Parsons v. Sisters of Charity of Leavenworth Health Systems Inc. ( 2012 )

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NOT FOR PUBLICATION JUL 25 2012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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