19-005173PL Department Of Health, Board Of Medicine vs. Anthony Glenn Rogers, M.D. Status: Closed Recommended Order on Wednesday, November 18, 2020.

Summary: 6 months' suspension, $20,000 fine, 2 years' probation, and reprimand for medical malpractice in performance of a lumbar transforaminal epidural steroid injection with hypertonic saline that left patient paralyzed in her lower extremities and incontinent

Respondent performe d a wrong procedure or wrong - site procedure , in

violation of section 456.072(1)(bb) ; and 4) if so, the determination of the

penalty , pursuant to Florida Administrative Code Rule 64B8 - 8.001 . (All

references to statutes and rules are to the Florida S tatutes and rules in effect

in 2012, as cited in the Amended Administrative Complaint.)

P RELIMINARY S TATEMENT

On June 30, 2017 , Petitioner filed an Amended Administrative Complaint

alleging that, on September 28, 2012, Respondent performed a lumbar

transforaminal epidural steroid injection with catheter and fluoroscopy on

M.S. The Amended Administrative Complaint alleges that, during the

procedure, Respondent inserted the tip of the catheter through the epidural

space and into the intrathecal space and injected co ntrast and injectate into

the intrathecal space instead of the epidural space.

The Amended Administrative Complaint alleges that Respondent "did not

create or keep documentation of obtaining" intra - and post - injection lateral

view epidurogram s to confirm the location of the catheter tip or the dispersal

pattern of the contrast and injectate. The Amended Administrative Complaint alleges that Respondent did not recognize, or did not create or keep documentation of recognizing, that he had performed an intrat hecal

administration instead of an epidural injection.

The Amended Administrative Complaint alleges that, after the procedure,

M.S. complained of bilateral hip and leg pain, numbness, and paralysis. She

was transferred to Bethesda Memorial Hospital where she was diagnosed with conus medullaris syndrome.

Count I alleges that Respondent violated section 458.331(1)(t)1. because

he failed to practice within the minimum standard of care required by

section s 456.50(1)(g) and 766.102(1) by failing to obtain an intra - injection

lateral view epidurogram to confirm the location of the catheter tip and

dispersal pattern of the contrast and injectate, failing to obtain a post -

injection lateral view epidurogram to confirm the location of the cat heter tip

and dispersal pattern of the contrast and injectate, and failing to recognize

that he had performed an intrathecal injection instead of an epidural

injection.

Count II alleges that Respondent violated section 458.331(1)(m) and (n n )

and r ule 64B8 - 9.003 (1), (2), and (3) b ecause he failed to obtain an

intra - injection lateral view epidurogram to confirm the location of the

catheter tip and dispersal pattern of the contrast and injectate, failed to

obtain a post - injection lateral view epidurogram to c onfirm the location of the

catheter tip and dispersal pattern of the contrast and injectate, and failed to

recognize that he had performed an intrathecal injection instead of an

epidural injection.

Count III alleges that Respondent violated section 456.07 2(1)(bb) because

he performed or attempted to perform a wrong - site procedure or a wrong

procedure by injecting contrast and injectate into a patient's intrathecal

space instead of epidural space.

The Amended Administrative Complaint seeks relief in the fo rm of

revocation, suspension, restriction of practice, imposition of an administrative

fine, imposition of probation, corrective action, refund of fees, and remedial

education.

Petitioner requested a formal hearing.

Respondent transmitted the file to DO AH on September 27, 2019. The

hearing was set for December 2 and 3, 2019, but continued at the request of

Respondent due to a death of a member of the family of Respondent's counsel.

After continuing the hearing to January 13 and 14, 2020, the administrati ve

law judge abated the case through January 21, 2020. Following that date, the

administrative law judge reset the hearing for April 6 and 7, 2020. This

hearing was continued at the request of Petitioner due to incomplete discovery and reset for June 15 an d 16, 2020. This hearing was continued at

the joint request of the parties due to Covid - 19 and reset for July 16 and 17,

2020.

At the hearing, Petitioner called two witnesses and offered into evidence

13 exhibits: Petitioner Exhibits 1 through 10, 13, 15, and 18 . Respondent

called one witness and offered into evidence eight exhibits: Respondent

Exhibits 1 through 3, 7 through 10, and 12. All exhibits were admitted for

all purposes except Petitioner Exhibit 13 (penalty only) and Respondent

Exhibits 7 (hearsay; basis for expert witness's testimony only) and 8

through 10 (hearsay; impeachment only).

The court reporter filed the transcript by July 31 , 2020. The parties filed

proposed recommended orders on August 31 , 2020.

F INDINGS OF F ACT

1. Respondent is a medical physician, holding license number ME

0062034. He is certified as a pain management specialist by the American Board of Anaesthesia and American Academy of Pain Management. Licensed for nearly 40 years, Respondent practice d in 2012 in Lake Worth at

the Palm Beach Pain Management Center , where he was the chief executive

officer . Respondent has performed the specific procedures involved in this

case at least 500 times and many thousands of epidural injections.

2. Respondent's expert witness was Dr. Bre tt Schlifka, who is an

osteopathic physician licensed in Florida and practicing in Wellington.

Dr. Schlifka is certified by the Board of Neurosurgeons of the American

College of Osteopathic Surgeons. As a neurosurgeon, Dr. Schlifka performs

epidural inject ions, but never of hypertonic saline, so he was unable to

address in any detail the epidural injection of hypertonic saline , nor does he

use a catheter in performing epidural steroid injection s (ESIs) , so he was

unable to address in any detail the specifics of the processes of threading a

catheter through epidural space and inadvertently into intrathecal space

and administering injectates through a catheter . Dr. Schlifka and

Respondent are friends and refer patients to each other.

3. Petiti oner's expert witness was Dr. Harold Cordner, who is a medical

physician licensed in Florida and practicing in Sebastian. Dr. Corner is

certified by the American Board of Anesthesiology with an added

qualification in Pain Management. For ten years, he has served as a clinical assistant professor at the Florida State University School of Medicine, where he teaches procedures such as those involved in this case -- procedures that

he himself has performed many times.

4. This case involves procedures performed by Re spondent on M.S. 's

back on September 28, 2012. F rom bottom to top, relevant vertebra are

sacral 1 (S1), lumbar 5 (L5), L4, L3, L2, and L1. Above the lumbar vertebra

are thoracic vertebra, which are not directly pertinent to this case. The spinal cord exten ds no lower than L1/L2; the tapered end of the spinal cord

is known as the conus.

5. Relevant anatomical features in the area of the lumbar vertebrae, from

the exterior to the interior, are ligament s , the epidural space, the dura, the

subdural space, the arachnoid, the subarachnoid space, and the spinal cord.

The subdural space is potential, presumably responding to changes in

posture or movement, or even theoretical, because the epidural and

subarachnoid spaces may be separated by less than one mm. Cerebr al spinal

fluid (CSF) is present in the subarachnoid space, but not the epidural space.

The subarachnoid space is also known as the intrathecal space, so an

intrathecal injection is an injection into the subarachnoid space. Intrathecal

injections may be in tentional or inadvertent, although this case does not

involve any intentional intrathecal injections.

6. "Bilateral" refers to the left and right sides of the vertebrae on the left

and right sides of a patient's body. " Transforaminal " is across the space,

wi thin the epidural space, occupied by the foramen, which is a bony

structure at each vertebral level through which spinal nerves pass. This case

involves epidural injections of various injectates, including steroids -- i.e.,

ESIs -- although an ESI routinely in cludes the epidural injection of contrast

and an anaesthetic in addition to a steroid . The ESIs in this case all involve

lumbar transforaminal ESIs, so any reference to an "ESI" is to a lumbar

transforaminal ESI. The alternative to a transforaminal ESI is an

interlaminar ESI , which is an ESI within the space between vertebrae. A t

the time in question, at least, an interlaminar ESI wa s a safer procedure

than a transforaminal ESI , if, for no other reason, than the proximity of an

artery to the nerve passing through a foramen and the possibility of causing

an infarction of the spinal cord by an inadvertent injection into the artery.

7. M.S. was a patient of Respondent at the Palm Beach Pain

Management Center from 2006 through September 28, 2012. On the latter dat e, Respondent performed procedures on M.S. , immediately after which

she has been left paralyzed in her lower extremities and incontinent of

bladder and bowe l.

8. Born in 1951, M.S. presented to Respondent in 2006 with complaints of

low back pain for many year s. She had undergone failed back surgeries in 1989, 1993, and 2003 . In the course of these surgeries, surgeons had

performed spinal fusions of L3/L4 and L4/L5 and implanted hardware at

L3/L4. M.S. was five feet, two inches tall and weighed 160 pounds.

9. At the time of M.S. 's initial office visit on February 7, 2006 , M.S.

described the pain in her low back as ranging from 5 to 10 on a scale of 0 - 10

and stated that she had not had "injection therapy" recently. Respondent's

impressions included lumbar failed back surgery syndrome and lumbar

radiculopathy , which is a condition in which a compressed spinal nerve

causes pain along the nerve . Respondent recommended a bilateral ESI.

Imaging conducted shortly after the initial office visit revealed the above - mentio ned hardware, postoperative changes in the disc at L4/L5, a

mild disc bulge at L1/L2, a "very minimal" posterior disc bu l ge at the

postoperative site of L3/L4, and a small central protrusion at L2/L3 causing

a mild compression along the central aspect of t he thecal sac, which is within

the subarachnoid space.

10. Besides the initial office visit and some imaging reports from late

2010, t he evidentiary record contains Respondent's medical records only

from December 2011 through September 28, 2012. In late 2010, imaging

disclosed disc degeneration at L1/L2 and L2/L3 with mild thecal sac impingement, the surgical fusion of L3/L4 and L4/L5, and disc desiccation at

L5/S1. There was also thickening or clumping of nerve roots through the

surgical levels that could be r egarded as arachnoiditis, which is

inflammation of the arachnoid membrane.

11. However, the evidentiary record contains billing records from late

2006 through September 28, 2012. These records indicate that Respondent

performed 21 epidural injection procedures on M.S. from December 6, 2006,

through September 28, 2012. The last ten such procedures, from April 19, 2010, were billed as ESIs using Code of Procedural Terminology (CPT)

code 64483, although one procedure was billed as CPT code 64473.

Respondent also billed ESIs under CPT code 64483 or 62311 on February 6,

2008, May 15, 2009, May 29, 2009, and February 22, 2010. The remaining

procedures were billed on December 6, 2006, March 20, 2007, June 13, 2007,

November 8, 2007, Februar y 21, 2008, September 5, 20 0 8, January 9, 2009,

and October 30, 2009, under CPT code 62264 as "Racz" procedures, which

are described below. Among other things, these records establish that

Respondent performed ESIs on M.S. on 90 - day intervals from late 201 0 until

September 28, 2012.

12. Obviously, the billing records also establish that the lumbar region of

M.S. was the site of numerous procedures over the six years leading up to

September 28, 2012. Although the experts agree that M.S. 's lumbar epidural

space w as challenging due to myriad deformities following years of disease

and multiple surg eries, Respondent had navigated this space over 20 times,

s o Respondent at least knew that he would encounter , if not where he would

encounter, lesions, narrowed openings, and other pathological changes .

13. For many years , Respondent had prescribed Percocet to control pain.

The medical records for the nine months preceding the September 28

procedures indicate that Respondent consistently administered drug

screens, which appropriately revealed only ox ycodone. However, o n at least a

half dozen office visits during 2012, M.S. admitted that she was not abiding

by the Narcotic Treatment Agreement, but, each time, Respond ent's notes

mis state that she was in compliance, so as to indicate no inquiry into the

details of the noncompliance or its significance, if any , and recordkeeping by

rote .

14. Respondent likewise displayed inattention to detail as to the informed

consent s that he obtained from M.S. during this nine month timeframe.

Each informed consent contain s a handwritten description of the procedure

to which M.S. was consent ing by signing the form . For each procedure, the

procedure is "lumbar transforaminal epidural steroid injections with

fluoroscopy and catheter "; the June 25 informed consent rephrase s the last

four words as "with catheter with fluoroscopy , " and the September 28

informed consent add s "left" to the typical description of the procedure.

Respondent nev er obtained M.S. 's informed consent for the injection of

hypertonic saline, even though Respondent injected hypertonic saline , with

the amounts shown par e nthetically, during the procedures of December 23

(5 cc), June 25 (5 cc), and September 28 (8 cc).

15. For the December 23 procedure s , Respondent took 12 minutes from

" start " to " end " for the actual procedure s and 18 minutes from " in " to " out " of

the operating room. Coincidentally , the December 23 procedure s ' start and

end and in and out times are identical to these times for the September 28

procedures. The start to end time s of other two procedures were 11 minutes.

This brisk pace betrays Respondent's experience as a pain specialist, but

belies M.S. 's challenge as a patient.

16. During each set of procedures fro m December 2011 through

September 28, 2012, Respondent injected the same injectates, except for the

March 23 procedure that omits hypertonic saline, but at different dosages,

which is discussed below. Respondent used a form that allowed him to

document his surgical plan by circling levels -- L1/L2, L2/L3, L3/L4, and

L5/S1 -- and sides -- left, right, and bilateral. For December 2011, Respondent

circled nothing; for March and June 2012, Respondent circled levels L3/L4,

L4/L5, and L5/S1 and the right side; and for September 28, 2012, Respondent circled the same levels, but the left side.

17. The efficacy of the epidural procedures is revealed in the notes

from postsurgical office visits during which M.S. described her pain. On

January 2, 2012, M.S. reported that her pain ranged from 6 - 10 all day and

all night, the pain range d from her back down her legs, everything made her

pain worse, and the injections help ed , although , after several i njections, she

reported that she had experienced "floppiness" in one leg -- side unspecified.

M.S. concluded that the pain relief from the injections made a difference in

her life and restored functionality.

18. On January 10, 2012, M.S. returned to Respondent's office

complaining of pain ranging from 8 - 10 without medications and 6 - 10 with

medications . The pain was radiating from her low back down her legs,

mostly her right leg . The pain was continuous and "sharp, burning, shooting,

achy, knife - like, stabbing, de ep, heavy, and gnawing." On February 7, 2012,

M.S. returned to Respondent's office with the same complaints.

Interestingly, on March 6, 2012, M.S. returned to Respondent's office

describing her pain as improved -- 5 - 10 without medications and 3 - 6 with

medications. This time the note specifi es that " transforaminal epidurals"

gave her the greatest relief. The note for this office visit mentions a

treatm ent plan of another ESI of a steroid and anaesthetic, but does not

specify the side.

19. On April 3, 2012, M.S. returned to Respondent's office for her first

visit after the March 23 ESI. Again, the pain was worse immediately after

the procedure -- 9 - 10 without medications and 5 - 8 with medications, although

the note adds, "the transforaminal epidural with catheter has also helped

her tremendously." The notes contain no analysis of the worsened pain 11 days after the ESI compared to 17 days before the ESI, but leg floppiness

does not recur in this or any subsequent note.

20. On May 5, 2012, M.S. returned to Respondent's office describing her

pain as 8 - 10 without medications and 5 - 9 with medications. M.S. stated that

the medications and "transforaminal epidurals with ca theter" were the only

treatments that help ed with the pain. On May 15, 2012, M.S. returned to

Respondent's office describing her pain as 6 - 10 without medications and 4 - 6

with medications. On June 22, 2012, M.S. returned to Respondent's office

following a trip to North Carolina, where she had been unable to obtain her

oxycodone and had been in considerable pain. On the day of the visit,

though, M.S. reported her pain to be a n 8 without medications and 6 with

medications. The treatment plan contained in the note includes a right ESI, which Respondent described to M.S. as the injection of Cortisone and

Marcaine or lidocaine with no mention of hypertonic saline.

21. On July 20, 2012, M.S. returned to Respondent's office for her first

visit after the June 25 ESI. M. S. described the pain as 8 - 10 without

medications and 5 - 8 with medications. The recent "right lumbar

transforaminal with catheter [helped] about 50% to 60%." On August 17,

2012, M.S. returned to Respondent's office describing her pain as 7 - 10

without medic ations and 1 - 7 with medications. The note adds, "She states no

real change in her status, just looking forward to another injection." The

treatment plan wa s for a left ESI with Cortisone and Marcaine or lidocaine,

but , again, with no mention of hypertonic saline.

22. O n September 28, 2012, Respondent performed three procedures --

first, a caudal lumbar epidurogram with interpretation ; second, an ESI ; and ,

third , a distinct procedure involving the injection of hypertonic saline . In all

three procedures , Respondent relie d on live or real - time fluoroscopy to guide

the spinal needle and catheter, which are described below. M.S. was

positioned on a table , which, as relevant to these procedures, accommodates

the 90 - degree rotation of a fluoroscope , which is also called a C - arm due to

the ability of the device to project onto a monitor anterior - posterior (AP),

lateral, and oblique views of the spine and related structures. The AP view is a head - on (or back - on) view, and the lateral view is a side view at 90 degrees

from the AP view . At the direction of Respondent, a technician not only

rotate d the C - arm, but also captured a still image from the radiographic

output, which otherwise r an live or in real time or was switched off entirely

when unneeded , to avoid over - exposing the patient to radiation.

23. T he cau d al lumbar epidurogram is a relatively simple diagnostic

procedure . Respondent passe d a spinal needle through the sacral hiatus,

which is a hole in the bony structure at the base of the spine below S 1 , and

into the caudal epidural space. By lightly pushing the syringe plunger,

Respondent employed the loss - of - resistance technique to sense the lack of

resistance characteristic of the epidural space; by lightly pulling the syringe

plunger, Respondent asp irated the needle and line to rule out the presence

of any CSF, which would reveal an intrathecal penetration, or blood, which

would reveal a vascular penet r ation. M.S. , who remained conscious during

the procedures, also did not indicate any paresthesia, which is numbness or

tingling. Respondent withdrew the hollow core of the spinal needle in

preparation for threading the catheter through the now - hollow needle and

up th rough the epidural space. Respondent has maintained five AP views

and one lateral view from the fluoroscopic imagery that he conducted on

September 28. The lone lateral view, which is of the sacrum, was taken and

preserved as part of the epidurogram.

24. Durin g the entirety of the September 28 procedures, including the

epidurogram, Respondent injected 6 cc of contrast in the form of Omnipaque

300 . As with all injectates , Respondent's records refer only to divided doses,

so it is impossible to know how much of any injectate , including the contrast,

that he administered at what level . The ESIs in March and June 2012 may

have involved fewer levels than the ESIs in December 2011 and September 2012, because the former involved 3 cc each of Omnipaque and

the latter involved 5 cc each of Omnipaque.

25. Returning to the epidurogram, a s t he contrast flowed up the epidural

space , the radiography revealed lesions at S1 on the right and L5 on the left.

The dispersal pattern of the contra s t indicated that the contra s t was within

the epidural space. Without incident, Respondent completed the

epidurogram about two minutes after starting the procedure .

26. For the ESI and hypertonic saline proce dures , Respondent pass ed the

catheter up through the epidural space to the level or levels that he was targeting for treatment . At each level, Respondent injected, in order, the

above - described contrast, an anaesthetic, a steroid known as Depo Medrol,

and hypertonic saline solution . For all four procedures from December 2011

through September 28, 2012, Respondent used Marcaine 0.25% and

lidocaine 1%, but his records did not indicate the location at which he

administered each anaesthetic. It appears that the anaesthetic used in the

greater dose was used in the epidural space, and the other anaesthetic was

used elsewhere, likely at the site of the initial injection. If so, for the

September 28 procedures, Respondent used 5 cc of lidocaine in the epidural

space -- or what he intended to be the epidural space -- and 1 cc of Marcaine

elsewhere. In March 2012, Respondent used 3 cc of Marcaine and no

lidocaine; in December 2011, Respondent used 5 cc of each anaesthetic; and,

in June 2012, Respondent used 2 cc of Marcain e and 3 cc of lidocaine.

27. Respondent's use of Depo Medrol was more consistent. He

administered 80 mg during the September 28 ESI , but had used 120 mg

during each of the three preceding ESIs .

28. The greatest variability occurred with the hypertonic saline, whi ch,

as already noted, was omitted from the March 2012 ESI. Respondent

administered 8 cc of hypertonic saline during the September 28 procedures

and only 5 cc -- nearly 40% less -- during the December 11 and June 2012

procedures . The record contains no indicati on of why he failed to inject

hypertonic saline during the March 12 procedure, but the sole reference to leg floppiness, as noted above, was after the preceding procedures in

December 2011.

29. There is some dispute in this case as to what may be injected as p art

of an ESI. Obviously, the ESI contemplates the injection of a steroid , as well

as contrast and an anaesthetic , which support the injection of the steroid by

heightening the safety of the ESI and the comfort of the patient during the

ESI. Also, these injectates are amenable to grouping because this record

does not suggest that an inadvertent intrathecal injection of these injectates,

even at the doses intended for the epidural space, affect s patient safety

nearly as much as an inadvertent intrathecal i njection of hypertonic saline.

An intrathecal injection of a very high dose of anaesthetic could proceed up

the spinal canal and cause respiratory and cardiovascular collapse, but the

record does not indicate that such dangers exist for the dosages involve d in

the September 28 procedures. For the same reason, an ESI may include an

injection of normal saline, which is harmless in the subarachnoid space.

30. The epidural injection of hypertonic saline is the distinguishing

feature of a Racz procedure, which also involves an epidural injection.

Named after its physician - developer, Gabor Racz , the Racz procedure is

intended to break up, or lyse, epidural lesions or adhesions that may be the

source of part or all of a patient's pain when a nerve is trapped by an

adhesion. In the Racz procedure, a physician injects hypertonic saline near

the lesion . The salinity of hypertonic saline solution is ten times greater

than the salinity of ambient conditions in the body , so the hypertonic saline

solution , by osmosis , caus es the body to compensate for the sudden

appearance of hypersaline conditions by delivering fluid that expands the

space and may thus lyse any nearby adhesions. Although the catheter is

typically not stiff enough to break up lesions mechanically, such mech anical lysis may also occur incidentally while performing a Racz procedure .

31. Other distinguishing features of an ESI and Racz procedure involve

the sources of pain and the term of pain relief. The lysis of an adhesion

permanently eliminates one potential s ource of pain -- a nerve trapped by an

adhesion. An ESI reduces inflammation wherever it may be present, so it

treats a wider range of conditions, but offers only temporary relief . The pain

relief from the steroid may extend weeks or month s . The pain relief from the

anesthetics -- one hour for lidocaine and four hours for Marcaine -- is not

intended to persist past the intra - operative and recovery stages of the

procedures.

32. There may also be a locational difference between the ESI and Racz

procedure s . As noted above, in the ESI, the catheter traverses the foramen

within the epidural space, and, in the Racz procedure, the catheter is threaded to lesions anywhere within the epidural space . Dr. Cord n er opined

that Respondent failed to perform an ESI due to the lack of proximity of the

injection sites to the various foramina. Labels notwithstanding, the procedures performed by Respondent on September 28 substantially

conformed to an ESI and, because an ESI does not include the epidural

injection of hypertoni c saline, a Racz procedure.

33. Determining that Respondent performed two distinct procedures in

addition to the epidurogram does not answer several relevant questions.

First, which injectate, once introduced into the subarachnoid space, injured

M.S. ? If intr oduced to the subarachnoid space, t he hypertonic saline is a

known cause of the pa r alysis and incont in ence that M.S. suffered , such as

myopathic injury resulting in paralysis . Because safe practices, as described

by Dr. Cordner below, include the provisional injections of contrast and

anaesthetic to confirm that a catheter tip is safely in the epidural space, the

only other injectate that might injure the patient is the steroid, but, again,

the record is silent on the consequenc e of the introduction of the Depo

Medrol, at the dosages used by Respondent, into the subarachnoid space.

34. Second, when did Respondent decide to inject the hypertonic saline ?

The record provides no basis to answer this question. As noted above, Respondent did not administer hypertonic saline in the March 2012

procedure, but administered hypertonic saline in the December 2011 and June 2012 procedures, as well as the September 28 procedure, in which he

increased the dose by 60%. For none of the three procedur es in which

Respondent injected hypertonic saline did his treatment plans or informed

consents mention hypertonic saline. Respondent may have decided, prior to

the day of surgery, to use hypertonic saline and merely failed to document

this decision in adva nce , or he may have decided, during surgery, to use

hypertonic saline and documented the use of hypertonic saline as noted

above .

35. Third, why did Respondent inject hypertonic saline and why did he

administer the dosages that he used? The record provides no basis to answer

these questions, al t hough , as noted above, the omission of hypertonic saline

f r om the March 20 12 procedure corresponds to leg floppiness after the

December 2011 procedure and the increased dose of hypertonic saline in the

September 28 procedures corresponds to a lower dose of the Depo Medrol.

The medical records indicate that M.S. believed that the ESIs relieved her

pain, but she could not have had a preference about hypertonic saline

because she evidently never knew that Respondent was using this injectate.

On the other hand, M.S. 's rating of her pain after the March 2012 procedure,

without hypertonic saline, was not much different from her rating of her

pain after the December 2011 and June 2012 procedures. The likely

inference is, if Respondent's use of hypertonic saline were not arbitrary or

capricious , he injected hypertonic saline , at least when M.S. had not

mentioned leg floppiness after the last inje c tion of hypertonic saline, because

he believed it worked and used considerably mo re of it on September 28

because he believed that more would work better.

36. Returning to the remaining S eptember 28 procedures , Respondent

injected the four injectates described above on M.S. 's left side at three levels:

S1/L5, L4/L5, and L3/L4. At each level, Respondent waited three or four seconds after injecting the contrast, while he watched the radiographic

output, before injecting the anaesthetic, after which he waited 30 to

40 seconds to allow the anaesthetic to numb the area. Then, Respond ent

injected the steroid, waited five seconds, and lastly he injected the

hypertonic saline. Assisted directly by the epidurogram, Respondent

properly located t he catheter tip in the epidural space at S1/L5 . The

evidence is mixed as to the location of the catheter tip at L4/L5, but the

catheter tip was in the subarachnoid space at L3/L4.

37. As Dr. Cordner testified, an inadvertent penetration of the

subarachnoid space by a catheter tip is not evidence of negligence; the

negligence arises in what a physician d oes or fails to do after such an

intrathecal penetration. Here, the reasons why Respondent failed to realize that the catheter tip was in the subarachnoid space at L3/L4 relate to the reasonable precautions that Respondent failed to take -- and thus establis h

Respondent's negligence. Respondent failed to realize that the catheter tip

had entered the subarachnoid space at L3/L4 because , after injecting the

contrast, he misread the AP real time view from the fluoroscope that showed

a dispersal pattern suggesti n g that the contrast was not within the epidural

space ; because, after injecting the contrast, he did not direct the technician

to obtain a lateral real time view , which would have provided another

dimension, so as to confirm that the contrast was not in the epidural space ;

because he did not perform the loss - of - reduction technique , which would

have confirmed that the catheter tip was no t in the epidural space; because

he did not aspirate the catheter and line, which would have revealed CSF;

and because, a fter injecting the anaesthetic, he did not wait at least

15 minutes to rule out a gross motor block of the lower extremities, which

would have indicated that the catheter tip was in the subarachnoid space.

38. U nre asonably unaware that the catheter tip was in the subarachnoid

space, Respondent injected the steroid and hypertonic saline, withdrew the

catheter, and completed the ESI and Racz procedures within ten minutes

from the end of the epidurogram procedure and turned over responsibility

for M.S. to Responde nt's nurse.

39. One minute after the completion of the procedure, at 9:38 a.m., M.S.

complained of pain in her hips and legs, and Respondent administered

60 mg of Toradol. Ten minutes later, M.S. stated that both of her legs were

numb, although by 10:15 a.m. s he was moving both legs. By 11:30 a.m., she

could move both legs, but had no feeling from the top of her thighs down. By 1:00 p.m., M.S. reported feeling to her mid - calf, but , three hours later, she

could not move her legs. Although Respondent justifiably had not been

concerned about transient numbness, the deterioration in the ability to move

the legs concerned him, and Respondent insisted that M.S. be admitted to a

nearby hospital. Respondent thus discharged M.S. at 5:25 p.m. for transfer

by ambulance to Bethesda Memorial Hospital (Bethesda) , where other

physicians assumed responsibility for her care.

40. Imaging conducted at Bethesda upon the admission of M.S. revealed

no epidural hematomas, but evidence of arachnoiditis, which is

inflammation of the arachno id membran e . Most significantly, a lumbar CT

scan revealed a small amount of air in the subarachnoid space, which was

consistent with Respondent's recent intrathecal injection s. Also, M.S. 's

thecal sac displayed enhancement of disc disease at S1 through L4

suggestive of a recent subarachnoid injury.

41. About six weeks after the procedures, an MRI at the JFK Medical

Center (JFK) revealed conus med u llaris syndrome posteriorly within the

thecal sac at L1/L2 through L3/L4. This syndrome results from injury to the

conus, such as from trauma , and is consistent with Respondent's intrathecal

injection of hypertonic saline . This hospitalization followed a finding from an

outpatient MRI of a large hematoma in the lumbar spine. Respondent and D r. Schlifka contend that the Bethesda physicians missed the hematoma,

but it is as likely that the hematoma formed after M.S. 's discharge from

Bethesda. M.S. underwent a resection of a mass, which was found to be an

arachnoid cyst. Post - operatively, M.S. s till was unable to move her lower

extremities, but started to regain sensation in her great toes.

42. Respondent relies on a succinct affidavit from Dr. Racz himself,

which, as noted in the Conclusions of Law, is available only to impeach

Dr. Cordner's testim ony. Dr. Racz's affidavit states that he has examined

Respondent's medical records, including the six fluoroscopic images retained

by Respondent ; all of the images available in connection with the Bethesda

and JFK hospitalizations ; and some earlier images . From these materials,

without more, Dr. Racz 's affidavit conclude s that Respondent's care was

" appropriate and that he met or exceeded the standard of care throughout

the lumbar transforaminal epidural steroid injection with catheter and

fluoroscopy on Se ptember 28, 2012. Further, the complications suffered by

[ M.S. ] are known risks and complications of the procedure that are not

indicative of negligence. "

43. The most obvious difference between the opinions of Dr. Cordner and

Dr. Racz is not the amount of wor k; each physician has examined all of the

available medical records. But Dr. Cordner has painstakingly analyzed the

September 28 procedures and Respondent's negligent actions and omissions,

and Dr. Racz has declare d by fiat that Respondent was not negligen t .

44. Undoubtedly, Dr. Racz learned from his examination of the medical

records that Respondent injected hypertonic saline on September 28, yet

Dr. Racz describes the procedure as an ESI and makes no mention of

hypertonic saline . Perhaps Dr. Racz is sensitive to the greater potential for

injury introduced by hypertonic saline, which is the prominent injectate of

his procedure. Perhaps, the procedure followed by Respondent on

September 28 failed to follow strictly the requirements of the Racz

procedure . Dr. Cor dner, who co - teaches the Racz procedure with Dr. Racz,

testified that the procedure requires a physician to wait 15 to 30 minutes

after injecting anaesthetic to confirm the injection is in the epidural space.

Regardless, an informed opinion as to Respondent's negligence must take

into account the injectate that, on this record, bears the clear potential for

patient injury, and Dr. Racz's opinion fails to do so.

45. Perhaps, Dr. Racz's affidavit is an expression of agreement with

Dr. Cordner's concession that, in itself, an inadvertent intrathecal

penetration is not evidence of negligence. But Dr. Racz's affidavit needs to

account for the acts and omissions, set forth above, that simultaneously

explain why Responden t failed to realize that the catheter tip was in the

subarachnoid space at L3/L4 and constitute hi s failure to take these simple

precautions against patient injury.

46. The last sentence of Dr. Racz's affidavit dismisses M.S. 's

"complications" -- a veiled ref erence verging on a euphemism when describing

permanent paralysis and incontinence -- as known risks of the ESI and not

indicative of negligence. Obviously, a bad result does not prove medical

malpractice, although , as explained in the Conclusions of Law, th e risk of a

bad result and the impact on a patient of a bad result drive the precautions

that a physician must take to avoid a finding of medical malpractice. On the

other hand, the known risk of permanent paralysis and incontinence from a

Racz procedure o r an ESI with the injection of hypertonic saline does not

obviate the necessity of analysis of the adequacy of the precautions taken by

Respondent to avoid such a result; to the contrary, these grave consequences

underscore the importance of such analysis.

47. Notwithstanding Dr. Racz's status in the field of pain management,

his affidavit is entitled to no weigh t whatsoever and fails to impeach the

testimony of Dr. Cordner.

48. Dr. Schlifka's testimony is better than Dr. Racz's affidavit in one

respect: he clearly acknowledged that injectate had entered the subarachnoid space. It is impossible to dispute this fact based on M.S. 's

dramatic response, the dispersal pattern of contrast depicted in one saved

AP view, air found in the subarachnoid space shortly after the September 28

procedures, the injury to the thecal sac, and the conus injury.

49. On the other hand, Dr. Schlifka's testimony shared the failure of

Dr. Racz's affidavit in addressing the particulars of the September 28

pro cedures performed by Respondent. As Dr. Racz failed to focus on

anyth i ng but a theoretical ESI, Dr. Schlifka failed to focus on anything but

the fragile anatomy of the dura -- never addressing, for instance, the

likelihood that a catheter during an ESI could tear the dura -- something that

the experienced Dr. Cordner has never encountered; whether a tear would

introduce air into the subarachnoid space ; or whether the injectate entering

through a tear could possibly injure the thecal sac and conus . Obviously,

Dr. Schlifka lacks the experience to opine as to whether a catheter may tear

the dura and, if so, the probability of this complication. On the other hand,

Dr. Schlifka failed to explain why a dural tear would admit injectates into

the subarachnoid space, b ut not allow injectates and CSF to escape from the

subarachnoid space into the epidural space. Nor did he address the behavior of injectates -- the most important one of which he has never worked with -- if

injected through the dura and into the subarachnoid s pace or if entering the

subarachnoid space through a tear in the dura. Although qualified to advise

that the dura may tear, and, as he testified, the dura may be more prone to

tearing after numerous surgeries and procedures in the affected area ,

Dr. Schlif ka clearly lacked the means to address, on these facts, the

probability that M. S.'s injuries were caused by a dural tear or an intrathecal

injection .

50. Compared to Dr. Cordner's detailed analysis and superior relevant

experience, Dr. Schlifka's opinions ar e speculative and perhaps reflective of

a n understandable desire to help a beleaguered friend . However,

Dr. Schlifka's explanation for the intrathecal penetration of the injectate by

a dural tear is rejected as unsupported by the evidence .

51. For Count I, Petitioner proved that , based on the standard of care in

effect in 2012, Respondent committed medical malpractice by failing to

recognize that he was performing intrathecal injection s of steroid and

hypertonic saline at L3/L 4. Petitioner failed to prove th at any injections at

L4/L5 and L5/S1 were intrathecal. The evidence of intrathecal injections at

L3/L4 is set forth in paragraph 48, and Respondent's negligent acts and

omissions are set forth in paragraph 37.

52. The intrathecal injections of the contrast an d an a esthetic at L3/L4

were wrongful solely because Respondent failed to use the information obtainable from these injections to discover that the catheter tip was in the

subarachnoid space . I n other words, Respondent would not have committed

medical malpractice (or a wrong - site procedure or wrong procedure ) if he had

injected intrathecally c ontrast and an anaesthetic as part of what is

intended to be epidural injections, as long as he learned from these

injections that the catheter tip wa s in the subarachnoid space and move d the

tip into the epidural space or terminate d the procedure : the epidural

injection of these injectates performs both a therapeutic and diagnostic

function.

53. For Count II, Petitioner failed to prove that , in 2012, Respondent was

required to obtain and retain a permanent image of any lateral view of

L3/L4 or any other location as part of the procedures after the epidurogram

or that Respondent's failure to realize that the catheter tip was in the

subarachnoid space violated his recordkeeping obligation. The latter point

finds no support in the record. As for the images, Dr. Cordner's testimony on

this "requirement" of medical recordk eeping was vague , conditional, and

never tethered to the requirements in effect in 2012. Although his practice is

different, Dr. Schlifka does not keep permanent views from his epidural

steroid injections by needles . Petitioner itself seems to have missed the point

that a permanent image of an AP view helped prove that the catheter tip

was in the subarachnoid space at L3/L4.

54. It is one thing to hold Respondent responsible for failing to interpret a

real time AP view of L3/L4 and failing to obtain a real time lateral view of

L3/L4, as discussed in connection with Count I, but it is another thing to hold Respondent responsible for failing to maintain permanent images of

any views for the procedures following the epidurogram. Among myriad

shortcomings in Petitio ner's case for Count II is the failure to address

whether, for reasons of cost or radiation exposure, a physician in 2012 could

still perform a blind ESI and, if so, the ramifications of more elaborate and

expensive recordkeeping requirements imposed on th e physician who

perform ed image - guided ESIs -- or otherwise would do so, but for this

expensive recordkeeping requirement.

55. For Count III, Petitioner proved that Respondent performed a wrong

procedure or a wrong - site procedure by injecting "injectate," but no t

contrast, into the intrathecal space when he intended to inject injectates into the epidural space. As noted above, an inadvertent intrathecal

administration is not evidence of carelessness, and the timely detection of such a mishap -- before the intrathec al injections of a steroid or hypertonic

saline -- may involve interpreting the dispersal of contrast or the effect of the

anaesthetic and determining that either or both injectates have been

accidentally injected into the subarachnoid space. For this reason, the

inadvertent intrathecal injections of contrast or anaesthetic into the

subarachnoid space is not a wrong procedure or wrong - site procedure

because of the secondary diagnostic value of this otherwise - therapeutic

procedure. The wrong pro cedure or wrong - site procedure occur red when

Respondent then injected the steroid and hypertonic saline into the

subarachnoid space at L3/L4 ; the intrathecal injection s of these injectates

lack ed any diagnostic purpose and were thus wrong procedures or wro ng - site

procedures .

56. In its proposed recommended order, Petitioner has proposed a

reprimand, probation for two years, and a $30,000 fine. Despite the passage

of seven years from the September 28 procedures and the transmittal of the

file to DOAH, Petitioner failed to identify important features of this

complicated case. Although not charged with these matters, Respondent wa s

guilty of serious failures to obtain informed consent for the use of injectate that caused M.S.'s catastrophic injuries -- hypertonic sal ine -- and to keep

medical records documenting his plans for an ESI or an ESI with hypertonic

saline and the locations and dosages of each injectate during the procedures,

as well as analysis of the efficacy of each set of procedures. T hese

aggravating facto rs necessitate the imposition of a suspension.

57. On the other hand, past discipline is not an aggravating factor. By

final order entered April 20, 2006, the Board of Medicine fined Respondent

for a failure to keep adequate medical records 20 years ago, but t he failure

was in performing adequate physical examinations , which is not an issue

here . Given the age and nature of the offense, past discipline is irrelevant in

this case .

C ONCLUSIONS OF L AW

58. DOAH has jurisdiction. §§ 120.569 , 120.57(1) , and 456.073(5), Fla.

Stats.

59. Petitioner must prove the material allegations by clear and

convincing evidence. § 120.57(1)(j); Dep't of Banking & Fin. v. Osborne Stern

& Co. , 670 So. 2d 932 (Fla. 1996). Clear and convincing evidence is evidence

that is "'precise, explicit, lacking in confusion, and of such weight that it

produces a firm belief or conviction, without hesitation, about the matter in

issue.'" Robles - Martinez v. Diaz, Reus & Targ, LLP , 88 So. 3d 177, 179 n.3

(Fla. 3d DCA 2011) (citing Fla. Std. Jury Instr. (Civ) 405.4).

60. A charging document must allege facts that support an alleged

violation of law, because disciplinary action against a licensee based on

unalleged facts would violate the licensee's right to a hearing under

chapter 120. Cottrill v. Dep't of Ins. , 685 So. 2d 1371, 1372 (Fla. 1st

DCA 1996). See also Trevisani v. Dep't of Health , 908 So. 2d 1108 (Fla. 1st

DCA 2005) .

61. The affidavit of Dr. Racz was availab le for use in the cross -

examination of Dr. Cordner, so as to impeach his testimony, but not to

establish the truth of the contents of the affidavit. Cf. Kirkpatrick v. Wolford ,

704 So. 2d 708 (Fla. 5th DCA 1998) (use of medical treatise).

62. Pursuant to section s 456.072(2) and 458.331(1), the Board of Medicine

is authorized to discipline Respondent's license for the following:

(t) Notwithstanding s. 456.072(2) but as specified in

s. 456.50(2):

1. Committing medical malpractice as defined in

s. 456.50. The board shall give great weight to the

provisions of s. 766.102 when enforcing this paragraph. Medical malpractice shall not be

construed to require more than one instance, event,

or act. [Count I]

* * *

(m) Failing to keep legible, as defined b y

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 bil ling 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 repor ts of consultations and

hospitalizations. [Count II]

* * *

(bb) Performing or attempting to perform health

care services on the wrong patient, a wrong - site

procedure, a wrong procedure, or an unauthorized procedure or a procedure that is medicall y

unnecessary or otherwise unrelated to the patient’s

diagnosis or medical condition. For the purposes of

this paragraph, performing or attempting to perform health care services includes the

preparation of the patient. [Count III]

63. Petitioner failed to pr ove the material allegations of Count II. The

Findings of Fact adequately address the alleged failure to keep images of

fluoroscopic views after the epidurogram was completed. The cryptic

allegation in Count II based on Respondent's failure to recognize th at the

catheter tip was in the subarachnoid space fails to meet the due process

standards recognized in Trevisani . Ultimately unable to understand this

allegation as a recordkeeping issue, the administrative law judge doubts

that Respondent understood it a ny better.

64. Petitioner proved the material allegations of Count III. This is a

straightforward case of a wrong - site procedure or wrong procedure with the

intrathecal injection of the steroid and hypertonic saline, regardless of whether Respondent did so negligently or completely innocently. Perhaps

wisely, Petitioner did not allege merely that the intrathecal penetration of

the catheter tip constituted the wrong - site procedure or wrong procedure,

although, under the terms of the statute, it does.

65. Petitioner proved the material allegations of Count I. Two statutes

apply to this count. First, section 458.331(1)(t) requires the administrative

law judge, as well as the Board of Medicine, to specify whether the licensee

has committed "medical malpractice," "gross medical malpractice," or

"repeated medical malpractice": the administrative law judge specifies

"medical malpractice."

66. Second , section 456.073(5) provides that "a determination of the

reasonable standard of care is a conclusion of law to be determined by the

board and is not a finding of fact to be determined by an administrative

law judge." Conclusions of law retain a precatory quality in any

recommended order, but especially so here. In any event, s ection 456.50(1)(g)

provides: " ' Medical malpractice' means the failure to practice medicine in

accordance with the level of care, skill, and treatment recognized in general

law related to health care licensure." Section 766.102(1) adds:

the claimant shall have the burden of proving

that the alleged actions of the health care provider

represented a breach of the prevailing professional

standard of care for that health care provider. The

prevailing professional standard of care for a given

health care provider shall be that level of c are,

skill, and treatment which, in light of all relevant

surrounding circumstances, is recognized as

acceptable and appropriate by reasonably prudent

similar health care providers.

Section 766.103(3)(b) cautions: "The existence of a medical injury does not

create any inference or presumption of negligence against a health care

provider, and the claimant must maintain the burden of proving that an

injury was proximately caused by a breach of the prevailing professional

standard of care by the health care provider."

67. Petitioner contends that Dr. Schlifka fails to meet the requirements of

section 766.102(5)(a)1. for failing to specialize in the same specialty as

Respondent. However, section 766.102(14) authorizes the trial court to

qualify an expert on ground s other than those stated in section 766.102, and,

in the end, Dr. Schlifka's testimony was discredited on its merits so as to

moot this issue.

68. A n informed formulation of a standard of care or identification of the

acts or omissions that constitute medical malpractice, as defined above,

must balance the risk of an adverse outcome and the gravity of an adverse

outcome against the burden of the precautions to avoid an adverse outcome.

U . S . v. Carroll Towing Co. , 159 F.2d 169, 173 (2d Cir.1947) . See also

Restatement (Third) of Torts : General Principles, § 4 "Negligent" (Oct. 2020

update).

69. Even assuming that the risk of an inadvertent intrathecal injection

was low, the gravity of an intrathecal injection of hypertonic saline was very

high, so as to require Respondent to undertake more extensive precautions

while performing the ESI and Racz procedures and, certainly, perform the

unburdensome tasks set forth in paragraph 37 . On these fact s , Respondent's

failure to perform these tasks and ensuing failure to recognize that the

catheter tip was in the subarachnoid space prior to injecting the steroid and

hypertonic saline at L3/L4 constituted medical malpractice.

70. As effective May 28, 2012, rule 64B8 - 8.001(2)(t) provides a penalty

range of one year's probation to revocation and a fine of $1000 to $10,000 for

a first violation of section 458.331(1)(t). Rule 64B8 - 8.001(2)(ss) provides a

$1000 fine, letter of concern, and education to a $10,000 fine, suspension

followed by probation, and education for a first violation of section 456.072(1)(bb). Rule 64B8 - 8.001(3) identifies as aggravating or mitigating

factors the severity of injury to the patient and the licensee's disciplinary

history and length of practice.

R ECOMMENDATION

It is

R ECOMMENDED that the Board of Medicine enter a final order finding

Respondent not guilty of the alleged violation of section 458.331(1)(n) in

Count II , but guilty of the alleged violations of sections 458.331(1)(t)1.

and 456.072(1)(bb) in Counts I and III , respectively, and imposing a

reprimand, six month s' suspension, two years' probation following the end of

the suspension , and a fine of $ 2 0,000.

D ONE A ND E NTERED this 1 8 th day of November, 2020, in Tallahassee,

Leon County, Florida.

R OBERT E. M EALE

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399 - 3060

(850) 488 - 9675

Fax Filing (850) 921 - 6847

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative H earings

this 1 8 th day of November, 2020.

C OPIES F URNISHED :

Sharon B idka Urbanek, Esquire

Forman Law Offices, P.A.

238 Northeast 1st Avenue

Delray Beach, Florida 33444 - 3715

(eServed)

Michael J . Williams, Esquire

Geoffrey M. Christian, Esquire

Department of Health

Prosec uti on Services Unit

4052 Bald Cypress Way , Bin C - 65

Tallahassee, Florida 32399 - 3565

(eServed)

Louise St. Laurent, Gen eral Counsel

Department of Health

4052 Bald Cypress Way , Bin C - 65

Tallahassee, Florida 32399 - 3565

(eServed)

Claudia Kemp, J.D., Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way , Bin C - 03

Tallahassee, Florida 32399 - 3253

(eServed)

N OTICE OF R IGHT T O S UBMIT E XCEPTIONS

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.