[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