Parsons v. Sisters of Charity of Leavenworth Health Systems Inc.

FILED
NOT FOR PUBLICATION JUL 25 2012

MOLLY C. DWYER, CLERK
UNITED STATES COURT OF APPEALS U.S. COURT OF APPEALS

FOR THE NINTH CIRCUIT

RANDEE PARSONS and PEGGY No. 11-35693
PARSONS,
D.C. No. 1:10-cv-00047-RFC
Plaintiffs - Appellants,

v. MEMORANDUM*

SISTERS OF CHARITY OF
LEAVENWORTH HEALTH SYSTEMS
INC., a Kansas corporation; et al.,

Defendants - Appellees.

Appeal from the United States District Court
for the District of Montana
Richard F. Cebull, Chief District Judge, Presiding

Argued and Submitted July 11, 2012
Seattle, Washington

Before: REINHARDT, KLEINFELD, and M. SMITH, Circuit Judges.

Plaintiffs-Appellants appeal from an order granting summary judgment in

favor of Sisters of Charity of Leavenworth Health Systems, Inc., BlueCross

*
This disposition is not appropriate for publication and is not precedent
except as provided by 9th Cir. R. 36-3.
BlueShield of Kansas City, and BlueCross BlueShield of South Carolina. We have

jurisdiction under 28 U.S.C. § 1291. We review the grant of summary judgment de

novo. Johnson v. Buckley, 356 F.3d 1067, 1071 (9th Cir. 2004).

The benefit plan declined to cover Randee Parsons for participating in a

clinical trial for autologous bone marrow transplant (ABMT) with Dr. Richard Burt

because the trial was “experimental and investigational,” and therefore not covered

by the plan. We need not decide whether the district court should have reviewed

the denial of coverage de novo or for abuse of discretion, or what law applies,

because regardless, there is no genuine issue of fact as to whether this ABMT

procedure was “experimental and investigational” under the plan.

A procedure is experimental and investigational under the plan if it: (1) has

not received required final approval to market from appropriate government

bodies; (2) is one about which the peer-reviewed medical literature does not permit

conclusions concerning its effect on health outcomes; (3) is not demonstrated to be

an established alternative; (4) has not been demonstrated to improve net health

outcomes; or (5) is one in which the improvement claimed is not demonstrated to

be obtainable outside the experimental and investigational setting.

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 Here, the procedure has only been approved by the FDA for the clinical trial

phase. It has not received FDA final approval. The only legible peer reviewed

literature submitted, coauthored by Dr. Burt, discusses a “pilot study” of twelve

patients, and says a “randomized study will be needed to confirm the efficacy of

this therapy.” In his deposition, Dr. Burt stated that he had not yet completed the

randomized trial. No improvements have been obtained, so far as the record

shows, outside the experimental and investigational setting. The consent form

signed by Randee Parsons describes this as an experimental procedure.

Accordingly, the Parsons failed to raise a genuine issue of material fact that

this procedure is not experimental and investigational under the plan. The

remaining arguments lack any outcome-changing force.

AFFIRMED.

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