99-003870
Department Of Health, Board Of Medicine vs.
Catherine Marie Lynch, M.D.
Status: Closed
Recommended Order on Monday, July 3, 2000.
Recommended Order on Monday, July 3, 2000.
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.
- Date
- Proceedings
- Date: 09/21/2000
- Proceedings: Final Order filed.
- 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.