Mid-South PCM Group, P.C.; Eye and Vision Clinic, P.C.; International Computerized Orthokeratology Society, Inc.; J. Mason Hurt, O.D.; Analysis To Aid Public Comment

FEDERAL TRADE COMMISSION

[File No. 962-3279]

Mid-South PCM Group, P.C.; Eye and Vision Clinic, P.C.;

International Computerized Orthokeratology Society, Inc.; J. Mason

Hurt, O.D.; Analysis To Aid Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed consent agreement.

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SUMMARY: The consent agreement in this matter settles alleged

violations of federal law prohibiting unfair or deceptive acts or

practices or unfair methods of competition. The attached Analysis to

Aid Public Comment describes both the allegations in the draft

complaint that accompanies the consent agreement and the terms of the

consent order--embodied in the consent agreement--that would settle

these allegations.

DATES: Comments must be received on or before October 27, 1997.

ADDRESSES: Comments should be directed to: FTC/Office of the Secretary,

Room 159, 6th St. and Pa. Ave., NW., Washington, DC 20580.

FOR FURTHER INFORMATION CONTACT:

Christa Vecchi, Federal Trade Commission, H-200, 6th St. and Pa. Ave.,

NW., Washington, DC 20580. (202) 326-3166. Matthew Daynard, Federal

Trade Commission, H-200, 6th St. and Pa. Ave., NW., Washington, DC

20580. (202) 326-3291.

SUPPLEMENTARY INFORMATION: Pursuant to section 6(f) of the Federal

Trade Commission Act, 38 Stat. 721, 15 U.S.C.

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46, and Sec. 2.34 of the Commission's rules of practice (16 CFR 2.34),

notice is hereby given that the above-captioned consent agreement

containing a consent order to cease and desist, having been filed with

and accepted, subject to final approval, by the Commission, has been

placed on the public record for a period of sixty (60) days. The

following Analysis to Aid Public Comment describes the terms of the

consent agreement, and the allegations in the accompanying complaint.

An electronic copy of the full text of the consent agreement package

can be obtained from the Commission Actions section of the FTC Home

Page (for August 21, 1997), on the World Wide Web, at ``http://

www.ftc.gov/os/actions/htm.'' A paper copy can be obtained from the FTC

Public Reference Room, Room H-130, Sixth Street and Pennsylvania Avenue

NW., Washington, DC 20580, either in person or by calling (202) 326-

3627. Public comment is invited. Such comments or views will be

considered by the Commission and will be available for inspection and

copying at its principal office in accordance with Sec. 4.9(b)(6)(ii)

of the Commission's rules of practice (16 CFR 4.9(b)(6)(ii)).

Analysis of Proposed Consent Order To Aid Public Comment

The Federal Trade Commission has accepted, subject to final

approval, an agreement to a proposed Consent Order (``proposed order'')

from Mid-South PCM Group, P.C., Eye and Vision Clinic, P.C., the

International Computerized Orthokeratology Society, Inc., and J. Mason

Hurt, O.D., the sole owner and President of the corporations.

The proposed consent order has been placed on the public record for

sixty (60) days for the reception of comments by interested persons.

Comments received during this period will become part of the public

record. After sixty (60) days, the Commission will again review the

agreement and will decide whether it should withdraw from the agreement

or make final the agreement's proposed order.

This matter concerns print, broadcast and Internet advertisement

provided directly to consumers, and to optometrists for distribution

under their own name to consumers, for proposed respondents' ``Precise

Corneal Molding'' orthokeratology (``PCM ortho-k'') service. PCM ortho-

k is an eye care service involving the use of a series of contact

lenses purportedly to reshape the cornea gradually for the treatment of

myopia, or nearsightedness (difficulty seeing at a distance),

hyperopia, or farsightedness (difficulty seeing up close), and

astigmatism (blurred vision).

The Commission's complaint charges that the proposed respondents

engaged in deceptive advertising in violation of sections 5 and 12 of

the FTC Act by making false and unsubstantiated claims that: (1) PCM

ortho-k provides a cure for any refractive vision deficiency thereby

permanently eliminating the need for all corrective eyewear, including

eyeglasses and contact lenses; and (2) all people can achieve normal

vision without eyeglasses or contact lenses on a permanent basis if

they wear PCM ortho-k devices occasionally or at night.

The complaint further alleges that proposed respondents made false

claims that: (1) PCM ortho-k has been approved by the Federal Aviation

Administration and all branches of the United States military for use

in correcting refractive vision deficiencies; (2) four named University

studies prove that PCM ortho-k is safe and effective in correcting

nearsightedness, farsightedness, and astigmatism; and (3) consumer

testimonials for respondents' PCM ortho-k services reflect the typical

or ordinary experience of members of the public who receive those

services, which experience is that PCM ortho-k patients typically

achieve 20/20 vision and no longer need corrective eyewear.

The complaint further alleges that proposed respondents made

unsubstantiated claims that: (1) A significant number of people can

achieve normal vision without eyeglasses or contact lenses on a

permanent basis if they wear PCM ortho-k devices occasionally or at

night; (2) all or most people will experience stabilized vision after

only a few weeks or months of PCM ortho-k treatments; (3) PCM ortho-k

prevents and reverses deteriorating nearsightedness in children; (4)

PCM ortho-k is safer than contact lenswear; (5) PCM ortho-k is more

effective than refractive surgical methods in eliminating

nearsightedness, farsightedness, and all forms of astigmatism; and (6)

PCM ortho-k has helped thousands of people achieve normal vision.

The proposed order contains provisions designed to remedy the

violations charged and to prevent proposed respondents from engaging in

similar acts in the future.

Paragraph I of the proposed order prohibits proposed respondents

from claiming that PCM ortho-k, or any substantially similar service

(defined as any ophthalmic service or procedure using contact lenses or

similar devices to modify the shape of the cornea and reduce or

eliminate refractive vision deficiencies): (1) Provides a cure for any

refractive vision deficiency thereby permanently eliminating the need

for all corrective eyewear, including eyeglasses and contact lenses:

and (2) has been approved by the Federal Aviation Administration and

all branches of the United States military for use in correcting

refractive vision deficiencies. Paragraph I further prohibits proposed

respondents from representing that: (1) All people can achieve normal

vision without eyeglasses or contact lenses on a permanent basis if

they wear devices used with PCM ortho-k or any substantially similar

service occasionally or at night; and (2) four named University studies

prove that PCM ortho-k or any substantially similar service is safe and

effective in correcting nearsightedness, farsightedness, and

astigmatism.

Paragraph II of the proposed order prohibits proposed respondents

from making any representation for PCM ortho-k, or any substantially

similar service, about: (1) The number of people who can achieve normal

vision without eyeglasses or contact lenses on a permanent basis if

they wear devices used with such service occasionally or at night; (2)

the number of people who will experience stabilized vision after only a

few weeks or months of treatments under such service; (3) the ability

of such service to prevent or reverse deteriorating nearsightedness in

children; (4) the comparative safety of such service and contact

lenswear; (5) the comparative effectiveness of such service and

refractive surgical methods in eliminating nearsightedness,

farshghtedness, or any form of astigmatism; and (6) the number of

people whom such service has helped achieve normal vision, unless, at

the time the representation is made, proposed respondents possess and

rely upon competent and reliable scientific evidence that substantiates

the representation.

Paragraph III of the proposed order prohibits respondents from

misrepresenting the existence, contents, validity, results,

conclusions, or interpretations of any test, study, or research.

Paragraph IV of the proposed order prohibits proposed respondents

from representing that any service, procedure, or product is endorsed

or approved by any governmental or professional organization or

association, or complies with or meets standards or guidelines for such

services, procedures, or products established by any such organization

or association, unless such is the case.

Paragraph V of the proposed order prohibits respondents from

representing that the experience represented by any user testimonial or

endorsement of any

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service, procedure, or product represents the typical or ordinary

experience of members of the public who use the service, procedure, or

product, unless the representation is true, and competent and reliable

scientific evidence substantiates that claim, or respondents clearly

and prominently disclose either: (1) What the generally expected

results would be for program participants; or (2) the limited

applicability of the endorser's experience to what consumers may

generally expect to achieve, that is, that consumers should not expect

to achieve similar results.

Paragraph VI of the proposed order prohibits respondents from

making any representation about the relative or absolute efficacy,

performance, benefits, safety, or success of any ophthalmic service,

procedure, or product purporting to treat, mitigate, or cure any

refractive vision deficiency, unless the representation is true and, at

the time the representation is made, proposed respondents possess and

rely upon competent and reliable scientific evidence that substantiates

the representation.

Paragraph VII of the proposed order requires that proposed

respondents: (1) Not disseminate to any optometrist or eye care

provider any material containing any representations prohibited by the

order; (2) send a required notice to each optometrist or eye care

provider with whom proposed respondents have done business since

January 1, 1994, requesting that the optometrist cease using any

materials previously received from proposed respondents that contain

any claims violative of the order, informing the optometrist of this

settlement, and attaching a copy of this proposed compliant and order;

(3) in the event that proposed respondents receive any information that

subsequent to receipt of the required notice any optometrist or eye

care provider is using or disseminating any advertisement or

promotional material that contains any representation prohibited by the

order, immediately notify the optometrist or eye care provider that

proposed respondents will terminate the optometrist or eye care

provider's right to market and/or perform PCM ortho-k if he or she

continues to use such advertisements or promotional materials; (4)

terminate any optometrist or eye care provider about whom proposed

respondents receive any information that such person has continued to

use advertisements or promotional materials that contain any

representation prohibited by the order after receipt of the required

notice; and (5) for a period of three (3) years following service of

the order, send the required notice to each optometrist or eye care

provider with whom proposed respondents do business after the date of

service of the order who has not previously received the notice; the

notices shall be sent no later than the earliest of: (1) The execution

of a sales or training agreement or contract between proposed

respondents and the prospective optometrist or eye care provider; or

(2) the receipt and deposit of payment from a prospective optometrist

or eye care provider of any consideration in connection with the sale

of any service or rights associated with PCM ortho-k. The mailing shall

not include any other documents.

Paragraph VIII of the proposed order contains record keeping

requirements for materials that substantiate, qualify, or contradict

covered claims and requires the proposed respondents to keep and

maintain all advertisements and promotional materials containing any

representation covered by the proposed order. In addition, Paragraph IX

requires distribution of a copy of the consent decree to current and

future officers and agents. Further, Paragraph X provides for

Commission notification upon a change in the corporate respondents.

Paragraph XI requires proposed respondent J. Mason Hurt, O.D. to notify

the Commission when he discontinues his current business or employment

and of his affiliation with any new business or employment. The

proposed order, in paragraph XII, also requires the filing of a

compliance report.

Finally, Paragraph XIII of the proposed order provides for the

termination of the order after twenty years under certain

circumstances.

The purpose of this analysis is to facilitate public comment on the

proposed order, and it is not intended to constitute an official

interpretation of the agreement and proposed order, or to modify in any

way their terms.

Donald S. Clark,

Secretary.

[FR Doc. 97-22902 Filed 8-27-97; 8:45 am]

BILLING CODE 6750-01-M