STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF ) MEDICINE, )

)

Petitioner, )

)

vs. )

)

JAMES P. WEINER, M.D., )

)

Respondent. )

Case No. 05-2648PL

)

RECOMMENDED ORDER

Pursuant to notice, a final hearing was held in this case on January 11, 2006, via video teleconference with sites in Fort Myers and Tallahassee, Florida, before Susan B. Harrell, a designated Administrative Law Judge of the Division of Administrative Hearings.

APPEARANCES

For Petitioner: Lynne A. Quimby-Pennock, Esquire

Department of Health

4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265

For Respondent: Sean M. Ellsworth, Esquire

Ellsworth Law Firm, P.A.

404 Washington Avenue, Suite 750 Miami Beach, Florida 33139

STATEMENT OF THE ISSUES

Whether Respondent violated Subsection 456.072(1)(aa), Florida Statutes (2003),1 and, if so, what discipline should be imposed.

PRELIMINARY STATEMENT

On April 26, 2005, Petitioner, Department of Health, Board of Medicine (Department), filed an Administrative Complaint against Respondent, James P. Weiner, M.D. (Dr. Weiner), alleging that he violated Subsection 456.072(1)(aa), Florida Statutes.

Dr. Weiner requested an administrative hearing, and the case was forwarded to the Division of Administrative Hearings on July 26, 2005, for assignment to an administrative law judge.

On September 6, 2005, Dr. Weiner filed Dr. Weiner's Motion for Brief Continuance, which was granted by order dated September 8, 2005. On October 13, 2005, Dr. Weiner filed

Dr. Weiner's Motion for Continuance, which was granted by order dated October 14, 2005. The final hearing date was rescheduled for January 11, 2006.

Prior to the final hearing, the parties submitted a Joint Pre-Hearing Stipulation, which contained facts to which the parties agreed. Those facts which are contained in Section E of the Joint Pre-hearing Stipulation are incorporated into this Recommended Order to the extent relevant.

At the final hearing, the Department called S.M. and

Dr. Weiner as its witnesses. Petitioner's Exhibits 1 through 5 were admitted in evidence. Dr. Weiner testified on his own behalf and called Dagmar Walker, R.N., as his witness.

Dr. Weiner did not offer any exhibits into evidence.

The Transcript was filed on January 30, 2006. The parties filed their Proposed Recommended Orders on February 9, 2006.

The parties' Proposed Recommended Orders have been considered in rendering this Recommended Order.

FINDINGS OF FACT

1. The Department is the state agency charged with the regulation of medicine pursuant to Chapters 20, 456, and 458, Florida Statutes.

2. Dr. Weiner, is and was at all times material to this proceeding, a licensed physician in the State of Florida, having been issued license number ME76902. He has been practicing medicine for 23 years and has not previously been the subject of a disciplinary proceeding. Dr. Weiner is board-certified in anesthesiology.

3. S.M. has been a patient of Dr. Weiner since 1999.

   
   

   S.M. sought treatment from Dr. Weiner for his lower back pain that he suffered as a result of a golf cart injury. Over the course of his care under Dr. Weiner up until the date of the

   incident, S.M. received numerous treatments for his back pain, including radiofrequency ablation and epidural steroids.

4. Radiofrequency ablation uses a specific frequency of radio waves to help put specific pain nerves that go to the joints of the spine to sleep for a period of time. In this procedure a steroid is deposited inside the epidural space outside the spine. The procedure can help to treat back pain as well as pain extending down the legs of the patient.

5. On January 29, 2005, S.M. presented to Dr. Weiner with complaints of lower back pain. After examining S.M., Dr. Weiner recommended that S.M. undergo a radiofrequency ablation procedure.

6. Dr. Weiner ordered the radiofrequency ablation procedure and instructed his office to coordinate with the Center for Digestive Health and Pain Management (Center), to have the procedure scheduled. The Center, which is a separate facility from Dr. Weiner's office, scheduled S.M.'s treatment for February 19, 2004. The Center scheduled S.M. for a Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, rather than the radiofrequency ablation procedure.

7. A Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, involves placing a needle down near the tailbone. A catheter is inserted through the needle into the space around the spine. A steroid medication is injected

   through the catheter. The purpose of the procedure is to decrease irritation and inflammation of the nerves as well as the discs. S.M. could have derived some benefit from the Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach.

8. Patient charts at the Center are separate from the patient charts at Dr. Weiner's office. The Center's charts are made up by the Center staff and consist of forms for the specific procedure, a template of the procedure for the specific procedure, the nursing notes, billing sheets, and other administrative paperwork. When the Center erroneously scheduled

   S.M. for a Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, the Center prepared paperwork necessary for the provision of that technique, including consent forms.

9. On February 19, 2004, S.M. went to the Center with the belief that he was going to receive the radiofrequency ablation procedure. During this visit, S.M. was in a lot of pain and was eager to receive treatment for his back.

10. Upon arrival to the Center, S.M. signed a consent form that referenced a Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach procedure. The nurse then confirmed with S.M., the technician, and Dr. Weiner that S.M. understood this procedure. Dr. Weiner also explained the Fluoroscopic

    Epidural Steroid Injection, RACZ Technique, caudal approach, to

    
    

    S.M before administering the treatment and also told S.M. that this was the first time he had undergone this procedure while under Dr. Weiner's care.

11. Subsequent to signing the consent form, S.M. got undressed and was hooked up to an IV. He was then moved to another bed, and Dr. Weiner started to perform the Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, on

    S.M. Dr. Weiner administered a local anesthesia and began to insert the tip of a needle into S.M.'s back.

12. After partially inserting the needle in S.M.'s back, Dr. Weiner stopped the procedure and reviewed S.M.'s chart. He requested that S.M.'s chart that was in Dr. Weiner's office be brought to the Center. The chart revealed that the Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, was not the procedure that was originally ordered at S.M.'s appointment on January 29, 2004.

13. Once he realized the discrepancy, Dr. Weiner apologized to S.M. and explained that he began to do the wrong procedure. S.M. was then taken to the recovery room, and

    Dr. Weiner ordered the radiofrequency ablation procedure for a later date.

14. S.M. did not receive the complete Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, procedure on February 19, 2005.

15. In or about March 2004, S.M. returned to the Center and had the radiofrequency ablation procedure completed.

    CONCLUSIONS OF LAW

    
    

16. 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. (2005).

17. The Department has the burden to establish by clear and convincing evidence the allegations in the Administrative Complaint. Department of Banking and Finance v. Osborne Stern and Co., 670 So. 2d 932 (Fla. 1996). The Department has alleged that Dr. Weiner violated Subsection 456.072(1)(aa), Florida Statutes, which provides that the following acts constitute grounds for disciplinary action:

    Performing or attempting to perform health care services on the wrong patient, a wrong- site procedure, a wrong procedure, or an unauthorized procedure or a procedure that is medically unnecessary or otherwise unrelated to the patient's diagnosis or medical condition. For the purposes of this paragraph, performing or attempting to perform health care services includes preparation of the patient.

    
    

18. The Department alleged that Dr. Weiner violated Subsection 456.072(1)(aa), Florida Statutes, by "performing the

    wrong surgical procedure on Patient S.M." The Department has established this allegation by clear and convincing evidence. Dr. Weiner ordered that S.M. undergo radiofrequency ablation during a regular office visit. When S.M. went to the Center for this procedure at a later date, Dr. Weiner received consent and started to perform the Fluoroscopic Epidural Steroid Injection, RACZ Technique, caudal approach, but then halted the process.

    Dr. Weiner testified that the patient was originally scheduled for the radiofrequency ablation and that the wrong procedure was attempted on S.M. at the Center. Nonetheless, Dr. Weiner argues that he was authorized to perform the treatment because the patient signed a consent form and verbalized an understanding of the procedure. However, the Department is only alleging that Dr. Weiner performed the "wrong procedure," rather than focusing on whether valid consent was obtained. Therefore, it is irrelevant that S.M. consented to the treatment before the procedure was initiated; the wrong procedure was attempted on

    S.M. regardless.

    
    

19. The disciplinary guidelines of the Board of Medicine found at Florida Administrative Code Rule 64B8-8.001 provide a range of penalties for a violation of Section 456.072, Florida Statutes.

20. The penalty for a violation of Subsection 456.072(1)(aa), Florida Statutes, ranges from a $10,000 fine,

    a letter of concern, a minimum of five hours of risk management education, a minimum of 50 hours of community service, and one- hour lecture on wrong-site surgery in the State of Florida to revocation for a first-time offense.

21. Florida Administrative Code Rule 64B8-8.001 provides that the Board of Medicine may deviate from the penalty guidelines based on the following aggravating or mitigating factors:

    1. Exposure of patient or public to injury or potential injury, physical or otherwise: none, slight, severe, or death;

    2. Legal status at the time of the offense: no restraints or legal constraints;

    3. The number of counts or separate offenses established;

    4. The number of times the same offense or offenses have previously been committed by the licensee or applicant;

    5. The disciplinary history of the applicant or licensee in any jurisdiction and the length of practice;

    6. The pecuniary benefit or self-gain inuring to the applicant or licensee;

    7. 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.

    8. 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 or produce the records.

    9. Any other relevant mitigating factors.

22. There are mitigating circumstances which would allow for deviation from the penalty guidelines. There has been no other disciplinary action taken against Dr. Weiner during his entire healthcare career; Dr. Weiner stopped the procedure once he realized it was the wrong treatment; Dr. Weiner ordered the correct procedure, and the Center scheduled the wrong procedure;

S.M. signed a consent form after the procedure was thoroughly explained to him; S.M. had undergone other steroid treatment before this incident; and the treatment may have provided some temporary relief to S.M.'s pain.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of Law, it is

RECOMMENDED that a final order be entered finding that James P. Weiner, M.D., violated Subsection 456.072(1)(aa), Florida Statutes; issuing a reprimand; imposing a $1,000 fine; requiring 25 hours of community service; and requiring five hours of risk management education.

DONE AND ENTERED this 31st day of March, 2006, in Tallahassee, Leon County, Florida.

S

SUSAN B. HARRELL

Administrative Law Judge

Division of Administrative 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 31st day of March, 2006.

ENDNOTE

1/ Unless otherwise indicated, all references to the Florida Statutes are to the 2003 version.

COPIES FURNISHED:

Sean M. Ellsworth, Esquire Ellsworth Law Firm, P.A.

404 Washington Avenue, Suite 750 Miami Beach, Florida 33139

Lynne A. Quimby-Pennock, Esquire Department of Health

4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265

R. S. Power, Agency Clerk Department of Health

4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701

Timothy M. Cerio, General Counsel Department of Health

4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701

Larry McPherson, Executive Director Board of Medicine

Department of Health 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.

Docket for Case No: 05-002648PL

Orders for Case No: 05-002648PL