Petition for Writ of Certiorari — Mutual of Omaha Life Insurance v. Dahl-Eimers

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Sota.

t Burreme urt, U.S.

4 I i: Ie D

No. | SEP 16 1993

OFFICE Ur iHE CLERK

In The

Supreme Court of the United States

October Term, 1993

MUTUAL OF OMAHA LIFE INSURANCE COMPANY,

Petitioner,

MARY P. DAHL-EIMERS,

Respondent.

Petition For A Writ Of Certiorari

To The United States Court Of Appeals For The

Eleventh Circuit

PETITION FOR A WRIT CERTIORARI

THomas E. JOHNSON RatpH A. PETERSON

STEVEN D. DaviDsoNn of Beccs & LANE

of Bairp, Hotm, McEACHEN, 3 West Garden Street

PEDERSEN, HAMANN Post Office Box 12950

& STRASHEIM Pensacola, Florida

1500 Woodmen Tower 32576-2950

Omaha, Nebraska 68102-2068 (904) 432-2451

(402) 344-0500

Counsel of Record

for Petitioner

Counsel for Petitioner

COCKLE LAW BRIEF PRINTING CO., (800) 225-6964

OR CALL COLLECT (402) 342-2831

QUESTIONS PRESENTED

1. Must a Federal-Court of Appeals which has

issued its panel opinion in an appeal from an order

denying a motion for a preliminary injunction, vacate its

opinion and dismiss the appeal upon learning that

changed circumstances rendered moot the motion for a

preliminary injunction prior to the issuance of its panel

opinion?

2. May a Federal Court of Appeals assert jurisdic-

tion to resolve questions of law raised in an interlocutory

appeal certified pursuant to 28 U.S.C. § 1292(b), when the

order appealed from was rendered moot by changed

circumstances occurring prior to the issuance of the

court’s panel opinion?

LIST OF PARTIES

All parties to the proceeding below appear in the

caption.!

1 Pursuant to Supreme Court Rule 29.1, Petitioner Mutual

of Omaha Insurance Company identifies the following subsid-

iaries and affiliates: Adjustment Services, Inc., ARD-RICH

Realty Corporation, Companion Life Insurance Company, Deco

Realty Inc., Exclusive Healthcare, Inc., Exclusive Healthcare of

Colorado, Inc., Health America/Capital Care, Inc., Kirkpatrick,

Pettis, Smith, Polian Inc., Omaha Capital Corporation, Mutual

Asset Management Company, Mutual of Omaha Fund Manage-

ment Company, Mutual of Omaha International Ltd., Mutual of

Omaha Marketing Corporation, Mutual Plan Administration,

Inc., Omaha Financial Life Insurance Company, The Omaha

Indemnity Company, Omaha Property and Casualty Insurance

Company, Omex Realty Inc., Tele-Trip Company Inc., UB realty

Inc., United of Omaha Life Insurance Company, United World

Life Insurance Company.

ili

TABLE OF CONTENTS

Page

ee Ba i

rn Seeded aug ds be o's b's Won eebeese vos ii

OE Pe POR CRUISED ooo ccc cs ccccvevsscvensess Vv

foe 8 1

eel sine ei ke Gist hike RKC ewes» 2

CONSTITUTIONAL AND STATUTORY PROVI-

Os re eae 2

eeeememee GP BPO CASE, 2. oo ccc ccc ccenscssess: 3

Re eee 3

B. The District Court Decision ................... 4

C. The Decision of the Panel on the Preliminary

EASE Se 5

D. The Change of Circumstances.................. 6

| 12

REASONS FOR GRANTING THE WRIT ........... 13

I. THE ELEVENTH CIRCUIT’S EXERCISE OF

JURISDICTION OVER AN APPEAL FROM A

MOTION FOR A PRELIMINARY INJUNCTION

RENDERED MOOT BY CHANGED CIRCUM-

STANCES OCCURRING IN ADVANCE OF THE

PANEL’S OPINION CONFLICTS DIRECTLY

WITH DECISIONS OF THIS COURT........... 13

A. Changed Circumstances Mooted Plaintiff's

Request for a Preliminary Injunction......... 13

TABLE OF CONTENTS —- Continued

Page

B. When Changed Circumstances Mooted the

Motion for a Preliminary Injunction, the Elev-

enth Circuit Was Left With No Basis for Con-

CEE TVGIICEIO 6 66's bce cbasesievcrenceses 20

C. The Proper Disposition is to Vacate Prior Opin-

ions and Dismiss the Appeal ................ 26

Il. THIS CASE PRESENTS AN IMPORTANT JURIS-

DICTIONAL QUESTION OVER WHICH THE

COURT SHOULD EXERCISE ITS SUPERVISORY

POPE ss Secutocseuwe Nhe waKaNs awed ardeewetues 29

ee) PPT ETT ere eer eee eee eee 30

TABLE OF AUTHORITIES

Page

Cases

Adkinson v. International Harvester Company, 975

fe Pr gee Sarre rer rer rer rey 25

Aetna Life Insurance Co. v. Haworth, 300 U.S. 227

Lk FRR err ren eer rar ee ea 14

Bumpus v. Clark, 702 F.2d 826 (9th Cir. 1983)........ 27

Clark v. K-Mart Corporation, 979 F.2d 965 (3rd Cir.

WOT oes boeentuces duets rere eet crere ene aees 14, 15

Clarke v. United States, 915 F.2d 699 (D.C. Cir. 1990) .... 27

Dahl-Eimers v. Mutual of Omaha Life Insurance Co.,

812 F.Supp. 1193 (N.D.Fla. 1992).......... 4, 5, 10, 18

Dahl-Eimers v. Mutual of Omaha Life Insurance Co.,

SOO Fie Bare CEN GR TRO cdr dccesscccvcess 6, 20

DeFunis v. Odergaard, 416 U.S. 312 (1974)............ 14

Dillon v. Alleghany Corp., 111 S.Ct. 1383 (1991)....... 27

Edwardsville National Bank & Trust Co. v. Marion

Laboratories, Inc., 808 F.2d 648 (7th Cir. 1987)...... 26

scone 0. 100, 466 US. SOb (ISN G hs ccccrcenccecsvces; 16

Honig v. Students of the California School for the

pel, SF0- TS, TOD CNG ev ccswerectsseuiece 13; 2

Independent Union of Flight Attendants v. Pan Amer-

ican World Airways, Inc., 966 F.2d 457 (9th Cir.

|. | MEMES Satie ore i Laine ao 27

Ivy Club v. Edwards, 943 F.2d 270 (3rd Cir. 1991),

cevt. Gemied, 132 SALA VERS CIGSED. 5. ccc skcccecvux. 25

Lewis v. Continental Bank Corp., 494 U.S. 472 (1990)

euatseebeeeues nusunuweayaeile tee 13, 14, 16, 19

TABLE OF AUTHORITIES - Continued

USC. 6 10000) .. 066666 eer

Page

Miller v. Bolger, 802 F.2d 660 (3rd Cir. 1986)......... 26

Murphy v. Hunt, 455 U.S. 478 (1982)................. 19

North Carolina v. Rice, 404 U.S. 244 (1971)........ 13, 14

Ray v. American National Red Cross, 921 F.2d 324

Ss ROUND hice rds 0440008 etedassae eee 25, 26

Schnitker v. Blue Cross Blue Shield, 787 F.Supp. 903

Se | Pe ererr yey ee reer ere 16

Siviey v. Soter, 113 S.Ct. 456 (1902) 2... cc ccceessnces 27

Steffel v. Thompson, 415 U.S. 452 (1974).............. 14

Stewart v. Southern Railroad Co., 315 U.S. 784 (1942) 13, 27

Thornburgh v. American College of Obstetricians and

Gynecologists, 476 U.S. 747 (1986) .............005. 22

United States v. Munsingwear, 340 U.S. 104 (1950)

MPN eT eT eTTETI TTT eT Ter ee 12, 13, 26, 27

United States v. Stanley, 483 U.S. 669 (1987)...24, 25, 26

University of Texas v. Camenisch, 451 U.S. 390 (1981)

SELES EOE EET E ET PTT ee rs ae 13, 20, 21, 22

Warth v. Seldin, 422 U.S. 490 (1975) ................. 13

Weinstein v. Bradford, 423 U.S. 147 (1975)......... 16, 19

Yellow Freight System, Inc. v. United States, 113 S.Ct.

BE CROMER Kecctcenscseeteecestehs user 27

CONSTITUTION AND STATUTUES

me USA. 6 TFG) ons ends vecseesesvie eee 2

Vil

TABLE OF AUTHORITIES - Continued

Page

MISCELLANEOUS

13A C. Wright, A. Miller & E. Cooper, Federal

Practice and Procedure § 3533.10 (1984)............. 28

R. Stern, E. Gressman, S. Shapiro, Supreme Court

Practice, § 4.15 (B.N.A. 6th Ed. 1986).............. 29

In The

Supreme Court of the United States

October Term, 1993

MUTUAL OF OMAHA LIFE INSURANCE COMPANY,

Petitioner,

MARY P. DAHL-EIMERS,

Respondent.

Petition For A Writ Of Certiorari

To The United States Court Of Appeals For The

Eleventh Circuit

PETITION FOR A WRIT CERTIORARI

The Petitioner, Mutual of Omaha Life Insurance

Company (“Mutual”), respectfully requests that a writ of

certiorari issue to review the order of the United States

Court of Appeals for the Eleventh Circuit, entered in the

above-entitled proceeding on June 21, 1993, denying Peti-

tioner’s Motion to Vacate Order and Dismiss Appeal as

Moot.

OPINIONS BELOW

The Eleventh Circuit’s order denying Petitioner’s

Motion to Vacate Order and Dismiss Appeal as Moot,

entered June 21, 1993, is unreported, but appended to this

Petition. The Eleventh Circuit’s order on reconsideration

of the June 21, 1993 order is unreported, but appended to

this Petition. The Eleventh Circuit’s panel opinion on the

merits of the appeal is reported at 986 F.2d 1379, and is

reprinted in the Appendix to this Petition. The Order of

the United States District Court for the Northern District

of Florida denying Plaintiff's Motion for a Preliminary

Injunction is reported at 812 F. Supp. 1193, and is

reprinted in the Appendix to this Petition.

JURISDICTION

The order sought to be reviewed in this Petition was

filed on June 21, 1993. Petitioner filed a Petition for

Rehearing and Suggestion of Rehearing en banc in the

Eleventh Circuit on July 9, 1993. The Eleventh Circuit

construed the Petition as a motion for reconsideration of

the June 21, 1993 order, and entered an opinion and order

denying the motion on August 10, i993. This Petition is

filed within 90 days of the order of June 21, 1993.

The jurisdiction of this Court to review the order of

the Eleventh Circuit is invoked under 28 U.S.C. § 1254(1).

CONSTITUTIONAL AND STATUTORY

PROVISIONS INVOLVED

Article III of the United States Constitution provides

in relevant part:

The judicial Power shall extend to all Cases, in

Law and in Equity, arising under this Constitu-

tion, the Laws of the United States, and... to

Controversies between citizens of different

States. ...

Section 1292(b) of Title 28 of the United States Code

provides as follows:

When a district judge, in maxing in a civil action

an order not otherwise appealable under this

section, shall be of the opinion that such order

involves a controlling question of law as to

which there is substantial ground for difference

of opinion and that an immediate appeal from

the order may materially advance the ultimate

termination of the litigation, he shall so state in

writing in such order. The Court of Appeals

which would have jurisdiction of an appeal of

such action may thereupon, in its discretion,

permit an appeal to be taken from such order, if

application is made to it within 10 days after the

entry of the order: Provided, however, that

application for an appeal hereu .der shall not

stay proceedings in the district court unless the

district judge or the Court of Appeals or a judge

thereof shall so order.

STATEMENT OF THE CASE

A. The Original Complaint.

The Plaintiff filed this action on July 2, 1992, in

response to Mutual’s decision, made June 10, 1992, to

deny a request for preauthorization of health insurance

benefits submitted on Plaintiff’s behalf by the H. Lee

Moffitt Cancer Center and Research Institute, Inc., in

Tampa, Florida (“Moffitt”). The request from Moffitt

sought preauthorization of benefits for Plaintiff’s partici-

pation in a clinical trial evaluating a procedure known

generally as high-dose chemotherapy with autologous

bone marrow transplant (“HDC-ABMT”). HDC-ABMT

involves the removal of a small portion of a cancer

patient’s own (“autologous”) bone marrow, followed by

the administration of chemotherapy at several times the

standard or conventional dose level, one which destroys

the patient’s remaining bone marrow. After the adminis-

tration of the high-dose chemotherapy, the stored marrow

components are reinfused into the patient. HDC-ABMT is

currently being tested in medical research facilities as a

means to overcome chemotherapy dose limitations relat-

ing to bone marrow destruction, and theoretically to

improve chemotherapeutic treatment in a variety of solid

tumor cancers, including breast cancer.

Mutual denied the Moffitt preauthorization request

in reliance upon the applicable policy’s defined scope of

covered expenses. The Mutual policy covers only pro-

cedures which are “medically necessary”, a term defined

to omit procedures not appropriate and consistent with

the diagnosis in accord with accepted standards of com-

munity practice; those considered experimental; or those

which could have been omitted without adversely affect-

ing the insured’s condition or quality of care.

In the Complaint, Plaintiff alleged that she desired to

immediately undergo HDC-ABMT at Moffitt under a

specific treatment protocol known in shorthand form as

the “ICE” protocol. Plaintiff claimed that time was of the

essence, and that grave medical consequences would

result from any delay. With the complaint, Plaintiff filed a

motion for a preliminary injunction, asking the district

court to immediately compel Mutual to preauthorize the

requested benefits. Plaintiff requested and received expe-

dited consideration of the motion in the district court. A

hearing on the motion was held on July 20, 1992, eighteen

days after the filing of Plaintiff’s complaint.

B. The District Court Decision.

Nine days later, on July 29, 1992, the district court

entered an Order and Memorandum Opinion denying the

motion, finding that Plaintiff had failed to demonstrate a

substantial likelihood of success on the merits of her

claim. Dahl-Eimers v. Mutual of Omaha Life Insurance Co.,

812 F.Supp. 1193 (N.D.Fla. 1992). The court reached what

it termed the “inescapable conclusion” that the procedure

proposed for Plaintiff by Moffitt is experimental, and

therefore outside of the policy’s coverage. Id. at 1197. The

court reviewed the status of medical research evaluating

HDC-ABMT in breast cancer, the federal regulatory

requirements imposed upon medical experimentation in

the United States, and the particular protocol and

informed consent documents applicable to the clinical

trial at Moffitt in which Plaintiff sought to participate.

The court found that there was “no doubt about the

nature of the [Moffitt] study. .. . Whether the ICE coinbi-

nation of drugs has a beneficial — or deleterious - effect

upon breast cancer that has progressed to stage IV is

— simply not known. That is, understandably, why the

Moffitt center desires to enroll the Plaintiff in its study.”

Id. at 1198. Finding the procedure experimental and

therefore not covered under the Mutual policy, the Court

did not find it necessary to discuss the other portions of

the policy definition of “medically necessary.”

The ultimate conclusion of the District Court was

that Plaintiff did not demonstrate “a substantial likeli-

hood of prevailing on the merits of this case,” and that

the prerequisites of a motion for a preliminary injunction

were therefore unsatisfied. Id. at 1198. The only substan-

tive ruling contained in the district court’s order was its

denial of Plaintiff’s motion for a preliminary injunction.

In the last paragraph of its opinion, the district court

recited the requirements of 28 U.S.C. § 1292(b), certifying —

that the order “involves a controlling question of law as

to which there is substantial ground for difference of

opinion, and an immediate appeal may materially

advance the ultimate determination of the litigation. Time

is also of the essence.” Id. at 1198.

C. The Decision of the Panel on the Preliminary

Injunction.

Given the district court’s certification, the Plaintiff

sought and obtained leave to file an interlocutory appeal

to the Eleventh Circuit under section 1292(b). The order

appealed from was the only order entered in the case by

the district court — its decision denying the motion for a

preliminary injunction.

After briefing and argument, the Eleventh Circuit

filed its opinion on March 9, 1993, ruling only on a

narrow question of law, concluding that the policy lan-

guage upon which the district court relied is ambiguous.

Dahl-Eimers v. Mutual of Omaha Life Insurance Co., 986 F.2d

1379 (11th Cir. 1993). In its opinion, the panel identified

the issue presented as whether “the district court cor-

rectly denied Plaintiff-Appellant Mary P. Dahl-Eimers’

application for a preliminary injunction.” Id. at 1380. The

Court characterized its inquiry as whether the district

court’s determination regarding Plaintiff’s likelihood of

success on the merits was correct. Id. The relief granted in

the panel opinion was focused particularly upon the pre-

liminary injunction, as the Court remanded the case to

the district court for a new determination regarding

whether there exists “a substantial likelihood that [Plain-

tiff] will prevail on the merits” in light of the panel's

decision. Id. at 1384.

D. The Change of Circumstances.

Over the several months in which the appeal was

pending before the Eleventh Circuit, Plaintiff continued

to receive medical care for her cancer. In the fall of 1992,

she received two courses of conventional dose chemo-

therapy. (Dahl-Eimers Dep. 17:12-22; R. Eimers Dep.

7:15-8:2).2, Her physicians also prescribed a course of

2 References are to the depositions and affidavits submitted

to the Eleventh Circuit in support of Petitioner’s Motion to

Vacate. The deposition of Plaintiff and her husband were taken

April 23, 1993.

radiation therapy, consisting of thirteen separate treat-

ments, which continued through January 4, 1993. (R.

Eimers Dep. 8:3-9). Then, from January 5 through 27,

1993, Plaintiff received treatment at the Contreras Clinic

in Tijuana, Mexico, consisting of Laetrile therapy, addi-

tional radiation therapy, and a specialized diet and

dietary supplement regimen. (Dahl-Eimers Dep.

24:16-25:24; 28:14-29:5; R. Eimers Dep. 8:13-17).

Fortunately, Plaintiff's condition improved substan-

tially following Plaintiff’s return from Mexico. Within

two weeks of completing the course of treatment in Mex-

ico, Plaintiff no longer experienced pain, exhibited no

clinical evidence of active disease, and blood tumor

marker tests showed no evidence of disease progression.

(Dahl-Eimers Dep. 29:15-31:14; 51:17-20). Plaintiff’s phy-

sicians advised her that she was in remission, without

evidence of active disease.

The Eleventh Circuit issued its opinion on March 9,

1993. After reviewing the opinion, Plaintiff’s husband

contacted each of Plaintiff’s three treating physicians

about the advisability of Plaintiff moving ahead with a

bone marrow transplant. (R. Eimers Dep. 11:12-12:12;

16:11-16). According to the Plaintiff and her husband,

each physician advised them not to go forward with

HDC-ABMT.

Q: [W]hat was [Dr. Vaughan’s] response?

A: His response was that as long as she is

feeling good and there is no sign of active dis-

ease, because she has already had two more

doses of chemotherapy, that he would wait until

the cancer definitely had returned before we

would go any further in this discussion.

* * .

Q: So the consensus of opinion among those

three physicians was to wait?

A: Yes.

Q: And that ultimately has been your decision?

A: Yes.

(R. Eimers Dep. 12:25-13:6; 16:20-24. See R. Eimers Dep.

12:1315:16; Dahl-Eimers Dep. 8:3-9:16).

Thus, beginning approximately February 10, 1993,

and continuing through all activity in the case before the

Eleventh Circuit, Plaintiff had no intent or desire to

undergo HDC-ABMT. Instead, Plaintiff decided that it

was in her best interest to reconsider HDC-ABMT only if

and when her disease recurs such that HDC-ABMT again

becomes medically appropriate.

Q: Let me ask you this: As we sit here today, is

it your intent to not go forward with the bone

marrow transplant until such time as you have

experienced some recurrence of your disease?

A: Yes.

Q: Is that based upon the advice and consulta-

tion of any physician?

A: Yes. —

(Dahl-Eimers Dep. 33:20-34:1). Plaintiff's physicians have

also indicated they have no way to predict when, if ever,

her disease will again become active.

Q: Did he give you any indication of when that

might be?

He doesn’t have a crystal ball.

He doesn’t know?

Has no idea.

Okay, all right.

How do they know when it’s going to reoc-

cur? They don’t know.

rOP?PO>

(R. Eimers Dep. 13:7-14). In fact, it is not medically possi-

ble to predict at what point in time Plaintiff may experi-

ence a change in her symptoms, nor to predict what will

a |

be the nature and scope of her disease if and when such a

change occurs. (Herberman Aff. | 16).

Plaintiff’s intent is to enjoy her current good health,

and upon the recurrence of her disease seek further

advice from her physicians about how best to proceed.

Whether that advice will be to pursue HDC-ABMT or

some other procedure is unknown, as that advice will

depend upon the nature of Plaintiff’s condition at the

time of relapse, the state of medical knowledge at that

time, and the personal desires of the Plaintiff.

Q: What is your intent if you should experi-

ence a reoccurrence of symptoms of your dis-

ease?

A: What is my plan of action?

Q: Intent with regard to therapy or your plan

of action, that’s a good term.

A: It depends on what the diagnosis is.

Q: I take it that if such an event occurs you

will go see Dr. Chang?

A: Yes.

Q: And you will consult with him about a

course of action?

A: Yes.

Q: And your understanding would be that that

course of action would be dependent upon what

those symptoms were and what -

A: Right, right.

Q: - was the nature of your disease?

A: Exactly.

Q: As you sit here today do you consider one

of the possibilities at that point in time to be a

bone marrow transplant?

A: Yes.

(Dahl-Eimers Dep. 42:5-43:1. See Herberman Aff. 4 16).

In addition, Plaintiff has now decided that she may

not want to receive the particular form of HDC-ABMT

offered at Moffitt, described in the district court’s opinion

as the “ICE Protocol.” See Dahl-Eimers, 812 F.Supp. at

1196-97. Instead, if and when she reconsiders HDC-

ABMT, Plaintiff intends to evaluate protocols offered at

several other research facilities throughout the country,

including the University of Alabama at Birmingham,

Sloan-Kettering Hospital, Dana Farber Cancer Institute,

Fred Hutchinson Cancer Research Center, and the M. D.

Andersen Tumor Center.

Q: If that possibility comes to fruition, have

you made a decision as of today’s date as to

where you will get that bone marrow trans-

plant?

A: Have | made a decision?

Q: Yes.

A: No.

* * .

Q: All right, that listing of six institutions that

I just mentioned, is that a complete listing of the

institutions that you have considered for a bone

marrow transplant?

A: No, I don’t - we really haven’t gotten into

that yet.

Q: Okay.

A: To me that’s like another issue. That’s not -

until I knew if | was getting it, it wasn’t worth

looking at where you are going to have it

exactly. | mean, originally we were going to the

Moffitt Center. We did a lot of research to get to

that point. It didn’t seem to help much, so we

don’t want to waste a lot of time.

(Dahl-Eimers Dep. 43:2-7; 47:24-48:12).

Accordingly, it is only when HDC-ABMT again

becomes a possible option that Plaintiff intends to decide

where to seek HDC-ABMT, and thus which particular

protocol in which to try to participate. Each such institu-

tion has its own specific approach to HDC-ABMT, includ-

ing differences in the chemotherapy drugs used, dosages,

schedules, and other important factors. (Herberman Aff.

{ 17). Moreover, each facility’s program evolves with

time, so that it is not possible to predict whether HDC-

ABMT for breast cancer will be offered at any given

facility at some unspecified future date, or if available,

the form in which the procedure might be offered. (Her-

berman Aff. { 17-19). Until the time of relapse, Plaintiff

cannot know whether she will meet the rigid patient

selection criteria contained within any given protocol,

ana thus whether she will be eligible to participate in any

given protocol. (Dahl-Eimers Dep. 63:21-64:4; Herberman

Aff. 4 20).

As a result of the change in Plaintiff’s circumstances,

she no longer possesses a present intent to seek HDC-

ABMT at Moffitt under the ICE protocol, nor does she

want or need the injunction originally requested. Plaintiff

does not intend to even reconsider HDC-ABMT unless

and until her current medical condition substantially

changes. If and when that occurs, she will seek further

medical advice and her course of treatment will depend

on her diagnosis at that time. Even if HDC-ABMT is

determined to be a proper avenue at that time, she

intends to then explore multiple approaches to HDC-

ABMT ata variety of facilities, for which she may or may

not be medically eligible. Plaintiff herself recognized the

impact of those changed circumstances upon her need for

injunctive relief, voluntarily withdrawing the motion for

a preliminary injunction in the district court on April 23,

1993.

E. The Motion to Vacate.

Mutual learned about the changed circumstances

shortly after issuance of the panel opinion. Mutual

promptly requested and completed additional discovery

about those changed circumstances, and filed a Motion to

Vacate Panel Opinion and Dismiss Appeal as Moot on

April 29, 1993. In the motion, Mutual argued that the

change of circumstances rendered moot Plaintiff’s request

for preliminary injunctive relief, that the events which

gave rise to mootness occurred in advance of the Elev-

enth Circuit’s panel opinion, and that in such circum-

stances the court is deprived of jurisdiction and

compelled to dismiss the appeal and vacate the panel

opinion. The motion was supported by the deposition

testimony of Plaintiff and her husband, and an affidavit

from Mutual’s expert oncologist.

On June 21, 1993, the Eleventh Circuit issued a one

paragraph order denying the motion without prejudice to

the right of the parties to raise the issue before the district

court. On July 9, 1993, Mutual filed a Petition for Rehear-

ing and Suggestion of Rehearing En Banc relating to the

jurisdictional issues, which was construed by the panel as

a motion for reconsideration of its June 21, 1993 order.

That motion was denied by the panel on August 10, 1993.

This time, the panel issued a one page opinion stating

that the case was not moot, and that vacatur of its initial

opinion was not required because the appeal concerned a

question of law certified under section 1292(b). The Court

concluded it was not obligated to follow the rationale of

United States v. Munsingwear, 340 U.S. 104 (1950), and

declined to vacate its prior order or dismiss the appeal as

moot.

REASONS FOR GRANTING THE WRIT

I. THE ELEVENTH CIRCUIT’S EXERCISE OF JURIS-

DICTION OVER AN APPEAL FROM A MOTION

FOR A PRELIMINARY INJUNCTION RENDERED

MOOT BY CHANGED CIRCUMSTANCES OCCUR-

RING IN ADVANCE OF THE PANEL’S OPINION

CONFLICTS DIRECTLY WITH DECISIONS OF

THIS COURT.

The Eleventh Circuit’s refusal to recognize the

absence of jurisdiction and vacate its judgment is directly

contrary to decisions of this Court on three particular

topics: (1) the constitutional requirement of an ongoing

case or controversy at all stages of the litigation, see Lewis

v. Continental Bank Corp., 494 U.S. 472 (1990); North Caro-

lina v. Rice, 404 U.S. 244 (1971); (2) jurisdictional limita-

tiens in an appeal from an order on a preliminary

injunction, see University of Texas v. Camenisch, 451 U-S.

390 (1981); Honig v. Students of the California School for the

Blind, 471 U.S. 148 (1985); and, (3) the appropriate dispo-

sition of an appeal when changed circumstances render

moot the order appealed from, see United States v. Mun-

singwear, 340 U.S. 104 (1950); Stewart v. Southern Railroad

Co., 315 U.S. 784 (1942).

A. Changed Circumstances Mooted Plaintiff's

Request for a Preliminary Injunction.

Concepts applicable to a federal court’s exercise of

jurisdiction are well settled. Under Article III, federal

courts may adjudicate only actual, ongoing cases or con-

troversies. Lewis v. Continental Bank Corp., 494 U.S. 472,

477 (1990); Warth v. Seldin, 422 U.S. 490, 499 (1975). Fed-

eral courts may decide only those questions which affect

the rights of the litigants in the case at issue. Artic!¢ III

confines federal court jurisdiction to “real and substantial

controversies admitting of specific relief through a decree

of a conclusive character, as distinguished from an opin-

ion advising what the law would be upon a hypothetical

state of facts.” Aetna Life Insurance Co. v. Haworth, 300 U.S.

227, 241 (1937). See North Carolina v. Rice, 404 U.S. 244, 246

(1971). The case or controversy requirement of Article III

applies at all stages of the case. Thus, when intervening

events render a case moot, destroying the interest of the

parties to the adjudication, federal courts are prohibited

from exercising continuing jurisdiction over the dispute.

Lewis, 494 U.S. at 477-78; DeFunis v. Odegaard, 416 U.S.

312, 316 (1974); Steffel v. Thompson, 415 U.S. 452, 459 n.10

(1974).

Plaintiff's request for preliminary injunctive relief

unquestionably became moot at the moment she no

longer possessed a current intent to undergo HDC-ABMT

under the ICE protocol at Moffitt. The relief requested in

the motion, an order compelling Mutual to preauthorize

medical benefits for Plaintiff’s participation in the Moffitt

clinical trial of HDC-ABMT, is no longer needed or —

desired by Plaintiff, and no order of any court on the

mution could affect the rights of the parties. Given Plain-

tiff’s decision to await a change in her medical condition,

and the numerous uncertainties regarding whether HDC-

ABMT may or may not be appropriate at that time, no

action or inaction of Mutual precludes Plaintiff from

obtaining benefits for the medical care she currently

desires. In fact, Plaintiff acknowledged that she no longer

desires the requested relief by withdrawing her motion

for a preliminary injunction in the District Court. This

case became moot at the time Plaintiff’s medical circum-

stances improved, and her need passed for a court order

compelling the payment of benefits for HDC-ABMT

under the ICE protocol at Moffitt.

An analogous situation was presented to the Third

Circuit in Clark v. K-Mart Corporation, 979 F.2d 965 (3rd

EEE

Cir. 1992). Clark involved an appeal from a preliminary

injunction requiring K-Mart to provide benefits for plain-

tiff’s participation in a clinical trial of HDC-ABMT for

breast cancer. While the appeal was pending, K-Mart

complied with the preliminary injunction and paid for

the procedure. The Third Circuit found that the appeal

from the order granting a preliminary injunction had

become moot by the plaintiff’s receipt of the procedure.

The court explained that the only issue before it on

appeal was the propriety of a preliminary injunction, and

that K-Mart’s compliance with the injunctive order

resolved the controversy on that particular portion of the

case. Id. at 967. The court found that there was no contro-

versy remaining for it to decide regarding the particular

issue on appeal — whether the district court properly

granted the motion for a preliminary injunction. Id.

Though the Plaintiff here has not yet received the

procedure, the same legal concept is applicable. In both

this case and in Clark, the injunctive aspect of the case

was rendered moot because the Plaintiff no longer could

benefit from an order compelling payment for the pro-

cedure. The origin cf that change in circumstances,

whether receipt of the procedure or a medical improve-

ment rendering the procedure no longer appropriate, is of

no relevance. The determinative fact is that the Plaintiff

no longer desires or needs the injunctive relief requested.

Further, this case is not saved from mootness by the

often cited but rarely applied exception for cases “capa-

ble of repetition yet evading review”. This Court has

departed from the jurisdictional demands of the moot-

ness doctrine only in those “exceptional situations”

where two circumstances are simultaneously present and

strictly satisfied: (1) the challenged action is of too short a

duration to be fully litigated prior to its cessation; and (2)

there is a reasonable expectation that the same complain-

ing party will be subject to the same action again. Lewis,

494 U.S. at 479; Weinstein v. Bradford, 423 U.S. 147, 149

(1975). The proper focus in addressing the exception is

not upon whether the particular claimant has demon-

strated that a recurrence of the same dispute is probable

for him or her, but is instead upon whether the contro-

versy in general is inherently capable of repetition, yet of

such limited duration as to be incapable of judicial

review. Honig v. Doe, 484 U.S. 305, 308 n.6 (1988). The

circumstances of this case fail to meet either element of

the exception.

First, there is nothing inherent about HDC-ABMT,

and the available period of time in which patients with

metastatic breast cancer may receive the procedure,

which precludes meaningful litigation of coverage dis-

putes. While in many cases decisions about coverage

must be made quickly through expedited proceedings,

meaningful and complete judicial review is not precluded

by the inherent nature of the dispute. Plaintiff’s own

briefs throughout this case have referred to the numerous

published decisions addressing insurance coverage for

HDC-ABMT in a variety of circumstances, which demon-

strate that judicial activity is not foreclosed by the dura-

tion of the dispute. See, e.g., Schnitker v. Blue Cross Blue

Shield, 787 F.Supp. 903 (D. Neb. 1991). The circumstances

which caused this particular case to become moot - the

improvement of Plaintiff’s medical condition, her chosen

course of therapy, and her decision not to proceed with

HDC-ABMT are unique to this case. If Plaintiff’s circum-

stances again change and were Plaintiff then to decide to

pursue HDC-ABMT, a new lawsuit could be filed and

litigated in time to grant meaningful relief, if such relief

were appropriate under the facts existing at that time.° At

best, the typical medical circumstances of those who seek

HDC-ABMT require prompt adjudication of their claims.

The need for such prompt adjudication does not mean

that the case evades review, nor does it warrant the

premature exercise of jurisdiction over facts which are

wholly speculative and uncertain.

Similar difficulties exist regarding the second

requirement. While Plaintiff contends that at some

unknown point in the future she may again seek HDC-

ABMT, the factual circumstances which will surround

that presumed request for preauthorization of benefits

are uncertain and entirely speculative. It is impossible to

define or predict the factual circumstances of the future

dispute which may arise, if any, and thus impossible to

predict whether this same Plaintiff will again litigate this

same controversy on similar facts. Factual contingencies

exist in several crucial areas.

1. The Course of Plaintiff's Health. It is impossible to

predict changes which may take place in Plaintiff’s medi-

cal condition between now and the date she eventually

decides to reconsider HDC-ABMT as a possible treatment

option. Plaintiff’s disease may progress such that HDC-

ABMT is not appropriate, she may develop another ill-

ness in the interim, she may become ineligible for HDC

ABMT through some unrelated cause, or she may be so

3 The need for an immediate decision will be tempered by

waiting periods which research institutions like Moffitt impose

upon those who desire to receive HDC-ABMT. For example,

when Plaintiff initially sought a preliminary injunction, she

could not have been admitted to Moffitt to receive the pro-

cedure, for, at a minimum, 60 to 90 days after qualifying to

participate in the protocol (Dahl-Eimers Dep. 48:25-49:11).

— —

fortunate as to remain in remission. Whatever may hap-

pen to Plaintiff’s medical condition in the future is abso-

lutely unpredictable, and the status of that condition is

crucial to a determination of the appropriate form of

medical care, and thus to the issues raised by her request

for injunctive relief. See Herberman Affidavit at { 16. No

suggestion has been made by Plaintiff that the circum-

stances of her illness at the time of any future change can

be predicted with any degree of reliability.

2. Policy Terms. If Plaintiff’s circumstances do

change, the terms of her insurance policy in force with

Mutual, if any policy is in force at that time, may be

different than the terms now in effect. A coverage dispute

of this nature turns heavily upon the terms of the contract

in effect at the time of the claim, which in this case is

unknown.

3. Selection of Research Institution and Form of Treat-

ment. Plaintiff has indicated that she intends to consider

at least five different research hospitals if she is advised

to again explore HDC-ABMT, each of which offers a

different form of the procedure under a unique, changing

protocol. As described by the district court, the particular

regimen of chemotherapy drugs and manner of adminis-

tration of those drugs in any given protocol is an impor-

tant factor in evaluating a dispute of this nature. For

example, the Moffitt protocol in place at the time of

Plaintiff’s initial request included “dose-escalation” fea-

tures in a phase | clinical trial, the earliest stage of clinical

research on human subjects. Dahl-Eimers, 812 F.Supp. at

1196. Unless and until Plaintiff chooses a protocol in

which to participate, and is declared at least potentially

eligible, it would be impossible for any court to deter-

mine the characteristics of the particular form of HDC

ABMT at issue. Further, research institutions continually

change and update research protocols to reflect new find-

ings, thus the particular protocol which may be in place

at any of the five institutions Plaintiff plans to investigate

also cannot be predicted.

4. Status of Research Efforts. As is also apparent, the

medical research community is actively and aggressively

evaluating HDC-ABMT for metastatic breast cancer.

Additional findings and conclusions may be available

before Plaintiff again desires to undergo the procedure,

which could weigh heavily in the inquiry one way or the

other. The medical community may reach important con-

clusions about the efficacy of the procedure, or the lack

thereof, which could entirely alleviate the need for this

litigation.

These questions can be answered now only through

guesswork and speculation. Each is an integral part of an

analysis of the issues presented. Until those facts are

definitively resolved, the exercise of jurisdiction by any

court would amount to nothing more than the rendering

of an advisory opinion on assumed facts which may or

may not come to fruition. Thus, the likelihood that this

same Plaintiff will again litigate this same controversy on

similar facts is remote and hypothetical. A mere hypoth-

esis or theoretical possibility of the same factual circum-

stances recurring is insufficient to satisfy the test stated in

Weinstein. See Lewis, 494 U.S. at 479-80; Murphy v. Hunt,

455 U.S. 478, 482 (1982).

When Plaintiff’s medical circumstances improved

such that HDC-ABMT no longer was appropriate, the

preliminary injunction she requested lost its value to her,

and the issue was rendered moot. The nature of the

dispute is not such that the case is saved from mootness

because the same dispute is inherently likely to recur, yet

evade review. The Eleventh Circuit’s conclusion to the

contrary conflicts with long standing jurisdictional limita-

tions imposed by Article III, and should not be permitted

to stand.

B. When Changed Circumstances Mooted the

Motion for a Preliminary Injunction, the Elev-

enth Circuit Was Left With No Basis for Con-

tinuing Jurisdiction.

The only issue on appeal before the Eleventh Circuit

was the propriety of the District Court’s refusal to issue a

preliminary injunction. The Eleventh Circuit clearly rec-

ognized the limits of the issue before it in its panel

opinion, correctly identifying the issue as “whether the

District Court correctly denied Plaintiff’s application for

a preliminary injunction,” and limiting its inquiry to

Plaintiff's likelihood of success on the merits. Dahl-

Eimers, 986 F.2d at 1380. The relief granted in the panel

opinion was particularly focused upon the preliminary

injunction. “Accordingly, we vacate the District Court’s

order denying Dahl-Eimers’ application for a preliminary

injunction and remand to the District Court to determine

whether there is a substantial likelihood that she will

prevail on the merits.” Id. at 1384. Thus, the Eleventh

Circuit properly did not address the merits of the Plain-

tiff’s claims in its panel opinion, but merely one of sev-

eral factors relevant to a consideration of the propriety of

a preliminary injunction. Once the motion for a prelimi-

nary injunction became moot, there was no continuing

basis upon which the appeal could continue.

The significant differences between an appeal on the

merits and an appeal from an interlocutory order grant-

ing or denying a motion for preliminary injunction were

explained by this Court in University of Texas v. Camenisch,

451 U.S. 390 (1981). In Camenisch, the Court discussed

whether the existence of issues arising by the presence of

an injunction bond preserved an otherwise moot appeal

from an order granting a preliminary injunction. Finding

that no other issues could be considered once the prelimi-

nary injunction became moot, the Court examined the

purpose of a preliminary injunction and its relationship

to a decision on the merits.

The purpose of a preliminary injunction is to

preserve the relative positions of the parties

until a trial on the merits can be held. Given this

limited purpose, and given the haste that is

often necessary if those positions are to be pre-

served, a preliminary injunction is customarily

granted on the basis of procedures that are less

formal and evidence that is less complete than

in a trial on the merits. . . . In light of these

considerations, it is generally inappropriate for

a federal court at the preliminary injunction

stage to give a final judgment on the merits.

Id. at 395.

The Court explained that there are significant pro-

cedural and substantive differences between a trial on the

merits and a hearing on a motion for a preliminary

injunction. As a result, a determination of Plaintiff’s like-

lihood of success on the merits, often made within a few

days of the filing of the lawsuit (18 in this case), cannot

be equated with a decision on the merits. The two ques-

tions are independent and unique. Accordingly, when the

injunctive aspects of an appeal from an order on a motion

for preliminary injunction become moot, the appellate

court is deprived of continuing jurisdiction to act on any

other issue. In Camenisch, the Court specifically held that

it is improper for an appellate court to reach or discuss

the merits when the motion for a preliminary injunction,

the only issue presented for review on appeal and the

only issue upon which appellate jurisdiction could be

premised, had become mcot.

In short, where a federal district court has

granted a preliminary injunction, the parties

generally will have had the benefit neither of a

full opportunity to present their cases nor of a

final judicial decision based on the actual merits

of the controversy. Thus when the injunctive

aspects of a case become moot on appeal of a

preliminary injunction, any issue presented by

an injunction bond can generally not be

resolved on appeal, but must be resolved in a

trial on the merits. . . . [I]t would be inappropri-

ate for this Court to intimate any view on the

merits of the lawsuit.

Id. at 1834-35. See Honig v. Students of the California School

for the Blind, 471 U.S. 148, 149 (1985) (when appeal from

an order on a preliminary injunction is moot, the court

should remand the proceeding to the district court for a

decision on other pending claims).4

This case presents a situation identical to that facing

the Court in Camenisch and Honig. This case was before

the Eleventh Circuit on an appeal only of the District

Court’s order addressing the propriety of a preliminary

injunction, utilizing the various factors adopted by the

Eleventh Circuit to evaluate such a request. No other

issue was decided by the district court, or presented by

the record on appeal. When the injunctive aspect of the

case became moot, the Eleventh Circuit had no basis

4 The Court’s decision in Thornburgh v. American College of

Obstetricians and Gynecologists, 476 U.S. 747 (1986), is not to the

contrary. There, the court identified a very limited circumstance

in which a Court of Appeals may proceed to consider the merits

in an appeal from a motion for a preliminary injunction. That

rule could apply only if the injunctive aspects of the case remain

justiciable. When the order appealed from is rendered moot, a

Court of Appeals may not consider the merits under any cir-

cumstances.

upon which to assert continuing jurisdiction over the

case. As a result, the Eleventh Circuit’s issuance of its

panel opinion and subsequent orders went beyond the

bounds of its constitutionally circumscribed jurisdiction.5

In its order denying Petitioner’s Motion for Rehear-

ing, the Eleventh Circuit suggested that its jurisdiction

continued because the appeal was certified under 28

U.S.C. § 1292(b), which permits interlocutory review of

an order which addresses a controlling question of law as

to which there is substantial ground for difference of

opinion, when an immediate appeal would materially

advance the litigation. The Court of Appeals concluded

that because this appeal was certified on a question of

law, and the legal question was not affected by the

change of factual circumstances, it possessed continuing

jurisdiction to decide that legal issue. That assertion of

jurisdiction is contrary not only to the terms of the inter-

locutory appeal statute, but to this Court’s decisions

interpreting the statute.

The terms of section 1292(b) focus upon the appeal of

“an order” entered by the District Court.

When a district judge, in making in a civil action

an order not otherwise appealable under this

> Plaintiff’s claim for declaratory relief remains pending in

the district court. That claim has not yet been ruled upon by the

district court, and was not before the Eleventh Circuit on

appeal. It does not provide a justiciable claim before the Elev-

enth Circuit upon which it could continue to assert jurisdiction

over the appeal. In addition, Plaintiff’s request for declaratory

relief is the subject of a pending motion to dismiss in the district

court on grounds of mootness and ripeness, arising from the

same change of circumstances which rendered moot the appeal

on the preliminary injunction.

section®, shall be of the opinion that such order

involves a controlling question of law as to

which there is substantial ground for difference

of opinion and that an immediate appeal from

the order may materially advance the ultimate

termination of the litigation, he shall so state in

writing in such order. The Court of Appeals

which would have jurisdiction of an appeal in

such action may thereupon, in its discretion,

permit an appeal to be taken from such order, if

application is made to it within 10 days after the

entry of the order... .

Id. (emphasis added). As the statute states, an interlocu-

tory appeal under section 1292(b) is from an order of the

district court, not from a question of law divorced from

district court action. While the legal question may be the

reason for the certification and interlocutory appeal, the

thing under review is the order, not the question.

This Court explained the difference in United States v.

Stanley, 483 U.S. 669 (1987). In addressing the scope of

jurisdiction under section 1292(b), the Court explained:

An appeal under this statute is from the certified

order, not from any other orders that may have

been entered in the case. Even if the court of

appeals’ jurisdiction is not confined to the pre-

cise question certified by the lower court

(because the statute brings the “order,” not the

question, before the Court), that jurisdiction is

confined to the particular order appealed from.

6 Section 1292(b) is arguably not applicable here at all, as

the statute confines the mechanism to those orders “not other-

wise appealable under this section.” Part (a) of section 1292

expressly permits an inteclocutory appeal from an order refus-

ing to issue an injunction. The district court’s certification was

not necessary to provide a basis for immediate appeal of its

order.

Id. at 677 (emphasis in original). As a result, if the order

appealed from becomes moot, section 1292(b) does not

provide an independent basis upon which the court of

appeals may continue to assert jurisdiction to decide the

legal question at issue apart from the order, regardless of

whether its decision may advance the ultimate termina-

tion of the litigation.

A similar issue was discussed by the Third Circuit in

Ivy Club v. Edwards, 943 F.2d 270 (3rd Cir. 1991), cert.

denied, 112 S.Ct. 1282 (1992). That case involved the

appeal of an interlocutory order reopening a stayed pro-

ceeding pursuant to section 1292(b). Before the Third

Circuit engaged in an analysis of the merits of the deci-

sion, it recognized its obligation to review the justi-

ciability of the order, because the order had arguably

been mooted by changed circumstances. In its discussion

of that issue, the court recognized that section 1292(b)

does not bring a legal issue before the court divorced

from the district court’s order in which that issue was

decided. Citing Stanley, the Court explained:

Because this Court has jurisdiction pursuant to

28 U.S.C. § 1292(b), the scope of appellate

review extends only to questions of law raised

by the order certified by the district court. How-

ever, it is the order that is appealable, and not

the controlling question; and thus we may

address any issue necessary to decide the appeal

before us. We must necessarily decide the issue

of mootness because this Court has a special

obligation to satisfy itself of its own jurisdiction

in every appeal presented to it.

Id. at 275-76 (citations omitted). See Adkinson v. Interna-

tional Harvester Company, 975 F.2d 208, 211 n.4 (5th Cir.

1992) (“On a certified interlocutory appeal under section

1292(b), we have jurisdiction to hear only questions that

are material to the lower court's certified order.”); Ray v.

American National Red Cross, 921 F.2d 324, 325 (D.C. Cir.

1990) (“The statute does not contemplate that a district

court judge may simply certify a question without first

deciding it.”); Edwardsville National Bank & Trust Co. v.

Marion Laboratories, Inc., 808 F.2d 648, 650 (7th Cir. 1987)

(“The question is the reason for the interlocutory appeal,

but the thing under review is the order.”); Miller v. Bolger,

802 F.2d 660, 666 (3rd Cir. 1986) (“Our review is of orders

and not of isolated legal questions.”).

Here, the order from which the appeal was taken was

the district court’s order addressing the Plaintiff’s motion

for a preliminary injunction. When that order became

moot, section 1292(b) did not provide a basis upon which

the Court of Appeals could continue to assert its jurisdic-

tion over a question of law addressed in that order.

Contrary to Stanley, the Eleventh Circuit found itself free

to address the legal question apart from the existence of a

justiciable controversy. Section 1292(b) does not permit

such an extension of the Court’s jurisdiction.

C. The Proper Disposition is to Vacate Prior Opin-

ions and Dismiss the Appeal.

This is a case in which the Court of Appeals became

aware, after its panel opinion was issued, that the order

appealed from had become moot prior to the issuance of

its opinion. In such circumstances, the proper disposition

of the case is governed, like those issues discussed above,

by established Supreme Court precedent.

When a federal appeal becomes moot in advance of

decision, opinions issued in the case should be vacated

and the appeal should be dismissed. The leading case

discussing that established practice is United States v.

Munsingwear, 340 U.S. 104 (1950). There, the Court

explained that when a case becomes moot while awaiting

review, prior opinions should be vacated to return the

legal relationships of the parties to the status existing

prior to initiation of the suit, and to avoid the res judicata

effects of an order which became jurisdictionally unre-

viewable. As the Court explained in Munsingwear, vacat-

ing a judgment “clears the path for future relitigation of

the issues between the parties and eliminates a judgment,

review of which was prevented through happenstance.

When that procedure is followed, the rights of all parties

are preserved; none is prejudiced by a decision which in

the statutory scheme was only preliminary.” Munsing-

wear, 340 U.S. at 40.

This Court consistently employs such a disposition

for cases which become moot pending a decision on

certiorari. Sivley v. Soler, 113 S.Ct. 454 (1992); Yellow

Freight System, Inc. v. United States, 113 S.Ct. 31 (1992);

Dillon v. Alleghany Corp., 111 S.Ct. 1383 (1991). The same

disposition is utilized for cases which have progressed to

later stages of review. For example, in Stewart v. Southern

Railroad Company, 315 U.S. 784 (1942), this Court vacated

its own decision in a case which became moot after the

decision had been filed but during the pendency of a

petition for rehearing. In such circumstances the Court

did not allow its previously entered opinion to remain in

place. Id. The practice of the Supreme Court is consis-

tently followed elsewhere. See, e.g., Independent Union of

Flight Attendants v. Pan American World Airways, Inc., 966

F.2d 457, 459 (9th Cir. 1992) (when case becomes moot

before mandate issued, “the appropriate dispositfon is to

vacate the panel’s opinion and dismiss the appeal.”);

Clarke v. United States, 915 F.2d 699, 706 (D.C. Cir. 1990)

(“The standard practice of both the Supreme Court and

the courts of appeals calls for automatic vacatur”);

Bumpus v. Clark, 702 F.2d 826, 827 (9th Cir. 1983).

Wright, Miller and Cooper go even further, and sug-

gest that vacatur by a court of appeals is appropriate not

ssnnssssetmnia

only when a case becomes moot prior to issuance of the

mandate, but through the time available to the losing

party to seek certiorari. Citing the Supreme Court’s estab-

lished policy regarding cases becoming moot pending

certiorari (to grant certiorari, vacate the opinion below

and dismiss the appeal), they suggest, “It is appropriate

for a court of appeals to vacate its own judgment if it is

made aware of events that moot the case during the time

available to seek certiorari.” 13A C. Wright, A. Miller & E.

Cooper, Federal Practice and Procedure § 3533.10 at 435

(1984).

At the moment the event occurred which rendered

this case moot - the improvement of Plaintiff’s physical

condition on or near February 10, 1993, and her accom-

panying decision not to go forward with HDC-ABMT

under the ICE protocol at Moffitt - the Court of Appeals

was deprived of jurisdiction. Mutual was immediately

thereafter deprived of the opportunity to litigate the mat-

ter to its conclusion. While Mutual did not learn of the

facts rendering the case moot until after the panel’s deci-

sion was issued, and was thus unable to bring those facts

to the Eleventh Circuit’s attention in advance of its deci-

sion, the effect of those facts remains the same. The

Eleventh Circuit was without jurisdiction to issue its deci-

sion, and Mutual should not suffer prejudice from a

jurisdictional inability to litigate the issues presented to a

conclusion. Federal courts are constitutionaily required to

continually address the existence of jurisdiction, and to

make an appropriate disposition of the matter in light of

jurisdictional issues. Here, the decisions of this Court

demand that the panel opinion be vacated and the appea!

dismissed, precedent ignored by the Eleventh Circuit

when it wrongfully continued to assert jurisdiction over

the case.

Il. THIS CASE PRESENTS AN IMPORTANT JURIS-

DICTIONAL QUESTION OVER WHICH THE

COURT SHOULD EXERCISE ITS SUPERVISORY

POWERS.

In this case, the Eleventh Circuit acted notwithstand-

ing the absence of jurisdiction, in direct violation of clear

precedent of this Court. A grant of certiorari is necessary

and appropriate to correct the Eleventh Circuit’s erro-

neous assertion of jurisdiction over a moot issue. This

Court often grants certiorari to correct a court of appeal’s

wrongful exercise of federal jurisdiction, especially when

an appeal is rendered moot by changed circumstances. R.

Stern, E. Gressman, S. Shapiro, Supreme Court Practice,

§ 4.15 at 220 (B.N.A. 6th Ed. 1986). As the court of last

resort in the federal system, the exercise of this Court's

supervisory authority over lower federal courts is espe-

cially appropriate to correct a jurisdictional defect.

Here, the Eleventh Circuit exercised jurisdiction in

direct conflict with Supreme Court precedent involving

(1) concepts of mootness, (2) the impact of mootness in an

appeal from an order on a preliminary injunction, (3) the

effect of certification under section 1221(b) on a moot

appeal, and (4) the proper disposition of a case rendered

moot on appeal. To allow such a decision to stand would

do violence to the jurisdictional limitations placed upon

federal courts by Article III, and to the importance of this

Court’s establishment of jurisdictional boundaries.

CONCLUSION

Mutual respectfully requests that its Petition for Cer-

tiorari be granted, the opinions below vacated, the appeal

dismissed, and the case remanded for disposition on the

merits.

Respectfully submitted,

MUTUAL OF OMAHA LIFE

INSURANCE COMPANY, Petitioner

By: /s/ THomas E. JoHNsON

StevEN D. Davidson

of Bairp, Hotm, McEAcHEN,

PeperRsEN, HAMANN &

STRASHEIM

1500 Woodmen Tower

Omaha, Nebraska 68102-2068

(402) 344-0500

Counsel of Record for Petitioner

RaceH A. PETERSON

of Beccs & LANE

Post Office Box 12950

Pensacola, Florida 32576-2950

(904) 432-2451

Counsel for Petitioner

September, 1993

APPENDIX

TABLE OF CONTENTS

APPENDIX A

Order Denying Appellee’s Motion to Vacate Order

and Dismiss Appeal as Moot..................+--- Al

APPENDIX B

Memorandum and Order Denying Appellee’s

Petition for Rehearing and Suggestion for

Rehearing En Banc, Construed as a Motion for

Reconsideration of the June 21, 1993, Order

Denying Without Prejudice Appellee’s Motion

to Vacate Order and Dismiss Appeal as Moot..... Bl

APPENDIX C

Order of the Eleventh Circuit on the Preliminary

Injunction, 986 F.2d 1379 (11th Cir. 1992) ......... Cl

APPENDIX D

Order of the District Court on the Preliminary

Injunction, 812 F. Supp. 1193 (N.D.Fla. 1992)...... D1

APPENDIX A

IN THE UNITED STATES COURT OF APPEALS

FOR THE ELEVENTH CIRCUIT

No. 92-2904

MARY P. DAHL-EIMERS,

Plaintiff-Appellant,

versus

MUTUAL OF OMAHA LIFE INSURANCE COMPANY,

Defendant-Appellee.

On Appeal from the United States District Court

for the Northern District of Florida

(Filed June 21, 1993)

BEFORE: HATCHETT and BLACK, Circuit Judges, and

DYER, Senior Circuit Judge.

BY THE COURT:

Appellee’s motion to vacate order (this Court’s

March 9, 1993 opinion) and dismiss appeal as moot is

DENIED without prejudice to the right of the parties to

raise the issue before the district court.

APPENDIX B

IN THE UNITED STATES COURT OF APPEALS

FOR THE ELEVENTH CIRCUIT

No. 92-2904

MARY P. DAHL-EIMERS,

Plaintiff-Appellant,

versus

MUTUAL OF OMAHA LIFE INSURANCE COMPANY,

Defendant-Appellee.

Appeal from the United States District Court

for the Northern District of Florida

(Filed Aug. 10, 1993)

Before HATCHETT and BLACK, Circuit Judges, and

DYER, Senior Circuit Judge.

BY THE COURT:

We are not convinced that this case is moot. We also

do not think that In re Ghandtchi, 705 F.2d 1315 (11th Cir.

1983), establishes a rule of automatic vacatur under all

circumstances. The rationale of Lnited States v. Munsing-

wear, 340 U.S. 104, 39-40, 71 S.Ct. 104, 106-07 (1950), upon

which Ghandtchi is based, is to clear the path for future

relitigation of the issues between the parties and to vacate

an order that could not be reviewed, so that the parties

are not prejudiced by a preliminary decision. This pur-

pose is not furthered by creating an automatic vacatur

rule. In Ghandtchi, vacatur was deemed appropriate. 705

F.2d at 1316. We do not consider vacatur to be appropri-

ate in this case. First, Munsingwear’s purpose would not

be furthered by vacatur. In addition, this Court's jurisdic-

tion under § 1292(b) and its opinion are based on a

question of law, not on the underlying facts surrounding

the disease. The legal question before this Court has not

changed — the contract and its language remains the

same. Nowhere in any of the briefs is this Court informed

of a modification in the contractual language this Court

construed. Section 1292(b) jurisdiction is specifically

designed to give ongoing litigation the benefit of acceler-

ated appellate review of controlling legal questions, so

that the litigation as a whole may be materially advanced.

That purpose has been satisfied and, therefore, Appel-

lee’s petition for rehearing and suggestion for rehearing

en banc, construed as a motion for reconsideration of the

June 21, 1993, order denying without prejudice appellee’s

motion to vacate order (this Court’s March 9, 1993, opin-

ion) and dismiss appeal as moot, is

DENIED.

APPENDIX C

Mary P. DAHL-EIMERS,

Plaintiff-Appellant,

MUTUAL OF OMAHA LIFE

INSURANCE COMPANY,

Defendant-Appellee.

No. 92-2904.

United States Court of Appeals,

Eleventh Circuit.

March 9, 1993.

Paul R. Miller, Miles Davis, Miles Davis & Associates,

Pensacola, FL, Raymond T. Elligett, Jr., Schropp, Buell &

Elligett, P.A., Tampa, FL, for plaintiff-appellant.

Thomas E. Johnson, Baird Holm McEachen, Omaha,

NB [sic], for defendant-appellee.

Richard G. Tuttle, Anderson, Kill, Olick & Oshinsky,

PC, Philadelphia, PA, amicus curiae.

David M. Caldevilla, L. David de la Parte, John R.

Thomas, Tampa, FL, for amicus curiae, Moffitt Cancer

Center.

Appeal! from the United States District Court-for the

Northern District of Florida.

Before HATCHETT and BLACK, Circuit Judges, and

DYER, Senior Circuit Judge.

BLACK, Circuit Judge:

The issue before this court is whether the district

court correctly denied Plaintiff-Appellant Mary P. Dahl-

Eimers’ application for a preliminary injunction. Dahl-

Eimers has advanced breast cancer, and she wants Defen-

dant-Appellee Mutual of Omaha Life Insurance Company

to pay for high dose chemotherapy with autolegous bone

marrow transplant (HDC-ABMT) under their major medi-

cal expense insurance contract. Mutual of Omaha refused

to provide coverage for HDC-ABMT because the com-

pany considers it experimental and therefore not medi-

cally necessary. The insurance policy covers only

medically necessary services, and under the policy medi-

cal services that are considered experimental are not

medically necessary.

In Dahl-Eimers’ application for a preliminary injunc-

tion to enjoin Mutual of Omaha from denying coverage

under the policy, the district court ruled that she did not

have a substantial likelihood of success on the merits. 812

F.Supp. 1193. The court based its ruling in part on its

legal determination that the contract term “experimental”

is not ambiguous. As explained below, we conclude that

the phrase “considered experimental,” standing alone in

a major medical insurance policy, is ambiguous as a mat-

ter of law, and we reverse the district court’s decision.

I. BACKGROUND

Dahl-Eimers has Stage IV metastatic breast cancer,

which is considered incurable by traditional cancer treat-

ments, but which may respond to chemotherapy drugs in

high doses. High dose chemotherapy, combined with

autologous bone marrow transplant, has recently been

shown to be an effective treatment in some breast cancer

cases,! and Dahl-Eimers’ treating physician referred her

to the H. Lee Moffitt Cancer Center and Research Insti-

tute for HDC-ABMT treatment.

The insurance contract between Mutual of Omaha

and Dahl-Eimers provides for reimbursement of expenses

incurred for medically necessary services or supplies. A

medically necessary service or supply is defined in the

contract as one that:

(a) is appropriate and consistent with the diag-

nosis in accord with accepted standards of com-

munity practice; (b) is not considered

experimental; and (c) could not have been omit-

ted without adversely affecting the insured per-

son’s condition or the quality of medical care.

Mutual of Omaha refused to pay for HDC-ABMT treat-

ment because it determined that the proposed treatment

was not medically necessary and therefore was not cov-

ered by the policy.

Before the district court, Dahl-Eimers identified the

central issues as being whether the term “experimental”

is ambiguous and whether the treatment is experimental.

Mutual of Omaha contended that Dahl-Eimers did not

meet any of the policy’s three criteria for a medically

1 HDC-ABMT is an established treatment for cancers char-

acterized by diffuse tumors, such as leukemia or lymphoma.

Breast cancer, however, is characterized by solid tumors. The

efficacy of HDC-ABMT for breast cancer is discussed in, e¢.g.,

Kulakowski v. Rochester Hospital Service Corp., 779 F.Supp. 710

(W.D.N.Y.1991); White v. Caterpillar, Inc., 765 F.Supp. 1418

(W.D.Mo.1991); and Adams v. Blue Cross/Blue Shield, Inc., 757

F.Supp. 661 (D.Md.1991).

necessary service. In its order, the district court focused

only on subparagraph (b) of the definition of medically

necessary and determined that the critical issue was

whether the term “experimental” is ambiguous.

The court held that the term “experimental,” as

applied to the facts of this case, is not ambiguous. It then

held that HDC-ABMT treatment for breast cancer is

experimental and therefore not covered by the policy. The

district court concluded that Dahl-Eimers did not have a

substantial likelihood of prevailing on the merits? and

denied her application for a preliminary injunction. The

court certified that its order involved a controlling ques-

tion of law as to which there is substantial ground for

difference of opinion. 28 U.S.C. § 1292.

On Appeal, Dahl-Eimers argues that the district court

erred by focusing on the word “experimental” instead of

the phrase “considered experimental.” She contends that

the insurance contract is ambiguous because it does not

define “experimental” and it does not specify who will

determine whether a service is considered experimental.

She asserts that there are a number of reasonable inter-

pretations about who will make the determination

2 For a preliminary injunction to issue, the plaintiff must

show that: (1) there is a substantial likelihood the plaintiff will

ultimately prevail on the merits, (2) the plaintiff will suffer

irreparable injury if the injunction does not issue, (3) the threat-

ened injury to the plaintiff outweighs whatever damage the

proposed injunction may cause to the defendant, and (4) the

injunction would not be adverse to the public interest. E.g.,

Sofarelli v. Pinellas County, 931 F.2d 718, 723-24 (11th Cir.1991).

The district court held that Dahl-Eimers satisfied the last three

factors.

whether a particular treatment is experimental. She also

argues that HDC-ABMT is no longer considered an exper-

imental treatment for breast cancer.

Mutual of Omaha counters that the alternative inter-

pretations offered by Dahl-Eimers are not reasonable. It

recognizes that there are various potential sources which

could determine whether a treatment is considered exper-

imental, but claims that the contract would only be

ambiguous if the various sources could adopt differing,

yet reasonable interpretations of the term. Finally, Mutual

of Omaha argues that HDC-ABMT, using the particular

combination of drugs proposed for Dahl-Eimers, is exper-

imental treatment for breast cancer.

Il. STANDARD OF REVIEW

Questions of law are reviewed de novo. Salve Regina

College v. Russell, U.S. __, 111 S.Ct. 1217, 113 L.Ed.2d

190 (1991). Under Florida law, interpretation of an insur-

ance contract, including determination and resolution of

ambiguity, is a matter of law. Sproles v. American States

Ins. Co., 578 So.2d 482, 484 (Fla. 5th DCA 1991); Gulf

Tampa Drydock Co. v. Great Atl. Ins. Co., 757 F.2d 1172, 1174

(11th Cir.1985). The portion of the district court’s denial

of the preliminary injunction based solely on its legal

construction of the insurance contract is likewise a ques-

tion of law. See E. Remy Martin & Co. S.A. v. Shaw-Ross

Int’l Imports, Inc., 756 F.2d 1525, 1529 (11th Cir.1985)

(conclusions of law in action on preliminary injunction

subject to broad review). The district court’s findings of

fact are reviewed under the clearly erroneous standard.

Newell v. Prudential Ins. Co., 904 F.2d 644, 649 (11th

Cir.1990).

Ill. DISCUSSION

A. Applicable Law

Under Florida law, courts must construe an insurance

contract in its entirety, striving to give every provision

meaning and effect. Excelsior Ins. Co. v. Pomona Park Bar &

Package Store, 369 So.2d 938, 941 (Fla.1979). An insurance

contract is ambiguous if it is susceptible to two or more

reasonable interpretations that can fairly be made. Her-

ring v. First S. Ins. Co., 522 So.2d 1066, 1068 (Fla. Ist DCA

1988); Ideal Mut. Ins. Co. v. C.D.I. Constr., Inc., 640 F.2d

654, 657 (5th Cir. Unit B Mar.i981). When one of these

interpretations results in coverage and another results in

exclusion, ambiguity exists in the insurance policy.

Weldon v. All Am. Life Ins. Co., 605 So.2d 911, 915 (Fla. 2d

DCA 1992); Gulf Tampa Drydock, 757 F.2d at 1174-75. ~~

Ambiguity also may arise from silence. Cf. Davis v.

Crown Life Ins. Co., 696 F.2d 1343, 1346 (11th Cir.1983)

(ambiguity resulting from silence in certificate of insur-

ance, which did not include a controlling provision

recited in the master policy, treated as an express ambi-

guity). Further, differing interpretations of the same pro-

vision is evidence of ambiguity, Dimmitt Chevrolet, Inc. v.

Southeastern Fidelity Insurance Corp., 1992 WL 212008, 17

Fla.L.Weekly S579 (Fla.1992), particularly when a term is

not explicitly defined or clarified by the policy. Grissom v.

Commercial Union Ins. Co., 610 So.2d 1299 (Fla. 1st DCA

1992).

Courts may not rewrite contracts or add meaning to

create an ambiguity. State Farm Mut. Auto. Ins. Co. v.

Pridgen, 498 So.2d 1245, 1248 (Fla.1986). There must be “a

genuine inconsistency, uncertainty, or ambiguity in mean-

ing [that] remains after resort to the ordinary rules of

construction.” Excelsior, 369 So.2d at 942. Further, ambi-

guity is not invariably present when a contract requires

interpretation, Weldon, 605 So.2d at 915; Gulf Tampa Dry-

dock, 757 F.2d at 1175, and failing to define a term does

not create ambiguity per se. Jefferson Ins. Co. v. Sea World,

Inc., 586 So.2d 95, 97 (5th DCA 1991). Nevertheless, “[t]he

insurer cannot, by failing to define the terms... or to

include any additional qualifying or exclusicnary lan-

guage, insist upon a narrow, restrictive interpretation of

the coverage provided.” National Merchandise Co. v. United

States Auto. Assoc., 400 So.2d 526, 530 (Fla. Ist DCA 1981).

Given these rules of construction, we turn now to the

insurance policy before us.

B. Determination of Ambiguity

Ordinary rules of construction require us, first, to

assess the natural or plain meaning of the policy lan-

guage. E.g., Landress Auto Wrecking Co., Inc. v. United

States Fidelity & Guaranty Co., 696 F.2d 1290, 1292 (11th

Cir 1983). We must strive to give meaning to every provi-

sion, so we must look at the phrase “considered experi-

mental” to determine its meaning within the policy. The

policy does not define the term “experimental.” The plain

language of subparagraph (b), the provision relied upon

by the district court to exclude coverage, does not indi-

cate who will determine whether a proposed treatment is

considered experimental.3 Further, it also omits standards

for how that determination will be made. Thus, the con-

tract phrase “considered experimental,” without more,

gives rise to a genuine uncertainty about who will deter-

mine whether a particular treatment is experimental and

how that determination will be madc. Indeed, even

Mutual of Omaha concedes that there could be more than

one source of such a determination. Ambiguity in the

contract terms arises from the contract’s silence on defini-

tions.

The absence of a definition does not create ambiguity

per se, as noted above. Nonetheless, the insurance com-

pany cannot then claim the narrow and favorable inter-

pretation that its determination, alone, is controlling. In

this case, Mutual of Omaha took upon itself the deter-

mination of whether the proposed treatment is consid-

ered experimental. While that is a reasonable

interpretation of the policy language, it is not the only

reasonable interpretation. It would also be reasonable to

allow the determination of what is considered experimen-

tal to made, for example, by the relevant medical special-

ists, according to generally accepted standards of

community practice, or by a national association.

% In subparagraph (a), the policy explicitly sets forth an

applicable standard for determining whether a service is appro-

priate and consistent with a diagnosis, i.e., “in accord with

accepted standards of community practice.” Subparagraphs (b)

and (c) are both silent on the relevant standards, and the entire

provision is silent on who would determine whether a particu-

lar medical service fits the criteria.

Mutual of Omaha’s interpretation excludes coverage,

but other reasonable interpretations may result in cover-

age. For example, although in its order in this case the

district court did not assess whether HDC-ABMT is con-

sidered an experimental treatment by the relevant medi-

cal specialists, other courts have found that the relevant

medical specialists do not consider HDC-ABMT experi-

mental. E.g., Adams v. Blue Cross/Blue Shield, Inc., 757

F.Supp. 661, 663 (D.Md.1991) (at the time Blue Cross

denied coverage, Maryland oncologists generally

acknowledged HDC-ABMT as accepted medical practice).

The existence of differing interpretations of the term

“experimental” provides further evidence of a genuine

ambiguity. Some courts* have found that ambiguity is

cured when the term “experimental” is qualified by spec-

ifying who will determine the experimental nature of the

treatment or by specifying the standards by which the

determination of experimental will be made. For exam-

ple, in Fuja v. Benefit Trust Life Insurance Company, 809

F.Supp. 1333 (N.D.II1.1992), the insurance contract pro-

vided coverage for medically necessary treatment, which

was defined as treatment that is, among other criteria,

“not deemed to be experimental . . . by any appropriate

technological assessment body established by any state or

federal government.” Id. at 1336. The court noted that a

4 We have not found any reported Florida or Eleventh Cir-

cuit cases construing the term experimental or the phrase con-

sidered experimental in medical insurance contracts to

determine whether the terms are ambiguous. We recognize that

the reported cases which do address the issue are ERISA cases

governed primarily by federal statute, but we consider the ana-

lytical reasoning instructive on the question of ambiguity.

C10

predecessor version of this criterion had been considered

ambiguous, but that the qualifier “deemed . . . by [a]

technological [assessment] body” largely removed any

ambiguity. Id. at 1340 n. 4. The court also noted that the

National Cancer Institute, an appropriate technological

assessment body under the contract, stated in its litera-

ture that “the term[] . . . ‘experimental’ cannot be simply

or unambiguously used to define new cancer therapies.”

Id. at 1340.

Similarly, in Boland v. King County Medical Blue Shield,

798 F.Supp. 638, 640 (W.D.Wash.1992), a collective bar-

gaining contract excluded experimental or investigational

procedures, which were defined as:

any services so classified by the National Blue

Cross and Blue Shield Association and any ser-

vice whose use is still under clinical investiga-

tion by health professionals or is not generally

recognized by the medical profession as tested

and accepted medical practice. This exclusion

also applies to items requiring Federal Drug

Administration or other governmental agency

approval if such approval was not granted at the

time the service or supply was ordered.

The court determined that the contract unambiguously

relied on a third-party classification of what was experi-

mental or investigational, and, because the National Biue

Cross and Blue Shield Association had classified the pro-

posed treatment as investigational, granted summary

judgment for the insurance company. Id. at 646.

Other courts have found that the term “experimen-

tal” is ambiguous when it is undefined in medical insur-

ance contracts. For example, in holding that Blue Cross-

Cll

Blue Shield’s policy excluding experimental procedures

was ambiguous, the United States District Court for the

Eastern District of Virginia noted that the policy did not

define “experimental” and did not explain what evidence

would be used to demonstrate whether a particular treat-

ment was experimental. Pirozzi v. Blue Cross-Blue Shield,

741 F.Supp. 586, 589-90 (E.D.Va.1990). See also Nesseim v.

Mail Handlers Benefit Plan, 792 F.Supp. 674 (D.S.D.1992)

(granting a preliminary injunction and requiring cover-

age for HDC-ABMT because the terms of the contract

were ambiguous). Indeed, in Johnson v. District 2 Marire

Engineers Beneficial Association, 857 F.2d 514, 516 (9th Cir.

1988), the court stated that “[i]n the context of the mod-

ern medicine, the term ‘experimental’ seems clearly

ambiguous on its face.” We agree that, in the context of a

major medical insurance policy, the term “experimental,”

and in this case the phrase “considered experimental,” is

ambiguous when it is undefined.

IV. CONCLUSION

We need not reach the factual question of whether

HDC-ABMT treatment for breast cancer is considered

experimental. We hold that the district court erred by

concluding that the term “experimental” is not ambig-

uous. The insurance policy does not clearly specify who

will determine whether a treatment is considered experi-

mental or how that determination will be made.

Accordingly, we vacate the district court’s order

denying Dahl-Eimers’ application for a preliminary

injunction and remand to the district court to determine

C12

whether there is a substantial likelihood that she will

prevail on the merits.

VACATED and REMANDED.

APPENDIX D

Mary P. DAHL-EIMERS, Plaintiff,

MUTUAL OF OMAHA LIFE

INSURANCE COMPANY,

Defendant.

No. 92-30254-RV.

United States District Court,

N.D. Florida,

Pensacola Division.

July 29, 1992.

Miles Davis, Pensacola, FL, and Wm. Dennis Bran-

non, Ft. Walton Beach, FL, for plaintiff.

Thomas E. Johnson, Omaha, NE, Ralph A. Peterson,

Beggs & Lane, Pensacola, FL, for defendant.

ORDER AND MEMORANDUM

OPINION

VINSON, District Judge.

Plaintiff, Mary P. Dahl-Eimers, initiated this litigation

for declaratory judgment, for injunctive relief, and for

damages, against defendant, Mutual of Omaha Life Insur-

ance Company. The plaintiff is insured under a policy of

major medical expense coverage issued by the defendant.

The plaintiff has Stage IV breast cancer, and desires to

undergo a procedure identified generally as high dose

chemotherapy with autologous bone marrow transplant

(“HDC-ABMT”), utilizing three chemotherapy drugs

known as Ifosfomide, Carboplatinum, and Etoposide

(“1.C.E.”). The issue presented is whether the HDC-

ABMT treatment utilizing the I.C.E. drugs is “experimen-

tal” within the meaning of the policy’s coverage.

(1) The preliminary injunction standard. In this Cir-

cuit, the four requisites for issuance of a preliminary

injunction are well known: (a) a substantial likelihood

that plaintiff will ultimately prevail on the merits; (b) that

plaintiff will suffer irreparable injury unless the injunc-

tion issues; (c) that the threatened injury to the movant

outweighs whatever damage the proposed injunction

may cause to the opposing party; and (d) that the injunc-

tion, if issued, would not be adverse to the public inter-

est. See, e.g., Sofarelli v. Pinellas County, 931 F.2d 718,

723-24 (11th Cir.1991). This matter was promptly set for

hearing on the plaintiff’s motion for a preliminary injunc-

tion because of the obvious need to deal quickly with the

issue. For purposes of the preliminary injunction, only

the first element needs to be considered, since the

remaining three elements are established by the circum-

stances of the case.

(2) The plaintiff's cancer and course of treatment. Plain-

tiff is a forty-year-old female who resides in Destin, Flor-

ida. Her breast cancer was initially confirmed by biopsy

on September 30, 1988. Following a right modified radical

mastectomy, plaintiff embarked upon an initial course of

chemotherapy and radiation treatments considered as

standard or conventional therapy. At the-end of that

course of treatment, there was no clinical evidence that

her disease was still existent. However, in August, 1991,

plaintiff developed pain in her right hip and was diag-

nosed with metastatic disease, for which she was treated

with a drug called “Taxol” between September 1991 and

March 1992. The cancer now appears to be in remission,

although it is classified as “Stage IV metastatic breast

cancer.” Stage IV metastatic breast cancer is considered

incurable by any known therapy. Plaintiff has now

decided to explore the possibility of enrolling in the

clinical trial of HDC-ABMT involving I.C.E. at the H. Lee

Moffitt Cancer Center and Research Institute at the Uni-

versity of South Florida in Tampa, Florida (“Moffitt”).

(3) The terms of the policy. Under the major medical

expense policy of insurance issued by the defendant, the

insuring clause on page 4 specifies that the insurance

company will reimburse the insured for “expenses”

incurred. The expenses are defined as limited to “medi-

cally necessary” services or supplies. In turn, that is

defined as follows:

A “Medically Necessary” service or supply

means one which: (a) is appropriate and consis-

tent with a diagnosis in accord with accepted

standards of community practice; (b) is not con-

sidered experimental; and (c) could not have

been omitted without adversely affecting the

insured person’s condition or the quality of

medical care.

The critical term for purposes of this case is “experimen-

tal.” The plaintiff contends that it is an ambiguous term,

while the defendant says that it is not. Under Fiorida law,

construction of the terms of an insurance contract is a

question of law to be resolved by the court. Epstein v.

Hartford Casualty Insurance Co., 566 So.2d 331, 332-33 (Fla.

lst DCA 1990). Further courts are to give the language

within an insurance policy a practical and sensible inter-

pretation in accordance with the natural meaning of the

————

words employed. Construction of the policy language

must be:

. . . by the rule of reason and the principle that

even insurance policies must be given practical,

sensible interpretations in accordance with the

natural meaning of the words employed. Obvi-

ously, the rule that ambiguities must be con-

strued against the insurer applies only when a

genuine inconsistency, uncertainty, or ambiguity

in meaning remains after resort to ordinary

rules of construction; it does not allow courts to

rewrite the contracts, adding meaning that is not

present, or otherwise reach results contrary to

the manifest intention of the parties.

Allstate Insurance Co. v. Shofner, 573 So.2d 47,

49 (Fla. lst DCA 1990) (citations omitted).

(4) The HDC-ABMT treatment. Among cancer

researchers, it is generally believed that higher doses of

chemotherapy drugs may result in destruction of a

greater portion of the cancer cells. However, since the

chemotherapy drugs are extremely toxic, the dosage for

each of these drugs is limited by the maximum that the

human body can tolerate. A significant limiting factor is

that very high doses substantially destroy the bone mar-

row which, ordinarily, is fatal since the bone marrow

provides necessary red blood cells, white blood cells, and

platelets.

Thus, a major research effort in recent years has been

an attempt to increase the maximum tolerated dosage by

means of protecting a small portion of the patient’s own

(“autologous”) bone marrow. A major break through was

being able to remove, freeze, and reuse the bone marrow.

The first trials of this process, “HDC-ABMT,” in cancer

treatment involved patients with “diffuse” tumors such

as leukemia or lymphoma. Through a series of laboratory

and clinical experiments, researchers were able to deter-

mine what specific patients were benefitted by specific

drugs or drug combinations at specific dose levels. As a

result HDC-ABMT for certain diffuse tumors is now rec-

ognized as standard therapy. There is no standard ther-

apy recognized today, however, for a “solid” tumor such

as breast cancer among women. Over the past few years,

perhaps ten to twenty university-affiliated medical insti-

tutions have initiated active research programs for HDC-

ABMT treatment of breast cancer. These programs

involve a limited number of patients at various stages of

the disease, and each program generally involves a test-

ing of a particular combination of drugs at various dos-

age levels, with and without bone marrow purging.

Despite high expectations from these clinical tests, the

data available from the experiments conducted to date

are inconclusive. The results of approximately 1,000 test

patients using about six different combinations of chemo-

therapy drugs are now known to the medical community.

For purposes of this case, it is important to note that there

is no known published data for the I.C.E. combination of

drugs on breast cancer, for which plaintiff seeks treat-

ment at the Moffitt Center.

(5) Medical Research Requirements. The requirements

of medical research involving human subjects is regu-

lated by the federal government under regulations pro-

mulgated by the Department of Health and Human

Services and the Food and Drug Administration. Medical

experiments with human subjects are generally known

within the profession as “clinical trials.” Clinical trials are

—

divided into “phases” which are defined in terms of the

research objective and the methodology. Phase I clinical

trials are the earliest stage of the testing of a drug or

procedure, and follow test tube and animal research. The

primary objective of a Phase | trial in the context of drug

testing is to determine the toxicity and maximum toler-

ated dosage of the substance. Dosages are escalated

among groups of patients until a dosage is reached where

toxicities prove unacceptable.

In Phase II trials, scientific information is gathered

regarding the medical effectiveness or ineffectiveness of

the procedure. Phase II trials are designed to attempt to

determine whether the experimental procedure produces

a biological response such as shrinkage of the tumor, and

the extent and duration of that response. Phase II clinical

trials are statistically designed to involve the fewest

number of research subjects necessary to achieve the

statistical reliability of the experiment’s results.

Finally, Phase III trials are conducted to attempt to

compare the medical result of the experimental therapy

to a standard therapy or to no therapy at all, in order to

allow for reasonable scientific comparison and test con-

clusions.

All of these testing procedures are implemented

through entities called Institutional Review Boards

(“IRBs”). An IRB must be established and maintained by

each institution engaged in medical research involving

human subjects. Every research project must be submit-

ted to the controlling IRB via a document known as the

“protocol.” The protocol sets out, inter alia, eligibility

requirements for subjects, the number of subjects to be

enrolled, and the objective of the research project. Full

disclosure is required.

Each participant in a research project is required to

be fully informed, and this is done via a specialized

document known as the “informed consent” document.

The Code of Federal Regulations sets out what must be

included in the “informed consent” document.

(6) The “protocol” document and the “informed con-

sent” document involved in this case. The protocol docu-

ment for the Moffitt Cancer Center, for which the plaintiff

seeks treatment, is in evidence, as is her informed consent

document. As the protocol’s title reflects, it is a “Phase

I-I] study of intensive-dose [I.C.E.] combination chemo-

therapy.” It contemplates dosage levels escalating up to

four times the approved dosage limit of Ifosfomide; up to

fifteen times the approved dosage of Carboplatin; and up

to three and one-half times the approved dosage of

Etoposide.

The protocol sets out the purpose of the study in

paragraph (2.4): “The present study proposes that the

combination of drugs . . . [I.C.E.], which represents a

novel multi-agent regimen, followed by autologous bone

marrow transplantation, be evaluated in a dose escalation

fashion. . . . ” A number of types of cancers are to be

included within the study, including “metastatic breast

cancer responding to therapy.” The concluding sentence

of paragraph (2.4) reads: “A major goal will be to define

the maximum tolerated dose of this combination of

drugs.”

In the “informed consent” document, the clinical trial

participant is required to acknowledge “I understand that

the investigators will be measuring how well my disease

responds to the drug as well as any side effects to the

drugs on the study.” The document sets out that partici-

pation as a research subject “is voluntary,” and “there is

no guarantee that this will be successful.” The clinical

trial is referred to throughout the document as a “study.”

The estimated cost of the plaintiff’s participation in

the Moffitt Center’s clinical trial is approximately

$150,000. Since there is apparently no outside funding for

this type of clinical research at the Moffitt Center, the

participants (or the participants’ insurance companies, if

applicable) are expected to pay. Naturally, the medical

research team members are most interested in getting the

appropriate representation of participants into the clinical

tests. Therefore, it must be recognized that the testimony

and affidavits of such medical personnel have a decided

bias in favor of attempting to get the insurance com-

panies to fund this research.

(7) Analysis. buth sides have submitted numerous

reported court decisions dealing with the question of

whether HDC-ABMT is within the scope of coverage of a

medical insurance policy. Although some of the reported

decisions deal with the subject in such a general fashion

as to be completely irrelevant to what I consider to be the

critical inquiry, and others are clearly distinguishable

because of the different types of cancer involved or the

different insurance policy clauses being applied, the cases

are about equally divided on the issue.

The inquiry in this case is plainly fact-specific, and

must be resolved by applying the term “experimental” to

the actual procedure being contemplated by the plaintiff

for her treatment. Within this context, the term “experi-

mental” is not ambiguous. It has a plain and ordinary

meaning which can be applied to the circumstances and

facts of this case without any conflict. As defined in

Webster’s Ninth New Collegiate Dictionary (Mariam-

[sic]Webster, Inc. 1985), an “experiment” is “an operation

carried out under controlled conditions in order to dis-

cover an unknown effect or law, to test or establish a

hypothesis, or to illustrate a known law.” In turn, “exper-

imental” means “relating to or having the characteristics

of experiment: TENTATIVE [still in the “experimental”

stage]”.

Under the facts of this case, the inescapable conclu-

sion is that plaintiff’s projected treatment is “experimen-

tal.” Both the protocol document and the informed

consent document associated with the clinical trial at the

Moffitt Center leave no doubt about the nature of the

study. It involves the testing of three chemotherapy drugs

which have not previously been utilized together in the

HDC-ABMT regimen. It is clearly an attempt to try to

isolate the maximum dosages that can be tolerated among

a variety of types of cancers. It sets out a prescribed

regimen of dosages that will be applied to all of the

study’s participants, without regard to any individual

characteristics or peculiarities. Under the protocol, each

patient “gets the same predetermined treatment, the same

dose, the same frequency.” [See Herberman deposition, p.

108] It is this characteristic of the study for which the

plaintiff seeks to be enrolled that easily distinguishes it

from any “treatment.” Accepted treatment “tends to be

an individualized approach,” in which the “physician

will adjust the dose or on a frequency of administration

D10

based on a variety of situations and their intuition about

what would be the optimum treatment for that given

patient.” [/d.] On the other hand, in protocol research,

“one needs to standardize as much as possible the treat-

ment amongst all the patients who are entered so that one

could compare as much as possible the results from one

patient to the next.” [Id. p. 109-109] Presumably, no treat-

ment could be ethically prescribed for a patient by a

physician unless there was some expectation that it was

potentially beneficial to the patient. Thus, | reject any

purported definitions framed by other courts or experts

which attempt to read an ambiguity into the term “exper-

imental” on the basis of whether it benefits a patient.

That type of analysis simply is wrong.

(8) Conclusion. The parties have submitted an abun-

dance of evidentiary material in connection with this

matter, and have also relied upon numerous reported

court decisions, as discussed above. However, | do not

feel it is necessary to further discuss the evidentiary

material or the legal authorities in any detail, for the

issue is quite narrow and quite focused. The plaintiff, like

approximately 50,000 other breast cancer patients each

year, is bravely facing a situation where her alternatives

are few, and none are particularly attractive. The clinical

study in which she seeks to be enrolled is definitely

“experimental” as applied to the I.C.E. combination of

chemotherapy drugs for treatment of breast cancer. The

insurance policy does not provide coverage for treatment

that is “experimental.” I am certainly sympathetic to the

plaintiff’s plight and her rational desire to pursue any

path of treatment that holds any promise of success. Yet,

in truth, whether the I.C.E. combination of drugs has a

iin

D11

beneficial — or deleterious — effect upon breast cancer that

has progressed to Stage IV is simply not known. That is,

understandably, why the Moffitt Center desires to enroll

the plaintiff in its study. It is equally understandable why

the plaintiff, after giving due consideration to all her

alternatives, may want to pursue that course of treat-

ment.

It is unfortunate that adequate funding for clinical

trials of drugs and treatments for catastrophic illnesses is

not available from the federal government. But such

funding is quite limited, and is thinly spread among

thousands of competing programs involving literally

hundreds of various illnesses and diseases. Thoughtful

people need to ponder how this problem can be fairly

resolved.

Since it does not appear that the plaintiff has sub-

stantial likelihood of prevailing on the merits of this case,

the motion for a preliminary injunction must be, and is,

DENIED.

In accordance with Title 28, United States Code, Sec-

tion 1292, | certify that this order involves a controlling

question of law as to which there is substantial ground

for different of opinion, and an immediate appeal may

materially advance the ultimate termination of the litiga-

tion. Time is also of the essence.

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.