00-004048PL Department Of Health, Board Of Medicine vs. Howard E. Gross, M.D. Status: Closed Recommended Order on Tuesday, February 13, 2001.

Summary: Respondent is not guilty of violating Subsection 458.331(1)(t), Florida Statutes, as alleged in the Administrative Complaint.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF )

MEDICINE, )

)

Petitioner, )

)

vs. ) Case No. 00-4048PL

)

HOWARD E. GROSS, M.D., )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, the Division of Administrative

Hearings, by its duly-designated Administrative Law Judge,

Jeff B. Clark, held a formal hearing in this case on Tuesday,

December 5 and 6, 2000, in Orlando, Florida.

APPEARANCES

For Petitioner: Ephraim D. Livingston, Esquire

Agency for Health Care Administration

Post Office Box 14229

Tallahassee, Florida 32317-4229

For Respondent: Robert D. Henry, Esquire

Martin D. Buckley, Esquire

Ringer, Henry & Buckley, P.A.

Post Office Box 4922

Orlando, Florida 32801-4922

STATEMENT OF THE ISSUE

Whether disciplinary action should be taken against the

license to practice medicine of Respondent, Howard E. Gross,

M.D., based on allegations that he violated Subsection

458.331(1)(t), Florida Statutes, as alleged in the

Administrative Complaint in this proceeding.

PRELIMINARY STATEMENT

By Administrative Complaint dated August 24, 2000,

Petitioner, Department of Health, Board of Medicine, alleges

that Respondent, Howard E. Gross, M.D., a licensed physician,

violated provisions of Chapter 458, Florida Statutes, governing

medical practice in Florida. Petitioner alleges that Respondent

failed to practice medicine with that level of care, skill, and

treatment which is recognized by a reasonably prudent similar

physician as being acceptable under similar conditions and

circumstances, as required by Subsection 458.331(1)(t), Florida

Statutes. Petitioner alleges that while performing a

ventriculogram, Respondent failed to ensure the accuracy and

safety of the material he injected into the patient, which

resulted in the injection of free air instead of dye into the

patient.

Petitioner forwarded the Administrative Complaint to the

Division of Administrative Hearings on October 2, 2000. A

Notice of Hearing was entered on October 10, 2000, setting the

case for hearing on November 16 and 17, 2000, in Orlando,

Florida. Respondent moved to continue the hearing date from

November 16 and 17, 2000, and an Order continuing the hearing to

December 5 and 6, 2000, was entered.

At the final hearing, Petitioner presented two

witnesses: A. Allen Seals, M.D., an expert witness, and

Cathleen Lauderback, R.N. Petitioner offered three exhibits

which were admitted into evidence.

Respondent presented three wi tnesses: Respondent,

Howard E. Gross, M.D.; Kevin Browne, Jr., M.D., an expert

witness; and Marcia A. Bryant, R.C.T. Respondent offered five

exhibits, all of which were admitted into evidence.

At the conclusion of the hearing, the Administrative Law

Judge advised each party of the option of providing proposed

recommended orders and memoranda of law. The court reporter

filed the Transcript of the hearing on January 16, 2001. The

parties filed a Joint Motion for Extension of Time to File

Proposed Recommended Orders and Memorandums of Law on January 3,

2001, requesting 15 days from the filing of the Transcript to

file Proposed Recommended Orders and Memorandum of Law; the

Administrative Law Judge granted the motion.

Petitioner filed its Proposed Recomm ended Order on

January 31, 2001. Respondent filed his Proposed Recommended

Order and Memorandum of Law on January 31, 2001.

FINDINGS OF FACT

Based on the oral and documentary evidence presented at the

final hearing and the entire record in this proceeding, the

following findings of fact are made:

1. Petitioner is the state agency charged with regulating

the practice of medicine in the State of Florida pursuant to

Section 20.43, Florida Statutes, and Chapters 455 and 458,

Florida Statutes.

2. At all times material to this proceeding, Respondent

was a licensed physician in the State of Florida, having been

licensed in 1971 and issued license number ME 0017039.

Respondent has never been disciplined previously.

3. Respondent is board-certified in inte rnal medicine

(1970) and cardiovascular diseases (1973). He is an

interventional cardiologist. He has practiced medicine in

Orlando since 1971. For the past 10 years, he has done a

high-volume catheterization practice. In the most recent

one-year period, he did approximately 500 interventional

procedures and 400 diagnostic procedure, and in almost all

instances, the catheterization involved a ventriculogram.

4. On or about February 18, 1997, patient L. D. L., an

84-year-old male with a history of coronary artery disease,

presented to Orlando Regional Medical Center, for

catheterization and possible rescue angioplasty to be performed

by Respondent. Respondent performed a cardiac catheterization

on the patient.

5. During the catheterization procedure, Respondent

advanced a 6-French pigtail catheter into the patient's left

ventricle and performed a ventriculogram by injecting what he

thought was approximately 20cc of ionic dye, utilizing a MEDRAD

injector.

6. During the catheterization proce dure, Respondent noted

that he did not obtain opacification of the left ventricle and

noted that free air was in the left ventricle.

7. In fact, Respondent injected the patient with

approximately 15cc to 20cc of free air rather than dye. As a

result, the patient suffered cardiac arrest, and his blood

pressure fell to zero.

8. Respondent initiated various life-saving measures to

counter the effects of the injection of free air, which were

unsuccessful, and the patient was pronounced dead at

approximately 1:55 p.m., as a result of cardiac arrest brought

on by an air embolus.

9. At the time, Orlando Regional Medical Center

(hereinafter "ORMC") had a policy/procedure (No. 3233-MEDRAD-

0001) for Cardiac Catheterization Laboratory (hereinafter

"Cardiac Cath Lab") personnel (Respondent's Exhibit 1). It

delineated specific procedures to ensure "the use and safe

applications of the power injector." In particular, it states

the procedure to be employed by Cardiac Cath Lab staff in

loading the MEDRAD injector.

10. At ORMC and other hospitals, Cardiac Cath Lab

personnel load the MEDRAD injectors without physician

supervision. As explained by both expert witnesses, loading the

syringe with dye is a very simple task for a nurse or scrub tech

to perform.

11. In t he instant case, the nurse loading the MEDRAD

injector interrupted the loading procedure because she was

concerned about the patient's lab values (kidney function) and

was uncertain about what type of dye Respondent would order.

Respondent was not yet in the Cardiac Cath Lab. The nurse

anticipated asking Respondent which type of dye he wanted and

then loading that type dye into the MEDRAD injector.

12. When she interrupted the loading procedure, the nurse

left the plunger positioned in the syringe where it appeared

that the syringe had been loaded with 20 to 25cc of dye and the

injector arm pointing upward.

13. The nurse then left the Cardiac Cath lab to get her

lead apron anticipating only a monetary absence from the lab.

Unknown to her, Respondent entered the Cardiac Cath Lab within

seconds after her departure.

14. Respondent was not in the Cardiac Cath Lab at any time

while the nurse was manipulating the MEDRAD injector.

15. As the nurse secured her lead jacket, she was called

to another patient to administer medication which required the

presence of a registered nurse per hospital procedures.

16. In the nurse's absence, the catheterization and

ventriculogram of the patient proceeded. The Registered

Cardiovascular Technician (hereinafter "RCT"), observing the

MEDRAD injector in what appeared to be a prepared state, wheeled

it to the patient's side and lowered the injector arm into a

position to receive the catheter.

17. The RCT testified that a MEDRAD injector would never

be left as she found it, plunger at the 20 to 25cc mark and arm

elevated, if the machine was not loaded with dye.

18. The ionic dye used in the procedure is clear and, due

to the nature of the MEDRAD plunger and casing, it is extremely

difficult to tell if dye is in the syringe.

19. Further compounding the difficulty in observing dye in

the syringe is the fact that the lights in the Cardiac Cath Lab

are lowered during the procedure to allow better visualization

of the video monitor.

20. While the RCT positioned the MEDRAD injecto r at the

patient's side, Respondent was in the process of entering the

catheter into the patient, manipulating the catheter in the

patient, visualizing its position in the patient's heart on the

video monitor and monitoring hemodynamics.

21. Petitioner's expert witness testified that Respondent

did justifiably rely on the Cardiac Cath Lab personnel to follow

the procedure outlined in Respondent's Exhibit 1. The nurse and

cardiovascular technician did not follow the policy/procedure

and, as a result, allowed the presence of air in the MEDRAD

injector.

22. After the catheter is properly located in the

patient's heart, the external end of the catheter is attached to

the MEDRAD injector.

23. Petitioner's expert witness opined the Respondent

should have used extension tubing to effect the connection

between the catheter and MEDRAD injector. Testimony revealed

that extension tubing is used by many physicians who perform

cardiac catheterization. Respondent's practice was not to use

extension tubing.

24. Both Petitioner's and Respondent's expert witnesses

agreed that Respondent's choice not to use extension tubing was

a "technique" choice and did not fall below the "standard of

care."

25. Petitioner's expert opined that Respondent should have

been present in the Cardiac Cath Lab to observe the loading of

the MEDRAD injector.

26. Testimony revealed that at ORMC and other hospitals it

was the Cardiac Cath Lab staff's responsibility to load the

MEDRAD injector without the direct supervision of physicians and

that physicians are rarely in the lab when the MEDRAD injector

is loaded.

27. The "standard of care" does not require the physician

to watch the loading of dye or the expulsion of air from the

syringe in the loading process.

28. Petitioner's expert opined th at Respondent should have

performed a test injection (a process where a small amount of

dye is injected into the heart prior to the main injection).

29. Respondent's expert testified that under certain

circumstances (none of which is applicable to the instant case)

test injections were appropriate; those circumstances occur less

than 5 percent of the time.

30. Electing not to perform a test injection in the

instant case does not fall below the "standard of care."

31. Petitioner's expert opined that Res pondent should have

observed a "wet to wet" connection between the catheter and the

MEDRAD injector to ensure that no air is in the system. This is

accomplished by withdrawing a small amount of blood from the

catheter into the MEDRAD injector. Small air bubbles may appear

between the blood and dye and are then "tapped" to rise to the

top of the syringe.

32. However, Respondent performed the "wet to wet"

connection and did not observe anything unusual. He has

historically performed some "wet to wet" connections where no

air bubbles were present between the blood and dye as it

appeared in this case.

33. The RCT confirmed that Respondent performed the "wet

to wet" connection, looked for air in the syringe, and tapped on

the syringe to loosen and expel air bubbles.

34. Respondent's expert witness testified that he

performed an experiment creating a "wet to wet" connection with

air in the MEDRAD injector syringe instead of dye. He found

that the miniscus formed by blood and air in the syringe has an

identical appearance to blood contacting dye in the syringe.

35. The "wet to wet" connection between blood and air in

the syringe has the same appearance as a "perfectly clean", "wet

to wet" connection between blood and dye in the syringe.

36. Respondent's exp ert witness testified that from five

to ten percent of the time a "perfectly clean", "wet to wet"

connection occurs in which no air bubbles appear between the

blood and dye.

37. Petitioner's expert witness testified that the

physician must make absolutely certain that no gross amount of

air is injected into the patient, and, relying on his view that

the Respondent as the physician was the "captain of the ship,"

he testified that "the injection of this volume of air during

the ventriculogram fell below the cardiology "standard of care."

38. Petitioner's expert rendered his opinion based upon

his examination of the hospital records.

39. Respondent's expert rendered his opinion based upon

his examination of the following:

a. Administrative complaint with supporting

documents.

b. Dr. Allen Seals' (Petitioner's expert) report

and deposition.

c. Agency for Health Card Administration

investigative report.

d. ORMC's Code 15 report.

e. Respondent's February 21, 1997 memo for peer

review purposes.

f. Hospital records.

g. Death résumé.

h. ORMC's MEDRAD policy/procedure.

i. Experimentation with a catheter and MEDRAD

injector.

40. Respondent's expert testified that Respondent met the

standard of care in the instant case because he practiced

medicine with that level of care, skill, and treatment which is

recognized by a reasonably prudent similar physician as being

acceptable under similar circumstances.

41. Based on the totality of the evidence presented, the

undersigned rejects the expert opinion of Dr. Allen Seals, M.D.,

Petitioner's expert witness, and accepts as being more credible

the testimony of David P. Browne, Jr., M.D., Respondent's expert

witness.

CONCLUSIONS OF LAW

42. The Division of Administrative Hearings has

jurisdiction over the parties and the subject matter of this

cause pursuant to Sections 120.57(1) and 455.225, Florida

Statutes.

43. License revocations and discipline procedures are

penal in nature. Petitioner must demonstrate the truthfulness

of the allegations in the Administrative Complaint dated

August 24, 2000, by clear and convincing evidence. Department

of Banking and Finance v. Osborne Stern and Company , 670 So. 2d

932 (Fla. 1996); Ferris v. Turlington , 510 So. 2d 292 (Fla.

1987).

44. The "clear and convincing" standard requi res:

[T]hat the evidence must be found to be

credible; the facts to which the witnesses

testify must be distinctly remembered; and

the testimony must be precise and explicit

and the witnesses must be lacking in

confusion as to the facts in issue. The

evidence must be of such weight that it

produces in the mind of the trier of fact a

firm belief or conviction, without

hesitancy, as to the truth of the

allegations sought to be established.

Slomowitz v. Walker , 429 So. 2d 797, 800 (Fla. 4th DCA 1983).

45. Petitioner must set forth the charges against

Respondent with specificity, carrying the burden of proving each

charge, and in the final order set forth explicit findings of

fact and conclusions of law addressing each specific charge.

Davis v. Department of Professional Regulation , 457 So. 2d 1074

(Fla. 1st DCA 1984); Lewis v. Department of Professional

Regulation , 410 So. 2d 593 (Fla. 2d DCA 1982).

46. Where Petitioner charges negligent violations of

general standards of professional conduct, as in this case,

Petitioner must present expert testimony that proves the

required professional conduct, as well as the deviation

therefrom. Purvis v. Department of Professional Regulation , 461

So. 2d 134 (Fla. 1st DCA 1984).

47. Petitioner has charged Respondent w ith violating the

following relevant provisions of Subsection 458.331(1)(t),

Florida Statutes:

[T]he failure to practice medicine with that

level of care, skill, and treatment which is

recognized by a reasonably prudent similar

physician as being acceptable under similar

conditions and circumstances.

48. Relying on a "captain of the ship" theory, Petitioner

implies that Respondent is responsible for the active negligence

of the Cardiac Cath Lab personnel. Variety Children's Hospital,

Inc. v. Perkins , 382 So. 2d 331 (Fla. 3d DCA 1980); Buzan v.

Mercy Hospital, Inc. , 203 So. 2d 11 (Fla. 3d DCA 1967). Where

the Cardiac Cath Lab personnel are subject to Respondent's

direct control, such might possibly be the case. In the instant

case, the loading of the MEDRAD injector was a simple,

ministerial function which does not require a physician's

supervision. Typically, the physician is not in the Cardiac

Cath Lab when the machine is loaded and relies on the hospital's

policy/procedure to be followed by the personnel who perform the

loading. In the instant case, the evidence demonstrated that

Respondent did not control the Cardiac Cath Lab personnel while

they loaded the MEDRAD injector and that Respondent did those

precautionary activities typically done by a reasonably prudent

physician. Beaches Hospital v. Lee , 384 So. 2d 234 (Fla. 1st

DCA 1980).

49. The clear statutory intent of Subsection

458.331(1)(t), Florida Statutes, is to impose discipline only

for personal misconduct of the licensed physician. There is no

language to clearly evidence a legislative intent to impose on a

physician responsibility for the negligence or misconduct of

others. Since disciplinary statutes are penal in nature and

must be strictly construed against the enforcing agency, without

a clear, unambiguous provision in the statute indicating

legislative intent to hold the physician responsible for the

negligent or wrongful act committed by another, the

administrative agency is not authorized to so extend the effect

of the statute. McDonald v. Department of Professional

Regulation , 582 So. 2d 660 (Fla. 1st DCA 1991); Federgo Discount

Center v. Department of Professional Regulation , 452 So. 2d 1063

(Fla. 3rd DCA 1984); Davis v. Department of Professional

Regulation , 457 So. 2d 1074 (Fla. 1st DCA 1984).

50. Petitioner failed to prove that, under the

circumstances, the Respondent deviated from the appropriate

standard of care. While there is the proven occurrence of the

tragic death of a patient undergoing a ventriculogram, that

incident alone does not indicate Respondent fell below the

standard of care.

51. Petitioner's expert witness testified that Respondent

failed to do several things that he felt should have been done:

(1) visually observe the loading of the dye; (2) performance of

a test injection; and (3) use of extension tubing.

52. In each instance, persuasive evidence was presented

that Respondent did not deviate from the standard of care at

Orlando Regional Medical Center and other hospitals or for the

procedure as performed by other physicians.

53. Such equivocal evidence on the critical allegations of

"failure to practice medicine with that level of care, skill,

and treatment which is recognized by a reasonably prudent

similar physician . . ." does not satisfy the clear and

convincing standard of proof imposed by Florida law.

RECOMMENDATION

Based upon the foregoing Findings of Fact and Conclusions

of Law, it is

RECOMMENDED that Petitioner enter a final order finding

that Respondent is not guilty of violating Subsection

458.331(1)(t), Florida Statutes, as alleged in the

Administrative Complaint.

DONE AND ENTERED this 13th day of February, 2001, in

Tallahassee, Leon County, Florida.

___________________________________

JEFF B. CLARK

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

[phone] SUNCOM 278-9675

Fax Filing [phone]

www.doah.state.fl.us

Filed with the Clerk of the

Division of Adm inistrative Hearings

this 13th day of February, 2001.

COPIES FURNISHED :

Ephraim D. Livingston, Esquire

Agency for Health Care Administration

Post Office Box 14229

Tallahassee, Florida 32317-4229

Robert D. Henry, Esquire

Martin D. Buckley, Esquire

Ringer, Henry & Buckley, P.A.

Post Office Box 4922

Orlando, Florida 32801-4229

Tanya Williams, Executive Director

Department of Health

Board of Medicine

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399-1701

Theodore M. Henderson, Agency Clerk

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399-1703

William W. Large, General Counsel

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399-1703

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within

15 days from the date of this Recommended Order. Any exceptions

to this Recommended Order should be filed with the agency that

will issue the final order in this case.