In Re Pharmaceutical Industry Average Wholesale Price Litigation

457 F. Supp. 2d 65, 2006 WL 2563453
District Court, D. Massachusetts·Decided September 6, 2006·No. MDL No. 1456. Civil Action No. 01-12257-PBS·Published·Cited by 4 cases

Opinion

*67 MEMORANDUM AND ORDER

SARIS, District Judge.

I. INTRODUCTION

The State of Florida brings this action against numerous pharmaceutical companies, alleging that they defrauded the state Medicaid program by misrepresenting the price of prescription drugs in violation of state law. Defendants removed the case from state court to the Northern District of Florida on the basis of federal question jurisdiction. 1 Before deciding the motion to remand, the district court transferred the case to this Court for inclusion in the Pharmaceutical Industry Average Wholesale Pricing multi-district litigation, requiring this Court to resolve the motion to remand. Plaintiffs motion to remand is ALLOWED.

II. FACTUAL BACKGROUND

This action arises out of the alleged scheme by defendant pharmaceutical manufacturers to fraudulently and grossly inflate the prices to consumers of many drugs by misstating the “Average Wholesale Prices” (“AWPs”) and “Wholesaler Acquisition Costs” (“WACs”) of their drugs in industry publications. These allegations have engendered an enormous class action suit and multi-district litigation in this Court. I have fully outlined these allegations in earlier orders. See, e.g., In re Pharm. Indus. Average Wholesale Price Litig., 230 F.R.D. 61 (D.Mass.2005); State of Montana v. Abbot Labs., et al, 266 F.Supp.2d 250 (D.Mass.2003). However, because this motion to remand depends heavily on this Plaintiffs specific allegations, I will briefly discuss the pertinent facts and procedural history in the context of the federal Medicaid system.

A. Introduction to Medicaid

In order to fully explain the nature of Plaintiffs complaint, and fully assess the extent to which it arises under federal law, it is necessary to introduce the general workings of the Medicaid system, as it operates under both federal and Florida statutes and regulations. This Court has had occasion to engage in a brief summary of how Medicaid works in several prior opinions. See Massachusetts v. Mylan Labs., 357 F.Supp.2d 314, 318-20 (D.Mass.2005); In re Pharm. Indus. Average Wholesale Price Litig., 321 F.Supp.2d 187, 195-97 (D.Mass.2004); Montana, 266 F.Supp.2d at 253-54.

Medicaid is a federal-state partnership designed to provide medical care to the poor. See 42 U.S.C. §§ 1396-1396v (2005); Ark. Dep’t of Health & Human Servs. v. Ahlborn, — U.S. -, -, 126 S.Ct. 1752, 1758, 164 L.Ed.2d 459 (2006) (describing Medicaid program as a “cooperative one” between the federal government and the states); Mylan Labs., 357 F.Supp.2d at 318 (describing Medicaid as “a uniquely cooperative federal-state program”). Under the Medicaid framework, each state develops a plan detailing standards for eligibility and the content of medical assistance it will provide, in accordance with federal statutes and regulations. See generally, 42 U.S.C. § 1396a(a). The program is administered by the Center for Medicare and Medicaid Services (“CMS”), which is under the authority of *68 the Secretary for Health and Human Services. See Montana, 266 F.Supp.2d at 252. The Secretary “shall approve” any state plan which complies with the myriad requirements set forth in § 1396a(a) and (b). 42 U.S.C. § 1396a(b). The federal government then reimburses the state a statutorily defined percentage of the costs incurred by the state. 42 U.S.C. § 1396b.

Under Medicaid, states are not required to provide coverage for prescription drugs, 42 U.S.C. § 1396d(a)(12), but forty-nine states do, such that drugs purchased by Medicaid recipients account for roughly ten percent of all prescription drugs purchased in the United States. In re Pharmaceutical Industry Average Wholesale Price Litigation, 321 F.Supp.2d at 195. In order to save costs, in 1990 Congress passed the Medicaid Rebate Statute, 42 U.S.C. § 1396r-8, which “requires drug companies to pay rebates to states on their Medicaid purchases.” See Pharm. Research & Mfrs. of Am. v. Walsh, 538 U.S. 644, 649, 123 S.Ct. 1855, 155 L.Ed.2d 889 (2003); 42 U.S.C. § 1396r-8 (b)(1)(A).

Section 1396r-8 provides a comprehensive regulatory scheme for the administration of Medicaid prescription drug coverage. In order to qualify for Medicaid payments, drug manufacturers must enter into contracts with the federal government to provide rebates directly to the states on outpatient prescription drugs sold. 42 U.S.C. § 1396r-8(a)(l). States may also enter into Supplemental Rebate Agreements (“SRAs”) directly with drug manufacturers as authorized by the Secretary. Id. Once the contract is entered into, the state must, with some limited exceptions, provide the drug under its Medicaid plan. 42 U.S.C. § 1396r-8(d). See also Walsh, 538 U.S. at 652, 123 S.Ct. 1855. In essence, states reimburse providers for covered drugs, and the drug companies provide rebates to the states. Any amount that the state receives as a rebate from drug manufacturers offsets the amount of money reimbursed to the state by the federal government under Medicaid; in other words, the rebate from the drug manufacturer reduces the amount of the state’s federal reimbursement. 42 U.S.C. § 1396r — 8(b)(1)(B); see In re Pharm. Indus. Average Wholesale Price Litig., 321 F.Supp.2d at 196 (noting that the rebate offset creates a financial interest for the federal government in the program).

The amount of the rebate paid to the state by the manufacturer is determined by the agreement between the manufacturer and the federal government under the Medicaid statute and any federally approved SRA between the state and the manufacturer. The amount the state will pay to providers is determined by the state itself. In order to facilitate this process, both the states and the drug manufacturers must report certain information to the CMS. The state must report “information on the total number of units of each dosage form and strength and package size of each covered outpatient drug ... for which payment was made during the period.” 42 U.S.C.

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