07-000688PL Department Of Health, Board Of Medicine vs. John C. Dali, M.D Status: Closed Recommended Order on Thursday, July 5, 2007.

Summary: Respondent violated the standard of care when he prescribed a drug for a patient knowing that she was possibly allergic to it.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF ) )

MEDICINE, )

)

Petitioner, )

) Case No. 07-0688PL

vs. )

)

JOHN C. DALI, M.D, )

)

Respondent. )

RECOMMENDED ORDER

A formal hearing was conducted in this case on May 9, 2007,

in Shalimar, Florida, before Suzanne F. Hood, Administrative Law

Judge with the Division of Administrative Hearings.

APPEARANCES

For Petitioner: Matthew Casey, Esquire

Department of Health

4052 Bald Cypress Way, Bin C-65

Tallahassee, Florida 32399-3265

For Respondent: Thomas F. Gonzalez, Esquire

Beggs and Lane

Post Office Box 12950

Pensacola, Florida 32591-2950

STATEMENT OF THE ISSUES

The issues are whether Respondent violated Sections

458.331(1)(m) and/or 458.331(1)(t), Florida Statutes (2005), and

if so, what penalty should be imposed.

PRELIMINARY STATEMENT

On December 11, 2006, Petitioner Department of Health,

Board of Medicine (Petitioner) issued an Administrative

Complaint against Respondent John C. Dali, M.D. (Respondent).

The complaint alleged that Respondent violated Section

458.331(1)(m), Florida Statutes (2005), by failing to keep

legible medical records justifying a course of treatment of

Patient A.R. The complaint also alleged that Respondent

violated Section 458.331(1)(t), Florida Statutes (2005), by

failing 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 in his treatment of Patient A.R.

On December 28, 2006, Respondent requested an

administrative hearing to contest the charges against him. On

February 12, 2007, Petitioner referred the request to the

Division of Administrative Hearings.

On February 21, 2007, Administrative Law Judge Charles C.

Adams issued a Notice of Hearing, scheduling the case for

May 9-10, 2007.

On April 30, 2007, Petitioner filed a Motion for Official

Recognition. On May 1, 2007, Judge Adams issued an order

granting the motion.

On May 1, 2007, the parties filed a Joint Pre-hearing

Stipulation. That same day, Petitioner filed an unopposed

Motion to Amend the Administrative Complaint to reflect the

language for Section 458.331(1)(t), Florida Statutes (2005). On

May 7, 2007, Judge Adams granted the motion.

On or about May 8, 2007, the Division of Administrative

Hearings transferred the case to the undersigned.

During the hearing, Petitioner presented the testimony of

Patient A.R. and the expert testimony of Robert P.

DerHagopian, M.D., F.A.C.S. Petitioner offered Exhibits

numbered, P1-P5, that were admitted as evidence.

Respondent testified on his own behalf and presented the

factual and expert testimony of Mark E. Schroeder, M.D., and

Patrick J. Anastasio, D.O. Of the eight exhibits offered by

Respondent, Exhibits numbered R1-R6 were accepted as evidence.

The court reporter filed the Transcript on June 7, 2007.

Petitioner filed its Proposed Recommended Order on June 18,

2007. Respondent filed his Proposed Recommended Order on

June 15, 2007.

FINDINGS OF FACT

1. Petitioner is the state agency responsible for

regulating the practice of medicine.

2. Respondent is a licensed Florida physician. He

practices medicine as a board-certified surgeon in Niceville,

Florida. His medical license number is ME 82923.

3. At all times relevant here, Mark Schroeder, M.D. shared

office space with Respondent in Niceville, Florida.

Dr. Schroeder is a primary care physician. He has been board-

certified in internal medicine since 1989.

4. At all times relevant here, Patrick J. Anastasio, D.O.,

was a practicing physician in Fort Walton Beach, Florida.

Dr. Anastasio is dual board-certified in internal medicine and

infectious disease.

5. In November 2005, Patient A.R. was a 35-year-old

female. Her primary care physician was Dr. Schroeder. As part

of her medical history, Patient A.R. reported to Dr. Schroeder

that she was allergic to Amoxil/Amoxcillian.

6. On November 2, 2005, Patient A.R. had an appointment

with Dr. Schroeder. Patient A.R. complained that she suffered

from constant nausea and stomach discomfort associated with her

meals.

7. On November 4, 2005, Patient A.R. underwent a

gallbladder ultrasound to rule out her gallbladder as the cause

of her nausea. The ultrasound indicated that Patient A.R.’s

gallbladder was normal.

8. On or about November 29, 2005, Patient A.R. had a blood

test. The test results showed a positive result for

Helicobacter pylori (H. pylori), which is a bacterium that

infects the stomach. H. pylori causes gastritis, ulcers, and

possibly even gastric cancer in some people. Other people

infected with H. pylori may never have these symptoms or

problems.

9. On December 6, 2005, Dr. Schroeder prescribed a 14-day

regimen of antibiotics to treat Patient A.R.’s gastritis and

H. pylori infection. Specifically, Dr. Schroeder prescribed

Tetracycline, Flagyl, and Nexium (a proton pump inhibitor).

10. Patient A.R. took the medicine as prescribed for two

days. She then called Dr. Schroeder’s office, requesting an

alternative treatment plan due to severe nausea and

sleeplessness.

11. Before providing Patient A.R. with an alternative

treatment plan, Dr. Schroeder consulted with Dr. Anastasio.

Dr. Schroeder explained that Patient A.R. was allergic to Amoxil

and that she had not been able to tolerate the regimen of

Tetracycline and Flagyl. After this consultation, Dr. Schroeder

prescribed a 7-day regimen of the following: (a) the antibiotic

Biaxin to substitute for the Tetracylcine; (b) Tigan to help

with Patient A.R.’s nausea; and (c) Xanax to relieve Patient

A.R.’s anxiety.

12. On December 13, 2005, Patient A.R. had a follow-up

office visit with Dr. Schroeder. Dr. Schroeder understood that

Patient A.R. was doing better overall on the Biaxin-based

treatment regimen.

13. On December 21, 2005, Patient A.R. reported to

Dr. Schroeder that she had almost finished her antibiotics but

was still not feeling well. Patient A.R. also reported that she

might have oral thrush and needed a prescription to treat it.

14. On December 27, 2005, Dr. Schroeder prescribed Nexium

for Patient A.R. Despite missing some days of work, Patient

A.R. completed the treatment therapy consisting of Biaxin,

Flagyl, and Nexium.

15. On January 3, 2006, Patient A.R. had another follow-up

office visit with Dr. Schroeder. Dr. Schroeder’s records

indicate that Patient A.R. was doing well and that her gastritis

had resolved. Dr. Schroeder prescribed continued use of Nexium.

16. On or about January 23, 2006, Patient A.R. called

Dr. Schroeder’s office to report problems with persistent nausea

and to request a referral for a “scope of her stomach.” She

made the request based on prior discussions with Dr. Schroeder

as to the next option if the Biaxin-based treatment regimen was

not successful. Dr. Schroeder referred Patient A.R. to

Respondent for a possible esophagogastroduodenoscopy (EGD or

upper endoscopy).

17. On February 13, 2006, Patient A.R. presented to

Respondent with complaints of epigastric and abdominal pain and

nausea. Respondent’s record of the visit indicates that Patient

A.R. had a history of H. pylori infection in a post-treatment

status. The record also indicates that Patient A.R. was

allergic to Amoxil.

18. On February 22, 2006, Respondent performed an EGD on

Patient A.R. After the procedure, Respondent diagnosed Patient

A.R. with moderate to severe gastritis. A pathology report

dated February 23, 2006, confirmed that Patient A.R. was

suffering from a H. pylori stomach infection.

19. On February 28, 2006, Patient A.R. had an office visit

with Respondent to discuss the pathology results. During this

visit, Respondent inquired about Patient A.R.’s reported and

documented allergy to Amoxil. Patient A.R. told Respondent that

when she was 15 years old and suffering from mononucleosis, her

family physician prescribed Amoxil for her.

20. Patient A.R. took Amoxil for about a week with no

indication of a reaction or sensitivity. When she began the

second bottle of the antibiotic, Patient A.R. developed a head-

to-toe rash and swelling. The delayed onset rash did not

present an anaphylactic or life-threatening reaction. The

symptoms resolved after cessation of the drug with no need for

further medical intervention.

21. There is a known interaction between ingestion of

amoxicillin and mononucleosis. The reaction manifests itself in

a delayed development of a rash occurring on the patient’s trunk

and extremities. Children who take amoxicillin while infected

with mononucleosis experience this symptomatic interaction in a

great percentage, almost 100 percent, of cases.

22. Respondent discussed Patient A.R.’s previous history

of allergy to Amoxil with Dr. Schroeder. Respondent’s record

states as follows:

. . . She has an allergy to penicillin and

failed other non-penicillin based drug

regimens for H. pylori treatment,

specifically, [T]etracycline/Flagyl and

Biaxin/Flagyl both prescribed by Dr. Mark

Schroeder. . . .

* * *

I immediately discussed this case with

Dr. Schroeder. Ms. [R.] and her husband

should both be treated with antibiotics for

Heliocobacter pylori infection concurrently.

After careful review of her previous history

with Dr. Schroeder, there is a possibility

that she is not allergic to amoxicillin, as

she developed a rash while she had a

mononucleosis infection, which is a common

side effect. Dr. Schroeder recommended a

trial of amoxicillin/Biaxin as she has

exhausted all other H. pylori treatments

that are not penicillin based. She will

take her amoxicillin judiciously, and if she

does develop any side effects will stop it

immediately and report this to either myself

or Dr. Schroeder. Otherwise, she will

follow up with me in six months for

consideration for repeat upper endoscopy.

23. Based on the determination that Patient A.R. possibly

was not allergic to Amoxil, Respondent prescribed her a 14-day

treatment regimen of Amoxicillin and Clarithromycin (Biaxin),

along with Nexium. As Patient A.R. left Respondent’s office,

Respondent told Patient A.R. to take the treatment, assuring her

that she absolutely was not truly allergic to Amoxcil.

24. Patient A.R. did not begin taking the Amoxil treatment

regimen until March 25, 2006. She delayed starting the

treatment because she knew the treatment would be “rough.” She

was concerned that she would miss work and be unable to enjoy a

visit from out-of-town family. Patient A.R. began the treatment

on a Saturday to give her body “a couple of days to adjust to

the medication.”

25. Within three hours of taking the Amoxil, Patient A.F.

experienced a tingling and stinging sensation in her left middle

finger. Because she had been working in the yard, Patient A.R.

believed that a bee might have stung her. She did not suspect

an allergic reaction because she had not had a localized

reaction to Amoxil when she was fifteen years old.

26. On Sunday, March 26, 2006, Patient A.R. continued to

take the Amoxil. Her finger continued to tingle, so she soaked

it in a saltwater solution.

27. On Monday, March 27, 2006, Patient A.R.’s finger

looked terrible; it was red and purple in color and swollen to

twice its normal size. As previously instructed by Respondent,

Patient A.R. called his office and spoke with a nurse. The

nurse suggested that Patient A.R. call an immediate care

facility because Respondent was in the operating room that

morning and had a “room full of patients” to see in the

afternoon.

28. On March 27, 2006, Patient A.R. ultimately saw a

physician or a physician assistant at Gulf Coast Immediate Care.

She was diagnosed with cellulites in the finger and prescribed a

cream to put on it twice a day. Patient A.R. was advised to

continue taking the Amoxil.

29. On March 28, 2006, Patient A.R.’s finger continued to

get worse, turning “purplish black” in color. Patient A.R.

continued to take the Amoxil-based treatment regimen because she

did not have a head-to-toe rash or swelling like she did when

she took the drug as a teenager.

30. On Wednesday, March 29, 2006, Patient A.R. woke up

with a head-to-toe rash, swelling, and tightness in her chest.

Realizing that she was suffering from an allergic reaction to

the Amoxil, Patient A.R. went to the emergency room of the Fort

Walton Beach Medical Center around 7:00 a.m.

31. The emergency room physician noted his clinical

impression of Patient A.R. to be an acute allergic reaction and

cellulites in her third left finger. He immediately treated her

intravenously with Benadryl, Pepcid, and Solumedrol.

32. After the trip to the emergency room, Patient A.R.

stopped taking the Amoxil. Patient A.R.’s rash and the problem

with her finger subsequently resolved.

33. On or about March 31, 2006, Patient A.R. saw Leo Chen,

M.D., an orthopaedic surgeon. Dr. Chen examined Patient A.R.’s

finger on a referral from Respondent.

34. On or about April 3, 2006, Patient A.R. presented to

Respondent for the last time. Regarding that visit,

Respondent’s notes state as follows:

Again I discussed this case with

Dr. Schroeder while the patient was in my

office, and a phone consultation was

obtained with Dr. Patrick Anastasio of

Infectious Disease. The patient did have an

allergic reaction to amoxicillin, and this

has now been confirmed. She developed an

allergic reaction to amoxicillin

approximately twenty years ago while she had

mononucleosis, and this was thought to be a

side effect due to the combination of

mononucleosis and amoxicillin, however this

apparently is not the case. She did seek

appropriate treatment at the emergency room

and was placed on appropriate drug therapy,

and seems to be resolving quite well at this

time. The patient will be sent for an

infectious disease consultation with

Dr. Patrick Anastasio, who will take on

treating the patient’s Helicobacter pylori

infection, which will need to be some form

of unconventional treatment or

desensitization to penicillin. . . .

35. On or about May 4, 2006, Patient A.R. presented to

Dr. Anastasio at Emerald Coast Infectious Diseases.

Dr. Anastasio prescribed “quadruple therapy” including the

antibiotics Biaxin and Flagyl for 14 days, along with Nexium and

Bismuth Subsalicylate, commonly known as Pepto Bismol.

36. Patient A.R. completed the treatment prescribed by

Dr. Anastasio. An August 2006 stool sample confirmed that the

treatment had eradicated the H. pylori stomach infection.

37. Subjecting Patient A.R. to Amoxil in 2006 was a

challenge to her reported allergy. Her allergic reaction was

more serious than when she was a teenager because it involved a

localized reaction in her finger. This time the challenge to

the allergy did not lead to anaphylaxis and death.

CONCLUSIONS OF LAW

38. The Division of Administrative Hearings has

jurisdiction over the parties and the subject matter of this

case pursuant to Sections 120.569 and 120.57(1), Florida

Statutes (2005).

39. Sections 456.072(2) and 458.331(2), Florida Statutes

(2005), authorizes Petitioner to impose penalties ranging from

the issuance of a letter of concern to revocation of a

physician’s license to practice in Florida if a physician

commits one or more acts specified therein.

40. Petitioner has the burden of proving, by clear and

convincing evidence, that Respondent violated Sections

458.331(1)(m) and 458.331(1)(t), Florida Statutes (2005), as

alleged in the Amended Administrative Complaint. See Department

of Banking and Finance, Division of Securities and Investor

Protection v. Osborne Stern Company , 670 So. 2d 932 (Fla. 1996).

41. Count I of the Amended Administrative Complaint

alleged that Respondent violated Section 458.331(1)(t), Florida

Statutes (2005), which states as follows:

(t) Notwithstanding Section 456.072(2) but

as specified in s. 456.50(2):

1. Committing medical malpractice as

defined in s. 456.50. The board shall give

great weight to the provision of s. 766.102

when enforcing this paragraph. Medical

malpractice shall not be construed to

require more than one instance, event, or

act.

2. Committing gross medical malpractice.

3. Committing repeated medical malpractice

as defined in s. 456.50. A person found by

the board to have committed repeated medical

malpractice based on s. 456.50 may not be

licensed or continue to be licensed by this

state to provide health care services as a

medical doctor in this state.

Nothing in this paragraph shall be construed

to require that a physician be incompetent

to practice medicine in order to be

disciplined pursuant to this paragraph. A

final order of the board finding a violation

under this paragraph shall specify whether

the licensee was found to have committed

“gross medical malpractice,” “repeated

medical malpractice,” or “medical

malpractice,” or any combination thereof,

and any publication by the board must so

specify.

42. Medical malpractice is defined in Section

456.50(1)(g), Florida Statutes (2005), which states as follows

in pertinent part:

(g) “Medical malpractice” means the failure

to practice medicine in accordance with the

level of care, skill, and treatment

recognized in general law related to health

care licensure. . . .

43. The “level of care, skill and treatment recognized in

general law related to health care licensure” means the standard

of care specified in Section 766.102(1), Florida Statutes

(2005), which states as follows in relevant part:

(1) . . . The prevailing professional

standard of care for a given health care

provider shall be that level of care, skill,

and treatment which, in light of all

relevant surrounding circumstances, is

recognized as acceptable and appropriate by

reasonably prudent similar health care

providers.

44. As alleged in Count I of the Amended Administrative

Complaint, Respondent violated the standard of care in one or

more of the following ways: (a) by prescribing Amoxil to

Patient A.R. despite being aware of her allergy to the drug;

(b) by failing to refer Patient A.R. to another specialist in

gastroenterology and infectious disease due to the complexity of

her problem; and (c) by failing to treat Patient A.R. with

antibiotics other than Amoxil.

45. Clear and convincing evidence indicates that

Respondent prescribed Amoxil to Patient A.R. in a non-emergent

situation. He did so with knowledge of Patient A.R.’s self-

reported allergy when at least one other reasonable treatment

regimen was available that did not involve the use of Amoxil.

46. Respondent did not consult with or refer Patient A.R.

to an infectious disease specialist like Dr. Anastasio before

erroneously deciding that there were no other Amoxil-free

treatment regimens available and that Patient A.R. was not truly

allergic to Amoxil. Instead, he was willing to take an

unnecessary chance, challenging Patient A.R.’s allergy and

causing her to suffer the pain associated with an allergic

reaction. There is no persuasive evidence to the contrary.

Based upon these findings, it is concluded that Respondent

committed medical malpractice in violation of Section

458.331(1)(t), Florida Statutes (2005).

47. In Count Two of the Amended Administrative Complaint,

Petitioner alleges that Respondent violated Section

458.331(1)(m), Florida Statutes (2005), which defines the

following offense:

(m) Failing to keep legible, as defined by

department rule in consultation with the

board, medical records that identify the

licensed physician or the physician extender

and supervising physician by name and

professional title who is or are responsible

for rendering, ordering, supervising, or

billing for each diagnostic or treatment

procedure and that justify the course of

treatment of the patient, including, but not

limited to, patient histories; examination

results; test results, records of drugs

prescribed, dispensed, or administered; and

reports of consultations and

hospitalizations.

48. In this case, Respondent’s record keeping was legible,

describing in detail his flawed reasoning. However, because

Respondent’s treatment of Patient A.R. was erroneous, it cannot

be justified. It follows that Respondent could not document a

sufficient legal reason for prescribing Amoxil to Patient A.R.

49. Respondent clearly violated Section 458.331(1)(m),

Florida Statutes (2005), by failing to document a justification

for his action. Even so, the offense depends entirely and is

subsumed by Respondent’s violation of the standard-of-care in

Count One. The offense does not serve to enhance a penalty for

the underlying substantive standard-of-care violation.

50. Florida Administrative Code Rule 64B8-8.001 provides a

range of penalties for certain violations. For Sections

458.331(1)(m) and 458.331(1)(t), Florida Statutes (2005), the

respective range of penalties is as follows:

(m) From a reprimand to denial or two (2)

years suspension followed by probation, and

an administrative fine from $1,000.00 to

$10,000.00.

* * *

(t) From one (1) year probation to

revocation or denial and an administrative

fine from $1,000.00 to $10,000.

See Fla. Admin. Code R. 64B8-8.001(2).

51. Pursuant to Florida Administrative Code Rule 64B8-

8.001(3), Respondent may deviate from the guideline penalties as

follows:

(3) Aggravating and Mitigating

Circumstances. Based upon consideration of

aggravating and mitigating factors present

in an individual case, the Board may deviate

from the penalties recommended above. The

Board shall consider as aggravating or

mitigating factors the following:

(a) Exposure of patient or public to injury

or potential injury, physical or otherwise:

none, slight, severe, or death.

(b) Legal status at the time of the

offense: no restraints, or legal

constraints;

(c) The number of counts or separate

offenses established.

(d) The number of times the same offense or

offenses have previously been committed by

the licensee or applicant;

(e) The disciplinary history of the

applicant or licensee in any jurisdiction

and the length of practice;

(f) Pecuniary benefit or self-gain injuring

to the applicant or licensee;

(g) The involvement in any violation of

Section 458.331, Florida Statutes, of the

provision of controlled substances for

trade, barter or sale, by a licensee. In

such cases, the Board will deviate from the

penalties recommended above and impose

suspension or revocation of licensure;

(h) Any other relevant mitigating factors.

52. This is a two-count case. Respondent has no prior

disciplinary history, but in this instance, he was willing to

unnecessarily put Patient A.R.'s health at risk.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law, it is

RECOMMENDED:

That Petitioner enter a final order finding that Respondent

violated the statutes as charged, issuing a letter of concern,

imposing a $10,000 fine, and requiring five hours of continuing

medical education.

DONE AND ENTERED this 5th day of July, 2007, in Tallahassee,

Leon County, Florida.

S

SUZANNE F. HOOD

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 Administrative Hearings

this 5th day of July, 2007.

COPIES FURNISHED :

Matthew Casey, Esquire

Department of Health

4052 Bald Cypress Way Bin C-65

Tallahassee, Florida 32399-3265

Thomas F. Gonzalez, Esquire

Beggs and Lane

Post Office 12950

Pensacola, Florida 32591-2950

Larry McPherson, Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way

Tallahassee, Florida 32399-1701

Josefina M. Tamayo, General Counsel

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399-1701

Dr. Ana M. Viamonte Ros, Secretary

Department of Health

4052 Bald Cypress Way, Bin A00

Tallahassee, Florida 32399-1701

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.