagreement.pdf; http://www.ftc.gov/os/caselist/0223098.htm and http://www.ftc.gov/opa/2003/03/lasikads.htm).
The FTC agreements stipulate that respondents "shall not make any representation, in any manner, expressly or by implication, about the efficacy, safety, performance, or benefits of such services, unless, at the time it is made, respondents possess and rely upon competent and reliable scientific evidence that substantiates the representation." And "in connection with the advertising, promotion, offering for sale, or sale, of LASIK refractive surgery services or any other refractive surgery services, in or affecting commerce, shall not misrepresent, in any manner, expressly or by implication:". . ."C. The information consumers will receive during a consultation for refractive surgery."
These agreements will protect consumers to some degree, but do they adequately protect consumers from injury sufficiently to meet the FTC's own objectives? Does an FTC agreement with any respondent have to be consistent with the FTC's own objectives for a respondent and with other agreements for different respondents perpetrating acts similar to those outlined in the FTC's complaints and associated exhibits? Please consider whether or Not these two agreements sufficiently protect other consumers from suffering the same fate as many of the thousands of consumers injured by LASIK who wish they never had purchased it.
Do these agreements mean that the respondents will conform to the FTC's objectives (seehttp://www.ftc.gov/opp/gpra/6strat5yrB.htm) such as "Objective 1: Identify fraud, deception, and unfair practices that cause the greatest consumer injury. Objective 2: Stop fraud, deception, and unfair practices through law enforcement. Objective 3: Prevent consumer injury through education."?
Do the agreements also address any omitted or potentially misleading information provided by the respondents that may be critical to a consumer making a permanently life altering decision? Do the agreements and related FTC objectives include any obligation to truthfully inform consumers about the true risks (and the likelihood of those risks occurring) and benefits of something that can and does lead to serious, permanent injury before they purchase it? Are the respondents required to accurately inform consumers about the commonly known risks and the likelihood of those risks occurring? Are the respondents required to provide consumers accurate directions for the procedure based on the manufacturers instructions including which light to look at during LASIK (the red, the green, and/or the blinking light)?
Do the agreements include prohibiting information that may be partly true, unfair or misleading to the consumer?
For example, would the representation that the cornea heals in a few days (or one day) be a substantiated representation based on reliable scientific evidence Or would it violate the agreement because it is unfair (or misleading) to most consumers in the event that the scientific evidence is that the flap created by LASIK in the cornea NEVER heals and LASIK permanently injures the cornea in ALL cases to such a degree that you should No longer actively participate in contact sports (seehttp://www.fda.gov/cdrh/LASIK/when.htm and you may have long-term recurring pain, permanent scarring, swelling, edema, or ebmd) even if part of the cornea (the epithelial layer) does heal somewhat in a few days? (also see http://www.fda.gov/cdrh/pdf/P970053S002c.pdf, http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11772601&dopt=Abstract and other published scientific research).
Are the respondents required to notify consumers before LASIK about other known risk factors that can dramatically impair their quality of life (including, but not limited to those listed in the manufacturer's Patient Information Booklets)?
For example, should consumers be informed that some doctor's consider LASIK too risky due to the likelihood of flap and other complications? Should consumers know ALL or most of the commonly known risks before LASIK including how likely it will cause visual aberrations/distortions in common ordinary indoor lighting conditions (e.g., diploplia, dlk, large pupils, striae, flattening of the cornea- as observed with keratoconus, increased eye strain, headaches, loss of contrast sensitivity, hazy vision, visual distortions, blurred or fuzzy vision, higher order aberrations, chronic pain (e.g., ebmd, edema, etc.), bad nighttime vision, and/or dry eyes? Are the respondents required to educate/notify consumers before LASIK that After LASIK some patients can no longer safely use regular eye drops, may need to use eye drops (and/or punctual plugs) for the rest of their lives, lose vision, develop debilitating visual symptoms? Should consumers be informed that "Some complications, such as migration of the flap, inflammation or infection, may require another procedure and/or intensive treatment with drops. Even with aggressive therapy, such complications may lead to . . . irreversible blindness.", and what happens with Monovision (Fromhttp://www.fda.gov/cdrh/LASIK/risks.htm)?
Are the respondents required to notify consumers before they have LASIK if there are some treatments for certain complications that they are Not adequately equipped to do? Are the respondents required to notify consumers before LASIK IF their procedures are Not safe as defined by reliable scientific evidence (e.g., if their outcomes are worse than those used by the FDA to approve that specific LASIK, for instancehttp://www.fda.gov/cdrh/pdf/P970053S002c.pdf)?
If the respondents notify consumers that there are no known long term effects of LASIK, then is this a substantiated representation based on reliable scientific evidence if the truth is that there are known long term effects of LASIK on the strength of the eye, that Long term risks of LASIK have not been determined (a subtle but meaningful difference in wording) and that the cornea never fully heals (the cornea flap can be lifted ten years after LASIK)?
Are they required to educate consumers before LASIK that "Although the effects of LASIK on visual performance under poor lighting conditions have Not been determined, it is possible that you will find it more difficult than usual to see in conditions such as very dim light, rain, snow, fog or glare from bright lights at night. These effects have been reported as being more common in persons with large pupils (over 6 mm). It is possible that these may be permanent effects."? (Seehttp://www.fda.gov/cdrh/pdf/P970053S002c.pdf and http://www.fda.gov/cdrh/pdf/P970053S002a.pdf)
Before deciding on the agreements, please consider the FTC's allegations and evidence in the FTC's exhibits (see (http://www.ftc.gov/os/2003/03/laservisionexh.pdf and http://www.ftc.gov/os/2003/03/lasikplusexh.pdf) And complaints (see http://www.ftc.gov/os/2003/03/lcacomplaint.pdf http://www.ftc.gov/os/2003/03/lvicomplaint.pdf)
For instance, "7. In truth and in fact, respondent did not possess and rely upon a reasonable basis that substantiated the representations set forth in Paragraph 5 , at the time the representations were made. Therefore, the representation set forth in Paragraph 6 was, and is, false or misleading." "8. The acts and practices of respondent as alleged in this complaint constitute unfair or deceptive acts or practices, and the making of false advertisements, in or affecting commerce in violation of Sections 5(a) and 12 of the Federal Trade Commission Act."
Is the FTC sufficiently protecting consumers from other unfair and/or misleading practices including, but not limited to, a respondent Not following the regulatory guidelines of another government agency like the FDA? For some LASIK, the FDA requires that "all advertisements and other descriptive printed material shall include a brief statement of the intended uses of the device and relevant warnings, precautions, side effects, and contraindications." And "In advance of surgery, all prospective patients must receive the Patient Information Booklet from their treatment provider" (seehttp://www.fda.gov/cdrh/pdf/P970053S002a.pdf). Isn't this also consistent with the FTC's own objectives? Do the agreements as worded require the respondents to do this or to at least inform consumers accurately about LASIK without omitting relevant information?
Do the agreements also protect consumers from violations of 15 U.S.C. § 45 to the extent that it prohibits "deceptive or unfair practices in or affecting commerce" as identified by the FTC since at least 1997? (seehttp://www.ftc.gov/bcp/guides/eyecare2.htm) "An advertisement is deceptive under Section 5 of the FTC Act, and therefore unlawful, if it contains a representation or omission of fact that is likely to mislead consumers acting reasonably under the circumstances, and that representation or omission is material, that is, likely to affect a consumer's choice or use of a product or service. It is important to note that advertisers are responsible for claims that are reasonably implied from their advertisements, as well as claims that are expressly stated. These requirements apply to all objective claims, including those made through the use of consumer testimonials.". . ."Finally, under the FTC Act, deception can occur through omission of information when that information is necessary to prevent an affirmative representation from being misleading, or simply by remaining silent, if doing so constitutes an implied but false representation. Not all omissions are deceptive, even if providing the information would benefit consumers. An omission is considered deceptive only if the absence of the information causes the advertisement to convey an inaccurate impression about a material fact.". . ."Under FTC law, therefore, advertisements, promotional brochures, informational tapes, seminars and other forms of marketing of RK, 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." (see http://www.ftc.gov/bcp/guides/hhsftc.htm) ". . .all advertising and promotional materials for PRK should be truthful and substantiated and that consumers have sufficient information to make an informed decision.". . ." For example, advertising that raises unrealistic consumer expectations such as 'throw away your eyeglasses' without further qualification should disclose the limitations of the PRK procedure."
Please consider whether or Not these two agreements sufficiently protect other consumers from suffering the same fate as many of the thousands of consumers injured by LASIK who wish they never had purchased it.