STATE OF MINNESOTA, BY ITS ATTORNEY GENERAL KEITH ELLISON v. SANOFI-AVENTIS U.S. LLC

CourtDistrict Court, D. New Jersey
DecidedMay 11, 2020
Docket3:18-cv-14999
StatusUnknown

This text of STATE OF MINNESOTA, BY ITS ATTORNEY GENERAL KEITH ELLISON v. SANOFI-AVENTIS U.S. LLC (STATE OF MINNESOTA, BY ITS ATTORNEY GENERAL KEITH ELLISON v. SANOFI-AVENTIS U.S. LLC) is published on Counsel Stack Legal Research, covering District Court, D. New Jersey primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
STATE OF MINNESOTA, BY ITS ATTORNEY GENERAL KEITH ELLISON v. SANOFI-AVENTIS U.S. LLC, (D.N.J. 2020).

Opinion

NOT FOR PUBLICATION

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY STATE OF MINNESOTA, by its Attorney General Keith Ellison, Plaintiff, Case No. 3:18-cv-14999 (BRM) (LHG) v. OPINION (Redacted) SANOFI-AVENTIS U.S. LLC, et al., Defendants.

MARTINOTTI, DISTRICT JUDGE Before the Court is a Joint Motion to Dismiss filed by Defendants Sanofi-Aventis U.S. LCC (“Sanofi”), Novo Nordisk, Inc. (“Novo Nordisk”), and Eli Lilly and Company (“Eli Lilly”) (collectively, “Defendants”), seeking to dismiss the First Amended Complaint (“First Amended Complaint”) of Plaintiff The State of Minnesota (“Plaintiff” or “State”). (ECF No. 47.) Plaintiff filed an Opposition to Defendants’ Motion to Dismiss (ECF No. 54), Defendants filed a Reply Brief to Plaintiff’s Opposition (ECF No. 57), and Plaintiff filed a sur-reply (ECF No. 63). For the reasons set forth herein, Defendants’ Motion to Dismiss is GRANTED IN PART and DENIED IN PART. I. BACKGROUND A. Factual Background1 Defendants are pharmaceutical manufacturers and three of the largest insulin manufacturers in the world. (ECF No. 22 ¶ 1.) Plaintiffs allege Defendants have engaged in a pricing scheme whereby they “publish and disseminate deceptively and misleadingly inflated

benchmark prices for their [insulin] products, which allow them to offer higher rebates to [pharmacy benefit managers (“PBMs”)] while still earning approximately the same, secret net price that they previously received.” (Id. ¶ 3.) As a result of Defendants’ actions, Minnesota residents who have purchased insulin products have been harmed. (Id.) 1. The Impact of Diabetes Approximately 445,000 Minnesota residents currently have diabetes and an additional 19,000 residents are diagnosed every year. (ECF No. 22 ¶ 12.) Individuals who have diabetes require insulin injections “to help process sugar and prevent long-term complications” from the disease. (Id. ¶ 14.) Plaintiff brings this action “to enforce [the State’s] laws, to vindicate the State’s

sovereign and quasi-sovereign interests in the integrity of its marketplace and the health and economic well-being of its residents, and to remediate all harm arising out of––and provide full relief for––violations of Minnesota and federal law.” (Id. ¶ 5.) Plaintiff alleges Defendants have harmed “Minnesota residents without insurance, Minnesota residents with high-deductible health plans, Minnesota residents who pay coinsurance, Minnesota Medicare beneficiaries, and the Minnesota Department of Corrections (“Minnesota DOC”), all of whom have paid more for a live-

1 For the purpose of this motion to dismiss, the Court accepts the factual allegations in the First Amended Complaint as true and draws all inferences in the light most favorable to the plaintiff. See Phillips v. Cty. of Allegheny, 515 F.3d 224, 228 (3d Cir. 2008). saving medication because of Defendants’ conduct.” (Id. ¶ 4.) Plaintiff requests this Court toll “[a]ll relevant statutes of limitations [because of] Defendants’ fraudulent concealment and denial of facts alleged herein.” (Id. ¶85.) Defendants are pharmaceutical companies headquartered in the United States who manufacture rapid-acting and long-acting analog insulins. (Id. ¶¶ 2, 6–8, 17.) Defendant Sanofi

makes the “rapid-acting” analog insulin Apidra and the “long-acting” insulins Lantus and Toujeo. (Id. ¶¶ 17–18.) Defendant Novo Nordisk makes the “rapid-acting” analog insulins NovoLog and Fiasp and the “long-acting” insulins Levemir and Tresiba. (Id.) Defendant Eli Lilly makes the “rapid-acting” analog insulin Humalog and also makes Basaglar, a “follow-on biologic of Lantus.” (Id.) Plaintiff alleges Defendants have published “deceptive, misleading, and misrepresentative benchmark prices” for their insulin products, resulting in patients paying exorbitant costs. (Id. ¶ 19.) Moreover, Defendants have increased the benchmark price for their long-acting insulins at least ten times since 2008. (Id.) The benchmark price of a 10-milliliter vial of Lantus has increased

from $99.35 in 2010 to $269.54 today. (Id.) The benchmark price of Levemir has increased from $113.81 in 2008 to $293.75 today. (Id.) The benchmark prices of Defendants’ rapid-acting insulins have also increased. (Id. ¶ 19.) NovoLog has increased in price from $132.74 in 2008 to $289.36 today, Humalog increased from $122.60 in 2011 to $274.70 today, and Apidra increased from $93.05 in 2010 to $269.91 today. (Id.) Plaintiff avers that these price increases “are not tied to any meaningful change or improvement to Defendants’ products” and in fact there have been “no meaningful improvement[s] to [Defendants’] products since they introduced them to the market.” (Id. ¶ 22.) These price increases have resulted in a substantial burden to diabetes patients, particularly “the uninsured, those with high-deductible health insurance [plans], and the elderly operating on limited budgets.” (Id. ¶ 23.) The high costs have left some patients “unable to afford to keep up with their treatment.” (Id. ¶ 24.) Patients taking less than the required dose of insulin “face increased risks of kidney dialysis, heart attacks, nerve damage, amputation, and ketoacidosis,” which in turn increases their overall medical expenses. (Id. ¶ 26.) 2. Drug Reimbursement

The approximate price at which a drug manufacturer sells a drug to a wholesale drug distributor is known as the Wholesale Acquisition Cost (“WAC”). (Id. ¶ 31.) This price is generally set by the manufacturer, including Defendants. (Id.). The WAC does not take into account rebates or other discounts a manufacturer offers to pharmacy benefit managers (“PBMs”). (Id.) Therefore, the actual price a manufacturer receives for the sale of a drug is less than the WAC. (Id.) Wholesale drug distributors often markup the WAC price prior to selling the drugs to pharmacies. (Id.). “The manufacturer-set WAC is generally used to establish a product’s Average Wholesale Price (“AWP”),” although certain markups are often included. (Id. ¶ 32.) Because the AWP “is merely a mathematical function of WAC,” a manufacturer effectively sets both prices. (Id.)2 The AWP is

used to calculate the price at which health plans and PBMs “reimburse pharmacies for prescriptions that they fill for plan members.” (Id. ¶ 33.) Drug manufacturers, like Defendants, publish the benchmark prices for their drugs through a variety of public reporting services. (Id. ¶ 34.) These reporting services “rely solely on Defendants’ representations about the price they receive” and make “no independent effort to verify” the reported price. (Id.) Plaintiff claims Defendants are aware health plans, wholesalers, pharmacies, and PBMs rely on the benchmark prices published by these reporting services to set

2 WAC and AWP are “colloquially referred to as the drug manufacturers’ ‘list’ or ‘benchmark’ price.” (Id. ¶ 32) their own prices or determine the “reimbursement rates that they pay to pharmacies.” (Id. ¶¶ 34, 36.) If Defendants raise the benchmark price of one of their drugs, the price paid by most Minnesota patients also increases. (Id. ¶ 36.) Markups added to the benchmark price by pharmacies and wholesalers do not affect the price paid by Minnesota patients because “Defendants’ benchmark prices are the lodestar for the price charged during all subsequent sales of insulin. (Id.)

PBMs are hired by health plans to manage the pharmaceutical benefits of their members. (Id. ¶ 37.) “PBMs create contractual networks of pharmacies” and “negotiate the rates at which the health plans reimburse pharmacies in the PBMs’ networks for the prescriptions the pharmacies fill.” (Id.) PBMs and health plans create and publish drug formularies. (Id. ¶ 39.) A formulary lists the prescription drugs a health plan will reimburse a pharmacy for on behalf of their members. (Id.) Placement on a health plan’s drug formulary is highly sought after.

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STATE OF MINNESOTA, BY ITS ATTORNEY GENERAL KEITH ELLISON v. SANOFI-AVENTIS U.S. LLC, Counsel Stack Legal Research, https://law.counselstack.com/opinion/state-of-minnesota-by-its-attorney-general-keith-ellison-v-sanofi-aventis-njd-2020.