Sandoz, Inc. v. State

100 So. 3d 514, 2012 Ala. LEXIS 88, 2012 WL 2866764
CourtSupreme Court of Alabama
DecidedJuly 13, 2012
Docket1081402
StatusPublished
Cited by11 cases

This text of 100 So. 3d 514 (Sandoz, Inc. v. State) is published on Counsel Stack Legal Research, covering Supreme Court of Alabama primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Sandoz, Inc. v. State, 100 So. 3d 514, 2012 Ala. LEXIS 88, 2012 WL 2866764 (Ala. 2012).

Opinions

PER CURIAM.

The defendant below, Sandoz, Inc. (“Sandoz”), appeals from a judgment entered on a jury verdict in favor of the plaintiff, the State of Alabama. The State alleged at trial that Sandoz, a manufacturer of generic pharmaceuticals, purposely reported inflated pricing information for generic drugs in third-party publications and that the State, using those published prices, overpaid certain reimbursements to providers of prescription drugs made pursuant to the Medicaid program. The State thus sued Sandoz seeking damages under various theories of fraud.

Previously, in AstraZeneca LP v. State, 41 So.3d 15 (Ala.2009), the State unsuccessfully sued manufacturers of brand-name pharmaceuticals under the same theories. Alabama law requires that a party claiming to be the victim of fraud must have actually relied on the false information it received and that such reliance must have been reasonable. Because in this case, as in AstraZeneca, the State knew that the prices reported by Sandoz were not what the State claims they should have been, Alabama law does not allow the State to claim that its reliance on that information was reasonable. Further, the State’s reimbursement decisions were not based on the allegedly false information provided by Sandoz; instead, its decisions were based on policy concerns and certain requirements of the federal Medicaid program. Thus, as was the case in AstraZ-eneca, the State’s claims should not have been submitted to the jury, and Sandoz is entitled to a judgment in its favor. Therefore, we reverse the trial court’s judgment and render a judgment in favor of Sandoz.

Facts

This case is part of “litigation currently pending in state and federal courts involving allegations that the nationwide pricing policies of pharmaceutical manufacturers caused states to over-reimburse providers of prescription drugs under the states’ respective Medicaid programs.” AstraZeneca, 41 So.3d at 18. In AstraZeneca, we discussed the background of these cases as follows:

“ ‘The Medicaid program was created in 1965, when Congress added Title XIX to the Social Security Act, 79 Stat. 343, as amended, 42 U.S.C. § 1396 et seq. ... [ (“the Medicaid Act”) ], for the purpose of providing federal financial assistance to States that choose to reimburse certain costs of medical treatment for needy persons.’ Harris v. McRae, 448 U.S. 297, 301, 100 S.Ct. 2671, 65 L.Ed.2d 784 (1980). ‘Although participation in the Medicaid program is entirely optional, once a State elects to participate, it must comply with the requirements of Title XIX.’ 448 U.S. at 301, 100 S.Ct. 2671. Medicaid provides ‘joint federal and state funding of medical care for individuals who cannot afford to pay their own medical costs.’ Arkansas Dep’t of Health & Human Servs. v. Ahlborn, 547 U.S. 268, 275, 126 S.Ct. 1752, 164 L.Ed.2d 459 (2006). The ‘[federal financial participation,’ 42 C.F.R. § 430.1, was, during the time relevant to this dispute, approximately 70% of the amount of the expense the [Alabama Medicaid Agency] incurred under its Medicaid program.
“At the federal level, Medicaid is administered by the Centers for Medicaid and Medicare Services (‘the CMS’), formerly known as the Health Care Financing Administration [ (‘the HCFA’) ]. See Centers for Medicare & Medicaid Services; Statement of Organization, Functions and Delegations of Authority; Reorganization Order, 66 Fed.Reg. 35,437 (July 5, 2001); Statement of Organization, Functions, and Delegations of Authority, 49 Fed.Reg. 35,247 (Sept. [518]*5186, 1984); Reorganization Order, 42 Fed. Reg. 13,262 (Mar. 9, 1977). The CMS monitors the states’ compliance with federal law to, among other things, ensure that ‘payments [are] sufficient to enlist enough providers so that services under the [program] are available to recipients at least to the extent that those services are available to the general population.’ 42 C.F.R. § 447.204. ‘Providers’ are typically physicians and retail pharmacies that disburse prescription drugs to persons eligible for Medicaid benefits.
“The [Alabama Medicaid Agency] reimburses providers for drugs they dispense to eligible recipients. Reimbursement must, however, be made consistent with a methodology adopted with the approval of the CMS that takes economy into account.”

AstraZeneca, 41 So.3d at 18-19 (footnote omitted).

Providers — usually pharmacies — participating in the Medicaid program dispense prescription drugs to eligible persons. In turn, the Alabama Medicaid Agency (“the AMA”) reimburses the providers for the dispensed drugs. There are several methods for determining the price of drugs for purposes of calculating a reimbursement, and each state’s method must be approved by the Centers for Medicare and Medicaid Services (“the CMS”). In the instant case, which involves generic drugs, the AMA used one of the following predetermined prices:

1. the estimated acquisition cost (“EAC”) of the drug, plus a reasonable dispensing fee,
2. the mandated federal upper limit (“FUL”), or
3.the “maximum allowable cost” (“MAC”).1

State’s brief, at 5 (citing 42 C.F.R. § 447.512 (2010) (formerly 42 C.F.R. § 447.331)). Each of these reimbursement prices are discussed more specifically below.

A EAC

The EAC is defined as “the agency’s best estimate of the price generally and currently paid by providers for a drug marketed or sold by a particular manufacturer or labeler in the package size of drug most frequently purchased by providers.” 42 C.F.R. § 447.502 (2010) (formerly 42 C.F.R. § 447.301). The determination of EACs was at the center of our discussion in AstraZeneca:

“Various reimbursement methodologies are employed by the various state Medicaid agencies to obtain the EAC for each drug disbursed under their Medicaid programs. The goal is to 'produce a payment rate sufficient to encourage providers to participate in the Medicaid program, while, at the same time, minimizing Medicaid costs.
“Federal financial participation in the state Medicaid programs is made contingent upon a methodology that, in the view of the CMS, sufficiently addresses the somewhat competing objectives of adequate compensation and economy. However, the CMS has afforded the states flexibility in the formulas by which they attempt to arrive at the EAC.

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100 So. 3d 514, 2012 Ala. LEXIS 88, 2012 WL 2866764, Counsel Stack Legal Research, https://law.counselstack.com/opinion/sandoz-inc-v-state-ala-2012.