[Federal Register Volume 60, Number 72 (Friday, April 14, 1995)]
[Notices]
[Pages 19065-19067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9266]
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FEDERAL TRADE COMMISSION
[File No. 942 3052]
David Green, M.D.; Proposed Consent Agreement With Analysis to
Aid Public Comment
AGENCY: Federal Trade Commission.
ACTION: Proposed consent agreement.
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SUMMARY: In settlement of alleged violations of federal law prohibiting
unfair acts and practices and unfair methods of competition, this
consent agreement, accepted subject to final Commission approval, would
prohibit, among other things, an individual doing business as The
Varicose Vein Center from making various representations about any vein
treatment or cosmetic surgery procedure he markets in the future unless
he possesses competent and reliable scientific evidence to substantiate
the claims.
DATES: Comments must be received on or before June 13, 1995.
ADDRESSES: Comments should be directed to: FTC/Office of the Secretary,
Room 159, 6th St. and Pa. Ave., N.W., Washington, D.C. 20580.
FOR FURTHER INFORMATION CONTACT:
Richard Kelly or Sondra Mills, FTC/H-200, Washington, D.C. 20580. (202)
326-3304 or 326-2673.
SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal
Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46 and Sec. 2.34 of the
Commission's Rules of Practice (16 CFR 2.34), notice is hereby given
that the following 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. 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)).
Agreement Containing Consent Order to Cease and Desist
In the matter of David Green, M.D., an individual doing business
as The Varicose Vein Center, a sole proprietorship.
The Federal Trade Commission having initiated an investigation of
certain acts and practices of David Green, M.D., an individual doing
business as The Varicose Vein Center, a sole proprietorship, and it now
appearing that David Green, M.D., sometimes referred to as proposed
respondent, is willing to enter into an agreement containing an order
to cease and desist from the use of the acts and practices being
investigated,
It Is Hereby Agreed by and between David Green, M.D., an individual
doing business as The Varicose Vein Center, a sole proprietorship, and
his attorney, and counsel for the Federal Trade Commission that:
1. Proposed respondent David Green, M.D. (``Dr. Green'') is an
individual doing business as The Varicose Vein Center, a sole
proprietorship (``VVC''). Respondent's principal place of business is
located at 4800 Montgomery Lane, Suite M50, in the City of Bethesda,
State of Maryland. Dr. Green formulates, directs and controls the
policies, acts and practices of VVC. [[Page 19066]]
2. This agreement is for settlement purposes only and does not
constitute an admission by the proposed respondent of facts, other than
jurisdictional facts, or of violations of law as alleged in the draft
Complaint.
3. Proposed respondent admits all the jurisdictional facts set
forth in the draft of complaint.
4. Proposed respondent waives:
(a) Any further procedural steps;
(b) The requirement that the Commission's decision contain a
statement of findings of fact and conclusions of law;
(c) All rights to seek judicial review or otherwise to challenge or
contest the validity of the order entered pursuant to this agreement;
and
(d) All rights under the Equal Access to Justice Act.
5. This agreement shall not become part of the public record of the
proceeding unless and until accepted by the Commission. If this
agreement is accepted by the Commission it, together with the draft of
complaint contemplated thereby, will be placed on the public record for
a period of sixty (60) days and information in respect thereto publicly
released. The Commission thereafter may either withdraw its acceptance
of this agreement and so notify the proposed respondent, in which event
it will take such action as it may consider appropriate or issue and
serve its complaint (in such form as the circumstances may require) and
decision, in disposition of the proceeding.
6. This agreement contemplates that, if it is accepted by the
Commission, and if such acceptance is not subsequently withdrawn by the
Commission pursuant to the provisions of Sec. 2.34 of the Commission's
Rules, the Commission may, without further notice to proposed
respondent, (1) issue its complaint corresponding in form and substance
with the draft of complaint and its decision containing the following
order to cease and desist in disposition of the proceeding and (2) make
information public in respect thereto. When so entered, the order to
cease and desist shall have the same force and effect and may be
altered, modified or set aside in the same manner and within the same
time provided by statute for other orders. The order shall become final
upon service. Delivery by the U.S. Postal Service of the complaint and
decision containing the agreed-to order to proposed respondent's
address as stated in this agreement shall constitute service. Proposed
respondent waives any right he may have to any other manner of service.
The complaint may be used in construing the terms of the order, and no
agreement, understanding, representation, or interpretation not
contained in the order or the agreement may be used to vary or
contradict the terms of the order.
7. Proposed respondent has read the proposed complaint and order
contemplated hereby. He understands that once the order has been
issued, he will be required to file one or more compliance reports
showing that he has fully complied with the order. Proposed respondent
further understands that he may be liable for civil penalties in the
amount provided by law for each violation of the order after it becomes
final.
Order
Definitions
For purposes of this Order, the following definitions shall apply:
1. ``Sclerotherapy'' means the treatment of venous disease by
injecting a solution into a vein with a needle.
2. ``venous disease treatment procedure'' includes, but is not
limited to, sclerotherapy, laser treatments, electrocautery, and
surgery.
3. ``Competent and reliable scientific evidence'' means tests,
analyses, research, studies or other evidence based on the expertise of
professionals in the relevant area, that have been conducted and
evaluated in an objective manner by persons qualified to do so, using
procedures generally accepted in the profession to yield accurate and
reliable results.
I
It Is Ordered that respondent David Green, M.D., an individual
doing business as The Varicose Vein Center, a sole proprietorship, his
successors, assigns, agents, representatives and employees, directly or
through any corporation, subsidiary, division or other device, in
connection with the advertising, promotion, offering for sale or sale
of any venous disease treatment procedure including, but not limited
to, sclerotherapy, or of any other cosmetic or plastic surgery
procedure, in or affecting commerce, as ``commerce'' is defined in the
Federal Trade Commission Act, do forthwith cease and desist from making
any representation, in any manner, directly or by implication:
A. that spider veins and varicose veins are permanently eliminated
following treatment by respondent, or otherwise making any
representation regarding the duration of results following treatment by
any cosmetic or plastic surgery procedure, including any venous disease
treatment procedure; or
B. that respondent's treatments succeed in eliminating varicose and
spider veins at a rate greater than 95%, or otherwise making any
representation regarding the success rate for, or the rate at which a
condition is likely to recur or return following treatment by, any
cosmetic or plastic surgery procedure, including any venous disease
treatment procedure; or
C. that patients do not experience any pain in connection with
respondent's regimen for treating their varicose and spider veins, or
otherwise making any representation regarding the nature, duration or
intensity of pain associated with any cosmetic or plastic surgery
procedure, including any venous disease treatment procedure; or
D. otherwise making any representation regarding the efficacy of,
or the risks, side-effects, or recovery period associated with, any
cosmetic or plastic surgery procedure, including any venous disease
treatment procedure;
unless, at the time of making such representation, respondent possesses
and relies upon competent and reliable scientific evidence that
substantiates the representation.
II
It is further ordered that for three (3) years after the last date
of dissemination of any representation covered by this Order,
respondent, or his successors and assigns, shall maintain and upon
request make available to the Federal Trade Commission for inspection
and copying:
A. All materials that were relied upon in disseminating such
representation; and
B. All tests, reports, studies, surveys, demonstrations or other
evidence in his possession or control that contradict, qualify, or call
into question such representation, or the basis relied upon for such
representation, including complaints from consumers.
III
It is further ordered that respondent shall distribute a copy of
this Order to each of his agents, representatives, and employees, and
shall secure from such person a signed statement acknowledging receipt
of this Order.
IV
It is further ordered that, for a period of five (5) years from the
date of entry of this Order, the individual respondent named herein
shall promptly notify the Commission of the discontinuance of his
present business or employment, with each such notice to include the
respondent's new business address and a statement of the nature of the
business [[Page 19067]] or employment in which the respondent is newly
engaged as well as a description of respondent's duties and
responsibilities in connection with the business or employment.
V
It is further ordered that respondent shall, within sixty (60) days
after service upon him of this order, file with the Commission a
report, in writing, setting forth in detail the manner and form in
which he has complied with the requirements of this order.
Analysis of Proposed Consent Order to Aid Public Comment
The Federal Trade Commission has accepted an agreement to a
proposed consent order from David Green, M.D. (herein ``Dr. Green''),
an individual doing business as The Varicose Vein Center, a sole
proprietorship (herein ``VVC''). Through VVC, Dr. Green markets a
procedure commonly known as ``sclerotherapy'' for treating venous
disease, including varicose veins and spider veins. Proposed respondent
currently offers his sclerotherapy services to the public at VVC's
clinic in Bethesda, Maryland.
Dr. Green's treatment method consists of injecting a sclerosing
solution into the veins, followed by compression of the area with a
bandage and post-procedure ambulation by the patient. As part of his
treatment regimen, Dr. Green refers certain patients with varicose
veins to surgeons for surgical division and ligation of their veins
procedure prior to performing his sclerotherapy injections. These
include patients Dr. Green has diagnosed as having truncal varicosities
with incompetence at the saphenofemoral or saphenopopliteal junction.
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 the comments received and will decide whether it should
withdraw from the agreement or make final the agreement's proposed
order.
The Commission's complaint charges that proposed respondent
deceptively advertised: (1) The permanence of the results of his
sclerotherapy treatments; (2) the success rate for his treatments; and
(3) the painlessness of his regimen for treating venous disease.
Permanence
The complaint alleges that proposed respondent failed to possess a
reasonable basis for claims he has made regarding the permanence of the
results of his treatments. In newspaper and magazine advertisements,
Dr. Green has represented that the treatments provided at VVC would
``permanently remove'' or ``permanently eliminate'' varicose and spider
veins. A brochure Dr. Green provided to prospective patients described
sclerotherapy as the ``non-surgical procedure used to permanently
remove spider and varicose veins from the legs and thighs.'' The
Commission believes that these permanence claims are deceptive because
at the time proposed respondent made these claims, he did not possess
adequate substantiation for those claims.
The proposed consent order seeks to address the alleged deceptive
permanence claims cited in the complaint by requiring Dr. Green to
possess a reasonable basis, consisting of competent and reliable
scientific evidence, substantiating any claim that spider veins and
varicose veins are permanently eliminated following treatment by
proposed respondent (Part I.A.). Part I.A. of the proposed order also
requires that Dr. Green possess a reasonable basis for any
representation he makes regarding the duration of results following
treatment by any cosmetic or plastic surgery procedure, including any
venous disease treatment procedure.
Success Rate
The Commission's complaint further alleges that proposed respondent
failed to possess a reasonable basis for his claim, made in newspaper
advertisements, that his non-surgical procedure has a ``success rate
greater than 95%.'' The Commission believes this success rate claim is
deceptive because at the time proposed respondent made it, he did not
possess adequate substantiation for this claim.
The proposed consent order seeks to address this alleged deceptive
success rate claim by requiring that Dr. Green possess a reasonable
basis, consisting of competent and reliable scientific evidence,
substantiating any claim that his treatments succeed in eliminating
varicose and spider veins at a rate greater than 95 percent (Part I.B).
Part I.B further requires that Dr. Green possess a reasonable basis for
any representation he makes regarding the success rate for, or the rate
at which a condition is likely to recur or return following treatment
by, any cosmetic or plastic surgery procedure, including any venous
disease treatment procedure.
Pain
The complaint also alleges that proposed respondent failed to
possess a reasonable basis for his claims that the treatments he
provides through VVC are painless. In newspaper advertisements, Dr.
Green has claimed that his treatments are ``Painless, Safe, Non-
Surgical'' and that his ``non-surgical, in-office procedures'' are
``painless.'' The Commission believes these claims about the pain
associated with the treatments provided at VVC are deceptive because at
the time proposed respondent made them, he did not possess adequate
substantiation for these claims.
The proposed consent order addresses these deceptive claims about
pain by requiring that Dr. Green possess a reasonable basis, consisting
of competent and reliable scientific evidence, substantiating any claim
that patients do not experience any pain in connection with proposed
respondent's regimen for treating their varicose and spider veins (Part
I.C). In addition, Part I.C of the proposed consent requires that
proposed respondent possess a reasonable basis for any representation
he makes regarding the nature, duration or intensity of pain associated
with any cosmetic or plastic surgery procedure, including any venous
disease treatment procedure.
Part I.D. of the proposed order further requires proposed
respondent to possess substantiation, consisting of competent and
reliable scientific evidence, for any representation regarding the
efficacy of, or the risks, side-effects, or recovery period associated
with, any cosmetic or plastic surgery procedure, including any venous
disease treatment procedure.
Finally, Paragraphs II, III and IV of the proposed order contain
the standard recordkeeping and notification provisions required by the
Commission in consent orders.
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.
Benjamin I. Berman,
Acting Secretary.
[FR Doc. 95-9266 Filed 4-13-95; 8:45 am]
BILLING CODE 6750-01-M