95-16255. Arizona Institute of Reproductive Medicine, Ltd., et al.; Proposed Consent Agreement With Analysis to Aid Public Comment  

  • [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
    
    

Document Information

Published:
07/03/1995
Department:
Federal Trade Commission
Entry Type:
Notice
Action:
Proposed consent agreement.
Document Number:
95-16255
Dates:
Comments must be received on or before September 1, 1995.
Pages:
34535-34537 (3 pages)
Docket Numbers:
File No. 942-3134
PDF File:
95-16255.pdf