Armstrong v. Dwyer , 155 F.3d 211 ( 1998 )

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Precedential or Non-Precedential: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
"Armstrong v. Dwyer" (1998). 1998 Decisions. Paper 209.
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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
_________________________________________________________________
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,
18
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).
20