Pfizer, Inc. v. Miles, Inc.
| Decision Date | 19 August 1994 |
| Docket Number | Civ. No. 3:93CV2023 (AVC). |
| Citation | 868 F. Supp. 437 |
| Court | U.S. District Court — District of Connecticut |
| Parties | PFIZER, INC., Plaintiff and Counterclaim Defendant, v. MILES, INC., Defendant and Counterclaim Plaintiff. |
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Ira B. Grudberg, David L. Belt, Jacobs, Grudberg, Belt & Dow, P.C., New Haven, CT, Joel E. Hoffman, Robert W. Clark, B. Brett Heavner, Sutherland Asbill & Brennan, Washington, DC, Patricia A. Gorham, Sutherland, Asbill & Brennan, Atlanta, GA, Michael J. Levin, Roger Boyle, Blair C. Fensterstock, Daniel F. Markham, Sutherland, Asbill & Brennan, New York City, for Pfizer, Inc.
Stefan Richard Underhill, James F. Stapleton, Day, Berry & Howard, Stamford, CT, Daniel Marcus, Thomas P. Olson, Susan P. Crawford, Lynn Charytan, Katherine Bradley, Kinsey S. Reagan, Michael L. Burack, Wilmer, Cutler & Pickering, Washington, DC, Stephanie A. Watkins, Day, Berry & Howard, Hartford, CT, for Miles, Inc.
RULING ON PLAINTIFF'S AND COUNTERCLAIM PLAINTIFF'S MOTIONS FOR PRELIMINARY INJUNCTION
This is an action for damages and for preliminary injunctive relief brought pursuant to § 43(a) of the Lanham Act, 15 U.S.C. § 1125(a); the Connecticut Unfair Trade Practices Act, ("CUTPA"), Conn.Gen.Stat. § 42-110b; the Federal Trade Commission Act, 15 U.S.C. § 45(a)(1); the Medicaid anti-kickback statute, 42 U.S.C. § 1320a-7b(b)(2), and common law in which the plaintiff, Pfizer, Inc., ("Pfizer") seeks to enjoin the defendant, Miles, Inc., ("Miles") from engaging in an allegedly false and misleading promotional campaign that purports to equate the Miles' product "Adalat CC" with Pfizer's product "Procardia XL."
Pfizer further seeks to enjoin Miles from engaging in an alleged kickback scheme of offering payments to pharmacists for certain "cognitive counseling services" in connection with new Adalat CC prescriptions. Although Miles has withdrawn the payment program by agreement with several states, including the state of Connecticut, Pfizer nevertheless seeks preliminary injunctive relief for fear of future program recurrence. In addition, Pfizer seeks the recall of existing Miles advertisements relating to the Miles product Adalat CC; corrective advertisements; court action compliance certificates from Miles' marketing employees; a twelve month cease and desist order precluding Miles from promoting Adalat CC beyond the findings of this court; a demand that Miles cancel all outstanding orders for Adalat CC received as a result of the promotional campaign; a cease and desist order pertaining to Miles' alleged kickback activities; treble damages; punitive damages; Miles' profits from the sale of Adalat CC; pre-judgment interest, costs and attorney fees.
By way of counterclaim, Miles seeks preliminary injunctive relief to enjoin Pfizer from disseminating allegedly false and misleading information concerning the Miles' product, Adalat CC. Further, Miles moves for an order requiring Pfizer to recall existing false material relating to the Miles product, Adalat CC; corrective advertisements; certification from Pfizer that they have held training sessions with Pfizer representatives to correct promotional activities; a twelve month order requiring Pfizer to cease dissemination of any advertising designed to compare Procardia XL, a similar Pfizer product, with Adalat CC; treble damages; profits from the allegedly false promotional campaign; pre-judgment interest, costs, and attorney fees.
The issues now presented are: 1) whether Pfizer is likely to succeed on the merits of its claim that Miles' promotional campaign is false and misleading; 2) whether in view of Miles' agreements, preliminary injunctive relief is necessary with respect to the Pharmacy Information Program; and 3) whether Miles is likely to succeed on the merits of its claim that Pfizer is disseminating into the market literally false information concerning the Miles product Adalat CC.
For the reasons hereinafter set forth, the court denies Pfizer's request for a temporary injunction and grants in part Miles' request for a temporary injunction.
This action arises pursuant to section 43(a) of the Lanham Act, 15 U.S.C. § 1125(a), and pursuant to CUTPA, Conn.Gen.Stat. §§ 42-110a-q. This court has jurisdiction over the Lanham Act claims pursuant to 28 U.S.C. §§ 1331 and 1338, and over the Connecticut law claims pursuant to 28 U.S.C. §§ 1338 and 1367. Venue is proper pursuant to 28 U.S.C. § 1391(a).
Documents submitted to the court disclose the following undisputed facts. Nifedipine is a "calcium channel blocker" that can be used to treat hypertension (high blood pressure). Both Pfizer and Miles have for several years marketed immediate-release nifedipine tablets, which have to be taken three times a day. In 1989, Pfizer obtained Food and Drug Administration ("FDA") approval for Procardia XL, an extended release version of nifedipine for 24 hour treatment of both hypertension and angina (pain associated with oxygen deprivation to the heart muscle). Procardia XL is delivered into a patient's blood stream through a special mechanism contained in the tablet called the gastrointestinal therapeutic system ("GITS"). GITS is a water osmosis system that enables the drug to pass into the patients blood stream at a relatively steady, constant rate over a 24 hour period.
In 1993, Miles secured FDA approval of a 24 hour, extended release nifedipine product for treatment of hypertension (but not angina), bearing the name Adalat CC, and having an average wholesale price 25% below that of Procardia XL. Once ingested, Adalat CC is delivered into a patient's blood stream through a special system called "Coat Core." Unlike GITS, Coat Core is not a water osmosis delivery system, but instead depends upon disintegration by gastrointestinal acid which leads to differing rates of drug absorption into a patient's blood plasma. Therefore, although the two drugs are similar in that both contain the same active ingredient nifedipine, and both are FDA approved for treatment of hypertension over a 24 hour period, the two differ in the rate and level of the release of the active ingredient into the patient's bloodstream over a 24 hour period. The differing concentrations of the active ingredient implicate differing pharmacokinetic profiles of the two drugs, which preclude the FDA from labeling the two drugs as "bioequivalent."1 Since Adalat CC is not the "bioequivalent" of Procardia XL, it may not be dispensed by a pharmacist as a literal substitute for Procardia XL without a physician's prescription.
The Lanham Act, § 43(a), as amended, 15 U.S.C. § 1125(a) prohibits the use of any false or misleading representation on or in conjunction with goods in commerce:2
The plaintiff is entitled to prevail on the merits of its § 43(a) claim against the defendant if it establishes either of two propositions; i.e., that the defendant's promotional campaign "is either literally false, or although literally true, is likely to mislead and confuse consumers." McNeil — P.C.C., Inc. v. Bristol Myers Squibb Co., 938 F.2d 1544, 1549 (2d Cir.1991).
The statute embraces false impressions, innuendo and ambiguous suggestions. See Johnson & Johnson v. GAC Int'l, 862 F.2d 975 (2d Cir.1988); Vidal Sassoon, Inc. v. Bristol-Myers Co., 661 F.2d 272 (2d Cir. 1981). When such a representation is literally true, a plaintiff has the burden of proving that the persons to whom the advertising or promotion is addressed would receive a false impression about a product. United States Healthcare v. Blue Cross of Greater Philadelphia, 898 F.2d 914 (3d Cir.1990). To show this, the plaintiff must demonstrate, by a preponderance of the evidence, that the defendant's representations are likely to confuse consumers. Demonstrating actual confusion is not necessary. McNeil-P.C.C., v. Bristol-Myers Squibb Co., 938 F.2d 1544, 1549 (2d Cir.1991).
"When a merchandising statement or representation is literally or explicitly false, the court may grant relief without reference to the advertisements' impact on the buying public." Coca Cola Co., v. Tropicana Products, Inc., 690 F.2d 312, 317 (2d Cir.1982). Relief can be granted without reference to the reaction of consumers. PPX Enterprises, Inc. v. Audiofidelity Enterprises, Inc., 818 F.2d 266, 272 (2d Cir.1987).
A violation of the Lanham Act is a per se violation of CUTPA, Conn.Gen.Stat. § 42-110b. "To the extent defendants' actions violated the Lanham Act, ... they should be held automatically to violate CUTPA." Dial Corp. v. Manghnani Inv. Corp., 659 F.Supp. 1230, 1239 (D.Conn.1987).
The general standard for issuance of a preliminary injunction in the Second Circuit is well established. A party seeking a preliminary injunction must demonstrate: (a) irreparable harm; and (b) either (i) a likelihood of success on the merits of the underlying claim; or (ii) sufficiently serious questions going to the merits of the claim so as to make it a fair ground for litigation and a balance of the hardships tipping decidedly toward the movant. Stewart B. McKinney Found., Inc. v. Town Plan and Zoning Comm'n, 790 F.Supp. 1197, 1208 (D.Conn. 1992).
The first element, irreparable harm, may be presumed once a Lanham Act plaintiff has demonstrated...
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