The Issue The ultimate issues in this case are whether Respondent violated Section 458.331(1)(m) and (t), Florida Statutes (1997), respectively, by failing to keep medical records that justify the course of treatment and by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances; and, if so, what penalty, if any, should be imposed against Respondent's license to practice medicine. (All chapter and section references are to Florida Statutes (1997) unless otherwise stated.)
Findings Of Fact Petitioner is the state agency responsible for regulating the practice of medicine in Florida pursuant to Sections 20.165 and 20.43 and Chapters 455 and 458. Respondent is licensed as a medical physician in Florida pursuant to license number ME0050478. Respondent has been a Board-certified plastic surgeon at all times material to this proceeding. The Administrative Complaint involves one patient who undertook elective plastic surgery. The record identifies the patient as E.O. in order to preserve the patient's confidentiality. In summary, the Administrative Complaint alleges that Respondent departed from the acceptable standard of care by: failing to perform the surgical procedure elected by E.O.; performing a surgical procedure other than the procedure E.O. authorized; failing to document a reason for changing the procedure; failing to advise the patient of the risks associated with the procedure performed; performing breast augmentation with implants that were too large; and failing to document a reason for using the larger implants. On December 31, 1997, E.O. presented to Respondent for consultation regarding reconstruction of her left breast. At the time, E.O. was approximately 48 years old. E.O.'s medical history included an abdominal hysterectomy, a biopsy of the right breast, two biopsies of the left breast, and a diagnosis of cancer in the left breast. A partial mastectomy of the left breast and radiation therapy resulted in significant scarring. The left breast had a concave, depressed area in the left side. The depressed area extended from the upper part of the breast, near the outer pectoral muscle, halfway to the nipple. The nipple on the left breast was pulled to the outside toward the depressed area. E.O. also suffered ptosis, i.e., the appearance of drooping, that was not related to her medical history. The radiation therapy to the left breast had caused a burn injury that left internal scar tissue. The scar tissue was not pliable and was not suitable for manipulation during plastic surgery. During E.O.'s initial visit with Respondent on December 31, 1997, Respondent noted E.O.'s prior medical history and radiation treatment. He noted the bilateral ptosis and the left breast deformity. Respondent recommended bilateral implants for the purposes of reconstructing the left breast and for achieving symmetry between the breasts. Respondent and E.O. did not agree on a plan of treatment during the initial visit but did agree to a second visit. On January 16, 1998, E.O. presented to Respondent for her second visit. After further consideration of E.O's case, Respondent made a specific recommendation of bilateral augmentation with prostheses, in the form of implants, and a latissimus dorsi flap (LDF) procedure to correct the depression in the left breast. An LDF procedure would have resected, or removed, the scarring in the left breast and would have replaced the resulting divot with healthy tissue. Respondent would have obtained healthy tissue by moving a flap of tissue and muscle from the patient's back underneath the patient's outer tissue layers and placing the flap internally in the left breast. E.O. agreed with Respondent's recommendation. E.O. agreed to the bilateral augmentation because Respondent advised her that an implant in her right breast was necessary to achieve appropriate symmetry. E.O. did not agree to the augmentation because she wanted larger breasts. Respondent assured E.O. that her breast size would increase only about one-half cup. Respondent's records do not include a reference to the size of the implants to be used. Respondent indicated he would seek preauthorization from the insurer for the LDF procedure with prosetheses. The LDF procedure required E.O. to stay overnight in the hospital following surgery. Surgery that omitted the LDF procedure could have been performed in "same-day" surgery. Respondent and E.O. did not discuss or agree upon any plan of treatment. On January 21, 1998, E.O. presented to Respondent for a third time. E.O.'s husband, L.O., was also present. Respondent discussed the LDF procedure with E.O. and L.O. Respondent stated that he believed the LDF procedure was necessary to fill-in the left breast after Respondent resected the radiated tissue as part of the reconstruction of E.O.'s left breast. Respondent, E.O., and L.O. did not discuss other treatment options. On January 21, 1998, Respondent requested authorization from E.O.'s insuror for breast reconstruction surgery that included an LDF procedure with the use of a prosthetic implant. On February 12, 1998, E.O. presented to Respondent for a fourth time. E.O. had additional questions about the surgery that included questions regarding the insurance coverage for the surgery. E.O. and Respondent did not discuss the LDF procedure or other treatment options. Respondent scheduled the surgery for February 26, 1998, at the Columbia Regional Medical Center Southwest Hospital ("Columbia" or the "hospital"). On February 24, 1998, E.O. presented to Columbia for a preoperative workup. At the preoperative workup, E.O. executed a written informed consent document that authorized Respondent to perform a, "Lat Flap with implant left Breast and Right endoscope augmentation." Respondent also signed the informed consent. E.O. did not consent to another procedure different from that stated in the informed consent. Nor did E.O. and Respondent agree upon a different procedure. Hospital records, including the Short-Stay History and Physical completed on the day of surgery and signed by Respondent, show that the procedure to be performed was an LDF procedure with implants. The hospital records are devoid of any indication that E.O. did not wish to undergo the LDF procedure or that E.O. expressed any reservations about the procedure. On the morning of February 26, 1998, E.O. fully expected to undergo the LDF procedure. E.O. presented to Columbia anticipating an overnight hospitalization that was consistent with an LDF procedure. E.O. brought with her the personal belongings she would need for an overnight hospitalization. The applicable standard of medical care required Respondent to perform the LDF procedure so long as it was medically reasonable to do so. On February 26, 1998, Respondent performed surgery on E.O. that included an implant in each breast. However, Respondent did not perform the LDF procedure. Rather, Respondent created breast flaps by incising existing scar tissue and utilizing the incised scar tissue to fill in the depression in the left breast. Respondent did not resect the scar tissue and replace it with healthy tissue. Immediately after the surgery, Respondent advised L.O., without explanation, that Respondent did not perform the LDF procedure and that E.O. was doing well. Columbia discharged E.O. on the same day of surgery. During the trip home in their car, L.O. advised E.O. that Respondent did not perform the LDF procedure. E.O. was surprised but groggy from medication. No medical reason prevented Respondent from performing the LDF procedure. Respondent encountered no difficulties or complications during surgery that precluded the LDF procedure. Moreover, there were medical reasons not to incise the scar tissue and use it to fill in the depression in the left breast. Irradiated scar tissue is not well vascularized, is not pliable, and is not easy to manipulate. The only reason that Respondent offered for failing to perform the LDF procedure was that E.O. expressed concern over the procedure. Respondent testified that E.O. expressed her concern to Respondent when Respondent was in the holding area marking E.O.'s breasts for surgery. The holding area is an area that is physically separate from the operating room. E.O. did not expressly ask Respondent not to perform the LDF procedure. Rather, Respondent inferred that E.O. did not want him to perform the LDF procedure. As Respondent testified during cross examination: Q. And you had a conversation with her wherein she expressed some concern about the latissimus dorsi flap procedure; is that correct? A. The tenor of her conversation indicated some concern. She did not say to me please don't do it, but the tenor of her conversation was that there was concern when I was marking her for it. Transcript (TR) at 624. Respondent claims that the conversation with E.O. occurred when Respondent was in the holding area marking E.O. for surgery. Respondent's testimony during cross examination is illustrative. Q. And your testimony is that, is the holding area an area different than the actual operating room. A. Yes. * * * Q. I would like for you to look to the first line of this operative report, under procedures. It says the patient was brought to the operating room, and marked in the sitting position, then laid supine. A. Yes. Q. Doesn't that note say that you did not mark this patient in the holding area, but you marked her in the operating room? A. It sure does. And are you telling me today that this is in error? A. That is absolutely in error. I have never marked a patient in the operating room. TR at 625. Respondent's claim that he had a conversation with E.O. in the holding area before surgery is refuted by E.O. The testimony of E.O. concerning this factual issue is credible and persuasive. The testimony of E.O. is consistent with the operative report stating that E.O. was marked in the operating room rather than in the holding area. Respondent did not see E.O. in the holding area prior to surgery and did not have a conversation with E.O. in which E.O. expressed some concern over the LDF procedure. E.O. received preoperative medication in the holding area and was not capable of carrying on a conversation with Respondent in the operating room and was not capable of making an informed consent to a different procedure. If it were determined that Respondent had a conversation with E.O. in the holding area while marking her for surgery, there was ample time to amend the informed consent document to reflect a different treatment plan agreed to by E.O. and Respondent. The actual surgery performed by Respondent was a procedure that was different from the LDF procedure authorized by E.O. The actual surgical procedure performed by Respondent was not a lesser included procedure of the LDF procedure. The applicable standard of care would have required Respondent to amend the informed consent document under the facts and circumstances testified to by Respondent. An informed consent should include all anticipated treatment options. The informed consent signed by E.O. and Respondent did not include any options to the LDF procedure. Even if it were determined that the actual procedure performed is a lesser included procedure of the LDF procedure, E.O. did not consent to the lesser included procedure. The performance of a lesser included procedure for which E.O. was not informed and to which E.O. did not consent departs from the applicable standard of care. The procedure performed by Respondent during surgery increased the risk of failure and the need for subsequent surgery by using scar tissue rather than resecting the scar tissue and using healthy tissue to fill in the left breast. Respondent failed to inform E.O. of the increased risk of the procedure actually utilized by Respondent. Respondent failed to practice medicine with the level of care, skill, and treatment recognized by a reasonably prudent similar physician as acceptable under similar conditions and circumstances. First, Respondent failed to perform the procedure that E.O. authorized. Second, Respondent performed a procedure that placed implants in E.O.'s irradiated left breast without resecting the irradiated scar tissue. Third, Respondent failed to inform E.O. of the increased risk associated with the procedure Respondent utilized during surgery. Finally, Respondent failed to document in the records a reason or rationale for performing a surgical procedure other than the LDF procedure authorized by the patient. Prior to surgery, Respondent agreed to use the smallest implants possible. During surgery, Respondent placed very large implants in E.O.'s breasts. Respondent used a 480 cc implant in the left breast and a 460 cc implant in the right breast. Respondent used the large implant in the left breast, rather than the LDF, in an attempt to stretch the tissue, including the scar tissue, and to fill in the depression in the left breast. Respondent used the large implant in the right breast for symmetry. E.O. did not consent to the use of large implants in either breast. Rather, E.O. authorized the smallest implants possible. Respondent utilized implants that increased E.O.'s cup size from a small C cup to a DD cup. The weight and volume of the large implants stretched E.O.'s skin and exacerbated her ptosis. After surgery, E.O.'s clothes did not fit. A DD cup size was sometimes too small. An accepted method of determining the effect of implants is to sit the patient up on the operating table prior to completing surgery. Respondent did not sit E.O. up on the operating table to view the effect of the implants. Respondent had a complete range of implant types and sizes available for use during surgery. Respondent failed to practice medicine with the level of care, skill, and treatment recognized by a reasonably prudent similar physician as acceptable under similar conditions and circumstances. Respondent utilized implants that were not authorized by E.O. by placing overly large implants in E.O.'s breasts. Respondent failed to utilize the implants authorized by E.O. by failing to use the smallest implants possible. Respondent failed to document in the records a reason or rationale for using implants other than those authorized by E.O. Respondent's failure to practice medicine in accordance with the applicable standard of care caused substantial harm to E.O. At the first postoperative visit on March 2, 1998, E.O. asked Respondent why he did not perform the LDF procedure. Respondent stated that he had determined that E.O. could do without the LDF procedure. E.O. also expressed concern over the large size of her breasts. Respondent explained that the large size was attributable to swelling and that it would take several months for the swelling to dissipate. Until that time, it was impossible to assess the final result. During subsequent visits on March 11 and 18 and on April 3, 1998, E.O. expressed concern over the size and appearance of her breasts. However, she continued to trust Respondent and to accept his assurances that she needed to be patient and allow the swelling to go down before forming any final opinions regarding the outcome of the surgery. During a visit on May 1, 1998, Respondent examined E.O. and acknowledged that the procedure actually performed on February 26, 1998, did not produce the desired result. The implant and incised scar tissue had not stretched and filled in the left breast. Respondent advised E.O. that she needed the LDF procedure. E.O. elected for Dr. Brueck to perform reconstruction surgery on her. However, problems with insurance coverage delayed the surgery until July 11, 2000. The surgery included bilateral reconstruction with bilateral implant and mastopexy. E.O.'s breast size was a B cup after surgery. E.O. was very pleased with the results of the surgery.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED, in accordance with the terms of Petitioner's PRO, that Petitioner enter a Final Order finding Respondent guilty of violating Section 458.331(1)(m) and (t); issuing a written reprimand; imposing a fine of $5,000; and requiring Respondent to complete, within one year, 20 hours of continuing professional education above and beyond that required to maintain licensure. DONE AND ENTERED this 18th day of March, 2002, in Tallahassee, Leon County, Florida. DANIEL MANRY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 18th day of March, 2002. COPIES FURNISHED: William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Britt Thomas, Esquire Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Carol A. Lanfi, Esquire 1000 Riverside Avenue, Suite 800 Jacksonville, Florida 32204 Albert Peacock, Esquire 8554 Congressional Drive Tallahassee, Florida 32312 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
The Issue The issues in this case are whether the allegations of the Administrative Complaint are correct, and, if so, what penalty should be imposed.
Findings Of Fact The Petitioner is the state department charged with regulating the practice of medicine pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes (2005). At all times material to this case, the Respondent was a physician licensed by the State of Florida, holding license number 59702 and was board-certified in obstetrics and gynecology. The Respondent owned, and practiced medicine at, EPOC Clinic, 609 Virginia Drive, Orlando, Florida. On December 19, 2005, Patient S.B. presented to the EPOC Clinic to inquire about terminating a pregnancy, but elected not to proceed with the termination at that time. On February 3, 2006, S.B. returned to the EPOC Clinic, having decided to terminate the pregnancy. A sonogram was performed, and S.B. was determined to be approximately 18 to 19 weeks gestation. At that time, she executed consent forms for pregnancy termination by medication, and dilation and extraction (D&E). Patient S.B. had been pregnant three times previously and had birthed three children, each delivered live by cesarean section. The patient's pregnancy termination was scheduled to commence on February 4, 2006, but S.B. was late in arriving at the clinic, and the procedure was rescheduled for February 6, 2006. The patient returned to the EPOC Clinic as rescheduled. While at the EPOC Clinic on February 6 and 7, 2006, S.B. received medical care and treatment primarily from the Respondent and from Carmita Etienne, a medical assistant working at the clinic. The termination was initiated with the use of "Cytotec," a drug that causes cervical dilation and uterine contractions, and which generally results in passage of the fetus into the vaginal vault. Cytotec is commonly used in medication-based pregnancy termination. It is known to increase the potential for uterine rupture during labor and delivery, the risk for which is noted within the relevant consent documents executed by the patient. Cytotec tablets, in 200 microgram dosages, were administered orally to the patient by the Respondent's medical assistant. S.B. received 200 micrograms of Cytotec at 10:00 a.m. on February 6, 2006, and received the same dosage at four-hour intervals through 10:00 a.m. on February 7, 2006, at which time the patient's cervix remained undilated. The Respondent thereafter escalated the frequency of the Cytotec to every two hours, and the drug was administered two additional times on February 7, 2006, at noon and 2:00 p.m. According to progress notes contained in the medical records, S.B. complained of discomfort on February 6, 2006, at 7:45 p.m. and on February 7, 2006, at 3:00 a.m. Discomfort or pain is a typical element of labor, and S.B.'s discomfort was not unexpected. Demerol, a controlled substance, is routinely used to relieve pain during medical procedures, including pregnancy terminations. The medical assistant relayed S.B.'s reports of discomfort to the Respondent. The Respondent ordered Demerol on both occasions to relieve S.B.'s pain. A physician must be properly registered with the U.S. Drug Enforcement Administration (DEA) to order the administration of Demerol to a patient. The Respondent was not properly registered with the DEA on February 6 or 7, 2006. At the hearing, the Respondent denied that he ordered the Demerol. He testified that he was serving as a conduit between his medical assistant and another physician, Dr. Harry Perper, who also worked at the clinic and who was apparently properly registered with the DEA. The Respondent's testimony on this issue was not persuasive and has been rejected. The evidence failed to establish that Dr. Perper ordered the administration of Demerol to the patient or that the Respondent merely relayed such orders from Dr. Perper to the medical assistant. The Respondent asserted that he had not been registered with the DEA since 2002 and that everyone at the clinic knew he could not order controlled substances. The patient's progress notes, created contemporaneously with the patient's treatment at the clinic, explicitly state that the orders for Demerol came from the Respondent. The medical assistant who created the progress notes testified that she preferred talking to the Respondent rather than Dr. Perper and that the directions she received for the patient's Demerol came from the Respondent. The Respondent's assertion that he did not order the Demerol was not credible and has been rejected. The Demerol was administered by the medical assistant through injection of the medication into S.B.'s buttocks, and the patient's pain was reduced. The medical assistant denied that she personally administered the Demerol to the patient. Her denial was not credible and has been rejected. The progress notes also state that the patient complained of "right side" pain at 3:00 p.m. on February 7, 2006. At approximately 3:45 p.m. on February 7, 2006, the patient was apparently examined by Dr. Perper, who wrote "SROM" in the progress notes, signifying that a "spontaneous rupture of membranes" had occurred and indicating that the patient's "water had broken." He also documented his observation that a fetal part was protruding from the cervix into the vagina. By that evening, the patient's termination was not completed. At approximately 7:00 p.m. on February 7, 2006, the medical assistant moved the patient into a procedure room at the Respondent's direction. The instruments to perform a D&E were present in the procedure room. The Respondent began to perform an examination of S.B. to assess the situation and determine whether the termination procedure should be completed by D&E. The Respondent utilized a speculum to open the patient's vagina and performed a sonogram on the patient's abdomen to identify the location of the fetus. The fetus was observed to be within S.B.'s uterus. The Respondent observed a fetal part protruding through the cervical os into the vagina. In order to examine the extent of cervical dilation, he detached the part from the fetus by grasping the part with a "Hearn" instrument and twisting the instrument. After he detached the part, he withdrew the instrument and the part from the patient. The Petitioner alleged that the Respondent "apparently" attempted a D&E. The evidence failed to support the allegation. The evidence failed to establish that the Respondent pulled on the exposed fetal part in an attempt to extract the fetus from the uterus. The evidence failed to establish that the Respondent inserted the Hearn or any other instrument into the patient's cervix or uterus. After removing the fetal part from the vagina, the Respondent placed the part on a tray. Almost immediately thereafter, the Respondent's reviewed the ultrasound image and observed that the image indicated the fetus was no longer fully contained within the uterus. The Respondent understood that the ultrasound image indicated a potential uterine perforation or rupture and, appropriately, concluded that the situation could be life- threatening for the patient. He quickly contacted the Arnold Palmer Hospital to arrange for emergency transfer of S.B. to the hospital. The Respondent also spoke to two practitioners at the hospital. Initially, he spoke by telephone to Dr. Pamela Cates, a resident physician at the hospital. Dr. Cates did not have the authority to admit the patient to the hospital and directed the Respondent to talk to Dr. Norman Lamberty, the "Ob/Gyn" physician on call and present at the hospital. The Respondent spoke by telephone to Dr. Lamberty, who agreed to accept the transfer of the patient from the clinic to the hospital. The Respondent failed to inform either Dr. Cates or Dr. Lamberty that he had removed a portion of the fetus from the patient at the clinic. While waiting for an ambulance to arrive to transport the patient, the Respondent wrote a note to be transported to the hospital with the patient. Although in the note he documented the treatment provided to the patient at the clinic, he failed to include the removal of the fetal part in the note. The Respondent testified that he did not document his removal of the fetal part because he did not believe it was significant to the medical care the patient would receive at the hospital. S.B. was transported to the hospital along with some of her medical records from the clinic and the Respondent's handwritten note. None of the documentation indicated that a part of the fetus had been removed at the clinic. After S.B. arrived at the hospital, Dr. Lamberty removed the fetus and completed the abortion procedure. Dr. Lamberty also repaired a cervical laceration and performed a hysterectomy. He noted that the uterine rupture occurred on the patient's right side and that the fetus was located not "floating" in the abdomen but "between two layers of tissue on the right side of the pelvis." The evidence failed to establish that the cervical laceration occurred while the patient was at the clinic or that it was caused by treatment the patient received at the clinic. Upon removing the fetus, Dr. Lamberty observed that the fetus was incomplete and that a portion of the fetal leg was missing. Dr. Lamberty began efforts to locate the missing part, which he reasonably presumed remained in the patient. Dr. Lamberty's concern regarding the missing part was that potential exposure of the part to the patient's vagina would have contaminated the part with bacteria and that a risk of infection would be presented by leaving the part within the patient's pelvis or abdomen. Dr. Lamberty was unable to locate the missing part, and, thereafter, radiological studies, including X-rays and a CT scan, were performed in an unsuccessful attempt to locate the part. The patient remained hospitalized and on February 10, 2006, a second surgical procedure was performed on the patient, this time to remove a "Jackson-Pratt" drain that had been improperly sutured into the patient's abdomen at the time of the hysterectomy. The second surgery was unrelated to the search for the missing part. Also on February 10, 2006, the hospital contacted the clinic to inquire as to the missing part and was advised that the part had been removed by the Respondent at the clinic.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a final order finding James S. Pendergraft IV, M.D., in violation of Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes (2005), and imposing a penalty as follows: a two-year period of suspension followed by a three-year period of probation and an administrative fine of $20,000.00. DONE AND ENTERED this 21st day of September, 2009, in Tallahassee, Leon County, Florida. S WILLIAM F. QUATTLEBAUM 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 Hearings this 21st day of September, 2009. COPIES FURNISHED: Greg S. Marr, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Kenneth J. Metzger, Esquire Metzger, Grossman, Furlow & Bayo, LLC 1408 North Piedmont Way Tallahassee, Florida 32308 Kathryn L. Kasprzak, Esquire Fowler White Boggs Banker, P.A. 200 South Orange Avenue, Suite 1950 Orlando, Florida 32801 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
The Issue Whether Respondent, a licensed physician, committed record- keeping violations and repeated medical malpractice by committing three or more incidents of medical malpractice, as alleged in the Second Amended Administrative Complaint; and, if so, what is the appropriate penalty?
Findings Of Fact Petitioner is responsible for the investigation and prosecution of complaints against medical doctors licensed in the state of Florida, who are accused of violating chapters 456 and 458 of the Florida Statutes. Respondent is licensed as a medical doctor in Florida, having been issued license number ME 99126 on June 15, 2007. Respondent is not board-certified in any specialty recognized by the Florida Board of Medicine. Respondent has never had disciplinary action against his license to practice medicine. In May 2015, Respondent performed cosmetic surgery procedures, including liposuction and fat injection procedures (commonly referred to as a "Brazilian Butt Lift" or "BBL"), at Vanity Cosmetic Surgery (Vanity), Encore Plastic Surgery (Encore), and Spectrum Aesthetics (Spectrum). Liposuction is an elective cosmetic procedure that involves the removal of fat from a patient. Fat is removed with a cannula, or a long, thin, metal rod, attached to a suctioning device. The cannula is repeatedly passed through the patient's subcutaneous layer until the desired amount of fat is removed. Facts Related to Patient L.L. On May 2, 2015, Patient L.L., a 29-year-old female patient, contacted Vanity to undergo liposuction. On May 2, 2015, prior to her procedure, Patient L.L. underwent bloodwork that revealed she had a normal hematocrit level, normal hemoglobin level, and a normal red blood cell count. Respondent determined that Patient L.L. was of sufficiently good health to undergo liposuction. Respondent performed liposuction on Patient L.L. at Vanity on May 14, 2015. Several hours after being discharged to a hotel, Patient L.L. experienced pain, weakness, elevated heart rate (tachycardia), and excessive bleeding. Patient L.L. presented to Homestead Hospital, where she was admitted for three days of post-operative care and monitoring. L.L.'s recovery took several months and resulted in her losing her job. Upon admission, Patient L.L.'s hematology report revealed a low hematocrit, low hemoglobin, and a low red blood cell count, which signified severely diminished blood levels and necessitated her to be transfused with two units of blood and plasma. Facts Related to Patient D.M. On April 25, 2015, Patient D.M., a 31-year-old female patient, contacted Spectrum to undergo liposuction with gluteal fat transfer. On April 29, 2015, prior to her procedure, Patient D.M. underwent bloodwork that revealed she had a normal hematocrit level, normal hemoglobin level, and a normal red blood cell count. Also prior to her procedure, Patient D.M. indicated in her medical questionnaire that she was pregnant approximately five times. Because Patient D.M. disclosed her prior pregnancies to Respondent, Respondent knew, or should have known, that Patient D.M. had a potentially weak or thin abdominal wall. Respondent determined that Patient D.M. was of sufficiently good health to be an appropriate candidate to undergo liposuction with gluteal fat transfer. Respondent performed liposuction with gluteal fat transfer on Patient D.M. at Spectrum on May 15, 2015. Following the surgery, Patient D.M. experienced extreme pain, resulting in her admission to Westchester Hospital. Upon admission, Patient D.M.'s hematology report revealed a low hematocrit and low hemoglobin, which signified severely diminished blood levels and necessitated her to be transfused with three units of blood. During an exploratory surgery, Patient D.M. was found to have several holes in her liver and damage to her chest and abdominal wall. Facts Related to Patient N.F. On February 4, 2015, Patient N.F., a 35-year-old female patient, contacted Spectrum to undergo liposuction with gluteal fat transfer. On April 23, 2015, prior to the procedure, Patient N.F. underwent bloodwork that revealed she had a normal hematocrit level, normal hemoglobin level, and a normal red blood cell count. Also prior to her procedure, Patient N.F. indicated in her medical questionnaire that she was pregnant at least twice. Because Patient N.F. disclosed her prior pregnancies to Respondent, Respondent knew, or should have known, that Patient N.F. had a potentially weak or thin abdominal wall. Respondent determined that Patient N.F. was of good health and an appropriate candidate to undergo liposuction. Respondent performed liposuction with gluteal fat transfer on Patient N.F. at Spectrum on May 15, 2015. Following the surgery, Patient N.F. experienced abdominal pain, weakness, and an inability to walk, resulting in her admission to Baptist Hospital. During an exploratory surgery, Patient N.F. was found to have a hole in her small bowel (colon), which was leaking fluid into her abdominal cavity.1/ Facts Related to Patient P.N. On May 16, 2015, Patient P.N., a 35-year-old female patient, was scheduled to undergo liposuction with gluteal fat transfer at Encore. On May 4, 2015, prior to her procedure, Patient P.N. underwent bloodwork that revealed she had a normal hematocrit level, normal hemoglobin level, and a normal red blood cell count. Respondent determined that Patient P.N. was of sufficiently good health and an appropriate candidate to undergo liposuction. Respondent performed liposuction with gluteal fat transfer on Patient P.N. as scheduled. Following the surgery, Patient P.N. experienced extreme pain and heavy bleeding, resulting in her admission to Memorial Regional Hospital. Upon admission, Patient P.N.'s hematology report revealed a low hematocrit level, and low hemoglobin, which signified severely diminished blood levels and necessitated a blood transfusion. Facts Related to Concentration of Tumescent Solution Before harvesting Patients L.L.'s, D.M.'s, N.F.'s, and P.N.'s fat, Respondent infiltrated tumescent solution into the areas that were prepared to undergo liposuction. Tumescent solution is a mixture of natural saline, epinephrine, and lidocaine and is used to decrease the risk of excessive bleeding caused by large-volume liposuction procedures. Epinephrine, the active ingredient in tumescent solution, constricts blood vessels and reduces blood loss. The minimum concentration of epinephrine in tumescent solution needed to achieve its intended purpose of reducing blood loss is 1:1,000,000. This concentration was first popularized by Dr. Jeffrey Klein in 1965. After experimenting with several concentrations of epinephrine, Dr. Klein concluded that a 1:1,000,000 concentration of epinephrine appropriately balanced patient safety with effectiveness. The most dilute concentration of epinephrine Dr. Klein experimented with was 1:2,000,000. Dr. Klein's concentration of epinephrine in tumescent solution of 1:1,000,000 is the standard concentration in the state of Florida for BBL procedures. The medical records reflect that during each of the four procedures, Respondent used tumescent solution with an epinephrine concentration of 1:4,000,000. This concentration is too diluted to have the intended effect of restricting blood loss. However, the tumescent solution was prepared by the circulators who assisted during the surgeries. The circulators credibly testified that when preparing the tumescent solution, they used enough epinephrine to create at least a 1:1,000,000 concentration of epinephrine. The circulators prepared the tumescent solution by adding lidocaine with 1:100,000 epinephrine and one cubic centimeter (cc) of epinephrine to a one-liter (1000 cc) bag of normal saline. The circulators explained that the additional epinephrine that was used was not documented in the patients' operating room records because there was no designated space on the form for this information. In light of the circulators' credible testimony, no evidence was presented to support the conclusion that Respondent fell below the standard of care by using an inappropriate concentration of epinephrine in the tumescent solution. Further, there was no causal connection demonstrated between the patients' blood loss, a fairly common complication associated with BBL procedures, and the concentration of epinephrine used. Facts Related to Damage to Internal Organs During Patient N.F.'s liposuction procedure, Respondent used a cannula to remove 4,000 ccs of supernatant fat from Patient N.F.'s abdomen, waist, back, bra rolls, and flanks. While manipulating the cannula, Respondent pushed the cannula through Patient N.F.'s abdominal wall and punctured her small bowel. Because Respondent perforated Patient N.F.'s small bowel, Patient N.F.'s abdominal cavity was contaminated, and 10 to 15 centimeters of Patient N.F.'s bowel later had to be resected and removed. After Patient N.F.'s hospitalization, her mother confronted Respondent who admitted that he "messed up," and suggested that his instrument "cuts through muscle and fat like butter," and may have contributed to the perforation. During Patient D.M.'s liposuction procedure, Respondent used a cannula to remove 4,000 ccs of supernatant fat from Patient D.M.'s abdomen, waist, back, bra rolls, and flanks. While manipulating the cannula, Respondent pushed the cannula through Patient D.M.'s abdominal wall, damaging her chest wall, and Respondent punctured her liver at least five times. Respondent was responsible for ensuring that the cannula used during liposuction procedures was manipulated with precision and extreme care to avoid contact with the patients' internal organs. In order for the cannula to come into contact with an internal organ (with the exception of the heart and lungs), Respondent pushed the cannula at an inappropriate angle through a thick layer of muscle called the abdominal wall. The tough abdominal wall has a noticeably different consistency than the soft layers of subcutaneous fat. A surgeon is required to operate with a level of skill and care to be able to discern between subcutaneous fat and muscle tissue while passing the cannula through the patient. The standard of care in Florida requires surgeons to use extreme care to ensure that the abdominal wall is not breeched. This is especially true when the patient's medical history suggests the possibility of a thin abdominal wall. According to both Petitioner's and Respondent's experts the perforation of an internal organ during a liposuction procedure, even once, is an extremely rare incident. In fact, Respondent's world-renowned BBL expert, Dr. Mendieta explained, "I'm constantly thinking bowel, bowel, bowel perforation or I'm constantly thinking trying to avoid, so it is constantly on my mind in terms of what I am trying to avoid, so I'm always angling my cannula and making sure that I'm on the right plane."2/ Dr. Mendieta admitted that although perforating an internal organ is a "known complication" related to liposuction, it can result from medical negligence. Respondent argues he is absolved of any responsibility for the puncture of internal organs because Patients D.M. and N.F. signed consent forms that included the risk of "damage to deeper structures, including nerves, blood vessels, muscles, and lungs." Significantly, the informed consent forms for liposuction signed by the patients did not include damage to the liver, small bowel, or other intra-abdominal organs. Petitioner's expert, Dr. Greenberg, explained that the language in the consent form does not contemplate damage to internal organs shielded by the abdominal wall, and a lay person would be unlikely to make such an inference. Dr. Greenberg credibly testified that it is a violation of the standard of care to damage a patient's internal organs during a liposuction procedure, regardless of whether it is a known complication. Dr. Mendieta countered that the only way for a surgeon to violate the standard of care would be to either intentionally stab the patient, or to perform the surgery in such a reckless and careless manner, improperly angling the cannula, that damage to the surrounding structures is either inevitable or purposeful. As noted by all three experts, absent being present during the procedure, having it well-documented in the Respondent's notes, or talking with Respondent, it is not possible to tell with certainty what transpired. Respondent refused to testify on his own behalf. Respondent asserted his Fifth Amendment Privilege against self-incrimination, instead of clarifying any of the disputed issues. Based on the forgoing, Petitioner demonstrated by clear and convincing evidence that the puncture of the patients' internal organs was the result of Respondent's violation of the standard of care and improper angling of the cannula during the procedures. Facts Related to the Alleged Medical Records Violation The circulators at Vanity, Encore, and Spectrum Aesthetics testified that they prepared the tumescent solution that Respondent used during his liposuction procedures at Respondent's direction. The circulators testified that when preparing the tumescent solution, they used enough epinephrine to create at least a 1:1,000,000 concentration of epinephrine. However, the additional epinephrine that was purportedly used was never documented in the patients' operating room records. Respondent argues that it was the responsibility of the circulators who prepared the solutions or the facilities at which he operated that maintain the records, which bear responsibility for the accuracy of the records. Respondent is the surgeon who performed the surgery on each patient. The operative records for each surgery bear the same signature in every signature block for "Surgeon Signature," "Physician Signature," "Osakatukei O. Omulepu, M.D.," and "Osak Omulepu, MD." In most instances, the signature is clearly legible as O.O. Omulepu. The record supports by clear and convincing evidence that Respondent signed or approved these records and bears responsibility for their accuracy. However, Respondent reviewed and signed the medical records, all of which omitted the additional ampule of epinephrine that was purportedly added, without correcting the apparent discrepancy.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding that Respondent violated sections 458.331(1)(t) and 458.331(1)(m), Florida Statutes, as charged in Petitioner's Second Amended Administrative Complaint; imposing a fine of $14,000.004/; issuing a reprimand against Petitioner for the record-keeping violations; placing Respondent on probation for a period of two years; and imposing costs of the investigation and prosecution of this case. DONE AND ENTERED this 6th day of January, 2017, in Tallahassee, Leon County, Florida. S MARY LI CREASY 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 Hearings this 6th day of January, 2017.
The Issue Whether disciplinary action should be taken against Respondent's license to practice as a physician, license number ME 0060427, based on violations of Sections 458.331(1)(j) Florida Statutes, by exercising influence within a patient-physician relationship for purposes of engaging a patient in sexual activity and Section 458.331(1)(x), Florida Statutes, by violating any provision of this Chapter, in that he violated Section 458.329, Florida Statutes, and Rule 59R-9.008, Florida Administrative Code, by committing sexual misconduct in the practice of medicine.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that Respondent be found guilty of violating Sections 458.331(1)(j) and (x), Florida Statutes as to Patients T.S. and A.A. As discipline therefore, it is FURTHER RECOMMENDED: Respondent's license be suspended for a period of one year, commencing December 12, 1994, with his reinstatement upon demonstration that he can practice with skill and safety and upon such conditions as the Board of Medicine shall deem just and proper. Respondent pay an Administrative fine in the amount of $6,000.00. Respondent be placed on probation for a period of three years. DONE and ENTERED this 9th day of May, 1995, in Tallahassee, Florida. DANIEL M. KILBRIDE Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 9th day of May, 1995. APPENDIX The following constitutes my specific rulings, in accordance with section 120.59, Florida Statutes, on proposed findings of fact submitted by the parties. Proposed findings of fact submitted by Petitioner. Accepted in substance: paragraphs 1, 2, 3, 4, 5, 6, 8, 9 (in part), 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 29 (in part), 30, 3, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 49, 50, 51, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88. Rejected as subsumed or irrelevant and immaterial: paragraphs 7, 9 (in part), 17 (in part), 28, 29 (in part), 59, 61, 65. Rejected as not proven by clear and convincing evidence: paragraphs 52, 53, 54, 55, 56, 57, 58, 60, 62, 63, 64, 66, 67. Proposed findings of fact submitted by Respondent. Accepted in substance: paragraphs 1, 2, 3, 4, 5, 6, (in part), 7, 8, (in part), 9, 10 (in part), 12, 18 (in part), 19 (in part), 20 (in part), 21 (in part), 22 (in part) 27 (in part), 31, 44 (in part), 46 (in part), 47 (in part), 48 (in part), 49 (in part), 53 (in part), 57 (in part), 58 (in part). Rejected as subsumed or irrelevant and immaterial: paragraphs 6 (in part), 8 (in part), 10 (in part), 13, 15, 16, 18 (in part), 20 (in part), 21 (in part), 23, 24, 25, 26, 28, 29, 30 (in part), 34, 35, 36, 38, 39, 43, 44 (in part), 50, 55, 57 (in part), 58 (in part). Rejected as a restatement or commentary on the evidence: paragraphs 11, 14, 17, 22 (in part), 23, 27 (in part), 29, 30, 34, 35, 36, 37, 48, 40, 41, 42, 44 (in part), 45, 46 (in part), 47 (in part), 48 (in part), 49 (in part), 50, 51, 52, 53 (in part), 54, 55, 56. Rejected as not supported by the evidence: 19 (in part), 20 (in part), 32 and 33. COPIES FURNISHED: William Frederick Whitson, Esquire Senior Attorney Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0792 Lee Sims Kniskern, Esquire 2121 Ponce de Leon Blvd. Suite 630 Coral Gables, Florida 33134 Dr. Marm Harris Executive Director Department of Business and Professional Regulation 1940 North Monore Street Tallahassee, Florida 32399-0792 Tom Wallace Assistant Director Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303
The Issue The issues are whether Respondent deviated from the applicable standard of care, failed to keep medical records justifying the course of treatment, improperly delegated professional responsibilities, or prescribed, dispensed or administered controlled substances other than in the course of his professional practice; and, if so, what penalty should be imposed.
Findings Of Fact Respondent is a licensed physician in Florida, holding license number 59702. He has been licensed in Florida since 1991. Respondent is Board-certified in obstetrics and gynecology. His last certification was in November 2009. Respondent received his bachelor of science degree from the University of North Carolina at Chapel Hill in 1978. He received his doctor of medicine degree from Meharry Medical College in Nashville in 1982. He performed a surgical internship from 1982-83 with the Madigan Army Medical Center in Tacoma, an obstetrics and gynecology residency from 1987-91 at the Harbor Hospital Center in Baltimore, and a maternal fetal medicine fellowship from 1991-93 at the University of South Florida. During the residency, Respondent completed a six-week rotation in the mental evaluation, diagnosis, and treatment of transgendered patients. The training took place on the campus of Johns Hopkins University, which was one of the first medical schools to offer training in the diagnosis and treatment of transgendered patients. During this rotation, Respondent assumed responsibility for the care of about 30 patients, a little over half transitioning from female to male. From 1991-93, Respondent performed obstetrics and gynecology at several medical facilities in Florida, Maine, and Missouri. From 1993-96, Respondent was the Chief of Perinatology, Healthy Start Program, at the D.C. General Hospital/Howard University in Washington. In 1996, Respondent started the Orlando Women's Center (OWC) in Orlando, which he still owns and operates. He opened a second women's clinic in Orlando the following year. Respondent also participated in the starting of women's clinics in Ocala in 1998, Fort Lauderdale in April 1999, and Tampa in October 1999. In October 1996, about six months after opening, OWC hired M. W. as a medical assistant. She had nearly completed the coursework to become a licensed practical nurse, but at no time material to this case was she ever a licensed health care provider. M. W. was employed by OWC until 1999. M. W. was a diligent employee. Her initial duties were answering the telephone and working in the lab. However, her enthusiasm, intelligence, dedication, and discretion earned M. W. a promotion. In January 1997, Respondent promoted M. W. to a trusted position in which she would care for patients undergoing abortions during the second trimester of pregnancy. Working conditions required M. W. to be on-call nearly all of the time, as certain patients demanded to be admitted during nights or weekends to preserve confidentiality. The work was stressful because some patients bore fetuses with abnormalities, and protestors regularly demonstrated outside the clinic. M. W.'s new duties allowed Respondent himself to observe her work and determine that M. W. had the psychological stability to perform her job well. M. W. demonstrated her trustworthiness by dealing with patients' valuables, opening and closing the clinic, ordering supplies and stocking five surgical rooms, and drawing controlled substances for administration by Respondent. At the end of 1997, Respondent promoted M. W. to ordering and stocking the clinic's medical supplies, which include controlled substances. For Schedule II drugs, which includes narcotics, and Schedule III drugs, which includes steroids, M. W. had to fill out a DEA Form 222, using Respondent's DEA number to place the order. When OWC received Schedule III drugs, M. W. matched the order with the shipment. She then recorded the information in the OWC drug log. M. W. would place the drugs in a locked cabinet, if they were not needed for immediate use in the clinic. After nearly one year of ordering supplies, toward the end of 1998, M. W. approached Respondent to discuss a personal matter. At this point, the material disputes between the parties emerge. Respondent testified that M. W. discussed with him the possibility of undergoing transgender therapy, as well as treatment for an injured shoulder. According to Petitioner, M. W. discussed with Respondent the possibility of using anabolic steroids to improve her bodybuilding and weightlifting. The parties do not dispute that M. W. had participated in bodybuilding and weightlifting for several years prior to her employment with OWC. The Administrative Law Judge credits Petitioner's version of the purpose of treatment. Respondent testified that M. W. told him that she had thought about changing genders for several years. She did not like or want her breasts. She did not like the shape of her hips and thighs. She had decided that she did not want children and did not want to undergo menstruation. Although M. W. may have told Respondent that she did not like her body shape, she did not tell him that she wanted to change into a man. As discussed below, M. W. is not available to confirm or deny Respondent's version of events, and Respondent does not have any medical records documenting his care and treatment of M. W. Assigning a secondary reason for the treatment--healing a long-injured shoulder--is an awkward fit with Respondent's version of events, given the unlikelihood that someone considering a decision as major as changing genders would bother assigning a secondary reason for the decision. This secondary reason for the treatment is a better fit with Petitioner's version of events, although treatment of an injured shoulder was, at most, a very minor factor in the steroid treatment because the reconstructed medical records, discussed below, mention strength and bodybuilding, not recovery from a shoulder injury. The most important reason to credit Petitioner's version of the purpose of the steroid treatment over Respondent's version is that Petitioner's version conforms to Respondent's initial description of the purpose of the treatment. In other words, this is not a case of Respondent's word against contrary inferences drawn by Petitioner; this is a case of Respondent's later word against Respondent's earlier word. The parties do not dispute that, after the initial meeting to discuss the personal matter, Respondent agreed to allow M. W. to order anabolic steroids using his DEA number and at the discounted price charged to OWC. The drugs that Respondent expressly allowed M. W. to order--and which he prescribed for her--were Winstrol and, a short while later, depo-testosterone. Respondent prescribed for M. W. Winstrol orally at the rate of 2 mg per day, increasing to 10 mg per day at the end of six weeks, and depo-testosterone by intramuscular injection, which Respondent administered initially at the rate of 50 mg every two weeks, increasing to 200 mg every two weeks. The parties do not contest that, in early summer 2009, M. W. ordered through OWC sufficient Winstrol and Deca-Durabolin for her weightlifting father and brother, with whom she lived, to complete one six-week bodybuilding cycle each with these two anabolic steroids. For her brother, the evidence establishes that M. W. ordered through OWC additional Winstrol and sufficient depo-testosterone for him to complete a second six- week cycle. The evidence is undisputed that M. W. administered the injections of Deca-Durabolin and depo-testosterone to her brother, Deca-Durabolin to her father, and Deca-Durabolin to herself. M. W. probably took additional Winstrol at home. The evidence is also clear that, in addition to ordering the Winstrol and depo-testosterone in quantities in excess of the amount that she was authorized to order and Deca-Durabolin without any authority whatsoever, M. W. also ordered--without authorization--Xanax, an anti-anxiety drug, and Soma, a muscle relaxant, possibly for her own use. Petitioner contends that Respondent knew or reasonably should have known of these unauthorized orders, but the evidence that Respondent knew is nonexistent, and the evidence that he should have known is insubstantial. There is little, if any, dispute that, unknown to Respondent, M. W. was using cocaine and heroin--by her own admission since early 1998. In late July 1999, Respondent was informed that M. W. had passed out at work. When Respondent spoke with her about this incident, M. W. admitted to the use of cocaine and heroin, most recently a couple of weeks earlier. Respondent immediately withdrew his authorization of M. W. to order supplies and medications for OWC and immediately discontinued further steroid treatment. Acting as M. W.'s employer, not physician, Respondent ordered M. W. to submit to a drug screen for Demerol, which had been missing from OWC,2 Valium, and cocaine. Three weeks later, he received the results, which were positive for cocaine. After giving M. W. an opportunity to discontinue illegal drug use, Respondent ordered M. W. to submit to another drug screen for Demerol, Valium, fentanyl, cocaine, and heroin, and the report, received in late August, was positive for cocaine and Valium. On September 22, 1999, M. W. was found dead in her home by her father. The first law enforcement officers responding to the 911 call reported that they had found a lifeless male dressed in woman's panties; this mistaken observation was based on M. W.'s muscularization and shadowy presence of facial hair. A homicide detective conducting an initial investigation found large quantities of syringes and prescription drugs, mostly steroids, in M. W.'s bedroom. He also found shipping labels and receipts with the names of OWC and Respondent. The parties have stipulated that the death was unrelated to steroid use. M. W.'s death was classified as a natural death. She was 30 years old. In resolving the major factual dispute--i.e., the purpose of the treatment--the Administrative Law Judge has assigned considerable weight to Respondent's earlier responses to law enforcement and regulatory inquiries. In these responses, Respondent never mentioned transgender treatment or gender identity disorder, but instead admitted that the treatment was to enhance athletic performance and to facilitate bodybuilding. In a written reconstruction of the medical records done prior to the commencement of this case, Respondent stated that he was "unable to locate [M. W.'s] chart so I will reconstruct her chart from memory. Last time chart was seen was June [19]99 which was given to [her]." The reconstructed chart shows three office visits: November 7, 1998, March 20, 1999, and June 26, 1999. None of the reconstructed notes mentions anything about lab work being ordered, the results of any lab work, or anything about an injured shoulder and whether it was healing. The entry for November 7 starts: "[Patient] request being placed on testosterone for body building. States she . . . is considering Pro-Wrestling." The notes indicate blood pressure of 118 over 64, pulse of 72, and nothing remarkable from a basic physical examination. The notes state: "Wants to body build; requests steroids." The notes report that Respondent prescribed Winstrol in 2 mg doses and explained the side effects, and Respondent was going to allow M. W. to order her steroid medication from the clinic's vendors. This entry concludes with a note for a followup visit in three months. The entry for March 20, 1999, states that M. W. had no complaints, reported getting stronger, and was happy with "bench," meaning bench-pressing, a form of weightlifting. This note states that M. W. denied experiencing any side-effects and wanted to add a second steroid: "Request to add Depo- Testosterone." The entry for June 26, 1999, notes that M. W. "feels good about herself and her outlook on life is much improved" and is "continuing to [increase] strength [with] weights." This note contains findings of a physical exam, including blood pressure of 124 over 78 and pulse of 72, and the note concludes that M. W. was doing well and Respondent planned to continue the same steroid regime. The other time that Respondent discussed the purpose of the treatment was when he was interviewed by a law enforcement officer on March 10, 2000, in the presence of Respondent's attorney. Respondent did not say anything about transgender treatment or gender identity disorder, and he was evasive when asked if he were M. W.'s physician. When asked if M. W. were ever a patient or just an employee, Respondent responded by referring to the incident when she passed out at work: "She now when you say she would ah the only time when she and I were upstairs that day. . . . And when she had the overdose." The law enforcement officer asked, "And that's like in August [1999]?" Respondent replied, "Yeah. The question was and I and I still haven't been able to define that because she asked me not to tell anybody about her problem with her drug habits and this type of scenario. So the question is whether or not she was a, whether or not honestly she was a patient of mine at that particular point in time."3 Shortly after this exchange, the law enforcement officer asked Respondent if the steroids that Respondent allowed M. W. to order through the OWC were for competitive purposes, such as weightlifting. Respondent replied, "we had a discussion about her wanting to . . . make it so that her, that she could work out harder because she was having some problems with her shoulders and these type of things "4 These reconstructed records and statements to a law enforcement officer were not casual statements uttered in an informal setting. This was information that Respondent provided to assist in the investigation of the circumstances surrounding the death of this 30-year-old woman. Except for mention of a shoulder injury in the last-cited statement--an effort by Respondent to convert the treatment objective from pure enhancement of athletic performance to a mix of enhancement of athletic performance and therapy for some undiagnosed shoulder injury--the information consistently implies that the treatment objective was to improve M. W.'s efforts in bodybuilding and weightlifting. And the mention of the shoulder injury suggests only that its healing was subordinate to the weightlifting and bodybuilding. The failure of the reconstructed records to contain any diagnostic information or progress reports on the injured shoulder precludes a finding that the treatment objective was to heal a shoulder injury. Respondent testified about the importance of confidentiality for his patients, especially M. W., as she was undergoing "gender transformation." But patient confidentiality is not an end in itself; it is a means to assuring that the patient will trust the physician with all relevant information necessary for diagnosis and treatment. Respondent implied that the requirement of patient confidentiality somehow trumped the duty not to affirmatively frustrate investigations into the death of his employee and patient. This makes no sense. Respondent's strained "explanation" for creating a misleading set of medical records yields to the simpler explanation that Respondent told the truth in these reconstructed records and in the police interview: Respondent was treating M. W. with steroids for bodybuilding and wrestling, not for gender transformation and not for an injured shoulder. These findings are supported by the fact that the first drug that Respondent prescribed M. W. was Winstrol. The anabolic effect of a steroid promotes muscularization, and the androgenic effect of a steroid promotes masculinization. Because Winstrol produces more anabolic than androgenic effect, it was long favored by females who wanted to produce muscle mass, such as for bodybuilding, without masculinization. Initiating treatment with Winstrol and following with depo- testosterone is a conventional example of the cyclical use of steroids for muscularization, not masculinization. One of Respondent's expert witnesses made an interesting observation based on the misidentification of the gender of the body of M. W. by the first responders. He testified that, if Respondent had been ordering the anabolic steroids for weightlifting and bodybuilding, M. W. must have been seriously dissatisfied with the masculinization that she had undergone. However, this observation overlooks the fact that M. W., without Respondent's knowledge, had administered to herself unknown quantities of the prescribed anabolic steroids and Deca-Durabolin. Like Winstrol, Deca-Durabolin is more anabolic, or muscle-making, than androgenic, or masculinizing-- which is consistent with M. W.'s intent to enhance her athletic performance and bodybuilding, not change her gender. Although the first responders observed some facial hair, in addition to muscularization, nothing in the record suggests that M. W. could take all of these anabolic steroids in unknown quantities without experiencing some masculinization, or that she expected no such masculinization side effects. Under these circumstances, M. W. could not legitimately have confronted Respondent over the incidental masculinization that she had experienced, while self-administered steroids whose main effect was muscularization, without running the risk that he would detect her unauthorized ordering of steroids. As noted above, there are no available medical records. Respondent testified that he gave M. W.'s medical chart and drug log "VIP" treatment to preserve confidentiality: Respondent allowed M. W. to keep her medical records and the drug log pertaining to her medications. Each time M. W. presented to Respondent, such as for an injection, she brought with her these files, according to Respondent. Petitioner contends that these records never existed, and, therefore, Respondent failed to document that he monitored the effects of the anabolic steroids that he ordered for M. W. The Administrative Law Judge credits Petitioner's version of the situation regarding medical records. At the hearing, Respondent characterized as a mere "sampling" the medical records that he had initially called a reconstruction. He implied that the reconstructed medical records were illustrative of what the records originally contained. This probably explains how he could reconstruct blood pressure readings of 118 over 64 and 126 over 78 taken six and nearly twelve months prior to the reconstruction of the records. Likely, he recalled that the values were normal and inserted these readings merely to illustrate his recollection. However, as noted above, these reconstructed records are significant for their omission of any similar illustrative reconstructions of an SBC for blood chemistry, SMAC 18 for electrolytes and kidney and liver function, and lipids for cholesterol and triglycerides. This lab work is essential, at the start of a course of treatment with anabolic steroids and periodically during treatment, to ensure the safety of any patient, especially when orally ingested anabolics--here, Winstrol--are administered, due to the possibility of liver damage. Respondent testified at the hearing that the lab results were normal, but, unlike his addition of illustrative, normal values for blood pressure and pulse, Respondent never added illustrative, normal values for this lab work. This is because he never ordered such lab work. These lab tests are common in a variety of circumstances, so they did not require the "VIP treatment" that Respondent claimed was required for the transgender treatment plan. However, Respondent never produced medical records or even lab paperwork, such as test results or invoices, documenting that these tests had been done. Also, if such records had existed and Respondent had allowed M. W. to keep them, one obvious place for them would have been in M. W.'s room at her home, but Respondent never sent anyone there to look for them after her death. As to the Standard of Care allegations, Petitioner has thus proved first, that Respondent prescribed steroids for M. W. both for muscle building (not to treat an injured muscle) and for enhancement of athletic performance; and, second, that Respondent did not order lab work to monitor the effects of the steroids that he prescribed for M. W. The evidence fails to establish that Respondent ever undertook the treatment of M. W.'s drug addiction (despite his statement to the contrary, which has been discredited). The evidence fails to establish the circumstances out of which a duty to treat could have arisen, especially within the brief time frame between Respondent's discovery of her drug problems and her death. Any evidence relevant to the remaining allegations within Count One involves the employer-employee relationship, not the physician-patient relationship, between Respondent and M. W. As to the medical records violation, Petitioner has proved that Respondent's medical records failed to adequately document the monitoring of the effects of anabolic steroids that Respondent prescribed for M. W. The evidence establishes the necessity of lab work, at the start and during steroid treatment, to ensure the safety of the patient. Without this lab work, documented in the medical records, the course of steroid treatment is not justified. The evidence fails to establish that Respondent delegated responsibilities to a person whom Respondent knew or reasonably should have known was not qualified by training, experience, or licensure to administered controlled substances to patients. Drug addiction is not a deficit in training, experience, or licensure. Even if drug addiction fell within one of these statutory categories, the evidence fails to establish any improprieties in M. W.'s administration of controlled substances to patients, and, even if the evidence proved such improprieties, the evidence fails to establish that Respondent knew of M. W.'s drug addiction at a point to have timely relieved her of her duties, or that Respondent reasonably should have known of M. W.'s drug addiction in time to do anything about it. To the contrary, Respondent's termination of these responsibilities of M. W. appears to have been timely. Petitioner has proved that Respondent prescribed and administered controlled substances--i.e., anabolic steroids--for muscle building, not the treatment of an injured muscle, and for enhanced athletic performance. Respondent has previously been disciplined. By Final Order entered on December 18, 2007, in DOAH Case No. 06-4288PL, the Board of Medicine imposed one year's suspension, a $10,000 fine, and three years' probation for failing to perform a third- trimester abortion in a hospital and failing to obtain the written certifications of two physicians of the necessity for the procedure; committing an associated medical-records violation; and committing a Standard of Care violation for failing to perform a third-trimester abortion in a hospital. Respondent's acts and omissions occurred in 2005. The Fifth District Court of Appeal affirmed the Final Order in Pendergraft v. Department of Health, Board of Medicine, 19 So. 3d 392 (Fla. 5th DCA 2009). By Final Order entered on January 28, 2010, in DOAH Case No. 08-4197PL, the Board of Medicine imposed two years' suspension, a $20,000 fine, and three years' probation for committing a Standard of Care violation for failing to a advise subsequent treating physicians that he had removed a portion of a patient's fetus and an associated medical-records violation. Respondent's acts and omissions occurred in 2006. Although Respondent has been disciplined prior to this recommended order, the acts and omissions in this case took place several years prior to the acts and omissions in the two cases described immediately above.
Recommendation It is RECOMMENDED that the Board of Medicine enter a Final Order finding Respondent guilty of violations of Section 458.331(1)(m), (t), and (q), Florida Statutes (1998), and suspending his license for one year followed by three years' probation, imposing a fine of $10,000, and assessing costs as provided by law. DONE AND ENTERED this 8th day of June, 2010, in Tallahassee, Leon County, Florida. ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 8th day of June, 2010.
The Issue Whether the Petitioner committed the violations alleged in the Administrative Complaint dated September 10, 2004, as amended by Order entered January 11, 2006, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: Parties The Department is the state agency responsible for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. See § 455.225, Fla. Stat. The Board is the entity responsible for regulating the practice of medicine in Florida and for imposing penalties on physicians found to have violated the provisions of Section 458.331(1), Florida Statutes. See § 458.331(2), Fla. Stat. Dr. Byrd is, and was at the times material to this proceeding, a physician licensed to practice medicine in Florida, having been issued license number ME 43323, and he is Board-certified in Family Practice. At the times material to this proceeding, Dr. Byrd conducted an office practice and saw approximately 20 patients each day, including those who had an appointment and those who walked in without an appointment. In addition to his private practice, Dr. Byrd was, at the times material to this proceeding, a full-time physician for the Brevard County Department of Corrections and was responsible for providing medical care for all prisoners in that system. Facts underlying charges in Administrative Complaint Patient J.S. was a patient of Dr. Byrd's from approximately 1999 until June 2001. Dr. Byrd treated Patient J.S. during that period primarily for general medical issues. Patient J.S.'s last visit to Dr. Byrd's office was June 11, 2001. The office visits material to this proceeding occurred on December 27, 2000; January 29, 2001; and June 11, 2001. Beginning when she was approximately 20-to-21 years of age, Patient J.S. routinely performed breast self-examinations once or twice a month. She performed a self-examination a few days before Christmas 2000, while she was visiting in New Jersey, and believed she felt a lump in her right breast. She drove home the day after Christmas and telephoned Dr. Byrd's office. She told the person she spoke with that she had found a lump in her breast. The record of Patient J.S.'s December 27, 2000, contact with Dr. Byrd's office was inserted into a form that had been completed for an office visit on November 15, 2000. The date "12.27.00" appears approximately mid-way down the page, with a diagonal line drawn underneath. Below the diagonal line was written "Mammo & ultrasound script given[.] Pt feels she may have a lump in Breast." What appear to be the initials "DS" are included beneath the notation, and the handwriting in this notation is that of Dr. Byrd's medical assistant. Dr. Byrd did not examine or speak to Patient J.S. on December 27, 2000, and he relied on the information conveyed to him by his medical assistant in making the decision to write a prescription for Patient J.S. to obtain an ultrasound and a mammogram.2 Dr. Byrd's staff scheduled an appointment with Boston Diagnostic Imaging for Patient J.S., and she had a bilateral film mammogram and an ultrasound of her right breast done on January 3, 2001.3 In the report of the January 3, 2001, bilateral mammography examination, which was dictated January 3, 2001, the radiologist stated: CLINICAL INDICATIONS: Diagnostic mammography. The patient reports a palpable abnormality within the upper outer quadrant of the right breast. This site was marked with triangular marker. FINDINGS: There is a 2 cm asymmetric area of parenchymal density within the upper outer quadrant of the right breast at the approximately 12 o'clock position. This appears fairly distant from the palpable marker. I would recommend additional cone compression views of the right breast at this time. Some small subcentimeter nodular parenchymal densities are scattered through both breasts. No discreet [sic] mass is noted underlying the region of palpable area of clinical concern. Any clinically suspicious palpable abnormality should be aspirated and biopsied. Some benign microcalcifications are noted bilaterally. * * * IMPRESSION: NUMEROUS SUBCENTIMETER NODULAR DENSITIES SCATTERED THROUGHOUT BOTH BREASTS. GIVEN THE MULTIPLICITY OF FINDINGS THESE ARE LIKELY BENIGN. I WOULD RECOMMEND COMPARISON WITH PRIOR MAMMOGRAPHIC STUDY TO DETERMINE STABILITY. ASYMMETRIC 2 CM NODULAR DENSITY LOCATED IN THE 12 O'CLOCK POSITION OF THE RIGHT BREAST POSTERIORLY. I WOULD RECOMMEND CORRELATION WITH PRIOR STUDY OR ADDITIONAL CONE COMPRESSION VIEWS OF THE RIGHT BREAST AT THIS TIME.[4] Dr. Byrd received a copy of this report from Boston Diagnostic Imaging, signed it, and made a notation on the report to "give ptn copy." He assumes that his staff followed his instructions and gave Patient J.S. a copy of the report, but Dr. Byrd does not recall discussing this report with Patient J.S. The report of the January 3, 2001, bilateral mammography examination showed an abnormality in Patient J.S.'s right breast. Dr. Byrd did not, however, order a cone compression view of the right breast or any other diagnostic test as a result of the report. Rather, Dr. Byrd waited for the Boston Diagnostic Imaging radiologist to do a comparison study of the January 3, 2001, mammography results and the results of any prior mammographic study that the radiologist might locate. A second report of the results of the January 3, 2001, examinations was issued by Boston Diagnostic Imaging, the substance of which is a more comprehensive report of the results of the ultrasound examination of Patient J.S.'s right breast.5 In this second report, which was captioned "Bilateral Film Mammography" and dictated on or about January 5, 2001, the radiologist stated: CLINICAL INDICATIONS: Diagnostic breast ultrasound. Palpable lesion in the upper outer quadrant of right breast. FINDINGS: Sonographic evaluation of the 9-12 o'clock position of the right breast was performed at the site of the patient's reported palpable abnormality. At the 10-11 o'clock position in the right breast at the patient's site of reported abnormality, no discrete solid or cystic nodules are noted by ultrasound. There are two small hypoechoic solid nodules noted at the 12 o'clock position of the right breast measuring 8 x 6 mm. in aggregate size. This is nonspecific and may represent small fibroid adenomas. No dominant solid or cystic nodules are noted by ultrasound in the 12 o'clock position of the right breast to correspond to 2 cm. asymmetric parenchyma density noted on the mammography. Recommend additional cone compression views of the right breast at this time.[6] No simple cyst is noted within the upper outer quadrant. IMPRESSION: TWO SMALL SUBCENTIMETER HYPOECHOIC NODULES NOTED AT THE 12 O'CLOCK POSITION IN THE RIGHT BREAST. THIS IS FAIRLY DISTANT FROM THE REGION OF THE PATIENT'S PALPABLE ABNORMALITY. CONSIDER SHORT TERM FOLLOWUP EXAMINATION. CONSIDER FOLLOWUP RIGHT BREAST ULTRASOUND EXAMINATION IN 6 MONTHS TO EVALUATE FOR STABILITY. NO DISCRETE SOLID OR CYSTIC NODULE IS NOTED IN THE 9-11 O'CLOCK [POSITION] IN THE RIGHT BREAST AT THE SITE OF THE PATIENT'S REPORTED PALPABLE ABNORMALITY. ANY CLINICALLY SUSPICIOUS PALPABLE ABNORMALITY SHOULD BE ASPIRATED BY BIOPSY. NO DOMINANT 2 CM. SOLID OR CYSTIC MASS IS NOTED AT THE 12 O'CLOCK POSITION OF THE RIGHT BREAST BY ULTRASOUND. A "Corrected Copy" of the second report contained the following changes: (1) The heading of the corrected report was changed to "RIGHT BREAST ULTRASOUND" examination; (2) the corrected report stated that the technique involved "[u]sing hand-held sonographic technique, breast was scanned"; and (3) the corrected report indicated that the results of the test were compared with the bilateral mammography of January 3, 2001. In all other respects, the "Corrected Copy" of the report was identical to the second report.7 Dr. Byrd did not receive the Corrected Copy of the report of the ultrasound examination of the right breast. He did, however, receive a copy of the second report. Dr. Byrd signed his copy of the second report, and made the following notation: "Patient aware to follow up in six months with ultrasound." Dr. Byrd did not recall speaking with Patient J.S. about the second report, but he assumed from this note that he did speak with her, probably by telephone. Dr. Byrd did not order a cone compression view of Patient J.S.'s right breast, nor did he schedule a short-term follow-up examination. Boston Diagnostic Imaging issued a fourth report, dictated on January 16, 2001, which was entitled an "Addendum" to the report of Patient J.S.'s January 3, 2001, bilateral mammography examination.8 In the Addendum, the radiologist stated: FINDINGS: Study done here 01/03/01 is compared with exam of 03/02/95. Multiple nodular densities were noted on the previous study. Now that old films available, three area[s] of densities, two in left breast and one in the right breast, are significantly larger than they were then. Ultrasound is recommended for further evaluation. The largest of these is on the right [breast] at 12 o'clock and measures 2 cm. Second of these is in the left breast, slightly superior and slightly lateral to the nipple and contains a single calcification. It is probably 1 cm in maximal diameter and these two side by side lesions are seen on the oblique lateral view of left breast superior aspect. One of these twin densities lies medial to the nipple and measures approximately 14 mm while the other of these twin lesions probably lies slightly lateral to the nipple. No skin thickening, nipple retraction, hypervasculature or microcalcifications can be seen. IMPRESSION: 1. BILATERAL BREAST ULTRASOUND IS RECOMMENDED TO EVALUATE A 2 CM LESION AT 12 0'CLOCK IN RIGHT BREAST AND TO EVALUATE THREE NODULAR MASSES IN LEFT BREAST, ALL OF WHICH ARE SLIGHTLY LARGER IN SIZE THAN THEY WERE ON THE 03/02/95 STUDY. ULTRASOUND SHOULD BE DONE AS SOON AS CAN BE SCHEDULED. Dr. Byrd received and reviewed this Addendum report, circled "BILATERAL BREAST ULTRASOUND IS RECOMMENDED," signed and noted "Done" on the first page of the report. Dr. Byrd did not discuss the results of the Addendum report with Patient J.S., did not schedule a follow-up appointment to discuss the report, and did not give Patient J.S. a copy of this report. Dr. Byrd felt that it was sufficient that he intended to order an ultrasound examination of Patient J.S.'s left breast. Patient J.S. called Dr. Byrd's office and scheduled a follow-up appointment for January 29, 2001. She believed that the lump in her right breast was getting bigger. Dr. Byrd saw Patient J.S. during an office visit on January 29, 2001, at which time he did a physical examination and an examination of her breasts. He was unable to find a lump in her right breast, which caused him to question whether Patient J.S. did, in fact, feel a lump. He noted that he found cystic structures in Patient J.S.' left breast. Dr. Byrd also noted in the medical record of the January 29, 2001, office visit the plan to refer Patient J.S. for another ultrasound. Dr. Byrd did not, however, order a bilateral breast ultrasound as the radiologist recommended in the Addendum report; rather, he ordered only an ultrasound examination of Patient J.S.'s left breast because an ultrasound examination of the right breast had been done on January 3, 2001, and Dr. Byrd felt that no new information would be obtained from another ultrasound examination of Patient J.S.'s right breast. Dr. Byrd was also concerned that Patient J.S.'s insurance company might not pay for another ultrasound examination of her right breast and that she would have to pay for the examination. Dr. Byrd did not include in the medical record of Patient J.S.'s January 29, 2001, office visit a notation that he performed an examination of Patient J.S.'s breasts. According to Dr. Byrd, one can infer that he examined Patient J.S.'s breasts from the notation on the record that he detected cystic structures on her left breast and from the fact that Patient J.S.'s complaint was noted on the medical record as pain in her right breast. The only notation on the medical record regarding Patient J.S.'s complaint of a lump in her right breast was "Large mass ?". There is no mention in the medical records of the January 29, 2001, office visit that Dr. Byrd discussed with Patient J.S. the results of the mammogram, ultrasound of the right breast, or the addendum to the mammogram. Dr. Byrd did not recall Patient J.S. requesting at the January 29, 2001, office visit a referral for a biopsy, but he did recall that Patient J.S. was very anxious about what she perceived as a lump in her right breast. Even though he could not palpate a lump in the location indicated by Patient J.S., in light of the suspicions in the report of the January 3, 2001, mammogram examination of the right breast and in the addendum to this report, Dr. Byrd would "probably" have referred her for a biopsy on January 29, 2001, if she had asked him to do so. In Dr. Byrd's opinion, however, there was no clinical indication in his physical examination of Patient J.S.'s breasts on January 29, 2001, or in the reports of the mammography examination and addendum or in the ultrasound examination of her right breast to indicate that he should refer Patient J.S. for a biopsy of her right breast. The ultrasound examination of Patient J.S.'s left breast was done by Boston Diagnostic Imaging on March 7, 2001, and the report was dictated on March 9, 2001. According to the report, the ultrasound examination of Patient J.S.'s left breast correlated with the results of the mammography examination and showed multiple cystic regions in Patient J.S.'s left breast, ranging in size from 1 mm to 3 mm. in diameter. The radiologist noted that the cysts were benign. Dr. Byrd received and initialed the report of the March 7, 2001, ultrasound, but he did not discuss the results of the ultrasound with Patient J.S. Patient J.S. became concerned because the lump she felt in her right breast was getting bigger, and she called Dr. Byrd's office and scheduled another office visit for June 11, 2001. When she called to make the appointment, she told Dr. Byrd's nurse that the lump was getting bigger. Dr. Byrd did not examine Patient J.S. during the June 11, 2001, office visit. Rather, Patient J.S. was seen by Dr. Byrd's physician's assistant, who noted on the medical record of the office visit that "Pt wants referral for breast Bx." Dr. Byrd's physician's assistant did not examine Patient J.S.'s breasts during the June 11, 2001, office visit, but Dr. Byrd, when he reviewed the physician's assistants notes of the June 11, 2001, office visit, approved a referral to a general surgeon for a breast biopsy. Patient J.S. called Dr. Jeffrey Smith on Dr. Byrd's referral. Dr. Smith advised Patient J.S. to get an updated mammogram and ultrasound examination of her right breast. Before she obtained these tests, however, Dr. Smith performed a core needle biopsy of the mass in her right breast that produced a finding that the mass was benign. Mammography and ultrasound examinations of Patient J.S.'s right breast were performed at Boston Diagnostic Imaging on July 13, 2001, and both the mammogram and ultrasound indicated a mass in the upper outer quadrant of Patient J.S.'s right breast, at the 11:00 o'clock position, that was "highly suggestive of malignancy." The radiologist called his report in to Dr. Smith and strongly recommended a biopsy. Dr. Smith performed a lumpectomy that produced a finding that the mass was malignant. Patient J.S. had a mastectomy of her right breast, followed by chemotherapy. Standard of Care Dr. Byrd was required to practice medicine in his care of Patient J.S. with "that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances." Based on the credited opinions of George Wilson, M.D., Dr. Byrd's treatment and care of Patient J.S., violated the standard of care for the following reasons. Even though a family practice physician is justified in relying on the findings, impressions, and recommendations of a radiologist, the standard of care applicable to family practice physicians under the circumstances presented in this case requires the physician to assess all of the information available to him or her and to refer the patient for further evaluation if medically indicated. Specifically, when a female patient presents with a complaint that she has felt, or even has possibly felt, a lump in her breast, the standard of care requires a family practice physician to rule out a malignancy. In this case, at the time of Patient J.S.'s January 29, 2001, office visit, Dr. Byrd had available the information that Patient J.S. believed that she had detected a lump in her right breast and that she was experiencing pain in her right breast; the report of the January 3, 2001, bilateral mammography examination, in which the radiologist reported an abnormality in the form of an "asymmetric 2 cm nodular density located in the 12 o'clock position of the right breast posteriorly," the general area in which Patient J.S. had reported feeling a lump; and the Addendum report dictated on or about January 15, 2001, in which the radiologist reported that a comparison of the January 3, 2001, mammography examination and a 1995 mammography examination showed that the two-centimeter mass in Patient J.S.'s right breast, as well as two "densities" in her left breast, were either "significantly" or "slightly" larger than they were in 1995. Even though it was reasonable for Dr. Byrd to rely on the recommendations of the radiologist, there were inconsistencies in the recommendations included in the "FINDINGS" and "IMPRESSIONS" sections of the reports, though not in the substantive observations, of the radiologist's reports of the January 3, 2001, ultrasound and mammography examinations, as well as in the Addendum report. Dr. Byrd did not, however, contact the radiologist to clarify any of these inconsistencies when formulating his treatment plan for Patient J.S. Nonetheless, the information available to Dr. Byrd in late January 2001, taken together, was sufficient to warrant the referral of Patient J.S. for further evaluation of her right breast, either to a radiologist for a mammography cone compression view focusing on the area in which the two centimeter mass appeared or to a general surgeon for a biopsy of the two centimeter mass. The evidence presented clearly and convincingly establishes that Dr. Byrd violated the standard of care applicable to family practice physicians under similar circumstances as those presented in this case because he failed to refer Patient J.S. for further evaluation of her right breast on the basis of her complaint and of the substantive information included in the mammography reports. Dr. Byrd's care and treatment of Patient J.S. did meet the standard of care in the following respects, again based on the credited testimony of Dr. Wilson: Dr. Byrd's referral of Patient J.S. to Boston Diagnostic Imaging for bilateral mammography and an ultrasound examination of the right breast after her contact with his office on December 27, 2000, was consistent with the standard of care for family practice physicians under the circumstances. Likewise, Dr. Byrd did not deviate from the standard of care by making this referral without having conducted an examination of Patient J.S. and prior to referring Patient J.S. to a general surgeon for a biopsy. Finally, Dr. Byrd's failure to diagnose Patient J.S. as having a malignant mass in her right breast did not constitute a deviation from the standard of care applicable to family practice physicians because, under the applicable standard of care, a family practice physician is not expected to make such a diagnosis. Medical Records The medical record of Patient J.S.'s contact with Dr. Byrd's office on December 27, 2001, does not meet Florida's standards for medical records. The entry for December 27, 2000, when Patient J.S. contacted Dr. Byrd's office complaining that she felt a lump in her right breast, was included only as a note inserted in the medical record of an office visit on November 15, 2000. Although the note indicates that Patient J.S. was given a prescription for a mammogram and ultrasound, it cannot be determined from the note whether Patient J.S. visited Dr. Byrd's office on December 27, 2000; who she communicated with regarding her complaint; or whether she was examined or by whom.9 Although Dr. Byrd made a notation on the report of the January 3, 2001, bilateral mammography examination issued by Boston Diagnostic Imaging that Patient J.S. should be given a copy of the report, there is nothing in the medical records submitted into evidence documenting the actual transmittal of the report to Patient J.S. Similarly, although Dr. Byrd made a notation on the second report, which was misidentified as a report of the bilateral mammography examination, that Patient J.S. was "aware" that she should follow-up with an ultrasound examination in six months, there is nothing in the medical records submitted into evidence documenting how, when, and by whom Patient J.S. was made "aware" of the need for a follow-up examination or any instructions that were given to Patient J.S. for follow-up. The medical record maintained by Dr. Byrd of Patient J.S.'s office visit on January 29, 2001, does not meet Florida's standards for medical records: Portions of the medical record are illegible. There is no clear indication that Dr. Byrd conducted a breast examination during that office visit. Rather, Dr. Byrd testified that it must be inferred from the notations in the medical record that he did an examination of Patient J.S.'s right and left breasts. There is no indication in the medical record of the results of an examination of Patient J.S.'s right breast. The marks in the boxes by which the results of the "Health Examination" are recorded are sloppy; it is difficult to determine whether Dr. Byrd examined Patient J.S.'s "chest/lungs" or "heart" or both and whether the results were normal or abnormal; and Dr. Byrd admittedly erroneously indicated by a checkmark that he had examined Patient J.S.'s "genitals and anus" and that the results were abnormal. Dr. Byrd's assessment of Patient J.S.'s condition at the January 29, 2001, office visit was "mastodynia," or pain in the breast, which merely confirmed Patient J.S.'s complaint, and there is no data in the medical record to support the assessment. There is no indication in the medical record that Dr. Byrd explored the possible cause of the breast pain by questioning Patient J.S. or by examination. Finally, there is no indication in the medical record for the January 29, 2001, office visit that Dr. Byrd discussed with Patient J.S. the results of the bilateral mammography examination, of the ultrasound examination of her right breast, or of the results of the comparison of the 1995 and 2001 mammography examination results. Prior disciplinary history Two previous disciplinary actions have been filed against Dr. Byrd. In both cases, the actions were resolved without resort to an administrative hearing. The first action arose out of an Administrative Complaint in which Dr. Byrd was charged with having failed to practice medicine within the acceptable level of care; with failing to maintain appropriate medical records; with having inappropriately prescribed medication to a patient; and with delegating professional responsibilities to a person not qualified to perform the duties. A Final Order was entered on January 7, 1999, as a result of a Consent Order in which Dr. Byrd neither admitted nor denied the facts alleged in the Administrative Complaint. The Board reduced the fine specified in the Consent Order to $1,000.00; deleted in toto the suspension set forth in the Consent Order; and adopted the requirements in the Consent Order that Dr. Byrd attend a drug course and a medical records course and undergo a quality assurance review. The second action arose out of an Administrative Complaint in which Dr. Byrd was charged with having failed to comply with the 1999 Final Order. A Final Order was entered in the second action on December 13, 2000, as a result of a Consent Order in which Dr. Byrd neither admitted nor denied the facts alleged in the Administrative Complaint. The Board adopted the Consent Order in toto and required Dr. Byrd to appear before the Board and pay investigative costs in the amount of $415.96.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding the Bill Byrd, M.D., is guilty of having violated Section 458.331(1)(m) and (t), Florida Statutes, and Issuing a reprimand to Dr. Byrd; Imposing an administrative fine in the amount of $12,000.00; Placing Dr. Byrd on probation for a period of two years under such terms and conditions as the Board shall deem appropriate; and Requiring Dr. Byrd to complete a medical records course approved by the Board. DONE AND ENTERED this 9th day of June, 2006, in Tallahassee, Leon County, Florida. S PATRICIA M. HART Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 9th day of June, 2006.
Findings Of Fact Respondent Anila Poonai began her medical education in her native land, India, and, in 1960, she received a medical degree from Bombay University. After an internship in Bombay, she spent three months in training in the United Kingdom, before travelling to Georgetown, Guyana, to become a resident medical officer at the public hospital there. After two years in Guyana, she returned to England where, in 1964, she passed a post-graduate examination. As a result of a residency in obstetrics and gynecology and a satisfactory showing on the requisite examinations, she became a member, in 1969, of the Royal College of Obstetrics and Gynecology. All told, respondent has spent six years as a resident in obstetrics and gynecology. From England, she travelled to the University of the West Indies in Kingston, Jamaica. At the University of the West Indies, she was senior registrar in obstetrics and gynecology and, for six months, acting lecturer in obstetrics and gynecology. In 1973, she and her husband, who is a general surgeon, moved to Cleveland, Ohio. Respondent has not sought certification by the American College of Obstetrics and Gynecology. She testified that the American College of Obstetrics and Gynecology recognized her membership in the Royal College of Obstetrics and Gynecology as an equivalent certification. Until moving to Port St. Joe, she worked as a house physician in St. Alexis and Hillcrest hospitals in Cleveland. Respondent and her husband moved to Florida at the invitation of the Board of Trustees of the Municipal Hospital of Port St. Joe. The Board wanted to upgrade the Hospital. Almost from the time of their arrival, respondent and her husband found themselves at the center of controversy. Respondent's husband testified that, when he and respondent began work at the Municipal Hospital of Port St. Joe, in August of 1976, norms of practice at the Hospital were "miles below standard" and that the medicine practiced by other physicians in the community was "about 25 years" out of date. Whether true or false, this view, and its blunt articulation, may account for the friction respondent and her husband experienced in their relationships with some of the nurses and physicians with whom they came into contact. Being the only such specialist on the staff, respondent was named chief of obstetrics and gynecology at the Municipal Hospital of Port St. Joe. In this capacity, she ordered drugs and other obstetric and gynecologic supplies for the Hospital. Chief of staff at the Hospital, from 1961, until the spring of 1977, was John Wayne Hendrix, who has practiced medicine in Port St. Joe for some three decades. During Dr. Hendrix' tenure as chief of staff, Dr. Orr of Wewahitchka, a general practitioner, was granted "courtesy privileges" at the Municipal Hospital of Port St. Joe. At all pertinent times, Hospital bylaws forbade a physician to whom only courtesy privileges had been granted, to attend a delivery, except under the supervision of the chief of obstetrics and gynecology. On March 27, 1977, in violation of the Hospital's bylaws, Dr. Orr attempted, for the first and only time, to deliver a baby in the Municipal Hospital of Port St. Joe. When Gloria Pippin, R.N., arrived to begin the 3 to 11 shift, Dr. Orr's patient was already in labor. At 9:30 that night, the patient's cervix was fully dilated; at 9:45 she was taken to the delivery room. At 11:00 Dr. Orr "did a saddle block," i.e., he administered a spinal anesthetic. Five minutes later he had finished an episiotomy. At quarter past eleven, he used Tucker-McClain forceps in an effort to extract the baby. That failing, he tried long Simpson forcens at 11:25 and Kielland forceps at ten minutes before midnight, March 27, 1977. The baby's head was too big for the mother's pelvis. Five minutes later, Ms. Pippin telephoned respondent, at Dr. Orr's request. Respondent expressed dismay that Dr. Orr had been permitted to begin, and asked Ms. Pippin to notify Dr. Hendrix of the situation. She herself telephoned Gerald Sullivan, the chairman of the Hospital's Board of Trustees. Afterwards, she and her husband, Dr. Parmanand Vijay Poonai, went to the Hospital. They arrived at approximately 12:40. Dr. Hendrix, who had considerable experience in performing Ceasarean sections, preceded them to the Hospital. By the time the Drs. Poonai reached the hospital, arrangements had been made for Dr. Orr's patient to be transferred to Panama City's Bay Memorial Hospital. At quarter past midnight, when Dr. Hendrix arrived at the hospital, the mother's blood pressure was 134/78. Ten minutes before she left in the ambulance, her blood pressure was 137/98 and her pulse was 112. At that time, the fetal pulse was 156. At 1:20 a.m., an ambulance left the Municipal Hospital of Port St. Joe for Panama City. When they reached Bay Memorial Hospital, the mother's vital signs and the infant's heart beat were within normal limits. Dr. Stephen Smith, the obstetrician who performed a Caesarean section upon the patient's arrival in Panama City, was the man of the hour. Mother and baby did well. For many years, it has been common to send women in labor to Panama City from Port St. Joe, and hundreds have made the trip. It takes a half hour to an hour to drive from the Port St. Joe hospital to the Panama City hospital. The longer a woman in the condition Dr. Orr's patient was in continues in labor, the greater are the chances of injury or death to the fetus and even to the mother. At no time did Dr. Hendrix telephone respondent on the night of the 27th or morning of the 28th. Neither Dr. Hendrix nor Dr. Orr ever asked respondent for assistance with Dr. Orr's patient. When respondent and her husband arrived at the Hospital early on the morning of March 28, 1977, neither Dr. Hendrix nor Dr. Orr spoke to either of them. Dr. Hendrix refused to speak to them, even though respondent addressed him and asked him specifically about Dr. Orr's patient. Both respondent and her husband remained at the Hospital until after the ambulance left for Panama City. It is unethical for one physician to intervene in the care of a patient whose treatment is being actively managed by another physician, unless requested. It may also be dangerous. On January 16, 1978, Dr. P. V. Poonai saw Beverly R. Bass in his office. Ms. Bass, who was born on December 15, 1951, told Dr. P. V. Poonai that a Dr. Vasquez of Port St. Joe (of whose wife Ms. Bass was a cousin) and other physicians had recommended a hysterectomy; that she had been passing blood clots for the preceding four months; that she had epigastric pain; that her most recent menstrual period was December 19, 1977; that she had two daughters and a son by three different men; that she wanted no more children; and that she wanted a hysterectomy both to prevent conception and to stop her bleeding. After examining her and finding an ovarian cyst and a slightly bulky uterus, Dr. P. V. Poonai prescribed hospitalization for a series of gastrointestinal X-rays to investigate the possibility of an ulcer, and for an obstetric and gynecologic consultation with respondent. On January 18, 1978, Ms. Bass entered the Municipal Hospital of Port St. Joe. An electrocardiogram was done. Dr. J. B. Harbison prepared a report of the X-rays taken as prescribed by Dr. P. V. Poonai. Respondent met Ms. Bass for the first time, in the Hospital, on January 19, 1978. She took Ms. Bass' history and examined her under general anesthesia, finding a left ovarian cyst, a normal cervix and a bulky anteverted uterus. Respondent recommended a dilatation and curettage (d & c) for diagnostic and therapeutic purposes, and, on the same day, Ms. Bass signed a form consent to diagnostic and treatment procedures authorizing respondent to perform a d & c. The following day, January 20, 1978, respondent did perform a routine d & c. Afterwards, the curettings resulting from the procedure were transmitted to a pathologist. After examining this material, the pathologist prepared a tissue report, and stated, as the pathological diagnosis: SECRETORY PHASE, DYSFUNCTIONAL BLEEDING. NO EVIDENCE OF POLYPS, PREGNANCY OR MALIGNANCY OBSERVED IN THE SPECIMEN SUBMITTED. FRAGMENT OF ENDOCERVIX WITH SQUAMOUS METAPLASIA, ACUTE AND CHRONIC INFLAMATION. Petitioner's exhibit No. 2. On January 21, 1978, Ms. Bass left the hospital, with a final diagnosis of dysfunctional bleeding. Before discharging Ms. Bass, respondent instructed her to refrain from sexual intercourse and from douches for four to six weeks. Eight to ten days after her discharge, Ms. Bass resumed sexual intercourse. On February 2, 1978, respondent saw Ms. Bass at her office and discussed the pathologist's tissue report with her. She related to Ms. Bass her clinical impression of uterine fibroids and prescribed Orthonovum, a birth control pill, as an additional means of forestalling dysfunctional bleeding. On February 2, Ms. Bass reported no bleeding subsequent to the d & c. Respondent did not ask and Ms. Bass did not volunteer that she had failed to follow instructions to abstain from sexual intercourse. Although the birth control pills respondent prescribed were to be taken daily, Ms. Bass did not take one every day. Respondent next saw Ms. Bass on February 13, 1978, when her only complaint was of an upper respiratory tract infection. On March 4, 1978, Ms. Bass returned to respondent's office complaining of heavy breakthrough bleeding, and reported that she was passing blood clots. Respondent examined her and suggested a hysterectomy. Ms. Bass asked if she could enter the hospital on March 12, 1978, saying she could make arrangements for her children by then. Respondent administered no pregnancy test to Ms. Bass on March 4, 1978, or at any time thereafter. She thought none was necessary because she believed that Ms. Bass had followed her instructions. Respondent does not knowingly perform abortions, even for therapeutic purposes, on account of religious scruples. A d & c elicits inflamatory responses hostile to fertilization. Even when a pregnancy has begun, no pregnancy test will be positive before 41 days have elapsed since the last menstrual period. Some hospitals, like Jackson Memorial in Miami, require pregnancy tests before surgery as a matter of routine, but the Municipal Hospital of Port St. Joe had no such policy. On March 12, 1978, Ms. Bass was admitted to the Municipal Hospital of Port St. Joe. The following day respondent performed a hysterectomy and an incidental appendectomy. An appendectomy ordinarily accompanies this procedure. Respondent's pre-operative diagnosis was "menorrhagia and fibroid uterus," and her postoperative diagnosis, on March 13, 1978, was unchanged. This was the same condition specified on the form consent to diagnostic and treatment procedures which Ms. Bass signed on March 12, 1978, authorizing respondent to perform a hysterectomy. Ordinarily, a surgeon performing a hysterectomy removes the uterus intact, as respondent did in the case of Beverly Bass. After its removal but while still intact, Ms. Bass' uterus yielded no additional information pertinent to the diagnosis of her condition. The uterus was sent to a pathologist. After examining the uterus, the pathologist prepared a tissue report and stated, as the pathological diagnosis: APPENDIX WITH FIBROUS OBLITERATION (DISTAL) AND FOCAL FIBROUS ADHESIONS. LUTEAL CYST OF LEFT OVARY, BENIGN. PARATUBAL CYST, BENIGN, RIGHT. ENLARGED UTERUS (205 GMS) WITH: ENDOMETRIUM: CHANGES RELATED TO PREGNANCY (HYPERSECRETORY GLANDS AND DECIDUAL REACTION). ACUTE ENDOMETRITIS. ANGULAR IMPLANT OF PLACENTA ASSOCIATED WITH UNDERLYING NECROSIS AND ACUTE INFLAMMATION OF DECIDUA, ACCOMPANIED BY HEMATOMAS. CHORION-AMNIONITIS, ACUTE, NECROTISING ASSOCIATED WITH NECROSIS OF GROUPS OF CHORION VILLI. EMBRYO, APPROXIMATELY 4-6 WEEKS OLD. FLUID BLOOD PRESENT IN UTERINE CAVITY. MYOMETRIUM: HYPERTROPHY (FUNCTIONAL). CERVIX: ACUTE AND CHRONIC CERVICITIS ASSOCIATED WITH SQUAMOUS METAPLASIA OF THE ENDOCERVICAL LINING, FOCAL. SQUAMOUS CELL HYPERPLASIA OF ECTOCERVIX, BENIGN. MUCUS CYSTS. When the pathologist opened the uterus, he found an enlarged cavity partly occupied by a ruptured ovisac. Extruded through the perforation, hanging outside of the ovisac from the umbilical cord, was an embryo 1.8 centimeters long. The placenta, which was acutely inflamed, adhered to the fundus at a right angle. Uterine rupture is inevitable if an angular pregnancy continues, but it is possible for an angular pregnancy to go to term, just as it is possible for a fetus to live after the ovisac has burst. In Ms. Bass' case, however, the embryo was probably non-viable at the time of the hysterectomy. The pathologist's report arrived while Ms. Bass was still in the hospital. Because respondent was upset on reading it, she asked Dr. P. V. Poonai to tell Ms. Bass what the pathologist had learned. Dr. P. V. Poonai did tell Ms. Bass, at which time she confirmed that she had engaged in sexual intercourse shortly after the d & c. Confusing an incipient pregnancy with a fibroid uterus is an occasional mistake any physician could make. An isolated mistake of this kind does not constitute a deviation from acceptable medical practice. The most conservative approach is to wait for two months after the patient has stopped taking birth control pills, before performing a "semi-elective" procedure, and to administer a pregnancy test beforehand. Several physicians testified, however, that they would not have ordered a pregnancy test before performing a hysterectomy in the circumstances of Ms. Bass' case. Respondent did not prepare the summary sheet at the end of Ms. Bass' stay after her March 12, 1978, admission, Chart No. 23622. Petitioner's exhibit No. 2A. The summary sheet that was prepared is not signed by anybody. When respondent asked for the chart in order to prepare a summary sheet, the Hospital's records custodian advised her that it was not with the other charts. When Beverly D. Stover was about three and a half months pregnant, she began seeing respondent. She saw her every month until November, when she began seeing her every two weeks. On her first visit, she told respondent she wanted to be sterilized after the birth of the child she was carrying, her second. At respondent's request, Mrs. Stover brought her husband to respondent's office, about six weeks before the baby was born. The three of them discussed Mrs. Stover's planned sterilization. On November 22, 1977, both Mr. and Mrs. Stover signed a form request for sterilization witnessed by two persons who were not called to testify at the hearing. On November 30, 1977, Mrs. Stover was admitted to the Municipal Hospital of Port St. Joe. On the day of her admission, she signed a form consent to diagnostic and treatment procedures authorizing respondent to perform a bilateral tubal transection and ligation, and both she and her husband signed another form request for sterilization. At the time of the signing of the last two documents, Mrs. Stover told Sarah Maddux, the nurse who gave her the forms to sign, that she did not want to be sterilized unless her baby was normal. Ms. Maddux never relayed this oral reservation to respondent. It is impossible to tell, at the time of birth, whether an infant has a sense of smell, whether it is intellectually impaired, or whether it can see or hear. At 1:50 on the afternoon of November 30, 1977, Mrs. Stover was delivered of a daughter, Katrina. Respondent examined the eight pound two ounce infant for two minutes. She put her fingers in the infant's mouth, cleared a passage for air, and checked for a cleft palate. The child started crying. Respondent observed good muscle tone. Respondent clamped, then cut the umbilical cord. She inspected the baby all over, noticed puffiness on the child's back, which she attributed to the trauma of birth, and noticed that the baby's anal opening was smaller than normal, but was not alarmed. She thought she had seen even smaller such openings which had not affected function. Respondent placed Katrina on her mother's stomach, and asked Mrs. Stover whether she was ready for surgery. When Mrs. Stover answered affirmatively, at 1:55, anesthesia was administered, at respondent's direction. A nurse took the baby from respondent for cleaning. In contemporaneous notes, the nurse described the baby as apparently normal. In fact, Katrina had an imperforate anus or anoperitoneal fistula, and a lipoma on the sacral area of her back. These conditions were discovered a few hours later by a nurse in the Hospital nursery. The nurse brought both problems to the attention of Dr. Shirley R. Simpson, a physician who had been on the staff of the Municipal Hospital of Port St. Joe for approximately ten years and who happened to be in the Hospital at the time. Respondent had left Port St. Joe to meet her husband at the airport in Panama City. Examining Katrina at the nurse's request, Dr. Simpson mistook the lipoma for a meningomyocele. Dr. Simpson took no further action in the case, other than leaving word with the nurse for respondent to call her, until she furnished the Board of Medical Examiners Katrina's hospital chart. By that time, somebody had forged an entry in the nurse's notes for 1:50 P.M. on November 30, 1977, viz., "Appears to have NO rectal orifice-Dr. A. Poonai notified." Petitioner's exhibit No. 4. After her return from Panama City, on December 1, 1977, respondent correctly diagnosed the lipoma. At respondent's request, Dr. P. V. Poonai examined Katrina. After obtaining consent, Dr. P. V. Poonai, used surgical implements, when the baby was 16 hours old, to remove the obstruction which had prevented the expulsion of all but the merest drop of meconium during the first 16 hours of the baby's life. Although this emergency procedure solved the immediate problem and allowed the baby to defecate, further surgery has been necessary to move the anal opening to its norman site posterior of the dimple where Dr. P. V. Poonai made his incision. An imperforate anus occurs once in 5,000 births. The imperforation may or may not be visible, depending on its location. In the past five years, three infants with this problem have been born in Panama City. In each instance, the examining pediatrician did not discover the imperforation, which came to light some hours after birth, on account of the baby's failure to expel its first stool. In Katrina's case, however, the abnormality could be seen and its existence could be confirmed by an attempt to probe. The lipoma on Katrina's back measured less than four by five centimeters in area. It was a soft, skin-colored mass of benign, fatty tissue, which a pediatric surgeon has since removed. The trauma of birth sometimes causes edemas that resemble lipomas. No harm befell Katrina as a result of respondent's failure to diagnose either her lipoma or her anal abnormality at birth. Beverly Stover continued as a patient of respondent for some time after Katrina's birth. Respondent first saw a certain patient on September 19, 1977. This patient, who was born on June 1, 1907, suffered from diabetes mellitus and congestive heart failure, among other things. Two months earlier she had had a second pacemaker inserted. On her first visit to respondent, the patient complained of pain in her chest and of dysuria. She said she had difficulty retaining urine, but that she was unable to empty her bladder completely. In examining her, respondent discovered a moderate cystocele, which is a herniation of the bladder into the vagina. Respondent admitted her into the Municipal Hospital of Port St. Joe for treatment of her congestive heart failure, the cause of the chest pain. Congestive heart failure is not a disease of which people are cured, but it is a condition that may grow better or worse. When this patient's condition improved, respondent sent her home. Respondent saw her again in her office on October 3, 1977, when she complained of paroxysmal dyspnea and swollen feet. Respondent diagnosed superimposed congestive cardiac failure and prescribed a diuretic. On November 18, 1977, respondent admitted her to the hospital because symptoms like those she had complained of during the office visit persisted. On November 22, 1977, she was discharged. A similar episode resulted in rehospitalization from January 10, 1978, through January 19, 1978. The patient entered the hospital again, on February 12, 1978, with congestive cardiac failure. She complained about nocturnal incontinence and asked respondent to correct her bladder problem. At this time, respondent described the cystocele as large. After medical care which petitioner's own witness described as excellent, the patient's condition stabilized. Respondent testified that, in her judgment, the patient's general condition just before surgery was as good as it was likely ever to be. Nine days after she admitted the patient, respondent effected a repair of the cystocele by performing an anterior colporrhapy under local anesthetic. This procedure requires unusual surgical skill, and most surgeons do not attempt it. The repair of a cystocele is a therapeutic measure. In the absence of treatment, urine is likely to stagnate in the herniated portion of the bladder, and become a source of possibly serious infections. All surgical techniques for repairing cystoceles, other than the one employed by respondent, require general anesthesia. The risk from anesthesia to which respondent's patient was subjected was very moderate compared to the risk from general anesthesia. It was the same risk a person faces whose mouth is numbed by local anesthesia before a tooth is filled. Respondent had performed this operation 20 or 30 times before, and had performed it on her own mother, who was 75 years old and suffered from myocardial ischemia at the time. Sometimes, although decreasingly in recent years, a physician may employ a pessary as treatment for a cystocele. A pessary is a rubber or plastic solid that can be inserted in the vagina as a support for the intruding bladder. This is only a temporary measure, however, and involves a high risk of infection, which is the principal danger the cystocele itself poses. Respondent testified that her prescription for temporary relief was bed rest, since lying flat relieves the pressure that forces part of the bladder into the vagina. Respondent first saw another patient, the 29 year old mother of three children, on December 23, 1976. This patient was in the Municipal Hospital of Port St. Joe at the time, for a hemorrhoidectomy, and respondent was called in because the patient had complained of profuse, irregular and painful vaginal bleeding over a period of several years, and particularly during the preceding nine months to a year. The patient was anemic, according to tests run two days earlier. In July of 1976, the patient had been hospitalized on account of pelvic sepsis and bleeding. At that time, Dr. Simpson told her she would need a hysterectomy in the near future. She had been hospitalized for the same reasons in 1975. Respondent ordered a pap smear and an X-ray to locate a coil that had been inserted into the patient's uterus, as a contraceptive measure. When she recovered from the hemorrhoidectomy, the patient was discharged. After three weeks of severe menorrhagia, including two final days of heavy clotting, the patient was readmitted, on January 24, 1977, to the Municipal Hospital of Port St. Joe. Respondent had earlier prescribed iron pills. Perhaps as a result, the patient was no longer anemic. Respondent observed the patient's uterus "enlarged to about 10 weeks size with [what she thought was] fibroids. Petitioner's exhibit No. 6. Respondent ordered no pregnancy test. When an intrauterine device is in place, excessive vaginal bleeding is inconsistent with a viable pregnancy. An intrauterine device not only irritates the wall of the uterus, making conception unlikely, but also operates to abort incipient pregnancies, in the event of conception. With the intrauterine device still in place, on January 26, 1977, respondent performed a total abdominal hysterectomy and an incidental appendectomy, with conservation of both ovaries. Afterwards, the appendix, part of the cervix, and the uterus were sent to a pathologist. The pathologist examined these materials, and, on January 31, 1977, prepared a tissue report, in which he stated as the pathological diagnosis: APPENDIX WITH SEROSAL FIBROSIS, FOCAL (INCIDENTAL). ENDOMETRIUM: DECIDUA WITH EXTENSIVE NECROSIS ASSOCIATED WITH CHORIONIC VILLI (PREGNANCY) WHICH ARE LARGELY NON-VIABLE. SECRETORY ENDOMETRIUM WITH ACUTE AND CHRONIC ENDOMETRITIS. MYOMETRIUM: HYPERTROPHY, POSTERIOR. CERVIX: CHRONIC ENDOCERVICITIS AND MUCUS CYSTS. SLIGHTLY HYPERTROPHIC UTERUS (95 GRAMS). The pathologist found no evidence of fibroids. This demonstrates that respordent's clinical diagnosis of fibroids was inaccurate. One of the pathologists who routinely examined tissue removed by surgeons in the Municipal Hospital of Port St. Joe, Dr. Garcia-Rios, also routinely examined tissue removed by surgeons in other hospitals. Whenever a tissue report indicated disagreement between a clinical diagnosis and the pathological diagnosis, Dr. Garcia-Rios designated the tissue report "Code 3." The frequency of Code 3 tissue reports did not differ as between specimens removed by respondent and specimens Dr. Garcia-Rios examined which had been removed by other surgeons, taken as a group. From the presence of morphologically viable chorionic villi, the pathologist concluded that the patient had been pregnant. From pathological findings alone, he was unable to determine whether the pregnancy had terminated weeks or months earlier; or whether an ongoing microscopic pregnancy was interrupted by the hysterectomy. (Clinical evidence-excessive bleeding-ruled out the possibility of a viable pregnancy.) The pathologist's findings were consistent with, but did not conclusively establish the existence of, a placental polyp. Placental polyps may cause prolonged bleeding. Before surgery, respondent discussed three options with this patient: removal of the intrauterine device, removal of the intrauterine device followed by a d & c, and hysterectomy. The patient said that the presence or absence of an intrauterine device had made no difference in her bleeding problem in the past. She also told respondent that she wanted no more children, and that she wanted prompt, definitive treatment for her bleeding. After listening to explanations from respondent about the available options, the patient chose a hysterectomy. Respondent did not tell her that a hysterectomy was the only way to correct her problem. The patient testified that she has had no problems since her surgery; and that, knowing what the pathologist's tissue report subsequently revealed, she would make the same choice again, at least if it would not involve her as a witness in legal proceedings. Respondent initialled a summary sheet in the patient's chart, which stated the patient's final diagnosis as, inter alia, "FIBROID UTERUS [and] MENORRHAGIA." This final diagnosis fails to take the pathologist's tissue report into account, even though the tissue report routinely becomes part of the chart and presumably was available to respondent at the time she initialled the summary sheet. Respondent testified that she initialled this summary sheet as one of a group of documents, and that she did not read it beforehand. Any discrepancy between the tissue report and the final diagnosis would have been apparent to a knowledgeable reader. Without the tissue report, respondent would not necessarily have known that the pathologist's findings had demonstrated the error of her diagnosis of fibroid uterus. After controversy about this case arose, respondent caused an addendum to be prepared and incorporated into the chart, on August 16, 1978, and amended the discharge diagnosis to state, inter alia: "Menorrhagia, Chronic endometritis [and] Hypertrophy of the myometrium." This diagnosis is consistent both with respondent's clinical findings and with the pathologist's tissue report. In stating her amended discharge diagnosis, respondent took the tissue report, which had been incorporated into the chart, into account. This amended discharge diagnosis was not shown to be erroneous. On August 11, 1976, respondent saw Linda Whitfield for the first time. She came as a patient to respondent's office and related that her last menstrual period had taken place on June 26, 1976. Respondent examined her, observed a uterus of six weeks' size, and diagnosed early pregnancy. Respondent next saw Mrs. Whitfield in the emergency room of the Municipal Hospital of Port St. Joe on August 27, 1976, when her uterus looked to be of eight weeks' size. There Mrs. Whitfield told respondent that, while driving a tractor earlier in the day, she had experienced abdominal cramps and fairly heavy bleeding. Mrs. Whitfield did not report and respondent did not observe the passage of a fetus. Respondent diagnosed a threatened abortion (miscarriage) admitted Mrs. Whitfield to the Hospital, ordered bed rest, ordered that Mrs. Whitfield's urine be tested for the presence of chorionic gonadotropin, and prescribed an intramuscular injection of two cubic centimeters (cc.) of Depo-Provera (Upjohn's registered trademark for sterile medroxyprogesterone acetate suspension, U.S.P.). Although respondent did not specify the strength, she had ordered the Hospital's entire supply of Depo-Provera, and knew that the only strength on hand was 100 milligrams per milliliter. Depo-Provera is a synthetic progestational agent in an oily base. It has been commercially available for approximately 15 years. The 1971 Physicians' Desk Reference (PDR) reported that daily doses were indicated in the event of a threatened miscarriage. The 1972 PDR reported pregnancy as a contraindication for the use of Depo-Provera. (In 1972, respondent lived in Jamacia.) The 1976 PDR and the 1977 PDR, however, contain neither indications nor contraindications for Depo-Provera, in the event of pregnancy. The 1979 PDR reports pregnancy as a contraindication for the use of Depo-Provera. The phrase "missed abortion" describes the situation where a non- viable fetus remains in its mother's uterus. "Missed abortion" was named as a contraindication for Depo-Provera in the literature that accompanied each vial of Depo-Provera, at the time respondent prescribed it for Mrs. Whitfield. The contraindication of Depo-Provera for missed abortion reflected the view, generally shared in the medical community for many years but now rejected, that Depo-Provera acts to prevent uterine contractions and so make fetal expulsion less likely. The only indication stated in the literature that accompanied each vial of Depo-Provera, at the time respondent prescribed it for Mrs. Whitfield, was "[a]djunctive therapy and palliative treatment of inoperable, recurrent, and metastatic endometrial carcinoma." Petitioner's exhibit No. 12B. Also on petitioner's exhibit No. 12B, under the heading "ADVERSE REACTIONS," is the statement: There is inferential evidence supporting the existence of an association between the administration of progestins early in pregnancy and the occurence of congenital malformations (see also WARNINGS). The referenced warning stated that "[u]sage in pregnancy is not recommended because of data indicating a possible association between administration of progestins early in pregnancy and congenital heart defects in the offspring." Petitioner's exhibit No. 12B. Mrs. Whitfield bled, off and on, during her first stay in the Hospital under respondent's care, until two or three days before her discharge. Because Mrs. Whitfield was bleeding on August 28, 1976, respondent prescribed an intra- muscular injection of one cc. of Depo-Provera. Altogether, respondent prescribed 1100 milligrams of Depo-Provera for Mrs. Whitfield over a 16 day period. She ordered administrations of two cc. doses of Depo-Provera on September 2, 1976, on September 4, 1976, on September 7, 1976, and on September 11, 1976, the day Mrs. Whitfield was discharged. At that time, respondent was hopeful that the pregnancy had been saved. At the time respondent prescribed Depo-Provera for Mrs. Whitfield, she believed she was aware of the inferential evidence referred to in the adverse reaction portion of petitioner's exhibit No. 12B. The evidence of which respondent was aware was the result of a retrospective study involving 10,000 mothers who took various hormonal substances during pregnancy and 10,000 mothers who did not. The number of deformed children born to mothers who had taken the hormonal substances exceeded by two percent the number of deformed children born to the mothers who had not. At the time she prescribed Depo-Provera for Mrs. Whitfield, respondent was one of a considerable number of physicians who believed that this drug could supply a hormonal deficiency that a woman faced with a threatened abortion (miscarriage) might lack, and which might be causing premature uterine contractions. Respondent weighed Depo-Provera's possibly teratogenic effect against its possibly ameliorative effect and made a conscientious professional judgment to prescribe Depo-Provera for Mrs. Whitfield. The 1971 PDR specifies a dosage of 50 milligrams day for threatened abortion, as long as symptoms persist. No dosages for threatened abortion are specified in the 1976 PDR, the 1977 PDR or on petitioner's exhibit No. 12B, the literature that accompanied each vial of Depo-Provera. When used to treat "inoperable, recurrent and metastatic endometrial carcinoma," Depo-Provera is prescribed in doses of 100 to 1000 milligrams at intervals of one week to one month. No evidence adduced at the hearing suggested that Depo-Provera has any known or suspected toxic effect on the mother, regardless of the dosage. Nor was it shown to have been scientifically established that Depo-Provera has had an adverse effect on any fetus, when administered to the mother, regardless of the dosage. It is no longer used in the case of threatened miscarriages because recent evidence suggests that it is inefficacious for this purpose. Outside of the United States, Depo-Provera is used as a contraceptive. While Mrs. Whitfield was in the Hospital, on August 29, 1976, respondent ordered a blood serum test to determine the level of chorionic gonadotropin. The results of this test, which respondent saw for the first time on September 16, 1976, were 6,554 milliunits of chorionic gonadotropine per milligram of test fluid. On September 16, 1976, Mrs. Whitfield came to respondent's office and complained of additional bleeding. At that time, a two minute slide test for pregnancy was performed, with negative results. Respondent examined Mrs. Whitfield and concluded that her pregnancy had miscarried despite the efforts to preserve it. She was admitted to the Municipal Hospital of Port St. Joe on September 17, 1976, with the diagnosis of "incomplete abortion," which was changed to "missed abortion," as the pre-operative diagnosis. On the day of her admission, additional pregnancy tests were ordered. A two minute test was negative, but a two hour test was positive. Every pregnancy test is fallible to some extent. These test results did not alter respondent's clinical judgment that the pregnancy had miscarried. A pregnancy test of a urine specimen can yield positive results from four days to two weeks after a pregnancy ends, and sometimes even later. It was undisputed that a result on a blood serum test for chorionic gonadotropin of 6,554 milliunits per milliliter virtually rules out a viable pregnancy of two or three months' duration, although the level may fall that low after the fifth month of a normal pregnancy. At eight to ten weeks, normal levels range from 46,000 to 60,000 milliunits per milliliter. Respondent performed a routine d & c on September 18, 1976. Fifteen grams of the resultant curettings were transmitted to a pathologist who reported "products of conception," but no embryo. Port St. Joe is not a prosperous town. At the time of the hearing, respondent and her husband were the only physicians in Port St. Joe who accepted patients on medicaid. Respondent has admitted patients approximately 500 times to the Municipal Hospital of Port St. Joe. During her time in Port St. Joe, respondent has treated numerous medicaid patients, and has delivered 249 babies. In one instance there was a neonatal fatality. This record compares favorably with a national average on the order of 12 neonatal fatalities per 1,000 births. Respondent has three articles in respectable technical journals to her credit, including two in "Obstetrics and Gynecology." On one she collaborated with her husband. They received 168 requests for reprints from interested persons in some 15 countries. The other article in "Obstetrics and Gynecology" she co-authored describes the first documented full-term pregnancy of a woman with diabetes mellitus, Addison's disease, and hyperthyroidism. The patient described in the article was under respondent's care for the duration of her pregnancy, which eventuated in a normal delivery.
Recommendation Upon consideration of the foregoing, it is RECOMMENDED: That petitioner dismiss counts one, two, four, five and six of the administrative complaint. That petitioner reprimand respondent for her failure to diagnose the imperforation at the time of birth, in violation of Section 458.1201(1)(m), Florida Statutes (1978 Supp.), as alleged in count three of the administrative complaint. That, in all other respects, petitioner dismiss count three of the administrative complaint. DONE and ENTERED this 15th day of November, 1979, in Tallahassee, Florida. ROBERT T. BENTON, II Hearing Officer Division of Administrative Hearings Room 101, Collins Building Tallahassee, Florida 32301 904/488-9675 COPIES FURNISHED: Clifford L. Davis, Esquire 197 South Bronough Street Tallahassee, Florida 32301 J. Ben Watkins, Esquire Post Office Drawer 1814 Tallahassee, Florida 32302 ================================================================= AGENCY FINAL ORDER ================================================================= BEFORE THE STATE OF FLORIDA DEPARTMENT OF PROFESSIONAL REGULATION BOARD OF MEDICAL EXAMINERS IN RE: The License to Practice Medicine as a Physician of: CASE NO. 79-1144 ANILA POONAI, M.D. License No. 27070 /
