STATE OF FLORIDA DIVISION OF ADMINISTRATIVE HEARINGS
DEPARTMENT OF HEALTH, BOARD OF MEDICINE, Petitioner, vs. RAVI VELISETTI, M.D., Respondent. | ) ) ) ) ) ) ) ) ) ) ) | Case No. 08-0662PL |
RECOMMENDED ORDER
Notice was provided and on May 22, 2008, a formal hearing was held in this case. Authority for conducting the hearing is set forth in Sections 120.569 and 120.57(1), Florida Statutes (2007). The hearing location was the Marion County Government Complex, Conference Room 105, 601 Southeast 25th Avenue, Ocala, Florida. The hearing was held before Charles C. Adams, Administrative Law Judge.
APPEARANCES
For Petitioner: Greg S. Marr, Esquire
Ephraim Livingston, Esquire Department of Health
4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265
For Respondent: Michael R. D'Lugo, Esquire
Wicker, Smith, O'Hara, McCoy, Graham & Ford, P.A.
Post Office Box 2753 Orlando, Florida 32802-2753
STATEMENT OF THE ISSUE
Should discipline be imposed against Respondent's license to practice medicine, for violation of Section 458.331(1)(m) and (t), Florida Statutes?
PRELIMINARY STATEMENT
On November 7, 2002, in Case No. 2000-04679, before the Department of Health (DOH), DOH, as Petitioner, brought a Corrected Administrative Complaint against Respondent, accusing him of violations of the statute referred to in the Statement of the Issue.
Respondent was provided several options in addressing the Corrected Administrative Complaint. He chose the third option. That option was to dispute the allegations of fact contained in the Corrected Administrative Complaint. Through that option, as evidenced in the executed form provided him, Respondent asked that he be heard in accordance with Section 120.569, Florida Statutes, before an administrative law judge to resolve the dispute. He made known this choice in executing the Election of Rights Form before a notary on December 5, 2002.
On February 6, 2008, the Division of Administrative Hearings (DOAH) received the case from DOH, requesting an administrative law judge be assigned to conduct a formal hearing consistent with Respondent's request. That assignment was made by Robert S. Cohen, Director and Chief Judge of DOAH, in
reference to DOAH Case No. 08-0662PL. The assignment was to the present administrative law judge.
After two continuances, the hearing took place on May 22,
2008.
Respondent filed a Motion to Dismiss the Corrected Administrative Complaint. That motion was premised upon the adverse consequences that Respondent suffered, brought about by delay in the prosecution. Petitioner opposed the motion. On February 27, 2008, the motion was denied without prejudice to Respondent in his opportunity to preserve the record on his assertions. Further discussion concerning this opportunity is found in the hearing transcript filed June 4, 2008, submitted with this record.
On May 6, 2008, Petitioner filed a Motion to Amend Corrected Administrative Complaint, noting Respondent's objection to the motion. On May 14, 2008, the motion was granted. When the hearing commenced, Petitioner through its counsel, was allowed to clarify the Amended Corrected Administrative Complaint, by calling attention to a version which carried the signature of Greg S. Marr, as Assistant General Counsel for DOH.
The pertinent factual allegations that support the Amended Corrected Administrative Complaint are as follows:
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On or about June 1, 1995, Patient T.N., a then forty-seven (47) year old male, was admitted to Munroe Regional Medical Center for a trial intrathecal morphine injection after diagnosis of severe benign intractable pain in the thoracic spine, secondary to severe Kyphoscoliosis (a condition in which the spinal disorders of kyphosis and scoliosis occur together) with convexity to the right with collapsed vertebral bodies.
On or about June 1, 1995, Patient T.N. responded well to the procedure and reported adequate pain relief.
Therefore, Patient T.N. was scheduled for implantation of an intrathecal morphine pump.
On or about June 12, 1995, Respondent implanted a morphine pump in Patient T.N.'s abdomen.
Shortly after implantation, Patient T.N. complained of pain over the inferior aspect of the morphine pump pocket.
On or about June 19, 1995, Respondent performed a right C6-7 facet joint injection on Patient T.N.
On or about July 10, 1995, August 4, 1995, and November 17, 1995, Respondent performed revisions in the placement of Patient T.N.'s morphine pump after continued complaints of abdominal pain.
However, after the July 10, 1995, August 4, 1995, and November 17, 1995 revisions, Patient T.N. continued to complain of pain and discomfort in and around the intrathecal pump site.
On or about May 16, 1996, Respondent removed the morphine pump, the connecting catheter and the intrathecal catheter.
Following the May 16, 1996 removal, Patient T.N. continued to experience substantial unrelieved pain in and around the intrathecal pump site.
On or about February 25, 1999, an x-ray revealed that Patient T.N. had retained a portion of the intrathecal catheter from the procedure of [sic] on or about May 16, 1996.
On or about March 17, 1999, using local anesthesia the Respondent attempted to remove the intrathecal catheter from Patient
T.N. which had been left in place during the procedure of May 16, 1996.
However, Respondent was unable to remove the retained intrathecal catheter without extensive surgical dissection.
In the operative report of March 17, 1999, Respondent stated that the presence of the retained intrathecal catheter was not causing Patient T.N. any problems.
On or about October 5, 1999, a subsequent treating physician performed a lumbar laminectomy to remove the intrathecal catheter.
The removed intrathecal catheter measured approximately 17 centimeters.
As a consequence, Respondent is alleged in Count One to have violated Section 458.331(1)(t), Florida Statutes, in that:
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 under similar conditions and circumstances, in one or more of the following:
failed to remove the entire intrathecal catheter on May 16, 1996;
failed to determine nature of Patient T.N.'s pathology regarding his complaint of abdominal pain;
Failed to obtain the appropriate orthopedic or neurological assistance to remove the retained intrathecal catheter.
Based on the foregoing, Respondent violated Section 458.331(1)(t), Florida Statutes, 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 addition, Respondent is alleged in Count Two to have violated Section 458.331(1)(m), Florida Statutes, in that:
Respondent failed to keep legible medical records that justify the course of treatment of Patient T.N. based upon one or more of the following:
Failed to justify the diagnosis of Patient T.N.'s continued abdominal pain;
Failed to obtain appropriate orthopedic or neurological assistance in attempting to retrieve the retained intrathecal catheter on March 17, 1999;
Failed to justify the determination that the retained intrathecal catheter was not causing Patient T.N.'s continuing pain/problems.
Section 458.331(1)(m), Florida Statutes, provides that the Board of Medicine may take disciplinary action against a licensed physician upon the physician's failure to keep legible, as defined by department rule in consultation with the board, medical records 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.
At hearing Petitioner presented Peter Preganz, M.D., as its witness. Respondent testified in his own behalf. No other witnesses testified. The Joint Exhibits numbered one through twelve were admitted. Respondent's Exhibits numbered one and two were admitted.
Petitioner's counsel requested official recognition of Section 458.331(1)(t), Florida Statutes, in effect in 1995 and 1998 and Section 456.073(5), Florida Statutes, in effect in 2002 and 2007, as well as Florida Administrative Code Rule 61F6-20, in effect in 1995 and Florida Administrative Code Rule 64B8-8, in effect in 1998. Those requests for official recognition were granted as reflected in the hearing transcript.
Consistent with the Order of Pre-hearing Instructions, the parties' filed a Joint Pre-hearing Stipulation, as Amended. In that submission the parties have set out facts upon which they agree. The factual stipulations are reflected in the findings of fact to this Recommended Order.
After the hearing transcript was filed, the parties submitted Proposed Recommended Orders that were considered in preparing this Recommended Order.
FINDINGS OF FACT
Stipulated Facts
Petitioner is the state department charged with regulating the practice of medicine pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes.
Respondent is and has been at all times material to this matter a licensed physician in the State of Florida, having been issued license number 45978.
Petitioner has jurisdiction over Respondent's license pursuant to Chapters 456 and 458 and Section 20.43, Florida Statutes.
On or about June 1, 1995, Patient T.N., a then forty- seven (47) year old male, had been diagnosed with severe benign intractable pain in the thoracic spine secondary to severe Kyphoscoliosis with convexity to the right with collapsed vertebral bodies.
On or about June 1, 1995, Patient T.N. was admitted to Munroe Regional Medical Center for a trial intrathecal morphine injection.
On or about June 1, 1995, Patient T.N. responded well to the morphine trial procedure and reported adequate pain relief.
After the morphine trial of June 1, 1995, Patient T.N. was scheduled for implantation of an intrathecal morphine pump.
On or about June 12, 1995, Respondent placed a morphine pump in Patient T.N.'s abdomen and a catheter was placed in the space around L-3 and L-4 of the spine.
Shortly after the implantation of the morphine pump Patient T.N. complained that the pump bothered him as it moved around when he moved.
Patient T.N. complained of discomfort at the pump pocket site and on July 10, 1995, August 4, 1995, and
November 17, 1995, Respondent performed interventions in order to alleviate these concerns.
On or about May 16, 1996, Respondent removed the morphine pump and part of the intrathecal catheter system.
On or about February 25, 1999, an x-ray revealed that a portion of the intrathecal catheter from the procedure of on or about May 16, 1999, remained in Patient T.N.'s body.
On or about March 17, 1999, using local anesthesia, removal of the retained catheter piece was attempted by Respondent.
On or about March 17, 1999, Respondent was unable to remove the retained portion of the intrathecal catheter without extensive surgical dissection.
In the operative report of March 17, 1999, Respondent stated that the presence of the retained portion of the intrathecal catheter was not causing Patient T.N. any problems.
On or about October 5, 1999, a subsequent treating physician performed a lumbar laminectomy on Patient T.N. and removed the retained portion of the intrathecal catheter.
The removed portion of the intrathecal catheter measured approximately seventeen (17) centimeters in length. Respondent's Care of Patient T.N.
Respondent has practiced medicine in Ocala, Florida, since 1985. At present he works for Anesthesia Care Team, which provides anesthesia services at Munroe Regional Medical Center.
Before being licensed to practice medicine in Florida, Respondent finished medical school in India. He undertook four years of surgical training in New Orleans, Louisiana. Then he went to Cincinnati, Ohio, and did a year of house physicianship, followed by one year rotating internship at St. Thomas Hospital, Akron, Ohio. He received anesthesia training at Chicago Medical Center of Chicago, Illinois. Following his training he moved to Ocala, Florida.
As part of Respondent's anesthesia practice, he commenced a sub-specialty in pain management. He practiced pain management from 1987 into 1998.
One of the patients seen for problems associated with pain was Patient T.N. The patient came to Respondent complaining of pain in the upper back and neck, with thoracic kyphoscoliosis, related to curvature of the spine. This was the
result of a motor vehicle accident that the patient had been involved in 10 years before he was seen by the Respondent.
Respondent diagnosed the patient's condition as chronic benign intrathecal pain in the upper back, secondary to kyphoscoliosis.
Respondent initially saw Patient T.N. on January 5, 1995. At first, Respondent employed conservative measures to try and control the patient's pain. The complaints consisting of neck pain and upper shoulder pain were addressed with trigger point injections and oral pain medications. The patient continued to complain of severe pain and needed greater amounts of pain medication to address his concerns. On the scale for the subjective measurement of pain, the patient reported a level of eight to nine.
Ultimately, Respondent determined that the use of a morphine pump would serve the patient best in addressing the condition. Preliminary to the implementation of the morphine pump, the patient was provided a trial injection with a small amount of morphine. The trial was well tolerated and the patient gained relief from his discomfort.
Before proceeding with the implantation, the patient was sent to a psychologist for testing. The visit to the psychologist was made on May 30, 1995, with a report by
Dr. Ferrell, the psychologist, that Patient T.N. was perceived as a good candidate for the placement of an intrathecal morphine
pump. The patient had reported to the psychologist that he had taken pain medications for a long period of time and believed himself to be addicted to pain medications. With this in mind, Respondent thought that it would be appropriate to try and manage the pain by the use of the morphine pump which provided a small amount of medication at any given time. This was all done in the interest of improving the quality of life experienced by the patient.
Respondent is not unfamiliar with the implementation of morphine pumps. He has performed that procedure more than 50 times. The protocol for this undertaking includes the decision on the candidacy for such placement. As described, that decision here was supported by the trial and the results of the psychological testing. Respondent also gained Patient T.N.'s consent for the implantation.
The morphine pump used on Patient T.N. was the Medtronic Model 8703W. The list of possible complications in association with the use of that pump, about which Respondent was aware, included the possibility of excessive bleeding, catheter breakage and infection of the pump pocket in association with the pump placement and circumstances beyond that point.
The mechanisms involved with the morphine pump include the morphine pump, that fits in a surgically created pocket in
the right or left abdominal wall, the portion of the catheter system extending from the pump, an intrathecal portion of the catheter system and connectors that link up the parts of the catheter system and the morphine pump.
On June 12, 1995, when Respondent placed the morphine pump with catheter in Patient T.N., this procedure was performed with the provision of spinal anesthesia. The procedure is described in the operative report, Joint Exhibit numbered one. Respondent used fluoroscopy to identify the lumbar interspaces. As the operative report prepared by Respondent describes, "The spinal connecting catheter and intrathecal catheter were trimmed to the appropriate size and a small loop was created over the lumbar spine. Both catheters were connected with a metal connector." No indication was given as to specific measurements in association with the catheter system before it was placed and after its placement. In the June 1995 surgery no measurement was made of the catheter because Respondent did not deem that necessary. In particular, Respondent does not believe that the standard of care incumbent upon him requires him to measure the length of the catheter placed in the patient or removed from the patient.
The procedure performed required a small incision into the intrathecal space, leaving the intrathecal portion of the catheter within that space. A tunnel in the abdomen extending
from the location of the intrathecal catheter and the pocket where the morphine pump was placed was created. No complications were experienced in the implantation procedure.
Although no indication is made in the operative report, Respondent recalls that the length of distal or intrathecal catheter implanted was about four and one-half inches in length right next to the spinal cord, with another amount that ". . . traverses the depth of the patient from under the skin going all the way through the ligaments to reach that point." Not all of that portion of the catheter went inside the patient. Some of that portion of the catheter was excised. Respondent cannot recall the overall amount of catheter implanted in the patient. He refers to it " . . . as about half the length of the catheter."
Although no complications were experienced in the June 12, 1995, placement of the morphine pump with catheter system, later Patient T.N. began to complain of experiencing pain at the site of the morphine pump, the pocket. It was pain at the inferior portion of the pump pocket, experienced when the patient sat or would bend to tie his shoes. As a consequence Respondent "opened him up" and observed scar tissue. Within Respondent's experience scar tissue will contract around the morphine pump tightening the pocket and causing pain.
Respondent excised the scar tissue and re-closed the site.
The patient continued to complain of pain in the same area. Respondent was unconvinced concerning the patient's report of continuing pain at the pocket site. The patient said that when he would bend down, sometimes he felt a portion of the pocket contents that would strike the hip bone or a rib. That being stated, Respondent made a second attempt to revise the pocket. The morphine pump was moved to a higher location, so that when the patient would bend over the morphine pump would not push against the iliac crest.
Beyond the last attempt to place the morphine pump in a more comfortable location, the patient continued to complain. He complained of pain in his left groin. This complaint was made with Respondent's knowledge of an examination performed on the patient by a surgeon prior to Respondent's first visit with the patient, in which the surgeon believed that the patient might have an inguinal hernia. Respondent saw no evidence of inguinal hernia on the left side.
On another occasion the patient complained of pain across the abdomen and sometimes on the right side. Respondent investigated those complaints. Respondent referred the patient to a general surgeon who did not find anything wrong.
The patient complained of pain in the right groin.
Respondent referred him to a urologist. The urologist thought that pain might be caused by inflammation of the testicle,
radiating pain but could find nothing to confirm the initial response to the patient's condition.
All the while the patient complained about pain and was asking for more pain medication.
By morphine pump infusion, increasing doses were provided as a means of relief. This did not promote a change in the patient's complaints about pain and his requests for pain medication to address his complaints of pain. Respondent believed that this was some indication of addiction. It was determined that the best course was to remove the morphine pump under the circumstances.
Respondent was also interested in ruling out any type of irritation from the intrathecal catheter. He sent the patient for a CT of the thoracic thoracolumbar. This evaluation was performed on November 7, 1995. It showed the tip of the catheter placed in the spinal area, in the dorsal segment, right where Respondent expected it to be. Therefore he did not believe that part of the catheter system was irritating a nerve. Nonetheless on March 16, 1996, a further procedure was performed to remove the morphine pump and catheter system.
Joint Exhibit numbered three, a copy of the operative report prepared by Respondent, describes the procedure performed under local anesthesia that was monitored. It states:
The patient was taken to the Operating Room. He was placed in the right lateral position. His back and abdomen were prepped and draped. Xylocaine 1% with Eppy, 8 cc was infiltrated subcutaneously into deeper tissues over the lumbar spine at the previous incisional site. A small traverse incision was made and the incision was deepened. The intrathecal catheter was identified. The retaining suture was removed and the intrathecal catheter was withdrawn from the intrathecal space. The fibrous tissue around the catheter was excised and freed. About 10 cc of 1% Lidocaine with Eppy was infiltrated along the incisional scar over the pump pocket over the left lower quadrant of the abdomen, and incision was made along the previous incisional scar. Incision was deepened.
Hemostasis was secured. Morphine pump was identified and was removed from the pocket. Then the pump and the catheter were withdrawn along the subcutaneous tunnel.
The wound over the abdomen and over the lumbar spine were irrigated with Kantrex antibiotic solution. Hemostasis was secured. The subcutaneous layer was closed with #3-0 Vicryl suture. The wound over the lumbar spine was closed with #3-0 Vicryl suture and staples. The wound over the abdomen was closed with some interrupted vertical mattress sutures and skin staples. Both wounds were dressed with Betadine.
During the May 16, 1996, procedure to remove the morphine pump and catheter system, fluoroscopy was not utilized. In the report no indication was given concerning the length of the various parts to the catheter system that were retrieved through the operation. Respondent explains that he did not use fluoroscopy in the removal of the morphine pump and catheter system " . . . because the catheter location is identified by
the scar incision on the back, the entry points so when you go back to the same incision after dissection (you) would be able to identify the catheter. That is why I did not use fluoroscopy." Respondent does not believe that you need to use fluoroscopy in every case involving these procedures and that it was not necessary in the subject case.
Respondent explains that when removing the intrathecal portion of the catheter system and scar tissue, that part of the catheter system "came out very easy without any kind of resistance." Respondent indicated in his testimony that "I didn't have to tug it hard to cause any breakage at the time so that's why we thought the catheter came out very easy." No complications were experienced during the procedure. Respondent believed that all portions of the catheter system had been removed.
For a couple of years beyond the point of removing the morphine pump and catheter system, no complaints were made by the patient.
In February 1999, Patient T.N. returned to Respondent's pain clinic. He told Respondent that a piece of the catheter had been retained following the May 16, 1996, surgery intended to remove the catheter. The existence of the retained portion of the catheter was confirmed by an incidental finding on an x-ray taken of the patient. The patient told
Respondent that he would like to have that retained segment removed. Respondent agreed and scheduled the patient for surgery. The patient was not complaining of any pain per se. The patient did tell Respondent that the catheter was irritating the nerve roots.
Respondent is familiar with the expectation that the catheter system placed in patients is designed to remain there over a period of years. In that sense, Respondent does not believe that a retained portion of the catheter poses a risk to the patient. Respondent was comfortable with his opinion that the patient was suffering no consequences concerning the retained segment because ". . . there are no complications, no signs of any kind of irritation from the catheter because the catheter is as I noted in that CT of the lumbar spine it is absolutely in the midline not deviated to either side, nor wrapped around any nerve roots, not causing any problem. . . ". Respondent agrees that there is no medical purpose served by leaving a segment of the catheter in place in the patient, and normally an attempt would be made to remove it unless it is very hard to get at and then it would not be removed. Respondent concedes that medical complications could result from leaving the catheter segment in place. It may or may not happen. The catheter might irritate a nerve if it is in the wrong position.
In this case Respondent did not believe its placement was in the wrong position.
When Respondent made the judgment to proceed with further surgery to try and remove the remaining portion of the catheter, he believed that this was within the scope of his expertise. More specifically, Respondent believed that it was appropriate to proceed with the March 1999, surgery without the presence of an orthopedic surgeon or a neurosurgeon in attendance or immediately available. Before commencing the surgery in March 1999, Respondent told the patient that if he could not remove the catheter segment, it was not causing a problem for the patient at the moment, "but if you need to have it definitely removed, we need a deeper dissection, that I can refer him (the patient) to a neurosurgeon or back surgeon to have it removed."
On March 17, 1999, Patient T.N. was returned to surgery and the surgery performed under local anesthesia in an effort to remove the retained portion of the catheter. Respondent's operative note concerning that surgery is Joint Exhibit numbered four. It says in pertinent part:
INDICATIONS: Mr. N is a 51-year-old gentlemen, who had a Morphine pump removed in May of 1996. The pump, the connecting catheter, and a portion of the intrathecal catheter were removed at that time. A segment of catheter which is in the
intrathecal space was retained. The patient requested to have the catheter removed.
I informed Mr. N that it was not necessary to have the catheter removed, however, the patient wished to have the catheter removed so I have scheduled him for surgery for the removal of intrathecal catheter under local anesthesia.
DESCRIPTION OF PROCEDURE: The patient was taken to the Operating Room and was placed in the sitting position. Using fluoroscopy in the AP and lateral views the intrathecal catheter was identified and it was noted to emerge through L3-4 interspace and the catheter distal tip appears to lie within the substance of the interspinous ligament at the L3-4 level. The location of the catheter was marked with the skin marking pen. Then the patient was placed in the right lateral position and his back was prepped and drapped.
Using local anesthesia (local anesthetic mixture of Lidocaine 1% and Marcaine 0.5% with epinephrine) 8 cc were infiltrated subcutaneously and into deeper tissues over the L3-4 interspace. Then a vertical incision was made and the incision was deepened. The deep fascia was identified and the deep fascia was incised over the L3-
4 interspace.
Then under fluoroscopic guidance and by fine dissection I attempted to retrieve the intrathecal catheter by grasping the distal tip to be able to remove it from the intrathecal space and the tip of the catheter appears to be lying fairly deep in the interspinous ligament and in order to remove the catheter it is necessary to open up the interspinous space by excising the spinous process and I felt it was unnecessary to perform this extensive surgical dissection to retrieve a catheter which is not causing any problems.
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Having dissected the area to a certain depth, Respondent was not able to identify the tip of the catheter and was persuaded that dissecting much deeper was not a safe choice. Had Respondent been able to see the tip of the catheter in the March 1999, surgery he would have grabbed it and removed it. Respondent also decided that the retained portion was "not causing any problem." Respondent felt that the patient could be brought back for elective surgery in the future or consult with another physician who could remove the retained segment.
On October 5, 1999, Dr. Mark Oliver, a surgeon, with Patient T.N. provided general anesthesia, performed a lumbar laminectomy with removal of the retained intrathecal morphine pump catheter, so described. The operative report of Dr. Oliver is found as Joint Exhibit five. In pertinent part it says, under the description of Findings and Procedures:
. . . Following infiltration of 0.5 percent lidocaine with epinephrine, a midline lumber incision was made, excising his old lumbar scar. This incision was carried down to the lumbar fascia and the lumbar fascia was subsequently incised. The paraspinal musculature was then taken down subperiosteally bilaterally to reveal the spinal process and lamina of the L3 and L4. A Penfield #4 was then positioned beneath the lamina or L3 and a lateral lumbar spine x-ray used to confirm our position. It was very difficult to visualize the intrathecal catheter on the plain x-ray. A partial
laminectomy of L3 was carried out at which time the catheter became more visible. The catheter was subsequently withdrawn however, there was a fibrous sleeve leading from the durotomy out into some soft tissues. This had to be cleansed off and a purse string suture was placed around the durotomy to obtain a watertight closure. . . .
The pathology that followed the surgery performed by Dr. Oliver, as described by the pathologist Dr. Margaret Cohen in Joint Exhibit Numbered six, identified the catheter segment removed by Dr. Oliver as "a tubular, white plastic object consistent with a catheter measuring 17 centimeters in length and 0.1 centimeter in diameter."
Expert Opinion
(Hearing Testimony)
Peter R. Preganz, M.D. was retained by Petitioner as a consultant and in these proceedings offered his opinion concerning issues of standard of care and the adequacy of Respondent's medical records in association with treatment provided to Patient T.N., reflective of Dr. Preganz's understanding of the allegations set forth in the Amended Corrected Administrative Complaint.
Dr. Preganz is licensed to practice in Florida. He became licensed in this state in 1981. At present he practices in Lake Mary, Florida.
Dr. Preganz attended college at Emory University in Atlanta, Georgia. He attended the Emory University School of Medicine. Following medical school he did his internship in the Department of Surgery at Emory and Emory-affiliated hospitals. He did an additional year of surgical training as a resident. Dr. Preganz did training in anesthesiology and pain management at Vanderbilt University Hospital in Nashville, Tennessee.
Dr. Preganz is board-certified in anesthesiology. His medical practice is related to pain management.
To prepare himself to offer his opinion concerning Respondent's care and treatment of Patient T.N., Dr. Preganz reviewed extensive patient records related to the patient, Respondent's office records concerning Patient T.N., the operative notes related to the procedures performed by Respondent in association with the implantation and attempts to remove the morphine pump and catheter system, nurses records, emergency room records, and the records of Dr. Mark Oliver related to the surgery performed by that physician. Dr. Preganz read literature concerning the technical specifications in association with the morphine pump and catheter system utilized in addressing Patient T.N.'s condition.
Having reviewed these materials, Dr. Preganz in his testimony described his understanding of the underlying facts of the care provided by Respondent for Patient T.N., to include the
surgeries that formed the basis for allegations in the Corrected Amended Administrative Complaint.
Dr. Preganz has experience in the implantation of a morphine pump and catheter system such as that involved in the present case. He began implanting morphine pumps and catheter systems around the period 1993 to 1994. To prepare himself to utilize this approach to pain management, Dr. Preganz attended courses and seminars that were designed to teach practitioners the proper manner of placement of the overall device. He visited with other physicians who had performed that type of surgical procedure and worked with those physicians in a mentorship arrangement. Dr. Preganz performed morphine pump implantation procedures regularly in his medical practice during the period 1993 through 1999.
Dr. Preganz was received as an expert for purposes of offering his opinion concerning the issues of standard of care and adequacy of Respondent's medical records related to the allegations set forth in the Corrected Amended Administrated Complaint.
In explaining the surgical technique for implanting the morphine pump and catheter system, Dr. Preganz described the use of what he referred to as a C-arm, fluoroscopy, a type of portable x-ray unit utilized to take pictures of the spine.
With this assistance the physician visualizes the segment of the spine in the lower lumbar where the device is to be placed.
The model of catheter utilized by Respondent in Patient T.N.'s case had a 38 centimeter length in the disputed portion that was marked at intervals to describe its length. The fluoroscopy is utilized in placing the intraspinal catheter in the intrathecal space. The other portion of the catheter as described by Dr. Preganz, is the extraspinal catheter. The necessary length of the extraspinal portion of the catheter system is assessed, allowing for some redundancy to connect the end with the morphine pump. The morphine pump is placed in the pocket and the opposite end of the extraspinal catheter trimmed to an appropriate length is set aside and measured. Then the
extraspinal catheter is connected to the intraspinal part of the catheter system with the use of a clip device with the morphine pump connected at the other end. The measuring scale with the catheter system provided by the manufacturer allows measurement so that it can be determined the amount of the catheter system that has not been placed in the patient and by virtue of that knowledge and by subtraction determine the amount of the overall catheter system remaining in the patient. Information concerning the length of catheter left in the patient is made known for the record, so that if the catheter system had to be removed, the length of the catheter placed in the patient when
initially implanted when compared to that removed is available to determine that the catheter has been successfully removed. These calculations are normally provided for the patient's records in Dr. Preganz's experience. This also aids in the determination of appropriate volumes to be purged in the system when priming the morphine pump.
Dr. Preganz has had occasion to remove a morphine pump and the associated catheter system that he had implanted in a patient. He has performed the removal procedure twice on two different patients. In one case he successfully removed the catheter system in the patient. This outcome was confirmed by a visual inspection of the catheter system for tears and by measurement and comparison of the length removed against the length of catheter system initially implanted born out by the record. The practice of measuring the catheter removed from the patient to make certain that it coincides with records concerning the amount implanted was in accordance with training that Dr. Preganz received and what he was told at seminars he attended concerning implantation of morphine pumps and catheter systems. In Dr. Preganz's, opinion the fact that the catheter segment being removed comes out smoothly, without resistance, does not provide complete assurance that the entire catheter system placed has been removed. In addition to making a visual inspection of the catheter removed to find any frayed or torn
features to the catheter, it is necessary to compare the patient chart as to what length was implanted in the patient against what was removed from the patient to make certain that those lengths are equivalent.
Dr. Preganz's experience with the second patient did not go so well. In attempting to remove the morphine pump and catheter system, he observed substantial inflammatory reaction within the second patient where the catheter was placed. He expressed his opinion that it had probably been caught up in fibro-adhesive tissue. The case was more complicated in that the clinical circumstances confronted in trying to remove the morphine pump and catheter system included infection within the morphine pump pocket.
In the second case of removal, a fluoroscopy was being utilized to support the effort at removal. Nonetheless, it was difficult to identify the catheter when utilizing fluoroscopy, and with the dura open there was a dense inflammatory reaction and the catheter could not be seen. An operating microscope was employed and Dr. Preganz and a neurosurgeon spent 30 minutes locating the catheter.
In Dr. Preganz's opinion the treatment provided Patient T.N. was appropriate up to and including the decision to implant the morphine pump and catheter system. The problems, in Dr. Preganz's opinion, came about when Respondent performed
surgery to remove the morphine pump and catheter system in which ". . . the standard was deviated from by failing to recognize that the catheter was still in place and (had) not been removed," Dr. Preganz explains, that in his opinion, the removal procedure was not done the way that it was supposed to be done and that he, Dr. Preganz, had been taught to do it. The catheter remained in place for a substantial period of time, and the patient continued to experience abdominal pain that was felt by Dr. Preganz to be coming from the catheter itself. It did not matter to Dr. Preganz whether the segment of the catheter left in place was of the length recovered in the last operation performed by Dr. Oliver or a shorter length. To Dr. Preganz it is below the standard of care to leave any length of intrathecal catheter in place because it presents a risk to the patient.
The only occasion where allowing a portion of the intrathecal catheter to remain in its place, would be if the patient was, as Dr. Preganz describes it, at "death's door" and you wish not to subject the patient to a surgical procedure. Then it might be appropriate to leave the retained segment of catheter in the patient. Otherwise it should be completely removed.
Dr. Preganz offered the opinion that where the surgeon is uncertain about removal of the catheter and he does not have any recorded measurements to compare with the portion being
removed, then radiographic imaging would be an appropriate response to try and locate the catheter.
The fact that the catheter may have broken because of a defect in the catheter does not relieve the physician of the need to remove the entire catheter, once the decision has been made to remove the morphine pump and catheter system. To leave the retained segment in place presents a danger to the patient.
According to Dr. Preganz, in the event that the initial attempt at removing the catheter system does not succeed, the possibility exists that complications may be encountered with the next attempt to remove the retained catheter segment. There is a concern about introducing infection into the wound site on the second effort in addressing the catheter, in this instance the retained portion. In the event that the second effort is one in which the retained segment does not come out easily, Dr. Preganz speaks of there being an explanation for that, in that, it may be hung up between pieces of bone or osteophyte, on a bone spur formation or it might be looped around a nerve or part of the cord, in which case general traction is needed, especially recognizing that it is in the location of the spinal chord and spinal tissue and the risk of paralyzing the patient. The effort at removing the retained catheter segment in Patient T.N. was made the more difficult given his kyphoscoliosis.
In preparing to address by surgery the retained catheter segment, Dr. Preganz might try to do it himself or send a patient to someone who is a surgeon and who does spinal surgery, an orthopedic doctor with specialty training in spinal surgery or a neurosurgeon. In the instance where Dr. Preganz made the attempt to try to remove the retained catheter segment, Dr. Preganz would wish to have a neurosurgeon or spinal surgeon attending or available if problems were experienced in the effort made to remove the retained segment. If the retained segment cannot be removed with "gentle traction," then it becomes necessary to perform an operation requiring an expansion of the incision, that is to say deepening the incision, perhaps requiring removing portions of bone, through a laminectomy, or laminotomy. Those surgeries are not within the realm of what an anesthesiologist such as Dr. Preganz or the Respondent are trained to do. In the further attempt to remove the catheter system, the retained segment, the physician would need to gain the consent of the patient and tell the patient that if the segment did not come out easily, then it would be necessary to take other measures because of the threat and danger that it would pose to the patient not to remove the retained segment, and that in such an event another doctor might be necessary to help perform the surgery.
On March 17, 1999, when Respondent attempted to remove the retained catheter segment, Dr. Preganz expresses the opinion that the Respondent deviated from the standard of care, absent the presence of a spinal surgeon or a neurosurgeon in the hospital where Respondent made his effort at removing the catheter segment. Alternatively, Dr. Preganz thinks the patient could have been sent to a tertiary center where arrangements had been made for someone to actually do the procedure on that single occasion.
Dr. Preganz does not take issue with the Respondent, as an anesthesiologist, removing the retained catheter segment, if it could be seen. The facts show that the Respondent had difficulty visualizing the retained catheter segment when performing the surgery on March 17, 1999.
Dr. Preganz is aware that the catheter system utilized in Patient T.N. was susceptible to breakage.
As Dr. Preganz notes the amount of catheter segment retained by the patient following the initial effort at removing the overall catheter system was 17 centimeters in length. This represents almost half of the intrathecal or intraspinal portion of the catheter system which was 38 centimeters in length.
(By Deposition)
In his opinion, Dr. Preganz believes that on May 16, 1996, when Respondent performed the surgery to remove the
morphine pump and catheter system, he left a portion of the catheter in the intrathecal space without making appropriate efforts to identify and retrieve it. The amount of catheter left in place was not inconsequential. It was 16 to 17 centimeters in length. Leaving the catheter in the intrathecal space, in Dr. Preganz's opinion, failed to meet the standard of care. Beyond that point the patient experienced recurring abdominal pain, symptoms consistent with a retained intrathecal catheter being at the T-11 level.
Dr. Preganz's criticism concerning Respondent's performance in the May 16, 1996 surgery, was that Respondent did not make a full assessment to determine that the catheter system had been removed in toto, so a substantial portion of the catheter was left in place.
Dr. Preganz expressed the opinion that the catheter segment remaining in place following the May 16, 1996, surgery served no purpose, as no medication was being distilled through it. As it was located in the intrathecal space, it was "floating in the central nervous system, subject to infection, subject to nerve trauma." It presented a problem. Dr. Preganz does not believe that anyone would recommend that a non- functioning catheter be left in the intrathecal space of the patient, absent a case in which the patient had a short life
expectancy, recognizing the potential for complications, to include damage to nerves, that would cause pain and infection.
When Respondent made the decision to make another effort at retrieving the catheter segment left over from the initial surgery to remove the morphine pump and catheter system, Dr. Preganz expresses the opinion that consideration should have been given to having someone with a surgeon's background, either an orthopedist or a neurosurgeon, to assist Respondent in removing the remaining catheter segment.
Initially when the decision was made to remove the morphine pump and catheter system, it should have been removed in toto. According to Dr. Preganz an appropriate course of treatment to make certain of the success of that effort would be compare the length of catheter that was implanted, at the time of the original implantation, with that was removed from the patient in the surgery to perform the removal. Dr. Preganz expressed the opinion that the standard of care for a pain management specialist, anesthesiologist, is that when the catheter system is placed, an operative note is made as to the amount of catheter implanted, to serve the purpose of the future prospect of having to remove the catheter system, as well as serving the immediate purpose of purging of the overall system so that the medication starts to be instilled. To this end, the
device comes with a measuring apparatus to provide the information for those two functions.
Dr. Preganz testified that he has performed a similar type procedure for the placement of a morphine pump and associated catheter system approximately 15 times, the last occasion being in 2003. All devices used by Dr. Preganz when performing this type implantation were Medtronics.
Dr. Preganz in his testimony referred to the distal markings associated with the intraspinal catheter, which would be placed in the intrathecal space of the patient. The other portion of the catheter was referred to as an extraspinal catheter that would be connected to the pump, that is to say the reservoir and battery device.
After the initial implantation of the morphine pump and catheter system, Respondent made attempts to reposition the morphine pump in its pocket. When that did not promote relief in addressing the patient's complaints, Dr. Preganz expressed the opinion that this circumstance should have created a high index of suspicion that the catheter itself might explain the problem. When the patient did not respond to the replacement of the morphine pump, the diagnosis that the pain experienced was attributable to that placement was no longer appropriate, according to Dr. Preganz. When the efforts at addressing the patient's complaint concerning pain did not end with the
replacement of the morphine pump, the possibility of the catheter causing the discomfort should have been incorporated into Respondent's differential diagnosis.
Beyond the point at which the Respondent made his attempt on May 16, 1996, to remove the morphine pump and catheter system, to the extent that the patient continued to complain of pain, part of that differential diagnosis may have been that the catheter in dwelling was causing pain that Respondent did not know about. Dr. Preganz thinks that Respondent should have addressed that prospect by removing all of the catheter system.
Recognizing the patient's underlying condition, it could be reasonably anticipated that the catheter would not come out easily and that further surgical exploration might be required to remove the catheter completely, according to
Dr. Preganz. If a more thorough dissection is necessary to get the catheter out, there should be someone available who is capable of drilling dura, bone and getting the whole catheter out in a single surgery. The use of fluoroscopy and inspection of the catheter would verify whether there was any necessity to have the other specialist lend a hand. The fact that the catheter can be visualized through the use of radiographs, CT's scan or MRI's does not indicate that there will be no problems experienced in trying to remove the catheter.
Dr. Preganz agrees that there are risks of neurological injury whether the catheter is left in the patient or surgery is performed to remove it. He still expresses the opinion that it is appropriate to remove the catheter, absent a case in which the patient has a limited expectation for living.
(By Depositions)
Timothy Sternberg, D.M.D., M.D., testified in behalf of Respondent, offering his opinion about the Respondent's care and treatment provided Patient T.N. Dr. Sternberg was retained by Respondent as an expert in this case. Otherwise he has no relationship with the Respondent. Dr. Sternberg is accepted as an expert entitled to offer his opinions.
Dr. Sternberg looked at the necessary records to familiarize himself with the case of Patient T.N., to allow him to offer his opinion testimony and explains in some detail his understanding of the treatment received, as this is pertinent to the dispute.
Generally stated Dr. Sternberg thinks the Respondent met the standard of care in treating Patient T.N.
Dr. Sternberg is licensed to practice medicine in Florida. He has been licensed since 1994. He is board- certified in anesthesiology. He practices in the subspecialty involving pain management.
Dr. Sternberg is familiar with the Medtronic morphine pump and catheter system utilized with Patient T.N., the model 8703. Dr. Sternberg became familiar with catheters of this type, in general, during his fellowship in 1996. He is familiar with the evolution of the various models of Medtronic devices that have been marketed over time. Dr. Sternberg also had some familiarity with catheter systems in the period 1988 through 1991, when undergoing his residency.
Dr. Sternberg first assisted in the implantation of the devices similar to those described in this case, in 1996 and 1997 at the Medical University of South Carolina. Dr. Sternberg first used the morphine pumps and catheter system as the principal surgeon in 1998 or 1999.
In his terminology Dr. Sternberg refers to a portion of the catheter which is described, as epidural, outside the dura and the intrathecal, which is inside that layer, the dura being the covering of the spinal chord and the spinal chord fluid. Those elements to the overall catheter system are referred to by Dr. Sternberg as the interspinal portion of the catheter including the epidural and intrathecal aspects.
Dr. Sternberg expressed the opinion that the choice to use the morphine pump as a means to deliver pain management medication to the patient comes about with the person who has significant medical problems that were not controlled by other
means. The patient must be screened before selecting this treatment modality. Assuming the selection process has shown the patient to be a proper candidate, the implantation can be made.
In performing implantation Dr. Sternberg used fluoroscopic guidance to generally outline spinal segments.
In his recollection, the Medtronic 8703 was a two- section device, cut to the appropriate size or length so that you would not have redundancy in the catheter system but with enough left over to have a coil that goes around the pump. This would allow movement by the patient in the patient's occurrence of daily living, to have some slack, if this were the preference of the surgeon. The two catheter sections are connected by a metal tube.
Dr. Sternberg has removed two or three intrathecal catheters and on several other occasions made that attempt but the catheters were not accessible. When deemed inaccessible and if further surgery would be necessary to gain access, and it would be considered as incurring more risk than a minimal risk, then it would be the choice of most physicians, in
Dr. Sternberg's opinion, to conclude that it is not worth it "to go in and get that."
Dr. Sternberg has only had one occasion where it was necessary for him to remove the morphine pump and catheter
system from a patient, as opposed to other instances in which he removed a catheter alone. The removal of the overall device was brought about by a problem with infection, due to the patient's underlying medical health.
To locate the intrathecal catheter in surgery to remove it, there maybe some difficulties. There you use imaging data, that is to say x-rays, fluoroscopic images, CAT scans. Sometimes dye is injected through the side port of the morphine pump to track the injectate through the catheter system to make out the details.
If a patient desires the whole device to be removed, Dr. Sternberg would respond by trying to remove the whole system. If, by contrast, the patient wanted the pump out because of its nature, he would remove the morphine pump leaving the catheter system in place for a period of time. By that
Dr. Sternberg means that there is no reason in most cases to take the catheter system out. Removal would be for some reason other than the patient simply saying that the patient did not like the way that the device felt.
In an effort to make certain that the entire catheter system has been removed from the patient, Dr. Sternberg considers the ease with which the catheter can be removed in relation to the epidural or intrathecal parts of the catheter.
If there is significant resistance, this points out something is wrong and there is the possibility of a break. A visual examination would be made to see if the system was intact, looking for areas that were sheared or broken in any fashion.
Dr. Sternberg would look for the integrity of the tip of the catheter when compared to its appearance after manufacture but before implantation. Dr. Sternberg recognizes that the original length of what he refers to as the distal catheter is about 38 centimeters in length. In his approach, a lot of times it is not known the amount that was cutoff upon implantation, so if the amount that he removed is less than 38 centimeters this does not lead him to conclude that the catheter was definitely broken. Dr. Sternberg relies on visual inspection to satisfy himself about removal. He does not utilize measurements per se. He recognizes the possible uncertainty in that approach but does not utilize measurement in his practice. The recording of data upon implantation and the use of the Medtronic device, is normally through an entry by the company representative and is designed to establish proper volumes in dispensing the pain medication, not to determine the length for purposes of further reference. If it was necessary to remove the catheter, in Dr.
Sternberg's understanding, the company Medtronic does not keep that data on the length that was cutoff upon implantation in its data base because of concerns about legal liability.
Dr. Sternberg is not concerned about complications being experienced by the patient if a portion of the catheter is left in the intrathecal space. He agrees there is the potential, that if left in place it could cause nerve root irritation, but not in his experience. The prospect of infection is unlikely in his opinion.
Dr. Sternberg believes that the report by the patient of pain coming from the area of the pump pocket was in actuality related to pain in that area, given Dr. Sternberg's experience.
Dr. Sternberg believes that Respondent met the standard of care in the implantation of the morphine pump and catheter system in Patient T.N., based upon Dr. Sternberg's understanding of that procedure.
In 1996, the year in which the Respondent performed the initial surgery to remove the morphine pump and catheter system, Dr. Sternberg believed that the standard was that there needed to be a reason for removal and generally that would be related to infection.
Dr. Sternberg believes that it was appropriate to perform the operation in May 1996 to remove the morphine pump and catheter system under the circumstances in the case related to Patient T.N.
Dr. Sternberg does not believe that the fact that a portion of the catheter was retained following the May 1996 surgery by Respondent indicated a deviation from the standard of care on the Respondent's part.
Dr. Sternberg believes that the surgical procedure performed by Respondent in March 1999 met the standard of care. The lack of success in that procedure does not indicate a violation of the standard of care by Respondent, in
Dr. Sternberg's opinion. It was appropriate not to change the type of operation once it was understood that the catheter segment was inaccessible. At that time Dr. Sternberg does not believe that Respondent should have undertaken some sort of thought process to equate the earlier report by the patient of abdominal pains with the fact of the retained catheter in the March 1999 surgery. Dr. Sternberg believes that the retained catheter segment would be highly unlikely to cause the abdominal pain.
When Respondent was unsuccessful in removing the retained catheter segment, it was appropriate to refer the patient to the neurosurgeon for the removal, given the patient's request, or it was appropriate for Respondent to recommend to the patient that the retained catheter segment be left in place in Dr. Sternberg's opinion.
Dr. Sternberg believes that Respondent kept legible medical records to justify the course of treatment in the case, both as to legibility and concerning Respondent's impression that the abdominal pain experienced by the patient was from the pocket and the irritation from the morphine pump.
Dr. Sternberg believes that there were appropriate medical records to justify the Respondent's attempted removal of the intrathecal catheter.
Dr. Sternberg does not believe that the fact that a
17 centimeter segment was left in the patient is a deviation from the standard of care. He explains that no one would wish to leave it there, but it had broken and most of the time you would not have a knowledge of how much was actually there in the first place and the portion that was initially removed appeared to satisfy Respondent, according to Dr. Sternberg, and even if a portion were left it would not violate the standard of care.
According to Count One in the Amended Corrected Administrative Complaint, Respondent violated the standard of care in that he failed 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 when he "failed to remove the entire intrathecal catheter on May 16, 1996" in the surgery performed to effect those purposes. This determination is made
in keeping with the opinion expressed by Dr. Preganz, as to the proper manner for accessing and retrieving the catheter system, recognizing Respondent's intention to remove the entire device. In fact, Respondent left a considerable portion of the catheter in place, measuring 17 centimeters in length, an amount difficult to explain under the perceptions held by Dr. Preganz and further evidence that the necessary assessment process to assure removal fall short.
According to Count One in the Amended Corrected Administrative Complaint, having considered the opinions of the experts, as described, it has not been shown that Respondent's efforts at determining the ". . . nature of patient's T.N.'s pathology regarding his complaint of abdominal pain" fall below the standard expected when practicing 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. Respondent made a reasonable effort at determining that pathology in addressing the patient's various complaints, concerning pain in the area of his abdomen and did so over time. Under the circumstances Dr. Preganz's belief that the in dwelling catheter or a segment of the in dwelling catheter explains the abdominal pain is not accepted.
According to Count One in the Amended Corrected Administrative Complaint, Respondent failed 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 that he "failed to obtain the appropriate orthopedic or neurological assistance to remove the retained intrathecal catheter." This is understood to address the further effort on March 17, 1999, to remove the segment of the intrathecal catheter that had not been removed earlier. Having considered the opinion of both experts, under the facts and circumstances in this case, it is not accepted that it was a failure of care to make his attempt on March 17, 1999, to remove the retained segment of the intrathecal catheter, without an orthopedic surgeon or neurological surgeon being in attendance or available prior to proceeding with the surgery. Respondent acted within his expertise and made an appropriate decision not to proceed beyond his skill level when he recognized that this surgery could not be brought to a successful conclusion.
According to Count Two in the Corrected Amended Administrative Complaint, Respondent is charged with certain failures to maintain medical records. Notwithstanding the reference in the administrative complaint to language in Section 458.331(1)(m), Florida Statutes, related to issues of legibility
of medical records kept, the specific allegations do not refer to problems with legibility and they have not been considered here. Instead, there is a reference to Respondent's failure ". . . to justify the diagnosis of patient's T.N. continued
abdominal pain." Expert opinion testimony has been considered to address the allegations, concerning the efforts by Respondent to keep the necessary medical records, that would include among other things patient history, examination results, test results, records of drugs prescribed, dispensed or administered in any reports in relation to consultations and hospitalizations. That testimony does not establish the lack of justification in the medical records for Respondent's opinion concerning his explanation for the abdominal pain experienced by the patient.
According to Count Two in the Amended Corrected Administrative Complaint Respondent also "failed to obtain appropriate orthopedic or neurological assistance in attempting to retrieve the retained intrathecal catheter on March 17, 1999." This is not an event contemplated by the requirement to keep medical records pertaining to the justification for the course of treatment of the Patient T.N., nor has there been an opinion expressed by the experts criticizing Respondent for this failure in his medical records, as an issue involving the need to keep medical records that justify the course of treatment of the Patient T.N. This allegation by its terms does not refer to
the need to justify action or inaction by entering information in the medical records. It is properly seen as a standard of care issue, as previously discussed.
According to Count Two in the Amended Corrected Administrative Complaint, Respondent "failed to justify the determination that the retained intrathecal catheter was not causing Patient T.N.'s continuing pain/problems." The testimony by the experts does not establish this alleged inadequacy in Respondent's medical records when considering whether the retained intrathecal catheter could be responsible for the patient's continuing pain/problems.
Prior Disciplinary History
No indication was given concerning any prior discipline imposed against Respondent in Florida or any other jurisdiction where he may have practiced medicine.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the parties and the subject matter of this proceeding in accordance with Sections 120.569, 120.57(1), Florida Statutes (2005), and 455.225(5), Florida Statutes (1995 and 1998).
Respondent is a licensed physician in Florida. He was issued the license by DOH. The licensed number is ME45978.
Through the Amended Corrected Administrative Complaint, Respondent has been accused in two counts with violating provisions found in Section 458.331, Florida Statutes (1995 and 1998).
Count One accuses Respondent of violating Section 458.331(1)(t), Florida Statutes (1995 and 1998), both versions calling for discipline to be imposed for:
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.
Count Two accuses Respondent of violating Section 458.331(1)(b), Florida Statutes (1995 and 1998). The (1995) version allows discipline to be imposed for:
Failing to keep written medical records justifying 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.
The (1998) version allows discipline to be imposed for:
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.
This is a disciplinary case and for that reason Petitioner bears the burden of proof. That proof must be sufficient to sustain the allegations in the Corrected Amended Administrative Compliant by clear and convincing evidence. See Department of Banking and Finance, Division of Securities and Investor Protection v. Osborne Stern and Co., 670 So. 2d 932 (Fla. 1996); and Ferris v. Turlington, 510 So. 2d 292 (Fla. 1987). The terms clear and convincing evidence is explained in the case In re: Davey, 645 So. 2d 398 (Fla. 1994), quoting with approval from Slomowitz v. Walker, 429 So. 2d 797 (Fla. 4th DCA 1983).
Given the penal nature of this case, Section 458.331(1)(m) and (t), Florida Statutes (1995) and Section 458.331(1)(m) and (t), Florida Statutes (1998), have been strictly construed. Any ambiguity favors the Respondent. See State v. Pattishall, 99 Fla. 296, 126 So. 147 (1930), and Lester v. Department of Professional and Occupational Regulation, State Board of Medical Examiners, 348 So. 2d 923 (Fla. 1st DCA 1977).
Any violation of Section 458.331, Florida Statutes (1995 and 1998), must be based upon specific allegations within the Amended Corrected Administrative Complaint. See Trevisani
v. Department of Health, 908 So. 2d 1108 (Fla. 1st DCA 2005); Cottrill v. Department of Insurance, 685 So. 2d 1371 (Fla. 1st DCA 1996); and Hunter v. Department of Professional Regulation, 458 So. 2d 842 (Fla. 2nd DCA 1984).
The disciplinary response that may be imposed should Respondent be found in violation of any provisions referred to is as envisioned by Sections 458.331(2), Florida Statutes (1995), and Section 458.331(2), Florida Statutes (1998).
The specific acts referred to in Count One that constitute an alleged violation occur where Respondent:
failed to remove the entire intrathecal catheter on May 16, 1996;
failed to determine nature of Patient T.N.'s pathology regarding his complaint of abdominal pain;
failed to obtain the appropriate orthopedic or neurological assistant to remove the retained intrathecal catheter.
Clear and convincing evidence was presented to show that Respondent failed to remove the entire intrathecal catheter during the May 16, 1996 surgery. In this failure Respondent failed 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 set out to remove the morphine pump and catheter system but he was not successful in this endeavor,
given his unacceptable methods for accessing the success in his attempt. He bore the duty to reach a successful conclusion.
Instead he left a considerable amount of the intrathecal portion of the catheter system in place following the surgery, some 17 centimeters upon the gross pathology in the case. That outcome was unacceptable, given conditions and circumstances. Thus Respondent violated Section 458.331(1)(t), Florida Statutes.
It was not been shown that Respondent "failed to determine the nature of Patient T.N.'s pathology regarding his complaint of abdominal pain." Respondent adequately investigated those complaints and responded to them in an appropriate manner.
It has not been shown that it was necessary for Respondent to obtain appropriate orthopedic or neurological assistance to remove the retained intrathecal catheter, either in relation to the original effort on May 16, 1996, or the further effort on March 17, 1999. In spite of an unsuccessful outcome, Respondent proceeded within the bounds of what would be a reasonable expectation for a prudent similar physician, confronted with similar conditions and circumstances and it was not necessary to gain the assistance of an orthopedic surgeon or a neurosurgeon before proceeding.
The specific acts referred to in Count Two that constitute an alleged violation pertain where Respondent:
Failed to justify the diagnosis of Patient T.N.'s continued abdominal pain;
Failed to obtain appropriate orthopedic or neurological assistance in attempting to retrieve the retained intrathecal catheter on March 17, 1999;
Failed to justify the determination that the retained intrathecal catheter was not causing Patient T.N.'s continuing pain/problems.
Based upon the proof there has been presented, the evidence is not clear and convincing that Respondent failed to keep necessary medical records related to his diagnosis of Patient T.N.'s continued abdominal pain. No showing has been made that his record keeping explaining his choices for treatment were insufficient.
Respondent did not obtain orthopedic or neurological assistance in attempting retrieve the retained intrathecal catheter on March 27, 1999. Therefore it is not anticipated, in accordance with the law, that he be required to establish, in writing, matters unrelated to his treatment choices, failing which he would be considered as violating the statutory provision. This has been considered as a standard of care issue in Count One.
It has not been shown that the medical records maintained by Respondent for the March 17, 1999 surgery, was inadequate to explain the belief that the retained catheter was
not causing the patient pain, given the explanation found in the operative record and absent compelling expert testimony to the contrary. To the extent that the regulatory body disagrees with the explanation, it is a subject that has been addressed as an issue of standard of care in accordance with Section 458.331(1)(t), Florida Statutes, related to Paragraph 21.(b) to Count One.
The potential disciplinary action to be imposed for the violation found is as set forth in Section 458.331(2), Florida Statutes (1995), which states in pertinent part:
When the board finds any person guilty of any of the grounds set forth in subsection (1) . . . it may enter an order imposing one or more of the following penalties:
Refusal to certify, or certification with restrictions, to the department an application for licensure, certification, or registration.
Revocation or suspension of a license.
Restriction of practice.
Imposition of an administrative fine not to exceed $5,000 for each count or separate offense.
Issuance of a reprimand.
Placement of the physician on probation for a period of time and subject to such conditions as the board may specify, including, but not limited to, requiring the physician to submit to treatment, to attend continuing education courses, to submit to
reexamination, or to work under the supervision of another physician.
Issuance of a letter of concern.
Corrective action.
Refund of fees billed to and collected from the patient.
In addition, Florida Administrative Code Rule 61F6-
20.001 includes disciplinary guidelines pertaining to Section 458.331(1)(t), Florida Statutes (1995), which suggests the penalty range as "from two (2) years probation to revocation or denial, and an administrative fine from $250.00 to $5,000.00."
Florida Administrative Code Rule 61F6-20.001(3) lists aggravating and mitigating circumstances to be considered in imposing a penalty where it states:
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:
Exposure of patient or public to injury or potential injury, physical or otherwise: none, slight, severe, or death;
Legal status at the time of the offense: no restraints, or legal constraints;
The number of times the same offense or separate offenses established;
The number of times the same offense or offenses have previously been committed by the licensee or applicant;
The disciplinary history of the applicant or licensee in any jurisdiction and the length of practice;
Pecuniary benefit or self-gain inuring to the applicant or licensee;
Any other relevant mitigating factors.
The Patient T.N. was exposed to potential injury by Respondent's failure to remove the catheter segment during the May 16, 1996 surgery. There was one violation in association with one count. There is no indication that this same offense has been committed by Respondent on a prior occasion. Respondent is without a disciplinary history. There was no showing of pecuniary benefit or self-gain that inured to Respondent. No other relevant factors enter in to this deliberation.
it is
Based upon the findings of facts found and the conclusions,
RECOMMENDED:
That a final order be entered by the Board finding the
Respondent to have violated Section 458.331(1)(t), Florida Statutes (1995), placing Respondent on probation for two (2) years under conditions established by the Board; imposing an
administrative fine of $2,500.00; requiring Respondent to perform 25 hours of community service; and requiring the completion of five hours of continuing medical education on risk management.
DONE AND ENTERED this 4th day of August, 2008, in Tallahassee, Leon County, Florida.
S
CHARLES C. ADAMS
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 4th day of August, 2008.
COPIES FURNISHED:
Greg S. Marr, Esquire Ephraim Livingston, Esquire Department of Health
4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265
Michael R. D'Lugo, Esquire Wicker, Smith, O'Hara, McCoy,
Graham & Ford, P.A. Post Office Box 2753
Orlando, Florida 32802-2753
Larry McPherson, Executive Director Board of Medicine
Department of Health 4052 Bald Cypress Way
Tallahassee, Florida 32399-1701
R. S. Power, Agency Clerk Department of Health
4052 Bald Cypress Way, Bin A02 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.
| Issue Date | Document | Summary |
|---|---|---|
| Oct. 16, 2008 | Agency Final Order | |
| Aug. 04, 2008 | Recommended Order | Respondent violated the standard of care by leaving a catheter segment in the patient`s spine. |
