STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD ) OF MEDICINE, )

)

Petitioner, )

)

vs. ) Case No. 99-0306

)

HOWARD B. RUBIN, M.D., )

)

Respondent. )

)

RECOMMENDED ORDER

Robert E. Meale, Administrative Law Judge of the Division of Administrative Hearings, conducted the final hearing in Tampa, Florida, on June 17, 1999.

APPEARANCES

For Petitioner: Britt Thomas, Senior Attorney

Agency for Health Care Administration Fort Knox Building 3, Suite 3431

2727 Mahan Drive

Tallahassee, Florida 32308

For Respondent: William B. Taylor, IV

Macfarlane, Ferguson & McMullen Post Office Box 1531

Tampa, Florida 33601-1531 STATEMENT OF THE ISSUE

The issue is whether Respondent failed to practice medicine at the level of care, skill, and treatment that is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances and, if not, the penalty.

PRELIMINARY STATEMENT

By Administrative Complaint dated June 1, 1998, Petitioner alleged that Respondent is a licensed physician, holding license number ME 0026784. The Administrative Complaint alleges that Respondent is a Board-certified radiologist.

The Administrative Complaint alleges that, on January 30, 1997, a 30-year-old female, who was 32 weeks pregnant, presented at the Columbia Largo Medical Center with severe left flank pain consistent with a history of kidney stones, which were confirmed by x-rays.

The Administrative Complaint alleges that a urologist, after being unable to place a stent and catheter past the stone, requested Respondent to perform a nephrostomy. The Administrative Complaint alleges that, on February 1, 1997, Respondent inserted a percutaneous nephrostomy tube, but only a small amount of fluid began draining out the tube. The patient allegedly continued to improve and was discharged the next day.

The Administrative Complaint alleges that a reasonably prudent physician under similar conditions and circumstances should have known, when urine did not pour out of a patient with a blocked kidney, that the tube was incorrectly placed. The Administrative Complaint alleges: "When only a trickle was noted to be intermittently draining, Respondent should have known something was wrong and confirmed the location of the tube by x-ray."

The Administrative Complaint alleges that the patient presented on February 5, 1997, at the St. Petersburg Medical Center with complaints of pain. Hospital physicians allegedly placed dye in the tube and found that it was located in the spinal column. Because the dye is contraindicated in the spinal canal, the patient allegedly underwent a series of violent maternal convulsions. Physicians attempted an emergency

C-section delivery, but were unable to save the baby.

The Administrative Complaint alleges:

Respondent incorrectly inserted a percutaneous nephrostomy tube into a pregnant female patient's spinal canal. When only a small amount of fluid began draining out of a kidney which had been obstructed for some time the Respondent should have recognized that something was wrong and attempted to confirm the location of the tube by x-ray.

. . .

The Administrative Complaint alleges that Respondent thus violated Section 458.331(1)(t), Florida Statutes, by failing to practice medicine with that level of care, skill, and treatment that is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances.

Respondent requested a formal hearing.

At the hearing, Petitioner called three witnesses and offered into evidence three exhibits. Respondent called two witnesses and offered into evidence three exhibits. All exhibits were admitted.

The court reporter filed the Transcript on July 9, 1999.

FINDINGS OF FACT

1. Respondent is a licensed physician, holding license number ME 0026784. He is Board-certified in radiology.

2. On January 30, 1997, T. D., a 30-year-old female who was eight months pregnant, presented to the emergency room of the Columbia Largo Medical Center complaining of pain in the left flank radiating to the left groin, together with nausea and vomiting. She also reported a prior history of kidney stones.

3. A urologist diagnosed T. D. as suffering from kidney stones and severe hydronephrosis, which is the dilation of the kidney due to an obstruction in the flow of urine. The urologist was unable to pass a stent and catheter by the stones to drain the urine and relieve the pressure on the kidney, so he asked Respondent to perform a left percutaneous nephrostomy.

4. A percutaneous nephrostomy is a procedure in which a physician places a tube through the skin and into the collecting system of the kidney to drain the kidney. The tube remains in place until the obstruction is removed.

5. On February 1, Respondent performed a left percutaneous nephrostomy under local anaesthesia. For guidance in placing the tube, Respondent used ultrasound, rather than ultrasound and a flouroscopy.

6. Respondent has performed 100-150 nephrostomies. As is the common practice, he normally does not rely exclusively ultrasound in guiding the placement of the tube in the kidney.

   In this case, the urologist asked that he not use a flouroscopy, in deference to the patient's pregnancy and the duration of x-ray exposure in a flouroscopy. Respondent was comfortable doing the procedure in this manner, although he decided that, if he encountered any problems in placement, he would resort to flouroscopy.

7. Respondent proceeded to perform the percutaneous nephrostomy in the morning. As is typical, the radiology technician helped position T. D. on the table for the procedure.

8. T. D.'s advanced pregnancy necessitated a slight adjustment to the normal posture of patients being prepared for this procedure, so T. D. lay slightly more up on her side than is usual. However, this did not change the point of entry chosen by Respondent. And, regardless of her precise position, the location of the spinal canal relative to the kidney relative to the point of entry into the skin remains constant: an imaginary line from the kidney to the spinal canal is perpendicular to an imaginary line from the point of entry to the kidney.

9. The point of entry is on the lower back of the patient.

   
   

   T. D. is thin and her pregnancy did not manifest itself on her back, so the length of tube used by Respondent was relatively short. T. D.'s thin build makes it less likely that Respondent would have placed sufficient excess tube into the patient so as to permit the tube to run from the kidney to the spinal cord.

10. Upon placement of the tube, at least 100 cc of fluid drained through the tube. This is well within the range of urine that would be expected under the circumstances. The color was well within the range of color for urine. The preponderance of the evidence indicates that the fluid was urine and that Respondent had placed the tube correctly in the kidney. At the end of the procedure, T. D. appeared a lot more comfortable.

11. Late in the afternoon, someone called Respondent and told him that the drainage had slowed to a very small amount or nothing at all. This is not uncommon, as moving the patient or over-energetic nurses may accidentally dislodge the stent in the kidney. It is also possible that the tube has rested in a part of the kidney that does not facilitate maximum drainage.

12. Using ultrasound, Respondent confirmed that the tube remained in place in the kidney, although he could not tell whether the stent had come to rest in a narrow place in the kidney or possibly even against a stone. Even with this uncertainty, Respondent still was able to determine that the stent was predominantly in the collecting system. Because T. D. was resting comfortably, she said that she felt fine, her fever was going down, and the hydronephrosis had decreased, Respondent decided to do nothing until after re-examining T. D. the next morning.

13. However, at about 11:00 p.m. or midnight, Respondent, who was visiting a nearby patient, dropped in on T. D. The nurse

    said that she was fine and her kidney was draining a little better. T. D. also said that she was feeling fine.

14. About three or four hours later, T. D. reported a feeling of some paralysis. Petitioner's expert testified that this was linked to the misplacement of the stent in the spinal canal, but he was unaware that T. D. had undergone a spinal block for the percutaneous nephrostomy and that a problem with the first anaesthetic procedure had necessitated a second. It is more likely that T. D.'s paralysis was in response to the two spinal blocks.

15. At 9:00 a.m. the next day, Respondent returned and examined T. D. He found that she was still doing better, and her urologist was preparing to discharge her from the hospital. She looked better, and her urine flow had improved. He told her to call him if she had any problems, but he never heard from her again or even about her until he learned from the urologist that

    T. D. had been admitted to another hospital where a radiologist had inserted contrast material into the tube to locate the stent and found it in the spinal canal.

16. The father of the baby picked up T. D. at the Columbia Largo Medical Center. He picked her up out of the wheelchair and placed her in the car. Her condition deteriorated once she got home.

17. A hospital nurse directed the father to change the collection bag, if it filled prior to the visit of the home

    health care nurse. In the three or four days that T. D. remained at home, he changed the bag several times. He daily checked the site at which the tube entered T. D.'s skin and noticed that it had pulled out a little bit. However, he testified that he did not try to adjust the length of tube inside T. D., nor did he change the setting on the tube, which had "open" and "closed" settings for the pigtail at the end of the tube. The proper setting was closed, as the pigtail is not to be open once the stent has reached its destination in the kidney.

18. On February 5, the father took T. D. to the emergency room of the Columbia St. Petersburg Medical Center, where she presented with complaints of severe back pain. An ultrasound confirmed the presence of kidney stones, whose removal had been deferred until the delivery of the baby. In an effort to locate the end of the tube, a radiologist inserted radiographic contrast dye, which showed that the end of the tube was in the intrathecal space of the spine. A urologist removed the tube. However,

    T. D. suffered a seizure. Another physician attempted an emergency C-section, but the baby did not live.

19. There are two alternatives to explain how the stent at the end of the tube found its way into the spinal canal. First, Respondent placed it there during the procedure. Second, it migrated from the kidney, where Respondent placed it, to the spinal canal. If not unprecedented, both alternatives are extremely rare.

20. The drainage during the procedure and initial improvement of the distended kidney are consistent with the proper initial placement of the stent. The difficulty of inadvertently turning a relatively short length of tube 90 degrees from the kidney to the spinal canal also militates against a finding that Respondent misinserted the tube. Problems with the first spinal tap may have contributed to some of the complaints, such as paralysis, that T. D. experienced after the procedure.

21. Although unlikely, the migration alternative would be consistent with well-intended, but incorrect, attempts by the baby's father or a home health care nurse to ensure that the tube did not travel too far in or our of the point of entry.

    Migration would be facilitated if either the father or nurse misread the "open" and "closed" settings and turned to "open," in the hope of improving drainage, when such a setting opens the pigtail, which would increase the possibility that the stent could migrate into the spinal canal.

22. In a case requiring proof that is clear and convincing, it is impossible to find that Petitioner has adequately proved that Respondent misinserted the tube during the procedure. Likewise, the evidence is not clear and convincing that Respondent should have recognized at anytime prior to T. D.'s discharge from the Columbia Largo Medical Center that something was wrong with the procedure that he had performed or that he

    needed to confirm by x-ray the location of the stent at the end of the tube.

    CONCLUSIONS OF LAW

    
    

23. Division of Administrative Hearings has jurisdiction over the subject matter. Section 120.57(1), Florida Statutes. (All references to Sections are to Florida Statutes.)

24. Section 458.331(1)(t) authorizes Petitioner to discipline Respondent for:

    Gross or repeated malpractice or the 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. The board shall give great weight to the provisions of s. 766.102 when enforcing this paragraph. . . . As used in this paragraph, "gross malpractice" or "the 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," 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.

25. Petitioner must prove the material allegations by clear and convincing evidence. Department of Banking and Finance v. Osborne Stern and Company, Inc., 670 So. 2d 932 (Fla. 1996) and Ferris v. Turlington, 510 So. 2d 292 (Fla. 1987).

26. Petitioner has failed to prove the material allegations of the Administrative Complaint.

RECOMMENDATION

It is

RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint.

DONE AND ENTERED this 2nd day of August, 1999, in Tallahassee, Leon County, Florida.

ROBERT E. MEALE

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 2nd day of August, 1999.

COPIES FURNISHED:

Britt Thomas, Senior Attorney

Agency for Health Care Administration Fort Knox Building 3, Suite 3431

2727 Mahan Drive

Tallahassee, Florida 32308

William B. Taylor, IV Macfarlane, Ferguson & McMullen Post Office Box 1531

Tampa, Florida 33601-1531

Angela T. Hall, Agency Clerk Department of Health

Bin A02

2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701

Pete Peterson, General Counsel Department of Health

Bin A02

2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701

Tanya Williams, Executive Director Board of Medicine

Department of Health 1940 North Monroe Street

Tallahassee, Florida 32399-0750

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 must be filed with the agency that will issue the final order in this case.

Docket for Case No: 99-000306

Orders for Case No: 99-000306