Plaintiff, United States of America, acting upon the notification and authorization to the Attorney General by the Federal Trade Commission ("Commission"), for its Complaint alleges that:

1. Plaintiff brings this action 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), to obtain injunctive and other relief from defendant for its violations of a final order to cease and desist.

4. Defendant Bayer Corporation is an Indiana corporation with an office and place of business located within the District of New Jersey at 36 Columbia Road, Morristown, New Jersey 07960.

5. At all times material herein, defendant Bayer Corporation has been engaged in the advertising, offering for sale, sale or distribution of Bayer aspirin products and other nonprescription internal analgesic products, in or affecting commerce, as "commerce" is defined in Section 4 of the Federal Trade Commission Act, 15 U.S.C. § 44.

6. In a Commission proceeding bearing Docket No. 8919, in which Sterling Drug, Inc., and others were charged by the Commission with violating Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a) and 52, the Commission, on July 5, 1983, entered a final order against Sterling Drug, Inc., to cease and desist certain advertising practices ("Commission's Order"). On August 28, 1984, the United States Court of Appeals for the Ninth Circuit affirmed the Commission's Order, 741 F.2d 1146 (1984). On March 25, 1985, the Supreme Court of the United States denied Sterling Drug's petition for a writ of certiorari, 470 U.S. 1084 (1985), and on that day, by operation of law, the Commission's Order became final and enforceable. 15 U.S.C. § 45(g). The order has remained in full force and effect ever since.

7. In 1994, defendant Bayer Corporation (then named Miles, Inc.) acquired the North American over-the-counter drug business of Sterling Winthrop (formerly Sterling Drug, Inc.), including the rights to Bayer® aspirin products (hereinafter "Bayer aspirin products"). Defendant Bayer Corporation, therefore, is a successor to Sterling Drug, Inc. As a successor of Sterling Drug, Inc., Bayer Corporation is subject to the Commission's Order.

8. A copy of the Commission's Order is attached to this Complaint as Exhibit A.

9. The Commission's Order includes the following provision:

IT IS FURTHER ORDERED that respondent Sterling Drug, Inc., its successors and assigns, and its officers, agents, representatives and employees, directly or through any corporation, subsidiary, division or other device, in connection with the advertising, offering for sale, sale, or distribution of "Bayer Aspirin," "Bayer Children's Aspirin," "Vanquish," "Cope," "Midol," or any other nonprescription internal analgesic product in or affecting commerce, as "commerce" is defined in the Federal Trade Commission Act, do forthwith cease and desist from making any therapeutic performance claim for such product unless respondent possesses a reasonable basis for making that claim. A reasonable basis for such claim shall consist of competent and reliable scientific evidence supporting that claim. Well-controlled clinical tests conducted in accordance with the criteria set forth in Order Paragraph I shall be deemed to constitute a reasonable basis for a claim.

10. In 1980, the U.S. Food and Drug Administration (FDA) concluded that, based on a review of published studies, regular use of aspirin could reduce the risk of recurrent transient ischemic attacks (TIA's) and the risk of stroke in men who have had transient ischemia of the brain due to fibrin platelet emboli. The FDA also concluded that aspirin should be taken for this purpose only under the direction of a health care professional. The FDA therefore permitted aspirin labeling provided to health care professionals, but not to the general public, to include the following indications for use: "For reducing the risk of recurrent transient ischemic attacks (TIA's) or stroke in men who have had transient ischemia of the brain due to fibrin platelet emboli." See 53 F.R. 46204 at 46258-59 (Nov. 16, 1988), in which the professional labeling sanctioned by FDA in 1980 was published.

11. In 1985, the FDA concluded that, based on a review of published studies, regular use of aspirin could reduce the likelihood of heart attacks for individuals who have had a previous heart attack and could reduce the risk of a first heart attack in patients with unstable angina pectoris. The FDA also concluded that aspirin should be taken for this purpose only under the direction of a health care professional. The FDA therefore permitted aspirin labeling provided to health care professionals, but not to the general public, to include the following indications for use: "Aspirin is indicated to reduce the risk of death and/or non-fatal myocardial infarction in patients with a previous infarction or unstable angina pectoris." See 53 F.R. at 46259 (Nov. 16, 1988), in which the professional labeling sanctioned by FDA in 1985 was published.

12. In 1998, the FDA issued, as a final rule, professional labeling for over-the-counter internal analgesic, antipyretic, and antirheumatic drug products containing aspirin, buffered aspirin, and aspirin in combination with an antacid. 63 F.R. 56802-56819 (Oct. 23, 1998). The final rule became effective on October 25, 1999. The professional labeling set forth in the final rule is codified at 21 C.F.R. § 343.80 and incorporates the indications for aspirin use described in paragraphs 10 and 11 above.

13. Labeling provided to health care professionals is referred to as "professional labeling," whereas labeling directed to consumers is referred to as "over-the-counter (OTC) labeling." Professional labeling is not provided to the general public, and the information contained in professional labeling does not appear on the labels of OTC products.

14. In addition to disclosing that aspirin is indicated to reduce the risk of heart attacks, TIA's and strokes in certain persons, professional labeling for aspirin also discloses certain adverse reactions, such as an increased risk of gastrointestinal bleeding, which may be associated with regular aspirin use for prevention of heart attacks, TIA's or strokes. In addition, professional labeling for aspirin sets forth certain precautions regarding long-term aspirin use. For example, aspirin has been associated with elevated hepatic enzymes, blood urea nitrogen and serum creatinine, and prolonged bleeding time.

15. Because the information contained in professional labeling does not appear on the labels of OTC products, OTC labeling of aspirin includes only information about the benefits and risks associated with occasional use of aspirin for temporary relief of minor aches and pains and for reducing fever.

16. Since 1995, defendant Bayer Corporation has disseminated television and radio advertisements relating to the use of Bayer aspirin to prevent heart attacks, examples of which are attached hereto as Exhibits B-1 through B-9. The persons appearing in the television advertisements include men and women of varying ages.

17. Since May 1998, defendant Bayer Corporation has disseminated radio advertisements relating to the use of Bayer aspirin products to prevent strokes, examples of which are attached as Exhibits B-10 through B-12.

18. Since at least 1997, defendant Bayer Corporation has disseminated Internet advertisements relating to the use of Bayer aspirin products to prevent heart attacks and strokes, examples of which are attached as Exhibits B-13 and B-14.

19. On numerous occasions since 1995, defendant Bayer Corporation has disseminated or caused to be disseminated advertisements for Genuine Bayer Aspirin, and other Bayer aspirin products, including, but not necessarily limited to, the attached Exhibits B-1 through B-9, B-13 and B-14. These advertisements contain the following statements and depictions, among others:

A. Television:

Video: (Large print on screen) If you think all leading pain relievers are the same

Video: They're not.

Video: Shot of EKG screen showing heart beats (SFX: Beep, beep, beep)

Video: (Large print on screen) Only Genuine Bayer can help save your life when taken regularly

(Small print at bottom of screen) Among leading pain relievers.

Video: (Large print on screen) Not Advil, not Tylenol.

Video: Shot of packages of Advil, Excedrin, Tylenol and Aleve

Video: Close-up of package of Genuine Bayer (SFX: SLAM)

Video: (Large print on screen) Only Bayer Aspirin can reduce the risk of another heart attack by up to 50%.

(Small print at bottom of screen) Studies show aspirin, taken regularly, along with a regimen of diet and exercise, can help prevent a second heart attack.

Video: (Large print on screen) Just ask your doctor. . . .

(Exhibit B-3)

B. Radio:

SFX: CLOCK TICKING, GRADUALLY GETS LOUDER

ANNCR: Every minute, someone suffers a stroke. Every four minutes, a stroke victim dies. (CLOCK SFX STOPS ABRUPTLY) Bayer reminds you May is Stroke Awareness Month, a time to learn about stroke and recognize its warning signs. Genuine Bayer Aspirin is the only leading brand of pain reliever that helps reduce the risk of recurrent stroke when taken regularly with a diet and exercise regimen. Ask your doctor and use as directed. (SFX: CLOCK TICKING) And take time to learn about stroke. (SFX FADE) Bayer. Powerful pain relief and so much more.

(Exhibit B-11)

C. Internet:

Women and Cardiovascular Disease

. . .

Aspirin and Women

For many years, it was thought that men and women would not benefit equally from the effects of aspirin. In fact, for many years, cardiovascular health was less of a concern for women, as fewer middle-aged women were believed to suffer from heart attack than men. Now, we know that cardiovascular disease claims more women's lives than any other disease. Thanks to recent research, we also know aspirin can benefit hundreds of thousands of women each year. [Footnote omitted.]

. . .

(Exhibit B-13)

20. Through the means described in PARAGRAPH 19, including, but not necessarily limited to, those attached as Exhibits B-1 through B-9, B-13 and B-14, defendant has made the therapeutic performance claim that regular use of Genuine Bayer Aspirin is appropriate for the prevention of heart attacks in the general adult population.

21. Defendant made the therapeutic performance claim set forth in PARAGRAPH 20 without possessing a reasonable basis consisting of competent and reliable scientific evidence supporting the claim, as required by Part III of the Commission's Order, thereby violating Part III of the Commission's Order. In fact, regular use of aspirin has not been shown to be appropriate for prevention of heart attacks in the general adult population. First, the potential heart attack prevention benefits of regular aspirin use are not the same for everyone. Pre-menopausal women, for example, are less likely to benefit from regular aspirin use because they have a very low risk of heart attack compared to those persons who have had a previous heart attack or who have unstable angina pectoris. Second, for some adults, regular use of aspirin may be associated with important adverse health effects that are not disclosed on OTC labeling of aspirin. It is therefore recommended by FDA that individuals who are considering regular aspirin use to reduce the risk of heart attacks consult with a health care professional to weigh the potential heart benefits of regular aspirin use against the risks of adverse health effects associated with regular use of aspirin. Defendant's advertisements, which, for example, contain the statement, "Just ask your doctor" or "Ask your doctor and use only as directed," do not adequately convey to the consumer the importance of consulting with a health care professional prior to deciding whether to take aspirin to help prevent heart attacks.

22. Through the means described in PARAGRAPH 19, including, but not necessarily limited to, those attached as Exhibits B-10 through B-14, defendant has made the therapeutic performance claim that regular use of Genuine Bayer Aspirin is appropriate for the prevention of strokes in the general adult population.

23. Defendant made the therapeutic performance claim set forth in PARAGRAPH 22 without possessing a reasonable basis consisting of competent and reliable scientific evidence supporting the claim, as required by Part III of the Commission's Order, thereby violating Part III of the Commission's Order. In fact, regular use of aspirin has not been shown to be appropriate for prevention of strokes in the general adult population. First, the potential stroke prevention benefits of regular aspirin use are not the same for everyone. For example, persons who have not had a prior TIA have a lower risk of a clotting stroke than persons who have had a prior TIA. Second, for some adults, regular use of aspirin may be associated with important adverse health effects that are not disclosed on OTC labeling of aspirin. Third, regular aspirin use may help prevent clotting strokes, but will not help prevent hemorrhagic strokes. It is therefore recommended by FDA that individuals who are considering regular aspirin use to reduce the risk of strokes consult with a health care professional to weigh the potential stroke prevention benefits of regular aspirin use against the risks of adverse health effects associated with regular use of aspirin. Defendant's advertisements, which, for example, contain the statement, "Ask your doctor and use as directed," do not adequately convey to the consumer the importance of consulting with a health care professional prior to deciding whether to take aspirin to help prevent strokes.

24. Under Section 5(l) and 13(b) of the FTC Act, 15 U.S.C. §§ 45(l) and 53(b), this Court is authorized to issue a permanent injunction against defendant's violating the Commission's Order and the FTC Act and to order ancillary relief.

WHEREFORE, plaintiff requests this Court, pursuant to 15 U.S.C. §§ 45(l), 49 and 53(b), and pursuant to the Court's own equitable powers to:

(1) Enter judgment against defendant and in favor of plaintiff for each violation alleged in this Complaint;

(2) Enjoin defendant from violating the Commission's Order issued in FTC Docket No. 8919;

(3) Order defendant to conduct a consumer education program relating to the use of aspirin to prevent heart attacks and clotting strokes; and

(4) Award plaintiff such additional relief as the Court may deem just and proper.

 

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).

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:

A. In an advertisement communicated through an electronic medium (such as television, video, radio and interactive media such as the Internet and online services), the disclosure shall be presented simultaneously in both the audio and video portions of the advertisement. Provided, however, that in any advertisement presented solely through video or audio means, the disclosure may be made through the same means in which the ad is presented. The audio disclosure shall be delivered in a volume and cadence sufficient for an ordinary consumer to hear and comprehend it. The video disclosure shall be of a size and shade, and shall appear on the screen for a duration, sufficient for an ordinary consumer to read and comprehend it. In addition to the foregoing, in interactive media the disclosure shall also be unavoidable.

B. In a print advertisement or promotional material, the disclosure shall be in a type size and location sufficiently noticeable so that an ordinary consumer will read and comprehend it, in print that contrasts with the background against which it appears. In multi-page documents, the disclosure shall appear on the cover or first page.

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.

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.

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:

A. At the time such representation is made, defendant possesses and relies upon competent and reliable scientific evidence that substantiates the representation; and

B. Defendant makes the following disclosure, clearly and prominently, and in close proximity to the representation:

Aspirin is not appropriate for everyone, so be sure to talk to your doctor before you begin an aspirin regimen.

Provided, however, that when a representation about the benefits of regular aspirin use is made in any television or video advertisement that has a duration of 15 seconds or less, defendant may comply with subparagraph 9.B. by making the following disclosure, clearly and prominently, and in immediate conjunction with the representation:

Be sure to talk to your doctor before you begin an aspirin regimen.

Provided further, that subparagraph 9.B. shall not apply to any representation for aspirin, or a combination of aspirin and other over-the-counter drugs, that is permitted in over-the-counter labeling for any such drug under any tentative final or final standard promulgated by the Food and Drug Administration, or any new drug application approved by the Food and Drug Administration.

Provided further, that subparagraph 9.B. shall not apply to the brochure attached hereto as Appendix C.

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.

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).

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