Findings Of Fact Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.30 and Chapters 455 and 458, Florida Statutes. Respondent is a licensed physician in the State of Florida and holds license number ME 0043566. Respondent has never been the subject of a previous complaint from the Department of Professional Regulation (now the Department of Business and Professional Regulation). No patient involved in this proceeding incurred injury as a result of any procedure performed by Respondent or as a result of any medical record kept by Respondent, nor did any patient claim injury or make a complaint against Respondent. Respondent derived no financial gain from any act or omission alleged in the administrative complaint. All events pertaining to this proceeding occurred in 1987 or 1988. Prior to February 8, 1988, the effective date of Chapter 88-1, Laws of Florida, Section 458.331(1), Florida Statutes provided, in pertinent part, as follows: The following acts shall constitute grounds for which the disciplinary action specified in subsection (2) may be taken. * * * (m) Failing to keep written medical records justifying the course of treatment of the patient, including, but not limited to, patient histories, examination results, and test results. * * * (t) Gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment which is acceptable under similar conditions and circumstances. The board shall give great weight to the provisions of s. 768.45 when enforcing this paragraph. As used in this paragraph, "repeated malpractice" includes, but is not limited to, three or more claims for medical malpractice within the previous 5-year period resulting in judgment or settlement and which incidents involved negligent conduct by the physician. As used in this paragraph, "gross malpractice" or "the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances", shall not be construed to require more than one instance, event, or act. Section 25 of Chapter 88-1, Florida Statutes, became effective February 8, 1988, and amended the pertinent provisions of Section 458.311(1), Florida Statutes, to read as follows: The following acts shall constitute grounds for which the disciplinary action specified in subsection (2) may be taken. * * * (m) Failing to keep written medical records justifying the course of treatment of the patient, including, but not limited to, patient histories, examination results, test results, records of drugs prescribed, dispensed, or administered, and reports of consultations and hospitalizations. * * * (t) Gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment which is acceptable under similar conditions and circumstances. The board shall give great weight to the provisions of s. 768.45 when enforcing this paragraph. As used in this paragraph, "repeated malpractice" includes, but is not limited to, three or more claims for medical malpractice within the previous 5-year period resulting in judgment or settlement and which incidents involved negligent conduct by the physician. As used in this paragraph, "gross malpractice" or "the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances", shall not be construed to require more than one instance, event, or act. Nothing in this paragraph shall be construed to require that a physician be incompetent to practice medicine in order to be disciplined pursuant to this paragraph. At the times pertinent to this proceeding, Petitioner had adopted no rules pertaining to the keeping of records by a licensed physician. Imperial Point Medical Center (Imperial Point) is a hospital located in Broward County, Florida. Unless otherwise indicated, all hospital records referred to in this matter are from Imperial Point. PATIENT #1 (C.S.) On August 8, 1988, Respondent performed an upper endoscopy on Patient #1, a male, who was 44 years old at the time of the procedure. This procedure was performed at Imperial Point on an outpatient basis. An upper endoscopy is the viewing of the mouth, the pharynx, the esophagus, the stomach and portions of the duodenum with a fiber optic instrument that allows direct visualization of the lining of these structures and allows therapeutic maneuvers. The records kept of this procedure performed on Patient #1 on August 8, 1988, include an outpatient hospital record entitled "Operative Report". The description of the procedure portion of this report includes the following: ". . . The gastric portion was infiltrated with 1:1,000 adrenaline . . ." Adrenaline, also known as epinephrine, is a vasoconstrictor that can be used to control minor bleeding and oozing. It is used regularly in gastroenterology to treat actively bleeding lesions or ulcers with evidence of recent bleeding prior to performing a more permanent type of hemostasis. Dr. Goldberg testified that epinephrine was usually injected into these areas by a needle. Dr. Goldberg was of the opinion that epinephrine should not be used in cases of trivial bleeding or oozing or after routine biopsies unless there is an imminent danger of a significant arterial bleed. The testimony of Dr. Cerda and Dr. Singh established that spraying epinephrine over an area that is subject to bleeding is a precautionary technique some gastroenterologists follow. Dr. Singh and Dr. Cerda have both either used this technique, or have observed its use by other physicians. The expert witnesses agreed that the injection by needle of epinephrine into the gastric wall would be a procedure that falls below an established standard of care. There was a dispute among the expert witnesses as to how the term "infiltrated" should be interpreted. Petitioner contends that the term "infiltrated" is synonymous with the term "injected", and that the medical records should be construed to mean that Respondent injected the gastric wall with a needle, and therefore practiced below the standard of care. This contention is consistent with the testimony of Dr. Goldberg. Respondent asserts that the medical record should be construed to mean that Respondent sprayed the gastric wall as a precautionary measure. This contention is consistent with the testimony of the expert witnesses who testified on behalf of the Respondent. This dispute is resolved by finding that the term "infiltrated" does not have the same meaning as the term "injected" and does not prove that Respondent injected Patient #1's gastric wall with a needle. This conclusion is based, in part, on the definition of the term "infiltrate" and on the context in which epinephrine is sometimes administered by gastroenterologists during this type procedure. According to The American Heritage Dictionary of the English Language, the term "infiltrate" means to pass a liquid or a gas into something through its interstices or to permeate with a liquid or gas passed through interstices. Dorland's Illustrated Medical Dictionary, Twenty Sixth Edition (Dorland) has a similar definition of the term "infiltrate". According to Dorland, an "interstice" is small interval, space, or gap in a tissue or structure. According to Dorland, the term permeate means to penetrate or pass through, as through a filter. Also according to Dorland, the term inject means the act of forcing a liquid into a part, as into the subcutaneous, the vascular tree, or an organ. Based on these definitions, it is found that the use of the term "infiltrate" is more consistent with the practice of spraying epinephrine onto the gastric wall, and that the use of the term "infiltrate" does not prove that Respondent injected the epinephrine into the gastric wall with a needle. It is found that Petitioner failed to prove that the use of epinephrine was improper or that the manner in which Respondent used the epinephrine during the subject procedure was improper. Since Petitioner failed to prove that Respondent injected Patient #1 with epinephrine, its charge that Respondent failed to document his reasons for doing so must also fail. A pathology report dated August 8, 1988 contained in the medical file provided a pathological diagnosis as follows: "esophageal brushings: no evidence of malignancy." Brushings are the result of passing a small brush through the biopsy channel of an endoscope, rubbing it over an area of concern that might have either a malignancy or a fungal infection, taking the brush out of the scope, wiping it on a microscopic slide, and sending the slide to the pathologist for cytological examination. The reference to the "esophageal brushings" in the pathology report was error. The brushings taken from Patient #1 during the procedure on August 8, 1988, came from the stomach, a fact obvious to all of the expert witnesses in light of the operative report and operative drawing made by Respondent. Because Petitioner failed to prove that Respondent took esophageal brushings from Patient #1, its charge that he failed to properly document his reasons for doing so must also fail. 1/ Petitioner proved that Respondent's medical records, including his office notes as to Patient #1 failed to contain an adequate medical history for Patient #1 and failed to reflect the findings of any physical examination of Patient #1 by Respondent. Petitioner further proved that such failures fall below an established standard of care as alleged in Count Two of the Amended Administrative Complaint. PATIENT #2 (R.B.) Patient #2 was a 70 year old male seen by Respondent for a consultation because of the patient's history of hematemesis, which is the vomiting of blood. Respondent prepared a formal consultation note dated September 25, 1988. The consultation note contains a description of the patient's condition, references a rectal exam, which was positive for blood, and indicates that a physical examination of the patient was made. Respondent again saw the patient on September 27, 1988 and performed an upper endoscopy. Dr. Goldberg was critical of the medical records kept by Respondent as to this procedure and was of the opinion that the medical records were inadequate. Other, equally credible expert witnesses were of the opinion that the medical records provided sufficient information to document the procedure. While it may be concluded that Respondent's medical records could be improved, it is found that Petitioner failed to prove that the medical records pertaining to this patient were inadequate. It is further found that Petitioner failed to prove the standard by which the adequacy of medical records are to be judged, other than the pertinent statutory standards set forth above. The records kept of this procedure reflect that Respondent "infiltrated" Patient #2 with epinephrine. This is the identical dispute over the meaning of the term "infiltrated" that pertained to Patient #1 as discussed above. For the reasons given in resolving the dispute as it pertains to Patient #1, it is found that the term "infiltrated" does not have the same meaning as the term "injected" and that the use of the term does not prove that Respondent administered the epinephrine by injecting Patient #2 with a needle. It is found that Petitioner failed to prove that the use of epinephrine was improper or that the manner in which Respondent used the epinephrine during the subject procedure was improper. Since Petitioner failed to prove that Respondent injected Patient #2 with epinephrine, its charge that Respondent failed to document his reasons for doing so must also fail. PATIENT #3 (B.B.) Patient #3, a 65 year old female was admitted to Imperial Point with chest pains by her physician, a Dr. Fanfan. Patient #3 had a history of cancer which included the prior surgical removal of a tumor. On October 3, 1988, Respondent performed a colonoscopy of Patient #3. A colonoscopy is an examination of the colon from the anus to the ileocecal valve using a fiber optic instrument. A colonoscopy is indicated to evaluate abnormal X-rays, changes in bowel habits, evidence of bleeding, suspicions of inflammation, tumors, or polyps. Respondent adequately performed the procedure on Patient #3. The colonoscopy detected that Patient #3 had polyps. Subsequent laboratory results established that these were hyperplastic polyps that required no follow-up. Had the polyp been an adenomatous polyp, which is a true neoplasm with malignant potential, a follow-up for recolonoscopy would have been appropriate in one year. Prior to receiving the pathology reports, on the polyp, Respondent recommended a six month follow-up for the patient. This follow-up recommendation was appropriate at the time it was made. Petitioner failed to prove that the recommendation that a follow-up be performed was below an established standard of care. Petitioner failed to prove that the recommendation that the follow-up for this patient with a history of cancer be in six months as opposed to one year fell below an established standard of care. The barium enema for this patient was originally scheduled by the attending physician, Dr. Fanfan. Dr. Fanfan clearly wrote a note on the same day following Respondent's report of the colonoscopy that the barium enema was pending, yet the attending physician did not cancel the barium enema. There is no disagreement among the experts that the barium enema was unnecessary in light of the findings of the colonoscopy. It is medically unnecessary and inappropriate for both tests to be performed on the same day. Dr. Goldberg was of the opinion that Respondent was responsible for the patient once he began his consultation and that Respondent should have canceled the barium enema. Dr. Cerda, Dr. Eberly and Dr. Singh were of the opinion that the attending physician was responsible for scheduling the barium enema and that the attending physician or the radiologist should have canceled the barium enema. Dr. Eberly testified that as the primary care physician, the admitting physician is the "captain of the ship" and has the responsibility to make final determinations with respect to tests of this nature. Because of the conflicting testimony from equally credible expert witnesses, it is found that Petitioner failed to prove that Respondent violated an established standard of care by not cancelling Patient #3's enema. Dr. Goldberg was of the opinion that Respondent's medical records pertaining to Patient #3 were inadequate. He had several criticisms of the records. Dr. Goldberg opined that there should have been a formal consultation note on Patient #3's chart that included past history, present illness, review of systems, allergies, pertinent laboratories, a thorough organ specific or system examination, an impression, an adequate discussion of the consultant's impression and the consultant's plans. He opined that the indications for Patient #3's procedure were inadequately dictated on the procedure notes and that Respondent's history pertaining to Patient #3 was inadequate because there was no pertinent review of systems or past history, no mention of the previous tumor, no mention of allergies, and an extremely scant examination. Other, equally credible expert witnesses were of the opinion that the medical records were adequate. It is found that Petitioner failed to prove the standard by which the adequacy of this patient's medical records are to be judged, other than the pertinent statutory standards set forth above. While it may be concluded that Respondent's medical records could be improved, it is found that Petitioner failed to prove that the medical records fell below an established standard of acceptability. PATIENT #4 (E.K.) On October 4, 1988, Patient #4, a 92 year-old female, was admitted to the hospital with an acute onset of vomiting, dehydration, and abdominal pain. Respondent was asked by Patient #4's attending physician to evaluate Patient #4 for a potential small bowel obstruction following an X-ray that was consistent with a small bowel obstruction. Respondent performed an upper endoscopy on Patient #4 on October 7, 1988. An obstruction of the intestines is a blockage in the large or small intestine. The bowel behind the blockage may become inflated with fluid or air and may be seen on X-ray. The obstruction may result from a variety of abnormalities. Dr. Goldberg was of the opinion that the upper endoscopy was contra- indicated and potentially dangerous to the patient because of the X-ray indicating a complete bowel obstruction. Dr. Goldberg was also of the opinion that an upper endoscopy should be used only under compelling circumstances if there is a partial bowel obstruction. Dr. Goldberg was of the opinion that Respondent did the right tests on Patient #4, but in the wrong order since he did not first rule out an obstruction. Prior to performing the upper endoscopy Respondent monitored the patient for several days. During that time period, examinations indicated that the patient was having bowel movements. Both the attending physician's notes, Respondent's notes, and the nurse's notes indicate positive bowel signs on October 5 and 6, indicating that there was not a complete bowel obstruction. Respondent ordered a Golytely preparation administered to the patient, which usually consists of one or two liters of non-absorbable solution that basically washes the bowel out. That preparation would have been improper with a complete bowel obstruction. Dr. Goldberg was of the opinion that the use of a Golytely prep in this patient was a gross judgment error. Dr. Singh was of the opinion that there was no contra-indication for using the preparation in this situation. Petitioner failed to prove that Patient #4 had a complete bowel obstruction or that the procedure, including the use of the Golytely preparation, violated an established standard of care. It is found that Respondent was acting within the scope of his discretion as the consulting physician to order the administration of the Golytely preparation and to perform the upper endoscopy. On October 11, 1988, Respondent performed a colonoscopy on Patient #4. Respondent stated on the operative report that the colonoscopy was indicated because of diverticulitis. Diverticulitis was not mentioned in any of Respondent's notes concerning Patient #4, and there was no notation as to the reasons Respondent thought the patient had diverticulitis. Although Respondent failed to document why he felt that diverticulitis was an appropriate indication for the colonoscope, there is no dispute that a colonoscope was, in fact, indicated. Further, the colonoscope established that the pretest diagnosis of possible diverticulitis was not incorrect. The colonoscopy revealed areas of colitis, and the pathology report noted an ulcer with acute and chronic inflammation. Respondent's experts testified that they were of the opinion that Respondent violated no established standard by listing diverticulitis as an indication for the colonoscopy. It is found that Petitioner failed to prove that Respondent practiced below an established level in listing diverticulitis as an indication for the colonoscope. During the colonoscopy, Respondent found several mildly bleeding areas and infiltrated Patient #4 with epinephrine. For the reasons discussed pertaining to Patient #4, it is found that Petitioner failed to prove that Respondent violated an established standard of care in administering epinephrine to Patient #4. Dr. Goldberg was of the opinion that Respondent's handwritten consultation report was inadequate. Dr. Goldberg bases his conclusion on the following observations. The report was difficult to read and failed to include any significant historical events concerning Patient #4. In his consultation report, the Respondent failed to note anything about having done a rectal examination on this patient, whether or not the abdomen was distended, and whether there were active or inactive bowel sounds. Dr. Goldberg was of the opinion that these findings would help to distinguish between an obstruction and an ileus or paralysis of the bowel. Dr. Goldberg was also of the opinion that the patient's records of the upper endoscopy performed October 7, 1998, fail to reveal any significant findings. Other, equally credible expert witnesses were of the opinion that the medical records were adequate. It is found that Petitioner failed to prove the standard by which the adequacy of medical records are to be judged, other than the pertinent statutory standards set forth above. While it may be concluded that Respondent's medical records could be improved, Petitioner failed to prove that the medical records fell below an established standard of acceptability. PATIENT #5 (J.T.) Patient #5, an 89 year-old male, was admitted to Imperial Point with a history of peptic ulcer disease and arthritis. This patient was seen by Respondent on a consulting basis. The patient was vomiting blood and Respondent was asked to see the patient to determine the source of the bleeding. Respondent performed an upper endoscopy on October 13, 1988, and found a significant outlet obstruction. On October 17, 1988, a G.I. series was performed and a repeat upper endoscopy and pyloric dilatation was performed. The procedures performed by Respondent were properly indicated and had a beneficial result to the patient. Back-to-back pyloric dilatations were appropriate and clinical judgment was properly exercised. Dr. Goldberg was of the opinion that Respondent failed to keep adequate written medical records pertaining to the upper endoscopy of October 13, 1988, in that Respondent's operative report failed to document Respondent's findings in detail. Dr. Goldberg testified that an essential endoscopy report that physicians are trained to do should include the following: indications for the procedure, medication used to sedate the patient, identification of instrument used, description of the anatomical landmarks and their condition as visualized by the physician passing the endoscope, the removal of the scope, the physician's impressions and what the physician plans to do about those impressions, how the patient tolerated the procedure and what the patient's condition was after the procedure, and that the patient was sent to the recovery area. Dr. Goldberg was of the opinion that Respondent failed to keep adequate written medical records pertaining to the procedures performed on this patient on October 17, 1988, in that Respondent's operative report did not document Respondent's findings in detail and did not indicate if the scope was passed through Patient #5's dilated pylorus into the duodenum. In Respondent's impressions on the second endoscopy, he noted pyloric stenosis and duodenal ulcer. In his procedure note Respondent does not mention whether he passed the scope into the duodenum or how he knew there was a duodenal ulcer. Dr. Goldberg was of the opinion that Respondent did not properly document what he did. On October 18, 1988, Respondent performed a repeat pyloric dilation on Patient #5. Dr. Goldberg was of the opinion that Respondent failed to record the reasons for the second procedure and to document his findings. Dr. Goldberg was of the opinion that the third endoscopy note did not adequately detail the examinations of the esophagus and stomach. Dr. Goldberg was of the opinion that every procedure note stands alone, and that if a physician does an endoscopy on day one and repeats it on day two, the physician still must make that report complete because it is not always going to be part of a document. Dr. Goldberg was of the opinion that Respondent's records did not stand alone. Dr. Goldberg was of the opinion that Respondent's handwritten consultation note was sketchy and should have contained a history of allergies because of the need to give the patient medications for sedation. Dr. Goldberg's criticisms of Respondent's medical records do not prove that the medical records kept by Respondent were inadequate as measured by an established standard. Other, equally credible expert witnesses were of the opinion that the medical records provided sufficient information to document the procedures and that the records were adequate. While it may be concluded that Respondent's medical records could be improved, it is found that Petitioner failed to prove that the medical records were inadequate. It is further found that Petitioner failed to prove the standard by which the adequacy of medical records are to be judged, other than the pertinent statutory standards set forth above. PATIENT #6 (D.Y.) From October 19, 1988, until October 22, 1988, Respondent was consulting physician to Patient #6, a 72 year-old male, who was admitted to Imperial Point with rectal bleeding. Dr. Goldberg was of the opinion that Respondent failed to keep adequate written medical records pertaining to Patient #6 because a formal consultation note was lacking. The medical records which were reviewed by Dr. Goldberg were incomplete when reviewed by him. A specific reference is made to a consultation note that is not contained in the hospital records. Respondent established that other medical records were missing from the hospital records. In light of the specific reference to the consultation note, it is found that the absence of this consultation note from the hospital records is insufficient to prove that there existed no consultation note. On October 20, 1988, Respondent performed an colonoscopy on this patient and a biopsy was taken in the segmental descending colon area. The colonoscopy could not be completed because the colonoscopy could not pass to the patient's cecum. The following recommendation was made by Respondent (the original is in all capital letters): IN VIEW OF NOT REACHING TO THE CECUM, THE PATIENT WOULD NEED BE (this is an abbreviation for barium enema) AND ALSO IF EVERYTHING IS NEGATIVE, RECOLONOSCOPY IN ONE YEAR AND IF THERE ARE ANY CHANGES IN THE BIOPSY OF THE POLYP, THEN ACCORDINGLY WILL PLAN. On October 21, 1988, the follow-up barium enema was performed by Dr. Nicholas M. Arfaras, a radiologist. The radiology report reflected the following finding: "Also in the sigmoid there is an approximately 1 cm. rounded filling defect identified near the junction with the descending colon. This is felt to be secondary to a polyp." The possible polyp detected by the barium enema should have been followed up. However, it was not established that Respondent was consulted by the attending physician about the results of the barium enema. Dr. Lipton, as the attending physician, would have had the responsibility for following up the recommendations made by Respondent and for bringing Respondent or another gastroenterologist in for further consultations following the barium enema if Dr. Lipton had believed it necessary to do so. This patient was discharged from Imperial Point by Dr. Lipton on October 22, 1988. The final page of the discharge summary for this patient reflected the following notation: "Condition was improved. The patient is to have a follow up in one week in the office with Dr. Lipton and with Dr. Gupta in two weeks." The evidence presented in this proceeding, including Respondent's office notes, does not reflect that Respondent had any involvement with this patient after October 21, 1988, until 1990, when he performed on the patient at North Broward Medical Center a procedure described as a "multiple colonoscopy with multiple biopsies and cauterization." This procedure in 1990 revealed multiple polyps. The polyp removed on colonoscopy in 1988 was an adenomatous polyp, a polyp with significant malignant potential. This patient needed a follow-up colonoscopy in one year. Respondent was the consulting physician and recommended reevaluation of the patient in one year. Follow-up care was not the responsibility of Respondent, but of the treating physician. Dr. Goldberg was of the opinion that Respondent failed to keep adequate written medical records in that Respondent failed to adequately document the indications for the colonoscopy performed on Patient #6 and why the colonoscope could not be passed to Patient #6's cecum. Dr. Goldberg opined that a physician doing a colonoscopy needs to tell why he did not get to the cecum so that the next physician colonoscoping this patient can take appropriate precautions. Other, equally credible expert witnesses were of the opinion that the medical records were adequate and provided sufficient information to document the procedures that were performed. Petitioner failed to prove that the medical records were inadequate. Petitioner failed to prove the standard by which the adequacy of medical records are to be judged, other than the pertinent statutory standards set forth above. PATIENT #7 (C.R.) Respondent was a consulting physician to Patient #7, a 64 year old male who was hospitalized with rectal bleeding. Respondent saw this patient because of a possible colonic fistula, which is a connection with any piece of the intestine and some other structure. Respondent recommended a barium small bowel X-ray and a barium enema, both appropriate clinical recommendations. On November 11, 1987, Respondent performed a colonoscopy on Patient #7. Petitioner contends that Respondent failed to keep adequate written medical records pertaining to the aforementioned procedure in that Respondent failed to document an adequate history as an indication of Patient #7's colonoscopy. This contention is rejected based on the testimony of Dr. Singh. The medical records provide adequate justification for the procedure. Dr. Goldberg was critical of Respondent's records pertaining to this patient and considered the records inadequate. He was of the opinion that the records should have better detailed his findings and should have recorded any follow-up plans for a repeat colonoscopy on the patient. Other, equally credible expert witnesses were of the opinion that the medical records were adequate and provided sufficient information to document the procedures that were performed. Petitioner failed to prove that the medical records were inadequate. Petitioner failed to prove the standard by which the adequacy of medical records are to be judged, other than the pertinent statutory standards set forth above.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that Petitioner enter a final order which finds that Respondent violated the provisions of Section 458.331(1)(m), Florida Statutes, by failing to provide a history or physical examination for Patient #1 as alleged in Count Two, which reprimands Respondent for that violation, and which imposes an administrative fine in the amount of $250.00 against the Respondent for that violation. It is further recommended that all other charges against Respondent contained in the Amended Administrative Complaint be dismissed. DONE AND ENTERED this 12th day of October, 1993, in Tallahassee, Leon County, Florida. CLAUDE B. ARRINGTON 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 12th day of October, 1993.
The Issue The issues in this case are whether Respondent, a physician specializing in obstetrics and gynecology, committed medical malpractice in delivering a baby and/or failed to maintain medical records justifying the course of the mother's treatment; if so, whether Petitioner should impose discipline on Respondent's medical license within the applicable penalty guidelines or take some other action.
Findings Of Fact At all times relevant to this case, Respondent Mark N. Scheinberg, M.D., was licensed to practice medicine in the state of Florida. He is board-certified in obstetrics and gynecology. Petitioner Department of Health (the "Department") has regulatory jurisdiction over licensed physicians such as Dr. Scheinberg. In particular, the Department is authorized to file and prosecute an administrative complaint against a physician, as it has done in this instance, when a panel of the Board of Medicine has found that probable cause exists to suspect that the physician has committed a disciplinable offense. Here, the Department alleges that Dr. Scheinberg committed two such offenses——namely, medical malpractice and failure to keep records justifying the course of treatment——in connection with the vacuum-assisted vaginal delivery of an infant born to Patient L.G. on February 2, 2005, at West Boca Medical Center. The crux of this case (though not the sole issue) is whether, as the Department contends, the standard of care required Dr. Scheinberg to perform a Caesarean section ("C- section") on L.G. due to the passage of time, instead of allowing her to continue to labor for approximately 13 hours and, ultimately, deliver vaginally. The events giving rise to this dispute began on February 1, 2005, at around 11:00 a.m., when L.G., whose pregnancy was at term, checked into the hospital after having experienced ruptured membranes. At 12:30 p.m. that day, L.G. signed a form bearing the title "Authorization for Medical and/or Surgical Treatment," which manifested her consent to a vaginal delivery or C-section together with, among other things, "such additional operations or procedures as [her physicians might] deem necessary." Immediately above L.G.'s signature on the form is an affirmation: "The above procedures, with their attendant risks, benefits and possible complications and alternatives, have been explained to me " The evidence is not clear as to when, exactly, Dr. Scheinberg first saw L.G., but that fact is unimportant. The medical records reflect that at 8:30 p.m. on February 1, 2005, Dr. Scheinberg gave a telephone order to initiate an IV push of the antibiotic Ampicillin; therefore, he had taken charge of L.G.'s care by that time. The nurses' notes indicate that at 10:00 p.m., L.G.'s cervix had dilated to "rim" or approximately nine centimeters—— meaning that the dilation was complete, or nearly so. At this time, and throughout the duration of L.G.'s labor, an external fetal heart monitor was in place to detect and record the baby's heartbeats and the mother's uterine contractions. An intrauterine pressure catheter ("IUPC")——a device that precisely measures the force of uterine contractions——was not inserted into L.G.'s uterus at any time during this event. The Department argues (although it did not allege in the Complaint) that, at some point during L.G.'s labor, the standard of care required Dr. Scheinberg either to place an IUPC or perform a C-section. Pet. Prop. Rec. Order at 10, ¶36. The Department's expert witness, Dr. John Busowski, testified unequivocally and unconditionally, however, that the standard of care does not require the use of an IUPC. T. 36. The undersigned credits this evidence and finds that Dr. Scheinberg's nonuse of an IUPC did not breach the standard of care. Dr. Scheinberg conducted a physical at around 2:00 a.m. on February 2, 2005, which included taking L.G.'s complete history and performing a vaginal examination. L.G.'s cervix remained dilated to approximately nine centimeters, and her labor had not substantially progressed for about four hours. Dr. Scheinberg noted in L.G.'s chart that the baby was in the posterior position at 2:00 a.m. The Department argues, based on Dr. Busowski's testimony, that as of 2:00 a.m., the standard of care required [Dr. Scheinberg to] choose one of the following options: (1) watch the patient for a few more hours to allow for progress; (2) place an IUPC to determine the adequacy of Patient L.G.'s contractions; (3) start Pitocin without the placement of an IUPC; or (4) perform a C- section. Pet. Prop. Rec. Order at 9-10, ¶ 32. The Department contends that Dr. Scheinberg breached the standard of care by choosing "simply to watch the patient for approximately 10 more hours"—— which was tantamount to "choosing to do nothing." Id. at 10, ¶¶ 33-34. In fact, Dr. Scheinberg chose to watch the patient, which was, according to Dr. Busowski, within the standard of care. Obviously, at 2:00 in the morning on February 2, 2005, Dr. Scheinberg did not choose to wait for 10 more hours, because at that point he (unlike the parties to this litigation) did not know what was about to happen. The nurses' notes reflect that L.G. was under close observation throughout the early morning hours, and that Dr. Scheinberg was following the situation. At 4:30 a.m., L.G. was set up to push and at 4:45 a.m. was pushing well. At 6:15 a.m., the notes indicate that Dr. Scheinberg was aware of the mother's attempts to push. At 6:45 a.m., he reviewed the strips from the fetal heart monitor. At 7:45 a.m., he was present and aware of L.G.'s status. From 7:00 a.m. until 8:00 a.m., no contractions were identifiable on the external monitor. At 8:00 a.m., however, L.G. was comfortable and pushing well. She stopped pushing at 8:30 a.m., but remained comfortable. Dr. Scheinberg then ordered the administration of Pitocin, a medicine which is used to strengthen contractions and hasten delivery. Although the Department faults Dr. Scheinberg for giving L.G. Pitocin at this relatively late stage of her labor, Dr. Busowski (the Department's expert witness) admitted being unable to say "that Dr. Scheinberg should have started Pitocin earlier " T. 72. The Department therefore has no clear evidential basis for second-guessing Dr. Scheinberg's professional judgment in this particular, and neither does the undersigned. At 9:10 a.m., L.G. resumed pushing. The baby's fetal heart tones (heartbeats) were stable. L.G. continued pushing, with her family present, until around 11:00 a.m., at which time Dr. Scheinberg discussed the situation with the patient and her family. Dr. Scheinberg explained to L.G. or her husband the risks of, and alternatives to, performing a vacuum-assisted vaginal delivery. Either L.G. or her husband gave verbal consent to the use of a vacuum device to assist in the delivery. Between 11:00 a.m. and 11:10 a.m., the fetal heart monitor detected some variable decelerations, meaning a decrease in heart rate that could be a sign of fetal distress. Dr. Scheinberg delivered the baby at 11:23 a.m., using a vacuum device to help pull the infant out of the birth canal. In his post-operative notes, Dr. Scheinberg wrote that his "pre-operative diagnosis" was "+3 station — prolonged second stage 2½ hrs." As a "post-operative diagnosis," Dr. Scheinberg recorded, "same + tight cord." He reported the following "findings": "tight cord cut on perineum[;] mec[onium] aspirated on perineum."
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding Dr. Scheinberg not guilty of the charges set forth in the Complaint. DONE AND ENTERED this 20th day of June, 2011, in Tallahassee, Leon County, Florida. S JOHN G. VAN LANINGHAM 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 20th day of June, 2011.
Findings Of Fact Respondent Anila Poonai began her medical education in her native land, India, and, in 1960, she received a medical degree from Bombay University. After an internship in Bombay, she spent three months in training in the United Kingdom, before travelling to Georgetown, Guyana, to become a resident medical officer at the public hospital there. After two years in Guyana, she returned to England where, in 1964, she passed a post-graduate examination. As a result of a residency in obstetrics and gynecology and a satisfactory showing on the requisite examinations, she became a member, in 1969, of the Royal College of Obstetrics and Gynecology. All told, respondent has spent six years as a resident in obstetrics and gynecology. From England, she travelled to the University of the West Indies in Kingston, Jamaica. At the University of the West Indies, she was senior registrar in obstetrics and gynecology and, for six months, acting lecturer in obstetrics and gynecology. In 1973, she and her husband, who is a general surgeon, moved to Cleveland, Ohio. Respondent has not sought certification by the American College of Obstetrics and Gynecology. She testified that the American College of Obstetrics and Gynecology recognized her membership in the Royal College of Obstetrics and Gynecology as an equivalent certification. Until moving to Port St. Joe, she worked as a house physician in St. Alexis and Hillcrest hospitals in Cleveland. Respondent and her husband moved to Florida at the invitation of the Board of Trustees of the Municipal Hospital of Port St. Joe. The Board wanted to upgrade the Hospital. Almost from the time of their arrival, respondent and her husband found themselves at the center of controversy. Respondent's husband testified that, when he and respondent began work at the Municipal Hospital of Port St. Joe, in August of 1976, norms of practice at the Hospital were "miles below standard" and that the medicine practiced by other physicians in the community was "about 25 years" out of date. Whether true or false, this view, and its blunt articulation, may account for the friction respondent and her husband experienced in their relationships with some of the nurses and physicians with whom they came into contact. Being the only such specialist on the staff, respondent was named chief of obstetrics and gynecology at the Municipal Hospital of Port St. Joe. In this capacity, she ordered drugs and other obstetric and gynecologic supplies for the Hospital. Chief of staff at the Hospital, from 1961, until the spring of 1977, was John Wayne Hendrix, who has practiced medicine in Port St. Joe for some three decades. During Dr. Hendrix' tenure as chief of staff, Dr. Orr of Wewahitchka, a general practitioner, was granted "courtesy privileges" at the Municipal Hospital of Port St. Joe. At all pertinent times, Hospital bylaws forbade a physician to whom only courtesy privileges had been granted, to attend a delivery, except under the supervision of the chief of obstetrics and gynecology. On March 27, 1977, in violation of the Hospital's bylaws, Dr. Orr attempted, for the first and only time, to deliver a baby in the Municipal Hospital of Port St. Joe. When Gloria Pippin, R.N., arrived to begin the 3 to 11 shift, Dr. Orr's patient was already in labor. At 9:30 that night, the patient's cervix was fully dilated; at 9:45 she was taken to the delivery room. At 11:00 Dr. Orr "did a saddle block," i.e., he administered a spinal anesthetic. Five minutes later he had finished an episiotomy. At quarter past eleven, he used Tucker-McClain forceps in an effort to extract the baby. That failing, he tried long Simpson forcens at 11:25 and Kielland forceps at ten minutes before midnight, March 27, 1977. The baby's head was too big for the mother's pelvis. Five minutes later, Ms. Pippin telephoned respondent, at Dr. Orr's request. Respondent expressed dismay that Dr. Orr had been permitted to begin, and asked Ms. Pippin to notify Dr. Hendrix of the situation. She herself telephoned Gerald Sullivan, the chairman of the Hospital's Board of Trustees. Afterwards, she and her husband, Dr. Parmanand Vijay Poonai, went to the Hospital. They arrived at approximately 12:40. Dr. Hendrix, who had considerable experience in performing Ceasarean sections, preceded them to the Hospital. By the time the Drs. Poonai reached the hospital, arrangements had been made for Dr. Orr's patient to be transferred to Panama City's Bay Memorial Hospital. At quarter past midnight, when Dr. Hendrix arrived at the hospital, the mother's blood pressure was 134/78. Ten minutes before she left in the ambulance, her blood pressure was 137/98 and her pulse was 112. At that time, the fetal pulse was 156. At 1:20 a.m., an ambulance left the Municipal Hospital of Port St. Joe for Panama City. When they reached Bay Memorial Hospital, the mother's vital signs and the infant's heart beat were within normal limits. Dr. Stephen Smith, the obstetrician who performed a Caesarean section upon the patient's arrival in Panama City, was the man of the hour. Mother and baby did well. For many years, it has been common to send women in labor to Panama City from Port St. Joe, and hundreds have made the trip. It takes a half hour to an hour to drive from the Port St. Joe hospital to the Panama City hospital. The longer a woman in the condition Dr. Orr's patient was in continues in labor, the greater are the chances of injury or death to the fetus and even to the mother. At no time did Dr. Hendrix telephone respondent on the night of the 27th or morning of the 28th. Neither Dr. Hendrix nor Dr. Orr ever asked respondent for assistance with Dr. Orr's patient. When respondent and her husband arrived at the Hospital early on the morning of March 28, 1977, neither Dr. Hendrix nor Dr. Orr spoke to either of them. Dr. Hendrix refused to speak to them, even though respondent addressed him and asked him specifically about Dr. Orr's patient. Both respondent and her husband remained at the Hospital until after the ambulance left for Panama City. It is unethical for one physician to intervene in the care of a patient whose treatment is being actively managed by another physician, unless requested. It may also be dangerous. On January 16, 1978, Dr. P. V. Poonai saw Beverly R. Bass in his office. Ms. Bass, who was born on December 15, 1951, told Dr. P. V. Poonai that a Dr. Vasquez of Port St. Joe (of whose wife Ms. Bass was a cousin) and other physicians had recommended a hysterectomy; that she had been passing blood clots for the preceding four months; that she had epigastric pain; that her most recent menstrual period was December 19, 1977; that she had two daughters and a son by three different men; that she wanted no more children; and that she wanted a hysterectomy both to prevent conception and to stop her bleeding. After examining her and finding an ovarian cyst and a slightly bulky uterus, Dr. P. V. Poonai prescribed hospitalization for a series of gastrointestinal X-rays to investigate the possibility of an ulcer, and for an obstetric and gynecologic consultation with respondent. On January 18, 1978, Ms. Bass entered the Municipal Hospital of Port St. Joe. An electrocardiogram was done. Dr. J. B. Harbison prepared a report of the X-rays taken as prescribed by Dr. P. V. Poonai. Respondent met Ms. Bass for the first time, in the Hospital, on January 19, 1978. She took Ms. Bass' history and examined her under general anesthesia, finding a left ovarian cyst, a normal cervix and a bulky anteverted uterus. Respondent recommended a dilatation and curettage (d & c) for diagnostic and therapeutic purposes, and, on the same day, Ms. Bass signed a form consent to diagnostic and treatment procedures authorizing respondent to perform a d & c. The following day, January 20, 1978, respondent did perform a routine d & c. Afterwards, the curettings resulting from the procedure were transmitted to a pathologist. After examining this material, the pathologist prepared a tissue report, and stated, as the pathological diagnosis: SECRETORY PHASE, DYSFUNCTIONAL BLEEDING. NO EVIDENCE OF POLYPS, PREGNANCY OR MALIGNANCY OBSERVED IN THE SPECIMEN SUBMITTED. FRAGMENT OF ENDOCERVIX WITH SQUAMOUS METAPLASIA, ACUTE AND CHRONIC INFLAMATION. Petitioner's exhibit No. 2. On January 21, 1978, Ms. Bass left the hospital, with a final diagnosis of dysfunctional bleeding. Before discharging Ms. Bass, respondent instructed her to refrain from sexual intercourse and from douches for four to six weeks. Eight to ten days after her discharge, Ms. Bass resumed sexual intercourse. On February 2, 1978, respondent saw Ms. Bass at her office and discussed the pathologist's tissue report with her. She related to Ms. Bass her clinical impression of uterine fibroids and prescribed Orthonovum, a birth control pill, as an additional means of forestalling dysfunctional bleeding. On February 2, Ms. Bass reported no bleeding subsequent to the d & c. Respondent did not ask and Ms. Bass did not volunteer that she had failed to follow instructions to abstain from sexual intercourse. Although the birth control pills respondent prescribed were to be taken daily, Ms. Bass did not take one every day. Respondent next saw Ms. Bass on February 13, 1978, when her only complaint was of an upper respiratory tract infection. On March 4, 1978, Ms. Bass returned to respondent's office complaining of heavy breakthrough bleeding, and reported that she was passing blood clots. Respondent examined her and suggested a hysterectomy. Ms. Bass asked if she could enter the hospital on March 12, 1978, saying she could make arrangements for her children by then. Respondent administered no pregnancy test to Ms. Bass on March 4, 1978, or at any time thereafter. She thought none was necessary because she believed that Ms. Bass had followed her instructions. Respondent does not knowingly perform abortions, even for therapeutic purposes, on account of religious scruples. A d & c elicits inflamatory responses hostile to fertilization. Even when a pregnancy has begun, no pregnancy test will be positive before 41 days have elapsed since the last menstrual period. Some hospitals, like Jackson Memorial in Miami, require pregnancy tests before surgery as a matter of routine, but the Municipal Hospital of Port St. Joe had no such policy. On March 12, 1978, Ms. Bass was admitted to the Municipal Hospital of Port St. Joe. The following day respondent performed a hysterectomy and an incidental appendectomy. An appendectomy ordinarily accompanies this procedure. Respondent's pre-operative diagnosis was "menorrhagia and fibroid uterus," and her postoperative diagnosis, on March 13, 1978, was unchanged. This was the same condition specified on the form consent to diagnostic and treatment procedures which Ms. Bass signed on March 12, 1978, authorizing respondent to perform a hysterectomy. Ordinarily, a surgeon performing a hysterectomy removes the uterus intact, as respondent did in the case of Beverly Bass. After its removal but while still intact, Ms. Bass' uterus yielded no additional information pertinent to the diagnosis of her condition. The uterus was sent to a pathologist. After examining the uterus, the pathologist prepared a tissue report and stated, as the pathological diagnosis: APPENDIX WITH FIBROUS OBLITERATION (DISTAL) AND FOCAL FIBROUS ADHESIONS. LUTEAL CYST OF LEFT OVARY, BENIGN. PARATUBAL CYST, BENIGN, RIGHT. ENLARGED UTERUS (205 GMS) WITH: ENDOMETRIUM: CHANGES RELATED TO PREGNANCY (HYPERSECRETORY GLANDS AND DECIDUAL REACTION). ACUTE ENDOMETRITIS. ANGULAR IMPLANT OF PLACENTA ASSOCIATED WITH UNDERLYING NECROSIS AND ACUTE INFLAMMATION OF DECIDUA, ACCOMPANIED BY HEMATOMAS. CHORION-AMNIONITIS, ACUTE, NECROTISING ASSOCIATED WITH NECROSIS OF GROUPS OF CHORION VILLI. EMBRYO, APPROXIMATELY 4-6 WEEKS OLD. FLUID BLOOD PRESENT IN UTERINE CAVITY. MYOMETRIUM: HYPERTROPHY (FUNCTIONAL). CERVIX: ACUTE AND CHRONIC CERVICITIS ASSOCIATED WITH SQUAMOUS METAPLASIA OF THE ENDOCERVICAL LINING, FOCAL. SQUAMOUS CELL HYPERPLASIA OF ECTOCERVIX, BENIGN. MUCUS CYSTS. When the pathologist opened the uterus, he found an enlarged cavity partly occupied by a ruptured ovisac. Extruded through the perforation, hanging outside of the ovisac from the umbilical cord, was an embryo 1.8 centimeters long. The placenta, which was acutely inflamed, adhered to the fundus at a right angle. Uterine rupture is inevitable if an angular pregnancy continues, but it is possible for an angular pregnancy to go to term, just as it is possible for a fetus to live after the ovisac has burst. In Ms. Bass' case, however, the embryo was probably non-viable at the time of the hysterectomy. The pathologist's report arrived while Ms. Bass was still in the hospital. Because respondent was upset on reading it, she asked Dr. P. V. Poonai to tell Ms. Bass what the pathologist had learned. Dr. P. V. Poonai did tell Ms. Bass, at which time she confirmed that she had engaged in sexual intercourse shortly after the d & c. Confusing an incipient pregnancy with a fibroid uterus is an occasional mistake any physician could make. An isolated mistake of this kind does not constitute a deviation from acceptable medical practice. The most conservative approach is to wait for two months after the patient has stopped taking birth control pills, before performing a "semi-elective" procedure, and to administer a pregnancy test beforehand. Several physicians testified, however, that they would not have ordered a pregnancy test before performing a hysterectomy in the circumstances of Ms. Bass' case. Respondent did not prepare the summary sheet at the end of Ms. Bass' stay after her March 12, 1978, admission, Chart No. 23622. Petitioner's exhibit No. 2A. The summary sheet that was prepared is not signed by anybody. When respondent asked for the chart in order to prepare a summary sheet, the Hospital's records custodian advised her that it was not with the other charts. When Beverly D. Stover was about three and a half months pregnant, she began seeing respondent. She saw her every month until November, when she began seeing her every two weeks. On her first visit, she told respondent she wanted to be sterilized after the birth of the child she was carrying, her second. At respondent's request, Mrs. Stover brought her husband to respondent's office, about six weeks before the baby was born. The three of them discussed Mrs. Stover's planned sterilization. On November 22, 1977, both Mr. and Mrs. Stover signed a form request for sterilization witnessed by two persons who were not called to testify at the hearing. On November 30, 1977, Mrs. Stover was admitted to the Municipal Hospital of Port St. Joe. On the day of her admission, she signed a form consent to diagnostic and treatment procedures authorizing respondent to perform a bilateral tubal transection and ligation, and both she and her husband signed another form request for sterilization. At the time of the signing of the last two documents, Mrs. Stover told Sarah Maddux, the nurse who gave her the forms to sign, that she did not want to be sterilized unless her baby was normal. Ms. Maddux never relayed this oral reservation to respondent. It is impossible to tell, at the time of birth, whether an infant has a sense of smell, whether it is intellectually impaired, or whether it can see or hear. At 1:50 on the afternoon of November 30, 1977, Mrs. Stover was delivered of a daughter, Katrina. Respondent examined the eight pound two ounce infant for two minutes. She put her fingers in the infant's mouth, cleared a passage for air, and checked for a cleft palate. The child started crying. Respondent observed good muscle tone. Respondent clamped, then cut the umbilical cord. She inspected the baby all over, noticed puffiness on the child's back, which she attributed to the trauma of birth, and noticed that the baby's anal opening was smaller than normal, but was not alarmed. She thought she had seen even smaller such openings which had not affected function. Respondent placed Katrina on her mother's stomach, and asked Mrs. Stover whether she was ready for surgery. When Mrs. Stover answered affirmatively, at 1:55, anesthesia was administered, at respondent's direction. A nurse took the baby from respondent for cleaning. In contemporaneous notes, the nurse described the baby as apparently normal. In fact, Katrina had an imperforate anus or anoperitoneal fistula, and a lipoma on the sacral area of her back. These conditions were discovered a few hours later by a nurse in the Hospital nursery. The nurse brought both problems to the attention of Dr. Shirley R. Simpson, a physician who had been on the staff of the Municipal Hospital of Port St. Joe for approximately ten years and who happened to be in the Hospital at the time. Respondent had left Port St. Joe to meet her husband at the airport in Panama City. Examining Katrina at the nurse's request, Dr. Simpson mistook the lipoma for a meningomyocele. Dr. Simpson took no further action in the case, other than leaving word with the nurse for respondent to call her, until she furnished the Board of Medical Examiners Katrina's hospital chart. By that time, somebody had forged an entry in the nurse's notes for 1:50 P.M. on November 30, 1977, viz., "Appears to have NO rectal orifice-Dr. A. Poonai notified." Petitioner's exhibit No. 4. After her return from Panama City, on December 1, 1977, respondent correctly diagnosed the lipoma. At respondent's request, Dr. P. V. Poonai examined Katrina. After obtaining consent, Dr. P. V. Poonai, used surgical implements, when the baby was 16 hours old, to remove the obstruction which had prevented the expulsion of all but the merest drop of meconium during the first 16 hours of the baby's life. Although this emergency procedure solved the immediate problem and allowed the baby to defecate, further surgery has been necessary to move the anal opening to its norman site posterior of the dimple where Dr. P. V. Poonai made his incision. An imperforate anus occurs once in 5,000 births. The imperforation may or may not be visible, depending on its location. In the past five years, three infants with this problem have been born in Panama City. In each instance, the examining pediatrician did not discover the imperforation, which came to light some hours after birth, on account of the baby's failure to expel its first stool. In Katrina's case, however, the abnormality could be seen and its existence could be confirmed by an attempt to probe. The lipoma on Katrina's back measured less than four by five centimeters in area. It was a soft, skin-colored mass of benign, fatty tissue, which a pediatric surgeon has since removed. The trauma of birth sometimes causes edemas that resemble lipomas. No harm befell Katrina as a result of respondent's failure to diagnose either her lipoma or her anal abnormality at birth. Beverly Stover continued as a patient of respondent for some time after Katrina's birth. Respondent first saw a certain patient on September 19, 1977. This patient, who was born on June 1, 1907, suffered from diabetes mellitus and congestive heart failure, among other things. Two months earlier she had had a second pacemaker inserted. On her first visit to respondent, the patient complained of pain in her chest and of dysuria. She said she had difficulty retaining urine, but that she was unable to empty her bladder completely. In examining her, respondent discovered a moderate cystocele, which is a herniation of the bladder into the vagina. Respondent admitted her into the Municipal Hospital of Port St. Joe for treatment of her congestive heart failure, the cause of the chest pain. Congestive heart failure is not a disease of which people are cured, but it is a condition that may grow better or worse. When this patient's condition improved, respondent sent her home. Respondent saw her again in her office on October 3, 1977, when she complained of paroxysmal dyspnea and swollen feet. Respondent diagnosed superimposed congestive cardiac failure and prescribed a diuretic. On November 18, 1977, respondent admitted her to the hospital because symptoms like those she had complained of during the office visit persisted. On November 22, 1977, she was discharged. A similar episode resulted in rehospitalization from January 10, 1978, through January 19, 1978. The patient entered the hospital again, on February 12, 1978, with congestive cardiac failure. She complained about nocturnal incontinence and asked respondent to correct her bladder problem. At this time, respondent described the cystocele as large. After medical care which petitioner's own witness described as excellent, the patient's condition stabilized. Respondent testified that, in her judgment, the patient's general condition just before surgery was as good as it was likely ever to be. Nine days after she admitted the patient, respondent effected a repair of the cystocele by performing an anterior colporrhapy under local anesthetic. This procedure requires unusual surgical skill, and most surgeons do not attempt it. The repair of a cystocele is a therapeutic measure. In the absence of treatment, urine is likely to stagnate in the herniated portion of the bladder, and become a source of possibly serious infections. All surgical techniques for repairing cystoceles, other than the one employed by respondent, require general anesthesia. The risk from anesthesia to which respondent's patient was subjected was very moderate compared to the risk from general anesthesia. It was the same risk a person faces whose mouth is numbed by local anesthesia before a tooth is filled. Respondent had performed this operation 20 or 30 times before, and had performed it on her own mother, who was 75 years old and suffered from myocardial ischemia at the time. Sometimes, although decreasingly in recent years, a physician may employ a pessary as treatment for a cystocele. A pessary is a rubber or plastic solid that can be inserted in the vagina as a support for the intruding bladder. This is only a temporary measure, however, and involves a high risk of infection, which is the principal danger the cystocele itself poses. Respondent testified that her prescription for temporary relief was bed rest, since lying flat relieves the pressure that forces part of the bladder into the vagina. Respondent first saw another patient, the 29 year old mother of three children, on December 23, 1976. This patient was in the Municipal Hospital of Port St. Joe at the time, for a hemorrhoidectomy, and respondent was called in because the patient had complained of profuse, irregular and painful vaginal bleeding over a period of several years, and particularly during the preceding nine months to a year. The patient was anemic, according to tests run two days earlier. In July of 1976, the patient had been hospitalized on account of pelvic sepsis and bleeding. At that time, Dr. Simpson told her she would need a hysterectomy in the near future. She had been hospitalized for the same reasons in 1975. Respondent ordered a pap smear and an X-ray to locate a coil that had been inserted into the patient's uterus, as a contraceptive measure. When she recovered from the hemorrhoidectomy, the patient was discharged. After three weeks of severe menorrhagia, including two final days of heavy clotting, the patient was readmitted, on January 24, 1977, to the Municipal Hospital of Port St. Joe. Respondent had earlier prescribed iron pills. Perhaps as a result, the patient was no longer anemic. Respondent observed the patient's uterus "enlarged to about 10 weeks size with [what she thought was] fibroids. Petitioner's exhibit No. 6. Respondent ordered no pregnancy test. When an intrauterine device is in place, excessive vaginal bleeding is inconsistent with a viable pregnancy. An intrauterine device not only irritates the wall of the uterus, making conception unlikely, but also operates to abort incipient pregnancies, in the event of conception. With the intrauterine device still in place, on January 26, 1977, respondent performed a total abdominal hysterectomy and an incidental appendectomy, with conservation of both ovaries. Afterwards, the appendix, part of the cervix, and the uterus were sent to a pathologist. The pathologist examined these materials, and, on January 31, 1977, prepared a tissue report, in which he stated as the pathological diagnosis: APPENDIX WITH SEROSAL FIBROSIS, FOCAL (INCIDENTAL). ENDOMETRIUM: DECIDUA WITH EXTENSIVE NECROSIS ASSOCIATED WITH CHORIONIC VILLI (PREGNANCY) WHICH ARE LARGELY NON-VIABLE. SECRETORY ENDOMETRIUM WITH ACUTE AND CHRONIC ENDOMETRITIS. MYOMETRIUM: HYPERTROPHY, POSTERIOR. CERVIX: CHRONIC ENDOCERVICITIS AND MUCUS CYSTS. SLIGHTLY HYPERTROPHIC UTERUS (95 GRAMS). The pathologist found no evidence of fibroids. This demonstrates that respordent's clinical diagnosis of fibroids was inaccurate. One of the pathologists who routinely examined tissue removed by surgeons in the Municipal Hospital of Port St. Joe, Dr. Garcia-Rios, also routinely examined tissue removed by surgeons in other hospitals. Whenever a tissue report indicated disagreement between a clinical diagnosis and the pathological diagnosis, Dr. Garcia-Rios designated the tissue report "Code 3." The frequency of Code 3 tissue reports did not differ as between specimens removed by respondent and specimens Dr. Garcia-Rios examined which had been removed by other surgeons, taken as a group. From the presence of morphologically viable chorionic villi, the pathologist concluded that the patient had been pregnant. From pathological findings alone, he was unable to determine whether the pregnancy had terminated weeks or months earlier; or whether an ongoing microscopic pregnancy was interrupted by the hysterectomy. (Clinical evidence-excessive bleeding-ruled out the possibility of a viable pregnancy.) The pathologist's findings were consistent with, but did not conclusively establish the existence of, a placental polyp. Placental polyps may cause prolonged bleeding. Before surgery, respondent discussed three options with this patient: removal of the intrauterine device, removal of the intrauterine device followed by a d & c, and hysterectomy. The patient said that the presence or absence of an intrauterine device had made no difference in her bleeding problem in the past. She also told respondent that she wanted no more children, and that she wanted prompt, definitive treatment for her bleeding. After listening to explanations from respondent about the available options, the patient chose a hysterectomy. Respondent did not tell her that a hysterectomy was the only way to correct her problem. The patient testified that she has had no problems since her surgery; and that, knowing what the pathologist's tissue report subsequently revealed, she would make the same choice again, at least if it would not involve her as a witness in legal proceedings. Respondent initialled a summary sheet in the patient's chart, which stated the patient's final diagnosis as, inter alia, "FIBROID UTERUS [and] MENORRHAGIA." This final diagnosis fails to take the pathologist's tissue report into account, even though the tissue report routinely becomes part of the chart and presumably was available to respondent at the time she initialled the summary sheet. Respondent testified that she initialled this summary sheet as one of a group of documents, and that she did not read it beforehand. Any discrepancy between the tissue report and the final diagnosis would have been apparent to a knowledgeable reader. Without the tissue report, respondent would not necessarily have known that the pathologist's findings had demonstrated the error of her diagnosis of fibroid uterus. After controversy about this case arose, respondent caused an addendum to be prepared and incorporated into the chart, on August 16, 1978, and amended the discharge diagnosis to state, inter alia: "Menorrhagia, Chronic endometritis [and] Hypertrophy of the myometrium." This diagnosis is consistent both with respondent's clinical findings and with the pathologist's tissue report. In stating her amended discharge diagnosis, respondent took the tissue report, which had been incorporated into the chart, into account. This amended discharge diagnosis was not shown to be erroneous. On August 11, 1976, respondent saw Linda Whitfield for the first time. She came as a patient to respondent's office and related that her last menstrual period had taken place on June 26, 1976. Respondent examined her, observed a uterus of six weeks' size, and diagnosed early pregnancy. Respondent next saw Mrs. Whitfield in the emergency room of the Municipal Hospital of Port St. Joe on August 27, 1976, when her uterus looked to be of eight weeks' size. There Mrs. Whitfield told respondent that, while driving a tractor earlier in the day, she had experienced abdominal cramps and fairly heavy bleeding. Mrs. Whitfield did not report and respondent did not observe the passage of a fetus. Respondent diagnosed a threatened abortion (miscarriage) admitted Mrs. Whitfield to the Hospital, ordered bed rest, ordered that Mrs. Whitfield's urine be tested for the presence of chorionic gonadotropin, and prescribed an intramuscular injection of two cubic centimeters (cc.) of Depo-Provera (Upjohn's registered trademark for sterile medroxyprogesterone acetate suspension, U.S.P.). Although respondent did not specify the strength, she had ordered the Hospital's entire supply of Depo-Provera, and knew that the only strength on hand was 100 milligrams per milliliter. Depo-Provera is a synthetic progestational agent in an oily base. It has been commercially available for approximately 15 years. The 1971 Physicians' Desk Reference (PDR) reported that daily doses were indicated in the event of a threatened miscarriage. The 1972 PDR reported pregnancy as a contraindication for the use of Depo-Provera. (In 1972, respondent lived in Jamacia.) The 1976 PDR and the 1977 PDR, however, contain neither indications nor contraindications for Depo-Provera, in the event of pregnancy. The 1979 PDR reports pregnancy as a contraindication for the use of Depo-Provera. The phrase "missed abortion" describes the situation where a non- viable fetus remains in its mother's uterus. "Missed abortion" was named as a contraindication for Depo-Provera in the literature that accompanied each vial of Depo-Provera, at the time respondent prescribed it for Mrs. Whitfield. The contraindication of Depo-Provera for missed abortion reflected the view, generally shared in the medical community for many years but now rejected, that Depo-Provera acts to prevent uterine contractions and so make fetal expulsion less likely. The only indication stated in the literature that accompanied each vial of Depo-Provera, at the time respondent prescribed it for Mrs. Whitfield, was "[a]djunctive therapy and palliative treatment of inoperable, recurrent, and metastatic endometrial carcinoma." Petitioner's exhibit No. 12B. Also on petitioner's exhibit No. 12B, under the heading "ADVERSE REACTIONS," is the statement: There is inferential evidence supporting the existence of an association between the administration of progestins early in pregnancy and the occurence of congenital malformations (see also WARNINGS). The referenced warning stated that "[u]sage in pregnancy is not recommended because of data indicating a possible association between administration of progestins early in pregnancy and congenital heart defects in the offspring." Petitioner's exhibit No. 12B. Mrs. Whitfield bled, off and on, during her first stay in the Hospital under respondent's care, until two or three days before her discharge. Because Mrs. Whitfield was bleeding on August 28, 1976, respondent prescribed an intra- muscular injection of one cc. of Depo-Provera. Altogether, respondent prescribed 1100 milligrams of Depo-Provera for Mrs. Whitfield over a 16 day period. She ordered administrations of two cc. doses of Depo-Provera on September 2, 1976, on September 4, 1976, on September 7, 1976, and on September 11, 1976, the day Mrs. Whitfield was discharged. At that time, respondent was hopeful that the pregnancy had been saved. At the time respondent prescribed Depo-Provera for Mrs. Whitfield, she believed she was aware of the inferential evidence referred to in the adverse reaction portion of petitioner's exhibit No. 12B. The evidence of which respondent was aware was the result of a retrospective study involving 10,000 mothers who took various hormonal substances during pregnancy and 10,000 mothers who did not. The number of deformed children born to mothers who had taken the hormonal substances exceeded by two percent the number of deformed children born to the mothers who had not. At the time she prescribed Depo-Provera for Mrs. Whitfield, respondent was one of a considerable number of physicians who believed that this drug could supply a hormonal deficiency that a woman faced with a threatened abortion (miscarriage) might lack, and which might be causing premature uterine contractions. Respondent weighed Depo-Provera's possibly teratogenic effect against its possibly ameliorative effect and made a conscientious professional judgment to prescribe Depo-Provera for Mrs. Whitfield. The 1971 PDR specifies a dosage of 50 milligrams day for threatened abortion, as long as symptoms persist. No dosages for threatened abortion are specified in the 1976 PDR, the 1977 PDR or on petitioner's exhibit No. 12B, the literature that accompanied each vial of Depo-Provera. When used to treat "inoperable, recurrent and metastatic endometrial carcinoma," Depo-Provera is prescribed in doses of 100 to 1000 milligrams at intervals of one week to one month. No evidence adduced at the hearing suggested that Depo-Provera has any known or suspected toxic effect on the mother, regardless of the dosage. Nor was it shown to have been scientifically established that Depo-Provera has had an adverse effect on any fetus, when administered to the mother, regardless of the dosage. It is no longer used in the case of threatened miscarriages because recent evidence suggests that it is inefficacious for this purpose. Outside of the United States, Depo-Provera is used as a contraceptive. While Mrs. Whitfield was in the Hospital, on August 29, 1976, respondent ordered a blood serum test to determine the level of chorionic gonadotropin. The results of this test, which respondent saw for the first time on September 16, 1976, were 6,554 milliunits of chorionic gonadotropine per milligram of test fluid. On September 16, 1976, Mrs. Whitfield came to respondent's office and complained of additional bleeding. At that time, a two minute slide test for pregnancy was performed, with negative results. Respondent examined Mrs. Whitfield and concluded that her pregnancy had miscarried despite the efforts to preserve it. She was admitted to the Municipal Hospital of Port St. Joe on September 17, 1976, with the diagnosis of "incomplete abortion," which was changed to "missed abortion," as the pre-operative diagnosis. On the day of her admission, additional pregnancy tests were ordered. A two minute test was negative, but a two hour test was positive. Every pregnancy test is fallible to some extent. These test results did not alter respondent's clinical judgment that the pregnancy had miscarried. A pregnancy test of a urine specimen can yield positive results from four days to two weeks after a pregnancy ends, and sometimes even later. It was undisputed that a result on a blood serum test for chorionic gonadotropin of 6,554 milliunits per milliliter virtually rules out a viable pregnancy of two or three months' duration, although the level may fall that low after the fifth month of a normal pregnancy. At eight to ten weeks, normal levels range from 46,000 to 60,000 milliunits per milliliter. Respondent performed a routine d & c on September 18, 1976. Fifteen grams of the resultant curettings were transmitted to a pathologist who reported "products of conception," but no embryo. Port St. Joe is not a prosperous town. At the time of the hearing, respondent and her husband were the only physicians in Port St. Joe who accepted patients on medicaid. Respondent has admitted patients approximately 500 times to the Municipal Hospital of Port St. Joe. During her time in Port St. Joe, respondent has treated numerous medicaid patients, and has delivered 249 babies. In one instance there was a neonatal fatality. This record compares favorably with a national average on the order of 12 neonatal fatalities per 1,000 births. Respondent has three articles in respectable technical journals to her credit, including two in "Obstetrics and Gynecology." On one she collaborated with her husband. They received 168 requests for reprints from interested persons in some 15 countries. The other article in "Obstetrics and Gynecology" she co-authored describes the first documented full-term pregnancy of a woman with diabetes mellitus, Addison's disease, and hyperthyroidism. The patient described in the article was under respondent's care for the duration of her pregnancy, which eventuated in a normal delivery.
Recommendation Upon consideration of the foregoing, it is RECOMMENDED: That petitioner dismiss counts one, two, four, five and six of the administrative complaint. That petitioner reprimand respondent for her failure to diagnose the imperforation at the time of birth, in violation of Section 458.1201(1)(m), Florida Statutes (1978 Supp.), as alleged in count three of the administrative complaint. That, in all other respects, petitioner dismiss count three of the administrative complaint. DONE and ENTERED this 15th day of November, 1979, in Tallahassee, Florida. ROBERT T. BENTON, II Hearing Officer Division of Administrative Hearings Room 101, Collins Building Tallahassee, Florida 32301 904/488-9675 COPIES FURNISHED: Clifford L. Davis, Esquire 197 South Bronough Street Tallahassee, Florida 32301 J. Ben Watkins, Esquire Post Office Drawer 1814 Tallahassee, Florida 32302 ================================================================= AGENCY FINAL ORDER ================================================================= BEFORE THE STATE OF FLORIDA DEPARTMENT OF PROFESSIONAL REGULATION BOARD OF MEDICAL EXAMINERS IN RE: The License to Practice Medicine as a Physician of: CASE NO. 79-1144 ANILA POONAI, M.D. License No. 27070 /
