Arizona, State of v. GlaxoSmithKline LLC

District Court, D. Arizona·Decided August 26, 2025·No. 2:25-cv-00860·Unknown

Opinion

WO

State of Arizona, et al., No. CV-25-00860-PHX-MTL

Plaintiff, ORDER

v.

GlaxoSmithKline LLC,

Defendant. Congress created the Medicaid Drug Rebate Program (“MDRP”) with the passage of the Omnibus Budget Reconciliation Act of 1990. 42 U.S.C. § 1396r-8; Pharm. Rsch. & Mfrs. of Am. v. Walsh, 538 U.S. 644, 652 (2003). “The purpose of creating the MDRP was to reduce the cost of prescription drugs to the Medicaid program and to ensure that Medicaid recipients had access to a variety of prescription drug choices.” Sarepta Therapeutics, Inc. v. Health Care Auth., 497 P.3d 454, 457 (Wash. App. 2021) (citing H.R. Rep. No. 101-881 at 96-97 (1990)). Under the MDRP, to receive reimbursement for branded drugs, pharmaceutical manufacturers were always required to enter into agreements to rebate a portion of the Medicaid reimbursement to the state agency (which was shared with the federal agency). See 42 U.S.C. § 1396r-8; Pharm. Rsch. & Mfrs of Am., 538 U.S. at 652. Federal law establishes the method for determining the rebate, which includes a fixed and inflationary component. 42 U.S.C. § 1396r-8(c). The fixed rebate requires manufacturers to pay up to 23.1 percent of the average paid price. § 1396r-8(c)(1)(B). The inflationary component requires the manufacturers to rebate the difference between the drug’s current price and the inflation-adjusted price of the drug when it was originally released. § 1396r-8(c). The inflation-adjusted rebate was capped at 100 percent of the drug’s average price—protecting manufacturers from selling its pharmaceuticals at a loss to Medicaid. See § 1396r- 8(c)(2)(D). (Doc. 1-3 ¶¶ 65-67.) Under the American Rescue Plan Act of 2021, Congress changed the landscape of Medicaid pharmaceutical reimbursement. See American Rescue Plan Act of 2021, Pub. L. No. 117-2, § 9816, 135 Stat. 4, 216 (2021). The American Rescue Plan amended the MDRP and removed this inflation-adjusted rebate cap protection effective January 1, 2024— requiring pharmaceutical manufacturers to make difficult business decisions, including discontinuing a profitable drug or pay the federal government with each sale of this drug to a Medicaid beneficiary.1 See id. (Doc. 1-3 ¶¶ 74-75.) Defendant GlaxoSmithKline LLC (“GSK”) sold a branded drug called Flovent since the early 2000s. (Id. ¶¶ 36-38.) In 2022, GSK launched a generic version of Flovent (the “Authorized Generic”). (Id. ¶¶ 1, 75; Doc. 1 at 3 (clarifying that GSK launched the Authorized Generic in May 2022).) On January 1, 2024, GSK stopped selling its Flovent- branded products, but the Authorized Generic was and is still available for sale. (Doc. 1- 3 ¶ 75; Doc. 1 at 3.) As a result, the State of Arizona filed a single-count civil complaint in Arizona Superior Court against GSK alleging a violation of the Arizona Consumer Fraud Act, A.R.S. § 44-1521, et seq. (“AZCFA”). (Doc. 1-3.) It alleges that GSK engaged in unfair practices when it “suddenly discontinued one of the most prescribed asthma medications in the country, Flovent, and replaced it with a materially identical [A]uthorized [G]eneric” to “avoid the obligation to pay rebates to Medicaid under [the MDRP].” (Id. ¶¶ 1, 4.) In a nutshell, the State sues GSK for making a business decision.

1 See, e.g., Elizabeth Williams, What Are the Implications of the Recent Elimination of the Medicaid Prescription Drug Rebate Cap?, Kaiser Family Foundation (Jan. 16, 2024), https://www.kff.org/policy-watch/what-are-the-implications-of-the-recent-elimination-of- the-medicaid-prescription-drug-rebate-cap/ (Finding insulin manufactures cut prices by as much as 80 percent and Eli Lilly and Novo Nordisk were expected to pay $430 million and $350 million, respectively, in additional Medicaid rebates in 2024). GSK filed a notice of removal claiming that the State’s claim “is based entirely on an alleged violation of public policy set forth in the [MDRP] at 42 U.S.C. § 1396r-8,” and “thus[,] arising under federal law.” (Doc. 1 at 1.) The State filed a motion to remand, arguing that this Court lacks subject matter jurisdiction over this action because it arises solely out of an alleged state-law violation. (Doc. 12.) The Court will grant the motion to remand (Doc. 12) because it lacks subject matter jurisdiction over this case.2 Federal courts possess limited jurisdiction and only have “that power authorized by Constitution and statute.” Gunn v. Minton, 568 U.S. 251, 256 (2013) (citation modified). A case filed in state court may be removed if it is an action “arising under the Constitution, laws, or treaties of the United States.” 28 U.S.C. § 1331. A case may “arise under” federal law in one of two ways. Gunn, 568 U.S. at 257. Either “a case arises under federal law when federal law creates the cause of action asserted,” or, under a “special and small category,” when a federal issue in the state-law action is “(1) necessarily raised, (2) actually disputed, (3) substantial, and (4) capable of resolution in federal court without disrupting the federal-state balance approved by Congress.” Id. at 257-58 (citation modified). “The mere presence of a federal issue in a state cause of action does not automatically confer federal-question jurisdiction.” Nevada v. Bank of Am. Corp., 672 F.3d 661, 675 (9th Cir. 2012) (quoting Merrell Dow Pharms., Inc. v. Thompson, 478 U.S. 804, 813 (1986)). “The defendant has the burden of proving by a preponderance of the evidence that the requirements for removal jurisdiction have been met.” Cnty. of San Mateo v. Chevron Corp., 32 F.4th 733, 746 (9th Cir. 2022). In its notice of removal, GSK argues that, though the State’s sole theory of liability

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