Mosaic Health, Inc. v. Sanofi-Aventis U.S., LLC

CourtDistrict Court, W.D. New York
DecidedSeptember 2, 2022
Docket6:21-cv-06507
StatusUnknown

This text of Mosaic Health, Inc. v. Sanofi-Aventis U.S., LLC (Mosaic Health, Inc. v. Sanofi-Aventis U.S., LLC) is published on Counsel Stack Legal Research, covering District Court, W.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Mosaic Health, Inc. v. Sanofi-Aventis U.S., LLC, (W.D.N.Y. 2022).

Opinion

UNITED STATES DISTRICT COURT WESTERN DISTRICT OF NEW YORK _____________________________________

MOSAIC HEALTH INC., and CENTRAL VIRGINIA HEALTH SERVICES, INC., individually and on behalf of all those similarly situated, DECISION AND ORDER Plaintiffs, 6:21-CV-06507 EAW v.

SANOFI-AVENTIS U.S., LLC, ELI LILLY AND COMPANY, LILLY USA, LLC, NOVO NORDISK INC., and ASTRAZENECA PHARMACEUTICALS LP,

Defendants. _____________________________________

INTRODUCTION Plaintiffs Mosaic Health, Inc. (“Mosaic Health”) and Central Virginia Health Services, Inc. (“CVHS”) (collectively “Plaintiffs”) allege that defendant pharmaceutical companies Sanofi-Aventis U.S. (“Sanofi”), Eli Lilly and Company and Lilly USA, LLC (“Eli Lilly”), Novo Nordisk Inc. (“Novo Nordisk”), and AstraZeneca Pharmaceuticals LP (“AstraZeneca”) (collectively “Defendants”) have violated state and federal antitrust laws by coordinating to rescind a long-standing discount for “safety-net” hospitals and clinics that treat patients who would otherwise be unable to obtain care. (Dkt. 1). Presently before the Court is a joint motion to dismiss filed by Defendants. (Dkt. 47; Dkt. 48)1. For the reasons that follow, the Court grants Defendants’ motion, but conditionally grants Plaintiffs’ request for leave to file a second amended complaint.

BACKGROUND I. Factual Background The instant facts are taken from Plaintiffs’ amended complaint, which is the operative pleading. As is required at this stage of the proceedings, Plaintiffs’ factual allegations are taken as true.

Mosaic Health is a nonprofit healthcare organization with its principal place of business in Rochester, New York. (Dkt. 41 at ¶ 9). It is “a federally qualified health center that receives funds from the U.S. Department of Health and Human Services, Health Resources and Services Administration to provide healthcare services to people residing in medically underserved areas, regardless of their ability to pay” and operates 22 safety-net

clinics. (Id.). CVHS is a nonprofit healthcare organization with its principal place of business in New Canton, Virginia. (Id. at ¶ 10). It is “a federally qualified health center that receives funds from the U.S. Department of Health and Human Services, Health Resources and Services Administration to provide healthcare services to people residing in medically underserved areas, regardless of their ability to pay” and operates 18 safety-net

clinics. (Id.).

1 Defendants have also filed a motion to stay discovery pending resolution of the motion to dismiss. (Dkt. 51). In light of the Court’s resolution of the motion to dismiss, the motion to stay is denied as moot. In 1992, Section 340B of the Public Health Service Act, 42 U.S.C. § 256b, created the “340B Drug Discount Program,” which “require[s] discounts on outpatient drugs purchased by healthcare providers serving underserved populations.” (Id. at ¶ 21). “The

net savings and revenue generated through access to 340B Drug Discounts [are] sometimes referred to as 340B Savings” and “340B Savings are often a critical component of covered entities’ ability to provide healthcare services to patients.” (Id. at ¶¶ 23-24). Mosaic Health, for example, uses 340B savings to “help fund sliding fee discounted medications for patients in need.” (Id. at ¶ 25).

“Since its inception, the 340B Drug Discount has been a defined discount, specific to each drug, calculated by the 340B Drug Discount Program.” (Id. at ¶ 29). More specifically, Section 340B imposes a ceiling price for a drug, which is “generally equal to the ‘Average Manufacturer Price’ minus a ‘Unit Rebate Amount.’” (Id. at ¶ 30). Pharmaceutical companies report their 340B ceiling prices to the Health Resources and

Services Administration (“HRSA”) on a quarterly basis, and the HRSA in turn makes those prices available to covered entities via its 340B Office of Pharmacy Affairs Information System (“340B OPAIS”), “an online database that allows covered entities to access ceiling prices for covered outpatient drugs.” (Id. at ¶ 31). “Since at least 1996, and in greater volumes since 2010, all drug companies

participating in the 340B Drug Discount Program have offered Contract Pharmacy 340B Drug Discounts to covered entities. To do so, drug companies have offered covered entities the 340B Drug Discount on covered outpatient drugs purchased on the covered entities’ own accounts but shipped to their registered Contract Pharmacy sites.” (Id. at ¶ 55). A typical arrangement involving a contract pharmacy would work as follows: (1) a covered entity’s patient arrives at a contract pharmacy for a covered outpatient drug; (2) the contract pharmacy, “sometimes itself and sometimes working with a 340B vendor . . . reviews the

pharmacy prescription to identify the patient’s prescription as 340B eligible and to match it to a particular covered entity”; (3) the contract pharmacy fills the prescription with inventory from the purchasing account of the covered entity; (4) the contract pharmacy charges the patient for any required co-pay or fee, “adjusted downward as appropriate by any sliding-fee scale arrangement between the pharmacy and the covered entity”; (5) the

contract pharmacy collects reimbursements from any third-parties such as private insurers or Medicare Part D; and (6) the contract pharmacy remits any amounts collected to the covered entity and the covered entity pays the contract pharmacy a dispensing fee. (Id. at ¶ 56). Diabetes “is often coincident with low-income populations and in lower-income

neighborhoods that are underserved by private healthcare practices” and is “a common area of treatment for 340B covered entity hospitals and clinics.” (Id. at ¶¶ 72-73). “Consequently, diabetes medications make up a significant portion of 340B covered entities’ outpatient prescriptions and 340B Drug Discounts. And three of the most significant diabetes medications are rapid-acting analog insulins, long-acting analog

insulins, and incretin mimetics.” (Id. at ¶ 74). The defendant pharmaceutical companies “dominate three of today’s most lucrative markets for diabetes treatments: (i) rapid-acting analog insulins; (ii) long-acting analog insulins; and (iii) incretin mimetics. Defendants compete against each other, as horizontal competitors, in these markets.” (Id. at ¶ 68). Sanofi, Eli Lilly, and Novo Nordisk compete in the sale of rapid-acting analog insulins and long-acting analog insulins. (Id. at ¶¶ 75-84). Sanofi, Eli Lilly, Novo Nordisk, and AstraZeneca compete in the sale of incretin mimetics.

(Id. at ¶¶ 85-90). These products collectively represent “hundreds of millions or billions of dollars in annual sales for each company.” (Id. at ¶ 91). In 2020, Defendants spent millions of dollars “collectively lobbying the federal government . . . to limit 340B Drug Discounts with respect to diabetes medicines.” (Id. at ¶ 100). However, those efforts were largely unsuccessful. (Id. at ¶¶ 100-116). On July

24, 2020, then-President Donald Trump issued Executive Order 13937, which “addressed the use of insulin (as well as epinephrine) within the 340B Drug Discount Program,” but was “extremely limited in scope.” (Id. at ¶¶ 102-103). “Executive Order 13937 promised to have relatively little impact on the volume of 340B Drug Discounts for insulin medications[.]” (Id. at ¶ 104).

On July 24, 2020, AstraZeneca advised the United States Department of Health and Human Services (“HHS”) that it intended to limit contract pharmacy 340B drug discounts. (Id. at ¶ 118). More particularly, AstraZeneca stated that beginning October 1, 2020, and for certain of its products, it would “recognize one contract pharmacy per covered entity for those covered entities that do not maintain an on-site dispensing pharmacy.” (Id.).

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Turkmen v. Ashcroft
589 F.3d 542 (Second Circuit, 2009)
Illinois Brick Co. v. Illinois
431 U.S. 720 (Supreme Court, 1977)
Bell Atlantic Corp. v. Twombly
550 U.S. 544 (Supreme Court, 2007)
Ashcroft v. Iqbal
556 U.S. 662 (Supreme Court, 2009)
DiFolco v. MSNBC Cable L.L.C.
622 F.3d 104 (Second Circuit, 2010)
Burtch v. Milberg Factors, Inc.
662 F.3d 212 (Third Circuit, 2011)
SD3, LLC v. Black & Decker (U.S.) Inc.
801 F.3d 412 (Fourth Circuit, 2015)
In Re: Domestic Airline Travel Antitrust Litigation
221 F. Supp. 3d 46 (District of Columbia, 2016)
Park Irmat Drug Corp. v. Express Scripts Holding Co.
911 F.3d 505 (Eighth Circuit, 2018)
WI3, Inc. v. Actiontec Electronics, Inc.
71 F. Supp. 3d 358 (W.D. New York, 2014)
In re Interest Rate Swaps Antitrust Litigation
261 F. Supp. 3d 430 (S.D. New York, 2017)
Wells Fargo Bank, N.A. v. Allstate Ins. Co.
290 F. Supp. 3d 715 (N.D. Ohio, 2017)
N. Am. Soccer League, LLC v. U.S. Soccer Fed'n, Inc.
296 F. Supp. 3d 442 (E.D. New York, 2017)
Anderson News, L.L.C. v. Am. Media, Inc.
899 F.3d 87 (Second Circuit, 2018)
Nielsen v. AECOM Technology Corp.
762 F.3d 214 (Second Circuit, 2014)
Malin v. XL Capital, Ltd.
312 F. App'x 400 (Second Circuit, 2009)

Cite This Page — Counsel Stack

Bluebook (online)
Mosaic Health, Inc. v. Sanofi-Aventis U.S., LLC, Counsel Stack Legal Research, https://law.counselstack.com/opinion/mosaic-health-inc-v-sanofi-aventis-us-llc-nywd-2022.