Savient Pharmaceuticals, Inc. v. Department of Health Services

53 Cal. Rptr. 3d 689, 146 Cal. App. 4th 1457
CourtCalifornia Court of Appeal
DecidedFebruary 6, 2007
DocketC050171
StatusPublished
Cited by15 cases

This text of 53 Cal. Rptr. 3d 689 (Savient Pharmaceuticals, Inc. v. Department of Health Services) is published on Counsel Stack Legal Research, covering California Court of Appeal primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Savient Pharmaceuticals, Inc. v. Department of Health Services, 53 Cal. Rptr. 3d 689, 146 Cal. App. 4th 1457 (Cal. Ct. App. 2007).

Opinion

Opinion

MORRISON, J.

Savient Pharmaceuticals, Inc. (Savient), challenges the structure and actions of a Department of Health Services (Department) program administered by Ramsell Corporation (Ramsell).

“The AIDS epidemic was and continues to be one of the most dangerous of the modem era, killing over half a million Americans as of the end of 2003. Despite the introduction of antiretroviral therapy, AIDS remains the fifth leading cause of death among those ages 25 to 44. Sadly, HIV mortality declines have slowed while, at the same time, AIDS diagnoses have risen.” *1461 (John B. v. Superior Court (2006) 38 Cal.4th 1177, 1195 [45 Cal.Rptr.3d 316, 137 P.3d 153].)

HIV infection “can be a manageable, though chronic, condition with the use of drugs,” and for “reasons of compassion and cost effectiveness, the State of California has a compelling interest in ensuring that its citizens infected with the HIV virus have access to these drugs.” (Health & Saf. Code, § 120950, subds. (a), (b); further unspecified section references are to this code.)

“The AIDS Drug Assistance Program (ADAP), within the [Department], was established in 1987 to help ensure that HTV-positive uninsured and under-insured individuals have access to pharmaceutical (drug) therapies. . . . Without the drugs available through ADAP, thousands of HIV-positive Californians would face rapidly deteriorating health.” (Department of Health Services, AIDS Drug Assistance Program Fact Sheet (Oct. 2005) at <www.dhs.ca.gov/AIDS/Programs/ProgramFactsheets/2516ADAP.pdf> [as of Jan. 23, 2007].)

The Department subsidized some drugs for some people, but federal budget decisions threatened the program. (§ 120950, subds. (c)-(e).) Accordingly, in 1995 the Legislature adopted a new mechanism whereby the Department maintains a list of drugs to be dispensed (the ADAP formulary) and collects manufacturer rebates to fund the program. (§§ 120955, 120956; Stats. 1995, ch. 415, § 7.)

Savient makes Oxandrin, a drug used to treat weight loss. In 2003 the Department restricted it to use in females, because of cheaper drugs “for treatment of HIV-related wasting in males.” We refer to this as a delisting, although Oxandrin remains listed for some uses.

Savient filed a petition for writ of mandate and. declaratory relief to invalidate the delisting and to nullify the Department’s contract with Ramsell. The trial court rejected all of Savient’s claims and Savient timely appealed.

Although we reject most of Savient’s claims, we agree that the ADAP formulary is a regulation subject to the Administrative Procedure Act (Gov. Code, § 11340 et seq.; APA). Accordingly, we reverse with directions.

FACTUAL AND PROCEDURAL BACKGROUND

Savient’s amended petition sought to undo Oxandrin’s delisting and compel the adoption of regulations governing the formulary. Savient sought *1462 refund of “all rebates” collected under the program and an order “to set aside any contracts delegating any portion of the administration” of the program. Savient sought a declaration of the lawfulness of the Department’s actions in administering the formulary and in contracting with Ramsell. Savient raised numerous theories, miscaptioned as 11 purported “causes of action.”

The answers of the Department and Ramsell questioned Savient’s standing and defended the program.

The Department’s answer tendered the declaration of Celia Banda-Brown, a “Health Program Specialist I” whose duties include “primary liaison to the ADAP Medical Advisory Committee (MAC)” and managing the formulary. Because Savient did not tender contrary facts, we accept as true the facts stated in her declaration.

The ADAP (AIDS Drug Assistance Program) was created in 1987 and is separate from Medi-Cal, “with different eligibility criteria and benefits, including distinct drug formularies.” Funding “comes from the state’s general fund, the federal Ryan White Care Act and rebates paid by drug manufacturers, as required by section 120955(d).” Except for a few statutory mandates (such as to provide antiretroviral drugs), “there is no other state or federal requirement for specified drugs [or] classes of drugs to be provided on the ADAP formulary. On the other hand, Medi-Cal must cover all FDA-approved drugs.”

The MAC (Medical Advisory Committee) evaluates AIDS drugs and recommends changes to the formulary, including “any restrictions or medical access criteria”; these recommendations, combined with a departmental fiscal analysis, inform the Department director when she or he makes changes to the formulary. “Because California ADAP is not an entitlement program, it must provide drugs within an existing budget and assure sufficient funds are available before adding any new drug to the formulary. Therefore, given this budgetary criteria, a drug may be recommended by the MAC yet never make it on the formulary due to cost constraints or because other drugs have a higher [medical] priority (e.g., antiretrovirals). There are currently 153 drugs on the ADAP formulary . . . and over 27,000 ADAP clients who access these drugs annually.”

Oxandrin was added to the formulary in 1998, “restricted to use by women and persons with liver disease,” “due to the high cost of the drug and the availability of other, less expensive anabolic steroids for treatment of *1463 HIV-related wasting in males.” In 1999 the program budget increased and the restrictions were removed. By 2003, due to increased client demand, a projected “funding shortfall, and the recent availability of a new but very high cost antiretroviral drug,” the MAC recommended reinstating the restrictions, which was done. The decision was made based on the MAC recommendation “and the fiscal analysis by the department. The department’s contractor, Ramsell Corporation did not have any involvement in the analysis or decision-making leading to the restriction of the drug. Furthermore, Ramsell Corporation exercises no discretion concerning what drugs are on the ADAP formulary, the criteria for determining eligibility of ADAP recipients, pricing of drugs or any aspect of the rebate program between the Department and the drug manufacturers.”

After a hearing the trial court denied relief on all legal theories. Savient timely appealed from the ensuing judgment.

THE PRINCIPAL STATUTE

Section 120955 provides in part as follows:

“(a)(1) To the extent that state and federal funds are appropriated in the annual Budget Act for these purposes, the director shall establish and may administer a program to provide drug treatments to persons infected with human immunodeficiency virus (HIV), the etiologic agent of acquired immune deficiency syndrome (AIDS). . . .
“(2) The director shall develop, maintain, and update as necessary a list of drugs to be provided under this program.
“(b) The director may grant funds to a county public health department through standard agreements to administer this program in that county. . . .

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Bluebook (online)
53 Cal. Rptr. 3d 689, 146 Cal. App. 4th 1457, Counsel Stack Legal Research, https://law.counselstack.com/opinion/savient-pharmaceuticals-inc-v-department-of-health-services-calctapp-2007.