| ROBERT J. CLEARY United States Attorney Assistant United States Attorney UNITED STATES DISTRICT COURT UNITED STATES OF AMERICA, Plaintiff, CONSENT DECREE WHEREAS: Plaintiff, the United States of America, has commenced this action by filing the Complaint herein; defendant, Bayer Corporation, has waived service of the Summons and Complaint; the parties have been represented by the attorneys whose names appear hereafter; and the parties have agreed to settlement of this action upon the following terms and conditions, without adjudication of any issue of fact or law and without defendant admitting liability for any of the matters alleged in the Complaint; THEREFORE, on the joint motion of plaintiff and defendant, it is hereby ORDERED, ADJUDGED, and DECREED as follows: 1. This Court has jurisdiction over the subject matter and the parties. 2. The Complaint states a claim upon which relief may be granted against defendant under Sections 5(l), 9, 13(b) and 16(a) of the Federal Trade Commission Act ("FTC Act"), 15 U.S.C. §§ 45(l), 49, 53(b) and 56(a). DEFINITIONS 3. For purposes of this Consent Decree, "Commission's Order" shall mean the Federal Trade Commission ("Commission") Order in FTC Docket No. 8919, a copy of which is attached as Appendix A to this Consent Decree. 4. For purposes of this Consent Decree, "clearly and prominently" shall mean as follows:
5. For purposes of this Consent Decree, "competent and reliable scientific evidence" shall mean tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has 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. CONSUMER EDUCATION 6. Defendant Bayer Corporation, its successors and assigns, shall conduct a consumer education program that includes dissemination of print advertisements and brochures as set forth in Appendices B, C and D. The cost of this consumer education program is estimated to be $1 million. 7. Within sixty (60) days after complying with paragraph 6 above, defendant shall provide to Commission staff a written report detailing defendant's compliance with paragraph 6 above. INJUNCTION 8. Defendant Bayer Corporation, its successors and assigns, and their officers, agents, representatives and employees, and all persons in active concert or participation with any one or more of them who receive actual notice of this Consent Decree by personal service or otherwise, are hereby permanently enjoined from ever, directly or through any corporation, subsidiary, division, or other device, violating any provision of the Commission's Order. 9. Defendant Bayer Corporation, its successors and assigns, and their officers, agents, representatives and employees, and all persons in active concert or participation with any one or more of them who receive actual notice of this Consent Decree by personal service or otherwise, in connection with the manufacturing, advertising, promotion, offering for sale, sale or distribution of any aspirin product, in or affecting commerce, as "commerce" is defined in the FTC Act, are hereby permanently enjoined from ever, directly or through any corporation, subsidiary, division, or other device, making any representation, in any manner, expressly or by implication, about the benefits of regular aspirin use, including, but not limited to, the prevention of heart attacks, transient ischemic attacks and strokes, unless:
10. In the event that the Commission's Order is hereafter modified, defendant's compliance with such Order as so modified shall not be deemed a violation of this injunction. PERSONS AFFECTED; CONTINUING JURISDICTION 11. Defendant Bayer Corporation, shall, within thirty (30) days after the entry of this Consent Decree, provide a copy of the Commission's Order and a copy of this Consent Decree to each of its officers, and to each of its agents and employees responsible for the advertising or promotion of any nonprescription internal analgesic product. Within ten (10) days of complying with this paragraph, defendant shall file an affidavit with the Court and serve the Commission, by mailing a copy thereof, to the Associate Director for Enforcement, Bureau of Consumer Protection, Federal Trade Commission, Washington, D.C. 20580, setting forth the fact and manner of its compliance, including the name and title of each person to whom a copy of the Commission's Order and this Consent Decree has been provided. 12. For a period of five (5) years from the date of entry of this Consent Decree, defendant, its successors and assigns, shall maintain and, upon request, make available to the Commission, copies of all business records demonstrating compliance with the terms and provisions of this Consent Decree. 13. This Court shall retain jurisdiction of this matter for the purpose of enabling any of the parties to this Consent Decree to apply to the Court at any time for such further orders or directives as may be necessary or appropriate for the interpretation or modification of this Consent Decree, for the enforcement of compliance therewith, for the redress of any violations thereof, or for the punishment of any violations thereof. JUDGMENT IS THEREFORE ENTERED in favor of plaintiff and against defendant, pursuant to all the terms and conditions recited above. Dated this ________ day of _______________, 2000. _________________________________ The parties, by their respective counsel, hereby consent to the terms and conditions of the Consent Decree as set forth above and consent to the entry thereof. Defendant waives any rights that may arise under the Equal Access to Justice Act, 28 U.S.C. § 2412, amended by Pub. L. 104-21, 110 Stat. 847, 863-64 (1996). FOR THE UNITED STATES OF AMERICA: DAVID W. OGDEN
By: EUGENE M. THIROLF ___________________________________ FOR THE FEDERAL TRADE COMMISSION: ELAINE D. KOLISH MARY K. ENGLE
_____________________________ FOR THE DEFENDANT: BAYER CORPORATION By: By: APPENDIX B UNITED STATES v. BAYER CORPORATION CONSUMER EDUCATION Background 1. Pursuant to Paragraph 6 of the Consent Decree, Bayer Corporation shall implement a national consumer education campaign. The goal is to provide consumers with information about (a) benefits and risks associated with an aspirin regimen for prevention of heart attacks and strokes, and (b) the need to consult a doctor prior to beginning an aspirin regimen. Consumer Brochure 2. As described below, Bayer Corporation shall distribute a consumer brochure, attached to the Consent Decree as Appendix C (hereinafter "brochure"). Internet Availability of Consumer Brochure 3. For a period of one (1) year beginning February 1, 2000, Bayer Corporation will place, clearly and prominently, a link to the full text of the consumer brochure on the home page of Bayer Corporation's primary web site for Bayer aspirin products (currently www.bayeraspirin.com). The link to this brochure shall be "Aspirin Regimen Therapy - Is It Right for You?" Print Advertisements for Consumer Brochure 4. Bayer Corporation shall place a full page print advertisement, attached to the Consent Decree as Appendix D, in the following publications from February to May 2000:
5. If Bayer Corporation, from February 1 through June 30, 2000, disseminates any other print advertisement that contains any representation, directly or by implication, about aspirin's cardiovascular benefits (for example, help save lives, prevent heart attack or stroke, reduce the risk of death from a heart attack, depiction of an EKG trace), Bayer Corporation shall include the following statement, clearly and prominently, in said print advertisement: "For a free brochure on aspirin, heart attack and stroke, call 1-800-332-2253." Toll-free Number for Consumers 6. For a period of one (1) year beginning February 1, 2000, Bayer Corporation shall provide a toll-free number, reasonably accessible 24 hours/day, for consumers to call and leave a message requesting free copies of the brochure. Bayer Corporation shall list this toll-free number in the above-mentioned print advertisements, as well as in the above-mentioned brochure. 7. Within seven (7) calendar days after receiving a consumer's request for brochures, Bayer Corporation shall mail the requested brochures to the consumer. Bayer Corporation shall fulfill all requests for one (1) to twenty-five (25) copies of the brochure, but may, at its own discretion, limit the number of brochures sent to an individual consumer to a total of twenty-five (25). Distribution of Consumer Brochures to Physicians and Others 8. Within six (6) months after the effective date of the Consent Decree, Bayer Corporation, through its medical sales force, shall deliver, by hand or mail, 625,000 copies of the brochure to approximately 25,000 physicians, including cardiologists, general practitioners and obstetricians/gynecologists. Approximately twenty-five (25) copies of the brochure will be delivered to each physician. 9. Within one (1) year after the effective date of the Consent Decree, Bayer Corporation shall distribute an additional 50,000 copies of the brochure through its consumer relations efforts and ad hoc sampling opportunities, which may include NASCAR events, Walking for Wellness, trade shows, etc. |