Leal v. SECRETARY, US DEPT. OF HHS

[PUBLISH]

IN THE UNITED STATES COURT OF APPEALS

FILED

FOR THE ELEVENTH CIRCUIT U.S. COURT OF APPEALS

________________________ ELEVENTH CIRCUIT

SEPT 22, 2010

No. 09-15727 JOHN LEY

_______________________ CLERK

D. C. Docket No. 08-01062-CV-ORL-22-GJK

JORGE J. LEAL,

Jorge J. Leal, M.D.,

Plaintiff-Appellant,

versus

SECRETARY, U.S. DEPARTMENT OF

HEALTH AND HUMAN SERVICES,

and his Successors,

UNITED STATES DEPARTMENT OF

HEALTH AND HUMAN SERVICES,

NATIONAL PRACTITIONER DATA BANK,

an Entity of and Run by the U.S.

Department of Health and Human

Services,

Defendants-Appellees.

________________________

Appeal from the United States District Court

for the Middle District of Florida

_________________________

(September 22, 2010)

Before EDMONDSON and CARNES, Circuit Judges, and GOLDBERG,* Judge.

CARNES, Circuit Judge:

One day Dr. Jorge J. Leal, a urological clinician and surgeon, was waiting

for the operating room at Cape Canaveral Hospital in Cocoa Beach, Florida to

become available. It was, as the doctor would later describe it, “a very long day.”

And not a good one for him. Instead, it appears that, like Alexander in the classic

children’s story, Dr. Leal was having “a terrible, horrible, no good, very bad day.”1

And at around 6:30 p.m., he was told that his use of the operating room was going

to be delayed (for 20 minutes as it turned out). Apparently, that was the final

straw for him.

What Dr. Leal did after he was told that he would have to wait to use the

operating room led the Hospital to suspend his clinical privileges for a period of

sixty days and to file a report explaining why. To summarize, in colloquial terms,

that report’s description of Dr. Leal’s conduct: he pitched a fit. More specifically,

the Hospital reported that Dr. Leal became so enraged that he broke a telephone, he

shattered the glass on a copy machine, he shoved a metal cart into the doors of the

operating suite so hard that it damaged one of them, he threw jelly beans down the

*

Honorable Richard W. Goldberg, Judge, United States Court of International Trade,

sitting by designation.

1

Judith Viorst, Alexander and the Terrible, Horrible, No Good, Very Bad Day (1972).

2

hallway in the surgical suite, he “flung a medical chart to the ground” when a nurse

asked him for written authorization to proceed with surgery, and he “verbally

abused a nurse manager” by raising his voice, using profanity, and calling her a

liar. According to the report, Dr. Leal’s “violent and unprofessional actions” on

that occasion “caused various members of the nursing and technical staff to

announce [that] they were fearful of working with him in the future.”

The Hospital filed its report of the adverse action taken against Dr. Leal with

the Secretary of the Department of Health & Human Services, as it felt compelled

to do under the Health Care Quality Improvement Act, 42 U.S.C. § 11101 et. seq.

The Secretary included the report in the National Practitioner Data Bank, which

was set up under the Act “to collect and release certain information relating to the

professional competence and conduct of physicians, dentists and other health care

practitioners,” 45 C.F.R. § 60.1 (2010).

Dr. Leal was unhappy enough about the suspension, and he certainly did not

want a report of it in the National Practitioner Data Bank where other hospitals

would have access to it. See 42 U.S.C. § 11135(a). He sought the Secretary’s

review of the report, arguing that it was not factually accurate, and he asked that

the report be removed from the Data Bank because the Hospital’s action against

him was not of the type that should be reported. The Secretary rejected Dr. Leal’s

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assertion that the report was not factually accurate. Relying on documents

submitted by Dr. Leal as part of his request for Secretarial review, the Secretary

concluded that the report accurately described the Hospital’s action and “reasons

for action as stated in the [Hospital’s] decision documents.” The Secretary also

refused Dr. Leal’s demand to remove the report, explaining that “[t]here is no basis

on which to conclude that the report should not have been filed in the [Data

Bank].” He did allow Dr. Leal to file a response, a copy of which would be given

to anyone who obtained the report itself from the Data Bank. Not happy with that

outcome, Dr. Leal filed an action under the Administrative Procedure Act seeking

a court order requiring the Secretary to remove the report from the Data Bank.

The district court entered a judgment denying relief, and this is Dr. Leal’s appeal.

I.

“In APA actions, we review agency determinations under the ‘arbitrary and

capricious’ standard, which ‘provides the reviewing court with very limited

discretion to reverse an agency decision.’” Warshauer v. Solis, 577 F.3d 1330,

1335 (11th Cir. 2009) (quoting City of Oxford v. FAA, 428 F.3d 1346, 1351 (11th

Cir. 2005)). “The court’s role is to ensure that the agency came to a rational

conclusion, not to conduct its own investigation and substitute its own judgment

for the administrative agency’s decision.” Sierra Club v. Van Antwerp, 526 F.3d

4

1353, 1360 (11th Cir. 2008) (quotation marks omitted); see also Miccosukee Tribe

of Indians of Fla. v. United States, 566 F.3d 1257, 1264 (11th Cir. 2009)

(explaining that “[t]he arbitrary and capricious standard is exceedingly deferential”

and that this Court is “not authorized to substitute [its] judgment for the agency’s

as long as [the agency’s] conclusions are rational” (quotation marks and citations

omitted)).

II.

In the Health Care Quality Improvement Act, Congress directed the

Secretary of the Department of Health & Human Services to promulgate

regulations establishing “procedures in the case of disputed accuracy of the

information” in the National Practitioner Data Bank. 42 U.S.C. § 11136(2). Under

those regulations, a physician who disputes the accuracy of a report can seek

Secretarial review, see 45 C.F.R. § 60.16(c)(2), which is limited to having the

report reviewed “for accuracy of factual information and to ensure that the

information was required to be reported.” U.S. Dep’t of Health & Human Servs.,

National Practitioner Data Bank Guidebook F-3 (2001),

http://www.npdb-hipdb.hrsa.gov/pubs/gb/NPDB_Guidebook.pdf (“Guidebook”);

see also Christensen v. Harris Cnty., 529 U.S. 576, 587, 120 S.Ct. 1655, 1662–63

(2000) (explaining that interpretations contained in enforcement guidelines get

5

Skidmore deference).

Under the regulations, when a physician seeks Secretarial review of a report

“the Secretary . . . review[s] the written information submitted by both parties.” 45

C.F.R. § 60.16(c)(2); see also Guidebook, at F-3 (explaining that a physician

challenging a report’s factual accuracy must “[s]ubmit documentation

substantiating that the reporting entity’s information is inaccurate”). And that

happened in this case. To show that the report was not factually accurate, Dr. Leal

submitted his own affidavits in which he gave his version of the events that led the

Hospital to suspend his clinical privileges. According to those affidavits, he

accidentally broke a telephone when he tripped on its long cord; he closed the lid

of a copy machine with “some force” and the glass cracked; he moved a metal cart

that was blocking the doors of the operating suite; he ate jelly beans, some of

which may have fallen on the floor when he tried to throw away flavors that he did

not like; and when he was handed a medical chart by a nurse some of the chart’s

loose papers fell to the floor. In other words, this urological surgeon, who earns

his living wielding a razor-sharp scalpel on some of the most delicate parts of the

body, does not have a bad temper — he is just clumsy. Dr. Leal did admit in his

affidavits, however, that he had on that occasion spoken “sternly” to a nurse who

incorrectly told him that his patient was not cleared for surgery. Dr. Leal also

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submitted to the Secretary letters from the Hospital’s administrators to him

formally stating that “in the best interests of patient care” his clinical privileges

were suspended due to his “violent, threatening and physically destructive and

damaging behavior.” Based on that documentation, the Secretary determined that

the Hospital’s report was factually accurate in the relevant sense.

Dr. Leal challenges the Secretary’s finding. It is his position that a report is

factually accurate only if the administrative record includes statements from

eyewitnesses that substantiate the information in a hospital’s report about a

doctor’s misconduct. Without that requirement, he contends that a hospital could

unfairly “blacklist” a physician by filing a report in the Data Bank based on

conduct that never occurred. Because the Hospital did not submit statements from

eyewitnesses to back up what it said about him, Dr. Leal argues that it was

arbitrary and capricious for the Secretary to find that the report was accurate.

Dr. Leal’s position misunderstands the purpose of the Data Bank and the

scope of the Secretary’s review. Congress enacted the Health Care Quality

Improvement Act, which led to the creation of the Data Bank, after finding that

there was “a national need to restrict the ability of incompetent physicians to move

from State to State without disclosure or discovery of the physician’s previous

damaging or incompetent performance.” 42 U.S.C. § 11101. The Data Bank

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prevents a physician who applies to become a member of a hospital’s medical staff

or for clinical privileges from being able to hide disciplinary actions that have been

taken against him. See id. § 11135(a)(1) (requiring a hospital to request

information from the Data Bank about a physician when the physician applies to be

on the medical staff or for clinical privileges). Information in the Data Bank is

intended “only to alert . . . health care entities that there may be a problem with a

particular practitioner’s professional competence or conduct” because the

practitioner has been the subject of a disciplinary action. Guidebook, at A-3; see

also id. at E-1 (explaining that the “principal purpose [of the Data Bank] is to

facilitate a comprehensive review of professional credentials” (emphasis added));

id. at A-3 (noting that the Data Bank “provides another resource to assist . . .

hospitals[ ] and other health care entities in conducting extensive, independent

investigations of the qualifications of the health care practitioners they seek to . . .

hire, or to whom they wish to grant clinical privileges.”); id. at E-1 (explaining that

the Data Bank serves as a “flagging system”). The Data Bank contains not only

the hospital’s side of the story but also the physician’s response. What the

requesting hospital does with the information it obtains from the Data Bank is

entirely up to that hospital. It could completely discount the information, or it

could back off from any professional relationship with the physician, or it could

8

make further inquiries to determine what had actually happened.

Because information in the Data Bank is intended only to fully notify the

requesting hospital of disciplinary action against a physician and the charges on

which that action was based, the Secretary’s review of information in the Data

Bank is limited in scope. The review process does not provide a physician with a

procedure for challenging the reporting hospital’s adverse action. See id. at F-1

(“The dispute process is not an avenue . . . to appeal the underlying reasons of an

adverse action . . . .”); id. at F-3 (“The Secretary does not review the . . .

appropriateness of, or basis for, a health care entity’s professional review action . .

. .”). Nor does it provide a physician with a procedure for changing the allegations

about the conduct that led to the action that is reported. The Secretary reviews a

report for factual accuracy deciding only if the report accurately describes the

adverse action that was taken against the physician and the reporting hospital’s

explanation for the action, which is the hospital’s statement of what the physician

did wrong. See 42 U.S.C. § 11133(a)(3)(B) (requiring a hospital to include in the

report “a description of the acts or omissions or other reasons for the action”); see

also Guidebook, at F-4 (giving as examples of pertinent documentation to prove

that a report is not factually accurate: “[t]he findings of fact and recommendations

of the health care entity” and “[t]he final report of the hearing panel or other

9

appellate body upon which the description of acts or omissions was based”). The

Secretary does not act as a factfinder deciding whether incidents listed in the report

actually occurred or as an appellate body deciding whether there was sufficient

evidence for the reporting hospital to conclude that those actions did occur. See

Guidebook, at F-1 (explaining that the “basis for” the adverse action may not be

disputed by the physician).

Dr. Leal’s affidavits disputed to some extent the Hospital’s version of his

conduct. That dispute is outside the scope of the Secretary’s review. See id. The

letters to Dr. Leal from the Hospital’s administrators, which he submitted to the

Secretary, confirmed that his clinical privileges were suspended, and they

confirmed that the reason for the suspension was that the Hospital believed he had

engaged in “disruptive” and “violent, threatening and physically destructive and

damaging behavior.” The information in the report was consistent with the charges

outlined in the Hospital’s letters to Dr. Leal. The report stated that his clinical

privileges were “summarily suspended . . . due to his violent and unprofessional

actions” and also stated in some detail what those actions were. The consistency

between the Hospital’s letters and its report to the Data Bank establishes the

report’s factual accuracy in the only sense that matters under the Act. The

Secretary reasonably determined that the report was factually accurate in that

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sense.

As for Dr. Leal’s concern about an unscrupulous hospital filing a report

based on conduct that never occurred and blacklisting a physician, we have three

things to say. First, the requesting hospital is free to ignore information in the Data

Bank for purposes of making its hiring decision or to investigate it. Second, a

physician who is the subject of a report can add a statement to the report giving his

side of the story. Guidebook, at F-1. Other than a restriction on including “names,

addresses, or phone numbers,” the contents of a physician’s statement are left

entirely up to the physician. Id. The statement is included with the report and is

sent to every entity that gets the report. Id. Third, the Data Bank is not designed to

provide protection to physicians at all costs, including the cost of not protecting

future patients from problematic physicians.

III.

Dr. Leal also challenges the Secretary’s determination that the Hospital’s 60-

day suspension of his clinical privileges was a reportable event. Under the Act, a

hospital that “takes a professional review action that adversely affects the clinical

privileges of a physician for a period longer than 30 days” is required to report the

action to the Data Bank. See 42 U.S.C. § 11133(a)(1)(A). A professional review

action is defined as:

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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.

Id. § 11151(9) (emphasis added). Dr. Leal argues that he was not suspended for

conduct “which . . . affects or could affect adversely the health or welfare of a

patient or patients,” id., because no patients were involved in the incidents

described in the adverse action report. Accordingly, he asserts that the Hospital

did not take a “professional review action” against him that required reporting to

the Data Bank.

In interpreting § 11151(9), “[o]ur starting point is the language of the statute

itself.” Harrison v. Benchmark Elecs. Huntsville, 593 F.3d 1206, 1212 (11th Cir.

2010) (quotation marks omitted). If the statutory text is unambiguous, we will

enforce the statute as written and no further inquiry is necessary. See United States

v. Dodge, 597 F.3d 1347, 1352 (11th Cir. 2010) (en banc); see also Warshauer,

577 F.3d at 1335 (“If the language at issue has a plain and unambiguous meaning

with regard to the particular dispute in the case, and the statutory scheme is

coherent and consistent, the inquiry is over.” (quotation marks omitted)).

Under § 11151(9), a disciplinary action taken against a physician qualifies as

a professional review action if the physician is disciplined for conduct that either

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adversely affects patient health or welfare, or could do so. See 42 U.S.C. §

11151(9). The plain language of § 11151(9) makes it clear that actual harm to a

patient is not a prerequisite for a disciplinary action to qualify as a professional

review action. It is enough that a physician is disciplined for conduct that could

result in harm to a patient. See Moore v. Williamsburg Reg’l Hosp., 560 F.3d 166,

172 (4th Cir. 2009) (“Th[e] parenthetical clearly implies that the term ‘professional

conduct’ is not limited to past medical conduct that has already affected patient

welfare. . . . [N]othing in the statute requires peer review committees to wait until

medical disaster strikes.”); Gordon v. Lewistown Hosp., 423 F.3d 184, 203 (3d Cir.

2005) (“The plain language of the statute indicates the breadth of ‘conduct’

encompassed within the definition of ‘professional review action’ by the inclusion

of conduct that ‘could affect adversely the health or welfare of a patient.’” (quoting

42 U.S.C. § 11151(9))). The fact that no patients were hit by pieces of the broken

telephone, or by the shattered copy machine glass, or by the careening metal cart,

or by the flying jelly beans, or by the airborne medical chart, is not dispositive.

The Hospital was required to report its disciplinary action to the Data Bank even

though its halls were not littered with injured patients as a result of Dr. Leal’s very

bad day.

Disruptive and abusive behavior by a physician, even if not resulting in

13

actual or immediate harm to a patient, poses a serious threat to patient health or

welfare. A physician must work collaboratively with other members of a medical

staff in order to provide quality care to patients. A hospital is one place where no

one can do his job alone, where better teamwork means better care, and where

disruptive behavior threatens lives. When a physician becomes enraged and lashes

out at other members of the medical staff, patient welfare is endangered. That kind

of behavior intimidates other health care workers, discouraging the kind of open

communication and close cooperation that is essential to providing the best care to

patients. The Hospital reported that as a result of Dr. Leal’s violent outburst some

of the nurses and technical staff were afraid to work with him in the future. That

entirely predictable response is a serious problem. See Laurie Tarkan, Arrogant,

Abusive, and Disruptive—and a Doctor, N.Y. Times, Dec. 2, 2008, at D1

(reporting about a survey of health care workers at 102 nonprofit hospitals

revealing that 18 percent of the workers said that “they knew of a mistake that

occurred because of an obnoxious doctor”); David O. Weber, For Safety’s Sake

Disruptive Behavior Must be Tamed, The Physician Executive, Sept.-Oct. 2004, at

17, http://net.acpe.org/MembersOnly/pejournal/2004/SeptemberOctober/

Articles/WeberDavid2.pdf (noting that in a survey of nurses, pharmacists, and

other hospital workers, 7 percent of those surveyed had been involved in a

14

medication error during the past year because of their failure to speak up to a

known intimidator about dispensing or giving a drug); Greta Porto & Richard

Lauve, Disruptive Clinician Behavior: A Persistent Threat to Patient Safety, Patient

Safety & Quality Healthcare, July-Aug. 2006,

http://www.psqh.com/julaug06/disruptive.html (noting that “studies have shown

that recipients of abusive behavior learn to cope by avoiding the abuser, even if

this means failing to call when warranted and avoiding making suggestions that

might improve care”).2 The Secretary reasonably determined that Dr. Leal’s

reported “violent and unprofessional actions,” although not resulting in any known

harm to a patient, is conduct that “could affect adversely” patient health or welfare.

See 42 U.S.C. § 11151(9).

Dr. Leal contends that his suspension was not a reportable event for another

reason. The Hospital summarily suspended his clinical privileges the day after the

incident, and he argues that under the Act summary suspensions are to be treated

differently from other professional review actions. In order for a summary

suspension to be reportable, he asserts, it must have been imposed by the hospital

“to protect patients from imminent danger.” See Guidebook, at E-20 (noting that

2

In keeping with Eleventh Circuit Internal Operating Procedure 10, “Citation to Internet

Materials in an Opinion,” under Federal Rule of Appellate Procedure 36, copies of all of the

internet materials cited in this opinion are available at this Court’s Clerk’s Office.

15

the Department of Health & Human Services “assumes that hospitals use summary

suspensions . . . to protect patients from imminent danger, rather than for reasons

that warrant routine professional review actions”). His suspension was not

imposed because of imminent danger to patients.

“Imminent danger” is not required before a summary suspension is

reportable. The term “imminent danger” only appears in § 11112 of the Act, which

sets out standards that professional review actions must comply with in order for

those who participate in them to be immune from liability for money damages in

suits brought by disciplined physicians. See 42 U.S.C. §11112; Bryan v. Holmes

Reg’l Med. Ctr., 33 F.3d 1318, 1321–22 (11th Cir. 1994) (explaining that if a

professional review action meets certain due process and fairness requirements the

action’s participants are immune from liability for money damages in suits brought

by the disciplined physician). Section 11112 does not govern when a summary

suspension, which is a type of professional review action, is reportable.

The plain language of the Act requires a hospital to report to the Data Bank

“a professional review action that adversely affects the clinical privileges of a

physician for a period longer than 30 days.” 42 U.S.C. § 11133(a)(1)(A). A

summary suspension is “a professional review action.” See also Guidebook, E-19

(“A summary suspension is reportable if it is: “(1) In effect or imposed for more

16

than 30 days; (2) Based on the professional competence or professional conduct of

the physician . . . that adversely affects, or could adversely affect, the health or

welfare of a patient; [and] (3) The result of a professional review action taken by a

hospital . . . .” (numbering added)). Because Dr. Leal’s suspension plainly fits

within § 11133(a)(1)(A), the Secretary’s determination that it was reportable was

not arbitrary and capricious.

AFFIRMED.

17

Edmondson, Circuit Judge, concurs in the result.

18