08-001074PL Department Of Health, Board Of Medicine vs. Gerard Romain, M.D. Status: Closed Recommended Order on Tuesday, September 23, 2008.

Summary: Prescriptions for hydrocodone provided without the physician`s evaluation of the patient`s condition or history warrants discipline.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF )

MEDICINE, )

)

Petitioner, )

)

vs. ) Case No. 08-1074PL

)

GERARD ROMAIN, M.D., )

)

Respondent. )

)

RECOMMENDED ORDER

On August 8, 2008, a formal administrative hearing in this

case was held in Tampa, Florida, before William F. Quattlebaum,

Administrative Law Judge, Division of Administrative Hearings.

APPEARANCES

For Petitioner: Elana J. Jones, Esquire

Ephraim D. Livingston, Esquire

Department of Health

4052 Bald Cypress Way, Bin C-65

Tallahassee, Florida 32399-3265

For Respondent: Dale R. Sisco, Esquire

Stacy Estes, Esquire

Sisco-Law

Post Office Box 3382

Tampa, Florida 33601-3382

STATEMENT OF THE ISSUES

The issues in this case are whether the allegations of the

Amended Administrative Complaint are correct, and, if so, what

penalty should be imposed.

PRELIMINARY STATEMENT

By Administrative Complaint dated July 16, 2007, the

Department of Health (Petitioner) alleged that

Gerard Romain, M.D. (Respondent), violated Subsections

458.331(1)(t), 458.331(1)(q), and 458.331(1)(m), Florida

Statutes (2005). The Respondent disputed the allegations and

requested a formal administrative hearing. By letter dated

February 29, 2008, the Petitioner forwarded the matter to the

Division of Administrative Hearings, which scheduled and

conducted the hearing. Without objection, the Administrative

Complaint was amended on July 28, 2008, to correct patient

identification and statutory reference.

At the hearing, the Petitioner presented the testimony of

one witness and had Exhibits numbered 1, 2, 4, and 5 admitted

into evidence. The Respondent presented no testimony or

exhibits.

The hearing Transcript was filed on August 21, 2008. Both

parties filed Proposed Recommended Orders that have been

considered in the preparation of this Recommended Order.

FINDINGS OF FACT

1. The Respondent is a licensed physician in the State of

Florida, holding license number ME 81249.

2. At all times material to this case, the Respondent was

board-certified in family medicine. The Respondent held no

board certification at the time of the administrative hearing,

and, according to his response to the Petitioner's First Request

for Admissions, the family medicine certification expired in

July 2007.

3. On February 8, 2006, the Respondent prescribed

hydrocodone (10/325, generic Norco, 10mg.) to Patient M.R.

through an internet service called ERMeds.com.

4. On June 26, 2006, the Respondent prescribed hydrocodone

(Hydro/APAP 10/325, generic Norco, 10/325) to Patient M.R.

through the internet service called ERMeds.com.

5. Hydrocodone is a Schedule II controlled substance

listed in Chapter 893, Florida Statutes.

6. Hydrocodone/APAP is hydrocodone combined with

acetaminophen, and the combined drug is a Schedule III

controlled substance listed in Chapter 893, Florida Statutes.

7. Both hydrocodone and hydrocodone/APAP have high

potential for abuse and addiction.

8. The prescriptions issued to Patient M.R. contained the

Respondent's identification including address and DEA number on

the prescription form, as well as the Respondent's electronic

facsimile signature.

9. The Respondent had no contact with Patient M.R. either

before or after the prescription was issued to Patient M.R.

10. The Respondent conducted no health evaluation of

Patient M.R. The Respondent did not obtain or review any

medical information related to Patient M.R.

11. The Respondent testified during deposition that a

physician's assistant for whom the Respondent was the

supervising physician was responsible for gathering and

reviewing medical information from the patient.

12. According to the Respondent's response to the

Petitioner's First Request for Admissions, the physician's

assistant obtained patient history, including current

medications and complaints, and the "information was available

to Respondent at the time the prescriptions were authorized."

13. According to the Respondent's response to the

Petitioner's First Request for Admissions, a completed medical

questionnaire was available for the Respondent's review.

14. There is no evidence that the Respondent reviewed any

information or questionnaire regarding the patient's medical

history or complaint either before or at the time the

prescriptions were authorized.

15. The Respondent did not know and never met the

physician's assistant and was unable to recall the last name of

the physician's assistant.

16. There is no evidence that the Respondent had any

discussion with any physician's assistant related to

Patient M.R. either before or at the time the prescriptions were

authorized.

17. At the hearing, the Petitioner presented the testimony

of Bernd Wollschlaeger, M.D., a Florida-licensed physician

holding board certification in family practice.

18. Dr. Wollschlaeger testified that a physician must

evaluate a patient, take a patient's medical history, review any

available medical records, and document the findings and

diagnosis in a contemporaneous record prior to issuing a

prescription for hydrocodone to a patient.

19. Based upon the Respondent's deposition testimony and

the responses to the Petitioner's First Request for Admissions,

it is clear that the Respondent failed to evaluate Patient M.R.

in any respect prior to issuing the prescriptions for

hydrocodone to the patient.

20. The Respondent reviewed no medical history or records

related to Patient M.R.

21. The Respondent failed to diagnose any medical

condition that would support prescribing hydrocodone to

Patient M.R.

22. The Respondent failed to document any medical

information related to Patient M.R. in any written record.

CONCLUSIONS OF LAW

23. The Division of Administrative Hearings has

jurisdiction over the parties to and the subject matter of this

proceeding. §§ 120.569 and 120.57, Fla. Stat. (2008).

24. The Petitioner is the state agency charged with

regulating the practice of medicine. § 20.43 and Chapters 456

and 458, Fla. Stat. (2008).

25. The Administrative Complaint charges the Respondent

with violations of Subsection 458.331(1), Florida Statutes

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

(1) The following acts constitute grounds

for denial of a license or disciplinary

action, as specified in s. 456.072(2):

* * *

(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.

* * *

(q) Prescribing, dispensing, administering,

mixing, or otherwise preparing a legend

drug, including any controlled substance,

other than in the course of the physician's

professional practice. For the purposes of

this paragraph, it shall be legally presumed

that prescribing, dispensing, administering,

mixing, or otherwise preparing legend drugs,

including all controlled substances,

inappropriately or in excessive or

inappropriate quantities is not in the best

interest of the patient and is not in the

course of the physician's professional

practice, without regard to his or her

intent.

* * *

(t) Notwithstanding s. 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 provisions 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

recommended order by an administrative law

judge or 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.

26. Subsection 456.50(1)(g), Florida Statutes (2005),

defines medical malpractice as follows:

"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. Only for the purpose of

finding repeated medical malpractice

pursuant to this section, any similar

wrongful act, neglect, or default committed

in another state or country which, if

committed in this state, would have been

considered medical malpractice as defined in

this paragraph, shall be considered medical

malpractice if the standard of care and

burden of proof applied in the other state

or country equaled or exceeded that used in

this state.

27. The Petitioner has the burden of proving by clear and

convincing evidence the allegations set forth in the

Administrative Complaint against the Respondent. Department of

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

932, 935 (Fla. 1996); Ferris v. Turlington , 510 So. 2d 292

(Fla. 1987).

28. Clear and convincing evidence is that which is

credible, precise, explicit, and lacking 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 the firm belief of

conviction, without hesitancy, as to the truth of the

allegations. Slomowitz v. Walker , 429 So. 2d 797, 800 (Fla. 4th

DCA 1983). In this case, the burden has been met.

29. The evidence clearly and convincingly establishes that

the Respondent committed medical malpractice and violated

Subsection 458.331(1)(t), Florida Statutes (2005), by

prescribing medications to Patient M.R. without obtaining or

reviewing any medical information related to the patient. The

evidence establishes that the Respondent failed to practice

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

recognized by a reasonably prudent similar physician as being

acceptable and appropriate under similar conditions and

circumstances.

30. The evidence clearly and convincingly establishes that

the Respondent violated Subsection 458.331(1)(q), Florida

Statutes (2005), by inappropriately prescribing hydrocodone, a

controlled substance, to Patient M.R. without obtaining or

reviewing any medical information related to the patient.

31. The evidence clearly and convincingly establishes that

the Respondent violated Subsection 458.331(1)(m), Florida

Statutes (2005), by failing to keep any medical records to

justify the course of treatment. The evidence establishes that

the Respondent kept no records at all related to Patient M.R.

32. The Respondent asserts that a physician's assistant

was responsible for obtaining medical information from the

patient, performing a medical evaluation of the patient,

diagnosing the patient's medical condition, issuing the

prescription, and documenting the information. The

documentation was supposedly maintained by the owners of the

ERMeds Internet website. There is no credible evidence to

support the exculpatory assertions, and they have not been

credited.

33. Paragraphs 13 through 15 of the Amended Administrative

Complaint alleged that, on September 23, 2006, Patient M.R. was

taken to a hospital emergency department after being found by

his wife cold and unresponsive"; that attempts to resuscitate

the patient were unsuccessful; and that on September 28, 2006,

an autopsy identified the cause of death as "acute hydrocodone

intoxication."

34. The Petitioner presented no evidence whatsoever to

support the allegations of paragraphs 13 through 15. Further,

there is no credible evidence that the patient received or

ingested the medication identified on the prescriptions at issue

in this proceeding.

35. Dr. Wollschlaeger testified based upon his review of

materials provided to him by the Respondent, which included a

number of emails, all of which were hearsay. During cross-

examination, it became apparent that some of the documents

reviewed by Dr. Wollschlaeger lacked any information identifying

either the patient or the internet website relevant to this

proceeding. The testimony specifically related to the email

documents has been disregarded.

36. Dr. Wollschlaeger also testified as to his

understanding of the manner in which medication prescriptions

can be obtained through the internet. His testimony in this

regard was corroborated by the deposition testimony and

admissions of the Respondent concerning the operation of ERMeds.

Accordingly, Dr. Wollschlaeger's opinions related to the

standard of care applicable to a physician issuing or

authorizing prescriptions through an internet-based service are

credited.

37. The Respondent has not been the subject of any prior

disciplinary proceedings. Florida Administrative Code

Rule 64B8-8.001 sets forth the disciplinary guidelines

applicable to the statutory violations relevant to this

proceeding.

38. Florida Administrative Code Rule 64B8-8.001(2)

provides that the penalty for a first offense of

Subsection 458.331(1)(m), Florida Statutes, ranges from a

reprimand to denial or two years' suspension followed by

probation, and an administrative fine from $1,000.00

to $10,000.00.

39. Florida Administrative Code Rule 64B8-8.001(2)

provides that the penalty for a first offense of

Subsection 458.331(1)(q), Florida Statutes, ranges from a one-

year period of probation to revocation or denial and an

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

40. Florida Administrative Code Rule 64B8-8.001(2)

provides that the penalty for a first offense of

Subsection 458.331(1)(t), Florida Statutes, ranges from a one-

year period of probation to revocation or denial and an

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

41. Florida Administrative Code Rule 64B8-8.001(3)

provides as follows:

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 inuring

to the applicant or licensee;

(g) The involvement in any violation of

Section 458.331, F.S., 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) Where a licensee has been charged with

violating the standard of care pursuant to

Section 458.331(1)(t), F.S., but the

licensee, who is also the records owner

pursuant to Section 456.057(1), F.S., fails

to keep and/or produce the medical records.

(i) Any other relevant mitigating factors.

42. In this case, the Respondent twice prescribed

Schedule II and III medications to a patient with whom he had no

interaction. The Respondent failed to review any medical

information related to the patient prior to the prescriptions

being issued. There is no credible evidence that any

physician's assistant obtained any medical information from the

patient or conducted any medical evaluation of the patient on

behalf of the Respondent. The issuance of two prescriptions for

hydrocodone under these circumstances exposes the patient and

public to potential injury.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law, it is RECOMMENDED that the Department of Health enter a

final order finding Gerard Romain, M.D., in violation of

Florida Statutes (2005), and imposing a penalty as follows: a

reprimand; a three-year period of probation, the first year of

which shall include a prohibition on issuing prescriptions for

Schedule II and III controlled substances; an administrative

fine of $20,000.00; and such additional continuing education and

community service requirements as the Department of Health

determines appropriate.

DONE AND ENTERED this 23rd day of September, 2008, in

Tallahassee, Leon County, Florida.

S

WILLIAM F. QUATTLEBAUM

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 23rd day of September, 2008.

COPIES FURNISHED :

Elana J. Jones, Esquire

Ephraim D. Livingston, Esquire

Department of Health

4052 Bald Cypress Way, Bin C-65

Tallahassee, Florida 32399-3265

Dale R. Sisco, Esquire

Stacy Estes, Esquire

Sisco-Law

Post Office Box 3382

Tampa, Florida 33601-3382

Josefina M. Tamayo, General Counsel

Department of Health

4052 Bald Cypress Way, Bin A-02

Tallahassee, Florida 32399-1701

Larry McPherson, Executive Director

Board of Medicine

4052 Bald Cypress Way

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.