| ROBERT J. CLEARY United States Attorney Assistant United States Attorney UNITED STATES DISTRICT COURT UNITED STATES OF AMERICA, Plaintiff, CIV. ACTION NO. 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. JURISDICTION AND VENUE 2. This Court has jurisdiction over this matter under 28 U.S.C. §§ 1331, 1337(a), 1345 and 1355 and under 15 U.S.C. §§ 45(l), 49, 53(b) and 56(a). 3. Venue in the United States District Court for the District of New Jersey is proper under 15 U.S.C. § 53(b) and under 28 U.S.C. §§ 1391(b-c) and 1395(a). DEFENDANT 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. PRIOR COMMISSION PROCEEDING 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 BayerŽ 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. * * * BACKGROUND 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. COURSE OF BUSINESS 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. ORDER VIOLATIONS 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:
FIRST CAUSE OF ACTION 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. SECOND CAUSE OF ACTION 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. INJUNCTIVE AND OTHER EQUITABLE RELIEF 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. PRAYER FOR 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:
DATED:
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