STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF PROFESSIONAL ) REGULATION, BOARD OF MEDICINE, )

)

Petitioner, )

)

vs. ) CASE NO. 87-2283

)

MANIHI G. MUKHERJEE, M.D., )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, an administrative hearing was held before Diane D. Tremor, Hearing Officer with the Division of Administrative Hearings, on March

15 and 16, 1988, in St. Petersburg, Florida. The issue for determination in this proceeding is whether respondent's license to practice medicine should be disciplined for the reasons set forth in the Administrative Complaint filed on May 4, 1987.

APPEARANCES

For Petitioner: Stephanie A. Daniel

Senior Attorney

Department of Professional Regulation

130 North Monroe Street Tallahassee, Florida 32399-0750

For Respondent: Donald V. Bulleit and Nelly Khouzam

Fowler, White, Gillen, Boggs, Villareal & Banker, P.A.

P. O. Box 210

St. Petersburg, Florida. 33731 INTRODUCTION

By an Administrative Complaint filed on May 4, 1987, respondent Manihi G. Mukherjee, M.D. is charged with violating Chapter 458, Florida Statutes, in her treatment of two patients. More specifically, it is alleged that respondent violated Section 458.331(1)(t) by gross or repeated 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. It is further alleged that, with respect to patient J.B., respondent violated Section 458.331(1)(m) by 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.

In support of the charges, the petitioner presented the testimony of patient J.B., patient R.L. and Walter F. Scott, who was accepted as an expert witness in the field of pathology. Additionally, petitioner presented by video tape depositions the testimony of Janet A. Marley, M. D. and Robert Yelverton,

1. D., both of whom are accepted as expert witnesses in the fields of obstetrics and gynecology. Petitioner's Exhibits 1 through 10 were received into evidence.

   
   

   The respondent testified in her own behalf and also presented the testimony of Thelma Maragos, M. D., who was accepted as an expert witness in the area of obstetrics and gynecology. By way of deposition, the petitioner presented the testimony of Benjamin Abinales, M.D., Minguan Suksanong, M.D.,and Morris J. LeVine, M.D. Respondent's Exhibits 1 through 4 were received into evidence.

   
   

   Subsequent to the hearing, both parties submitted proposed findings of fact and proposed conclusions of law. To the extent that the parties' proposed factual findings are not included in this Recommended Order, they are rejected for the reasons set forth in the Appendix hereto.

   
   

   FINDINGS OF FACT

   
   

   Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found:

   
   

   1. 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.

      
      

   2. 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.

      
      

   3. 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.

      
      

   4. 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.

   5. 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.

      
      

   6. 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.

      
      

   7. 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.

      
      

   8. 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..."

      
      

   9. 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.

      
      

   10. 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.

       
       

   11. 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.

       
       

   12. 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.

       
       

   13. 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.

       
       

   14. 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.

       
       

   15. 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.

       
       

   16. 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.

       
       

   17. 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.

       
       

   18. 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.

       
       

   19. 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.

       
       

   20. 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.

       
       

   21. 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

1. 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.

   
   

   1. 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.

      
      

   2. 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.

      
      

      CONCLUSIONS OF LAW

      
      

   3. With respect to patients J.B. and R.L., respondent is charged with violating Section 458.331(1)(t), Florida Statutes, by failing to practice medicine with that level of care, skill and treatment which a reasonably prudent similar physician recognizes as acceptable under similar conditions and circumstances. With respect to patient J.B., respondent is also charged with violating Section 458.311(1)(m), Florida Statutes, by failing to maintain adequate records to justify her course of treatment, including, patient history, examination results and test results. The petitioner has the burden of proof in this proceeding to clearly and convincingly demonstrate that the alleged violations occurred with respect to patients J.B. and R.L.

      
      

   4. The evidence clearly demonstrates that respondent failed 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 with respect to patient J.B. The respondent failed to advise J.B. that respondent did not remove any tubal matter from the right fallopian tube. She failed to advise J.B. that she could become pregnant if the right tube were not appropriately blocked, and, therefore, needed to utilize contraceptive measures until the matter could be appropriately investigated. Respondent should then have either obtained J.B.'s previous medical records from her 1973 surgery to confirm or deny the removal of the right fallopian tube during that surgical procedure, or she should have performed a hysterosalpingogram to determine whether the right tube was blocked or ligated. Respondent's failure to practice with an acceptable level of care, skill and treatment lies not so much at the time of the surgical procedure, but rather with her failure to inform the patient of the results of the surgery and the consequences of such results, and her subsequent failure to take appropriate action to determine whether there was a right fallopian tube or a previous removal or ligation.

      
      

   5. In addition, the respondent's records for patient J.B. do not accurately reflect the surgical procedure performed or the results of the pathological evaluation of the specimens from the surgery. As such, respondent is guilty of violating Section 458.331(1)(m), Florida Statutes, by failing to keep written medical records justifying the course of treatment of the patient, including patient history, examination results and test results.

      
      

   6. With respect to patient R.L., respondent's delay in surgical intervention was clearly substandard. The evidence demonstrates that respondent's initial conservative treatment of R.L. with antibiotics and testing was appropriate for the first 72 hours, or even for a period of four or five days given the young age of the patient. In this instance, respondent allowed some sixteen days to pass before she performed an exploratory laparotomy and other surgical procedures. This was inappropriate given the fact that the patient had demonstrated no significant or sustained clinical improvement since her admission to the hospital. At the very least, when the first colpotomy

procedure performed on September 11, 1981, did not produce lasting clinical improvement, that procedure should not have been repeated again on September 16, 1981, with a further delay of another five days before exploratory surgery was finally performed. A sixteen-day delay in performing a definitive procedure under these conditions and circumstances constitutes a failure to practice medicine with that level of care, skill and treatment which a reasonably prudent gynecologist recognizes as acceptable.

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.

1. First sentence rejected as unsupported by the evidence.

2. 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

Docket for Case No: 87-002283

Orders for Case No: 87-002283