Fruth, Inc. v. Cardinal Health, Inc.

CourtDistrict Court, S.D. West Virginia
DecidedJune 28, 2024
Docket3:23-cv-00801
StatusUnknown

This text of Fruth, Inc. v. Cardinal Health, Inc. (Fruth, Inc. v. Cardinal Health, Inc.) is published on Counsel Stack Legal Research, covering District Court, S.D. West Virginia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Fruth, Inc. v. Cardinal Health, Inc., (S.D.W. Va. 2024).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA

HUNTINGTON DIVISION

FRUTH INC. and FRUTH PHARMACY, INC.,

Plaintiffs,

v. CIVIL ACTION NO. 3:23-0801

CARDINAL HEALTH, INC., CARDINAL HEALTH 411, INC., CARDINAL HEALTH 110, LLC, and CARDINAL HEALTH 112, LLC,

Defendants.

MEMORANDUM OPINION AND ORDER

Pending is Defendants’ Motion to Dismiss. ECF No. 14. For the reasons that follow, the motion is GRANTED in part and DENIED in part.1

I. BACKGROUND

A. Section 340B of the Public Health Service Act Before the Court delves into the factual allegations made by the Plaintiffs Fruth Inc. and Fruth Pharmacy, Inc. (collectively, “Fruth”), it must first understand the “340B Drug Pricing Program.” The 340B Drug Pricing Program was authorized under Section 340B of the Public

1 In making its decision, the Court considered the following memoranda: Memorandum of Law in Support of Defendants’ Motion to Dismiss (“Defs.’ Mem.”), ECF No. 15; Plaintiffs’ Memorandum of Law in Opposition to Defendants’ Motion to Dismiss (“Pls.’ Opp.”), ECF No. 21; and Defendants’ Reply Memorandum in Further Support of Their Motion to Dismiss Plaintiffs’ Complaint, ECF No. 26 (“Defs.’ Reply”). Health Service Act and created under Section 602 of the Veterans Health Care Act of 1992. See 42 U.S.C. § 256b. The program is administered by the Health Resources and Services Administration (“HRSA”), a unit within the United States Department of Health and Human Resources (“HHS”). See Astra USA, Inc. v. Santa Clara Cnty., Cal., 563 U.S. 110, 113 (2011).

Section 340B “imposes ceilings on prices drug manufacturers may charge for medications sold to specified health-care facilities. Those facilities, here called ‘340B’ or ‘covered’ entities, include public hospitals and community health centers, many of them providers of safety-net services to the poor.” Id.; 42 U.S.C. § 256b(a)(1). Fruth alleges the 340B Program operates as follows.2 HHS enters into “purchase price agreements” (“PPAs”) with drug manufacturers, who produce pharmaceuticals. Drug manufacturers then enter into separate, but related, agreements with drug wholesalers, like Defendants Cardinal Health, Inc., Cardinal 411, Inc.; Cardinal Health 110, LLC; and Cardinal Health 112, LLC (collectively “Cardinal”), who purchase and resell the drugs. Compl. ¶ 45. Under the 340B Program, “wholesalers are contractually required to sell a manufacturer’s

product at the price agreed to by the manufacturer in the PPA.” Id. Thus, wholesalers are essentially “agents” of drug manufacturers. Id. “Under the terms of the PPAs, manufacturers (either directly or through their agents) agree to sell certain outpatient drugs to specified health care facilities (known as ‘covered entities’)3 at or below a ‘ceiling price,’ which is calculated under a statutory formula.” Id. at ¶ 46 (citing 42 U.S.C. § 256b(a)(l)). This ceiling price “is calculated based upon the difference

2 This description does not appear to be challenged by Cardinal at this stage. 3 “Covered entities” are statutorily defined to include 15 types of entities, including Federally Qualified Health Centers, critical access centers, and sole community hospitals. See 42 U.S.C. § 256(b)(4). between the manufacturer’s Average Manufacturer Price and the Medicaid unit rebate amount for a particular pharmaceutical drug.” Id. at ¶ 49 (citing 42 U.S.C. § 256b(a)(1)-(2), (b)). But it doesn’t stop there. Additional players can be added into the mix. Covered entities “may elect to rely on a pharmacy (known as a ‘contract pharmacy’ under the 340B Program) to

dispense pharmaceutical drugs to eligible patients under the 340B Program.” Id. at ¶ 50. As Fruth puts it, contract pharmacies “assume a significant risk by participating in the 340B Program[.]” Id. at ¶ 57. Instead of directly purchasing the drugs from the wholesaler at or below the ceiling price, they “often rely on drugs they already have in stock when they dispense drugs on behalf of a covered entity to eligible patients under the 340B Program.” Id. at ¶ 54.4 After dispensing the drug, the contract pharmacy is “made whole” by the manufacturer or wholesale “either by way of physical product replenishment or invoice credit for the cost of the drug.” Id. at ¶ 56. B. Fruth’s Factual Allegations Fruth alleges that at all relevant times, Cardinal served as the primary wholesaler for all

of Fruth’s retail pharmacy locations. Id. at ¶ 58. The parties entered a “Prime Vendor Agreement” on December 10, 2009, which “memorializ[ed] the terms of the parties’ customer and supplier relationship” (the “2009 PVA”). Id. at ¶ 59 (citing 2009 PVA, ECF No. 1-1). The 2009 PVA was amended several times, including a November 8, 2014, amendment which reflected “Fruth’s agreement to purchase 90% of all generic drug products through Cardinal’s generic source program . . ..” Id. at ¶ 61. Fruth alleges that it “relied on drugs it purchased under the 2009 PVA in connection with its participation in the 340B Program” and that “[b]etween entering the 2009 PVA and

4 These in stock drugs are presumably purchased at a rate higher than the 340B ceiling price. continuing though in or about 2016, Fruth dispensed drugs under the 340B Program and then was made ‘whole’ by Cardinal when it received a physical shipment of replacement product.” Id. at ¶¶ 62–63. Beginning in early 2015, Cardinal’s representatives began talking with Fruth

representatives about a “new pilot invoicing credit program that it was offering to contract pharmacy participants of the 340B Program, including Fruth.” Id. at ¶ 64–65. Fruth describes the pilot programs as follows: [I]f a contract pharmacy purchased a drug that was dispensed to an eligible patient under the 340B Program within the last 12 months, Cardinal would issue a credit to the contract pharmacy (rather than shipping physical replacement drugs to a contract pharmacy after it dispensed a drug to an eligible patient under the 340B Program). If the contract pharmacy did not purchase the drug that was dispensed to an eligible patient under the 340B Program within the last 12 months, Cardinal would then ship the product to the contract pharmacy, consistent with prior practice.

Id. at ¶ 65. Fruth specifically alleges that Fruth and Cardinal representatives discussed how the new program would work and that Fruth’s Chief Financial Officer even memorialized an April 13, 2015, conference between representatives noting, “Fruth will receive a credit and the credit will be via an [Manufacturer’s Return Authorization] in the same manner as if [Fruth] received the product and returned it.” Id. at ¶¶ 70–71 (alterations in Compl.). Despite an invitation to “supplement or correct” the CFO’s memorialization, Cardinal’s representatives did not correct that statement. Id. at ¶¶ 72–73. Consequently, Fruth’s Complaint asserts that “[c]redit owed to Fruth under Cardinal’s new 340B crediting program was to be handled consistent with returns for non-340B Program purchases, as memorialized in the applicable prime vendor agreement.” Id. at ¶ 75. The applicable prime vendor agreement (“PVA”) at the time Cardinal enrolled Fruth into the invoice program on March 14, 2016, was the “2009 PVA.” See id. at ¶ 59. On November 1, 2016, Fruth entered into the now operative “2016 PVA.” Id. at ¶¶ 83– 84.

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