The Issue The issue in this case is whether Respondent is guilty of gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment that is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances, and, if so, what penalty should be imposed.
Findings Of Fact At all material times, Respondent has been licensed as a physician in Florida, holding license number ME 0024024. He has not been disciplined previously. R. S. was a 19 year old, about 32-33 weeks' pregnant at the time of the caesarian section. She was admitted at Walker Memorial Hospital with ruptured membranes on the evening of January 6, 1991. She remained in the hospital overnight and was seen by Respondent on the following morning. When admitted, R. S.'s cervix was 2-3 centimeters dilated and partially effaced, or thinned. Her contractions were lasting 30-70 seconds. When seen by Respondent at about 9:15 am on January 7, R. S. was still having mild contractions. Her cervix had dilated to about 4.5 centimeters. Her contractions were about two to three minutes apart and lasted about 40 seconds. The fetal heart tones were good. After 11:00 am, R. S.'s cervix did not dilate further. Respondent checked her several times to confirm that her labor was not progressing, despite adequate labor in terms of the strength, frequency, and duration of the contractions. At the same time, Respondent observed moulding or elongation of the cartiliginous fetal skull in response to the pressures it encountered above the cervix. Through palpitation, Respondent confirmed that the frequency, duration, and strength of the contractions remained adequate. Due to the head-first position of the fetus and absence of other abnormalities, Respondent appropriately concluded that the most likely reason that the labor was not progressing was cephalopelvic disproportion. This is a condition in which the head of the fetus is too large for the pelvic area of the mother. Based on his determination of the adequacy of the contractions and the presence of cephalopelvic disproportion, Respondent decided not to use Pitocin, which is a medication used to stimulate labor. The use of Pitocin is contraindicated when the baby's head is too large for the mother's pelvic area. By 2:00 pm, three hours had passed without further dilation of the cervix. At this time, Respondent decided to perform a caesarian section. A couple of hours later, Respondent performed a caesarian section on R. S. The baby was delivered without complications, and the mother and baby were discharged from the hospital without any problems. Compared to vaginal delivery, a caesarian section involves various risks to the mother and fetus, including injury to the mother or fetus from the anaesthesia or incision. Incidents of aspiration are more common among newborns taken by caesarian section. There is a somewhat increased chance that the mother will have to undergo caesarians for subsequent pregnancies. Also, the duration and cost of hospitalization are greater for a caesarian section. However, Respondent's decision to perform a caesarian after three hours of no progress in labor did not violate the applicable standard of care and did not constitute gross or repeated malpractice. L. C. was a 26 year old in her seventh pregnancy. She had previously delivered three babies at full term and one preterm at about 36 weeks. Normal term is 38-40 weeks. L. C. had suffered spontaneous abortions of two fetuses at two and three months' gestation. Respondent first saw L. C. in February, 1990, and thereafter provided her prenatal care. After June 13, Respondent saw L. C. weekly. In early July, L. C.'s cervix began to dilate and efface. She was hospitalized on July 11, 1990. L. C. presented with definite uterine contractions at about 32.5 weeks' gestation. Her cervix was dilated to 2 cm. Respondent saw L. C. and gave her medications to stop preterm labor by relaxing the uterus. After ruling out preterm contractions, Respondent appropriately diagnosed an incompetent cervix, which is a painless effacement and dilation of the cervix that often leads to preterm delivery. The diagnosis of an incompetent cervix is often based on a patient's history. L. C. had no history of incompetent cervix. However, the diagnosis may also be based on physical findings. L. C.'s cervix was about 80 percent effaced at the time of her hospitalization. Combined with the dilation of two centimeters, she could appropriately be diagnosed as having an incompetent cervix. The primary health risk of an incompetent cervix is a preterm delivery. Premature infants may suffer from a variety of problems stemming from organ immaturity. A factor aggravating the risk is that the hospital in question is in a rural area, contains only about 100 beds, and has no secondary or tertiary facilities for the treatment of neonatals. Weighing these factors, Respondent decided to apply a cervical cerclage. A cerclage involves suturing the cervix shut so that it can withstand the pressure of the fetus without dilating and causing premature delivery. There are risks in the cerclage. A pursestring suture must be placed high in the cervix. There is thus the risk of rupture of the membranes. Infection is another risk. These risks are greater in the presence of greater effacement and dilation, as well as when the membrane is bulging into the cervical area. A cerclage is normally performed at about 24 weeks' gestation. Cerclages are rarely if ever installed at 32 weeks' gestation, as Respondent did in this case. However, the procedure was performed without complications to the mother or fetus. The mother's postoperative contractions were eliminated with medication and did not recur until she delivered a healthy baby at 38 weeks. The baby weighed 6 pounds 14 ounces, which was more than the weight of the babies delivered in any of the mother's four prior live births. Respondent's decision to apply a cerclage at 32 weeks' gestation did not violate the applicable standard of care and did not constitute gross or repeated malpractice.
Recommendation Based upon the foregoing, it is hereby RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint. ENTERED on June 6, 1994, in Tallahassee, Florida. ___________________________________ ROBERT E. MEALE Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings on June 6, 1994. APPENDIX Treatment Accorded Proposed Findings of Petitioner 1-5: adopted or adopted in substance. 6-8: rejected as unsupported by the appropriate weight of the evidence. 9: adopted or adopted in substance. 10-11: rejected as unsupported by the appropriate weight of the evidence. 12-20: adopted or adopted in substance. 21-22: rejected as unsupported by the appropriate weight of the evidence. 23: rejected as recitation of evidence. 24: rejected as unsupported by the appropriate weight of the evidence. 25: rejected as subordinate. 26: rejected as recitation of evidence. 27: rejected as unsupported by the appropriate weight of the evidence. 28-33: adopted or adopted in substance. 34: rejected as unsupported by the appropriate weight of the evidence. 35-43: adopted or adopted in substance. 44: rejected as unsupported by the appropriate weight of the evidence. 45: rejected as irrelevant. 46: adopted or adopted in substance. 47-51: rejected as recitation of evidence. 52: rejected as unsupported by the appropriate weight of the evidence. Treatment Accorded Proposed Findings of Respondent 1-9: adopted or adopted in substance. 10-19: rejected as recitation of evidence and subordinate. 20-25: adopted or adopted in substance. 26-28: rejected as recitation of evidence and subordinate. 29-30: adopted or adopted in substance. 31: rejected as recitation of evidence. 32-33: adopted or adopted in substance. 34: rejected as recitation of evidence and subordinate. COPIES FURNISHED: Jack McRay, General Counsel Department of Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792 Dorothy Faircloth Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, FL 32399-0792 Francesca Plendl, Senior Attorney Department of Business and Professional Regulation 1940 N. Monroe St. Tallahassee, FL 32399-0750 Grover C. Freeman Freeman, Hunter & Malloy 201 E. Kennedy Blvd., Ste. 1350 Tampa, FL 33602
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, as well as certain stipulations of fact, the following relevant facts are found: The respondent Ali Azima was born in Iran and graduated from the Medical College at Tehran University, where he received his M.D. degree in 1961. He is Board-certified as an obstetrician-gynecologist. His experience includes the delivery of approximately 5,000 to 6,000 babies, the performance of approximately 3,500 termination of pregnancy procedures and the provision of about 1,000 intrauterine contraceptive devices to patients. At all times relevant to the charges in these proceedings, respondent was licensed by the Board of Medical Examiners in the State of Florida. Prior to the instant charges, respondent has had no Administrative Complaints filed against him. On February 18, 1981, Christine Sellers (now Kuchar) was admitted to the emergency room of Ft. Myers Community Hospital with severe abdominal pain. On that occasion, she learned that she was pregnant. On February 19, 1981, she went to the Southwest Florida Women's Clinic in Ft. Myers, operated by the respondent, for the purpose of terminating her pregnancy. Upon her arrival at the Clinic, she was asked to pay the requested fee and to complete two forms, a form entitled "Consent for Abortion, Anesthesia and Other Medical Services" and a form entitled "Patient Registration Record." The only medical information requested on these forms, in addition to height, weight and eye and hair color, regarded allergies to foods or medication, medication currently being taken and past operations or serious illnesses. For the latter question, N. Sellers answered "rheumatic fever." Respondent spoke to her for a few moments prior to the procedure, and performed a quick pelvic examination. He then performed the procedure for termination of the pregnancy, gave her some medication and instructed her to come back the following week for a follow-up examination. Respondent did not send any tissue specimen obtained from the procedure to a pathologist for examination nor did he administer Rhogam to the patient subsequent to the procedure. According to Ms. Sellers, neither respondent nor his staff performed any blood work or determined her vital signs before or after the abortion procedure, nor did anyone inquire of her as to her blood type or Rh factor. She knew that her Rh factor was negative, but did not volunteer this information to respondent because she did not realize that a negative Rh factor was important for purposes of a termination of pregnancy procedure. Respondent's medical records for Ms. Sellers do not indicate that blood was drawn from her or that her Rh factor was determined or known. While the record does indicate that a physical examination was "normal," no further information is provided. Ms. Sellers did not desire to return to respondent for her follow-up appointment. Instead, she made an appointment with Dr. Randall Cowdin for the same day she was supposed to see the respondent, February 26, 1981. On that occasion, Ms. Sellers was given a complete physical examination and her blood type was drawn. Upon learning that she had not been administered Rhogam following her termination procedure by respondent, Dr. Cowdin gave her an injection of Mini-Rhogam on February 26, 1981. Approximately one week later, on March 5, 1981, Ms. Sellers returned to Dr. Cowdin's office with complaints of severe right lower quadrant abdominal pain, with some nausea and vomiting. Dr. Cowdin determined that she was bleeding internally due to a ruptured right ectopic pregnancy, and immediately admitted her to the hospital. Emergency surgery was performed, resulting in the removal of the patient's right Fallopian tube and ovary. Ectopic or tubal pregnancies are difficult to diagnose. However, had a specimen of the tissue extracted from Ms. Sellers as a result of the procedure performed by respondent been carefully examined, it would have revealed that the products of conception had not been obtained from the patient's uterus as a result of that procedure. This finding would have at least raised the suspicion of an ectopic pregnancy. It would be extremely rare for a woman to have both an ectopic and a normal pregnancy at the same time. The chances for such an event are one out of 30,000. When performing abortions, four other physicians in the Ft. Myers area routinely send a tissue specimen to a pathology laboratory for examination. The purposes for this are to detect abnormalities, to determine if the patient was indeed pregnant and to determine the existence of an ectopic pregnancy. It is the respondent's practice to examine the tissue himself, having had some residency training in pathology and feeling competent to perform such an examination. If he has any doubts, he then sends a tissue specimen to a pathologist for further examination. It is extremely important to do a blood screening on a patient undergoing a termination of pregnancy proceeding. A determination of the hemoglobin level is significant in order to assess the risk of a procedure performed in a non-hospital setting and to prepare for the possibility of anemia after the procedure. The Rh factor needs to be determined so that Rhogam may be administered to the Rh negative patient. This injection combats antibodies and prevents sensitization or isoimmunization problems in the event of future pregnancies or future transfusions where the patient could again come into contact with Rh positive blood cells. The performance of a procedure to terminate a pregnancy without a determination of the patient's hemoglobin level and Rh factor constitutes medical treatment which falls below an acceptable standard of care. The patient medical records for Holli Schmidt indicate that she first went to the Southwest Florida Women' a Clinic, Inc. on December 1, 1977, and Dr. Azima performed a termination of pregnancy procedure. Her "Patient Information Sheet" lists her blood type and Rh to be "A+." On her follow-up exam, an IUD was inserted. This device was removed in December of 1980. On February 23, 1981, Holli Schmidt again went to respondent's Clinic. She completed a "Consent for Abortion, Anesthesia and Other Medical Services" form, told respondent that her last menstrual period had been about six weeks ago and that she was experiencing breast tenderness and nausea. A pregnancy test was performed on her, and the results were negative. Respondent performed a physical exam, noting on her record "Normal," and a pelvic exam, noting "Normal, uterus is not enlarged." Respondent then inserted a Copper 7 IUD, and instructed Mrs. Schmidt to return in one week. Ms. Schmidt did return on March 5, 1981, still complaining of breast soreness and slight nausea. Respondent performed another physical exam, noting "Normal," and a pelvic examination, noting "String is not visible, uterus sounded and IUD is in situ." The medical records do not indicate that she was given another pregnancy test on March 5, but respondent testified that she was and that such was written in the "pregnancy test book," a document not offered for admission into evidence. The records dated February 23 and March 5, 1981, do not indicate that blood work was done or that vital signs were taken. Mrs. Schmidt was instructed to return on March 14, 1981, but did not do so. On April 27, 1981, Holli Schmidt went to the offices of Yankopolos, Waterman and Cowdin, each of whom specializes in obstetrics and gynecology. The record dictated by Dr. Yankopolus indicates that Mrs. Schmidt told him that respondent had examined her the week before. She also told Dr. Yankopolus that she was having trouble with her IUD and was not feeling quite right, having symptoms of pregnancy. Dr. Yankopolus examined her, did not see the IUD string and determined that she was approximately 12 weeks pregnant. Fetal heart tones, which can be detected at 9 1/2 to 10 weeks of pregnancy, were heard. Dr. Yankopolus did no tests to determine if the IUD was still present, but did explain to Ms. Schmidt the dangers of possible miscarriage and infection from the presence of the IUD during pregnancy. It was noted that Ms. Schmidt "will consider all of the alternatives." On May 1, 1981, Ms. Schmidt presented herself to Dr. Waterman "for termination of pregnancy with a Copper 7 in place." After an examination, Dr. Waterman estimated that she was then "12-14 weeks size," and Dr. Cowdin concurred. This meant that conception occurred 10-12 weeks prior to the May 1st examination. Dr. Waterman performed the termination of pregnancy procedure. While his medical records for May 1, 1981, do not specifically state that he removed the IUD during the termination procedure, Dr. Waterman recalls that he did. A later notation on her medical records indicates that on March 30, 1982, Ms. Schmidt stated "she specifically remembers my removing it." Prior to the insertion of an intrauterine contraceptive device, the most important factor to determine is that the patient is not pregnant. An IUD can be the source of infection, thus endangering the mother and the baby during pregnancy. The safest and most appropriate time to insert an IUD is during the woman's normal menstrual period. While there are exceptions to this method, especially when the physician knows and trusts the patient, it falls below an acceptable level of care for a physician to insert an IUD when the patient has not had a menstrual period for six weeks, has symptoms of pregnancy and has been engaging in unprotected intercourse. Colleen Lundy, a registered nurse, went to respondent's office on March 5, 1981, for the purpose of undergoing a termination of pregnancy procedure. She completed the consent form and "Patient Registration Record" and spoke briefly with the respondent regarding some questions she had as to the procedure. Prior to the beginning of the procedure, no vital signs were taken and no blood work was performed. Respondent's medical record for Ms. Lundy simply indicates that the physical examination was "Normal." After respondent inserted the speculum, he requested his assistant to bring him Betadine, an antiseptic. The assistant informed him they were out of Betadine, and respondent replied, "use alcohol." Thereafter, patient Lundy felt a severe burning and was feeling very uncomfortable with the whole procedure. She informed respondent that she was not going to have the procedure, respondent removed the speculum and left the room, she dressed, received a refund of her fee and left. The burning sensation abated quickly. The following day, patient Lundy received a termination of pregnancy procedure at another clinic. Respondent admits that he told his assistant that alcohol could be used, but denies using any alcohol on patient Lundy. He further states that he did not perform the blood work because he did not perform the abortion. Darlene Baker first underwent a termination of pregnancy procedure performed by respondent in January of 1981. At that time, she completed a "Patient Registration Form," which inquired as to her height, weight, eye and hair color, allergies, prior operations or illnesses and current medications. She returned for another procedure on December 23, 1982, which was performed by the respondent. She received no counseling prior to the performance of this procedure, but did sign a consent form and a form explaining the procedure and risks for abortion. No further written information was obtained from her. While patient Baker does not recall that a physical examination or blood work was performed prior to the performance of the termination procedure, respondent's medical records for this patient indicate that a physical and pelvic examination were performed, that a blood pressure reading was taken and that the patient's "Rh is positive." Respondent did not send a tissue sample of the products of conception to a pathologist for further examination. Other physicians specializing in obstetrics and gynecology in the Ft. Myers area make it a routine practice to counsel abortion patients prior to the performance of the procedure. During the counseling session, the risks of the procedure involved are examined and other options for the management of an unwanted pregnancy are explored. Sufficient time is afforded between the counseling session and the performance of the termination procedure for patient reflection. The physical examination performed by these physicians includes the taking of vital signs, blood pressure, blood tests and a check of the abdomen, heart and lungs. Subsequent to the procedure, the products of conception are sent to a pathology laboratory for examination and the results are made a part of the patient's medical records.
Recommendation Based upon the findings of fact and conclusions of law recited herein, it is RECOMMENDED that respondent be found guilty of violations of Section 453.331(1)(t), Florida Statutes, and that his license to practice medicine in Florida be suspended for a period of one (1) year. Respectfully submitted and entered this 24th day of July, 1984, in Tallahassee, Florida. DIANE D. TREMOR, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 24th day of July, 1984. COPIES FURNISHED: J. Riley Davis, Esquire 225 S. Adams St. Tallahassee, Florida 32301 Stephen Marc Slepin, Esquire 1114 E. Park Ave. Tallahassee, Florida 32301 Ellis S.Rubin, Esquire 265 NE 26 Terrace Miami, Florida 33137 Dorothy Faircloth, Executive Director Board of Medical Examiners 130 N. Monroe St. Tallahassee, Florida 32301 =================================================================
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
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found: At all times relevant to this proceeding, respondent, Manihi G. Mukherjee, has been a licensed physician in Florida, holding license number ME 0027749. She received her medical degree in New Delhi, India, in 1965. Respondent is Board certified in obstetrics and gynecology and is a Fellow of the American College of OB/GYN. She attends conferences regularly and has attended more than 150 hours of continuing medical education courses between 1979 and 1987. Since 1976, she has been in private practice in St. Petersburg, Florida, specializing in obstetrics and gynecology. Respondent first saw patient J.B. on November 30, 1979, for a routine gynecological examination and renewal of birth control pills. While obtaining an initial history on the patient, respondent learned that J.B. had a previous appendectomy performed in 1973, and noted the surgical incision located in the right lower quadrant. During a visit to respondent on or about September 9, 1980, J.B. told respondent that she wanted more information' about methods of contraception other than birth control pills. Respondent advised J.B. about the various alternative methods of contraception, including tubal ligation, as well as their effectiveness and complications. With regard to tubal ligation, respondent explained to J.B. that a bilateral partial salpingectomy using a mini-laparotomy could be performed for sterilization purposes and that the failure rate of such a procedure was 4 to 6 persons per 1,000. A laparotomy procedure involves the creation of an incision of about 8 to 10 inches in the anterior abdominal wall. A mini-laparotomy involves a smaller incision of between one and three inches. A salpingectomy is the removal of the fallopian tube. A partial salpingectomy is the removal of a portion of the fallopian tube. A bilateral partial salpingectomy is the partial removal of both fallopian tubes. On or about April 1, 1981, J.B. returned to respondent for a six-month check up, and advised respondent that she wanted to have a tubal ligation. Respondent again advised J.B. about the method of tubal ligation which would be used (the mini-laparotomy with bilateral partial salpingectomy) as well as the complications and failure rates of the procedure. Thereafter, on April 14, 1981, J.B. was admitted to what is now known as Humana Hospital Northside in St. Petersburg Florida, for elective tubal ligation. On that date, she signed a form entitled "Consent to Operation, Administration of Anesthetics, and the Rendering of Other Medical Services," authorizing respondent to perform a mini-laparotomy and a bilateral partial salpingectomy. While obtaining a further medical history from J.B. at the hospital prior to the scheduled surgery, respondent was informed that the patient had previously had an exploratory laparotomy in 1973, at the same time that the appendectomy was performed. On or about April 15, 1981, respondent performed a mini-laparotomy and what was described in respondent's records as a "bilateral partial salpingectomy" with a modified Pomeroy procedure on patient J.B. A Pomeroy procedure is a method of sterilization accomplished by picking up a loop of the fallopian tube, clamping across the loop, cutting and removing that portion of the loop above the clamp and ligating, or tying off, the tissue beneath the clamp with catgut sutures. Respondent modified the procedure by using chromic O sutures. In performing the surgery, respondent identified the left tube and ovary and ligated the loop of the tube. She then attempted to locate the right tube and ovary. Respondent visualized a distorted right tube, but did not see a right fimbria or a right ovary. The fimbria is the fringe-like outer end of the fallopian tube. Respondent testified that she assumed that the patient's right ovary and tube had been removed during the patient's previous exploratory laparotomy and/or appendectomy. Respondent sent specimens from what purported to be the right and left fallopian tubes to the pathology department for pathological evaluation. Her dictated operative report describes the following: "Operative Findings: On opening the abdominal cavity, her right tube was blocked, fibrial (sic) end was absent. Right ovary was absent. Left tube and ovary looked normal. Ovaries looked normal. Operative Procedure: . . . Both tubes were identified. They were held in their mid portion with the Bab- cock and transfixed with chromic O catgut suture... The loop of the right and left fallopian tube were transected and sent separately to the lab..." The pathological evaluation was performed on or about April 16, 1981. It revealed that the specimen identified as "Specimen A," which purported to be a portion of the right fallopian tube, contained sections of veins and fibrofatty tissue. Specimen A did not contain tubal matter. Specimen B contained, as expected, a portion of the left fallopian tube. The respondent was advised of the pathology evaluation report, though the time of such advice was not established. Patient J.B. remained hospitalized until April 7, 1981. Shortly after performing surgery on J.B., respondent advised J.B. that during the course of the operative procedure, respondent could not find a right ovary. However, she advised J.B. that there was nothing to worry about and that everything went well. After leaving the hospital, J.B. saw respondent on three more occasions. On April 20, 1981, respondent removed the staples from J.B.'s abdomen. She advised J.B. to remain on birth control pills for healing purposes. On May 15, 1981, and on June 8, 1981, respondent saw J.B. for postoperative visits. At the latter visit, J.B. advised respondent that she would be moving to Louisiana because of her husband's job. At no time did respondent advise J.B. that the pathological evaluation of the specimens submitted from the April 15, 1981, surgery revealed that the specimen purporting to contain a portion of tubal matter from the right fallopian tube did not in fact contain such material. At no time did respondent advise J.B. that respondent believed that the right tube was removed during the previous surgery performed in 1973. Respondent did not advise J.B. that she could become pregnant if the right tube were note properly blocked, and, therefore, that she needed to remain on birth control pills until the matter could be appropriately investigated. Respondent did not advise J.B. of the necessity to "follow-up" on the results of the pathology report by either obtaining records from the 1973 surgery to confirm respondent's belief that the patient's right fallopian tube was previously removed or by performing appropriate testing on J.B. to confirm blockage of the right ovary. On or about June 20, 1981, well after being apprised of the results of the pathological evaluation, respondent dictated a Discharge Summary for the hospitalization of J.B. from April 14-17, 1981. The Discharge Summary provided in pertinent part: Hospital Course: On April 15, 1981, a mini-laparotomy and partial bilateral salpingectomy was performed without any complications under general anesthesia. Postoperatively, the patient did fairly well. She was discharged on the second postoperative day with the advice to be seen in the office in one week. The Discharge Summary contained no reference to the results of the pathological evaluation. It also contains no documentation that respondent believed that the patient's right fallopian tube was removed during the 1973 surgery. On or about September 29, 1981, patient J.B. telephoned respondent's office because her period was two weeks late and a home pregnancy test had given a positive result. J.B. was informed that it was unlikely, but not impossible, that she was pregnant, and that with a tubal ligation procedure, a part of each tube is removed. On or about October 2, 1981, J.B. went to a physician in Louisiana and was determined to be pregnant. On October 7, 1981, she had an elective abortion. Following the termination of pregnancy, a diagnostic laparoscopy and a D & C (a scraping of the uterus) was performed on October 20, 1981. The laparoscopy revealed that the right ovary was present and a cyst was on the ovary. The right fallopian tube was present in its entirety (including the fimbria), was surgically untouched and was otherwise normal. The injection of methylen blue dye revealed that the fallopian tube was open and not blocked. A failed tubal ligation is not in and of itself malpractice or substandard care. However, a reasonably prudent physician, under the circumstances present in this case, should have immediately advised the patient that the possibility existed that one of the tubes had not been properly ligated, and, therefore, the possibility existed that the patient might become pregnant. The patient should have been advised to continue utilizing birth control methods until appropriate investigation could be undertaken to determine the condition of the right fallopian tube. A reasonably prudent physician would have then undertaken appropriate investigation. This could have included either the obtaining of previous medical records to confirm or deny that the right fallopian tube had been removed during the earlier surgical procedures performed in 1973, or the performance of a hysterosalpingogram. This latter procedure is a test which involves the injection of radiographic dye into the uterus and through the tubes. The dye is examined under x-ray to determine whether it flows freely through the fallopian tube or is stopped by blockage or ligation. The respondent admits that the term used in J.B.'s medical records to describe the procedure performed on the patient during her April, 1981, hospitalization was incorrect. Respondent did not perform a bilateral salpingectomy as noted in the Discharge Summary, but instead performed a left partial salpingectomy and excision of the tissue from the right tube. On September 5, 1981, patient R.L., an 18 year old female, was admitted to the emergency room complaining of abdominal pains. After examining the patient, the emergency room physician determined that R.L. was suffering from bilateral lower quadrant tenderness in the abdomen. A pelvic examination revealed bilateral tenderness in the adnexa and tenderness in the cervix. The impression of the emergency room physician was that R.L. had pelvic inflammatory disease (PID). PID is a progress of infection in the reproductive organs which can start in the vagina and spread to the cervix and progress upward to the uterine cavity, continue on outward to the fallopian tubes and involve the pelvis, either by direct continuous spread or through the blood supply and the lymphatics. It may be associated with either a bacterial or a viral type of infection. The emergency room physician ordered several tests to be conducted for the patient, including a complete blood count test. This test revealed that the patient's white blood cell count was 17,500. A normal count is approximately 7,800. R.L.'s white blood cell count was significantly elevated, indicating the presence of an infective process. The emergency room physician contacted the respondent, who agreed to assume the care of patient R.L. Respondent ordered the admission of the patient to the hospital, with a diagnosis of PID with peritonitis. Peritonitis is an inflammation of the peritoneum or lining of the abdomen. Upon admission, the respondent obtained an initial medical history and performed an initial physical examination on R.L. The medical history revealed that the patient had never had children, had been on birth control pills for one and one-half years, and she denied having had sexual intercourse for the past four months R.L. informed respondent that she had started having abdominal pain and a low-grade fever on the morning of the day before and that the pain had become increasingly worse and generalized, associated with some nausea and vomiting. The respondent's examination of the patient's abdomen and a pelvic examination revealed vague distention or bulging of the abdomen, muscle guarding and rigidity. Sluggish bowel sounds were audible, and there was marked tenderness and rebound tenderness in the patient's lower abdomen. The respondent's impression was acute PID with peritonitis. She ordered that R.L. be placed on intravenous fluids, that her vital signs be taken four times a day, that a chest x-ray be given, and that pain medication, aspirin, and antibiotics be administered. The respondent's main objective was to try to resolve the patient's PID conservatively, without performing surgery. R.L.'s daily progression varied with respect to her white blood cell count, her temperature, abdominal tenderness and rigidity, bowel sounds and daily activity between September 5 and 14, 1981. The patient's white blood cell count fell to 13,100 on September 7, and rose to 16,700 on September 9th. Her temperature would rise and fall on any given day. Her abdomen remained distended and rigid until September 12, when she began having less tenderness and better bowel sounds. She showed some improvement in her diet intake and in ambulation. The respondent ordered that various tests and changes of medication be performed between September 6 and 14, 1981. These included a urinalysis, a flat plate x-ray of the abdomen, an ultra sound of the abdomen and changes in antibiotics. On September 10, respondent performed a culdescentesis (the insertion of a needle into the cul-de-sac under general anesthesia), and withdrew ten cubic centimeters of frank pus. On September 11, respondent performed a colpotomy (a procedure in which an incision is made into the cul-de- sac through the upper wall of the vagina, into the peritoneal cavity) in order to drain the cul-de-sac. The patient appeared to improve somewhat after this procedure. On September 14, 1981, respondent requested Dr. Benjamin Abinales to perform a surgical consultation. Dr. Abinales' examination of R.L. on September 14 revealed that R.L.'s abdomen was slightly distended, with marked tenderness. He noted muscle guarding and rebound tenderness, and the presence of peristalsis. Dr. Abinales felt that the patient was suffering from pelvic peritonitis, and recommended that respondent continue the present plan of treatment for several days. If no improvement was evident, Dr. Abinales suggested that exploratory surgery be considered. The patient's condition did not improve after September 14th. Her white blood count value rose to 27,800 and her temperature was as high as 101 degrees on September 15, 1981. E-coli bacteria, usually found in the gastrointestinal system, were revealed from cultures performed on the pus drained during the culdescentesis. On September 16, the responded performed a second colpotomy, again draining frank pus. On September 17, R.L. was administered a new type of antibiotic, and this was changed again on September On September 18, a chest x-ray revealed that there was a possibility of a subphrenic abscess on the left side of the lungs with pleural effusion present. Thereafter, specialists in infectious diseases and pulmonary medicine were consulted. The infectious disease specialist recommended a CT Scan of the abdomen and surgical intervention after the CT Scan results were evaluated. On September 21, 1981, respondent and Dr. Abinales performed an exploratory laparotomy, lysis of extensive intestinal lesions, what was described as "removal of tubovarian abscess from the right side," an appendectomy, drainage of subphrenic abscess on the left side, and peritoneal lavage. The operative description of the exploratory laparotomy demonstrates that there was significant inflammation of the fallopian tube and the ovary on the right side and also significant inflammation of the appendix on the right side. Thus, the etiology of the infection could have been either an appendicitis with perforation or a tubo-ovarian abscess. Patient R.L. recuperated uneventfully after the surgery and was discharged from the hospital on October 4, 1981. Where possible, conservative treatment (non-surgical treatment) is the treatment of choice for PID. This is particularly true for young female patients of child bearing years. The accepted standard of practice for gynecologists is to initially pursue conservative treatment of PID with antibiotic therapy, especially in the presence of peritonitis, for a period of about 72 hours. Generally, if the proper antibiotics are administered, PID responds dramatically within 72 hours. If clinically significant improvement does not occur in that period, other complications, such as appendicitis or abscess formation, should be suspected and exploration of the abdomen surgically is necessary. The extent of surgical intervention required depends, in large part, on the condition of the abdomen as revealed on exploratory laparotomy. While a physician should be concerned about making every effort to preserve the reproductive organs in a young female, the need to preserve the reproductive system must be balanced against the need to preserve the patient's life, particularly where peritonitis exists.
Recommendation Based upon the findings of fact and conclusions of law recited herein, it is RECOMMENDED that respondent Manihi G. Mukherjee, M.D. be found guilty of violating Section 458.331(1) (m) and (t) , Florida Statutes, that she pay a fine o $2,500.00 and that she be placed on probation for a period of three years, with conditions and restrictions to be established by the Board of Medicine relating to her surgical assessment and care of patients and her record keeping. Respectfully submitted and entered this 28th day of September, 1988, in Tallahassee, Florida. Diane D. Tremor, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1500 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 28th day of September, 1988. APPENDIX TO RECOMMENDED ORDER CASE NO. 87-2283 The parties' proposed findings of fact have been fully considered and are accepted and/or incorporated in this Recommended Order, with the following exceptions: Petitioner 7. Rejected as irrelevant and immaterial to the issues in dispute. 13. Rejected as irrelevant and immaterial to the issues in dispute. 40. First sentence rejected as irrelevant. 49. Second sentence rejected as irrelevant. 61(b). Second sentence rejected as unsupported by competent, substantial evidence. 63. Rejected as unrelated to the charges in the Administrative Complaint. Respondent (as to J.B.) 11. Rejected as contrary to and inconsistent with the greater weight of the evidence. 13, 14, 15 and 17. Rejected as contrary to and inconsistent witch the greater weight of the evidence. (as to R.L.) 4. Rejected as unsupported by competent, substantial evidence. First sentence rejected as unsupported by the evidence. Rejected as contrary to the evidence. 9, 10 and 11. Accepted, except with regard to timeliness. 12. Rejected, as contrary to the greater weight of the evidence. COPIES FURNISHED: Stephanie A. Daniel Senior Attorney Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Donald V. Bulleit and Nelly Ehouzam Fowler, White, Gillen, Boggs, Villareal & Banker, P.A. P. O. Box 210 St. Petersburg, Florida 33731 Dorothy Faircloth Executive Director Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Bruce D. Lamb, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
The Issue The issues in this case are whether Respondent violated Subsections 458.331(1)(m), 458.331(1)(t), and 458.331(1)(bb), Florida Statutes (2005),1 and, if so, what discipline should be imposed.
Findings Of Fact The Department is the State of Florida agency charged with regulating the practice of medicine in Florida pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes. At all times material to the Administrative Complaint, Dr. Labs was a licensed medical doctor within the State of Florida, having been issued license number ME 61579. Dr. Labs is certified by the American Board of Surgery and the American Board of Plastic Surgery. In April 2006, W.S. went to see Dr. Labs for a consultation. In the late 1980’s, W.S. had had breast implants placed by a physician in Texas. In 1995, another physician did a mastopexy to lift her breasts. W.S. wanted Dr. Labs to replace the breast implants that had been in place since the late 1980’s with smaller implants, to reduce the size of her breasts by excising tissue, and to lift the breasts with a mastopexy. She was under the impression that the implants which she currently had had been placed underneath the pectoral muscle, and she told Dr. Labs that she wanted to have the new, smaller implants also placed underneath the muscle, meaning subpectoral placement. Dr. Labs agreed to place the implants subpectorally. There are two ways that implants can be placed subpectorally. The first method involves placing the implant entirely under the muscle and then suturing the implant in place. There is very little migration of the implant with this method because the implant is tightly held by the muscle. The second method is called a dual-plane technique. In this method, a portion of the implant is placed under the pectoral muscle and a portion of the implant is covered by the glandular or lower part of the breast. Dr. Labs performed a bilateral reduction, mastopexy, and implant exchange on W.S. on April 25, 2006. His operative report described the procedure as follows: The patient was taken to the operating room after being marked in the standing position. She was placed in the supine position for smooth induction of anesthesia. Sequential compression boots were placed for DVT prophylaxis. The procedure began with de- epithelization of skin above each nipple for reinset. Scars were then excised around the nipple and from the vertical incision beneath the nipple to inframammary fold. Skin flaps were elevated and, then the central nipple pedicle preserved. Implants were removed, and breast tissue was excised laterally. The implants were then replaced with silicone implants after Betadine irrigation and surgical glove change. The removed implants were 220cc. The replaced implants were 175cc, and each breast was subjected to a 75 gram reduction. Towel clips were placed, and the patient was placed in the sitting position. Symmetry was excellent at the conclusion of the procedure. Multiplayer inset was then performed. The patient was placed in a sterile bulky dressing and Ace wrap. She returned to the recovery room in satisfactory condition, having tolerated the procedure well. Final sponge, needle and instrument counts were correct at the conclusion of the procedure. The patient was given explicit postoperative instructions for the care and maintenance of her wound and will be seen again in followup at the plastic surgery office. Dr. Labs took out the 220cc implants and placed 175cc implants in the same pocket where the 220cc implants had been placed. The 220cc implants which Dr. Labs removed had a small rim of the superior portion of the implants placed underneath the muscle. The remaining portion of the implants were subglandular. Dr. Labs placed the superior medial portion of the 175cc implants between .5 and 2.5 centimeters under the muscle, meaning that about ten percent of the implants were placed under the muscle. The remainder of the implants was subglandular. The method used by Dr. Labs was the dual-plane method and is considered to be a subpectoral placement. W.S. signed a consent form, which included an explanation of risks associated with open capsulectomy with breast implant exchange surgery. The risk of implant displacement was explained as follows: Displacement or migration of a breast implant may occur from its initial placement and can be accompanied by discomfort and/or distortion in breast shape. Difficult techniques of implant placement may increase the risk of displacement or migration. Additional surgery may be necessary to correct this problem. Subsequent to the surgery by Dr. Labs, W.S. began to experience problems with her breasts. The breasts were distorted, became an odd shape and stuck out more than her breasts had done with the implants placed by the Texas physician. Her breasts were bulging in the front and middle. W.S.’s breasts became uncomfortable, and W.S. was unable to lie on her stomach. The breasts did not look or feel natural; they were stiff, hard, and tight. The problems began to occur not long after the surgery; however, the distortion was not present until a month after the surgery. On December 6, 2006, W.S. visited Alexia Marciano, M.D., a board-certified plastic surgeon, for a consultation concerning the problems she was having with her breasts. On examination, Dr. Marciano noted that W.S. had pseudoptosis, which means there was some loose skin, but the nipple was still above the inframammary fold. Dr. Marciano observed that W.S.’s breasts were distorted, irregular in shape and position. There were capsular contractures, which are scar tissue that forms around the implants. The capsular contractures were a grade IV,2 which means that one could look at the breast and visually see the tightening. To Dr. Marciano, the implants appeared to be on top of the muscle, based on “the superficiality and the position of the implants in relation to the skin above and to the pectoralis muscle on the upper portion of the chest and on palpation.”3 W.S. advised Dr. Marciano that she wanted to have surgery to correct the problems she was having with her breasts and that she wanted to have smaller implants placed under the muscle. On January 19, 2007, Dr. Marciano performed a capsulectomy, which is moving the capsule or shell of the scar around the implant; an explantation of the silicone implants, which is removing the current implants; and an augmentation, which is putting in new implants. When Dr. Marciano made incisions in each breast to find the capsules, she found the capsules right beneath the subcutaneous tissue, which is basically right beneath the skin and above the pectoralis major muscle. Although Dr. Marciano found the implants which had been placed by Dr. Labs, above the major pectoralis muscle, she could not determine where the implants were actually placed by Dr. Labs at the time he performed the implant exchange on W.S. Dr. Marciano removed the silicone implants, identified the pectoralis muscle, incised the inferior edge of the pectoralis muscle, and dissected the plane underneath the muscle. Dr. Marciano placed new implants, which were 150cc’s, on both breasts. The new implants were placed entirely underneath the muscle, and the small opening that was made in muscle fascia was closed with sutures so that the implants were in a closed pocket. Capsular contraction, such as W.S. experienced, can cause the implants to move. Additionally, during the early stages after an implant has been placed, there is more potential for the implant to move before the capsule forms. Based on the evidence presented, the logical inference is that the capsular contraction caused the implants placed by Dr. Labs to move from underneath the pectoralis muscle so that the implants came to rest in a subglandular position as Dr. Marciano found them. There were no medical records admitted in evidence from the Texas physician who placed the original implants in the 1980’s. Based on what Dr. Labs found when he exchanged the implants, it is probable that the Texas physician used the dual- plane method to insert the implants, meaning that a portion of the implants were subglandular. This scenario comports with one of the hypotheses set forth by the Department’s expert, who surmised that, based on the preoperative photographs taken by Dr. Labs, it appeared that the Texas physician may have placed the original implants in a subglandular position rather than in a subpectoral position. If the Texas physician had used a dual- plane method and placed a small portion of the implants under the rim of the pectoralis muscle, then a large portion of the implants would appear to be placed in a subglandular position as surmised by the Department’s expert; when, in fact, the implants had been placed subpectorally as that term is commonly understood by plastic surgeons. Dual-plane placement also comports with W.S.’s distinct impression that the original implants had been placed under the muscle.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Dr. Labs did not violate Subsections 458.331(1)(m), 458.331(1)(t), or 456.072(1)(bb), Florida Statutes, and dismissing the Administrative Complaint. DONE AND ENTERED this 14th day of October, 2009, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL 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 14th day of October, 2009.
The Issue The issues in this case are whether Respondent violated Subsections 456.072(1)(k), 458.331(1)(g), 458.331(1)(m), and 458.331(1)(t), Florida Statutes (2005),1 and Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes (2004), and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state agency in Florida charged with regulating the practice of medicine pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes. At all times material to the Amended Administrative Complaint, Dr. Pendergraft has been a licensed physician in the State of Florida, having been issued license No. ME 59702. Dr. Pendergraft is board-certified in Obstetrics and Gynecology. He does not have hospital privileges in Florida. At all times material to the Amended Administrative Complaint, Dr. Pendergraft, alone or with one or more partners, owned and operated Orlando Women’s Center, Inc. (OWC), a clinic located in Orlando specializing in abortions. OWC is not a hospital. At all times relevant to the Amended Administrative Complaint, Dr. Pendergraft did not have a current, valid Drug Enforcement Administration (DEA) number. On June 3, 2005, R.W. presented to her primary care physician symptoms of weight gain, fatigue, and lack of a menstrual period for several months. R.W. was a marathon runner and had experienced a delay in her menstrual cycle before because of her strenuous training. She had been taking oral contraceptives. At that time, her primary care physician did not diagnose R.W. as being pregnant. A couple of weeks after her visit with her primary care physician, R.W. still had not regained her menstrual cycle and took a home pregnancy test. The results of the home pregnancy test were positive. R.W. contacted her primary care physician, who ordered laboratory tests for R.W. Laboratory tests were conducted on June 14, 2005, and June 21, 2005. Both tests confirmed the pregnancy. R.W. was referred to Bert Fish Medical Center for an ultrasound on June 21, 2005. The ultrasound showed that R.W. was pregnant. The physician who prepared the diagnostic imaging report based on the ultrasound stated in the report: There is a single intrauterine fetus with an estimated gestational age of 24.5 weeks. Positive fetal heartbeat is present at 142 beats per minute. However, there is severe oligohydiamnios with no positive fetal movement. Gestational age is usually calculated from the first day of the last menstrual period (LMP) of the pregnant woman. On average, the last menstrual cycle occurs two weeks prior to conception. Thus, the gestational age that is determined by the LMP is actually two weeks more than the date of conception.2 When the LMP is unknown, fetal measurements are used to calculate the gestational age. Oligohydramnios means a lack of amniotic fluid. Amniotic fluid is basically the fetus’ urine. A lack of amniotic fluid can be caused by the lack of kidneys or obstructed kidneys, rupture of the membranes, or a malfunction of the placenta. The lack of amniotic fluid makes it difficult to assess the fetal measurements using ultrasound. R.W. was referred to an obstetrician, Dr. P.C., who admitted R.W. to Halifax Medical Center for routine laboratory work and an obstetrical ultrasound. The ultrasound was performed on June 22, 2005, and showed that the fetus was in a breech presentation, there was markedly decreased amniotic fluid, the bowel was abnormal, and the ventral wall was suspicious. Based on the ultrasound, it appeared there was gastroschisis or omphalocele. Gastroschisis occurs when the abdominal wall of the fetus does not close properly and the intestines are outside the body. Omphalocele is a herniation of the intestines, and a sac-like structure covers the intestines outside the abdominal wall. The assigned gestational age estimated by the physician reviewing the ultrasound was 25 weeks and five days.3 R.W. was referred to a perinatologist in Jacksonville. Another ultrasound was performed on June 23, 2005. The assigned gestational age was 25 weeks and six days, which would mean that the age of the fetus was 23 weeks and six days from conception.4 The lack of amniotic fluid and the position of the fetus made it difficult to determine the actual gestational age of the fetus. The perinatologist reported the following to Dr. P.C.: At this time, an ultrasound examination was performed which showed a single living fetus in breech presentation. There is no amniotic fluid which precluded an adequate examination of fetal anatomy. The right kidney and bladder were visualized essentially excluding diagnosis of renal agenesis. A normal appearing 4 chamber structure was seen which visually appears to occupy more than 50% of the chest cavity. This is also very difficult to evaluate due to the position of the baby. There appears to be an anterior abdominal wall defect most likely a gastroschisis, however, again this is impossible to evaluate in great detail. Of importance and further complicating the problems in this case, is the biometry. Measurements of head circumference and cerebellum are consistent with 30 weeks, however, the femur length is consistent with 25 weeks. The fact that this patient has been amenorrheic since October when she could be up to 34 weeks gestation is significant. We don’t know the exact gestation but it is of concern that there is a dramatic difference between the extremities, abdomen, and head circumference as well as the cerebellum. This points to a growth retardation process. Doppler studies of the umbilical circulation were slightly elevated but if there had been placental disfunction I would have expected an absent diastolic component which was not the case. * * * [M]y biggest concern has to do with the anhydramnios and the fact that we don’t know for how long this process has been active. Pulmonary hypoplasia is a strong consideration given the size of the chest and the virtual absence of fluid. Nevertheless, not knowing for how long she has not had fluid is difficult to quote her a risk. The second area of concern is that of the appearance of a structural abnormality. Typically gastroschisis is not associated with a chromosomal anomaly, however, given the discrepancies in biometries and the absence of amniotic fluid, I wonder if this is not a gastroschisis or if it is, part of a more complex situation. The perinatologist conveyed his findings to Dr. P.C., who discussed the situation with R.W. R.W. decided to terminate the pregnancy. The office notes of Dr. P.C. stated, “It was felt by me and my partners that facilitating delivery of this non-viable child was appropriate.” Dr. P.C. called Dr. Pendergraft to discuss the case. Dr. Pendergraft agreed to help, and Dr. P.C. gathered R.W.’s medical records to send to Dr. Pendergraft. On July 7, 2005, R.W. presented to Dr. Pendergraft at OWC. R.W. filled out an information sheet and listed the first day of her last normal period as January 5, 2005.5 R.W. filled out the appropriate consent forms, which a counselor reviewed with her. R.W.’s vital signs were taken and laboratory tests were performed by staff at OWC. Dr. Pendergraft’s notes stated that the sonogram showed severe growth restriction of the fetus. He further indicated that there was a possibility of severe pulmonary hypoplasia and risk of life-threatening sudden health issues or probable fetal, prenatal demise. Dr. Pendergraft wrote in his notes that R.W.’s PMD OB/GYN physician concurred with the maternal health reasons for the termination of the pregnancy. On July 7, 2005,6 at approximately 4:27 p.m., Dr. Pendergraft administered Digoxin into the heart of the fetus to stop the fetal heart beat. Dr. Pendergraft and his medical assistant, S.M., monitored the fetal heart beat using a sonogram until the fetal heart stopped. The procedure was documented on a form used by the OWC entitled “Second Trimester Medical Procedure.” On the form, it is noted that the patient was evaluated on July 7, 2005, and found to be 27 to 28 weeks pregnant, which is 25 to 26 weeks from conception. According to T.S., a medical assistant employed by Dr. Pendergraft, the handwriting which indicates the estimated length of the pregnancy belongs to Dr. Perper, a colleague of Dr. Pendergraft. Both Dr. Perper and Dr. Pendergraft signed the form. After the Digoxin procedure was completed, R.W. was taken to a private room and given Cytotec to induce labor. S.M. continued to administer Cytotec and monitor R.W. until 8:30 p.m., when T.S. relieved S.M. At approximately 12:30 a.m., on July 8, 2005, R.W. developed a fever and the administration of Cytotec was discontinued. T.S. administered Ibuprofen to R.W. to lower the fever. At 1:30 a.m., T.S. noted that R.W. was having some cramping. T.S. wrote the following in the progress notes: “I have a standing order from Dr. Pendergraft for 2 cc Demerol [with] 1 cc Phenergran.” This order was to alleviate the pain from the cramping. At the final hearing, T.S. stated that the note was not totally accurate, because the standing order was from Dr. Perper and not Dr. Pendergraft because Dr. Pendergraft did not have DEA authorization. She attributes the error in her notes to her 20-year working relationship with Dr. Pendergraft and her automatically thinking of Dr. Pendergraft in terms of standing orders. The standing order itself was not submitted into evidence. The evidence is not clear and convincing that Dr. Pendergraft gave the standing order for the Demerol and Phenergran. At 4:30 a.m., the cramping had increased. T.S. gave R.W. an injection of 2 cc of Demerol with 1 cc of Phenergran. At 6:30 a.m., R.W. delivered the fetus and placenta at the same time inside an empty water sack. The products of conception, which included the fetus, membranes, and placenta weighed 800 grams. The weight of the products of conception was recorded on a form used by the OWC, entitled “Clinic Examination of Products of Conception.” The form listed the preoperative estimate of gestational age to be 28 weeks, which would be 26 weeks from conception. Dr. Pendergraft was one of the signatories on the form. Dr. Pendergraft charged R.W. $12,000 for the procedure. Although, both Dr. Pendergraft and his associate Dr. Perper, felt that, preoperatively, the gestational age of the fetus was between 27 and 28 weeks, Dr. Pendergraft did not transfer R.W. to a hospital. Jorge Gomez, M.D., testified as an expert witness on behalf of the Department. Dr. Gomez is board-certified in obstetrics and gynecology and in maternal-fetal medicine. Dr. Gomez opined that on July 7, 2005, the age of the fetus from conception was 27 weeks. His opinion was based on biparietal diameter (BPD), the head circumference, the size of the cerebellum, and the femur length. He discounted the abdominal circumference because the abdominal wall defect would result in a less reliable measurement of the age of the fetus. The abdominal wall defect would cause the measurement to be smaller than would be expected for the age of the fetus. Jay Neil Plotkin, M.D., testified as an expert witness for Dr. Pendergraft. Dr. Plotkin has been a licensed physician for 37 years and is board-certified in obstetrics and gynecology. Dr. Plotkin has not treated patients for four years and has not performed an abortion in six or seven years. It was Dr. Plotkin’s opinion that the abortion occurred during the second trimester rather than the third trimester. His opinion is based on the combined fetal and placental weight at time of delivery. He concluded that the gestational age at the time of delivery was 24 weeks, which would translate to 22 weeks of pregnancy from conception. He used a chart to determine the age based on the weight of the fetus, but he did not know if the chart was based on normal fetuses or included fetuses with abnormalities such as the one at issue. Dr. Pendergraft also called Steven Warsof, M.D., as an expert witness. Dr. Warsof is an obstetrician/gynecologist with a subspecialty in maternal-fetal medicine. He has spent most of his professional career pursuing academic issues in obstetrical ultrasonography. It was his opinion that R.W.’s pregnancy was in the second trimester. He also based his opinion on the weight of the products of conception after delivery. Based on the evidence presented, it is clear and convincing that R.W. was in her third trimester of pregnancy when she had the abortion. The only two doctors who placed the pregnancy in the second trimester based their opinions on the weight of the fetus and placenta at the time of delivery. Because of the complications of R.W.’s pregnancy, it is clear that the fetus had not developed normally and was underweight for its age. There had been a lack of amniotic fluid which is essential to development of the fetus. Based on his office records, it is also clear and convincing that Dr. Pendergraft was under the impression that R.W. was in her third trimester of pregnancy when he performed the abortion. The medical records of Dr. Pendergraft do not contain a written certification from two physicians that within a reasonable degree of medical probability the termination of R.W.’s pregnancy was necessary to save the life or preserve the health of R.W. The evidence established that Dr. Pendergraft wrote in his notes that there was a risk of life-threatening, sudden health issues. Assuming he was referring to the health issues of the pregnant woman, this note could be considered a certification that to a degree of medical probability that the abortion was necessary to preserve the health of R.W. However, there is no written certification from another physician that that was the case, and the note of Dr. Pendergraft that R.W.'s primary care physician concurred with the maternal health reasons for termination of the pregnancy is not a written certification from another physician. The medical records kept by Dr. Pendergraft do not contain a written certification that there is a medical necessity for emergency medical procedures to terminate the pregnancy and that no other physician is available for consultation. No evidence was presented concerning the allegations in Counts IV, V, and VI of the Amended Administrative Complaint.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding Dr. Pendergraft guilty of violations of Subsection 456.072(1)(k), 458.331(1)(g), 458.331(1)(m), and 458.331(1)(t)1., Florida Statutes; dismissing Counts IV, V, and VI of the Amended Administrative Complaint; suspending his license for one year followed by three years of probation with indirect monitoring; imposing an administrative fine of $10,000.00; and denying his motion for attorney's fees pursuant to Subsection 120.595(1)(b), Florida Statutes. DONE AND ENTERED this 26th day of October, 2007, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL 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 26th day of October, 2007.
Findings Of Fact I. Respondents Are Licensed General Surgeons. At all times material hereto, respondents SPIEGEL and EBKEN were licensed to practice medicine in Florida as general surgeons. They practiced as a professional association, with offices located at 9299 Coral Reef Drive, Miami, Florida. They worked closely together, frequently assisting each other in surgical procedures. The respondents are charged with professional misconduct in connection with surgery they performed on Caroline Pedraza, 25, respondent SPIEGEL's patient. (Hereafter she will be referred to as "the Patient.") In four separate courts, the DEPARTMENT accuses them of failing to conform to standards of acceptable and prevailing medical practice in their area of expertise (general surgery). Count I alleges that respondent SPIEGEL, assisted by respondent EBKEN, surgically removed the Patient's uterus (a procedure commonly referred to as a hysterectomy) together with her right ovary, and that, based on what respondent SPIEGEL knew of the Patient's medical history and symptoms, such surgery was unjustified and unnecessary. II. Count I: Removal of the Patient's Uterus and Right Ovary The Patient first saw respondent SPIEGEL on August 1, 1977, pursuant to a referral by Marilyn Marcus, M.D., a general practitioner who also practices office gynecology. As explained by the Patient, Dr. Marcus had referred her to respondent SPIEGEL for a hysterectomy, subject to his decision that such an operation was appropriate. (Testimony of Spiegel; P-3) Upon questioning, the Patient appeared to be troubled and uncomfortable. She complained of irregular menses; severe pain, cramps, and blood spotting during menses; headaches before and during menses; and severe pain during sexual intercourse ("dyspareunia"). She explained that she had experienced these symptoms since her sterilization (by tubal ligation) three years earlier; that a D and C ("dilation and curettage," a procedure by which the cervix is dilated and the inside of the uterus is curetted to obtain tissues for pathologic diagnosis) had been performed on her one year earlier and fibroids had been removed; and that her last menses had lasted three weeks. Respondent SPIEGEL then physically examined her. (Testimony of Spiegel; P-3) His examination revealed, and his office notes document, that the lower portion of the Patient's abdomen was tender. Pelvic examination indicated that her external genitalia, the Bartholin, and the urethra were normal; the cervix showed chronic cystic cervicitis; the ovary (right or left) was of normal size but tender; and the uterus was large, retroverted and retroflexed. When a uterus is retroverted and retroflexed, it is tipped backwards, can impinge on the colon, and is frequently associated with symptoms similar to those complained of by the Patient. (Testimony of Spiegel; P-3) The uterus serves to carry babies and is vital to the birthing process. When a female is sterilized, the uterus no longer serves a useful purpose. Rather, it remains and becomes a potential source of bleeding, infection and cancer. Based on the Patient's complaints and his physical examination, respondent SPIEGEL recommended that she have a hysterectomy, reasoning that removal of the uterus would end her dysfunctional uterine bleeding and cramps; that the Patient's symptoms had been chronic and progressive during the last three years; and that a D and C had previously been performed and fibroids removed. The Patient agreed to the operation and appeared pleased to have some potential for relief. (Testimony of Spiegel, Ebken; R-3) On August 9, 1977, several days later, respondent SPIEGEL admitted her to Miami-Dade General Hospital for the purpose of performing the hysterectomy. The next day he performed the operation and, at his request, respondent EBKEN acted as a surgical assistant. Respondent EBKEN functioned solely as a surgical assistant in this operation; his role was narrow and limited. He did not know the patient, had not talked with her prior to her admission, and was unfamiliar with her medical condition. His lack of knowledge about the Patient was consistent with prevailing and acceptable standards of medical care governing general surgery, which do not require surgical assistants to examine the patients prior to surgery, review their records, or ascertain whether the surgery is justified or necessary. (Testimony of Caster, Ebken, Spiegel) Before performing the hysterectomy on the Patient, respondent SPIEGEL performed a D and C to check for cancer -- the result was negative. (If a cancer had been discovered, he would have first treated the uterus with radiation therapy.) As a precaution he also performed a pregnancy test. Then he commenced surgery. On opening the Patient, respondent SPIEGEL noted that the left ovary looked normal, but that the right ovary was enlarged and appeared to have a corpus lutiem cyst. He judged it appropriate to remove the right ovary, the tubes, and the uterus, but leave the left ovary intact. (Testimony of Spiegel; P-3) He removed the right ovary because it was cystic and enlarged. Normal ovary size is 4 centimeters, which it exceeded. Further, when he manipulated the ovary, it was friable or bled -- an abnormal condition. (Testimony of Spiegel; P-3) The DEPARTMENT contends that respondent SPIEGEL is guilty of misconduct, claiming that the right ovary and uterus were normal and that the operation was unnecessary and unjustified. This contention is unsupported by the weight of the evidence, and is rejected. Under the circumstances of this case, removal of the Patient's uterus and right ovary conformed to, and did not deviate from, standards of acceptable and prevailing medical practice in the area of general surgery. Respondent SPIEGEL's decision to recommend and perform a hysterectomy was consistent with the Patient's complaints, symptoms and medical history; it was a reasonable and permissible exercise of medical judgment. During the operation, the right ovary was observed to be abnormal, enlarged, cystic, and friable. The decision to remove it was also a reasonable, justifiable and permissible exercise of medical judgment. (Testimony of Spiegel, Ebken; R-3) Respondent EBKEN, as a surgical assistant, assisted with the operation. He observed that the Patient's uterus looked normal, but did not protest or question respondent SPIEGEL concerning the purpose or necessity of the operation. (Testimony of Ebken, Spiegel) Respondent EBKEN's conduct as a surgical assistant was proper and conformed to standards of acceptable and prevailing medical practice in the area of general surgery. The primary surgeon is the decision maker in the operating room; an assisting surgeon may give advice, but his main role is to provide assistance to the primary surgeon. A patient's uterus may (and often does) look totally normal on an operating table, yet is properly removed. The decision to remove is arrived at by using a variety of diagnostic tools other than visualization. (Testimony of Spiegel, Ebken; R-3) The DEPARTMENT contends that respondent EBKEN has a medical duty to protest or question respondent SPIEGEL about the necessity for the hysterectomy because the uterus looked "normal." This contention is also unsupported by the weight of the evidence and is rejected. The testimony of Milton P. Caster, M.O. on this question is equivocal and unconvincing. Acceptable and prevailing standards of medical practice in the area of general surgery did not impose such a duty on respondent EBKEN. The retroverted uterus, alone, could have caused some of the symptoms complained of by the Patient and provided justification for its removal. Finally, given the symptoms and medical history of the Patient, the surgery performed by respondent SPIEGEL conformed to prevailing and acceptable standards of medical practice; it follows that respondent EBKEN cannot be guilty of misconduct by virtue of his surgical assistance. (Testimony of Joseph, Spiegel, Ebken; R-3) III. Count II: Performance of Bilateral Subcutaneous Mastectomy In Count II, the DEPARTMENT charges that respondent SPIEGEL, assisted by respondent EBKEN, performed a bilateral subcutaneous mastectomy (removal of internal breast tissue without damaging skin or nipple) on both breasts of the Patient; that this surgery was unnecessary; that neither respondent SPIEGEL nor EBKEN explained the possible adverse effects of surgery to the Patient; and that respondent EBKEN provided surgical assistance without questioning the need for the surgery. Such conduct, the DEPARTMENT alleges, violated acceptable and prevailing standards of medical practice in the area of general surgery, in violation of Section 458.331(1) Florida Statutes (1981). Respondent SPIEGEL next saw the Patient on August 19, 1977, when she came to his office complaining of soreness when she slept on her abdomen and a mass or lump on her left breast. Upon examination, he detected a lump or mass at 2 o'clock on her left breast, preliminarily diagnosed it as fibrocystic disease, and told her to return in two weeks for reexamination. (Testimony of Spiegel; P-3) On September 6, 1977, she returned to his office complaining of a week-long headache, and pain in her left breast. Explaining that she had a family history of breast cancer, she was nervous and jumpy. His examination of her left breast indicated that the lump was larger, dominant, and more tender. Because the lump had become larger and more defined, he recommended a biopsy, to which she agreed. He explained that the biopsy would lead to one of three alternatives. First: If, on examination, the pathologist determined that the breast lump was benign, they would close the incision and send her home. Second: If, instead, the tissue is found to be malignant (cancerous) he recommended the immediate performance of a radical mastectomy--removal of the entire breast, including the skin, nipple, and the pectoralis major and minor chest muscles. He explained that there were alternative cancer treatments which would cause less disfigurement -- radiation, lumpectomy, and a modified radical mastectomy -- but that, in his opinion, the radical mastectomy was the most statistically effective method for eliminating breast cancer. She agreed that if her breast was found to be cancerous, he should immediately perform a radical mastectomy. Third: If the pathologist, for one reason or another, is unable to definitively determine whether the breast lump is benign or cancerous, no further surgery would be performed until a definite conclusion was forthcoming. (Testimony of Spiegel; P-3) On September 9, 1977, the Patient was admitted to Miami-Dade General Hospital for the scheduled biopsy. Before it was performed, a hospital physician did a patient history and physical on her -- a procedure the hospital routinely followed prior to surgery. The history described her illness: Patient is a 25-year-old white female admitted to Miami-Dade Hospital with left breast mass. Patient has strong family history of carcinoma of the breast and is scheduled for biopsy and frozen section in the A. M. and possible mastectomy. Patient states that she noticed the lump two years ago and on [sic] the past two months she has been getting pain and increase in size. Patient states lump is in the lower left quadrant of the left breast (TR 112-113) Respondent SPIEGEL then performed the biopsy. (Respondent EBKEN did not attend, assist, or have any involvement with, the biopsy.) The pathologist, who was at first unable to make a definite determination, ultimately determined that the breast lump was not cancerous; that, rather, it indicated three diseases: fibrocystic disease, intraductal papillomatosis, and sclerosing adenosis of the breast. These are "pre-malignant" diseases. (Testimony of Spiegel, Ebken; P-3) Respondent EBKEN visited the Patient in the hospital the day after the biopsy (a Saturday), since he had agreed to cover respondent SPIEGEL's patients that weekend. Respondent EBKEN discussed the pathology reports with the pathologist, then met with the Patient and told her that she did not have cancer. He explained the significance of the three "pre-malignant" diseases and described alternative treatments, including monitoring and frequent breast examination, and a subcutaneous mastectomy. The nurses' progress notes confirm that respondent EBKEN explained the pathology report to the Patient at that time, and the patient's denial that this occurred is rejected. Respondent EBKEN also wrote a progress note on the Patient, then issued an order authorizing her discharge from the hospital. (Testimony of Spiegel, Ebken, Waltuck; P-5, R-1, R-3) On September 19, 1977, the Patient visited respondents' offices for the removal of the biopsy sutures. She asked respondent EBKEN (because respondent Spiegel was absent) about breast cancer, stating that she had two maternal aunts who had breast cancer and that she had decided to "go ahead" with the subcutaneous mastectomy (with implants), the procedure which he had earlier discussed with her in the hospital. He removed her sutures and told her to return in three weeks and discuss the matter further with respondent SPIEGEL. (Respondent EBKEN did not see or talk with the Patient again until May, 1978, subsequent to her undergoing a subcutaneous mastectomy in October, 1977, and a left oophorectomy (removal of left ovary) in May, 1978.)(Testimony of Ebken, Spiegel; P-3) As instructed by respondent EBKEN, the Patient returned on October 5, 1977, and talked to respondent SPIEGEL. She told him that she wanted a subcutaneous mastectomy, with implants, something that SPIEGEL had not previously discussed with her. Although it appeared that she had already made up her mind, he described the risks and benefits of such surgery and told her that, if he performed the operation, he required the assistance of a plastic surgeon. He described alternative treatment methods such as follow-up monitoring and frequent reexamination, and the potential for future biopsies. She indicated that she was anxious to proceed with the subcutaneous mastectomies, that she did not want more biopsies or further worry, that she wanted to end her breast pain and have steps taken which were most likely to eliminate the possibility of her getting breast cancer. She understood that her diagnosed breast diseases increased the likelihood of her getting cancer; her fear of cancer had some basis. Intraductal papillomatosis is a pre-malignant lesion which significantly increases the risk of getting breast cancer. (Testimony of Spiegel, Ebken, Coury; R-3) On October 6, 1977,--at respondent SPIEGEL's request--the Patient and her husband visited Frederick C. Swenson, M.D., the plastic surgeon scheduled to assist with the breast reconstruction phase of the mastectomy. Dr. Swenson discussed the proposed surgery, including breast implants and reconstruction, and gave them an opportunity to ask questions and express their concerns. (Testimony of Spiegel; R-1) On October 10, 1977, respondent SPIEGEL admitted the Patient to Miami- Dade General Hospital for the subcutaneous mastectomy and implants. Prior to surgery, a hospital physician took a medical-history of the Patient which indicated that she had breast masses, "with previous papillomatosis of left breast, fibrocystic disease and adenosis of breast. Patient has family history of cancer of the breast . . . ." (TR 129) Respondent SPIEGEL's note on her admission to the hospital contained a similar description, reciting that the Patient had a "family history of breast cancer and cancer phobia." (Testimony of Spiegel, Ebken; P-3) On that day, October 10, 1977, the bilateral subcutaneous mastectomy, with implants, was performed on the Patient by respondent SPIEGEL; Dr. Swenson assisted with placing the implants and reconstructing the breasts. The surgery was uneventful, and the DEPARTMENT does not allege that the results were other than promised or reasonably expected. (Testimony of Spiegel, Ebken; R-1; P-3) Rather, the DEPARTMENT contends that, under the circumstances, the bilateral subcutaneous mastectomy of both breasts was inappropriate, unjustified, and violated standards of acceptable and prevailing medical practice in the area of general surgery. This contention is unsubstantiated by the weight of the evidence and is rejected. General surgeons are allowed a wide range in the exercise of judgment and discretion on whether to perform a mastectomy when the breast is not malignant but other indicators are present which increase the likelihood of cancer occurring in the future. Here, the indicators were: a strong family history of cancer, multiple papillomatosis, severe lump in the breast, severe breast pain, and extreme fear of cancer. The pre-malignant diseases in the Patient's breast increased her risk of acquiring cancer in the future by three to five times that of the general public. The DEPARTMENT has shown that reasonably prudent similar physicians would have recommended treatment different than that recommended by respondent SPIEGEL, and refused to perform the mastectomies. Conversely, the evidence shows, with equal force, that other reasonably prudent similar physicians agree with, and have no objection to respondent SPIEGEL's actions. Since the evidence does not convincingly show, with the requisite substantiality, that respondent SPIEGEL's conduct violated the standard of acceptable and prevailing medical practice in the area of general surgery, it must be concluded that his actions constituted a permissible exercise of medical judgment and discretion. (Testimony of Coury, M.D., Joseph, M.D.; R-4) As to the conduct of respondent EBKEN, the evidence is insufficient to prove that he was negligent or guilty of professional misconduct toward the Patient. He informed her of the results of the pathology report, described a bilateral subcutaneous mastectomy and alternative treatments, including risks and benefits; he did not assist in the actual surgery. (Testimony of Ebken) IV. Count III: Alleged Misrepresentation in Obtaining Patient's Consent to Mastectomy In Count III, the DEPARTMENT alleges that the respondents induced the Patient to consent to the mastectomy by telling her that her left breast was malignant and that a mastectomy was an absolute necessity; that such misrepresentation deviates from standards of acceptable and prevailing medical practice in the area of general surgery. This charge, too, is unsupported by the weight of the evidence. As already established, the respondents described to the Patient, prior to surgery, the true nature of her breast disease -- that her breast was not malignant, although the diseases were considered pre-malignant. The Patient's own statements believe the allegation that respondents told her she had breast cancer. On separate occasions, she acknowledged to Oswald Coury, M.D., Bernard Waltuck, M.D., and Robert Hartog, M.D. that she knew, prior to surgery, that her breast was not cancerous. The physicians' and nurses' notes made during her hospitalization also corroborate respondents' assertion that they had told the Patient, and she was aware, that her breast was not cancerous. (Testimony of Coury, Hartog, Waltuck, Ebken, Spiegel; P-3, P-5) The only evidence offered to substantiate this charge is the deposition testimony of the Patient. She was an interested witness, having already sued respondents for civil damages. Her testimony was marked by evasiveness and uncertainty; she had difficulty recalling, and responding to questions about the facts. Her testimony lacks credibility. Count IV: Removal of the Patient's Left Ovary In Count IV, the DEPARTMENT alleges that respondent SPIEGEL surgically removed the patient's left ovary without medical justification. On October 28, 1977, the Patient returned to respondent SPIEGEL's office complaining of hot flashes, and pain in her breasts. The breasts appeared to be healing normally. Tubal ligations and hysterectomies may affect the supply of blood to the ovaries. (Knotting-off some of the nearby vessels may affect the functioning of an ovary.) Respondent SPIEGEL concluded that she had a hormone deficiency because the remaining left ovary was not functioning properly. As treatment, he prescribed Premarin, an estrogen-type (hormonal) medication to be taken the first 25 days of each month. (Testimony of Spiegel; P-3) On November 18, 1977, the Patient returned to respondent SPIEGEL's office with more complaints of hot flashes. He doubled the Premarin dosage. (Testimony of Spiegel; P-3) On December 16, 1977, the Patient returned to respondent SPIEGEL's office complaining of pain on the lower left side of her abdomen. He conducted a pelvic examination and found her left side tender but could not detect a mass. She appeared otherwise to be normal. As treatment, he increased the Premarin, prescribed an antibiotic, and suggested warm douches. (Testimony of Spiegel; P- 3) When she returned on January 17, 1978, she again complained of pain in the lower left quadrant of her abdomen. On examination, respondent SPIEGEL found tenderness, the left ovary was palpable and tender. He told her to return in two months for reexamination. (Testimony of Spiegel; P-3) She returned to his office in May, 1978, complaining of continued pain and tenderness in the lower left part of her abdomen, where the left ovary is located. He conducted another pelvic examination, this time finding that the left ovary was tender, and larger than four centimeters. He concluded, based on his seven months of treatment, that she had developed a pathologically enlarged left ovary. He discussed and recommended surgical removal of the remaining left ovary, explaining that such surgery would require her to take hormone supplements on a continuing basis. (Testimony of Spiegel; P-3) She consented to the surgical removal of her left ovary, a technique known as a left oophorectomy. Respondent SPIEGEL admitted her to the hospital, and, on May 10, 1978, performed the left oophorectomy. The left ovary was shown to be larger than normal, cystic and suggestive of endometriosis, a painful ovarian abnormality. The surgery was uneventful, and properly performed. (Testimony of Spiegel; P-3, P-5) This surgical procedure unequivocally provided the Patient relief from her abdomen pain, her complaints ceased. (Testimony of Spiegel; P-3) This charge, too, is unsubstantiated by the requisite quantum of evidence. The Patient's left ovary was enlarged, cystic, tender, and a source of chronic pain from December, 1977 to May, 1978. Its sole function was to produce female hormones, but since the Patient's right ovary had already been removed, she required, in any case, hormone supplements. Under these circumstances, respondent SPIEGEL's performance of a left oophorectomy conformed to, and did not deviate from, standards of acceptable and prevailing medical practice in the area of general surgery 2/ . The surgery, in fact, relieved the Patient of the chronic pain she had been suffering during the preceding six months. (Testimony of Spiegel, Joseph; P-3)
Recommendation Based on the foregoing, it is RECOMMENDED: That all administrative charges against respondents be Dismissed. DONE and ENTERED this 10th day of June, 1983, in Tallahassee, Florida. R. L. CALEEN, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 10th day of June, 1983.
Findings Of Fact Based upon the evidence adduced at hearing, and the record as a whole, the following Findings of Fact are made: The Agency is a state government licensing and regulatory agency. Respondent is now, and has been since July 1, 1980, an endocrinologist licensed to practice medicine in the State of Florida. His license number is ME 0036628. At no time during the period that he has been licensed to practice medicine in the State of Florida has he had any disciplinary action taken against him by the Board of Medicine. Respondent is board certified in internal medicine, nuclear medicine and endocrinology and metabolism. At all times material to the instant case, Respondent was in private practice in Palm Beach County, Florida. One of his patients was L.Y., who, at the time of her first visit, was 75 years of age. L.Y. had been treated by at least two other endocrinologists, Rachmel Cherner, M.D., and William Abelove, M.D., for a thyroid abnormality before being referred to Respondent for treatment. A physical examination of L.Y. conducted during a visit to Dr. Cherner's office in Pennsylvania in early September of 1984, revealed that there was "a firm three centimeter nodule in the inferior pol[e] of the right lobe" of L.Y.'s thyroid gland and that the "inferior margin of the gland apparently dip[ped] substernal." 2/ Dr. Cherner ordered a thyroid uptake and scan. The uptake and scan were performed on September 5, 1984. Dr. Cherner received the following report of the results of the uptake and scan: Thyroid studies were performed following the oral administration of 100 uCi. of Iodine 123 on 9/5/84. The thyroid uptake is 15 percent at 4 hours and 41 percent at 24 hours. The 24 hour value is in the high/normal to slightly elevated range for this age group. Visualization of the thyroid reveals the gland to be prominent due to enlargement of the right lobe. There is a relatively homogeneous distri- bution of nuclide in a normal size left lobe. The right lobe is slightly enlarged and bulboused. There is marked nuclide irregularity laterally suggesting one or more "cold" nodules. 3/ There is slightly increased activity noted inferiorly in the right lobe but this finding is less impressive. In February of 1985, L.Y. was seen by Dr. Abelove in Dr. Abelove's office in Coral Gables, Florida. Dr. Abelove's notes relating to the visit read as follows: [L.Y.] is a 71 year old female, resident of Delray Beach, Florida, referred by Dr. Cherner in Jenkintown for thyroid follow-up. [L.Y.] was found by Dr. Cherner to have enlargement of the right lobe of the thyroid gland. On September 5, 1984, he had a thyroid uptake and scan done at Abington Memorial Hospital. Uptake at four hours was 15 percent and at twenty-four hours was 41 percent. Thyroid scan disclosed the right lobe to be enlarged and bulboused with marked [n]uclide irregularity suggesting one or more cold nodules. [L.Y.] clinically is euthyroid. She has been on Hydrodiuril 50 mg. once daily in the AM and Valium 5 mg. prn for some time. Weight is stable. Physical examination disclosed slight stare but no significant tremors. Skin was dry. Palms were warm and dry. The right lobe of the thyroid gland was irregularly enlarged to about two and one-half to three times normal size. Left lobe was normal. The gland was not tender. Heart and lungs were okay. Reflexes were normal. I think [L.Y.] has a nodular goiter involving the right lobe of her thyroid gland. The uptake of radioactive iodine was marginal at 41 percent and she does have a slight stare but clinically no other findings compatible with hyperthyroidism. Her goiter has not increased in size and she has no hoarseness or dysphagia. Dr. Cherner felt that observation was indicated and he planned to repeat her thyroid scan. I will be in contact with him and advise her accordingly. Pursuant to Dr. Abelove's orders, an uptake and scan of L.Y.'s thyroid were performed on April 26, 1985, the results of which were reported as follows: The scan shows enlarged nodule over the base of the right lobe of the thyroid gland. This nodule [is] hypofunctioning 4/ when compared with the adjacent right and left lobes. The uptake values at 4 and 24 hours are 10.5 percent . . . and 23.1 percent . . . respectively. These are within euthyroid range. OPINION: Thyroid uptake and scan Hypofunctioning nodule right thyroid lobe. Thyroid uptake within euthyroid range. L.Y. next visited Dr. Abelove on November 14, 1985. Dr. Abelove's notes relating to this visit read as follows: [L.Y.] returns for a follow-up visit. In late April of this year, she had a thyroid uptake and scan done at the Bethesda Memorial Hospital. Thyroid function was normal The scan disclosed a hypofunctioning nodule. [L.Y.] remains asymptomatic. She's aware of the presence of the nodule and on physical examination it is unchanged. It involves the right lobe only and is somewhat irregular with the lobe being 2 1/2 times normal size. She denies any dysphagia or hoarseness. Weight is stable. Clinically, she is euthyroid. She remains on Hydrodiuril 50 mg once daily in the a.m. and Valium 5 prn. MHP ordered for today. My recommendation is a trial on thyroid suppression using Synthroid 0.05 mg once daily. 5/ Will call the results of the MHP to her tomorrow. I've asked [L.Y.] to call me in about 2 months and let me know if she notices any change on Synthroid 0.05 daily. Dr. Abelove next saw Respondent on May 21, 1987. His notes relating to this visit read as follows: [L.Y.] returns for a follow-up visit, having been seen last in November of 1985. She remains on Synthroid 0.05 mg daily. Clinically, she is euthyroid. Examination of her neck shows little change. The right lobe is irregularly enlarged and approximately 2 1/2 times normal size. The left lobe is not significantly palpable. Heart and lungs are okay. [L.Y.] is also on Hydrodiuril 50 mg once daily and calcium. I suggested that she have a complete work up while she is here. MHP, EKG, chest x-rays and dual photon absorption densi- tometry were ordered. We will discuss the findings with her when everything is completed in several days. In the meantime, she is to increase Synthroid to 0.1 daily. She was given Rxs for Hydrodiuril 50 mg to be taken once daily. We will speak to her next week. She finds it extremely difficult to drive here from Delray Beach as it takes her 2 hours. I am going to give her the name of an endocrinologist in Boca whom she can see for follow-up. Respondent was the "endocrinologist in Boca" to whom Dr. Abelove referred L.Y. 6/ L.Y. first presented to Respondent on November 22, 1988. At the time of the visit, Respondent did not have any of L.Y.'s prior medical records. At the outset of the visit, Respondent took a history from L.Y. 7/ L.Y. told Respondent that she had a thyroid "nodule" that Drs. Cherner and Abelove had monitored for the past five years and that she had been advised that there was a "low chance" that the "nodule" was malignant. 8/ Respondent then conducted a physical examination of L.Y. As part of the examination, he palpated L.Y.'s thyroid and noted a "prominent nodule 9/ in the lower pole of the right lobe." Based upon the history provided by L.Y. and his physical examination of her, Respondent reasonably believed that she had a multinodular goiter. Multinodular goiters are not uncommon in elderly persons. Unless they are characterized by a dominant mass, they generally have a low potential for malignancy. Accordingly, they are not always biopsied. Multinodular goiters that are not biopsied, however, should be carefully monitored, with particular attention paid to any changes in their size or the pattern of their growth that may be indicative of the presence of a carcinoma. Accurate measurements are necessary to determine if such changes have taken place. It is impossible to obtain such accurate measurements simply by physical examination where, as was situation in L.Y.'s case, a portion of the thyroid lies beneath the sternum. In such instances, a CAT scan or ultrasound must be performed to get the needed information. Consistent with the approach Drs. Cherner and Abelove had taken, Respondent did not perform or order a "fine-needle" biopsy 10/ or any other type of biopsy to ascertain whether L.Y. had thyroid cancer. Instead, he instructed L.Y. to continue to take thyroid suppression medication and to return to his office for reevaluation on at least an annual basis. At no time during, or in conjunction with, this initial visit did Respondent order a CAT scan or ultrasound or otherwise attempt to obtain any measurements of L.Y.'s thyroid. On October 24, 1989, L.Y. returned to Respondent's office for a follow-up visit. Respondent examined L.Y., but did not order a CAT scan or ultrasound or otherwise attempt to obtain any measurements of L.Y.'s thyroid. He determined that L.Y.'s "right prominent thyroid nodule [was] unchanged from last year," notwithstanding that he did not have the benefit of any measurements upon which to base such a conclusion. Respondent did not discover anything during L.Y.'s October 24, 1989, visit to cause him to perform or order a biopsy or to otherwise alter his course of care and treatment of L.Y. He continued L.Y. on thyroid suppression medication and asked her to return to his office for a follow-up visit in approximately a year. L.Y. made such a visit on November 12, 1990. Once again, Respondent examined L.Y., but failed to order a CAT scan or ultrasound or otherwise attempt to obtain any measurements of L.Y.'s thyroid. As he had done during L.Y.'s previous visit the year before, Respondent determined that the "thyroid nodule in her right lobe was unchanged," although he did not possess any measurements that would support such conclusion. Respondent did not discover anything during L.Y.'s November 12, 1990, visit to cause him to perform or order a biopsy. In light of the results of recent blood tests that L.Y. had taken, Respondent adjusted the dosage of L.Y.'s thyroid suppression medication. He made no other changes to her treatment regimen as a result of her November 12, 1990, visit. L.Y. made an unscheduled visit to Respondent's office on October 4, 1991, complaining of pain and inflammation near the medial aspect of her clavicle. Examination of her neck revealed marked swelling, which led Respondent to suspect that L.Y. had sustained a clavicular fracture. Respondent referred L.Y. to the emergency room of Delray Community Hospital for x-rays and treatment. L.Y. went to the emergency room. X-rays were taken. In addition, a CAT scan, which was ordered by the emergency room physician, was performed. The radiologist who read the CAT scan stated the following in a written report of his findings: There is a 7 mm [sic] well circumscribed inhomogeneous mass 11/ that replaces the right lobe of the thyroid. This is charac- terized by multifocal areas of low attenuation. 12/ There is marked left sided displacement of the trachea. The left lobe of the gland is unremarkable. CONCLUSIONS: 7 cm 13 inhomogeneous right thyroid mass. This may represent goiter with degenerated adenomas. But carcinoma cannot be excluded. 14/ The radiologist's report supported Respondent's view that L.Y. had a multinodular goiter and it did not contain any information that caused Respondent to suspect that L.Y. had thyroid cancer. Respondent, however, was unable to evaluate the significance of the finding that the "thyroid mass" described in the report was now "7 cm" inasmuch as he did not have any prior measurements of the full extent of this "mass" and therefore could not ascertain whether this "7 cm" measurement represented a significant increase in the size of the "mass." After consulting with the emergency room physician who had seen L.Y., Respondent prescribed Voltaren, an anti-inflammatory medication, for L.Y. and instructed her to return for a follow-up office visit in ten days. No biopsy was performed or ordered. L.Y. returned to Respondent's office on October 14, 1991, and was examined by Respondent. The swelling that Respondent had noted during L.Y.'s October 4, 1991, visit had "disappeared." The examination further revealed that L.Y.'s thyroid was "still enlarged." Respondent continued to believe that L.Y.'s enlarged thyroid was nothing more than a multinodular goiter with a low potential for malignancy and that it therefore did not need to be biopsied. Accordingly, no biopsy was performed or ordered. L.Y.'s next visit to Respondent's office was on September 4, 1992. During this visit, L.Y. reported that she felt well and that she was "having no further trouble with her clavicle." At the time of the visit, her weight was 121 pounds, seven and a half pounds less than she weighed on her last visit and thirteen pounds less than she weighed on her initial visit to the office on November 22, 1988. L.Y. attributed her weight loss to her having "changed her diet and markedly cut down on her intake of fat," a reasonable explanation that Respondent accepted. Respondent's examination of L.Y. revealed that she still had a "huge right thyroid lobe," which, in Respondent's opinion, had not changed since the last time he had seen her. Respondent, however, did not order a CAT scan or ultrasound or otherwise attempt to obtain the current measurements of this "huge right thyroid lobe" to see if it had grown since the October 4, 1991, CAT scan. L.Y. next visited Respondent's office on October 2, 1992. This was an unscheduled visit. Upon presenting at the office, L.Y. indicated that she was very concerned about her "thyroid nodule" because she felt that it was changing. Respondent's examination of L.Y.'s neck revealed a "huge thyroid mass." Respondent believed the "mass" to be "unchanged from prior examinations." Nonetheless, given L.Y.'s concerns, Respondent performed a "fine needle" biopsy "to determine the histology of this lesion." In waiting almost four years from the time of L.Y.'s initial visit to his office to perform such a biopsy, without having ordered, during this period of time, the CAT scans or ultrasounds that were necessary to properly monitor L.Y.'s multinodular goiter, Respondent acted in a manner that was inconsistent with what a reasonably prudent endocrinologist would have recognized as being acceptable and appropriate under the circumstances. The aspirate material collected from the biopsy was sent to a pathologist, Albert Cohen, M.D., for analysis. Dr. Cohen analyzed the biopsied aspirate and made the following findings, which he set forth in a written report: Multiple slides and fluid from cell block from thyroid aspiration biopsy showing markedly cellular aspirate with clusters of thyroid follicular cells some of these in papillary configuration and others scattered in a loose fashion. In addition there are large numbers of giant cells with many of the cells in the cell block showing mitotic activity. The differential diagnosis in this case is of a poorly differentiated neoplasm with giant cell features, including medullary, papillary or undifferentiated carcinoma. NOTE: Due to the marked cellularity and the giant cell formation of this aspirate, surgical excision is strongly recommended. The presence of giant cells in the biopsied aspirate indicated that L.Y. had an anaplastic carcinoma, which is an extremely aggressive and fast growing form of cancer. 15/ The prognosis for patients with an anaplastic carcinoma of the thyroid is very poor. The average life expectancy of such patients is approximately seven months from the time of diagnosis. L.Y. returned to Respondent's office on October 8, 1992. Respondent informed her of the results of the biopsy and suggested that she undergo a thyroidectomy. L.Y. indicated that she wanted to discuss the matter with her family before deciding whether to have the procedure performed in Florida or New York. In February of 1993, L.Y. died as a result of a metastatic carcinoma of the thyroid.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby recommended that the Board of Medicine enter a final order finding Respondent guilty of the violation of subsection (1)(t) of Section 458.331, Florida Statutes, alleged in the Administrative Complaint, and disciplining him for having committed this violation by fining him $2,500.00 and placing him on probation for a period of two years, subject to those terms and conditions the Board deems appropriate. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 16th day of June, 1995. STUART M. LERNER 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 16th day of June, 1995.
