[Federal Register Volume 62, Number 167 (Thursday, August 28, 1997)]
[Notices]
[Pages 45650-45652]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22902]
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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
