[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