David Green, M.D.; Proposed Consent Agreement With Analysis to Aid Public Comment

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