20-005447PL Department Of Health, Board Of Medicine vs. Stephanie Stover, M.D.
 Status: Closed
Recommended Order on Friday, August 13, 2021.


View Dockets  
Summary: Respondent committed medical malpractice in violation of section 458.331(1)(t) and (nn), but had mitigating circumstances resulting in a recommendation of one year probation, a $5,000 fine, and imposing the costs of investigation and prosecution.

1S TATE OF F LORIDA

6D IVISION OF A DMINISTRATIVE H EARINGS

13D EPARTMENT OF H EALTH , B OARD OF

21M EDICINE ,

23Petitioner ,

24vs. Case No. 20 - 5447PL

30S TEPHANIE S TOVER , M.D. ,

35Respondent .

37/

38R ECOMMENDED O RDER

42On January 28, 2021, Robert E. Meale, Administrative Law Judge ( Ñ ALJ Ò )

57of the Division of Administrative Hearings ( Ñ DOAH Ò ), conducted the final

71hearing by Zoom tele conference. Due to Judge Meale Ô s unexpected (at the

85time of hearing) ret irement , the undersigned ALJ was assigned to review the

98record and issue this Recommended Order.

104A PPEARANCES

106For Petitioner: Kristen M. Summers, Esquire

112Joseph William Mackey, Esquire

116Florida Department of Health

120Prosecution Services U nit

1244052 Bald Cypress Way, Bin C - 65

132Tallahassee, Florida 32399 - 3265

137For Respondent: Sean Michael Ellsworth, Esquire

143Ellsworth Law Firm, P.A.

1471000 5th Street, Suite 223

152Miami Beach, Florida 33139

156Kenneth J. Metzger, Esquire

160Metzger and Associates, LLC

1641637 Metropolitan Boulevard, Suite C - 2

171Tallahassee, Florida 323 08

175S TATEMENT OF T HE I SSUE S

183The issue s are whether Respondent injected fat into or below

194G.R. Ô s gluteal muscles in violation of section 4 58.331(1)(t) and/or

206458.331(1)(nn) , Florida Statutes (2020) ; and , if so, what penalty should be

217imposed.

218P RELIMINARY S TATEMENT

222Petitioner, Department of Health , Board of Medicine ( Ñ Department Ò or

234Ñ Petitioner Ò ) , filed a two - count Administrative Complaint ( Ñ AC Ò ) against

251Respondent, Stephanie Stover, M.D. ( Ñ Dr. Stover Ò or Ñ Respondent Ò ), charging

266her with violating Florida Administrative Code Rule 64B8 - 9.009(2)(f) Ñ in one

279or more of the following ways Ò : (1) Ñ By inserting fat into Patient G.R. Ô s gluteal

298muscles during her gluteal fat grafting procedure Ò ; (2) Ñ By inserting fat under

312Patient G.R. Ô s gluteal muscles during her gluteal fat grafting procedure Ò ;

325and/or (3) Ñ By crossing the gluteal fascia to inject fat during Patient G.R. Ô s

341gluteal fat grafting procedur e. Ò The Department asserts that precisely the

353same conduct and alleged violation of r ule 64B8 - 9.009(2)(f) constitutes a

366violation both s ection 458.331(1)(t) (Count One) and s ection 458.331(1)(nn)

377(Count Two).

379Dr. Stover responded and requested a disputed - fact hearing. The matter

391was referred to DOAH on December 18, 2020. The disputed - fact hearing was

405held on January 28, 2021, via Zoom teleconference .

414Prior to hearing, Dr. Stover filed a Motion t o Dismiss Count I o r Count II

431o f t he Administrative Complaint a s Multiplicitous, a Violation o f the

445Prohibition a gainst Double Jeopardy a nd Dr. Stover Ô s Right t o Due Process,

461arguing that one of the counts must be dismissed because the two were based

475on precisely the same conduct, and precisely the same alleged rule violation.

487The Department filed a response to Dr. Stover Ô s motion to dismiss, and

501conceded the Department Ñ charged Respondent with two statutory

510violation [s] that arose from the same conduct. Ò To the extent necessary in

524writing this Recommended Order, the undersigned will address the

533arguments made in this regard.

538At the hearing, Petitioner called Onelio Garcia, M.D., an expert in gluteal

550fat transfers, and Amelia Nakanishi, M.D., a pathologist, and offered into

561evidence Petitioner Ô s Exhibits 1 through 11 , without objection . Respondent

573testified on her own behalf. Respondent Ô s Exhibit 1 was admitted into

586evidence without objection, and Respondent Ô s Exhibits 2 and 3 were admitted

599over objection.

601A T ranscript of the final hearing was filed on February 8, 20 21, and the

617parties each filed a P roposed R ecommended O rder ( Ñ PRO Ò ). The timely PROs

635filed by the parties have been considered in the preparation of this

647Recommended Order. C itations to the Florida Statutes or Florida

657Administrative Code refer to the versi on s in effect during the time that the

672violation was allegedly committed.

676F INDINGS OF F ACT

6811. The Department is the state agency charged with regulating the

692practice of medicine in the s tate of Florida, pursuant to section 20.43 and

706chapters 456 and 458 , Florida Statutes .

7132. Dr. Stover is a licensed physician in the s tate of Florida, having been

728issued license number ME82217. Dr. Stover has been licensed to practice in

740the s tate of Florida since April 2001 and has never been disciplined in Florida

755or elsew here. She has an impressive academic record. After earning her

767d octor of m edicine degree from the University of Florida College of Medicine

781in 1996, where she was on the President Ô s List (GPA greater than 3.9),

796Dr. Stover completed her residency in general surgery at the Mount Sinai

808Medical Center of Greater Miami, during which she served as Administrative

819Chief Resident of Trauma and Vascular Surgery and as Administrative Chief

830Resident of General Surgery .

8353. After graduating from medical school and comple ting her five - year

848general surgery residency, Dr. Stover spent five years completing additional

858fellowships and residencies in plastic and reconstructive surgery. Dr. Stover

868completed a one - year Reconstructive Craniofacial and Aesthetic Fellowship

878at the U niversity of Mississippi Medical Center, a two - year Plastic and

892Reconstructive Surgery Residency at the University of Mississippi Medical

901Center, a one - year Breast Reconstruction and Microsurgery Fellowship at the

913Memorial Sloan - Kettering Cancer Center in New York City, and a one - year

928Breast and Aesthetic Surgery Fellowship with G. Patrick Maxwell, M.D., at

939the Baptist Hospital in Nashville, Tennessee.

9454. Over her career, Dr. Stover has regularly served as a speaker, panel

958member, and teacher, sharing her k nowledge, insights, and experience with

969other physicians, medical students, residents in surgical rotations, and the

979community. Dr. Stover regularly engages in continuing medical education

988and attends professional courses and meetings. She is a member of t he

1001International Society of Aesthetic Plastic Surgery, the American Society of

1011Plastic Surgeons, and the American College of Surgeons, among other

1021professional organizations and societies.

10255 . Respondent is cert ified by the American Board of Plastic and

1038Rec onstructive Surgery, and has previously been certified by the American

1049Board of General Surgery.

10536 . During the course of her professional practice , Dr. Stover has

1065successfully completed thousands of plastic and reconstructive surgeries,

1073including between 800 and 1,000 gluteal fat transfer procedures, also known

1085as a Ñ Brazilian Butt Lift Ò ( Ñ BBL Ò ) .

10987. Prior to this occasion, Dr. Stover never experienced anything other than

1110minor complication s in the 800 to 1,000 successful BBL procedures she

1123performed.

11248. O f the 800 to 1,000 successful BBL procedures Dr. Stover has

1138performed in her career, between 100 and several hundred were performed

1149on genetic males, either males or transgender females.

11579. While performing BBLs, Dr. Stover always follows a Ñ subcutaneous

1168o nly Ò approach, and employs all current recommendations and best practices

1180to avoid injecting into the muscle or below the fascia.

119010. Based upon her testimony at hearing, Dr. Stover has had a

1202distinguished career as an effective and caring practitioner, wi th vast

1213experience in plastic and reconstructive surgery, in general, tremendous

1222experience in performing BBLs, in particular, and something of a specialty in

1234performing BBLs on genetic males. As noted, throughout her more than

124520 years as a physician she has an unblemished record.

1255The Department Ô s Expert, Onelio Garcia, Jr., M.D.

126411. The Department presented the testimony of Onelio Garcia, Jr. , M.D.

1275Dr. Garcia is a plastic surgeon in private practice in Miami - Dade County.

1289Dr. Garcia earned his medical deg ree at the Autonomous University of

1301Guadalajara, Mexico. Like Dr. Stover, Dr. Garcia is b oard certified in plastic

1314surgery. Unlike Dr. Stover, Dr. Garcia has never been b oard certified in

1327general surgery.

132912. The B BL is among the procedures Dr. Garcia perf orms in Miami - Dade

1345County. It is found that Dr. Garcia is in economic competition with Dr. Stover

1359as a plastic surgeon performing the same types of procedures as she in close

1373geographic proximity.

137513. Dr. Garcia has performed far fewer BBL procedures than Dr. Stover.

1387Dr. Garcia testified that he has performed Ñ an average of 60 [BBLs] a year Ò

1403for the past Ñ several years. Ò He testified he has performed fewer than

1417500 BBLs over his career and Ñ maybe Ò fewer than 400.

142914. Dr. Garcia has Ñ never Ò performed a BBL o n a transgender individual,

1444and testified that he has performed Ñ very few Ò BBLs on anatomical males.

145815. A dispute arose at hearing regarding the mortality rate for individuals

1470undergoing a BBL. First, a statistic suggesting that one out of 3,000 BBL

1484proce dures result in death came from testimony at a public hearing given by

1498Respondent in 2019 at which she said that number of deaths referred to those

1512occurring over all BBLs, not just subcutaneous procedures. She was in favor

1524at that time of recommending a b an on non - subcutaneous or intramuscular

1538procedures. However, one year later, in 2020, research data showed the

1549mortality rate to be only one in 18,000 for those undergoing subcutaneous

1562BBL procedures, a far more acceptable mortality rate for a plastic surg ery

1575procedure. These data were from the Aesthetic Surgery Education and

1585Research Foundation Ô s ( Ñ ASERF Ò ) T ask F orce to study the mortality rate

1603associated with BBLs. The undersigned finds that, based upon the entirety of

1615the testimony, the lower mortality r ate of one in 18,000 is credited for those

1631receiving subcutaneous - only BBLs.

163616. In June 2019, in light of the findings from the studies, the Board

1650of Medicine enacted Emergency Florida Administrative Code Rule 64B8 -

1660ER19 - 1 ( Ñ Emergency Rule Ò ) , which states:

1671Standard of Care for Gluteal Fat Grafting. When

1679performing gluteal fat grafting procedures, fat may

1686only be injected into the subcutaneous space and

1694must never cross the gluteal fascia. Intramuscular

1701or submuscular fat injections are prohibited.

170717. The Emergency Rule was codified in r ule 64B8 - 9.009(2)(f). This rule

1721define d the standard of care in Florida relating to gluteal fat grafting and

1735explicitly prohibit ed intra muscular and submuscular fat injections. The

1745Emergency Rule was superseded by rule 64B8 - 9.009(2)(f), effective March 2,

17572020, which adopted the same standard of care.

1765The Procedure Generally

176818. The Ñ BBL Ò involves harvesting fat from the patient, i.e., Ñ remov[ing]

1782fat from the different parts of the body, typically around the trunk. Ò Ñ The fa t

1799is processed in a sterile container and it is injected into the soft tissues of the

1815buttock area in order to enlarge it. Ò

182319. In Ñ the most common method Ò of the procedure, the processed fat is

1838injected by hand from a syringe attached to a cannula, descri bed as Ñ a long

1854metal rod Ò with a blunt tip and a small hole near the tip . Ñ [I]t is a blind

1874procedure, Ò in that the injecting surgeon is unable to see the location of the

1889tip of the cannula.

189320. The Ñ pertinent layers Ò of the gluteal area, proceeding from t he

1907outermost in, are : the skin, the outermost layer ; Ñ [t]hen the subcutaneous

1920layer, which is the fatty layer Ò ; then Ñ the fascia which is covering the muscle Ò ;

1937then Ñ the gluteal musculature. Ò Ñ [T]here is no anterior fascia, Ò meaning that

1952the gluteus muscle has no fascia underneath the muscle; Ñ the muscle layer

1965only has one covering on the outside. Ò If fat gets below the fascia, which Ñ is

1982relatively thin, Ò Ñ [i]t has nowhere to go but down. Ò

199421. This is a serious problem because BBLs have been associated with

2006serious risk of pulmonary embolisms, often fatal, when injected fat enters the

2018bloodstream through the large blood vessels under the gluteal muscle and

2029ultimately impede blood flow to the lungs. The largest blood vessels,

2040including the gluteal veins are b eneath the gluteal muscle, and the vessels

2053get smaller and smaller as they progress toward, and penetrate the fascia.

206522. The evidence presented at hearing establishes that BBLs have become

2076significantly more popular in the United States over the past five to ten

2089years. Ñ Gluteal fat grafting has historically been a relatively unpopular

2100procedure in the United States, with little awareness of serious side effects

2112until 2015 Ò is a statement from one of Dr. Stover Ô s exhibits.

212623. Further, as both Dr. Stover an d Dr. Garcia testified, the medical

2139community, in general, and the plastic surgery community, in particular, are

2150aware of the dangers associated with BBLs and have made progress

2161identifying ameliorative techniques and instrumentation . Despite this,

2169researc h is still developing as to the precise mechanisms and causes of

2182pulmonary fat embolisms associated with BBLs.

218824. In 2017, the ASERF Task Force published a study indicating that

2200gluteal fat grafting carries a mortality risk of one out of 2,351 to one out

2216of 4,000, Ñ possibly 10 - 20 times greater than the average mortality rate for

2232aesthetic surgery procedures in AAAASF facilities È a nd it [the mortality

2244risk from BBLs] is possibly three to five times higher than the risk from

2258abdominoplasty, which until this paper [in 2016 - 17] was thought to have the

2272highest risk of any aesthetic procedure. Ò

227925. The ASERF Task Force indicated that the risks associated with BBLs

2291may be unavoidable even using the proper instruments, Ñ constant vigilance, Ò

2303and the best practices and procedures, stating:

2310It is not known whether with proper positioning

2318and constant vigilance a specific plane can be

2326reliably maintained or whether there will

2332inevitably be a rate of unintended deeper passes of

2341the cannula into the deep muscle. It is al so not

2352understood whether superficial injection might

2357possibly cause distraction injuries to the larger and

2365deeper veins or whether superficially injected fat

2372can travel along a tissue plane towards that

2380disrupted vessel. There are many hundreds or even

2388th ousands of cannula passes during a typical case,

2397so even the very slightest rate of accidental deeper

2406passes could present a significant risk. It is

2414impossible to ascertain whether with ideal

2420instrumentation, positioning, and constant

2424vigilance unintended deeper injections can be

2430eliminated or whether they will always occur with

2438some finite frequency.

244126. In May 2019, leading BBL surgeons published a study attempting to

2453explore Ñ the potential for fat placed in the subcutaneous space, Ò i.e., the fatty

2468tissu e under the skin and above the fascia and muscle, to migrate into the

2483deep submuscular space, Ò and whether Ñ fat could potentially enter and

2495migrate into the deep submuscular space Ò through Ñ perforations in the fascia Ò

2509caused by Ñ occasional unintended passe s into the muscle. Ò T he study

2523attempted to shed light on Ñ whether fat placed in the subcutaneous space

2536under a variety of pressures and fascial integrity scenarios can indeed

2547migrate into the deep submuscular space. Ò

255427. Dr. Garcia and Dr. Stover both test ified that studies are continuing to

2568investigate the causes of complications and adverse outcomes associated with

2578BBLs and to provide guidance and recommendations for practitioners.

258728. Despite all the uncertainties regarding BBL complications, and the

2597Ñ bl ind Ò nature of the procedure, the plastic surgery community has coalesced

2611around a set of recommendations and best practices to perform BBLs safely

2623and avoid serious complications. These include: (1) to Ñ use a stiff cannula, at

2637least four millimeters Ò ; (2) with only a single hole ; (3) to Ñ create angles Ò for

2654inserting the cannula ; (4) to angle the tip of the cannula up while injecting ;

2668(5) to palpate with the non - injecting hand to create three - dimensional

2682awareness of where the tip of the cannula is at all t imes ; (6) to keep the

2699cannula moving continuously ; (7) to inject only in retrograde, that is, while

2711withdrawing or moving the cannula away from the deeper tissue ; and (8) to

2724Ñ stay in the subcutaneous plane Ò with the cannula during injections.

273629. The rule discussed above establish ing the standard of care for gluteal

2749fat grafting, 64B8 - 9.009(2)(f), was based upon concern from the plastic

2761surgery community, the Board of Medicine, and the public, that the recent

2773popularity of BBLs brings with it the recognitio n of serious side effects, chief

2787among them the potential for pulmonary fat embolism.

279530. The pulmonary fat embolisms associated with BBLs are caused by

2806damage to the large vessels under the gluteal muscle, including the superior

2818and inferior gluteal vein s, that allow fat to enter the blood stream, and

2832eventually block blood flow to the lungs .

284031. Damage to the large vessels can be caused either by a direct injury

2854from a cannula or by fat that has migrated deep into the muscle Ñ expanding

2869the submuscular sp ace Ò and stretching the Ñ rich and cavernous venous plexus

2883[that] may result in tears [in the vessels] that allow migrated fat to be

2897siphoned into the low - pressure venous system. Ò Dr. Garcia testified that

2910Ñ [t] he injury can be direct or it can be caused by simple stretching of the

2927vessel. Ò

2929The Procedure on Patient G.R.

293432 . In September 2020, Respondent performed plastic surgery procedures

2944as an independent contractor at Xiluet Plastic Surgery in Miami, Florida. On

2956September 15, 2020, G.R., a 46 - year - old tra ns gender woman who was HIV

2973positive, presented to Xiluet to undergo several cosmetic procedures with

2983Respondent, including a BBL. G.R. was being treated with medication and

2994her HIV was under Ñ very good control Ò at the time of the surgery scheduled in

3011this case.

301333. Prior to surgery, Dr. Stover conducted a pre - operative medical

3025clearance, during which Dr. Stover reviewed G.R. Ô s lab work, EKG, chest

3038x - ray, and surgical history . Dr. Stover also conducted a Ñ medical interview, Ò

3054performed a Ñ physical exam, Ò and had discussions with the patient prior to

3068the day of surgery .

307334 . Dr. Stover advised G.R. of the risks of the BBL procedure prior to the

3089surgery on two occasions, first , as part of the pre - operative clearance and

3103consultation the day before the surgery, a nd , second , on the day of the

3117procedure. G.R. signed an informed consent form Ð Dr. Stover uses the forms

3130provided by the American Society of Plastic Surgery Ð indicating she was

3142aware of the surgical risks and consented to them.

315135. G.R. had been dieting prio r to her surgeries, including the BBL

3164procedure, and had lost significant weight and, as a result , Ñ she was

3177extremely thin and especially [in] the layer of the subcutaneous tissue in the

3190area of the buttocks. Ò In some areas of G.R. Ô s gluteal region, the

3205su bcutaneous layer was Ñ even less than a centimeter. Ò

321636. Because G.R. was born a n anatomical male, she had a Ñ very

3230[androgynous] shape, Ò and due to the Ñ inherent nature of [G.R. Ô s] tissues , Ò the

3247tissues were Ñ denser, Ò Ñ thicker, Ò Ñ more fibrous, Ò and , becaus e of her Ñ thin

3266subcutaneous plane, even less than a centimeter . Ò D uring the pre - injection

3281portion of the procedure Dr. Stover performed on G.R., Dr. Stover used a

32944 mm cannula to Ñ go in gently, but bluntly, to separate those tissues. Ò The

3310one to two dozen Ñ passes with the cannula, Ò made by Dr. Stover during the

3326pre - injection , Ñ pre - tunneling , Ò or Ñ blunt dissection , Ò portion of the procedure

3343are the same kinds of cannula passes made during the injection portion, but

3356without any injection of fat. The pre - injec tion cannula passes are also Ñ a

3372tactile procedure, Ò made blind, and could cause Ñ some trauma È to those

3386tissues. Ò

338837. Dr. Garcia acknowledged Ñ anatomical or genetic males and females

3399have È quantifiable differences in either the anatomy or the structural

3410anatomy of the gluteal area that is pertinent to BBL. Ò He testified: Ñ The male

3426pelvis is obviously narrower and the fatty layer is significantly thinner . È In

3440a male patient sometimes even running the cannula parallel to the skin will

3453have you within the m uscle, because the buttocks is a spare dome. It peaks at

3469the center and simply running your cannula parallel will not give you any

3482subcutaneous tissue. Ò He testified that Ñ obviously those patients, Ò anatomical

3494males, Ñ were more at risk because it is a blin d procedure. You have less of a

3512layer to work with. Ò

351738. Dr. Garcia testified that during a Ñ model for the study of BBLs Ò he

3533worked on, Ñ we had to discard all male specimens and only use females of a

3549certain [body mass index] because the angles were comple tely different . È

3562We wanted to create a situation of reasonably large fatty layer to inject to. Ò

357739. Dr. Garcia, who testified he has very little experience performing

3588BBLs on genetic males, provided no testimony regarding pre - tunneling or

3600blunt dissection . There was no evidence presented at hearing that Dr. Garcia

3613has ever performed pre - tunneling or blunt dissection to create space prior to

3627injecting during a BBL, or has any expertise or knowledge about this

3639technique.

364040. Dr. Stover performed the pre - tunn eling or blunt dissection on G.R., as

3655she had hundreds of times in other procedures, because G.R. had a

3667Ñ significantly thinner fatty layer Ò with very little subcutaneous tissue.

367841. Dr. Stover used a 4 mm, rigid , single - hole cannula with a blunt tip for

3695bo th the pre - injection dissection, where she separated the skin and

3708subcutaneous tissue from the underlying structure, and for injecting fat

3718during the injection portion of the procedure. The instruments Dr. Stover

3729used during this procedure comply with the recommendations of the ASERF

3740Task Force.

374242. Dr. Stover had previously done pre - tunneling or blunt dissection

3754thousands of times during surgery and approximately 300 times during

3764gluteal fat transfer procedures, most often on genetic males.

377343. Dr. Stover also performed the fat injection portion of the procedure on

3786G.R. in accordance with ASERF Task Force recommendations. She employed

3796a strategy to avoid injecting into the muscle. She positioned the patient on

3809her side and avoided the prone position. Dr. St over kept her cannula tip

3823Ñ angled up , Ò and she used her free hand to palpate Patient G.R. Ô s gluteal

3840region in order to stay aware Ñ from a 3D spa[t]ial dimension Ò where the tip of

3857her cannula was. Dr. Stover made sure that the paralytics (given as

3869anesthesi a to G.R.) had worn off so that she would be able to detect any

3885muscle twitches in the patient that might indicate the cannula was close to

3898entering the muscle. Dr. Stover avoided plunging the plunger on the syringe

3910Ð thus avoided injecting fat Ð while enteri ng the cannula, and instead only

3924injected Ñ in a [retrograde] fashion so you are going away from the structure, Ò

3939in other words , while the cannula was moving in an outward direction.

3951Dr. Stover only injected small amounts of fat at a time under steady

3964press ure, and always while her cannula was in motion, to avoid injecting Ñ a

3979bolus high amount at one time. Ò

398644. The technique used by Dr. Stover is the surgical approach and

3998procedural practice she employs in all the gluteal fat transfers she performs ,

4010and is t he surgical technique she employed in the September 15, 2020 ,

4023gluteal transfer procedure she performed on G.R.

403045. At the conclusion of the BBL procedure, within two to three minutes of

4044the final injection, G.R. began to show signs of distress. Dr. Stover

4056immediately followed advanced cardiac life support ( Ñ ACLS Ò ) protocols and

4069took all possible actions to save G.R. Ô s life, including initiating ACLS, which

4083comprises properly positioning the patient and confirming the tube is

4093properly placed to avoid blockin g the airway, then performing CPR,

4104immediately calling 911 , and going to Kendall Regional M edical Center with

4116G.R. to provide any information or assistance in life - saving efforts.

412846. All life - saving efforts failed and G.R. died. Her body was transferred t o

4144the Miami - Dade Medical Examiner Ô s Office, where Amelia Nakanishi, M.D.,

4157performed an autopsy.

4160Post - Mortem Findings

416447. During the autopsy, Dr. Nakanishi dissected G.R. Ô s lungs and opened

4177the veins returning to the lungs. Dr. Nakanishi observed numerous globules

4188of yellow fat inside the veins entering G.R. Ô s lungs.

419948. Dr. Nakanishi certified that G.R. died from pulmonary embolism Ð an

4211obstruction of blood flow to the lungs.

421849. Because emboli are not naturally occurring, Dr. Nakanishi continued

4228the autopsy to determine the source of the fat emboli .

423950. Dr. Nakanishi dissected G.R. Ô s hips and buttocks. First, Dr. Nakanishi

4252removed the skin covering G.R. Ô s buttocks to expose the subcutaneous layer.

4265The subcutaneous layer was full of Ñ yellow grafted fat Ò and Ñ red - peach fat. Ò

428351. Dr. Nakanishi then dissected the subcutaneous layer, exposing G.R. Ô s

4295muscles , followed by her dissecting G.R. Ô s gluteal muscles. The dissection

4307revealed gratuitous amounts of grafted fat in G.R. Ô s musculature, including

4319Ñ strands Ò of fa t clearly injected by a cannula into the muscle.

433352. Dr. Nakanishi observed damaged vessels in G.R. Ô s gluteal muscles .

4346Based on her clinical observations, Dr. Nakanishi determined that the fat in

4358G.R. Ô s muscles was deposited, and she specifically observed a rope - like

4372structure of fatty tissue protruding between G.R. Ô s muscle fibers that

4384indicated it had been injected there.

439053. Dr. Nakanishi determined that the gluteal fat transfer caused G.R. Ô s

4403pulmonary embolism. In the course of her examination, Dr. Naka nishi found

4415no disruption to the large vessels of G.R. Ô s gluteal muscle, but did find

4430evidence of disrupted small vessels . Dr. Stover explained this by testifying

4442that smaller vessels proceed up to and through the fascia into the

4454subcutaneous layer. She te stified: Ñ it is actually here where they [the smaller

4468vessels] pierce the fascia where the fascia has its weaknesses . Ò Dr. Garcia

4482acknowledged there is Ñ a tiny network [of vessels] that continues upward into

4495the subcutaneous tissue . Ò

450054. The medical examin er, not an expert in BBLs, did not specifically

4513testify the Ñ deposited fat Ò found in G.R. was deposited into her muscle; she

4528testified only that she Ñ believed Ò the fat in G.R. Ô s gluteal muscle was

4544Ñ deposited fat, Ò as opposed to native fat . Dr. Nakanishi pr ovided no testimony

4560explain ing how the fat in G.R . Ô s muscle entered that muscle. Further, neither

4576the medical examiner nor Dr . Garcia, the Department Ô s expert in BBLs,

4590testified there was any damage to G.R. Ô s gluteal muscles or gluteal fascia.

4604The Departme nt presented no evidence of traumatized muscle fiber or muscle

4616damage. The Department presented no testimony or evidence of cannula

4626tracks in or through the muscle. The Department presented no direct proof,

4638either physical evidence or testimony, that G.R. Ô s gluteal fascia was damaged.

4651However, Dr. Garcia testified there was no reasonable explanation for the

4662deposited fat in G.R. Ô s gluteal muscles other than Dr. Stover having directly

4676injected it there. Dr. Garcia Ô s testimony is credited.

468655. Despite acknowl edging the presence of grafted fat in and under G.R. Ô s

4701gluteal muscles, Dr. Stover denied performing intramuscular fat injections

4710and claimed to only inject fat subcutaneously.

4717How Did Fat E nter G.R. Ô s Gluteal Muscle?

472756. As framed by Respondent in her PR O, t he central issue in this case is

4744whether the fat in and/or under the central region of G.R. Ô s gluteal muscle

4759was injected there directly by Dr. Stover, or got there some other way, such

4773as by migrating from another region, such as from the subcutaneous plane

4785after Ñ tissue trauma. Ò

479057. As noted at hearing , this is a n issue that medical researchers are

4804trying to determine more generally. Medical and scientific research

4813introduced into evidence in this case sheds some light on the possibilities, but

4826fails to conclusively resolve the issue as a general matter, and , unfortunately,

4838provides no direct evidence with regard to the specific case of G .R.

485158. In this case, the evidence indicates Ñ grafted fat Ò Ð that is , fat that was

4868Ñ harvested Ò from G.R. Ô s body Ð was found in and under G.R. Ô s muscle during

4887the postmortem examination. There is no dispute that some of that Ñ grafted

4900fat Ò ended up in G.R. Ô s lungs and caused a fatal pulmonary embolism.

491559. In short, there is no serious dispute as to whether Ñ grafted fat Ò en ded

4932up in G.R. Ô s muscle. The determinative question here is : H ow did that fat g e t

4952there ? The evidence on this point is conflicting and contradictory. Two highly

4964qualified experts in the BBL procedure weighed in on the mystery.

497560. Dr. Stover testified that , with respect to the subject BBL procedure,

4987she employed a strategy to avoid injecting into the muscle that included

4999(1) using a Ñ rigid four [millimeter] single hole blunt tipped cannula Ò ;

5012(2) positioning the patient laterally to allow her trajectory to b e Ñ in a more

5028superficial plane Ò and to avoid dilation of the vessels ; (3) palpating with her

5042free hand to maintain three - dimensional Ñ 3D special dimension Ò of the

5056location of the tip of her cannula ; (4) injecting only a small amount of fat at a

5073time under steady pressure ; (5) injecting only while the cannula was moving

5085toward the superficial layers ; and (6) by waiting for the paralytics to have

5098worn off , so she could watch for muscle twitch es .

510961. Dr. Stover further testified that she did not Ñ insert fat in to patient

5124G.R. Ô s gluteal muscles, Ò she Ñ did not insert fat under patient G.R. Ô s muscles, Ò

5143and she did not Ñ cross the gluteal fascia to inject fat during patient G.R. Ô s

5160gluteal fat grafting procedure. Ò

516562. Dr. Stover did acknowledge that it was possible th at she inadvertently

5178injected fat into the gluteal muscles due to the fact that the muscles in the

5193area she was working in were thin, and it was possible they did not twitch or

5209she did not see them twitch when she was injecting small amounts of fat in

5224the area.

522663. Dr. Stover testified that, Ñ while anything is possible, Ò she did not

5240believe she accidentally or inadvertently injected fat into the gluteal muscle s

5252because her preparatory work had already created the space and pocket to

5264receive the fat without it being injected into the muscles.

527464. The blood vessels in the subcutaneous layer of the gluteal muscle s are

5288very small , even as small as a Ñ couple of milliliters, Ò so a small puncture was

5305possible. She testified that, even if a puncture was made before the fat

5318injection, there was time for the puncture to have closed up before the fat was

5333introduced into the area. She was not able to quote specific language from

5346any medical studies nor could she provide direct evidence that this might be

5359the case here, b ut she believed it to be a possible explanation.

53726 5 . Dr. Garcia , on the other hand, testified that while he Ñ believe[d] that

5388the operation here was designed to place this [fat] in the subcutaneous

5400tissue, Ò it was his opinion that Ñ fat was injected into the muscle. Ò He

5416concluded this from his review of the autopsy dissection materials and his

5428reliance on a 2019 published study.

5434The Del Vecchio Study

54386 6 . Each doctor finds support for his or her conclusions in the work of

5454Dr. Daniel Del Vecchio, principally fr om an article titled, Ñ Subcutaneous

5466Migration: A Dynamic Anatomical Study of Gluteal Fat Grafting Ò (the

5477Ñ Article Ò ) , authored by Dr. Simeon Wall, Jr. , Dr. Del Vecchio , and others, and

5493published in the May 2019 issue of Plastic and Reconstructive Surgery

5504Jou rnal , received into evidence. The A rticle reports the results of a very

5518small study conducted prior to September 2018. The researchers injected

5528dyed applesauce into the subcutaneous space of Ñ four hemibuttocks from two

5540cadavers Ò under different conditions in an effort to determine how the fat

5553would migrate.

555567. Dr. Stover also introduced into evidence a video featuring

5565Dr. Del Vecchio. The video establishes that vessels do penetrate the fascia

5577and create the weakest points in the fascia, confirming Dr. Stov er Ô s

5591testimony ( Ñ they pierce the fascia where the fascia has its weaknesses Ò ).

5606Dr. Del Vecchio Ô s video demonstrates that even when a cannula is kept

5620Ñ superficial, Ò Ñ not in the deep muscle Ò and Ñ not subjacent to the muscle, Ò

5638injected fat can track through t he muscle even when injected superficially.

565068. T he undersigned recognizes th at while the Article represents the only

5663impartial medical evidence presented at hearing, since each of the BBL

5674experts have some degree of partiality to their particular side of the case, it

5688has certain inherent limitations noted by its authors, including that its

5699findings are based on injections of applesauce, not human fat, into cadavers,

5711not living humans, outside a clinical setting, and that only two cadavers were

5724used, such t hat the range of variance in human fascia strength , integrity, and

5738many other properties, was not represented. The Article notes that Ñ different

5750cadaver[s] Ò have Ñ different subcutaneous capacities and different tissue

5760tolerances Ò ( further noting that Ñ some limitations that deserve discussion, Ò

5773including that Ñ fascial perforations were made, followed by fat grafting, but

5785not simultaneously with fat grafting. This may have underrepresented the

5795amount of fat that could get beneath the fascia given an inadverte nt pass. Ò ) .

5812Dr. Garcia agreed, noting that Ñ applesauce ha[s] a different flow and

5824dispersion characteristics as opposed to human fat . Ò

583369. Despite its obvious shortcomings from real life BBL surgery, the

5844Article does at least address some of the competing theories presented at

5856hearing. The A rticle discusses four gluteal injection scenarios (one on each

5868hemibuttocks used), of which scenarios 2 and 3 are most relevant here .

588170. In scenario 2, Ñ a random pattern of [15] cannula perforations was

5894m ade in the glut eus maximus fascia at its point of maximum projection

5908before fat insertion. Ò Under this scenario, Ñ the fascia permitted only a small

5922amount (1 cc) of proxy fat and dye to be noted beneath each perforation; no

5937proxy fat spread deeper into the muscle or bene ath it. È In this scenario,

5952despite suffering multiple perforations, fascial integrity remained robust and

5961maintained a barrier function under extremely high pressures. Ò With regard

5972to Ñ limitations that deserve discussion Ò regarding scenario 2, the authors

5984cautioned that Ñ fascial perforations were made, followed by fat grafting, but

5996not simultaneously with fat grafting, Ò as they would be in a real - life clinical

6012setting. Ñ This, Ò the authors observed, Ñ may have underrepresented the

6024amount of fat that could ge t beneath the fascia given an inadvertent pass. Ò

603971. Consequently, the most the authors could conclude based on scenario 2

6051is that: Ñ During intended Ó subcutaneous only Ô Brazilian buttock lift,

6063inadvertent passes beneath the gluteus maximus fascia most cert ainly occur.

6074However, the volumes of fat placed during these passes are not likely to be of

6089significant enough volume to cause deep intramuscular migration into the

6099submuscular space. Ò The A rticle suggests that 25 ccs of injected fat could end

6114up in the gl uteal muscle under scenario 2, the ÑÓ inadvertent pass Ô scenario, Ò

6130but concludes, Ñ it is unlikely Ò this amount of fat Ñ would be significant enough

6146to cause vascular or sciatic nerve injury in the deep muscular space, by

6159means of deep intramuscular migration . Ò

616672. Ñ In scenario 3, 15 random defects in the gluteus maximus fascia were

6180created with a 6 - mm Baker punch biopsy knife. Ò After fat insertion in this

6196scenario, the researchers observed that :

6202the submuscular space contained a significant

6208amount of proxy fa t. Applesauce and dye were

6217noted within the muscle, but the largest quantity of

6226fat could be seen to emanate from underneath the

6235most inferolateral portion of the muscle which, in

6243the prone position, is the most dependent space . È

6253The 6 - mm fascial fenestra tions in scenario

62623 allowed the proxy fat to flow freely beneath the

6272muscle in exactly the same pattern as did

6280subfascial injections in the deep intramuscular

6286migration article.

628873. In sum, the Article suggests fascial perforations (scenario 2) allow fat

6300to flow beneath the fascia, but that the amount of fat th at enters the gluteal

6316muscle is Ñ unlikely Ò to cause the type of vascular injury that would lead to a

6333pulmonary fat embolism. Further, the Del Vecchio article suggests that 6 mm

6345holes in the fascia wo uld allow fat injected properly into the subcutaneous

6358layer to flow freely into the muscle, potentially leading to severe vascular

6370and/or nerve injury that could cause a pulmonary fat embolism.

6380Dr. Stover Ô s Conclusions

638574. Dr. Stover testified that , based on Dr. Del Vecchio Ô s presentations and

6399her experience, she believes fat she injected into the subcutaneous space

6410migrated through the fascia and into the muscle. She believes this was

6422potentially caused by inadvertent punctures she may have made in G.R. Ô s

6435fascia during the pre - tunneling or blunt dissection portion of the procedure .

6449Dr. Stover further testified that punctures to the fascia were more likely to

6462have been made during the blunt dissection portion of the procedure than

6474during the injection porti on, because by the time she started making

6486injections , she had already Ñ created Ò the Ñ space and pocket Ò during the blunt

6502dissection . While doing this, she testified to the fact that she followed all the

6517recommendations and best practices to avoid crossing the fascia during the

6528injection portion.

653075. Dr. Stover acknowledged that she may have damaged the fascia,

6541punctured the fascia, or passed into the muscle near vessels (perhaps

6552repeatedly) during the Ñ pre - tunneling Ò or Ñ blunt dissection Ò portion of the

6568pro cedure, during which time no fat syringe was attached to the cannula and

6582She was not injecting fat. During this portion of the procedure , Dr. Stover

6595made between one dozen and two dozen cannula passes and immediately

6606proceeded to the injection portion of t he procedure.

661576. Dr. Stover explained further that the punctures she may have made

6627during the blunt dissection portion of the procedure , would most resemble the

6639Ñ six millimeter punch out of the fascia Ò described in scenario 3 of the Article

6655because , when Ñ you keep sliding [a four - millimeter cannula] forward it could

6669drive enough to make a six - millimeter defect, Ò or tear in the fascia. She

6685likened this to a tear in a pair of pantyhose that were pulled by the edge of

6702metal probe. Dr. Garcia was not recalled to rebut or refute this testimony

6715concerning Dr. Stover Ô s theory , but nonetheless, it stands as an admission by

6729Dr. Stover that punctures to the gluteal muscles could have resulted from the

67426 mm tear in the fascia .

674977. To the extent scenario 2 from the Art icle is analogous to what occurred

6764during G.R. Ô s procedure, Dr. Stover highlighted the differences between the

6776conditions present in the static, cadaver study and the dynamic, clinical

6787setting in which Dr. Stover was operating. In the study, Dr. Stover not ed they

6802made a perforation with the cannula, a one - time poke, and it is afterwards

6817that they injected. So even th e A rticle itself mentioned how this may not

6832really show what happens during a live surgery, because , in the Article, they

6845did one poke only, wh ich is different from passing the cannula repeatedly ,

6858resulting in the amount of fat ending up under the fascia , which Ñ could be

6873more in a real - life situation. Ò

688178. In this context, Dr. Stover presented credible, uncontradicted

6890testimony (by any other witn ess who was present at G.R. Ô s surgery) that ,

6905during the injection portion of the BBL procedure , she always injects, and did

6918in the case of G.R., in a retrograde fashion, meaning she inserts the cannula

6932to its deepest point and injects as she withdraws the cannula. As such, it is

6947possible , though not likely , based upon the totality of the evidence, that even

6960if Dr. Stover damaged the fascia or passed into the muscle after the blunt

6974dissection, she may have only inject ed fat after she had withdrawn from the

6988m uscle.

6990Dr. Garcia Ô s Conclusions

699579. In support of his opinion that Ñ fat was injected into the muscle Ò here,

7011Dr. Garcia testified there was Ñ loose injected fat Ò in the muscle. This,

7025however, only restates the significant question identified above: How did that

7036loose injected fat get there?

704180. On direct examination, in response to the question, Ñ Is it possible for

7055the fat that we are describing in these photos to have migrated from the

7069subcutaneous layer into these muscles? Ò Dr. Garcia testified: Ñ To the be st of

7084my knowledge that would never happen. Ò Dr. Garcia Ô s answer, albeit direct

7098and based upon his broad experience, assumes that the fascia has not been

7111damaged and he is considering only whether fat injected into the

7122subcutaneous area with an intact, und amaged fascia will not migrate into the

7135muscle.

713681. Dr. Garcia focused on the Article Ô s conclu sion that Ñ the gluteus

7151maximus fascia, even with multiple cannula perforations, prevented

7159subcutaneous injections to cross into the muscle, even under very high

7170i njection pressures. Ò

717482. Dr. Garcia opined that , based on the results of th e Article, and his

7189extensive experience in studying the risks associated with gluteal fat

7199grafting, there is no other explanation for the deposited fat found in G.R. Ô s

7214muscles than Respondent Ô s having directly inject ed it into the muscle. His

7228position in this regard is credited.

723483. Further, Dr. Garcia opined that the fat present in G.R. Ô s muscles was

7249not the result of one inadvertent pass through G.R. Ô s fascia, but several

7263hundred. While this number may be somewhat exaggerated, since there is no

7275way to accurately determine the exact number, there were a large number of

7288passes through G.R. Ô s fascia, not just one or two.

729984. Dr. Garcia testified that Dr. Stover took preventative measu res to

7311avoid intramuscular injections during G.R. Ô s surgery. For example, she stated

7323that oftentimes muscles will twitch if a medical instrument comes into

7334contact with the muscle during a procedure and she observes for muscle

7346twitches while injecting fat. However, as noted previously, Dr. Stover

7356acknowledged that , because the muscles in the area that she was working

7368were thin, it was possible that the muscles either did not twitch or that she

7383did not notice them twitch. Without the twitch warning from the muscles, it

7396became even more likely Dr. Stover could have inadvertently perforated the

7407gluteal muscles during the multiple passes and mistakenly injected some

7417undetermined amount of fat.

742185. Dr. Stover further acknowledged that because BBLs are a blind

7432pro cedure, it was possible that her cannula could have passed through the

7445gluteal fascia at any point during the procedure.

745386. Dr. Stover also testified that she primarily injected fat on G.R. Ô s

7467lateral hips and away from the Ñ danger zone Ò where the fat was found in the

7484autopsy photographs.

748687. However, the Article revealed that no matter where in the gluteal

7498anatomy fat is injected intramuscularly (under the fascia), it will migrate

7509into the deeper planes of the muscles.

751688. Dr. Garcia confirmed that , even i f Dr. Stover had limited her

7529intramuscular injections to the lateral hip area, the fat could follow a

7541pressure gradient to the deeper planes and structures, as observed in the

7553autopsy photographs.

755589. Ultimately, Dr. Stover Ô s claim that she did not violate the standard of

7570care is refuted by the results of G.R. Ô s autopsy. The clinical observations of

7585injected fat in G.R. Ô s gluteal muscles show that Respondent repeatedly

7597perforated G.R. Ô s gluteal fascia and injected fat intramuscularly, resulting in

7609G.R. Ô s su dden and tragic demise.

7617C ONCLUSIONS OF L AW

762290. DOAH has jurisdiction over the subject matter of this proceeding and

7634over the parties hereto pursuant to sections 120.569, 120.57(1), and

7644456.073(5) , Florida Statutes.

764791. This is a proceeding whereby Petitio ner seeks to revoke Respondent Ô s

7661license to practice medicine. Petitioner has the burden to prove the

7672allegations in its A C by clear and convincing evidence. Reich v. Dep Ô t of

7688Health , Bd. o f Med. , 973 So. 2d 1233, 1235 (Fla. 4th DCA 2008) (citing Dep Ô t

7706of Banking & Fin. v. Osborne Stern & Co. , 670 So. 2d 932 (Fla. 1996)); and

7722Ferris v. Turlington , 510 So. 2d 292 (Fla. 1987). As stated by the Supreme

7736Court of Florida:

7739clear and convincing evidence requires that the

7746evidence must be found to be credible; the facts to

7756which the witnesses testify must be distinctly

7763remembered; the testimony must be precise and

7770lacking in confusion as to the facts at issue. The

7780evidence must be of such a weight that it produces

7790in the mind of the trier of fact a firm belief or

7802co nviction, without hesitancy, as to the truth of the

7812allegations sought to be established.

7817In re Henson , 913 So. 2d 579, 590 (Fla. 2005) (quoting Slomowitz v. Walker ,

7831429 So. 2d 797, 800 (Fla. 4th DCA 1983)). This burden of proof may be met

7847where the evide nce is in conflict; however, Ñ it seems to preclude evidence that

7862is ambiguous. Ò Westinghouse Elec. Corp. v. Shuler Bros., Inc. , 590 So. 2d 986,

7876988 (Fla. 1st DCA 1991).

788192. Because the Medical Practice Act, section 458.331 , authorizes

7890suspension or revocat ion of a professional license, it is penal in nature and

7904must be strictly construed in favor of the licensed physician. Breesmen v.

7916Dep Ô t of Prof Ô l Reg., Bd. of Med. , 567 So. 2d 469, 471 (Fla. 1st DCA 1990).

793693. A hearing involving disputed issues of mater ial fact under

7947section 120.57(1) is a de novo hearing, and Petitioner Ô s initial action carries

7961no presumption of correctness. § 120.57(1)(k), Fla. Stat.; Moore v. Dep Ô t of

7975HRS , 596 So. 2d 759 (Fla. 1st DCA 1992).

798494. The grounds proving the Department Ô s as sertion that Dr. Stover Ô s

7999license should be disciplined must be those specifically alleged in the AC. See,

8012e.g. , Trevisani v. Dep Ô t of Health , 908 So. 2d 1108 (Fla. 1st DCA 2005); Kinney

8029v. Dep Ô t of State , 501 So. 2d 129 (Fla. 5th DCA 1987); and Hunter v. Dep Ô t of

8050Prof Ô l Reg . , 458 So. 2d 842 (Fla. 2d DCA 1984).

806395. Due process prohibits the Department from taking disciplinary action

8073against a licensee based on matters not specifically alleged in the charging

8085instrument, unless those matters have been tried by consent. See Shore Vill.

8097Prop. Owners Ô Ass Ô n, Inc. v. Dep Ô t of Envtl. Prot. , 824 So. 2d 208, 210 (Fla. 4th

8118DCA 2002); and Delk v. Dep Ô t of Prof Ô l Reg . , 595 So. 2d 966, 967 (Fla. 5th

8139DCA 1992).

814196. Petitioner Ô s A C charges Respondent with violating sectio n

8153458.331(1)(t) , which prohibits medical doctors from committing medical

8161malpractice as defined in section 456.50 . It further provides that medical

8173malpractice shall not be construed to require more than one instance, event,

8185or act. § 458.331(1)(t)1. , Fla. Stat.

819197. Florida law recognizes that physicians owe their patients a duty to

8203Ñ use the ordinary skills, means, and methods that are recognized as

8215necessary and which are customarily followed in the particular type of case

8227according to the standards of tho se who are qualified by training and

8240experience to perform similar services in the community or in a similar

8252community. Ò Brooks v. Serrano , 209 So. 2d 279, 280 (Fla. 4th DCA 1968). The

8267Board may discipline a physician for Ñ failure to practice medicine with that

8280level of care, skill, and treatment which is recognized by a reasonably

8292prudent similar physician as being acceptable under similar conditions and

8302circumstances. Ò §§ 458.331(1)(t) and 456.072(2), Fla. Stat.; See also Fox v.

8314Dep Ô t of Health , 994 So. 2 d 416, 418 (Fla. 1st DCA 2008). Section 458.331(1)(t)

8331further provides, Ñ The board shall give great weight to the provisions of

8344s.766.102 when enforcing this paragraph. Ò Section 766.102(3), Florida

8353Statutes, provides, Ñ [t]he existence of a medical injury s hall not create any

8367inference or presumption of negligence against a health care provider, and

8378the claimant must maintain the burden of proving that an injury was

8390proximately caused by a breach of the prevailing professional standard of

8401care by the health care provider. Ò

840898. There is no dispute that injecting fat intramuscularly or sub -

8420muscularly during gluteal fat grafting procedures falls below the level of care,

8432skill, and treatment recognized in Florida for this procedure.

844199. The Department proved by c lear and convincing evidence that

8452Dr. Stover injected fat into G.R. Ô s gluteal muscles during a gluteal fat

8466grafting procedure or BBL , which constitutes both medical malpractic e, as

8477defined in section 456.50 , and a violation of rule 64B8 - 9.009(2)(f). This

8490c onclusion does not mean that Dr. Stover performed the BBL on G.R.

8503resulting in misplaced fat injections either intentionally, recklessly, or

8512without regard for G.R. Ô s safety , nor did the Department present any

8525evidence to support such a finding. Moreover, Dr. Stover was not charged

8537with failing to utilize the best practices, procedures, and instrumentation in

8548performing the BBL on G.R., nor did the Department present any evidence to

8561support such a finding. Finally, Dr. Stover was not charged with medical

8573ma lpractice regard ing the Ñ pre - tunneling Ò or blunt dissection portion of G.R. Ô s

8591BBL procedure, nor did the Department present any evidence to support such

8603a finding.

8605100. Despite Dr. Stover Ô s best intentions and considerable experience and

8617skill, maybe more than any physician in Florida performing BBLs on males

8629and transgender women, the evidence here is clear and convincing that fat

8641was found in the gluteal muscles , with some of that fat migrat ing to G.R. Ô s

8658lungs to creat e a fatal embolism. This is evident from the autopsy performed

8672on G.R., from the uncontroverted evidence that the fat appeared in the

8684gluteal muscles, and from the expert testimony from Dr. Garcia that he was

8697certain the fat was injected, whether intentionally (not proven), negligently,

8707or i nadvertently. The fact is, with all the passes preparing the subcutaneous

8720area to receive fat injections , Dr. Stover used her best practices to only inject

8734fat when withdrawing the cannula from the patient, rather than when

8745inserting the syringe into the p atient . N o clear and convincing evidence was

8760presented by either party that the fat somehow migrated from the

8771subcutaneous area into the gluteal muscles.

8777101. Dr. Stover Ô s superior experience in performing BBLs on men and

8790transgender women made her keenly aware of the unique problems facing a

8802surgeon due to sometimes thinner patients who require special care and

8813expertise on the surgeon Ô s part to prepare the subcutaneous area to receive

8827the fat injections. Despite all her experience and training, the clear and

8839convincing evidence here points to Dr. Stover ma king errors that resulted in

8852fat being injected, albeit not intentionally or recklessly, into G.R. Ô s gluteal

8865muscles. This action violated rule 64B8 - 9.009(2)(f) , and, pursuant to

8876section 458.331(1)(t), c onstitutes medical malpractice. What remains to be

8886determined is what penalty should apply.

8892The Penalty

8894102. Penalties in a licensure discipline case may not exceed those in effect

8907at the time a violation was committed. Willner v. Dep Ô t of Prof Ô l Reg . , Bd . of

8928Med. , 563 So. 2d 805, 806 (Fla. 1st DCA 1990), rev. denied , 576 So. 2d 295

8944(Fla. 1991).

8946103. Section 456.079 requires the Board of Medicine to adopt disciplinary

8957guidelines for specific offenses. Penalties imposed must be consistent with

8967any discipli nary guidelines prescribed by rule. See Parrot Heads, Inc. v. Dep Ô t

8982of Bus . & Prof Ô l Reg . , 741 So. 2d 1231, 1233 - 34 (Fla. 5th DCA 1999).

9002104. Section 456.072(4) provides that in addition to any other discipline

9013imposed for violation of a practice act, the board shall assess costs related to

9027the investigation and prosecution of the case.

9034105. Rule 64B8 - 8.001(2)(t) provides that the recommended range of

9045penalty for a first - time violation of section 458.331(1)(t) is from one - year of

9061probation to revocation and an administrative fine from $1,000.00 to

9072$10,000.00.

9074106. Rule 64B8 - 8.001(2)(nn) provides that the recommended range of

9085penalty for a first - time violation of section 458.331(1)(nn) is from one year

9099probation to revocation and an administrative fine from $ 1,000.00 to

9111$10,000.00.

9113107. In mitigation of the penalty to be imposed, Dr. Stover offers ( 1) her

9128long and unblemished career and her substantial experience of thousands of

9139surgeries without any serious complications ; ( 2) the clear and unequivocal

9150testimo ny both she and Dr. Garcia, the Department Ô s expert, offered that she

9165intended to use a subcutaneous - only strategy and to avoid subfascial,

9177intramuscular, or submuscular fat injections in G.R. Ô s BBL procedure ; and

9189( 3) Dr. Stover Ô s credible and uncontrover ted testimony that she followed all

9204prevailing safety recommendations , best practices , and employed

9211instruments in performance of G.R. Ô s BBL procedure. Despite all these

9223precautions and her clean professional record, Dr. Stover perforated the

9233gluteal muscl es, which led to fat repeatedly being injected into those muscles,

9246resulting in the worst possible result, the death of her patient due to her

9260negligence.

9261108. The undersigned finds , however, that despite the tragic result in

9272G.R. Ô s case, these factors gra vitate toward mitigation of the penalty to be

9287imposed on Dr. Stover. Accordingly, she should receive penalties resulting

9297from her actions in the lower - to mid - range of the penalty matrix.

9312R ECOMMENDATION

9314Based on the foregoing Findings of Fact and Conclusi ons of Law, it is

9328R ECOMMENDED that the Board of Medicine enter a final order finding

9340Respondent violated section 458.331(1)(t) and /or 458.331(1)(nn) ; imposing a

9349one - year probation upon Respondent Ô s license to practice medicine , together

9362with a $5,000 fine ; and imposing costs of investigation and prosecution.

9374D ONE A ND E NTERED this 1 3 th day of August , 2021 , in Tallahassee, Leon

9391County, Florida.

9393S

9394R OBERT S. C OHEN

9399Administrative Law Judge

94021230 Apalachee Parkway

9405Tallahassee, Florida 32399 - 3060

9410(850) 488 - 9675

9414www.doah.state.fl.us

9415Filed with the Clerk of the

9421Division of Administrative Hearings

9425this 1 3 th day of August , 2021 .

9434C OPIES F URNISHED :

9439Kristen M. Summers, Esquire Louise St. Laurent, Gen eral Counsel

9449Joseph William Mackey, Esquire Office of the General Counsel

9458Florida Department of Health Florida Department of Health

9466Prosecution Services Unit 4052 Bald Cypress Way, Bin C - 65

94774052 Bald Cypress Way , Bin C - 65 Tallahassee, Florida 32399 - 3265

9490Tallahassee, Florida 32399

9493Sean Michael Ellsworth, Esquire Kenneth J. Metzger, Esqu ire

9502Ellsworth Law Firm, P.A. Metzger and Associates, LLC

95101000 5th Street , Suite 223 1637 Metropolitan Boulevard, Suite C - 2

9522Miami Beach, Florida 33139 Tallahassee, Florida 32308

9529Paul A. Vazquez, J . D . , Exec utive Director

9539Board of M edicine

9543Florida Department of Hea lth

95484052 Bald Cypress Way, Bin C - 03

9556Tallahassee, Florida 32399 - 325 3

9562N OTICE OF R IGHT T O S UBMIT E XCEPTIONS

9573All parties have the right to submit written exceptions within 15 days from

9586the date of this Recommended Order. Any e xceptions to this Recommended

9598Order should be filed with the agency that will issue the Final Order in this

9613case.

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PDF
Date
Proceedings
PDF:
Date: 06/02/2022
Proceedings: Final Order Assessing Costs filed.
PDF:
Date: 11/05/2021
Proceedings: Respondent's Exceptions to Recommended Order filed.
PDF:
Date: 11/05/2021
Proceedings: Petitioner's Response to Respondent's Exceptions to the Recommended Order filed.
PDF:
Date: 11/05/2021
Proceedings: Agency Final Order filed.
PDF:
Date: 11/02/2021
Proceedings: Agency Final Order
PDF:
Date: 08/13/2021
Proceedings: Recommended Order
PDF:
Date: 08/13/2021
Proceedings: Recommended Order (hearing held January 28, 2021). CASE CLOSED.
PDF:
Date: 08/13/2021
Proceedings: Recommended Order cover letter identifying the hearing record referred to the Agency.
PDF:
Date: 05/11/2021
Proceedings: Order Denying Motion for Judge to View Zoom Recording with Instructions.
PDF:
Date: 05/07/2021
Proceedings: Respondent, Stephanie Stover, M.D.'s Motion Requesting this Successor Administrative Law Judge View the Zoom Recording of the Hearing filed.
PDF:
Date: 04/20/2021
Proceedings: Notice of Transfer.
PDF:
Date: 02/18/2021
Proceedings: Stephanie Stover, M.D.'s Proposed Recommended Order filed.
PDF:
Date: 02/18/2021
Proceedings: Petitioner's Proposed Recommended Order filed.
PDF:
Date: 02/09/2021
Proceedings: Notice of Filing Transcript.
Date: 02/08/2021
Proceedings: Transcript of Proceedings (not available for viewing) filed.
Date: 01/28/2021
Proceedings: CASE STATUS: Hearing Held.
PDF:
Date: 01/28/2021
Proceedings: Petitioner's Response to Respondent's Motion to Dismiss filed.
PDF:
Date: 01/27/2021
Proceedings: Petitioner's Motion in Limine filed.
PDF:
Date: 01/26/2021
Proceedings: Notice of Filing Impeachment/Rebuttal Exhibits filed (exhibits not available for viewing).
PDF:
Date: 01/26/2021
Proceedings: Stephanie Stover, M.D.'s Motion to Dismiss Count I or Count II of the Administrative Complaint as Multiplicitous, a violation of the Prohibition against Double Jeopardy and Dr. Stover's Right to Due Process filed.
PDF:
Date: 01/26/2021
Proceedings: Notice of Filing Impeachment/Rebuttal Exhibits filed.
Date: 01/22/2021
Proceedings: Respondent's Proposed Exhibits filed (exhibits not available for viewing) (USB included).
PDF:
Date: 01/22/2021
Proceedings: (Petitioner's) Notice of Filing Exhibits filed.
Date: 01/22/2021
Proceedings: Petitioner's Proposed Exhibits filed (exhibits not available for viewing).
PDF:
Date: 01/08/2021
Proceedings: Notice of Intent to Seek to Admit Records Pursuant to Section 90.803(6)(c), Florida Statutes (Business Records) filed.
PDF:
Date: 01/07/2021
Proceedings: Respondent's Notice of Serving Supplemental Response to Interrogatories filed.
PDF:
Date: 01/06/2021
Proceedings: Notice of Service of Petitioner's Discovery Responses filed.
PDF:
Date: 01/06/2021
Proceedings: Respondent's Notice of Serving Response to Interrogatories filed.
PDF:
Date: 01/06/2021
Proceedings: Respondent's Notice of Serving Response to Request for Admissions filed.
PDF:
Date: 01/06/2021
Proceedings: Respondent's Notice of Serving Response to Request for Production filed.
PDF:
Date: 01/05/2021
Proceedings: Notice of Hearing by Zoom Conference (hearing set for January 28, 2021; 9:00 a.m., Eastern Time).
PDF:
Date: 12/28/2020
Proceedings: Petitioner's Notice of Taking Deposition via Zoom Teleconference (Stephanie Stover, M.D.) filed.
PDF:
Date: 12/23/2020
Proceedings: Joint Response to Initial Order filed.
PDF:
Date: 12/23/2020
Proceedings: Initial Order.
PDF:
Date: 12/18/2020
Proceedings: Notice of Appearance (Joseph Mackey) filed.
PDF:
Date: 12/18/2020
Proceedings: Respondent's Notice of Serving Request for Production filed.
PDF:
Date: 12/18/2020
Proceedings: Notice of Service of Petitioner's Requests for Discovery filed.
PDF:
Date: 12/18/2020
Proceedings: Petition for Administrative Hearing filed.
PDF:
Date: 12/18/2020
Proceedings: Administrative Complaint filed.
PDF:
Date: 12/18/2020
Proceedings: Agency referral filed.

Case Information

Judge:
ROBERT S. COHEN
Date Filed:
12/18/2020
Date Assignment:
04/20/2021
Last Docket Entry:
06/02/2022
Location:
Miami, Florida
District:
Southern
Agency:
ADOPTED IN TOTO
Suffix:
PL
 

Counsels

Related Florida Statute(s) (9):