[Federal Register Volume 60, Number 127 (Monday, July 3, 1995)]
[Notices]
[Pages 34535-34537]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-16255]



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FEDERAL TRADE COMMISSION
[File No. 942-3134]


Arizona Institute of Reproductive Medicine, Ltd., et al.; 
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, a Phoenix, Arizona based company and its 
president from misrepresenting the success rate of their in vitro 
fertilization program or any other infertility treatment services. In 
addition, it would require the institute and its president to possess 
competent and reliable scientific evidence for any future comparative 
success-rate claims for fertility services.

DATES: Comments must be received on or before September 1, 1995.

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: Michael Katz or Matthew Daynard, FTC/
H-200, Washington, DC 20580. (202) 326-3123 or (202) 326-3291.

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: Arizona Institute of Reproductive Medicine, Ltd., 
a limited corporation, and Robert H. Tamis, M.D., individually and as 
president of said corporation. [File No. 942-3134].

    The Federal Trade Commission having initiated an investigation of 
certain acts and practices of Arizona Institute of Reproductive 
Medicine, Ltd., a limited corporation, and Robert 

[[Page 34536]]
H. Tamis, M.D., individually and as president of said corporation, 
hereinafter sometimes referred to as proposed respondents or 
respondents, and it now appearing that proposed respondents are 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 proposed respondents and counsel 
for the Federal Trade Commission that:
    1. Proposed respondent Arizona Institute of Reproductive Medicine, 
Ltd., is a limited corporation existing and doing business under and by 
virtue of the laws of the State of Arizona, with its office and 
principal place of business located at 2850 North 24th Street, Suite 
500-A, Phoenix, Arizona 85008.
    Proposed respondent Robert H. Tamis, M.D., is president of 
respondent Arizona Institute of Reproductive Medicine. His principal 
office or place of business is the same as that of the corporate 
respondent. Dr. Tamis formulates, directs and controls the acts and 
practices of said corporation.
    2. Proposed respondents admit all the jurisdictional facts set 
forth in the draft complaint.
    3. Proposed respondents waive:
    (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) Any claim under the Equal Access to Justice Act, 5 U.S.C. 504.
    4. This agreement shall not become part of the public record of the 
proceeding unless and until it is accepted by the Commission. If this 
agreement is accepted by the Commission, it, together with the draft 
complaint, 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 respondents, 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.
    5. This agreement is for settlement purposes only and does not 
constitute an admission by proposed respondents of facts, other than 
the jurisdictional facts, or of violations of law as alleged in the 
draft of complaint.
    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 
respondents: (a) issue its complaint corresponding in form and 
substance with the draft complaint and its decision containing the 
following order to cease and desist in disposition of the proceeding; 
and (b) 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 
respondents' address as stated in this agreement shall constitute 
service. Proposed respondents waive any right they 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 have read the draft complaint and the 
following order. Proposed respondents understand that once the order 
has been issued, they will be required to file one or more compliance 
reports showing that they have fully complied with the order. Proposed 
respondents further understand that the may be liable for civil 
penalties in the amount provided by law for each violation of the order 
after it becomes final.

Order

Definitions

    ``Competent and reliable scientific evidence'' shall mean those 
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 respondents Arizona Institute of Reproductive 
Medicine, Ltd., a limited corporation, and Robert H. Tamis, M.D., 
individually and as president of said corporation, their successors and 
assigns, officers, agents, representatives, and employees, directly or 
through any corporation, subsidiary, division, or other device, in 
connection with the advertising, promotion, sale or offering for sale 
of services relating to the treatment of infertility, do forthwith 
cease and desist from representing, directly or by implication, that 
respondents' success rates in terms of achieving deliveries is higher 
than or compares favorably with the success rates of any single 
provider or group of providers of these services, unless at the time of 
making such a representation, respondents possess and rely upon 
competent and reliable scientific evidence for making such a comparison 
which shall, at a minimum, consist of results for its own patients that 
are based upon the same criteria for determining the calculation of 
delivery rates that were used to produce the results with which the 
comparison is made, or otherwise misrepresenting the past or present 
success of respondents in achieving live births or pregnancies or the 
past or present success of any single provider or group of providers of 
these services in achieving live births or pregnancies.
II
    It is further ordered that respondents, shall forthwith distribute 
a copy of this Order to each of their officers, agents, 
representatives, and employees, who are engaged in the preparation and 
placement of advertisements or promotional materials, who communicated 
with patients or prospective patients, or who have any responsibilities 
with respect to the subject matter of this Order; and for a period of 
ten (10) years from the date of entry of this Order, distribute same to 
all of respondents' future officers, agents, representatives, and 
employees having said responsibilities.
III
    It is further ordered that for five (5) years after the last date 
of dissemination of any representation covered by this Order, 
respondents, or their 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 their possession or control that contradict, qualify, or 
call into question such representation, or the basis relied upon for 
such representation, including complaints from consumers.

[[Page 34537]]

IV
    It is further ordered that:
    (1) Respondent Arizona Institute of Reproductive Medicine, Ltd. 
Shall notify the Commission at least thirty (30) days prior to any 
proposed change in respondent such as dissolution, assignment or sale 
resulting in the emergence of a successor corporation, the creation or 
dissolution of subsidiaries or any other change in respondent which may 
affect compliance obligations arising out of this Order; and
    (2) Respondent Robert H. Tamis, M.D. shall promptly notify the 
Commission of the discontinuance of his present business or of his 
affiliation with the corporate respondent. In addition, for a period of 
three (3) years from the date of service of this Order, the respondent 
shall promptly notify the Commission of each affiliation with a new 
business or employment that involves an infertility program. Each such 
notice shall include the respondent's new business address and a 
statement of the nature of the business 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.
    The expiration of the notice provision of this paragraph shall not 
affect any other obligation arising under this Order.
V
    It is further ordered that respondents shall, within (60) days 
after service of this Order, file with the Commission a report, in 
writing, setting forth in detail the manner and form in which they have 
complied with all 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 the Arizona Institute of Reproductive 
Medicine, Ltd. and its President, Robert H. Tamis, M.D. The Arizona 
Institute of Reproductive Medicine offers infertility services to the 
public, including in vitro fertilization.
    The proposed consent order has been placed on the public record for 
sixty (60) days for 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 has alleged that proposed respondents failed to 
possess a reasonable basis for claims they made regarding their 
comparative success in achieving live births for their patients. The 
Arizona Institute of Reproductive Medicine claimed a live birth per 
embryo transfer rate of 17 percent in 1991 and 16 percent for the first 
six months of 1992, as compared to a national average of 14 percent for 
1991.
    The Commission alleges that these claims were deceptive because the 
Arizona Institute of Reproductive Medicine calculated the success 
statistics in their promotional materials counting multiple births 
(i.e., twins, triplets, etc.) as multiple deliveries. The national 
percentage was based on data published by The Society for Assisted 
Reproductive Technology (``SART''), a national organization whose 
members, including proposed respondents, are providers of assisted 
reproductive technologies. SART publishes annually national averages 
for live births achieved through its members' services. National 
averages for live births are based on a protocol which requires members 
to report multiple births as single deliveries. The published report 
counts a multiple birth as a single delivery. Had proposed respondents 
likewise counted multiple births as a single delivery, their success 
statistics for deliveries would have been significantly lower than both 
the true national average for deliveries per embryo transfer, which was 
17 percent for 1991, and the 14 percent represented by respondents.
    Part I of the proposed consent order seeks to address the alleged 
misrepresentation cited in the accompanying complaint by requiring 
proposed respondents to possess competent and reliable scientific 
evidence for any future success rate comparative claims for their 
infertility procedures. Any comparison with other success rates must 
consist of results that are based upon the same or essentially 
equivalent tests that were used as a basis for the other rates. 
Moreover, a fencing-in provision prohibits any misrepresentation of 
success in achieving pregnancies or live births by respondents as well 
as prohibiting respondents from misrepresenting the success rates of 
any single provider or group of providers of these services.
    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. 95-16255 Filed 6-30-95; 8:45 am]
BILLING CODE 6750-01-M