06-003954PL Department Of Health, Board Of Medicine vs. Rameshibhai P. Patel, M.D. Status: Closed Recommended Order on Monday, March 26, 2007.

Summary: Respondent failed to tell the patient that a lump in her breast was indeterminate. Based on Respondent`s representation that the lump was benign, the patient elected to watch the lump rather than have a biopsy.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF )

MEDICINE , )

)

Petitioner , )

)

vs. ) Case No. 06 - 3954PL

)

RAMESHIBHAI P. PATEL, M.D. , )

)

Respondent . )

)

RECOMMEN DED ORDER

Pursuant to notice, a final hearing was held in this case

on January 10, 2007, in Titusville, Florida, before Susan B.

Harrell, a designated Administrative Law Judge of the Division

of Administrative Hearings.

APPEARANCES

For Petitioner: Ephr ai m Livingston, Esquire

Department of Health

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 32399 - 3265

For Respondent: Gregory A. Chaires, Esquire

Chaires & Hammond

283 Cranes Roost Blvd., No. 165

Altamonte Springs, Florida 32701

STATEMENT OF THE ISSUES

The issues in this case are whether Respondent violated

Subsection 458.331(1)(t), Florida Statutes (2004) , 1 and, if so,

what discipline should be i mposed.

PRELIMINARY STATEMENT

On May 15, 2006, Petitioner, Department of Health, Board of

Medicine (Department), filed an Administrative Complaint against

Respondent, Ramesh i bhai P. Patel, M.D. (Dr. Patel), alleging

that Dr. Patel violated Subsection 458.3 31(1)(t), Florida

Statutes. Dr. Patel requested an administrative hearing, and

the case was forwarded to the Division of Administrative

Hearings on October 12, 2006, for assignment of an

Administrative Law Judge.

The final hearing was originally scheduled for December 15,

2006. On November 30, 2006, Respondent filed Respondent's

Unopposed Motion for Continuance, which was granted by O rder

dated December 11, 2006. The final hearing was rescheduled for

January 10, 2007.

On December 6, 2006, Petitioner file d Petitioner's Motion

for Official Recognition, requesting official recognition of

Subsection 458.331(1)(t), Florida Statutes, and Florida

Administrative Code Rule 64B8 - 8.001, which motion was granted by

O rder dated December 13, 2006.

On December 27, 2006, Petitioner filed Petitioner's Motion

for Leave to Amend Administrative Complaint. The motion was

granted by O rder dated January 4, 2007 , and the Amended

Administrative Complaint was deemed filed on January 4, 2007.

On January 2, 2007, the parties filed a Joint Pre - Hearing

Stipulation, in which the parties agreed to certain facts

contained in Section E of the Joint Pre - Hearing Stipulation. To

the extent relevant those agreed facts are incorporated into

this Recommended Order.

At the final hearing, the De partment called S.A. and

Armand H. Katz, M.D. as its witnesses. Petitioner's Exhibits 1

through 6 were admitted in evidence. Dr. Patel testified on his

own behalf and called Edward Meadors Copeland III, M.D. as his

witness. Respondent Exhibits 1 throug h 4 were admitted in

evidence.

The one - volume Transcript of the final hearing was filed on

January 29, 2007. The parties timely filed their Proposed

Recommended Orders , which have been considered in rendering this

Recommended Order.

FINDINGS OF FACT

1. T he Department is the state agency charged with

regulating the practice of medicine pursuant to Section 20.43

and Chapters 456 and 458, Florida Statutes.

2. Dr. Patel is a licensed physician within the state of

Florida, having been issued license number 54 617. He has been

board certified in general surgery since 1990 and has been

practicing medicine in Florida since 1989.

3. For the past 20 years, S.A. has had yearly

gynecological examinations and mammograms. In 1994, a mammogram

revealed a lump in her l eft breast. She was referred to a

specialist, who removed the lump. The biopsy revealed that the

lump was a fibroadenoma, which is a common, benign tumor of the

female breast with unknown etiology.

4. In 2004, S.A. found a lump in her right breast durin g a

self - examination. She consulted her gynecologist, Dr. Hae Soo

Lim, who had been prescribing Clomid for S.A. Dr. Lim advised

S.A. that the Clomid could be causing the lump. S.A.

discontinued taking Clomid, but the lump did not dissipate. In

August 2 004, Dr. Lim ordered a mammogram for S.A.

5. The mammogram did not reveal an abnormality in the

right breast. Because a lump could be felt on examination, S.A.

was advised to have a supplemental bilateral breast sonography.

A sonogram was performed on t he same date as the mammogram and

revealed the following as it related to the right breast:

In the area of palpable abnormality, there

is a solid hyperechoic nodule that has a

central cleft. It is more ethogenic than

the adjacent breast parenchyma and cou ld

therefore represent a focal fatty deposit or

area of breast tissue fibrosis. This

measures approximately 1.5 cm x 1.2 cm.

This is 5 mm beneath the skin surface and is

readily palpable. This is 5 cm away from

the nipple in the 12 o'clock position.

Us ing color flow Doppler imaging, no

vascular flow is demonstrated within the

lesion. This would further support probable

benign etiology. This does not have the

appearance of a complicated cyst or of a

typical fibroadenoma or malignancy.

CONCLUSION: Hyp erechoic nodule accounting

for palpable abnormality. This is not seen

mammographically. This has indeterminate

characteristics and most likely represents a

focal fatty deposit and/or area of breast

tissue fibrosis. A biopsy or excision would

be needed t o establish pathology. It is

noted that the patient states that this

fluctuates in size during the course of her

period.

6. Dr. J.M. Swalchick, who prepared the report of the

sonogram findings, recommended a surgical consultation for the

palpable abnorm ality in the right breast. Dr. Swalchick noted

in his report that he discussed his findings with S.A. at the

time of the performance of the sonogram. His discussion was

limited to telling S.A. that she should follow up with a

surgical consultation and th at he would send the report to

Dr. Lim.

7. On or about August 12, 2005, S.A. presented to

Dr. Patel for a surgical consultation and evaluation of the

mammogram and breast ultrasound reports upon referral from

Dr. Lim. Dr. Patel reviewed the mammogram, ultrasound, and the

a ccompanying radiology reports.

8. In his office notes, which were dictated within 24

hours of S.A.'s visit, Dr. Patel made the following findings

during his examination of S.A.'s right breast:

Patient has a small palpable nodule in t he

right breast at 12:00 to 11:00 position and

appears to be right under the skin. Appears

to be more likely a simple fibroadenoma

without any skin dimpling or any nipple or

skin retraction. Patient did not have any

axillary adenopathy.

9. Dr. Patel ma de the following notation of S.A.'s

August 12, 2004, office visit:

Patient was explained regarding her

mammogram, regarding her ultrasound exam and

also regarding various breast problems with

the help of the booklet on the breast

disorders and was advised that what appears

to be a palpable nodule seen on the

ultrasound is a fibroadenoma and she can be

followed clinically and will advise her to

be seen again in six months in follow up.

Patient explained that if she wants this to

be removed, it can be remov ed either in the

office or in outpatient surgery and the

patient is agreeable to have simple follow

up done and will be seen again in six

months.

10. Dr. Patel does not have a specific recollection of

S.A.'s office visit on August 12, 2004, other than wh at he wrote

in the patient's chart. Dr. Patel's office notes comport with

S.A.'s testimony that he told her that she had a fibroadenoma.

He did not tell S.A. that the lump was indeterminate. Based on

Dr. Patel's representation that the lump was a fibroa denoma,

S.A. elected to wait and return to Dr. Patel in six months for a

follow - up visit.

11. There is conflict between S.A.'s testimony and

Dr. Patel's office notes concerning whether he explained the

mammogram and ultrasound to her and whether he showe d her a

booklet on breast disorders. I credit Dr. Patel's office notes

in that he did discuss the mammogram and ultrasound tests with

S.A. and that he did go over a booklet with S.A. on various

breast disorders. Additionally, I credit Dr. Patel's notes t hat

he told her that he could re move the nodule in his office if she

desired. However, I credit S.A. 's testimony that Dr. Patel told

her that she had a benign fibroadenoma and had nothing to worry

about. Had Dr. Patel told her that the lump was indetermi nate,

S.A. could have made an informed decision concerning the removal

of the mass versus waiting six months to see what would happen.

11. On February 22, 2005, S.A. returned to Dr. Patel's

office for a follow - up visit. The lump was still present.

Based on Dr. Patel's office notes, he was still under the

impression that the lump was a benign fibroadenoma. He told her

that he would remove the lump in his office under local

anesthesia. Another office visit was scheduled to remove the

lump.

12. On or ab out March 8, 2005, Dr. Patel excised the

breast mass in his office using local anesthesia. A biopsy of

the excised tissue revealed that S.A. had an infiltrating ducal

carcinoma (breast cancer).

13. On or about March 14, 2005, Dr. Patel performed a

right partial mastectomy on S.A.

14. Dr. Armand H. Katz testified as an expert for the

Department. Dr. Katz's testimony is credited that the standard

of care required that Dr. Patel tell S.A. that the lump was

indeterminate and could be cancerous.

CONCLUSIONS OF LAW

15. 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. (2006).

16. The Department bears the burden to establish the

allegations in the Amended Administrative Complaint by clear and

convincing evidence. Department of Banking and Finance v.

Osborne Stern and Company , 670 So. 2d 932 (Fla. 1996). In the

Amended Administrative Complaint, the Department alleges that

Dr. Patel violated Subsection 458. 331(1)(t), Florida Statutes,

which provides:

(1) The following acts constitute grounds

for denial or a license or disciplinary

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

* * *

(t) Gross or repeated malpractice or the

failure to practice medicine wi th 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 used

in this paragraph, "gross malpractice" or

"the failure to practice medi cine 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," shall not be

construed so as to require more than one

instance, event, or act. 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. . . .

17. The Department further alleges that Dr. Patel violated

Subsection 458.331(1)(t ), Florida Statutes, by the following

acts:

A . By failing to inform/explain to Patient

S.A. that the palpable mass/lesion on her

right breast's [sic] nature was

indeterminate;

B . By failing to adequately inform Patient

S.A. that the palpable mass/lesion on her

right breast was not a fibroadenoma, but an

indeterminate lesion.

17. The Department has established by clear and convincing

evidence that Dr. Patel violated 458.331(1)(t), Florida

Statutes , by failing to tell S.A. that the lump in her breast

was indeterminate. He told her that the lump was a benign

fibroadenoma. Dr. Patel should have informed S.A. that the lump

was indeterminate and could be cancerous. Dr. Patel failed to

practice medicine with that level of skill, care, and treatment

which is recognized by a reasonably prudent similar physician as

being acceptable under similar conditions and circumstances.

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

provides that the range of penalties for a violation of

Subsection 458.331(1)(t), F lorida Statutes, is from two year's

probation to revocation and an administrative fine from $1,000

to $10,000.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law, it is

RECOMMENDED that :

A Final Order be entered finding that Dr. Ramesh i bhai P.

Patel violated Subsection 458.331(1)(t), Florida Statutes;

placing him on probation for one year with indirect supervision,

with the terms to be set by the Board of Medicine; requiring

completion of five hours of continuing medical education in risk

management; and imposing an administrative fine of $1,000.

DONE AND ENTERED this day of , , in

Tallahassee, Leon County, Florida.

S

SUSAN B. HARRELL

Administrative Law Judge

Division of Admini strative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399 - 3060

(850) 488 - 9675 SUNCOM 278 - 9675

Fax Filing (850) 921 - 6847

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this day of , .

ENDNOTE

1/ Unless otherwise indicated, all references to the Florida

Statutes are to the 2004 version.

COPIES FURNISHED :

Ephraim D. Livingston, Esquire

Department of Health

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 3239 9 - 3265

Gregory A. Chaires, Esquire

Chaires Hammond, P.L.

283 Cranes Roost Boulevard, Suite 165

Altamonte Springs, Florida 32701

Larry McPherson , Executive Director

Department of Health

Board of Medicine

4052 Bald Cypress Way, Bin C03

Tallahassee, Florid a 32399 - 1701

R. S. Power, Agency Clerk

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399 - 1701

Josefina M. Tamayo, Gen. Co.

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399 - 1701

Dr. Ana M. Via monte 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.