J.B.D.L. Corp. v. Wyeth-Ayerst Laboratories, Inc.

485 F.3d 880, 2007 U.S. App. LEXIS 11003
CourtCourt of Appeals for the Sixth Circuit
DecidedMay 10, 2007
Docket05-3860/3988
StatusPublished
Cited by2 cases

This text of 485 F.3d 880 (J.B.D.L. Corp. v. Wyeth-Ayerst Laboratories, Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Sixth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
J.B.D.L. Corp. v. Wyeth-Ayerst Laboratories, Inc., 485 F.3d 880, 2007 U.S. App. LEXIS 11003 (6th Cir. 2007).

Opinion

OPINION

JULIA SMITH GIBBONS, Circuit Judge.

This litigation arose out of efforts by appellee, Wyeth-Ayerst Laboratories, Inc., to protect its market share in the oral estrogen replacement therapy market through the use of contractual agreements with third-party payer entities. Appellants, wholesale and retail purchasers, brought suit against Wyeth under § 2 of the Sherman Act, alleging that, as a result of Wyeth’s allegedly anticompetitive conduct, they were subject to increased prices on one of Wyeth’s drugs. On Wyeth’s motion, the district court granted summary judgment on appellants’ § 2 claim, and this consolidated appeal followed.

For the reasons below, we affirm.

I.

Plaintiffs-appellants, J.B.D.L. Corporation (“J.B.D.L.”) and McHugh Pharmacy Wynnewood, Inc. (“McHugh”), are the named representatives of a certified class of pharmaceutical wholesalers and retailers that purchased Premarin, an estrogen replacement medication, directly from defendant-appellee Wyeth-Ayerst Laborato *883 ries, Inc. (“Wyeth”). Plaintiffs-appellants CVS Meridian, Inc. and Rite Aid Corporation opted out of the class and filed suit separately. On appeal, the class and individual appellants have adopted each other’s briefs in their entirety, and we refer to them collectively as “the Purchasers.”

Wyeth produces Premarin, a brand-name prescription conjugated estrogen replacement medication. 1 Premarin is a form of estrogen replacement therapy (“ERT”) prescribed to treat women who have undergone hysterectomies and whose bodies no longer produce estrogen. 2 Wyeth produces, in addition to Premarin, other hormone therapy drugs, including Premphase and Prempro. Together, the three drugs constitute the “Premarin Family.”

Wyeth’s dominance in the field of oral ERT drugs is undisputed by the parties. Premarin was approved for marketing in the United States in 1942. Until 1999, Premarin was the only conjugated ERT available and, between 1999 and 2003, prescriptions for Premarin consistently accounted for more than 70 percent of the prescriptions written for oral ERT drugs. In 2000, Wyeth’s sales of Premarin generated revenues of nearly $1 billion.

In March 1999, Duramed Pharmaceuticals, Inc. (“Duramed”) won Food and Drug Administration (“FDA”) approval for Cen-estin, making Cenestin the second branded conjugated ERT drug on the market. Cenestin differs from Premarin in certain notable ways. While Premarin is composed of estrogen extracted from horse urine, Cenestin is made up of nine synthetic estrogen components chemically derived from plant material. Although Cenestin, like Premarin, is approved for the treatment of vasomotor symptoms associated with menopause, it is not approved for longterm use, in the prevention of osteoporosis, for example.

According to the Purchasers, Wyeth viewed Cenestin’s entrance into the oral ERT market 3 as a threat and acted accordingly to limit Cenestin’s success. It is undisputed that Wyeth developed the Pre-marin Preemptive Plan (“Preemptive Plan”) upon Cenestin’s FDA approval. The overarching aim of the Preemptive Plan was to hold Cenestin to 2 percent of total ERT prescriptions in 1999 by: (1) emphasizing to consumers the differences between Premarin and Cenestin; (2) limiting Cenestin distribution; and (3) limiting Duramed’s contracting opportunities in the ERT markets.

In this appeal, the Purchasers focus on the second and third strategies, specifically, Wyeth’s attempts to limit Cenestin’s distribution through the use of restrictive contractual arrangements with pharmacy benefit managers (“PBMs”) and managed care organizations (“MCOs”). MCOs, which include health maintenance organizations and preferred provider organizations, may independently manage their prescription drug benefit program or employ the services of an organization, a PBM, that specializes in pharmacy benefit management. Although the parties provide lengthy discussions of the distinctions between PBMs and MCOs, those distinctions are irrelevant here, and it is sufficient to know that these entities represent *884 a significant part of the third-party payer sector. We treat them identically and refer to them collectively as “MCOs.”

As one expert explained, MCOs “are not typically direct purchasers of brand-name pharmaceuticals,” but “they influence which products are available to members, and therefore which drugs are purchased” by making decisions about the drugs for which they will pay. Organizational structures known as “formularies” reflect these decisions. Formularies are, generally, a listing of medications for which an MCO provides coverage. They come in a variety of forms. An MCO with an “open formu-lary” structure will pay for drugs that are not on the formulary. A provider utilizing a “closed formulary,” by contrast, will not cover the costs of drugs not included on the formulary. MCOs also use incentive-driven formularies, wherein differing co-payments or other financial consequences associated with particular drugs are meant to influence selection. 4 Because a drug’s inclusion on an MCO’s formulary can dictate prescription choices for patients covered by MCOs, drug manufacturers seek to secure inclusion on MCO formularies as well as favorable placement within those formularies through financial rewards, including rebates, to MCOs.

Rebates awarded in return for advantageous formulary placement constituted a central part of Wyeth’s efforts to maintain Premarin’s market position. In 1996 and 1997, prior to Cenestin’s approval by the FDA, Wyeth entered into a number of reimbursement agreements with MCOs. Those agreements promised rebates on a number of Wyeth pharmaceuticals, including Premarin and the other members of the Premarin Family, subject to a variety of conditions. In challenging these agreements, the Purchasers take particular issue with Wyeth’s use of so-called “sole conjugated estrogen” or “sole CE” clauses, which, as their name suggests, required Premarin’s placement on formulary as the only conjugated estrogen drug. For example, the terms of the reimbursement agreement between Wyeth and Advance Paradigm conditioned payment of rebates on the listing of Premarin, Prempro, and Premphase on formulary as “the sole conjugated estrogen-containing products.” The rebate agreement between Aetna Health Management, Inc. and Wyeth required that the Premarin Family be the “only preferred hormone replacement therapy produces]” on formulary. Wyeth’s agreement with Medco Containment Services, Inc. required that Medco identify Premarin as the “exclusive branded conjugated estrogen” and the “preferred branded estrogen replacement therapy” on its Plan Formulary. Similarly, OHP Health Plan was entitled to rebates if the Premarin Family was listed as the “exclusive conjugated estrogen replacement therapies and the sole preferred estrogen replacement therapies on Formu-lary.” As of January 1, 2000, Wyeth had rebate contracts with 74 MCOs and, of those, 31 contained sole CE clauses preventing the MCO from including in its formulary any other conjugated estrogen therapy.

The agreements also included incentives for MCOs to assist in maintaining Prema-rin’s market share.

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Bluebook (online)
485 F.3d 880, 2007 U.S. App. LEXIS 11003, Counsel Stack Legal Research, https://law.counselstack.com/opinion/jbdl-corp-v-wyeth-ayerst-laboratories-inc-ca6-2007.