99-003870 Department Of Health, Board Of Medicine vs. Catherine Marie Lynch, M.D.
 Status: Closed
Recommended Order on Monday, July 3, 2000.


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Summary: Administrative Complaint charged that Respondent`s medical practice was below the standard of obstetrical care by failing to discontinue Pitocin and perform a Cesarean section soon enough. The charges were not proven by clear and convincing evidence.

1STATE OF FLORIDA

4DIVISION OF ADMINISTRATIVE HEARINGS

8DEPARTMENT OF HEALTH, BOARD )

13OF MEDICINE, )

16)

17Petitioner, )

19)

20vs. ) Case No. 99-3870

25)

26CATHERINE MARIE LYNCH, M.D., )

31)

32Respondent. )

34______________________________)

35RECOMMENDED ORDER

37On April 18-19, 2000, a formal administrative hearing was

46held in this case in Tampa, Florida, before J. Lawrence Johnston,

57Administrative Law Judge, Division of Administrative Hearings.

64APPEARANCES

65For Petitioner: Richard Ellis, Esquire

70Agency for Health Care Administration

75Post Office Box 14229

79Tallahassee, Florida 32317-4229

82For Respondent: Bruce D. Lamb, Esquire

88Ruden, McCloskey, Smith,

91Shuster & Russell, P.A.

95401 East Jackson Street, Suite 2700

101Tampa, Florida 33602-2378

104STATEMENT OF THE ISSUE

108The issue in this case is whether Respondent, Catherine

117Marie Lynch, M.D., should be disciplined on charges alleged in

127the Amended Administrative Complaint filed by Petitioner, the

135Department of Health (DOH), in DOH Case No. 98-14411.

144Essentially, the charges are that Respondent practiced

151obstetrical medicine below acceptable standards on November 9,

1591997, by not decreasing or discontinuing a patient's Pitocin and

169by delaying performance of a Cesarean section notwithstanding

177fetal heart rate (FHR) decelerations requiring contrary action.

185PRELIMINARY STATEMENT

187On August 24, 1999, DOH filed an Administrative Complaint

196against Respondent in DOH Case No. 98-14411. Respondent disputed

205the charges and requested a formal administrative proceeding.

213The case was referred to the Division of Administrative Hearings

223(DOAH) and set for final hearing in Tampa, Florida, on February

2342-4, 2000. On the parties' agreed motion, final hearing was

244continued to April 18-20, 2000. On February 16, 2000, Petitioner

254was given leave to file an Amended Administrative Complaint,

263which was filed on March 7, 2000.

270On March 27, 2000, Petitioner filed a Motion for Taking

280Official Recognition of the Amended Final Order in Department of

290Health v. Mohammad Fathi Abdel-Hameed, M.D. , DOAH Case Nos.

29997 -0337 and 97-0338. On April 17, 2000, Respondent filed a

310Motion to Take Official Recognition of Florida Administrative

318Code Rules 64B8-6.002 through 64B8-6.0005 in effect on November

3279, 1997--the date of the medical care in question in this case.

339At final hearing, both motions for official recognition were

348granted, subject only to relevance of the Abdel-Hameed Amended

357Final Order, which was marginal at best. (Petitioner's Proposed

366Recommended Order conceded that the Abdel-Hameed Amended Final

374Order only was being used to prove that " Pitocin must be used

386carefully.") Petitioner called the patient's husband, Frank

394Britt, Sheila Devanesan, M.D., and Harold Schulman, M.D.

402Petitioner had Petitioner's Exhibits 1 through 9 admitted in

411evidence. Petitioner's Exhibit 3 was a transcript of the

420deposition testimony of Scott E. Musinski, M.D. Respondent

428testified in her own behalf and called Robert W. Yelverton, M.D.

439Respondent had Respondent's Exhibits 1 through 5 admitted in

448evidence.

449After presentation of the evidence, Petitioner ordered a

457transcript, and the parties requested 20 days from the filing of

468the transcript in which to file proposed recommended orders. The

478Transcript was filed on May 4, 2000, and the timely proposed

489recommended orders filed by both parties have been considered.

498FINDINGS OF FACT

5011. Respondent, Catherine Marie Lynch, is and was at all

511times material to the allegations in the Amended Administrative

520Complaint, a licensed physician in the State of Florida, having

530been issued License No. ME 0061336.

5362. Respondent received a Bachelor of Science degree in

545science and biology from Georgetown University in Washington,

553D.C., in 1986. She received her Doctor of Medicine degree from

564the University of South Florida (USF) College of Medicine in

574Tampa, Florida, in 1990. She completed a standard residency

583program in obstetrics and gynecology through the USF College of

593Medicine in 1994. Dr. Lynch currently holds hospital

601appointments at Tampa General Hospital (Tampa General), H. Lee

610Moffitt Cancer Center, Bay Pines Veterans Administration

617Hospital, and Town 'N' Country Hospital, all in Tampa, Florida.

6273. After her formal education, Dr. Lynch joined the faculty

637of the USF College of Medicine in July of 1994 as an instructor.

650She was promoted to Assistant Professor of Medicine in July of

6611995 and was appointed Director of the Division of General

671Obstetrics and Gynecology of the USF College of Medicine in 1997.

682Since 1994, Dr. Lynch has been involved in the education of

693medical students and resident physicians, teaching both general

701obstetrics and gynecology, as well as urogynecology,

708incontinence, and pelvic reconstruction. She is responsible for

716oversight of the attending physicians within the Division of

725General Obstetrics and Gynecology, for operating room assignments

733and labor and delivery assignments, and coverage for these

742physicians. She also is responsible for the development of the

752schedule for resident physicians. These attending physicians and

760resident physicians provide care and treatment to patients at

769Tampa General Hospital, other hospitals, and obstetrics clinics.

7774. Respond ent is Board-certified in obstetrics and

785gynecology by the American Board of Obstetrics and Gynecology,

794having first become Board-certified in November 1996. She is a

804Fellow of the American College of Obstetrics and Gynecology.

813Staffing at Tampa General

8175. During November of 1997, there were approximately 24

826residents in the obstetrics and gynecology (OB/GYN) residency

834program at the USF College of Medicine. There were six residents

845per year of matriculation.

8496. During a regular work week in Novembe r of 1997, 21 of

862the 24 residents would cover a variety of services on the labor

874and delivery floor and throughout Tampa General. The other three

884would be at other locations, such as Genesis, a clinic, or the

896Moffitt Cancer Center. But November 9, 1997, the date in

906question in this case, was a Sunday. On weekends (and nights),

"917full services" were consolidated under the "on-call team." This

926team consisted of a first-year resident, a second-year resident,

935a third-year resident, a fourth-year resident, and one attending

944physician. The "on-call" team would cover all of the services

954provided at Tampa General, including not only labor and delivery

964but also antepartum, admissions to regular hospital floor, the

973postpartum ward, the gynecology ward, the gynecology-oncology

980ward, the emergency room, and emergency surgeries (such as

989ectopic pregnancy surgeries.)

9927. The "on-call" team's first-year resident is primarily

1000responsible for the triage (initial evaluation) of patients who

1009presented to labor and delivery for evaluation as to whether such

1020patients needed to be admitted to the hospital or could return to

1032their residence. In addition, the first-year resident is

1040primarily responsible for the "laboring" patients on labor and

1049delivery under the supervision of the third-year resident.

10578. The "on-call" team's second-year resident responds to

1065calls or questions on any of the wards for obstetrical or

1076gynecological problems or complaints other than labor and

1084delivery. The second-year resident also consults with other

1092physicians in the area of obstetrics and gynecology and sees

1102patients in the emergency room. The second-year resident also is

1112responsible for operative interventions, whether gynecological or

1119obstetrical in nature, under the supervision of the fourth-year

1128resident.

11299. The "on-call" team's third-year resident is responsible

1137for supervision of the first-year resident in labor and delivery.

1147Its fourth-year resident is responsible for oversight of the

1156other residents. The fourth-year resident also is responsible

1164for any sort of operative intervention, whether it be

1173gynecological or obstetrical in nature.

117810. The "on-call" team's attending physician oversees all

1186of the residents.

118911. Residents practice as unlicensed doctors-in-training

1195under Section 458.345, Florida Statutes. Florida Administrative

1202Code Rule 64B8-6.005 provides:

1206Resident Physician and Assistant Resident

1211Physician; Duties of. An assistant resident

1217or resident physician participates in an

1223organized graduate education program in which

1229he has daily contact with patients and

1236assumes increasing responsibility for their

1241care under the supervision of the attending

1248staff of the hospital. The assumption of

1255responsibility is a most important aspect of

1262residency training. As each assistant

1267resident or resident physician demonstrates

1272increasing knowledge and ability, an

1277increasing amount of reliance should be

1283placed in his judgment in the diagnosis and

1291in treatment of patients. He may also

1298participate in the teaching of interns and

1305medical students to an increasing extent. In

1312surgery and surgical specialties, the

1317assistant resident and resident physician

1322should be given ample opportunity to perform

1329major surgical procedures under direct

1334supervision of qualified members of the

1340professional staff of the hospital,

1345particularly in the later stages of his

1352training, in order that he may acquire

1359surgical skill and judgment.

1363This rule was in effect in November 1997, and remained in effect

1375at the time of the final hearing.

138212. In 1997, the USF OB/GYN residency program utilized both

1392didactic lectures and clinical training to educate medical

1400students and residents. Such training included the assessment of

1409patients in labor, including the interpretation of fetal heart

1418rate (FHR) monitoring strips.

1422Chronology of Events

1425at Tampa General

142813. On Sunday, November 9, 1997, Respondent was the "on-

1438call" team's attending physician at Tampa General. The team's

1447first-year resident was Sheila Devanesan, M.D. The second-year

1455resident was Cathy Johnson, M.D. The third-year resident was

1464Scott E. Musinski, M.D. The fourth-year (chief) resident was

1473Kimberly Huffman, M.D.

147614. On November 9, 1997, the patient, S.N., then age 40,

1487was two days past her estimated due date of delivery. The

1498gestational age of the fetus was 40 weeks. S.N. had received her

1510prenatal care at the Genesis outpatient clinic of Tampa General

1520and was classified as a low-risk patient. She had delivered

1530vaginally after normal pregnancies in 1978 and 1983. She had no

1541infections or any other medical condition during her pregnancy in

15511997 that would have impaired the health of the fetus.

156115. S.N. experienced a spontaneous rupture of the membranes

1570of the amniotic sac at approximately 8:00 a.m. on November 9,

15811997. She and her husband, Frank Britt, came to Tampa General

1592and arrived at approximately 9:35 a.m. Nursing staff initiated

1601electronic fetal heart monitoring for S.N. by way of the maternal

1612abdomen, along with electronic monitoring of the patient's

1620uterine contractions.

162216. At Tampa Genera l, the electronic fetal heart monitor

1632and uterine contraction sensors are attached to several display

1641monitors. One is in the patient's labor and delivery room;

1651others are located in the doctors' lounge, at the nursing

1661station, and in the "well" on the labor and delivery floor. The

1673display monitors only depict current events. The history of the

1683FHR and the patient's contractions while on labor and delivery

1693are recorded on a paper strip located only in the patient's room.

170517. The first "on-call" team me mber to examine and assess

1716S.N. on November 9, 1997, was Sheila Devanesan, M.D., who saw the

1728patient at approximately 9:45 a.m. Dr. Devanesan performed a

1737cervical examination, which indicated that S.N.'s cervix was

1745dilated to five centimeters. Dr. Devanesan also noted the

1754presence of light meconium (fetal fecal matter) in the amniotic

1764fluid. The volume of meconium was not felt to present a problem

1776for the fetus.

177918. In the course of her initial examination and

1788assessment, Dr. Devanesan also noted the presence of variable

1797fetal heart decelerations but characterized the fetal heart rate

1806(FHR) as "reassuring" at that time.

181219. Fetal heart decelerations denote a decline in fetal

1821heart beats-per-minute ( bpm) to a rate below the FHR "baseline."

1832The baseline is an average of the beat-to-beat variations in the

1843FHR when the FHR is neither accelerating nor decelerating. The

1853baseline can vary from fetus to fetus and also can vary during

1865the course of any one patient's labor. Generally, the baseline

1875heart rate of a fetus will be between 120 and 160 bpm.

188720. Fetal heart decelerations are not uncommon during labor

1896and delivery, and are not necessarily indicative of fetal

1905distress. However, certain categories of fetal heart

1912decelerations are of more concern to the clinician than others.

192221. In this case, "variable" fetal heart decelerations were

1931found virtually from the time electronic fetal heart monitoring

1940was initiated at 9:35 a.m. Variable decelerations can indicate a

1950compressed umbilical cord, which in turn can require intervention

1959by the obstetrician, or even a change in the plan of delivery

1971(from a vaginal delivery to delivery by Cesarean section).

1980Repeated variable decelerations can deplete fetal oxygen reserves

1988and lead to complications, including metabolic acidosis.

199522. At approximately 10:00 a.m. on November 9, 1997,

2004Dr. Musinski performed a sonogram in an attempt to determine the

2015cause of the variable decelerations. Based on the sonogram, he

2025diagnosed oligohydramnios, or deficient amniotic fluid.

2031Compression of the umbilical cord is a complication of

2040oligohydramnios.

204123. With help from Dr. Musinski, Dr. Devanesan placed a

2051fetal scalp electrode to more precisely monitor fetal heart rate

2061at approximately 10:12 a.m. Dr. Devanesan also ordered

2069amnioinfusion (infusion of fluid into the amniotic sac) in the

2079amount of 500 cubic centimeters (cc's), at approximately 10:19

2088a.m. Amnioinfusion is an appropriate intervention to treat

2096possible cord compression from oligohydramnios.

210124. Respondent came to S.N.'s bedside at 10:34 a.m. and

2111reviewed the FHR tracing strip recorded by electronic fetal heart

2121monitoring. Generally, it was Respondent's practice to review

2129the strip retroactively 30-45 minutes whenever she was at bedside

2139in labor and delivery. Appropriately, Respondent did nothing to

2148change the care being provided to the patient by the residents at

2160that point.

216225. At 11:00 a.m., it was decided to give the patient an

2174epidural for pain. An epidural is the infusion of pain

2184medication through a catheter into a location in the patient's

2194spine; it relieves pain without affecting the patient's level of

2204consciousness. To place an epidural catheter, the patient must

2213be repositioned to a sitting position. This repositioning can

2222cause FHR decelerations.

222526. The patient's labor record confirms that she was in a

2236sitting position for placement of the epidural at 11:00 a.m. The

2247patient's record indicates that a test dose was administered

2256through the epidural at 11:10 a.m.

226227. Dr. Devanesan performed another cervical examination at

227011:36 a.m., and found S.N.'s cervix still dilated to five

2280centimeters. The patient's record indicates that a bolus of

2289Fentanyl was given to the patient by epidural at 11:37 a.m.

230028. The administration of Fentanyl through an epidural

2308catheter can cause FHR decelerations.

231329. After conferring with Dr. Musinski, Dr. Devanesan gave

2322an order for a second amnioinfusion at 11:40 a.m. due to

2333continued variable decelerations. The second order was for

2341250 cc's; according to the patien t's hospital record, it was the

2353last amnioinfusion ordered for or administered to the patient.

236230. Due to S.N.'s lack of progress in labor, Dr. Devanesan

2373gave an order for Pitocin at 11:52 a.m., after conferring with

2384Dr. Musinski, to augment labor by stimulating uterine

2392contractions. Dr. Devanesan's order was for 1 milli-

2400International Unit ( mIU), to be increased by 1 mIU every 30

2412minutes up to 20 mIU's of Pitocin or until adequate contractions

2423began. There is no evidence that Respondent participated in the

2433decision to start Pitocin.

243731. Pitocin is a brand name; the generic name for the drug

2449is oxytocin. Pitocin is not used to manage fetal heart

2459decelerations. To the contrary, Pitocin is generally

2466contraindicated where FHR is considered non-reassuring. But one

2474mIU is a miniscule amount, and the progression of 1 mIU every 30

2487minutes was very conservative.

249132. Dr. Devanesan noted on S.N.'s chart that FHR was

"2501overall reassuring" at 11:40 a.m. Respondent reasonably

2508believed that Dr. Devanesan had the education and training to

2518identify nonreassuring, as well as reassuring, FHR patterns. But

2527Dr. Devanesan testified at final hearing that she did not have

2538the competence as a first-year resident to judge when FHR

2548patterns were nonreassuring overall.

255233. At approximately 12:03 p.m., after successive, milder

2560fetal heart decelerations that morning, the fetus experienced an

2569abrupt deceleration, from its baseline of approximately 120 bpm

2578to just under 50 bpm. The heart rate did not return to baseline

2591for approximately four minutes.

259534. At approximately 12:07 p.m., the notation "U/S" appears

2604on the heart monitor strip. That notation may refer to a second

2616ultrasound examination; however, neither Dr. Devanesan nor

2623Dr. Musinski could recall performing a second ultrasound.

263135. At approximately 12:10 p.m., Dr. Devanesan was at

2640S.N.'s bedside. The heart monitor strip bears a nurse's notation

2650at 12:10 p.m., reading "Off by Dr. Devanesan to stop flash

2661light." The monitor in the labor room flashed automatically to

2671call attention to significant FHR decelerations. The screen had

2680activated in response to the 12:03 p.m. deceleration. Dr.

2689Devanesan instructed nursing staff to turn off a flashing screen

2699at that time, since the medical professionals were aware of the

2710patient's recurrent decelerations.

271336. Following the 12:03 p.m. deceleration, the FHR

2721decelerated to approximately 50 bpm again at 12:10 p.m., 12:14

2731p.m., and 12:20 p.m., in tandem with uterine contractions. The

274112:10 p.m. deceleration is notable in itself due to its onset,

2752which is less abrupt than the 12:03 p.m., deceleration. The

2762gradual nature of the deceleration is suspicious for possible

2771hypoxia, or lack of oxygen, in the fetus.

277937. Fetal heart rate decelerated to 60 bpm at approximately

278912:27 p.m., remained at 60 bpm for approximately thirty seconds,

2799and did not return to baseline for approximately three minutes.

280938. Fetal heart rate decelerated to 50 bpm at approximately

281912:36 p.m., again during a uterine contraction. Also at that

2829time, Pitocin was increased from one mIU to two mIU's.

283939. Dr. Devanesan returned to S.N.'s bedside at

2847approximately 12:45 p.m. due to her concern with continued fetal

2857heart decelerations. At the same time, the FHR became irregular,

2867with multiple decelerations over the course of the next eight

2877minutes. Nurses' notes for 12:45 p.m. indicate fetal heart

2886decelerations to "60's-90's for approx. 3-4 [minutes with] slow

2895return to 100's".

289940. Dr. Musinski came to S.N.'s bedside at approximately

290812:55 p.m., likewise due to concern with fetal heart

2917decelerations. He performed a vaginal (cervical) examination at

2925that time, and found S.N. to be dilated to seven-to-eight

2935centimeters.

293641. At 12:58 p.m., Respondent joined Dr. Musinski at S.N.'s

2946bedside, along with Catherine Johnson, M.D., a second-year

2954resident in obstetrics and gynecology. Dr. Musinski did not

2963recall why Respondent came to the labor room. Respondent

2972testified that she observed the fetal heart tracing on one of the

2984remote monitors and made an independent determination to come to

2994S.N.'s bedside.

299642. Respondent testified further that she spent

3003approximately ten minutes at S.N.'s bedside; she also testified

3012that she was there until 1:15 or 1:20 p.m. She testified that

3024she instructed Dr. Musinski to perform a cervical examination.

3033Respondent also performed a cervical examination. The cervical

3041examination indicated that S.N.'s cervix remained dilated to

3049seven-to-eight centimeters.

305143. Respondent also testified that, while Respondent was at

3060bedside on this occasion, she instructed Dr. Musinski to perform

3070a fetal scalp stimulation. A fetal scalp stimulation (also known

3080as Clark's test) is a simple assessment measure used to learn

3091whether the fetus is acidotic. Essentially, the doctor

3099stimulates the fetal scalp and looks for a FHR acceleration in

3110response. If so, the doctor has some reassurance that the fetus

3121is not acidotic at that time.

312744. There is no notation in Dr. Musinski's progress note of

31381:03 p.m. to indicate that the fetal scalp stimulation was

3148performed, or what results were obtained if it was performed.

3158There is a notation in Dr. Musinski's 1:03 p.m. note indicating

3169significant variable fetal heart decelerations, with "prolonged

3176recovery" and good beat-to-beat variability. However, Respondent

3183testified that there was a reassuring response to the fetal scalp

3194stimulation performed by Dr. Musinski.

319945. During her time at bedside on this occasion, Respondent

3209became aware of the administration of Pitocin. The heart monitor

3219strip in fact indicates that the dosage of Pitocin was increased

3230to three mIU's at 1:01 p.m. Respondent did not think it was

3242necessary to decrease or discontinue Pitocin at that time.

325146. While at bedside on this occasion, Respondent reviewed

3260the fetal heart monitor strip. Respondent conceded that there

3269were nonreassuring FHR tracings prior to her arrival at 12:58

3279p.m. At approximately 1:07 p.m., fetal heart rate decelerated

3288from 150 to 90 bpm, recovered momentarily to 120, and then

3299decelerated to 60, returning to baseline approximately two

3307minutes later. But while Respondent was still at bedside, she

3317saw some improvement and drew the conclusion that FHR still was

3328reassuring overall, notwithstanding the variable decelerations.

3334She left with the instruction that she be notified if FHR

3345patterns deteriorated so that the team could decide what to do

3356next.

335747. At approximately 1:25 p.m., the FHR accelerated

3365momentarily to 150 bpm and then declined abruptly to 60, in

3376tandem with a uterine contraction. Robert Yelverton, M.D.,

3384Respondent's own expert witness, conceded that fetal heart rate

3393did not return to baseline until almost 1:30 p.m.

340248. At approximately 1:38 p.m., fetal heart rate

3410decelerated to approximately 65 bpm, in tandem with a uterine

3420contraction, and did not return to baseline for approximately two

3430minutes.

343149. At approximately 1:48 p.m., Dr. Musinski performed

3439another cervical examination; he found S.N.'s cervix dilated to

3448seven centimeters and 70% effaced. The fetus was in minus 1

3459station (not yet to mid-pelvis). The results of that examination

3469are noted on both the fetal heart monitor strip itself and in

3481Tampa General's nurses' notes. The strip itself indicates that

3490the fetus experienced a heart deceleration to 60 bpm at

35001:48 p.m., in tandem with a uterine c ontraction.

350950. At approximately 1:55 p.m., fetal heart rate

3517accelerated momentarily to 150 bpm, then abruptly decelerated to

352660, and did not return to baseline until over two minutes later,

3538and then decelerated twice more over the next four minutes.

354851 . At approximately 2:00 p.m., the dosage of Pitocin was

3559increased to five mIU's. Also at 2:00 p.m., Dr. Musinski came to

3571the patient's bedside and reviewed the fetal heart tracing.

358052. Beginning at approximately 2:01 p.m., the fetal heart

3589tracing took on a markedly different appearance. The tracing at

3599that point becomes notably flat in nature, whether at, above, or

3610below baseline. There was no more beat-to-beat variability.

361853. A marked lack or absence of beat-to-beat variability

3627can indicate metabolic acidosis, which is of great concern to the

3638clinician, and can dictate an intervention or change in the plan

3649of delivery, and on an emergency basis depending upon

3658circumstances.

365954. In instances of metabolic acidosis, the fetus begins

3668to break down fats as well as sugars in order to create energy

3681supply, due to lack of normal intake of oxygen. In the process,

3693lactic and other acids accumulate, resulting in acidosis.

370155. Dr. Musinski again reviewed the tracing on the heart

3711monitor strip and examined S.N. at 2:18 p.m. Again, he found

3722S.N.'s cervix dilated to seven centimeters.

372856. There was a conflict in the evidence as to what

3739happened next. Dr. Musinski recalled discussing a Cesarean with

3748Respondent at approximately 2:18 p.m. Other evidence tends to

3757support Dr. Musinski's version of events. A written consent form

3767for a Cesarean was signed by Dr. Musinski and the patient's

3778husband and bore the handwritten time of 2:18 p.m. Respondent

3788denied that Respondent discussed a Cesarean with her at 2:18 p.m.

3799She also testified that she never was notified of the loss of

3811baseline variability but saw the tracing on one of the other

3822three monitors at approximately 2:35 p.m., just after finishing a

3832Cesarean on another patient with Drs. Huffman and Devanesan.

3841Respondent testified that, at that point, she sent Dr. Huffman to

3852the patient's labor room and instructed the nursing staff to set

3863up for a fetal scalp pH test sample. Respondent believed that

3874the consent form must have been signed later when circumstances

3884became even more urgent. See Findings 66-67, infra . Otherwise,

3894Respondent would have expected the patient to sign, not just her

3905husband. But Respondent had no cogent explanation as to why the

3916time 2:18 p.m. would have been written on the form.

392657. The patient's husband also recalled talking to

3934Respondent about a Cesarean at some point during the afternoon,

3944presumably at or after the time the consent form was signed, and

3956being told that the delivery would be vaginal. But the evidence

3967is not clear as to exactly when the husband spoke to Respondent.

397958. Considering all of the evidence on this point, although

3989it may be suspected that Dr. Musinski spoke to Respondent about a

4001Cesarean around 2:18 p.m., the evidence on this point was not

4012clear and convincing, and the Respondent's version of the

4021circumstances leading to her coming to bedside must be accepted.

403159. Multiple fetal heart decelerations followed from 2:18

4039p.m. to 2:37 p.m., bearing an uncertain relationship to uterine

4049contractions during that span of time. In accordance with Dr.

4059Devanesan's order, Pitocin was increased to six mIU's at 2:30

4069p.m.

407060. Dr. Huffman arrived at S.N.'s bedside at 2:37 p.m. She

4081viewed the tracing on the heart monitor strip and performed a

4092cervical examination. Dr. Huffman's examination indicated that

4099S.N.'s cervix was still dilated to seven centimeters.

410761. Respondent herself entered S.N.'s room at 2:40 p.m.

4116She intended to proceed with a fetal scalp pH at that point and

4129ordered nursing staff to place S.N. in the lithotomy position for

4140the procedure.

414262. The term pH refers to potential of hydrogen, and the

4153value assigned upon clinical laboratory examination determines

4160the extent to which blood is normal, or has excessive alkaline

4171content, or excessive acid. The values given are logarithmic in

4181nature: e.g. , a blood pH of 6 is ten times more acidic than a

4195blood pH of 7; and a blood pH of 5 is one hundred times more

4210acidic than a blood pH of 7. Normal blood pH in the fetus is

42247.25 to 7.35.

422763. A fetal scalp pH te st is a means of assessing the

4240health of the fetus in labor. A mixture of arterial and venous

4252blood is taken from the fetal scalp. While somewhat useful, the

4263test only tells the clinician the fetal pH at the point in time

4276when the sample is drawn. The test lacks predictive value

4286concerning the onset of metabolic acidosis.

429264. After reviewing the tracing strip, and seeing that

4301baseline had increased to 150 bpm, but with no beat-to-beat

4311variability, Respondent abandoned the fetal scalp pH test,

4319deciding instead to try to complete a vaginal delivery. (This

4329may have been what the patient's husband was recalling when he

4340testified that Respondent told him it would not be a Cesarean but

4352a vaginal delivery.) Respondent performed a cervical examination

4360of S.N. and found S.N.'s cervix to be dilated to nine

4371centimeters. However, she also found that the fetus was in an

4382occiput transverse position, with the fetal head unfavorably

4390situated for a spontaneous vaginal delivery.

439665. At hearing, Respondent described h er actions at that

4406point as follows:

4409A. . . . And I hoped that if I could bring

4421it down just a little further, get rid of

4430that last bit of cervix, I could get forceps

4439in and pull the baby out in under five

4448minutes.

4449Q. You demonstrated that the fetal head was

4457turned sideways; is that correct?

4462A. Yes.

4464Q. And that's not the ideal position for use

4473of forceps; is that correct?

4478A. Correct.

4480Q. So what did you decide to do at that

4490point?

4491A. Well, since the baby had come down just

4500with repositioning the mother, obviously her,

4506you know, increasing intra-abdominal

4510pressure, just with the abdominal pressure,

4516with the change, in position of the tubal

4524lithotomy for the scalp pH, when I did the

4533exam I hoped that since she already had two

4542large babies, that if she could give me one

4551good push she could bring the baby down to

4560plus two and it would be a[n] easy-outlet

4568delivery.

456966. Respondent asked S.N. to push at approximately 2:45

4578p.m., in an attempt to deliver the baby vaginally. The baby was

4590not delivered at that point, however. Instead, the baby remained

4600in utero , and prolonged fetal bradycardia (slowing of heart rate)

4610ensued. Fetal heart rate decelerated to 60 bpm, and remained at

462160 bpm for approximately three minutes. The heart monitor strip

4631then shows a momentary return to baseline in tandem with a shift

4643of S.N. to left lateral position, following which fetal heart

4653rate decelerated back to 60 bpm, and then decelerated further to

466440 bpm, over the next several minutes.

467167. Pitocin continued to be administered throughout

4678Respondent's unsuccessful attempt to effect a vaginal delivery.

4686It was not discontinued until 2:51 p.m., and then apparently only

4697due to impending transport of S.N. to the operating room for an

4709emergency Cesarean section. Respondent ordered an emergency

4716Cesarean section at approximately that time, and the Cesarean

4725section was performed at approximately 3:00 p.m. by Dr. Johnson,

4735with Respondent assisting.

473868. The baby was delivered by Cesarean section at 3:01 p.m.

4749In the course of the baby's delivery, Respondent found the

4759umbilical cord over the baby's shoulder and down its back. The

4770shoulder over which the cord coursed had been pressing against

4780the maternal pubic bone, causing cord compression.

478769. One minute after birth, the baby's Apgar score was

4797zero, equivalent to an absence of any signs of life. The baby

4809was resuscitated following delivery, but there was a conflict in

4819the evidence as to whether and how quickly the baby was initially

4831intubated.

483270. Respondent's first iteration of the facts of this case,

4842given in her attorney's correspondence dated August 26, 1998,

4851indicates simply as follows: "Roberto Rivera, M.D., successfully

4859intubated Baby Boy N. and provided ventilation. Jennifer

4867Casetelli, M.D., monitored the heart rate, and the pediatric

4876nurse provided cardiac compressions. At 5 minutes, the Apgar

4885score was 3; 2 for heart rate, and 1 for skin color. At this

4899point, Baby N. was receiving positive pressure ventilation via

4908the endotracheal tube and was transported to the Neonatal

4917Intensive Care Unit (NICU)." Respondent reviewed the August 26,

49261998, correspondence before it was dispatched by her attorney,

4935and she authorized its dispatch.

494071. At hearing, Respondent told a different story.

4948According to her initial hearing testimony, she personally

4956witnessed a first-year pediatric resident unsuccessfully attempt

4963to intubate the baby, and it took over two minutes for the baby

4976to be intubated. Respondent later answered another question

4984about the intubation as follows:

4989Q. Do you know how many attempts it took

4998before the child was intubated?

5003A. I know there was only one interval in

5012which bagging occurred between attempts.

5017What I observed, and in fact asked the

5025anesthesia individual to go over and help, at

5033which time--by the time the anesthesia

5039resident got there the second-year had the

5046tube in, the clock was reading about 2:10. I

5055think it said 2:15. And it had been over a

5065minute or more that they had been trying to

5074get the tube down. (Vol. II transcript p.

5082228.)

508372. Ther e are no notations in either the mother's chart or

5095the baby's chart to indicate any difficulty of intubation. To

5105the contrary, the notation in the baby's chart reads: " Apgar at

51165 minutes was 3 with patient intubated." With the baby delivered

5127at 3:01 p.m., an Apgar score of 3 at five minutes "with patient

5140intubated" would mean that the baby was intubated at 3:06 p.m.,

5151if not sooner. Respiratory care notes in the baby's chart in

5162fact indicate that the baby was intubated as of 3:03 p.m.

517373. Upon the baby 's delivery at 3:01 p.m., the umbilical

5184cord was clamped and cut, and a blood specimen taken from the

5196cord for clinical laboratory analysis. The pertinent laboratory

5204result was a cord blood pH of 7.15, which would signify acidosis.

521674. The baby was admitted to the neonatal intensive care

5226unit (NICU) at 3:08 p.m. At 3:15 p.m., the baby suffered

5237cardiorespiratory arrest. A "code" (emergency response) was

5244called at that time in the NICU. The "Code 19 Flow Sheet"

5256indicates that the code ended at 3:30 p.m., with the baby

5267resuscitated at that time. NICU progress notes indicate that the

5277baby's heart rate was steady at 148 bpm at 3:30 p.m. However, a

5290blood sample drawn at 3:24 p.m. for arterial blood gas analysis

5301resulted in a pH of 6.81, which is grossly acidotic.

531175. The baby was hospitalized at Tampa General for 25 days.

5322He was treated with phenobarbital for seizures. He was diagnosed

5332with metabolic acidosis on November 9 and 10, 1997. Reports of

5343outpatient visits after discharge indicate developmental delays

5350and a diagnosis of severe static encephalopathy, i.e. , permanent

5359brain damage.

5361Medical Expert Evaluation

536476. The medical experts who testified in this case had

5374differences of opinion as to the nomenclature as well as the

5385significance of the variable decelerations evidenced by the FHR

5394monitor tracings in this case. They also differed to when it was

5406necessary to reduce or stop Pitocin and when it was necessary to

5418initiate a Cesarean section. Respondent and her witness, Robert

5427W. Yelverton, M.D., would be willing to wait longer than

5437Petitioner's expert, Harold Schulman, M.D. Preliminary excerpts

5444from authoritative literature will help put the subsequent

5452discussion of these differences of opinion in context.

546077. The American College of Obstetricians and Gynecologists

5468(ACOG) Technical Bulletin 207, published in July 1995, and still

5478in effect on November 9, 1997, begins by stating:

5487Intrapartum fetal heart rate (FHR) monitoring

5493can help the physician identify and interpret

5500changes in FHR patterns that may be

5507associated with such fetal conditions as

5513hypoxia, umbilical cord compression,

5517tachycardia, and acidosis. The ability to

5523interpret FHR patterns and understand their

5529correlation with the fetus' condition allows

5535the physician to institute management

5540techniques, including maternal oxygenation,

5544amnioinfusion, and tocolytic therapy.

5548* * *

5551Transient and repetitive episodes of hypomema

5557and hypoxia, even at the level of the central

5566nervous system (CNS), are extremely common

5572during normal labor and are generally well

5579tolerated by the fetus. Further, a

5585progressive intrapartum decline in baseline

5590fetal oxygenation and pH is virtually

5596universal; levels of acidemia that would be

5603ominous in an infant or adult are commonly

5611seen in normal newborns. Only when hypoxia

5618and resultant metabolic acidemia reach

5623extreme levels is the fetus at risk for long-

5632term neurologic impairment. For purposes of

5638this bulletin, the following definitions will

5644be used:

5646Hypoxemia: Decreased oxygen

5649content in blood

5652Hypoxia: Decreased level of

5656oxygen in tissue

5659Acidemia: Increased concentration

5662of hydrogen ions in the

5667blood

5668Acidosis: Increased concentration

5671of hydrogen ions in

5675tissue

5676Asphyxia: Hypoxia with metabolic

5680acidosis

5681The bulletin later makes the following pertinent statements about

5690interpretation of FHR patterns:

5694Variable decelerations are the most common

5700decelerations seen in labor and indicate

5706umbilical cord compression; they are

5711generally associated with a favorable

5716outcome. Only when they become persistent,

5722progressively deeper, and longer lasting are

5728they considered nonreassuring. Although

5732progression is more important than absolute

5738parameters, persisting variable decelerations

5742to less than 70 bpm lasting greater than 60

5751seconds are generally concerning. In

5756addition to prolonged and deep variable

5762decelerations, those with persistently slow

5767return to baseline are also considered

5773nonreassuring, as these reflect hypoxia

5778persistent beyond the relaxation phase of the

5785contraction. The response of the baseline

5791FHR to the variable decelerations and the

5798presence or absence of accelerations are

5804important in formulating a management plan

5810for the patient with significant variable

5816decelerations. When nonreassuring variable

5820decelerations are associated with the

5825development of tachycardia and loss of

5831variability, one begins to see substantial

5837correlation with fetal acidosis.

5841Late decelerations may be secondary to

5847transient fetal hypoxia in response to the

5854decreased placental perfusion associated with

5859uterine contractions. Occasional or

5863intermittent late decelerations are not

5868uncommon during labor. When late

5873decelerations become persistent ( ie, present

5879with most contractions), they are considered

5885nonreassuring, regardless of the depth of the

5892deceleration. Later decelerations caused by

5897reflex--those mediated by the CNS [central

5903nervous system]--generally become deeper as

5908the degree of hypoxia becomes more severe.

5915However, as metabolic acidosis develops from

5921tissue hypoxia, late decelerations are

5926believed to be the result of direct

5933myocardial depression, and at this point, the

5940depth of the late deceleration will not

5947indicate the degree of hypoxia.

5952A prolonged deceleration, often incorrectly

5957referred to as bradycardia, is an isolated,

5964abrupt decrease in the FHR to levels below

5972the baseline that lasts at least 60-90

5979seconds. These changes are always of concern

5986and may be caused by virtually any mechanism

5994that can lead to fetal hypoxia. The severity

6002of the event causing the deceleration is

6009usually reflected in the depth and duration

6016of the deceleration, as well as the degree to

6025which variability is lost during the

6031deceleration. When such a deceleration

6036returns to the baseline, especially with more

6043profound episodes, a transient fetal

6048tachycardia and loss of variability may occur

6055while the fetus is recovering from hypoxia.

6062The degree to which such decelerations are

6069nonreassuring depends on their depth and

6075duration, loss of variability, response of

6081the fetus during the recovery period, and,

6088most importantly, the frequency and

6093progression of recurrence. (Footnotes

6097omitted.)

6098The bulletin goes on to discuss evaluation and management of

6108nonreassuring patterns:

6110With a persistently nonreassuring FHR pattern

6116in labor, the clinician should approach the

6123evaluation and management in a four-step plan

6130as follows:

61321. When possible, determine the

6137etiology of the pattern.

61412. Attempt to correct the pattern

6147by specifically correcting the

6151primary problem or by

6155instituting general measure

6158aimed at improving fetal

6162oxygenation and placental

6165perfusion.

61663. If attempts to correct the

6172pattern are not successful,

6176fetal scalp blood pH assessment

6181may be considered.

61844. Determine whether operative

6188intervention is warranted and,

6192if so, how urgently it is

6198needed.

6199The search for the cause of the nonreassuring

6207FHR pattern should be directed by the

6214clinician's interpretation of the pattern.

6219. . . For severe variable or prolonged

6227decelerations, a pelvic examination should be

6233performed immediately to rule out umbilical

6239cord prolapse or rapid descent of the fetal

6247head. If no causes of such decelerations are

6255found, one can usually conclude that

6261umbilical cord compression is responsible.

6266General measures that may improve fetal

6272oxygenation and placental perfusion include

6277administering maternal oxygen by a tight-

6283fitting mask, ensuring that the woman is in

6291the lateral recumbent position, discontinuing

6296oxytocin, and, if maternal intravascular

6301volume status is in question, beginning

6307intravenous hydration.

6309After discussing administration of oxygen to the mother, which

6318was done in this case, the bulletin goes on to make the following

6331pertinent observations about maternal position, epidural block,

6338oxytocin, and amnioinfusion:

6341Maternal Position

6343Maternal position during labor can affect

6349uterine blood flow and placental perfusion.

6355In the supine position, there is an

6362exaggeration of the lumbar lordotic curvature

6368of the maternal spine facilitating

6373compression of the vena cava and aortoiliac

6380vessels by the gravid uterus. This results

6387in decreased return of blood to the maternal

6395heart leading directly to a fall in cardiac

6403output, blood pressure, and uterine blood

6409flow. In the supine position, aortic

6415compression by the uterus may result in an

6423increase in the incidence of late

6429decelerations and a decrease in fetal scalp

6436pH. The lateral recumbent position (either

6442side) is best for maximizing cardiac output

6449and uterine blood flow and is often

6456associated with improvement in the FHR

6462pattern. Other maternal positions may

6467accomplish similar uterine displacement.

6471Epidural Block

6473Some degree of maternal hypotension is a

6480relatively common complication of epidural

6485block, occurring in 5-25% of procedures.

6491. . . During the period of hypotension,

6499uteroplacental perfusion may be compromised.

6504This may be manifested by fetal tachycardia,

6511prolonged decelerations, decreased beat-to-

6515beat variability, late decelerations, or some

6521combination of these.

6524The frequency of prolonged decelerations

6529after administration of epidural analgesia

6534has been reported to be 7.9-12.5%. Uterine

6541hypertonia with resultant prolonged

6545decelerations has been observed in patients

6551receiving epidural block during labor even in

6558the absence of systemic hypotension.

6563Management of epidural-associated

6566decelerations should focus on treatment of

6572the specific cause--either the increased

6577uterine tone or maternal hypotension.

6582Oxytocin

6583Careful use of oxytocin is necessary to

6590minimize uterine hyperstimulation and

6594potential maternal and fetal morbidity. If

6600nonreassuring FHR changes occur in patients

6606receiving oxytocin, the infusion should be

6612decreased or discontinued. Restarting the

6617infusion at a lower rate or increasing it in

6626smaller increments may be better tolerated.

6632Amnioinfusion

6633Variable decelerations are frequently

6637encountered in both the first and second

6644stages of labor. Those occurring prior to

6651fetal descent at 8-9 cm of dilatation are

6659most frequently seen in patients with

6665oligohydramnios.

6666In patients with decreased amniotic fluid

6672volume in either preterm or term pregnancies,

6679replacement of amniotic fluid with normal

6685saline infused through a transcervical

6690intrauterine pressure catheter has been

6695reported to decrease both the frequency and

6702severity of variable decelerations.

6706Replacement of amniotic fluid may be elected

6713therapeutically in patients with progressive

6718variable decelerations. Although randomized,

6722controlled trials are lacking, it is

6728reasonable to replace amniotic fluid

6733prophylactically at the onset of labor in

6740patients with known oligohydramnios. Studies

6745also have demonstrated that amnioinfusion

6750results in reductions in rates of cesarean

6757delivery for "fetal distress," primarily due

6763to variable decelerations, and fewer low

6769Apgar scores at birth. Acute saline

6775amnioinfusion has been reported to be an

6782effective therapy that relieves most

6787repetitive variable or prolonged intrapartum

6792decelerations and is without apparent

6797maternal or fetal risk. Investigators have

6803also reported a decrease in newborn

6809respiratory complications from meconium in

6814patients who receive amnioinfusion. This

6819results presumably from the dilutional effect

6825of amnioinfusion and possibly from prevention

6831of in utero fetal gasping that may occur

6839during episodes of hypoxia caused by

6845umbilical cord compression. (Footnotes

6849omitted.)

6850Finally, the bulletin discusses management of persistent

6857nonreassuring FHR patterns as follows:

6862If the FHR pattern remains uncorrected, the

6869decision to intervene depends on the

6875clinician's assessment of the likelihood of

6881severe hypoxia and the possibility of

6887metabolic acidosis, as well as the estimated

6894time to spontaneous delivery. For the fetus

6901with persistent nonreassuring decelerations,

6905normal FHR variability and the absence of

6912tachycardia generally indicate the lack of

6918acidosis. However, variability is difficult

6923to quantify except in the extremes.

6929Persistent late decelerations or severe

6934variable decelerations associated with the

6939absence of variability are always

6944nonreassuring and generally require prompt

6949intervention unless they spontaneously

6953resolve or can be corrected rapidly with

6960immediate conservative measures (i.e.,

6964oxygen, hydration, or maternal

6968repositioning). The absence of variability

6973or markedly decreased variability

6977demonstrated on an external monitor is

6983generally reliable. The presence of FHR

6989variability is not confirmatory, however,

6994and, in the presence of nonreassuring

7000decelerations, a fetal electrode should be

7006placed when possible.

7009The presence of spontaneous accelerations of

7015greater than 15 bpm lasting at least 15

7023seconds virtually always ensures the absence

7029of fetal acidosis. Fetal scalp stimulation

7035or vibroacoustic stimulation can be used to

7042induce accelerations; these also indicate the

7048absence of acidosis. Conversely, there is

7054about a 50% chance of acidosis in the fetus

7063who fails to respond to stimulation in the

7071presence of an otherwise nonreassuring

7076pattern. In these fetuses, assessment of

7082scalp blood pH, if available, may be used to

7091clarify the acid-base status. This

7096technique, while occasionally helpful, is

7101used uncommonly in current obstetric

7106practice. If the FHR pattern remains

7112worrisome, either induced accelerations or

7117repeat assessment of scalp blood pH is

7124required every 20-30 minutes for continued

7130reassurance. In cases in which the FHR

7137patterns are persistently nonreassuring and

7142acidosis is present or cannot be ruled out,

7150the fetus should be promptly delivered by the

7158most expeditious route, whether abdominal or

7164vaginal. (Footnotes omitted.)

716778. Another publication accepted by the experts as

7175authoritative was an article by Drs. Low and Victory called

"7185Predictive Value of Electronic Fetal Monitoring for Intrapartum

7193Fetal Asphyxia with Metabolic Acidosis" published in Obstetrics

7201and Gynecology , February 1999 (the Low article). The Low article

7211reported the results of a matched case-control study of 71 births

7222with and 71 births without asphyxia. The Low article's

7231discussion of the results of the study stated in part:

7241The unnecessary intervention reported in

7246previous randomized clinical trials is

7251understandable in view of the results of this

7259study. Interpretation of FHR records is

7265complicated by false-positive FHR patterns.

7270Because predictive FHR patterns are not

7276specific and fetal asphyxial exposure is an

7283infrequent event, the positive predictive

7288values of these findings were low, ranging

7295from 18% for the most specific pattern to

73032.6% when all predictive patterns were

7309included. Because of the large number of

7316false-positive patterns, the potential for

7321unnecessary clinical intervention is great.

7326This study demonstrates that the prediction

7332of fetal asphyxial exposure by FHR patterns

7339is possible, but difficult. There is a

7346narrow window of 1 hour before diagnosis when

7354FHR patterns will predict a pronounced

7360metabolic acidosis. If the goal is to

7367predict fetal asphyxial exposure before

7372decompensation, one cannot wait for evidence

7378of absent baseline variability. At this

7384stage, the asphyxial exposure is moderate or

7391severe, with substantial newborn morbidity.

7396Asphyxial exposure must be considered if two

7403or more cycles of minimal baseline

7409variability and late or prolonged

7414decelerations are observed in the record.

7420Even these criteria will not identify all

7427cases of asphyxial exposure. In the asphyxia

7434group, ten infants had a single cycle of

7442minimal baseline variability or late or

7448prolonged decelerations, and four had no

7454predictive FHR variables. The asphyxial

7459exposure was mild in these latter cases.

7466* * *

7469During labor and delivery, fetal asphyxial

7475exposure occurs in 2% and moderate and severe

7483exposure in less than 0.3% of pregnancies.

7490The goal of intrapartum fetal surveillance is

7497to reduce the incidence of asphyxial exposure

7504and to prevent moderate and severe asphyxial

7511exposure. Electronic fetal monitoring with

7516the identification of predictive FHR patterns

7522can be a useful screening test in intrapartum

7530surveillance for fetal asphyxia. The

7535identification of predictive FHR patterns

7540requires continuous scoring of FHR records

7546because of the narrow 1-hour window of these

7554patterns with developing metabolic acidosis.

7559Predictive FHR patterns require supplementary

7564tests such as fetal blood gas and acid-base

7572assessment to confirm the diagnosis of fetal

7579asphyxia and to identify the false-positive

7585results to avoid unnecessary intervention.

7590The Low article defined "prolonged" decelerations as

7597decelerations lasting from 120 to 300 seconds. "Cycles"

7605consisted of ten-minute increments of time during the last four

7615hours of labor.

761879. Dr. Shulman defined a deceleration as a 15-bpm decline

7628in FHR lasting at least 15 seconds. According to Dr. Shulman's

7639definitions, a deceleration from 120 to 90 bpm would be called

"7650mild-to-moderate" if it lasted 45 seconds. A deceleration below

765970 bpm would be termed "severe" even if it lasted only 30

7671seconds, according to Dr. Shulman, as it could result in oxygen

7682deprivation. Dr. Shulman defined a "prolonged" deceleration as

7690one lasting more than 60-90 seconds, measured from onset to

7700return to baseline.

770380. Initially, Dr. Yelverton defined a "prolonged"

7710deceleration as a decline of 30 or more bpm lasting 120 or more

7723seconds. Later, he accepted the ACOG Technical Bulletin 207

7732definition of 60-90 seconds used by Dr. Shulman. However, Dr.

7742Yelverton measures the duration of a deceleration from beginning

7751to end of the nadir plateau. If that measurement does not exceed

776360 seconds, Dr. Yelverton would not call the deceleration

"7772prolonged" even if it took considerably longer for the FHR to

7783return to baseline. He would characterize such a deceleration as

7793a "classic variable deceleration with a slow return to baseline."

780381. Respondent defined a "prolonged" variable deceleration

7810as one that drops to 70 bpm or less and does not exceed 70 bpm

7825for 90 seconds or more.

783082. Dr. Shulman reserved his most serious criticism of

7839Respondent until her visit to bedside at 12:58 p.m. Regardless

7849of differences of opinion as to nomenclature and the seriousness

7859of the early variable decelerations, Dr. Yelverton conceded that,

7868by that point in time, the FHR patterns were becoming

7878nonreassuring. Dr. Schulman believed that it was necessary to

7887stop Pitocin and begin preparations for a Cesarean at that time

7898since repositioning, maternal oxygenation, and amnioinfusion had

7905not stopped the variable decelerations. In his view, there

7914already had been enough variable decelerations of sufficient

7922amplitude and duration. Respondent and Dr. Yelverton disagreed.

7930They thought caution was required but that labor toward a vaginal

7941delivery still could proceed at that point.

794883. Respondent and Dr. Yelverton were critical of Dr.

7957Shulman for not correlating the FHR monitoring strip with

7966information other than the uterine contractions being recorded on

7975the strip that could help explain some of the variable

7985decelerations. For example, progress notes and other information

7993in the record indicate various reasons why the patient was being

8004repositioned from time-to-time, either causing or relieving cord

8012compression. Similarly, the administration of epidural

8018medication can affect FHR patterns. But regardless of the reason

8028for variable decelerations, they can have an adverse effect on

8038the fetus, especially if they are severe or prolonged or

8048persistent. With good reason, Dr. Shulman was impressed with the

8058amplitude, duration, and persistence of the variable

8065decelerations regardless of their cause.

807084. Dr. Shulman's view of the case reflected an

8079unwillingness to accept much risk of compromise of the fetus as a

8091result of metabolic acidosis. Since metabolic acidosis is

8099difficult to predict, short of loss of baseline variability, Dr.

8109Shulman would be inclined to "bail out" and do a Cesarean after

8121two or three of what he termed "prolonged" or "severe" variable

8132decelerations. Although it could not be determined with

8140certainty, he would be fearful that the FHR patterns signified

8150hypoxia and that, by 12:58 p.m., the cumulative effects could

8160result in metabolic acidosis without much additional warning.

816885. Respondent and Dr. Yelverton disagreed. They thought

8176it was appropriate for Respondent to observe the patient until

8186approximately 1:15 p.m., as she did. There was some improvement

8196in the tracing by the time Respondent left the patient's bedside,

8207and both Respondent and Dr. Yelverton thought it was acceptable

8217to proceed further toward vaginal delivery at that point, with an

8228admonition to the residents to watch the tracings closely and

8238notify Respondent if they deteriorated. (It is noted that Dr.

8248Yelverton, at least, also would not have criticized a doctor who

8259opted for a Cesarean at 12:58 p.m.)

826686. Notwithstanding the testimony of Dr. Shulman, it is

8275found that a Cesarean was not mandatory at 1:15 p.m. There was

8287some improvement in the strip during Respondent's bedside visit,

8296and the evidence was not sufficient to prove that no reasonably

8307prudent physician would have allowed labor to continue. However,

8316as Respondent acknowledged in her instructions to the residents,

8325the team should have been very concerned about the tracings,

8335should have monitored the tracings and the condition of the fetus

8346closely, and should have been prepared to intervene promptly if

8356not reassured as labor progressed.

836187. Dr. Shulman also believed that it was mandatory to

8371cease Pitocin at 12:58 p.m. Respondent and Dr. Yelverton, on the

8382other hand, emphasized the low dosage of Pitocin being

8391administered at the time (3 mIU's). They also noted that the

8402patient's contractions were not very strong, and there was no

8412evidence of uterine hypertonis. They did not see a clear, direct

8423connection between the Pitocin and the FHR. Under these

8432circumstances, it is found that, notwithstanding Dr. Shulman's

8440testimony, it was not mandatory to stop Pitocin by 1:15 p.m. even

8452though Pitocin is relatively contraindicated if the FHR is

8461nonreassuring. However, they should have been prepared to stop

8470Pitocin if not reassured as labor progressed.

847788. Although the FHR tracings again became nonreassuring

8485after Respondent left the patient's bedside, Respondent was not

8494notified until sometime after baseline variability was lost at

8503approximately 2 p.m. The reason for the delay is not clear from

8515the evidence but probably was at least in part due to

8526Respondent's being occupied with the care of another patient who

8536required a Cesarean in this general time period. (Reference to

8546the other patient was general; there was no evidence as to

8557specifics at to the time or nature of the other Cesarean.)

856889. Respondent and her expert conceded that Pitocin should

8577have been discontinued when the FHR lost baseline variability.

8586Dr. Yelverton also conceded that a Cesarean should have been

8596initiated no more than ten minutes later. However, Respondent's

8605culpability for not discontinuing Pitocin and initiating a

8613Cesarean at that time is complicated by questions as to when

8624Respondent became aware of the loss of baseline variability. See

8634Findings 56-58, supra .

863890. Respondent also testified that, when she arrived at

8647bedside at 2:40 p.m., she assumed Pitocin already had been

8657discontinued by the nursing staff in accordance with a hospital

8667protocol for nurses. Respondent testified that she thought there

8676was a protocol requiring the nurses to discontinue Pitocin when a

8687doctor ordered a fetal scalp blood pH. In fact, the protocol

8698cited by Respondent did not address sampling for a fetal scalp

8709blood pH. It does, however, provide for discontinuance of

8718oxytocin immediately "if significant nonreassuring FHR patterns

8725occur, i.e., late or prolonged decelerations, bradycardia."

8732Based on the FHR tracings, it would have been reasonable for

8743Respondent to assume that the nursing staff had discontinued

8752Pitocin by the time Respondent arrived at bedside at 2:40 p.m.

876391. Besides the hospital protocol for oxytocin, the dosage

8772of Pitocin still was only 5 mIU's, and the patient's contractions

8783still were not especially strong. At the same time, Respondent

8793was occupied taking other actions on behalf of the patient. See

8804Finding 88, supra . Under these circumstances, it is

8813understandable and excusable that Respondent might not notice the

8822Pitocin and discontinue it. It is not found that her failure to

8834discontinue Pitocin immediately at 2:40 p.m. or during efforts to

8844deliver vaginally constituted a "failure to practice medicine

8852with that level of care, skill, and treatment which is recognized

8863by a reasonably prudent similar physician as being acceptable

8872under similar conditions and circumstances."

887792. Even assuming Respondent's version of the circumstances

8885leading to her coming to the patient's bedside at 2:40 p.m., the

8897evidence was clear and convincing that, at that time, she became

8908aware of the tracing strip showing no baseline variability since

8918approximately 2 p.m. Consistent with his belief that Respondent

8927already should have proceeded to a Cesarean, Dr. Shulman believed

8937that it was necessary to do so immediately at 2:40 p.m. Dr.

8949Yelverton also testified that a Cesarean should have been

8958initiated no later than 2:15 p.m. However, he excused

8967Respondent's decisions and actions after her arrival at bedside.

897693. As reflected in Dr. Yelverton's testimony, it is

8985difficult to second-guess a doctor's clinical judgment in such

8994circumstances. Respondent examined the patient; judged the

9001patient to be fully effaced and dilated to nine centimeters; and

9012judged the fetus to be at "zero station," i.e. , in mid-pelvis.

9023Given the patient's two previous vaginal deliveries, it was

9032Respondent's judgment that a relatively quick, assisted vaginal

9040delivery was possible. If she was right, her decision would have

9051been best for the baby (as well as the patient). However, the

9063baby's head position was not favorable for the hoped-for outcome.

9073Respondent's choice was risky, and failure would compound the

9082distress of the fetus and delay the Cesarean. In hindsight, it

9093is clear that Respondent made the wrong decision in trying for an

9105assisted vaginal delivery instead of proceeding immediately to a

9114Cesarean delivery. But under all of the circumstances, it is not

9125found that Respondent's decision constituted a "failure to

9133practice medicine with that level of care, skill, and treatment

9143which is recognized by a reasonably prudent similar physician as

9153being acceptable under similar conditions and circumstances."

916094. It also cannot be found that Respondent's decisions

9169alone resulted in the negative outcome in this case. It appears

9180from the evidence that events occurring after the Cesarean

9189delivery caused further damage to the baby. See Findings 69-74,

9199supra . It appears from the evidence that, absent the unfortunate

9210subsequent events, permanent brain damage may not have resulted.

9219CONCLUSIONS OF LAW

922295. Section 458.331(1)(t), Florida Statutes, authorizes the

9229Board of Medicine to discipline a physician on proof of:

9239Gross or repeated malpractice or the failure

9246to practice medicine with that level of care,

9254skill, and treatment which is recognized by a

9262reasonably prudent similar physician as being

9268acceptable under similar conditions and

9273circumstances.

927496. Section 458.331(3), Florida Statutes, provides:

9280In any administrative action against a

9286physician which does not involve revocation

9292or suspension of license, the division shall

9299have the burden, by the greater weight of the

9308evidence, to establish the existence of

9314grounds for disciplinary action. The

9319division shall establish grounds for

9324revocation or suspension of license by clear

9331and convincing evidence.

9334Petitioner concedes that its burden in this case was to prove the

9346allegations by clear and convincing evidence. See also Ferris v.

9356Turlington , 510 So. 2d 292 (Fla. 1987). (Even though

9365Petitioner's Proposed Recommended Order only sought imposition of

9373a fine and probation, the Amended Administrative Complaint sought

9382revocation or suspension.)

938597. In this case, the poor outcome resulted in part from

9396Respondent's misjudgments and willingness to accept more risk of

9405metabolic acidosis than Dr. Shulman. Nonetheless, Petitioner did

9413not prove by clear and convincing evidence that Respondent failed

9423to "practice medicine with that level of care, skill, and

9433treatment which is recognized by a reasonably prudent similar

9442physician as being acceptable under similar conditions and

9450circumstances."

9451RECOMMENDATION

9452Based upon the foregoing Findings of Fact and Conclusions of

9462Law, it is

9465RECOMMENDED that the Board of Medicine enter a final order

9475finding Respondent not guilty.

9479DONE AND ENTERED this 3rd day of July, 2000, in T allahassee,

9491Leon County, Florida.

9494___________________________________

9495J. LAWRENCE JOHNSTON

9498Administrative Law Judge

9501Division of Administrative Hearings

9505The DeSoto Building

95081230 Apalachee Parkway

9511Tallahassee, Florida 32399-3060

9514(850) 488-96 75 SUNCOM 278-9675

9519Fax Filing (850) 921-6847

9523www.doah.state.fl.us

9524Filed with the Clerk of the

9530Division of Administrative Hearings

9534this 3rd day of July, 2000.

9540COPIES FURNISHED:

9542Richard Ellis, Esquire

9545Agency for Health Care Administration

9550Post Office Box 14229

9554Tallahassee, Florida 32317-4229

9557Bruce D. Lamb, Esquire

9561Ruden, McCloskey, Smith,

9564Shuster & Russell, P.A.

9568401 East Jackson Street, Suite 2700

9574Tampa, Florida 33602-2378

9577Angela T. Hall, Agency Clerk

9582Department of Health

9585Bin A02

95872020 Capital Circle, Southeast

9591Tallahassee, Florida 32399-1703

9594William W. Large, General Counsel

9599Department of Health

96022020 Capital Circle, Southeast

9606Tallahassee, Florida 32399-1701

9609Tanya Williams, Executive Director

9613Board of Medicine

96161940 North Monroe Street

9620Tallahassee, Florida 32399-0750

9623NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

9629All parties have the right to submit written exceptions within 15

9640days from the date of this Recommended Order. Any exceptions to

9651this Recommended Order should be filed with the agency that will

9662issue the final order in this case.

Select the PDF icon to view the document.
PDF
Date
Proceedings
Date: 09/21/2000
Proceedings: Final Order filed.
PDF:
Date: 09/20/2000
Proceedings: Agency Final Order
PDF:
Date: 07/03/2000
Proceedings: Recommended Order
PDF:
Date: 07/03/2000
Proceedings: Recommended Order sent out. CASE CLOSED. Hearing held April 18-19, 2000.
Date: 06/27/2000
Proceedings: Notice of Substitution of Counsel (filed by R. Byerts) filed.
Date: 05/25/2000
Proceedings: (Respondent`s) Proposed Recommended Order filed.
Date: 05/23/2000
Proceedings: Notice of Filing of Petitioner`s Proposed Recommended Order; Petitioner`s Proposed Recommended Order filed.
Date: 05/10/2000
Proceedings: (Petitioner) Notice to Respondent That Transcript Has Been Filed (filed via facsimile).
Date: 05/04/2000
Proceedings: (2 Volumes) Transcript ; Notice of Filing filed.
Date: 04/18/2000
Proceedings: CASE STATUS: Hearing Held.
Date: 04/18/2000
Proceedings: (Respondent) Notice of Filing Supplemental Response to Petitioner`s Interrogatories and Request for Admissions filed.
Date: 04/17/2000
Proceedings: Respondent`s Motion to Take Official Recognition filed.
Date: 04/17/2000
Proceedings: Petitioner`s Exhibit List; Petitioner`s Witness List filed.
Date: 04/12/2000
Proceedings: (R. Ellis, B. Lamb) Prehearing Stipulation (filed via facsimile).
Date: 04/10/2000
Proceedings: Respondent`s Exhibit List; Respondent`s Witness List filed.
Date: 04/06/2000
Proceedings: Petitioner`s Motion to Compel Answers to Interrogatories or, in the Alternative, to Preclude Respondent`s Testimony filed.
Date: 04/03/2000
Proceedings: Respondent`s Response to Petitioner`s Motion for Taking of Official Recognition filed.
Date: 03/27/2000
Proceedings: Petitioner`s Motion for Taking of Official Recognition (For Judge Signature) filed.
Date: 03/27/2000
Proceedings: (B. Lamb) Notice of Taking Deposition Duces Tecum filed.
Date: 03/14/2000
Proceedings: Respondent`s Third Request for Production; Second Notice of Interrogatories to Petitioner; Second Set of Interrogatories filed.
Date: 03/07/2000
Proceedings: (Petitioner) Notice of Filing of Amended Administrative Complaint; Amended Administrative Complaint filed.
Date: 02/16/2000
Proceedings: Order Granting Leave to Amend sent out.
Date: 02/14/2000
Proceedings: Petitioner`s Reply to Respondent`s Response to Petitioner`s Motion for Leave to Amend (filed via facsimile).
Date: 02/11/2000
Proceedings: Memo from Rick Ellis to Judge Johnson (Motion Hearing) (filed via facsimile).
Date: 02/10/2000
Proceedings: Petitioner`s Response to "Motion to Quash Subpoena and Objection to Production" filed.
Date: 02/10/2000
Proceedings: (Respondent) Response to Petitioner`s Motion for Leave to Amend filed.
Date: 02/10/2000
Proceedings: (Petitioner) Memorandum of Law in Support of Petitioner`s Motion for Leave to Amend Administrative Complaint filed.
Date: 02/09/2000
Proceedings: Amended Notice of Hearing sent out. (hearing set for April 18 through 20, 2000; 9:00 a.m.; Tampa, FL, amended as to location)
Date: 02/07/2000
Proceedings: Notice of Motion Hearing (AHCA) filed.
Date: 02/04/2000
Proceedings: (Respondent) Motion to Quash Subpoena and Objection to Production filed.
Date: 02/03/2000
Proceedings: (R. Ellis) Notice of Production From Non-Party; Subpoena Duces Tecum filed.
Date: 01/28/2000
Proceedings: Petitioner`s Motion for Leave to Amend Administrative Complaint, and Request for Oral Argument filed.
Date: 01/26/2000
Proceedings: Order Granting Continuance and Re-scheduling Hearing sent out. (hearing set for April 18 through 20, 2000; 9:00 a.m.; Tampa, FL)
Date: 01/26/2000
Proceedings: Order of Pre-hearing Instructions sent out.
Date: 01/18/2000
Proceedings: Agreed-to Motion for Continuance (filed via facsimile).
Date: 12/13/1999
Proceedings: Respondent`s Second Request for Production filed.
Date: 10/06/1999
Proceedings: Petitioner, Department of Health`s First Set of Interrogatories to Respondent, Catherine M. Lynch, M.D.; Petitioner`s Notice of Serving Answers to Respondent`s First Set of Interrogatories filed.
Date: 10/06/1999
Proceedings: Notice of Filing of Petitioner`s First Set of Interrogatories and Respondent`s Answer to First Set of Interrogatories; Notice of Service of Petitioner`s First Set of Interrogatories to Respondent, Catherine M. Lynch, M.D. filed.
Date: 10/06/1999
Proceedings: Response to Petitioner`s First Request for Admissions filed.
Date: 10/06/1999
Proceedings: Petitioner`s First Request for Admissions; Petitioner`s First Request for Admissions to Respondent, Catherine M. Lynch, M.D. filed.
Date: 10/06/1999
Proceedings: (Petitioner) Notice of Filing of Petitioner`s First Request for Admissions and Respondent`s Response to First Request for Admissions filed.
Date: 10/06/1999
Proceedings: (Petitioner) Notice of Intent to Seek Costs Including Costs Associated With an Attorney`s Time filed.
Date: 10/05/1999
Proceedings: Order of Pre-hearing Instructions sent out.
Date: 10/05/1999
Proceedings: Notice of Hearing sent out. (hearing set for February 2 through 4, 2000; 9:00 a.m.; Tampa, FL)
Date: 10/04/1999
Proceedings: (Respondent) Response to Request for Production of Documents filed.
Date: 10/04/1999
Proceedings: Petitioner`s Notice of Serving Answers to Respondent`s First Set of Interrogatories; Response to Petitioner`s First Request for Admissions filed.
Date: 09/29/1999
Proceedings: Agreed-to Response to Initial Order (filed via facsimile).
Date: 09/20/1999
Proceedings: Initial Order issued.
Date: 09/15/1999
Proceedings: Agency Referral Letter; Administrative Complaint; Petition for Hearing filed.

Case Information

Judge:
J. LAWRENCE JOHNSTON
Date Filed:
09/15/1999
Date Assignment:
09/20/1999
Last Docket Entry:
09/21/2000
Location:
Tampa, Florida
District:
Middle
Agency:
ADOPTED IN TOTO
 

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