Armstrong v. Dwyer

Opinions of the United

1998 Decisions States Court of Appeals

for the Third Circuit

8-31-1998

Armstrong v. Dwyer

Precedential or Non-Precedential:

Docket 97-5388

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Recommended Citation

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Filed August 31, 1998

UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

No. 97-5388

WARREN ARMSTRONG and EMILY ARMSTRONG,

Appellants

v.

WILLIAM DWYER, M.D.; ST. JOSEPH'S HOSPITAL AND

MEDICAL CENTER; A. CHRISTIANO, M.D., Director of

Labs; VICKIE WILLE, Medical Technician; ATILLA

ARTURK, M.D., Transfusionist; GARY NALWANY, M.D.,

Transfusionist; CELIA GOMEZ, R.N., Transfusionist;

A. FERNANDEZ, M.D., Transfusionist; JOHN DOE(S), 1 -3

(individuals responsible for hiring Dr. Thrower);

DR. THROWER,

THE PEER REVIEW ORGANIZATION OF NEW JERSEY

(PRO NJ)

Intervenor-Defendant

On Appeal from the United States District Court

for the District of New Jersey

(D.C. No. 93-cv-03016)

Argued June 11, 1998

BEFORE: STAPLETON, COWEN, and RENDELL

Circuit Judges

(Filed August 31, 1998)

Alfred E. Fontanella, Esq. (Argued)

Fontanella and Benevento

246 Union Boulevard

Totowa, NJ 07512

Counsel for Appellants,

Warren Armstrong and Emily

Armstrong

Jay S. MacNeill, Esq. (Argued)

Post, Polak, Goodsell &

MacNeill, P.A.

75 Livingston Avenue

280 Corporate Center

Roseland, NJ 07068

Counsel for Appellee

William Dwyer, M.D.

James J. Madden, Esq. (Argued)

Madden, Madden & Del Duca

108 Kings Highway East

P.O. Box 210, Suite 200

Haddonfield, NJ 08033

Counsel for Intervenor-Appellee

Peer Review Organization of

New Jersey, Inc. (PRO NJ)

OPINION OF THE COURT

COWEN, Circuit Judge.

Plaintiff-appellant Warren Armstrong appeals from the

district court's final judgment entered upon the jury's

determination that defendant-appellee, William Dwyer,

M.D., was not negligent in providing medical services to

plaintiff in the course of three surgical operations and did

not breach his duty of informed consent. He also appeals

from the district court's orders denying his motion for a

new trial and affirming the magistrate judge's order denying

his motion to compel Dr. Dwyer to produce all peer review

documents pertaining to his treatment of plaintiff. Plaintiff-

appellant Emily Armstrong, Armstrong's wife, appeals from

2

the district court's final judgment entered against her on

her derivative claim for loss of consortium.1 We will affirm

the district court in all respects.

I.

A. Background Facts

On June 20, 1991, plaintiff met with Dr. Eileen Clifford,

an internist in practice with plaintiff's then-treating

physician, Dr. Richard Oliver.2 Plaintiff complained of

recurring abdominal pain, increasing fatigue, and

cramping. He also complained of nausea and a decreased

appetite. Dr. Clifford's preliminary assessment was that

plaintiff had diverticulitis, a disease in which portions of

the colon become inflamed. She prescribed a ten-day

course of antibiotics and ordered a barium x-ray of

plaintiff 's colon. After several days of antibiotic treatment,

however, Dr. Oliver referred plaintiff to Dr. Dwyer for a

surgical opinion because the radiologist's report suggested

the possibility of an abscess in plaintiff's colon.

Plaintiff met with Dr. Dwyer on July 9 and 12, 1991. Dr.

Dwyer reviewed plaintiff 's x-ray and determined that

plaintiff had marked diverticulitis in several areas in the

upper portion of the sigmoid colon and a possible

intramural abscess. Based upon this determination, as well

as plaintiff 's medical history and the nature of his

complaints, Dr. Dwyer recommended that plaintiff undergo

surgery. Dr. Dwyer explained to plaintiff that he would

remove the infected section of bowel and rejoin the two

healthy bowel ends, a procedure known as an anastomosis.

Dr. Dwyer performed the surgery on July 16, 1991.

Initially, plaintiff 's condition appeared to improve, and he

was discharged from the hospital on July 27, 1991. Three

days later, however, Dwyer readmitted plaintiff after

_________________________________________________________________

1. For the sake of clarity, the court's reference to "plaintiff" herein

includes only Mr. Armstrong unless otherwise indicated.

2. All evidence and inferences therefrom are taken in the light most

favorable to defendant, the verdict winner. See Doe v. Southeastern

Pennsylvania Transp. Auth., 72 F.3d 1133, 1135 (3d Cir. 1995) (citation

omitted).

3

plaintiff complained to him about fever and pain. Dr. Dwyer

diagnosed plaintiff with peritonitis, an infection in the

abdominal cavity, which resulted from a leak in the

anastomosis.

Dr. Dwyer performed a second operation on plaintiff on

July 31, 1991. Because he found extensive infection and

dead tissue in plaintiff 's abdomen during the surgery, he

performed a reversible colostomy with an opening or stoma

under plaintiff 's left rib cage. Dr. Dwyer left the incision

and wound open to heal "by secondary intention" or

without horizontal sutures. App. at 114-15. Plaintiff was

hospitalized for more than one month.

Plaintiff met several times with Dr. Dwyer during the next

few months. Once again, plaintiff 's overall condition

appeared to improve, and his colostomy seemed to be

functioning well. By November 12, 1991, however, Dr.

Dwyer concluded that the stoma was constricting and

additional surgery would be necessary.

Dr. Dwyer performed the revisionary procedure on

December 2, 1991 on an outpatient basis. On the following

day, plaintiff began treatment with Dr. John McConnell, a

rectal and colon specialist. Plaintiff never returned to the

care of Dr. Dwyer after his revisionary surgery, and he has

not undergone any further surgery.

B. Procedural History

Plaintiff filed the instant action on July 14, 1993,

asserting medical malpractice and informed consent claims

against Dr. Dwyer.3 Plaintiff alleged that Dr. Dwyer

provided improper medical care in connection with his

hospitalization, surgeries, and surgery after-care.4 As a

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3. Prior to trial, plaintiff settled his claims against all defendants

except

Dr. Dwyer.

4. Specifically, plaintiff alleges that Dr. Dwyer deviated from accepted

standards of medical care in the following eleven situations: (1) by

failing

to conduct an antibiotic trial prior to his first surgery; (2) by failing

to

administer perioperative antibiotic and mechanical bowel preparation

prior to the first surgery; (3) in the performance of the first surgery;

(4)

in the post-operative care given to plaintiff during his initial

4

result of this alleged negligence, plaintiff claimed that he

suffered serious physical and psychological injuries and

was left with an undesired, irreversible, and poorly

functioning colostomy. He also claimed that Dr. Dwyer

failed to secure plaintiff's informed consent for the first and

second surgical procedures and that he suffered damages

as a result of this breach. Plaintiff's wife, Emily Armstrong,

filed a loss of consortium claim for losses she allegedly

incurred as a result of her husband's alleged injuries.

On October 6, 1994, plaintiff moved for an order

"[c]ompelling the defendant William C. Dwyer to produce all

documentation that he has received and all responses given

to the Peer Review Organization, relating to his treatment of

the plaintiff, Warren Armstrong."5 App. at 122-23.

Defendant opposed this motion on the grounds that

disclosure of this information was prohibited under the

Peer Review Improvement Act of 1982 (the Act), Pub. L. No.

97-248, S 143, 96 Stat. 381 (1982) (codified as amended at

42 U.S.C. SS 1320c to 1320c-22 (1994)), and the so-called

self-critical analysis privilege. By consent order dated

December 2, 1994, the magistrate judge ordered that Peer

Review Organization of New Jersey (PRO NJ) be permitted

to intervene in this matter for the limited purpose of

submitting a brief in response to plaintiff 's motion to

compel.

On January 26, 1995, the magistrate judge filed an

opinion and order denying plaintiff's motion to compel the

_________________________________________________________________

hospitalization; (5) by prematurely discharging plaintiff from the

hospital

after the first surgery; (6) by providing inadequate quality of care to

plaintiff during the period in between his discharge from the first

hospitalization and his admission to the second hospitalization; (7) by

failing to perform surgery on plaintiff as soon as reasonably possible

upon plaintiff's readmission; (8) in the performance of the second

operation; (9) in the performance of the third operation; (10) in the

location of the plaintiff's stoma; and (11) in the formation of

plaintiff's

stoma.

5. Plaintiff became aware that Dr. Dwyer was the subject of a PRO

inquiry after Dwyer's colleague, Dr. Richard Oliver, produced in response

to plaintiff's subpoena two PRO documents identifying Dr. Dwyer and

plaintiff.

5

production of peer review documents pertaining to Dr.

Dwyer. The magistrate judge held that the documents

requested were "absolutely immune from discovery" under

the Act because "the responses to PRO inquiries, as well as

the inquiries themselves[ ] were generated and created by

the PRO . . . ." Magistrate Op. at 9. The magistrate further

held that "the documents inadvertently produced by Dr.

Oliver are also entitled to the statutory protection against

disclosure."6 Id. Because the magistrate denied plaintiff's

motion based on the Act, the judge did not consider

whether the self-critical analysis privilege would prohibit

disclosure of these documents. The district court

subsequently entered an order affirming the magistrate

judge's order in all respects.

Plaintiff's claims were tried before the district court and

a jury between February 19, 1997 and March 19, 1997.

The jury returned a verdict in favor of Dr. Dwyer on all of

his claims. The jury concluded that plaintiff failed to

demonstrate that Dr. Dwyer breached his duty of informed

consent or that he acted negligently in providing medical

care to the plaintiff. The district court entered judgment on

the jury's verdict on May 22, 1997.

Plaintiff filed a motion for a new trial. Plaintiff argued,

inter alia, that the district court abused its discretion: (1) by

denying the jury's request during deliberations for

transcripts of depositions; and (2) by submitting to the jury

interrogatories that did not require it to make separate

determinations regarding each alleged act of medical

negligence and each alleged failure by defendant to obtain

plaintiff's informed consent prior to performing surgery

upon him. The district court denied plaintiff 's motion. This

appeal followed.

II.

The district court exercised jurisdiction pursuant to 28

_________________________________________________________________

6. Although the magistrate judge ordered that plaintiff return to Dr.

Oliver the two documents that were produced at Dr. Oliver's deposition,

and the district court affirmed this aspect of the magistrate's order,

plaintiff has not raised this claim on appeal.

6

U.S.C. S 1332. This court has appellate jurisdiction of the

district court's final judgment pursuant to 28 U.S.C.

S 1291.

Our standard of review over the district court's decision

not to provide transcripts of depositions to the jury during

deliberations is under an abuse of discretion standard. See

United States v. Bertoli, 40 F.3d 1384, 1400 (3d Cir. 1994).

Likewise, we review the court's formulation of jury

interrogatories for abuse of discretion. In re Merritt Logan,

Inc., 901 F.2d 349, 367 (3d Cir. 1990). Finally, while we

generally review the denial of a motion to compel under the

abuse of discretion standard, see Berger v. Edgewater Steel

Co., 911 F.2d 911, 916 (3d Cir. 1990) (citations omitted),

our standard of review is plenary where the decision is

based upon the interpretation of a legal precept. Cf.

McAlister v. Sentry Ins. Co., 958 F.2d 550, 552-53 (3d Cir.

1992).

III.

A. Jury's Request for Deposition Transcripts

During the jury's deliberations, the jury sent out the

following question to the court: "We need a clarification on

this issue: Are we entitled to review any or all of the

depositions that are in evidence inside the jury room?" App.

at 346. After consulting with counsel, the district judge

determined that the jury sought transcripts of depositions,

rather than transcripts of the deposition testimony read

during trial or a readback of such testimony. Consequently,

the district judge told the jury that he would not send the

depositions into the jury room because they were not

admitted into evidence. The court further instructed the

jury that they should rely upon their collective recollection

of the depositions that were read into evidence during trial

and they should send out another question if the court did

not satisfactorily answer their question. No further

questions were submitted.

Plaintiff contends that the district court abused its

discretion "[b]y refusing the jury's request to review

transcripts of deposition testimony entered in evidence, or

alternatively, to permit readback of such testimony . . . ."

7

Plaintiff's Br. at 29 (citing United States v. Bertoli, 40 F.3d

1384 (3d Cir. 1994)). Plaintiff argues that, while such a

decision is committed to the sound discretion of the district

court, a court's discretion is nevertheless circumscribed by

two factors: "whether `(1) such requests may slow the trial

where the requested testimony is lengthy; (2) [and] when

read only a portion of testimony, the jury may give undue

weight to that portion.' " Id. (quoting Bertoli, 40 F.3d at

1400). According to plaintiff, the district court abused its

discretion because its ruling was not bottomed on either of

these concerns.

Plaintiff's argument merits little discussion. As the

district court correctly observed, the jury did not ask for

written transcripts of testimony or a readback of such

testimony. Instead, the jury requested transcripts of the

actual depositions. Because the deposition transcripts were

never admitted into evidence, however, we cannot conclude

that the district court abused its discretion by refusing the

jury's request.

B. Jury Interrogatories

Plaintiff next claims that the district court abused its

discretion by refusing to accept his proposed jury

interrogatories, which would have required the jury to make

findings with respect to each of the eleven alleged incidents

of medical malpractice and both of the alleged incidents

regarding informed consent. The district court rejected this

proposal in favor of the following interrogatories:

Question 1. Warren Armstrong's Negligence/Medical

Malpractice Claim

A. Did plaintiff prove by a preponderance of t he

evidence that the defendant Dr. William Dwyer was

negligent in providing medical services to the plaintiff?

B. Did plaintiff prove by a preponderance of t he

evidence that the defendant's negligence was a

proximate cause of some injury and consequent

damage sustained by the plaintiff?

Question 2. Walter Armstrong's Informed Consent

Claim

8

A. Did plaintiff prove by a preponderance of the

evidence that the defendant failed to comply with his

disclosure duty?

B. Did plaintiff prove by a preponderance of t he

evidence that the defendant's failure to comply with his

disclosure duty was a proximate cause of plaintiff's

injuries?

App. at 270-71.

In rejecting plaintiff's proposed malpractice

interrogatories, the court stated:

I understand your point, but you're making the jury's

job interminably difficult. Obviously the jury sat here

for many days, they listened for example to not only

your cross-examination of the witnesses produced by

defendant, but Dr. McConnell and they heard his

testimony in which he opined in which way he thought

Dr. Dwyer had been negligent.

I don't recall whether it was one, five, seven or ten.

The point is they heard it. In there--in evaluating their

case, your case, they will be in a position to determine

whether it's one, three, four, five or ten instances in

which the plaintiff proved, by the requisite standard of

proof, that Dr. Dwyer was negligent.

It seems to me that my charge, and in my considered

judgment, adequately gives them an opportunity to

consider all of these charges and make a

determination, whether individually or in the aggregate,

you demonstrated Dr. Dwyer was negligent and that

his negligence was a proximate cause of Mr.

Armstrong's injuries.

So while I understand what you would like to do, it

presents problems which, to coin a phrase, is of Mt.

Everest proportions in my judgment and I'm not going

to do that.

App. at 278-79. The court employed similar reasoning when

rejecting plaintiff's proposed informed consent

interrogatories.

9

Plaintiff contends that the district court abused its

discretion by "merg[ing] the numerous factual issues in the

case into two vague and broad special interrogatories."

Plaintiff 's Br. at 33. Specifically, plaintiff asserts that

the interrogatories put to the jury did not fairly present

the material factual questions. Nothing in Question 1A

apprised the jury that it was expected to consider

eleven separate deviations in the standard of care

alleged to have been committed by Dwyer and testified

to by plaintiff's expert weeks earlier. In the same way,

Question 2A did not indicate that the informed consent

inquiry applied to two separate procedures.

Plaintiff's Br. at 34-35. Once again, plaintiff's argument

must fail.

As noted above, the formulation of jury interrogatories is

entrusted to the discretion of the trial judge. See In re

Merritt Logan, Inc., 901 F.2d at 367; McNally v. Nationwide

Ins. Co., 815 F.2d 254 (3d Cir. 1987). " `The only limitation

[on this discretion] is that the questions asked of the jury

be adequate to determine the factual issues essential to the

judgment.' " McNally, 815 F.2d at 266 (quoting Kornicki v.

Calmar S.S. Co., 460 F.2d 1134, 1139 (3d Cir. 1972)). In

the present matter, the interrogatories submitted to the

jury clearly satisfy this standard. By asking whether

plaintiff adduced sufficient proof that defendant acted

negligently in providing medical care to plaintiff and

whether defendant breached his duty of informed consent,

as well as whether such negligence or breach proximately

caused some injury to plaintiff, the court properly asked

the jury to determine the factual issues essential to the

judgment. The district judge was not obliged to distill these

issues with any greater clarity.

C. Peer Review Improvement Act of 1982

Finally, plaintiff argues that the district court erred in

two respects by affirming the magistrate judge's order

denying plaintiff's motion to compel defendant to produce

all documents received by defendant from the PRO

concerning his treatment of the plaintiff and his responses

thereto. First, plaintiff contends that, while the Act "excepts

from discovery documents `produced by' a PRO `in

10

connection with its deliberations[,]' " Plaintiff's Br. at 42

(quoting 42 U.S.C. S 1320c-9(d)), the documents at issue

here do not fall within this limited category because they

consist of "discovery from a target physician of inquiries

and notices transmitted to him by the PRO and

communications sent by the target physician to the PRO in

response." Id. Second, plaintiff contends that the

redisclosure regulation, 42 C.F.R. S 476.107(g), requires

defendant to produce these documents because the PRO

"voluntarily shared allegedly `confidential' documents with

Dwyer . . . ." Plaintiff's Br. at 49. We will address each

argument in turn.

1. Discovery Barred Under The Act

a. Origin and Function of the PRO and PRO NJ

Congress enacted the Medicare program in 1965 to

establish a federally funded system of health insurance

benefits for the aged and disabled. See Social Security

Amendments of 1965, Pub. L. No. 89-97, 79 Stat. 286

(codified as amended at 42 U.S.C. SS 1395 to 1395ccc

(1994)). In 1982, Congress amended the Medicare statute

by enacting the Peer Review Improvement Act of 1982, Pub.

L. No. 97-248, S 143, 96 Stat. 381 (1982), which

established "a new method of reviewing the quality and

appropriateness of the health care provided . . . to Medicare

beneficiaries." American Hosp. Ass'n v. Bowen, 834 F.2d

1037, 1041 (D.C. Cir. 1987). The Act requires that the

Department of Health and Human Services (HHS) enter into

contracts with "peer review organization," or PROs, private

organizations of doctors that review, inter alia, whether

medical services "were reasonable and medically necessary"

and whether "the quality of such services meets

professionally recognized standards of health care .. . ." 42

U.S.C. S 1320c-3(a)(1)(A), (B). "In essence, the Act functions

as a quality and fiscal check upon the medical services of

physicians and institutions which provide health care

services under the Medicare and Medicaid programs." Todd

v. South Jersey Hosp. Sys., 152 F.R.D. 676, 685 (D.N.J.

1993).

PRO NJ is a PRO incorporated in the State of New Jersey.

PRO NJ was successful in obtaining the first contract with

11

the Health Care Financing Administration (HCFA) of the

HHS and has maintained a contract for Medicare Peer

Review in the State of New Jersey since 1984 on a

continuous basis. Prior to 1984, the predecessor to PRO

NJ, The Southern New Jersey Professional Standards

Review Organization, and Area VII Physician's Review

Organization, Inc., maintained Medicare peer review

contracts with HHS.

b. PRO NJ's Quality Review and Sanction Process

PRO NJ has adopted the following procedures to

determine whether a quality issue exists with respect to the

care of a Medicare beneficiary. At the outset, a nurse

employed by the PRO screens a medical record to determine

whether a potential or possible quality question might exist.

If the nurse determines that such a question exists, the

case is referred to a physician-reviewer of the PRO, who

then reviews the matter and determines whether there is, in

fact, a potential quality issue.

If the physician-reviewer determines that there is a

potential quality issue, the PRO prepares a quality inquiry

and issues it to the physician in question. The PRO also

requests a response from the physician. The physician

generally responds in writing to the quality inquiry by

submitting to the PRO a response on the same notice form.

Following receipt of the response form from the physician in

question, the matter is once again reviewed by the

physician-reviewer, who then determines whether there is a

confirmed quality problem. If there is no quality problem,

an acceptance notice is issued and no further action is

taken. However, if there is a confirmed quality problem, the

PRO may request further action on the part of a physician.

Such action may include a referral to the Sanction

Committee of the PRO, a standing committee of the PRO,

for additional review and a determination as to whether or

not a preliminary determination should be made that a

sanctionable offense has occurred.7

_________________________________________________________________

7. There are generally two types of sanctionable offenses: a "gross and

flagrant violation" and a "substantial violation in a substantial number

of cases." The former offense means that "a violation of an obligation has

12

In the event that the Sanction Committee makes a

preliminary determination that a sanctionable offense

occurred, a notice is issued to the physician in question,

along with an invitation to meet with the PRO of the New

Jersey Sanction Committee (in the case of a gross and

flagrant violation) or to respond in writing (in the case of a

substantial violation). If a meeting is held with the Sanction

Committee, a court reporter is in attendance. Also in

attendance is the physician in question, the physician's

attorney (if desired), the physician's expert witnesses (if

any), and members of the Sanction Committee together

with supporting staff.

Following the sanction meeting, the Sanction Committee

deliberates and reaches a determination as to whether or

not the previous preliminary determination should be

affirmed, modified, or reversed. In the event that the

preliminary determination is affirmed, the physician is

given an opportunity to enter into a corrective action plan,

assuming that the physician is willing and able to meet his

statutory obligations and the matter before the committee

is not considered egregious in nature. Communications

between the PRO and the physician then follow, at which

time the parties will generally agree upon an approved

educational plan which is then implemented by the

physician.

In cases considered egregious, or in cases where there is

an established pattern of care, the PRO may refer the

matter to the New Jersey Office of Inspector General. In

that case, a sanction report is prepared and issued to the

Office of Inspector General, which contains all of the

information upon which the Sanction Committee relied in

reaching its determination. A copy of the sanction report is

provided to the physician in question, who has a right to

_________________________________________________________________

occurred in one or more instances which presents an imminent danger

to health, safety, or well-being of a program patient or places the

program patient unnecessarily in high-risk situations." 42 C.F.R.

S 1004.1. The latter means "a pattern of providing care . . . that is

inappropriate, unnecessary, or does not meet recognized professional

standards of care, or is not supported by the necessary documentation

of care as required by the PRO." Id.

13

respond to the Office of Inspector General within thirty

days of receipt.

At the conclusion of a quality inquiry with PRO NJ, the

physician in question will generally have substantial

documentation in his or her file. This documentation may

include: (1) the initial quality assurance inquiry; (2) the

physician's response; (3) additional correspondence

regarding the quality issue; (4) a sanction notice, which

includes a quality assurance review sheet, a medical

director's committee review sheet, and other information

upon which the PRO bases its preliminary determination

regarding a sanctionable offense; (5) the physician's written

response to the sanction notice; (6) various correspondence

related to the sanction process; (7) a determination by the

Sanction Committee; (8) correspondence regarding the

corrective action plan; and (9) a certification of completion

of the corrective action plan.

c. Confidentiality of PRO Information

The Act reflects a strong policy of confidentiality with

respect to a PRO's quality review and sanction process. The

Act requires a PRO to hold all data and information that it

acquires in confidence and, subject to only limited

exceptions, prohibits a PRO from disclosing such

information. See 42 U.S.C. S 1320c-9(a). Congress has even

exempted PROs from the requirements of the Freedom of

Information Act. See id. In addition, any person who

discloses information in violation of the Act's confidentiality

provisions is subject to criminal penalties including a fine

and imprisonment of not more than six months. See 42

U.S.C. S 1320c-9(c). Finally, to further protect the

confidentiality of PRO-related materials, the Act immunizes

many documents from subpoena and discovery

proceedings:

No patient record in the possession of an organization

having a contract with the Secretary under this part

shall be subject to subpoena or discovery proceeding in

a civil action. No document or other information

produced by such an organization in connection with

its deliberations in making determinations under

14

section 1320c-3(a)(1)(B) or 1320c-5(a)(2) of this title

shall be subject to subpoena or discovery in any

administrative or civil proceeding; except that such an

organization shall provide, upon request of a

practitioner or other person adversely affected by such

a determination, a summary of the organization's

findings and conclusions in making the determination.

42 U.S.C. S 1320c-9(d).

Regulations promulgated pursuant to the Act further

buttress these confidentiality provisions. The regulations

broadly define confidential information as "(1) [i]nformation

that explicitly or implicitly identifies an individual patient,

practitioner or reviewer[;] (2) [s]anction reports and

recommendations[;] (3) [q]uality review studies which

identify patients, practitioners or institutions[;] (4) PRO

deliberations." 42 C.F.R. S 476.101(b). Furthermore, "PRO

information" includes any information "collected, acquired

or generated by a PRO in the exercise of its duties and

functions . . . ." Id.

The regulations impose specific requirements to ensure

the confidentiality of PRO information. For example, a PRO

must provide physical security measures to protect PRO

information, including measures necessary to secure

computer files. See 42 C.F.R. S 476.115(a). The PRO must

furnish confidentiality training and instructions to

participants in PRO activities, and must designate an

individual responsible for maintaining the system of

assuring confidentiality. See 42 C.F.R. S 476.115(a) (c).

Only persons who have completed a training program and

signed a statement indicating that they understand the

penalties for unauthorized disclosure are permitted access

to confidential information. See 42 C.F.R. S 476.115(d). In

addition, the regulations require a PRO to purge files of

personal identifiers as soon as such identifiers are no

longer necessary, to destroy hard copies of documents that

are no longer needed, and to assure that other

organizations providing data services to the PRO have

established procedures to maintain confidentiality. See 42

C.F.R. S 476.115(e).

Even where the disclosure of information by a PRO is

authorized, the regulations establish procedures to protect

15

confidentiality. A disclosure requires an accompanying

notice and statement advising the recipient of the

limitations on permissible redisclosure. See 42 C.F.R.

S 476.104. With certain enumerated exceptions, the

regulations prohibit any person who obtains confidential

PRO information from redisclosing it. See 42 C.F.R.

S 476.107.

These extensive provisions reflect a clear congressional

policy of protecting the confidentiality of information related

to PRO proceedings. This policy is consistent with"the

underlying purpose of the federal and state peer review

statutes, which is to encourage doctors to evaluate their

peers honestly, without fear that the proceedings might

later be used in a lawsuit." Todd, 152 F.R.D. at 686 (citing

Morse v. Gerity, 520 F. Supp. 470, 471 (D. Conn. 1981)).

An assurance of confidentiality is essential to facilitate the

open communication necessary for a PRO to perform its

duties. The Executive Vice President and Chief Executive

Officer of the PRO NJ submitted an affidavit stating that

without confidentiality, the organization "would have great

difficulty functioning and great difficulty obtaining

information now volunteered from physicians to whom

quality inquiries are advanced." App. at 167. See also

General Care Corp. v. Mid-South Foundation for Medical

Care, Inc., 778 F. Supp. 405, 417 n.10 (W.D. Tenn. 1991).

As the preceding discussion demonstrates, Congress has

clearly created a statutory scheme that is highly protective

of information related to PRO proceedings.

d. Analysis

As noted above, plaintiff contends that this section does

not bar discovery of the documents at issue because these

documents were not " `produced by' a PRO `in connection

with its deliberations.' " Plaintiff 's Br. at 42 (quoting 42

U.S.C. S 1320c-9(d)). Specifically, plaintiff argues that: (1)

correspondence from the PRO cannot be said to be "in

connection with [PRO] deliberations" because these

documents "do not include minutes and deliberations

whose protection from discovery is the heart of critical self-

analysis[,]" id. at 43; and (2) documents written by a

"target" physician cannot be considered "generated" by the

16

PRO. Id. at 46. We conclude that plaintiff's reading of the

phrase "produced by [the PRO] in connection with its

deliberations" is far too narrow.

"In passing the 1982 amendments, Congress painted

with a broad brush, leaving HHS to fill in many important

details of the workings of peer review." Bowen, 834 F.2d at

1043; see id. at 1043 (observing that Congress provided

"skeletal requirements . . . and left much of the specifics

. . . to the inventiveness of the HHS, empowering it to

promulgate regulations governing PROs in order to

implement the peer review program." (citation omitted)).

Two relevant details that HHS filled in are the definitions of

"PRO deliberations" and "PRO information." The Secretary

defines "PRO deliberations" as

discussions or communications (within a PRO or

between a PRO and a PRO subcontractor) including,

but not limited to, review notes, minutes of meetings

and any other records of discussions and judgments

involving review matters regarding PRO review

responsibilities and appeals from PRO determinations,

in which the opinions of, or judgments about, a

particular individual or institution can be discerned.

42 C.F.R. S 476.101(b). "PRO information" is defined as

"any data or information collected, acquired or generated by

a PRO in the exercise of its duties and functions . . . ." Id.

When PRO NJ's quality review and sanction process is

viewed in light of these broad definitions, it is clear the

quality review inquiry sent by the PRO to Dwyer were

generated by the PRO in connection with its deliberations.

The physician-reviewer sent this inquiry to Dwyer after

determining that there was, in fact, a potential quality issue

regarding Dwyer's treatment of plaintiff. Moreover, the

physician-reviewer asked Dwyer to respond to the inquiry.

Once Dwyer responded to the inquiry, the physician-

reviewer had to consider whether to end the inquiry and

send an acceptance notice to Dwyer or to refer the matter

to the Sanction Committee of the PRO. Regardless of which

course was ultimately taken in this particular case, the

physician-reviewer had to render a judgement on the

quality of care Dwyer provided to plaintiff. He thus engaged

17

in the deliberative process within the meaning of the Act,

and the inquiry sent to Dwyer was certainly "in connection

with" such deliberations.

Moreover, while the status of Dr. Dwyer's responses to

the PRO inquiry presents a closer question, we conclude

that this information was also generated by the PRO in

connection with its deliberations. The physician-reviewer

specifically requested that Dwyer assist the PRO by

responding to its quality review inquiry. See 42 C.F.R.

S 476.101(b) (" `PRO review system' means the PRO and

those organizations and individuals who . . . assist the

PRO[, and includes] . . . Health care institutions and

practitioners whose services are reviewed."). Moreover,

Dwyer's responses were generated solely as a result of, and

during the course of, the PRO's quality review. As the

district court aptly noted,

Documents utilized by the PRO in the course of its

quality inquiry--medical records for example--are

discoverable for [sic] any source other than the PRO

that might have them. However, documents generated

or created by the PRO are not discoverable from any

source. Thus, the documents generated by the PRO are

absolutely privileged but documents which are

generated for another purpose, but which the PRO

review in the course of investigating the doctor are not.

Dist. Ct. Op. at 6-7 (citing Todd, 152 F.R.D. at 687, 698).

Thus, the PRO generated these responses, which were

inextricably linked to the PRO review process and allowed

the PRO to perform its responsibilities under the Act.

Consequently, Dwyer's responses to the PRO inquiry are

not subject to subpoena or discovery.

In addition, the fact that plaintiffs sought to compel these

documents from Dwyer, rather than the PRO, does not alter

this outcome. Congress provided that the documents or

information generated by the PRO in the course of its

statutory duties is not subject to subpoena or discovery.

See 42 U.S.C. S 1320c-9(d). The bar against discovery runs

with the documents or information, not with the

organization or individuals who happen to possess the

documents or information at any given time. But see Todd,

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152 F.R.D. at 686 ("This court finds, therefore, that the

Peer Review Protect [sic] Act bars production of documents

solely as they exist in the possession of the Peer Review

Organization."). Indeed, to hold otherwise would necessarily

render the statute's mandate of confidentiality a nullity

because a subject physician will have most, if not all, of the

materials related to the inquiry within his possession.

Thus, the absolute prohibition against discovery of these

materials is not destroyed simply because the materials, or

copies of the materials, are in the hands of the physician

who is the subject of the PRO quality review inquiry and

part of the PRO review system. Accordingly, plaintiff's

argument must fail.8

2. Redisclosure Not Authorized Under 42 C.F.R.

S 476.107(g)

Plaintiff argues in the alternative that, even assuming the

documents or information at issue are not subject to

subpoena or discovery pursuant to 42 U.S.C. S 1320c-9(d),

the regulations governing redisclosure of confidential PRO

information require the production of the documents at

issue. Specifically, plaintiff argues that

42 C.F.R. S 476.107(g) provides that redisclosure of

PRO documents from a practitioner is permissible once

the PRO has, as in this case, revealed its documents to

him. This outcome is dictated by the extinction of any

rationale for the continuation of alleged confidentiality

once divulgence has occurred and by equity and

fairness. This outcome is further dictated in this case

by the absence of any reasoned basis for granting

derivative immunity to physician-authored documents

merely on account of their transmittal to the PRO. The

district court's recognition of privilege under those

_________________________________________________________________

8. Although plaintiff suggests in his brief that he also sought production

of a corrective action plan from defendant, it is not clear from the

record

whether this claim was made below. However, in light of our conclusions

with respect to the PRO inquiry sent to Dwyer, and Dwyer's response

thereto, such a document (assuming it even exists) would

unquestionably be deemed a document generated by the PRO in

connection with its deliberations.

19

circumstances constituted reversible error which

requires rectification by the Court.

Plaintiff's Br. at 50. Once again, plaintiff's argument must

fail.

The redisclosure regulation provides in pertinent part

that "[p]ersons or organizations that obtain confidential

PRO information must not further disclose the information

to any other person or organization except . . . (g)

[i]nformation pertaining to a patient or practitioner may be

disclosed by that individual provided it does not identify

any other patient or practitioner . . . ." 42 C.F.R.

S 476.107(g) (emphasis added). In the present matter, Dr.

Dwyer has never authorized disclosure of the documents.

Moreover, disclosure of the PRO documents to defendant

and his counsel did not effectuate a "waiver" of the bar

against discovery of these materials. This is not a common

law privilege to which the traditional concept of waiver

applies. Congress deemed that documents or information

produced by the PRO in connection with a quality review

study shall not be subject to subpoena or discovery.

Nothing within this statute supports plaintiff 's contention

that this discovery bar may be waived.9

IV.

We will affirm the March 22, 1997 judgment of the

district court in all respects.

A True Copy:

Teste:

Clerk of the United States Court of Appeals

for the Third Circuit

_________________________________________________________________

9. In light of the foregoing conclusions, we also conclude that the

district

court properly denied plaintiff's motion for a new trial. See Bertoli, 40

F.3d at 1392 (denial of a motion for a new trial is reviewed for abuse of

discretion).

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