United States Court of Appeals
FOR THE EIGHTH CIRCUIT
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No. 04-1553
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Sharon D. Lee, M.D., Kansas City *
Family Health Care, Inc., *
*
Appellants, *
*
v. * Appeal from the United States
* District Court for the
Trinity Lutheran Hospital, * Western District of Missouri.
Health Midwest, *
*
Appellees. *
*
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Submitted: January 14, 2005
Filed: May 24, 2005
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Before MURPHY, McMILLIAN and BYE, Circuit Judges.
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McMILLIAN, Circuit Judge.
Dr. Sharon D. Lee appeals from a final judgment entered in the District Court
for the Western District of Missouri1 granting summary judgment in favor of Trinity
Lutheran Hospital and its sole shareholder, Health Midwest (collectively the
hospital), on her federal and state claims. For reversal, Dr. Lee argues that the district
1
The Honorable Howard F. Sachs, United States District Judge for the Western
District of Missouri.
court erred in holding that the hospital was immune from her suit for money damages
under the Health Care Quality Improvement Act of 1986, 42 U.S.C.§§ 11101-52
(HCQIA).2 We affirm.
BACKGROUND
On May 27, 1994, Dr. Lee, a family practice physician on the hospital's staff,
prescribed two drugs to treat an HIV patient for pneumocystis carinii pneumonia
(PCP). A nurse was concerned about the combination of the two drugs and contacted
Dr. James Wooten, the supervisor of the hospital's pharmacy services. Dr. Wooten
researched the matter, but could find no information regarding usage of the drugs in
combination. He contacted the manufacturers of the drugs for more information. By
letters dated June 1 and June 2 of 1994, the drug manufacturers wrote to Dr. Wooten;
neither manufacturer could recommend using the drugs in combination. In the
meantime, Dr. Wooten talked to Dr. Lee, expressing his concern about the safety of
using the two drugs in combination, noting that if she proceeded to use the drugs in
combination she might expose the hospital to liability. Dr. Lee responded that she
would use the drugs in combination, even if it meant discharging the patient from the
hospital. Pursuant to hospital protocol, Dr. Wooten contacted the hospital's Pharmacy
and Therapeutic Committee. Dr. Beth Henry, a member of the committee, agreed that
using the two drugs in combination was inappropriate and advised peer review of the
matter.
On June 1, 1994, the Peer Review on Medicine Committee (Peer Review
Committee) met to discuss Dr. Lee's use of the drugs. Dr. Mollie O'Connor, chief of
the hospital's infectious diseases department, presented the matter, noting that the
patient's chart did not contain adequate documentation concerning the PCP diagnosis
2
Trinity Hospital closed in 2001, thus mooting Dr. Lee's claim for
reinstatement.
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and that the two drugs were not compatible and had highly toxic effects on a patient's
bone marrow. The Peer Review Committee voted unanimously to suspend use of the
drugs and to have Dr. Joan Akers, chair of the hospital's family practice section, talk
to Dr. Lee. On June 2, Dr. Akers and several others physicians talked to Dr. Lee. The
Peer Review Committee met again on July 6, 1994, and recommended that a sub-
committee talk to Dr. Lee and review her patient records prospectively. The
subcommittee, composed of Drs. Akers, Daniels and Sly, met with Dr. Lee to discuss
her interactions with physicians, practice patterns and appropriate use of medications.
Dr. Akers met again with Dr. Lee to set up a protocol for pharmacy review. On
October 5, 1994, the Peer Review Committee noted that the subcommittee had
reported that Dr. Lee had a consistent problem with drug usage, including
"unapproved uses of approved drugs or toxic combinations in HIV patients," and
approved prospective review of her charts and pharmacy review for six months.
In December 1994, Dr. Kathy Chase, director of the pharmacy, expressed
concern to Dr. Akers about Dr. Lee's care of another patient. Dr. Akers then asked
an infectious disease specialist and an oncologist to review the patient's chart. Both
doctors believed that Dr. Lee had not conducted an adequate work-up. On
December 7, 1994, the Peer Review Committee met and Dr. Akers discussed the
subcommittee's chart review, noting the review had indicated that Dr. Lee had used
drugs without adequate indications, had made probable diagnoses without
corroborating studies, and inadequately documented her thought processes. To avoid
a conflict of interest, the Peer Review Committee recommended that an outside
specialist review Dr. Lee's charts.
At a January 4, 1995, Peer Review Committee meeting, Dr. Lee read a letter
expressing her concerns with the peer review process, including that she had not been
invited to attend the meetings and that the committee had breached confidentiality.
On March 1, 1995, the Peer Review Committee met to discuss the chart of another
of Dr. Lee's patients and asked her to supply additional documentation pertaining to
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a diagnosis. On April 5, 1995, the Peer Review Committee met to review the charts
of two more of Dr. Lee's patients. As to one of the patients, the committee noted a
possible premature death, rated the chart a 4, which meant the "clinical practice was
unexpected and unacceptable," and sent Dr. Lee a letter of inquiry about the patient.
As to the chart of the other patient, the committee noted that Dr. Lee had already been
asked to supply documentation pertaining to diagnosis and completion of the patient's
history and physical, but had not done so. On May 3 and June 7, 1995, the Peer
Review Committee again discussed the charts, noting that Dr. Lee's responses to the
letters of inquiry did not address the concerns in the letters.
Pursuant to the Peer Review Committee's recommendation, in June 1995,
Dr. Akers asked Dr. Glen Hodges, a physician at the Veteran Administration Medical
Center in Kansas City, Missouri, and chairman of the medical center's AIDS task
force, to review the charts of five of Dr. Lee's patients. Dr. Hodges, who had eight
years experience at the medical center reviewing charts for documentation and
medical care purposes, concluded that in four of five of the cases Dr. Lee had not met
the standard of care. Dr. Hodges found numerous documentation deficiencies and
other problems in the cases. Dr. Hodges also questioned the standard of care in the
fifth case. At a July 26, 1995, Peer Review Committee meeting, Dr. Akers presented
Dr. Hodges's report. After the presentation, Dr. Lee joined the meeting and submitted
a letter in which she rebutted Dr. Hodges's report. She also expressed her belief that
she was the subject of a "witch hunt." Dr. Lee was excused from the meeting, and the
committee voted nine to two to suspend her clinical privileges pending her
completion of a personalized education program for physicians, which included a
psychiatric evaluation. By letter dated July 26, 1995, Dr. Akers advised Dr. Lee of
the committee's decision to suspend her privileges and that the action was being taken
because of her sub-standard treatment of the four patients whose charts Dr. Hodges
had reviewed and her sub-standard treatment of three other patients, noting that the
sub-standard care had placed the patients in potential imminent danger.
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At an August 2 meeting, the Peer Review Committee reviewed two more of
Dr. Lee's charts, rating them a 4. On August 3, 1995, the Executive Committee of the
Medical Staff (Executive Committee) met with Dr. Lee to discuss the decision of the
Peer Review Committee to suspend her privileges. Dr. Lee stated that she had
provided her patients with the highest standard of care, but admitted that record-
keeping was a problem. She asked that an ad hoc committee be appointed to review
the charts that resulted in her suspension. Dr. Lee was excused from the meeting and
after discussion of her comments, the committee voted to uphold the suspension
pending review by an ad hoc committee's evaluation of the seven cases cited in
Dr. Akers's letter. However, the Executive Committee rejected the Peer Review
Committee's requirement that Dr. Lee attend the physician education program.
By letter dated August 22, 1995, Dr. O'Connor wrote to Dr. Scott Thompson,
who was chairman of the Ad Hoc Committee, regarding Dr. Hodges's report.
Dr. O'Connor noted agreement with many of the report's concerns, including lack of
documentation supporting drug usage, but also noted her disagreement with several
specific items. By letter dated August 28, 1995, Dr. Thompson invited Dr. Lee to a
September 14 meeting of the committee to discuss patient care issues, which were set
forth on an enclosed document entitled "Clinical Issues." The document listed nine
categories of issues, including inappropriate use of medications, failure to follow
established protocols for drug use, treatment based on presumptive diagnosis,
inadequate or poor documentation, failure to address abnormal patient care data, and
failure to obtain appropriate consults. Under each category were sub-categories with
specific citations to the care of seventeen of Dr. Lee's patients. Dr. Lee attended the
September 14 meeting and discussed the clinical issues, but the specifics of each
patient were not discussed. On September 27, the Ad Hoc Committee sent a report
to the Executive Committee recommending that Dr. Lee's staff privileges be revoked,
noting that she did not meet the hospital's standard of care. The report further noted
that there was "no evidence of change in clinical practice from the first documented
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problem from a case in June 1994 as to the two most recent cases admitted in July
1995, despite numerous interventions."
On October 3, 1995, the Executive Committee unanimously adopted the Ad
Hoc Committee's recommendation. By letter dated October 4, 1995, Ronald Ommen,
chief executive officer and president of the hospital, notified Dr. Lee of the Executive
Committee's decision to revoke her privileges. Ommen stated that the decision was
based on the previously identified clinical issues and enclosed the document setting
forth the issues. Ommen advised Dr. Lee that pursuant to the hospital by-laws she
was entitled to a hearing to review the decision.
Pursuant to Dr. Lee's request, a Fair Hearing Committee, comprised of five
physicians who had no prior involvement with the peer review process, met on May
14 and June 28, 1996. Dr. Lee appeared and was represented by counsel, who
presented the testimony of Dr. Joseph Brewer, an infectious disease specialist.
Dr. Brewer, who reviewed the charts of the patients identified on the "Clinical Issues"
document, opined that in most of the cases Dr. Lee had met the standard of care of an
infectious disease doctor who treated HIV patients. However, Dr, Brewer noted he
had concerns that Dr. Lee had abruptly discontinued use of steroids for one patient
and apparently had failed to obtain a neurological consultation for another patient.
On July 18, 1996, the Fair Hearing Committee voted to reinstate Dr. Lee's privileges
conditioned on her attending the physician education program, receiving
psychological counseling and submitting medical records for review. By letter dated
July 22, 1996, the committee notified Dr. Lee of its decision, stating that the reasons
for the decision were her difficulty in cooperating with the hospital staff, inadequate
documentation of diagnosis, drug usage and patient care, underutilization of
consultations, and failure to meet the hospital standard of care. The letter noted that
if Dr. Lee refused to abide by the conditions, the committee would affirm the
Executive Committee's recommendation to revoke her staff privileges. On August
6, the Executive Committee voted to unconditionally revoke Dr. Lee's privileges,
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reasoning, among other things, that the suggested conditions would be difficult to
enforce and that the hospital could be exposed to liability for granting privileges to
Dr. Lee "when concerns of inappropriate care have been identified."
Pursuant to the hospital by-laws, Dr. Lee appealed the Executive Committee's
decision, and on September 18, 1996, appeared with counsel, before an Appellate
Review Committee. In response to an inquiry whether Dr. Lee would abide by the
conditions recommended by the Hearing Committee, Dr. Lee and her counsel stated
that two of the conditions concerned mental health, but asserted that there was no
evidence that Dr. Lee suffered from a mental health issue. Dr. Lee also complained
about several other of the conditions. The Appellate Review Committee unanimously
recommended to the board of directors that it unconditionally revoke Dr. Lee's
privileges. On September 23, 1996, the board accepted the recommendation and
notified Dr. Lee of its decision by letter dated September 24, 1996.
On October 11, 1996, pursuant to HCQIA regulations, 45 C.F.R. § 60.9(a), the
hospital submitted an adverse action report to the National Practitioner Data Bank,
reporting that Dr. Lee's clinical privileges had been revoked based on her
inappropriate use of medication, failure to follow accepted and established drug
protocols, providing treatment based on presumed diagnoses, inadequate or poor
documentation, failure to address abnormal patient care data, failure to obtain
appropriate consults, failure to work up mental status changes, failure to assume care
of hospitalized patients, and unprofessional behavior.
Dr. Lee and Greater Kansas City Family Health Care (GKC) filed suit in state
court against the hospital, alleging defamation and other state-law claims. After the
third amended complaint added a federal anti-trust claim, the hospital removed the
action to federal district court. Pursuant to the hospital's motion, the district court
dismissed GKC as a plaintiff. The district court also denied Dr. Lee's motion to
substitute another corporate plaintiff. On January 29, 2004, the district court granted
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the hospital's motion for summary judgment, holding that the hospital was immune
from suit for money damages under HCQIA.
DISCUSSION
The district court did not err in granting the hospital's motion for summary
judgment on the basis of HCQIA immunity. "Congress passed the [HCQIA] to
improve the quality of medical care by encouraging physicians to identify and
discipline physicians who are incompetent or who engage in unprofessional
behavior." Sugarbaker v. SSM Health Care, 190 F.3d 905, 911 (8th Cir. 1999)
(Sugarbaker) (internal quotations omitted). "Congress believed that effective peer
review would be furthered by granting limited immunity from suits for money
damages to participants in professional peer review actions.'' Id. (internal quotation
omitted). The HCQIA defines "professional review action" as:
an action or recommendation of a professional review body which is
taken or made in the conduct of professional review activity, which is
based on the competence or professional conduct of an individual
physician (which conduct affects or could affect adversely the health or
welfare of a patient or patients), and which affects (or may affect)
adversely the clinical privileges . . . of the physician.
42 U.S.C. § 11151(9).
In order to be immune from suits for money damages, a professional peer
review action must be taken:
(1) in the reasonable belief that the action was in furtherance of quality
health care,
(2) after a reasonable effort to obtain the facts of the matter,
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(3) after adequate notice and hearing procedures are afforded to the
physician involved or after such other procedures as are fair to the
physician under the circumstances, and
(4) in the reasonable belief that the action was warranted by the facts
known after such reasonable effort to obtain the facts and after meeting
the requirement of paragraph (3).
Id. § 11112(a).
In addition, "[a] professional review action shall be presumed to have met the
preceding standards . . . unless the presumption is rebutted by a preponderance of the
evidence." Id. "The statutory presumption included in section 11112(a) adds a rather
unconventional twist to the burden of proof in our summary judgment standard of
review, but the determination of whether a given factual dispute requires submission
to the jury must be guided by the substantive evidentiary standards that apply to the
case." Sugarbaker, 190 F.3d at 912 (internal quotation omitted). Thus, "we must ask,
Might a reasonable jury, viewing the facts in the best light for [Dr. Lee], conclude
that [s]he has shown, by a preponderance of the evidence, that [the hospital's] actions
are outside the scope of 1112(a)?" Id. (internal quotation omitted).
On de novo review, we conclude that Dr. Lee did not satisfy her "burden of
producing evidence that would allow a reasonable jury to conclude that [the
hospital's] peer review disciplinary process failed to meet the standards of HCQIA."
Id. (internal quotation omitted). In this case, in addition to being aided by the
statutory presumption, the hospital presented ample evidence that it met the statutory
criteria.
As to § 11112(a)(1) and (2), Dr. Lee argues that she rebutted the presumptions
that the hospital acted in a "reasonable belief that the action was in furtherance of
quality health care" and "after a reasonable effort to obtain the facts of the matter,"
because she presented evidence that the report of Dr. Hodges, the outside reviewer,
was "flawed." Dr. Lee notes Dr. Brewer's testimony at the hearing that in most cases
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she had met the standard of care of a specialist treating HIV patients and the
deposition testimony of Dr. Mark Jacobson, an HIV-specialist, who disagreed with
Dr. Hodges's conclusions. Dr. Lee also notes that Dr. O'Connor disagreed with some
of the specifics in Dr. Hodges's report, as stated in Dr. O'Connor's memo to the Ad
Hoc Committee. Dr. Lee's argument "miss[es] the mark." Sugarbaker, 190 F.3d at
913. Even if Dr. Lee could show that "the [peer review actions] reached an incorrect
conclusion . . . [that] does not meet the burden of contradicting the existence of a
reasonable belief that [the hospital] w[as] furthering health care quality." Id. at 916;
see also Mathews v. Lancaster Gen. Hosp., 87 F.3d 624, 636 n.9 (3rd Cir. 1996)
(conflicting medical opinions did not call in question whether the hospital's reliance
on report outside reviewer was reasonable).
Dr. Lee's argument concerning Dr. Hodges's report, which was based on his
review of the charts of five of Dr. Lee's patients, is also unavailing because in
suspending and revoking her privileges the hospital did not rely solely on the report,
as she suggests. Before the suspension, Dr. Wooten's concerns about her use of two
drugs in combination were confirmed by the drugs' manufacturers; the Peer Review
Committee had determined that Dr. Lee had problems with "unapproved uses of
approved drugs or toxic combinations [of drugs] in HIV patients;" an oncologist and
an infectious disease doctor believed that Dr. Lee had not conducted an adequate
work-up for a patient; and the Peer Review Committee noted documentation and
other problems in other patient charts. After the suspension, problems were noted in
the charts of at least ten other patients, as set forth on the "Clinical Issues" document.
Contrary to Dr. Lee's argument,"it is clear that concerns for health care quality
remained at the forefront throughout the peer review process." Sugarbaker, 190 F.3d
at 913. "The fact that some of the specific concerns shifted or changed over time
does not rebut the presumption" that the hospital acted in the reasonable belief that
it was furthering quality health care. Id. Nor does the fact that the Executive
Committee rejected the Hearing Committee's recommendation to conditionally
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reinstate Dr. Lee rebut the presumption that the hospital's decision to unconditionally
revoke her privileges was made in the reasonable belief that the decision was in
furtherance of quality health care. See id. at 913-14; see also Brader v. Allegheny
Gen. Hosp., 167 F.3d 832, 843 (3rd Cir. 1999) (Brader) (fact that "not every panel
reached the identical conclusions about the necessity of suspending [physician's]
privileges" did not "meet [his] burden of contradicting the existence of a reasonable
belief" the hospital was "furthering health care quality"). Objectively, it was
reasonable for the Executive Committee to conclude that Dr. Lee should not have
been allowed to continue to care for patients after numerous instances of sub-standard
care had been identified.
In order to satisfy her burden of proof as to § 1112(a)(1) and (2), Dr. Lee also
asserts that Dr. O'Connor, who first presented concerns about Dr. Lee's prescribing
drugs in an unapproved manner to the Peer Review Committee, started a "crusade"
against Dr. Lee because she was an economic competitor. The assertion is
insufficient to show that the hospital did not act in furtherance of quality health care
or after a reasonable effort to obtain the facts. Dr. Lee offers no evidence in support
of her assertion. In fact, the evidence is to the contrary. Dr. O'Connor wrote to the
Ad Hoc Committee to point out that, although she agreed with much of Dr. Hodges's
report, she disagreed with some of it. In any event, this court has stated that "[i]n the
HCQIA immunity contest, . . . the subjective bias or bad faith motives of the peer
reviewers is irrelevant." Sugarbaker, 190 F.3d at 914; see also Wayne v. Genesis
Med. Ctr., 140 F.3d 1145, 1149 (8th Cir. 1998) (physician's claim that two members
of peer review committee were in direct economic competition with her was
insufficient to rebut presumption that "peer review process was fair under the
circumstances"). Contrary to Dr. Lee's claim that the hospital "steam-rolled" the
process to "rubber-stamp" a "foregone conclusion," Appellant's Br. at 53-54, ample
evidence showed that the hospital made its decision after "a reasonable effort to
obtain the facts." Before Dr. Lee's privileges were revoked, the Peer Review
Committee and Ad Hoc Committee met numerous times, the Hearing Committee
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heard testimony for two days, and the Appellate Review Committee received
Dr. Lee's submissions, including letters in support, and heard argument.
We also reject Dr. Lee's argument that the hospital did not afford her "adequate
notice and hearing procedures," as required by § 11112(a)(3). There is no question
that before the hospital revoked her privileges, Dr. Lee had ample notice and an
opportunity to be heard. Indeed, in response to the Appellate Review Committee's
inquiry regarding procedural concerns, Dr. Lee's counsel stated: "With regard to the
Hearing itself, we have no challenge." Although Dr. Lee's counsel complained about
a lack of due process up to the hearing, her complaints are without merit. Dr. Lee had
notice of the Peer Review Committee's concerns and opportunities to present her
case. We also note that "'under the HCQIA's emergency provisions, summary
suspensions, 'subject to subsequent notice and hearing or other adequate procedures,'
do not result in the loss of immunity, 'where the failure to take such an action may
result in an imminent danger to the health of any individual.'" Sugarbaker, 190 F.3d
at 917 (quoting § 11112(c)(2)). Moreover, "[t]he [HCQIA] does not require
imminent danger to exist before a summary restraint is imposed. It only requires that
the danger may result if the restraint is not imposed." Id. (quoting Fobbs v. Holy
Cross Health Sys. Corp., 29 F.3d 1439, 1443 (9th Cir. 1994)).
Because "analysis under § 11112(a)(4) closely tracks . . . analysis under
§ 11112(a)(1)," id. at 916, as to this section, Dr. Lee reiterates arguments we have
already rejected. In addition, she invites this court to review excerpts of charts of
thirteen of her patients, asserting if we did so we would conclude that she "provided
quality medical care to critically ill and dying patients of whom she would not let go
without extraordinary, heroic effort." Appellant's Br. at 55. We cannot do so. "[T]he
role of federal courts on review of [peer review] actions is not to substitute our
judgment for that of the hospital's governing board or to reweigh the evidence
regarding the . . . termination of medical staff privileges." Bryan v. James E. Holmes
Regional Med Ctr., 33 F.3d 1318, 1337 (11th Cir. 1994) (internal quotation omitted).
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Indeed, "the intent of [the HCQIA] was not to disturb, but to reinforce, the preexisting
reluctance of courts to substitute their judgment on the merits for that of health care
professionals and of the governing bodies of hospitals in an area within their
expertise." Id. (internal quotation omitted).
Nor can we be influenced by Dr. Lee's assertion that in treating end-stage HIV
patients in 1994 and 1995 she employed cutting-edge treatments that later became the
standard of care. Even if true, in determining whether the hospital acted in a
reasonable belief that it was furthering quality health care, our focus is on whether
"the reviewers, with the information available to them at the time of professional
review action, would reasonably have concluded that their actions would restrict
incompetent behavior or would protect patients." Brader, 167 F.3d at 840 (quoting
H.R. Rep., No. 903, 99th Cong., 2d Sess. 10 (1986)) (emphasis added). In so doing,
and after consideration of Dr. Lee's other arguments concerning the statutory criteria,
we conclude that she failed to present sufficient evidence to show the hospital did not
act "in the reasonable belief that [its actions] w[ere] warranted by the facts known
after such reasonable effort to obtain the facts and after meeting the requirement of
[§ 11112(a)](3)." 42 U.S.C. § 11112(a)(4).
Because we hold that the district court did not err in granting the hospital
immunity under HCQIA on her claims seeking money damages, we do not address
Dr. Lee's argument that the district court abused its discretion in denying her motion
to amend her complaint to add a corporate plaintiff.
Accordingly, we affirm the judgment of the district court.
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