1 2 3 4 5 6 7 8 UNITED STATES DISTRICT COURT 9 SOUTHERN DISTRICT OF CALIFORNIA
10 Case No. 21-cv-329 DMS (BLM) FRV, a Minor, By and Through His 11 Guardian ad Litem, CRISTAL FINDINGS OF FACT AND CAZARES VALENZUELA; and CONCLUSIONS OF LAW 12 SONIA VALENZUELA PEREZ, Individually, 13 Plaintiffs, 14 v. 15 UNITED STATES OF AMERICA; 16 and DOES 1 through 20, Inclusive,
17 Defendant. 18 19 Plaintiffs FRV, a minor, by and through his guardian ad litem, Cristal Cazares 20 Valenzuela (“Ms. Cazares”), and Sonia Valenzuela Perez (“Ms. Valenzuela”), filed 21 their Complaint in this case on February 23, 2021, against Defendant United States 22 of America alleging one count of medical negligence under the Federal Tort Claims 23 Act (“FTCA”) relating to a birth injury of FRV. (ECF No. 1.) Plaintiffs allege an 24 employee of the United States, Melissa Hawkins, M.D. (“Dr. Hawkins”), an 25 obstetrician-gynecologist (“OBGYN”), committed medical malpractice by 26 mismanaging Ms. Valenzuela’s labor and delivery of her son, FRV, thereby causing 27 Plaintiffs injury and damages, including medical expenses, loss of earnings, and The case was presented to the Court through a bench trial beginning on June 1 26, 2023, and concluding on July 11, 2023. Kenneth Sigelman, Jonathan 2 Ehtessabian, and Max Gruenberg appeared for Plaintiffs. Assistant United States 3 Attorneys Janet Cabral, Stephanie Sotomayor, and Juliet Keene appeared for 4 Defendant. Eighteen expert witnesses and eight percipient witnesses testified at 5 trial. The case was well tried by counsel, which provided the Court with a full 6 understanding of FRV, his family, and the parties’ competing positions on the 7 standard of care, causation, injury and damages. Having carefully considered the 8 evidence and arguments of counsel, the Court makes the following findings of fact 9 and conclusions of law pursuant to Federal Rule of Civil Procedure 52, and finds 10 that Dr. Hawkins acted within the standard of care. Accordingly, the Court finds in 11 favor of Defendant for the reasons set forth below. 12 13 I. 14 SUMMARY 15 This case arises out of the alleged mismanagement of the labor of Ms. 16 Valenzuela and delivery of FRV. The discovery deadlines and trial date were 17 continued to allow meaningful neurocognitive testing of FRV once he turned four 18 years old. FRV was four years and nine months old at the time of trial. 19 Plaintiffs’ experts opine that FRV is cognitively impaired to a degree that he 20 will never work or live independently, and he will require attendant care for the rest 21 of his life. Plaintiffs contend FRV suffered hypoxic ischemic encephalopathy of 22 both an acute-profound and partial-prolonged pattern,1 and brachial plexus injury2 23 caused by shoulder dystocia3 as a result of Dr. Hawkins’ mismanagement of 24
25 1 Hypoxic ischemic encephalopathy (“HIE”) is a brain injury caused by oxygen deprivation to the brain. HIE is characterized by evidence of acute-profound or partial-prolonged asphyxia. Partial-prolonged asphyxia is a result of 26 inadequate oxygen to the brain for longer than 30 minutes. Acute-profound asphyxia is total, or near total, lack of oxygen to the brain that occurs over a period of minutes. 27 2 Ripping of the nerves that sends signals from the spinal cord to the shoulder, arm, and hand. 1 Plaintiffs’ labor and delivery. Plaintiffs contend that because of Dr. Hawkins’ failure 2 to properly interpret fetal heart tracings (“FHTs”), failure to detect signs of fetal 3 intolerance to labor, and failure to timely intervene and deliver FRV by Caesarean 4 section (“C-section”) in the face of persistent “nonreassuring” FHTs, FRV suffered 5 life-altering injuries. Specifically, Plaintiffs contend that Dr. Hawkins fell below the 6 standard of care by failing to recommend urgent cesarean delivery of FRV by 11:30 7 a.m. based on FRV’s nonreassuring heart tracings and other clinical factors, 8 including Ms. Valenzuela’s advanced maternal age (39 years), gestational diabetes,4 9 estimated fetal weight by sizing ultrasound, at 8 lbs., 14 oz., and pre-eclampsia.5 10 Plaintiffs’ theory is that FRV’s hypoxic ischemic encephalopathy and brachial 11 plexus injuries would not have occurred had he been delivered by C-section by 12:00 12 p.m., rather than naturally (vaginally) at 9:32 p.m. 13 Defendant’s experts opine that FRV will be able to graduate high school, post- 14 secondary school, and maintain gainful employment. Defendant acknowledges that 15 FRV will have life-long limitations to his right arm and shoulder because of the 16 brachial plexus injury, which likely occurred during the shoulder dystocia. 17 Defendant contends that Dr. Hawkins with the assistance of her nursing team 18 managed Ms. Valenzuela’s labor and delivery with the requisite skill of a reasonably 19 careful OBGYN, that she made appropriate evidence-based medical decisions 20 throughout labor based on the information known to her at the time, including her 21 interpretations of the fetal heart tracings, and that she properly expedited delivery 22 when confronted with the medical emergency of shoulder dystocia, ultimately 23 saving FRV’s life. Defendant points out that reading fetal heart tracings is subjective 24 (interpretive), and not amenable to objective calculation and precision. Defendant 25 further argues FRV’s estimated fetal weight of 8 lbs., 14 oz. was within normal 26 27 1 limits, that Ms. Valenzuela had previously naturally delivered three prior babies, 2 including a baby weighing 9 lbs., 2 oz., all without incident. Defendant also notes 3 Ms. Valenzuela had gestational diabetes with a prior pregnancy, yet delivered a 4 smaller than average baby, weighing 6 lbs., 10 oz. Based on the foregoing, 5 Defendant disputes that Dr. Hawkins was negligent, in addition to disputing 6 causation, injury and damages. 7 The Court had the occasion to meet FRV at trial and to hear from FRV’s 8 parents and family members. The family is close-knit, loving and inspirational in 9 its care of FRV—dealing with FRV’s present physical and emotional challenges 10 with fortitude and grace. The delivery of FRV was complex and traumatic given the 11 unforeseen shoulder dystocia, and FRV suffered serious and unfortunate injuries at 12 birth. 13 Many of the events regarding the labor of Ms. Valenzuela and delivery of 14 FRV are undisputed and documented in the medical charts and history. The key 15 disputes are between the parties’ expert witnesses and whether Dr. Hawkins 16 breached the standard of care, caused Plaintiffs’ injuries, and if so, the extent of those 17 injuries and damages. Because the Court finds Dr. Hawkins did not breach the 18 standard of care, the discussion below focuses on the opinions of the parties’ 19 OBGYN experts, Albert J. Phillips, M.D. (“Dr. Phillips”) for Plaintiffs and Jessica 20 Kingston, M.D. (“Dr. Kingston”) for Defendant, as well as Dr. Hawkins, the nurses, 21 and percipient witnesses, including Ms. Valenzuela, her husband and other family 22 members. The principal dispute between the OBGYN experts centers on their 23 interpretation of the fetal heart tracings and whether those tracings indicated an 24 urgent cesarean delivery by 11:30 a.m. 25 Based on Dr. Kingston’s interpretation of FRV’s heart tracings—which is 26 largely consistent with the charting of the nurses and opinions of Dr. Hawkins—and 27 her assessment of the totality of circumstances known to Dr. Hawkins at the time, 1 delivering FRV naturally. The balance of evidence regarding causation, injury and 2 damages will not be addressed in light of the Court’s finding that Plaintiffs have 3 failed to prove by a preponderance of evidence the first element of their negligence 4 claim: breach of the standard of care. 5 II. 6 FINDINGS OF FACT AND CONCLUSIONS OF LAW 7 Ms. Valenzuela became pregnant with FRV in early 2018, and received her 8 prenatal care from Vista Community Clinic (“VCC”) beginning on March 30, 2018.6 9 On October 16, 2021, an ultrasound was performed at Tri-City Medical Center 10 (“TCMC”), which indicated an estimated fetal weight of FRV of 8 lbs., 4 oz. (4,017 11 grams). Dr. Christos Karanikkis ordered that ultrasound and noted that if Ms. 12 Valenzuela did not deliver by October 23, 2018, labor would be induced. 13 On October 21, 2018, in the morning hours, Ms. Valenzuela’s water broke 14 while she was at home. She immediately headed for TCMC, and was admitted to 15 the labor and delivery unit at approximately 8:03 a.m. In addition to Dr. Hawkins, 16 Kate Wildern, R.N. (“Nurse Wildern”) was assigned to Ms. Valenzuela and served 17 as her primary labor and delivery nurse. When Nurse Wildern’s shift ended at 7:00 18 p.m., Monica Montes, R.N. (“Nurse Montes”) took charge as the primary labor and 19 delivery nurse. 20 Upon admittance, Dr. Hawkins performed a physical exam and obtained Ms. 21 Valenzuela’s history. Dr. Hawkins learned Ms. Valenzuela had mild pre-eclampsia, 22 gestational diabetes, and advanced maternal age. As part of the physical exam, Dr. 23 Hawkins performed a manual external palpitation to evaluate FRV’s size, which she 24 estimated to be 8 lbs., 5 oz. to 9 lbs.—consistent with the ultrasound a few days 25 earlier. Dr. Hawkins also learned about Ms. Valenzuela’s three prior pregnancies 26 resulting in natural births, including one LGA baby weighing 9 lbs., 2 oz. 27 1 Dr. Hawkins ordered labetalol to treat Ms. Valenzuela’s blood pressure, 2 measured at 162/94 and 160/93. Dr. Hawkins initially induced labor with Cytotec,7 3 and then administered Pitocin8 approximately four hours later. Per Ms. Valenzuela’s 4 medical chart, Cytotec was ordered at 10:22 a.m. and 10:40 a.m., and Pitocin was 5 started at 1:55 p.m. FRV’s heart tracings were recorded beginning at 8:17 a.m., 6 within minutes of Ms. Valenzuela’s admission. 7 As labor progressed, the nurses and Dr. Hawkins continued to monitor FRV’s 8 heart tracings remotely at the nurses’ station and at bedside. Every thirty minutes, 9 the nurses charted their impressions of FRV’s heart tracings and Ms. Valenzuela’s 10 overall health. The heart tracings were reviewed throughout the labor by the nurses 11 and Dr. Hawkins to monitor any accelerations, decelerations, and variability of 12 FRV’s heart rate to determine if FRV was well oxygenated and tolerating labor. 13 Ms. Valenzuela’s labor progressed, and at 8:29 p.m., she was 9.5 cm dilated.9 14 She had an intense urge to push at that time, and “pushed to the point of 15 exhaustion[,]” (Jt. Ex. 018-001), but failed to deliver FRV. At approximately 8:40 16 p.m., per Dr. Hawkins’ operative report, FRV’s heart tracings showed decreased 17 variability and overcompensation after each contraction, indicating intolerance to 18 labor, so Dr. Hawkins obtained Ms. Valenzuela’s consent for vacuum-assisted 19 delivery. Dr. Hawkins noted in the chart a fetal heart rate of 80 beats per minute, 20 well below the norm of 110 to 160 beats per minute, and consistent with terminal 21 bradycardia.10 The vacuum was applied at approximately 9:24 p.m., and this brought 22 FRV’s head to crowning, meaning the top of FRV’s head was visible at the opening 23 of the vagina. After applying the vacuum a second time, FRV’s head was delivered 24 25 7 Cytotec is a cervical ripening agent that softens the cervix to facilitate cervical dilatation to allow the baby to pass 26 through the birth canal. 8 Pitocin is a synthetic version of oxytocin, a hormone that causes the uterus to contract more frequently, strongly, and 27 regularly. 1 but Dr. Hawkins noticed FRV’s head turtling or retracting backwards, which 2 indicated shoulder dystocia. Ms. Valenzuela was put in a severe McRoberts position 3 to attempt to relieve the shoulder dystocia. Three nurses and Ms. Valenzuela’s 4 husband, Porfirio Rauda, applied suprapubic pressure to dislodge FRV. The 5 shoulder dystocia lasted somewhere between five and eight minutes. It was 6 unanticipated and traumatic. 7 FRV was born at 9:35 p.m. He weighed 10 lbs., 11 oz., placing him above 8 the 99th percentile, and he was noted to be floppy, limp without spontaneous 9 respirations, and blue in appearance. Resuscitation efforts were initiated and he was 10 transported to the TCMC Neonatal Intensive Care Unit (“NICU”). At the NICU, 11 FRV began to have seizure activity and was transferred to Rady Children’s Hospital. 12 During the newborn period, FRV was diagnosed with respiratory failure, 13 hypoglycemia, seizures, brachial plexus injury, hypoxic ischemic encephalopathy, 14 and intracerebral hemorrhage. FRV also suffered injury to the right C7 and C8 nerve 15 roots, with avulsion of the C8 nerve root, which has required two surgeries. 16 A. Jurisdiction 17 As a sovereign, the United States is immune from suit unless it consents to be 18 sued by statute. United States v. Palm, 494 U.S. 596, 608 (1990). The FTCA, 28 19 U.S.C. § 2671 et seq., is such a statute. See Steward v. U.S., 282 Fed.App’x. 595, 20 596 (9th Cir. 2008) (stating “[t]he FTCA waives the government’s immunity for tort 21 claims arising out of the negligent conduct of government employees acting within 22 the scope of their employment.”). The government may be sued “under 23 circumstances where the United States, if a private person, would be liable to the 24 claimant in accordance with the law of the place where the act or omission occurred.” 25 Terbush v. United States, 516 F.3d 1125, 1128-29 (9th Cir. 2008) (citing 28 U.S.C. 26 § 1346(b)(1)). Thus, the Court has jurisdiction over this matter pursuant to 28 U.S.C. 27 § 1346(b). 1 The United States’ sovereign immunity extends to federally deemed entities 2 and individuals sued in their official capacities. Gilbert v. DaGrossa, 756 F.2d 1455, 3 1458 (9th Cir. 1985). It is undisputed that Dr. Hawkins and VCC, which employed 4 Dr. Hawkins during the time in question, are federal employees for purposes of the 5 Public Health Service Act (“PHS”), 42 U.S.C. § 233. Section 233 of the PHS 6 provides liability protection under the FTCA for personal injury claims arising out 7 of alleged medical malpractice by federal employees acting within the scope of their 8 official duties. 28 U.S.C. §§ 2679(a)-(b)(1). It is undisputed Dr. Hawkins was acting 9 within the scope of her official duties. Under the FTCA, courts apply “‘the law of 10 the place where the act or omission occurred.’” US Air Inc. v. U.S. Dept. of Navy, 11 14 F.3d 1410, 1412 (9th Cir. 1994) (quoting 28 U.S.C. § 1346(b)). California law 12 therefore governs this dispute. 13 B. Negligence 14 Under California law, the elements of a medical negligence claim include: 15 “(1) a duty to use such skill, prudence, and diligence as other members of the 16 profession commonly possess and exercise; (2) a breach of the duty; (3) a proximate 17 causal connection between the negligent conduct and the injury; and (4) resulting 18 loss or damage.” Johnson v. Superior Court, 143 Cal. App. 4th 297, 305 (2006). 19 See also Judicial Council of California Civil Jury Instructions (“CACI”) 400 20 (Negligence Jury Inst.). “Plaintiffs have the burden of proving each of these 21 elements by a preponderance of the evidence.” Mgmt. Activities, Inc. v. United 22 States, 21 F. Supp. 2d 1157, 1174 (C.D. Cal. 1998) (citing BAJI 2.60). These 23 elements must be established by expert medical testimony, Cobbs v. Grant, 8 Cal.3d 24 229, 236 (1972), “unless the conduct required by the particular circumstances is 25 within the common knowledge of the layman.” Landeros v. Flood, 17 Cal.3d 399, 26 410 (1976). The parties agree each element of Plaintiffs’ claim must be established 27 by expert testimony. 1 1. Duty 2 In a medical malpractice case, the standard of care requires that “physicians 3 exercise in diagnosis and treatment that reasonable degree of skill, knowledge, and 4 care ordinarily possessed and exercised by members of [their] medical profession 5 under similar circumstances.” Munro v. Regents of Univ. of Cal., 215 Cal. App. 3d 6 977, 984 (1989); Landeros, 17 Cal.3d at 410; CACI 600 (Standard of Care Jury 7 Inst.). Dr. Hawkins had a duty to exercise in her management of Ms. Valenzuela’s 8 labor that reasonable degree of skill, knowledge, and care ordinarily possessed and 9 exercised by other obstetricians under the same or similar circumstances. 10 2. Breach of Duty 11 “An [obstetrician] is negligent if [she] fails to use the level of skill, 12 knowledge, and care in diagnosis and treatment that other reasonably careful 13 [obstetricians] would use in the same or similar circumstances.” CACI 501 14 (Standard of Care for Health Care Professionals Jury Inst.). This means that “[m]ere 15 error of judgment, in the absence of a want of reasonable care and skill in the 16 application of his medical learning to the case presented, will not render a doctor 17 responsible for untoward consequences in the treatment of his patient, for a doctor 18 is not a warrantor of cures, or required to guarantee results.” Huffman v. Lindquist, 19 37 Cal.2d 465, 473 (1951). In addition, “the fact that another [obstetrician] might 20 have elected to treat the case differently or use methods other than those employed 21 by defendant does not of itself establish negligence.” Lawless v. Calaway, 24 Cal.2d 22 81, 87 (1944). 23 a. Standard of Care Experts 24 Each party retained an obstetrical expert to opine on the standard of care. 25 Plaintiffs retained Dr. Phillips, and Defendant retained Dr. Kingston. As noted, the 26 experts reached different conclusions regarding whether Dr. Hawkins’ conduct fell 27 below the standard of care, and did so principally based on their opposing 1 cesarean delivery by 11:30 a.m. Dr. Phillips opined that the standard of care required 2 Dr. Hawkins to order an urgent C-section by 11:30 a.m. because of recurrent late 3 and variable decelerations, and prolonged decelerations of FRV’s heart rate 4 beginning at around 9:00 a.m. and continuing to 11:30 a.m., as well as intervals of 5 minimal-to-absent heart rate variability during the same timeframe. Specifically, 6 Dr. Phillips testified that if Dr. Hawkins had ordered an urgent cesarean section by 7 11:30 a.m., FRV would have been delivered by 12:00 p.m., and would have suffered 8 neither irreversible hypoxic brain injury nor brachial plexus injury. Dr. Phillips 9 opined Ms. Valenzuela was a high-risk patient—due to advanced maternal age, 10 gestational diabetes, the sizing ultrasound, and high blood pressure—with 11 “persistent nonreassuring” fetal heart tracings, and that subjecting FRV to further 12 ongoing stress of labor when Ms. Valenzuela was remote from delivery posed an 13 unreasonable risk of harm to FRV.11 14 In contrast, Dr. Kingston opined that the standard of care did not require Dr. 15 Hawkins to order an urgent C-section by 11:30 a.m., or at any other time. She did 16 not interpret FRV’s heart tracings to include nearly as many nonreassuring 17 classifications as Dr. Phillips found, and significantly, she did not find within those 18 classifications recurrent late or variable decelerations.12 19 / / / 20 / / / 21
22 11 Dr. Phillips is a board-certified obstetrician gynecologist, currently serving as a full-time Assistant Clinical Professor of Obstetrical and Gynecological Residents at Keck School of Medicine at the University of Southern 23 California (“USC”). Dr. Phillips has been practicing obstetrics and gynecology for thirty-eight years. In his thirty- seven years practicing at Saint John’s Health Center in Santa Monica (“St John’s”), Dr. Phillips served in roles 24 including Vice Chairman and ultimately Chairman of the Department, Medical Director for Women’s Services at St. John’s, and also founded and ran the Laborist Program at the hospital. Additionally, Dr. Phillips serves as a consultant 25 for the Medical Board of California and as an expert witness in legal disputes. 12 Dr. Kingston is a board-certified obstetrician gynecologist, currently practicing at University of California San 26 Diego (“UCSD”) Health. Dr. Kingston has been a practicing obstetrician gynecologist for twenty-one years. She is currently the Director for the Division of General Obstetrics and Gynecology at UCSD and is also a Clinical Professor. 27 In these roles, the bulk of Dr. Kingston’s time is spent practicing medicine and seeing patients directly. Dr. Kingston 1 b. Fetal Heart Tracings 2 Dr. Phillips and Dr. Kingston agree that nurses and obstetricians’ 3 interpretations of fetal heart tracings, along with other clinical circumstances, guide 4 an obstetrician in determining the appropriate course of action for labor and delivery. 5 Therefore, both experts carefully studied FRV’s heart tracings and were thoroughly 6 questioned at trial about their interpretations, including whether the tracings showed 7 decelerations (late, variable, prolonged, and whether they were recurrent) with 8 minimal-to-absent heart rate variability at specific times—particularly between 8:18 9 a.m. and 11:30 a.m. 10 The existence, duration and frequency of accelerations and decelerations of 11 fetal heart rate as well as variability of heart rate are critical to categorizing FHTs. 12 The American College of Obstetricians and Gynecologists (“ACOG”) promulgated 13 clinical management guidelines for OBGYNs in July 2009, Bulletin No. 106 14 (“ACOG 106”), in which it provided “nomenclature, interpretation, and general 15 management principles” to assist OBGYNs with intrapartum fetal heart rate 16 monitoring.13 AGOG uses a “three-tiered categorization fetal heart rate 17 interpretation system”—comprised of “Categories I, II and III”—to assist in 18 “determin[ing] if a fetus is well oxygenated.” At TCMC, like other medical centers, 19 the fetus’s heart rate and mother’s contractions are displayed on an electronic 20 monitor in a continuous manner; they are charted by the nurses and categorized 21 pursuant to the AGOG guidelines. The experts in this case interpreted printouts of 22 FRV’s heart tracings and Ms. Valenzuela’s contractions in eight-minute segments 23 to render their opinions. (See generally Ex. 100; Def. Ex. 319.) 24 The experts discussed four types of decelerations referenced in the ACOG 25 guidelines: early, late, variable and prolonged. The experts also discussed the 26 existence of recurrent decelerations. An early deceleration is not of concern, while 27 1 late, variable, prolonged, and recurrent decelerations require evaluation and 2 continued surveillance and reevaluation. An early deceleration is gradual and the 3 onset, nadir (lowest point of the fetal heart rate), and recovery coincide with the 4 beginning, peak, and end of a contraction in most cases. Early decelerations are 5 typically caused by compression of the baby’s head with the mother’s contraction. 6 A late deceleration is similar in appearance to an early deceleration, but the onset of 7 the deceleration begins after the start of a contraction. Its nadir is always past the 8 peak of the contraction, and the recovery back to baseline14 typically returns after 9 the contraction is over. A late deceleration is caused by uteroplacental insufficiency, 10 wherein the baby is not able to maintain or get oxygenation. The presence of a late 11 deceleration can indicate ongoing hypoxia (lack of oxygen) during that period of 12 time. A prolonged deceleration occurs when the heart rate decelerates fifteen beats 13 per minute from the baseline, and stays below the baseline for at least two minutes. 14 It can be caused by compression against the baby’s umbilical cord or by the baby 15 decompensating for something occurring during the stress of labor. A variable 16 deceleration is a sudden decrease of heart rate off the baseline that drops at least 17 fifteen beats below the baseline with a sharp, jagged edge going down to a nadir that 18 then recovers promptly back to the baseline. It can be caused by compression on the 19 umbilical cord, and can result in hypoxia and acidosis. Recurrent decelerations are 20 either late or variable decelerations that occur with at least half of the mother’s 21 contractions in a thirty-minute timeframe. 22 An acceleration of fetal heart rate means the heart rate reaches a peak of at 23 least fifteen beats per minute for at least fifteen seconds. Accelerations are 24 reassuring because they indicate the baby is not acidodic, i.e., the baby is getting 25 oxygen and not developing high amounts of acid in its blood. Variability of fetal 26 heart rate shows fluctuation of the fetal heart rate from the baseline. A normal 27 1 baseline for fetal heart rate is between 110 and 160 beats per minute. Moderate 2 variability is fluctuation from the baseline that is between five and twenty-five beats 3 per minute, and is desirable. Minimal variability indicates a change from the 4 baseline that is less than five beats per minute, and is nonreassuring, though it can 5 be caused from a baby’s innocuous sleep cycle, which can last from twenty to sixty 6 minutes. Absent variability means there is very little change from the baseline, and 7 is nonreassuring. 8 Category I means a baby has no evidence of decelerations, other than 9 potentially early decelerations, moderate variability, and may have some 10 accelerations. Category I essentially indicates the baby is tolerating labor well, is 11 well oxygenated, and has no acidosis. Category III is assigned where the fetal heart 12 tracings show absent variability with recurrent late or variable decelerations, or 13 bradycardia. Category III is “highly indicative of a baby that is having evidence of 14 acidosis, and it requires prompt intervention to extricate the baby from that 15 situation.” (Trial Tr. 533:17-19.) 16 Category II “is a very broad category that includes everything in between 17 Category I and Category III.” (Id. 533:20-21.) Category II includes, among other 18 things, late, variable, prolonged and recurrent declarations, minimal baseline 19 variability, and absent baseline variability with no recurrent decelerations. Category 20 II is “indeterminate,” meaning “you can’t be absolutely sure the baby is not having 21 hypoxia with acidosis.” (Id. 534:7-10.) According to ACOG 106: 22 Category II FHR tracings are not predictive of abnormal fetal acid-base status, yet presently there is not adequate evidence to classify these as 23 Category I or Category III. Category II tracings require evaluation and 24 continued surveillance and reevaluation, taking into account the entire associated clinical circumstances. In some circumstances, either 25 ancillary tests to ensure fetal well-being or intrauterine resuscitative 26 measures may be used with Category II tracings. 27 ACOG 106 is the authority Dr. Kingston used to define baseline, variability, 1 as the guide for her definitions because ACOG’s definitions were created in “an 2 effort to standardize our terminology so that it would improve our use of external 3 fetal monitoring in practice to really get everyone on the same page about defining 4 things . . . and so that is what then led to the categorization[.]” (Trial Tr. 728:12- 5 729:8.) Dr. Kingston testified she uses the ACOG definitions to teach her residents 6 and students. 7 While Dr. Phillips also uses the ACOG definitions and guidelines to teach his 8 students and residents, he does not consider ACOG publications to be “gospel” and 9 “can’t say in general ACOG guidelines are always correct or [represent] what is 10 practiced in the community.” (Id. 556:16-18; 675:9-15.) Notably, Dr. Phillips did 11 not point to any other authoritative source for interpretating fetal heart tracings, and 12 did not rely on any literature or authority to support his opinions when they differed 13 from AGOG. Dr. Phillips’ challenge to the efficacy of ACOG publications and 14 definitions, while failing to present an alternative source beyond his own opinions, 15 affects the weight to be given to his opinions. 16 Here, from admission to delivery, Nurses Wildern and Montes charted FRV’s 17 heart tracings. Each time the nurses charted FRV’s heart tracings, they documented 18 the events of the prior 30 minutes. At 9:00 a.m., Nurse Wildern documented a fetal 19 baseline of 155, with moderate variability, absent accelerations, no decelerations, 20 and Category I. (Jt. Ex. 25-007.) At 9:30, she documented a fetal baseline of 155, 21 with moderate variability, absent accelerations, “late, variable” decelerations, and 22 Category II. (Id.) At 10:00 a.m., she documented a fetal baseline of 155, with 23 minimal variability, absent accelerations, late deceleration, and Category II. (Id.) 24 As a result of the late deceleration, Nurse Wildern initiated the following care to Ms. 25 Valenzuela: “Administer O2, Notify primary health provider, Palpate uterus at rest 26 to ensure relaxation, Provide explanation to reduce anxiety, Turn to left side.” (Id.) 27 At 10:30 a.m., Nurse Wildern did not chart any observations. (See generally 1 and stated it could have been because Ms. Valenzuela was having an ultrasound or 2 was out of bed. At 11:00 a.m., Nurse Wildern documented a fetal baseline of 145, 3 with moderate variability, absent accelerations, no decelerations, and Category I, 4 (id.), indicating a positive response by Ms. Valenzuela and FRV to her intervention 5 at 10:00 a.m. At 11:30 a.m., she documented a fetal baseline of 150, with minimal 6 variability, absent accelerations, variable decelerations, and Category II. (Id.) And 7 at 12:00 p.m., she documented a fetal baseline of 155, with moderate variability, 8 absent accelerations, no decelerations, and Category I. (Id.) While Nurse Wildern 9 did not have an independent recollection of Ms. Valenzuela’s labor, based on her 10 review of the records, she testified there was nothing about this labor that stands out 11 in her mind. Nurse Wildern has been a labor and delivery nurse for more than 20 12 years. The Court credits her testimony. 13 Drs. Kingston and Hawkins, and the nurses—consistent with ACOG 14 guidelines—agree it is common for patients to transition between Categories I and 15 II during labor depending on the clinical situation and management strategies used. 16 As noted, however, where the parties’ experts diverge is on the categorization 17 indicated by the tracings (i.e., Category I or II), and the characterization of the 18 tracings within the assigned category, e.g., whether or not the tracings represent late, 19 variable or prolonged decelerations, and whether they are recurrent. 20 Dr. Phillips opined that by 11:30 a.m., there was “no evidence of reassuring 21 fetal monitoring,” (Trial Tr. 580:16-24), and there was a “persistent Category II strip 22 remote from delivery.” (Id. 583:2-7.) He believed that “90 to 95 percent of the 23 tracings [from 8:18 to 11:30 a.m.] demonstrated either minimal variability or 24 minimal to absent variability,” (id. 586:6-12), and indicated that FRV was not 25 getting enough oxygen. Moreover, Dr. Phillips opined that there were recurrent late 26 decelerations followed by minimal variability. On direct and cross-examination, 27 however, Dr. Phillips conceded it is “difficult to actually identify” many of the 1 because the interpretation of a tracing segment and whether it reflects a deceleration 2 depends on the contraction chart. Nevertheless, Dr. Phillips opined that it should 3 have been clear to Dr. Hawkins there was no evidence of reassuring fetal heart 4 tracings. 5 Dr. Kingston disagreed and noted FRV’s tracings from Ms. Valenzuela’s 6 admission until 11:30 a.m. showed “transient periods” of Category I mixed with 7 Category II. (Id. 768:4-9.) Dr. Kingston opined that about 50 to 60% of the tracings 8 between admission and 11:30 a.m. were Category II, and about 40% of the tracings 9 were Category I, or in between Categories I and II. Essentially, she disputed that the 10 tracings between 8:18 a.m. and 11:30 a.m. were persistently in Category II and that 11 they showed significant minimal-to-absent variability and recurrent decelerations. 12 Instead, Dr. Kingston noted minimal-to-moderate variability tracings, several 13 minimal variability tracings, and no tracings showing absent variability during that 14 time. She also noted one prolonged deceleration, up to three late decelerations, and 15 one variable deceleration, but no recurrent late or variable decelerations during that 16 time.15 17 The different conclusions reached by Dr. Phillips and Dr. Kingston is 18 unsurprising. Dr. Kingston testified that the research shows that when a focus group 19 of obstetricians is given a fetal heart tracing, and blinded to the outcome, only 20 to 20 40% agree on the interpretation of the tracing. She explained, “it is well-known that 21 there are significant limitations in applying external fetal monitoring to and making 22 conclusions about the outcome and about a baby’s status.” (Trial Tr. 724:21-24.) 23 She explained that “about 99 percent of the time when we are concerned that a 24 tracing is abnormal, the baby is actually fine.” (Id. 725:3-6.) ACOG 106 also states 25 that, “[d]espite the frequency of its [i.e., fetal heart tracings] use, limitations of 26 [FHT] include poor interobserver and intraobserver reliability, uncertain efficacy, 27 1 and a high false-positive rate.” 2 Dr. Kingston also pointed out that studies have “shown that when the outcome 3 is known that that influences the interpretation. So, for instance, if the obstetrician 4 knows that there was a bad outcome, they will be much more critical of the heart 5 rate tracing.” (Id. 726:18-21.) These studies are important because a finding of 6 breach of the standard of care in medical negligence cases must be based on what 7 the obstetrician knew at the time, without hindsight bias. See Vandi v. Permanente 8 Med. Grp., Inc., 7 Cal. App. 4th 1064, 1070 (1992) (stating, “in treating a patient a 9 physician can consider only what is known at the time he or she acts.”). 10 c. Dr. Hawkins 11 Dr. Hawkins is a board-certified obstetrician gynecologist. She has been a 12 practicing obstetrician gynecologist for twenty-eight years. In 2018, Dr. Hawkins’ 13 work was split evenly between obstetrics and gynecology, and she contracted to do 14 five obstetric on-calls per month for patients who go into labor at various hospitals. 15 When working an on-call shift, Dr. Hawkins’ duties entailed labor and delivery, 16 postpartum, emergency room, and post-op patients. Dr. Hawkins estimates she has 17 delivered between 10,000 and 50,000 babies during her career. The Court credits 18 Dr. Hawkins’ testimony. She testified at length and was visibly upset for FRV, Ms. 19 Valenzuela and the family about the outcome of FRV’s delivery, while standing by 20 the decisions she made. 21 Based on Dr. Hawkins’ testimony and the history she took of Ms. Valenzuela 22 at 9:41 a.m. on the day of admission, Dr. Hawkins knew that Ms. Valenzuela was 23 scheduled for an induction two days later, and that she had gestational diabetes, mild 24 pre-eclampsia, and advanced maternal age. She knew that Ms. Valenzuela had given 25 birth vaginally three prior times without incident, and her baby in 1998 was large, 26 weighing 9 lbs, 2 oz. at delivery. She knew the estimated weight of FRV was 8 lbs., 27 5 oz. to 9 lbs. based on her clinical exam, or 4,017 grams (8 lbs., 13 oz.) based on 1 “130 baseline, no decelerations, good variability, category I Occasional uterine 2 contraction.” (Jt. Ex. 016-001.) The plan, therefore, was for “normal vaginal 3 delivery.” (Jt. Ex. 016-002.) 4 Dr. Hawkins testified that a patient’s labor and delivery is a team process, and 5 that she is the captain of the team. Nurse Wildern was the primary nurse for Ms. 6 Valenzuela from her admission until Nurse Montes took over at 7:00 p.m. Typically, 7 too, there is a charge nurse responsible for all nurses working at the time who also 8 periodically reviews fetal heart tracings. There was a charge nurse working on the 9 day of Ms. Valenzuela’s labor. The nurses and Dr. Hawkins testified that when the 10 nurses charted FRV’s heart tracings as Category II, the nurse at the time would take 11 interventions, e.g., by changing Ms. Valenzuela’s position or administering oxygen 12 to attempt to bring the tracings back to Category I. Dr. Hawkins relied on the nurses 13 to take appropriate action and advise her if their interventions were not effective. 14 Nurse Wildern’s records are consistent with the foregoing practice. 15 Dr. Hawkins testified she was unable to recall when, or how often, she 16 reviewed FRV’s heart tracings, but she noted that her “customary practice [is] to 17 review the strip if I’m notified by the nurse that there is an issue with the strip.” 18 (Trial Tr. 186:2-6.) She stated that if the nurses charted late decelerations and 19 minimal variability, that would not cause her to review the tracings more frequently 20 because she trusts the nurses would take appropriate action and alert her if the 21 interventions were not successful. According to Nurse Wildern’s records, she 22 reviewed FRV’s heart tracings with Dr. Hawkins at 9:45 a.m., 12:34 p.m., and 1:20 23 p.m. Her records also indicate juice was given to Ms. Valenzuela for blood pressure 24 at 10:33 a.m., and Nurse Wildern testified she would have only given juice after 25 communicating with Dr. Hawkins. Dr. Kingston opined that an obstetrician acting 26 within the standard of care can rely on labor and delivery nurses to monitor fetal 27 heart tracings, take interventions to alleviate fetal stress, and generally assist the 1 the standard of care in doing so. 2 However, it was solely Dr. Hawkins’ responsibility to determine whether 3 cesarean delivery was necessary. It is undisputed that such a decision must be based 4 on all of the clinical circumstances, and that it is not without risk. Obstetricians 5 “have to be very careful and very judicious when [they] are considering how to 6 deliver . . . it is a constant balancing act between risks and benefits of continuing 7 with labor versus risks and benefits of the cesarean.” (Trial Tr. 770:19-23.) Dr. 8 Kingston stated that “[w]e are, as human beings, designed to birth babies vaginally, 9 and we should support that when we feel it is safe[,]” (id. 835:18-20), noting that 10 cesarean delivery involves “major abdominal surgery.” (Id. 769:11-19.) Dr. 11 Hawkins testified “[i]t has been shown that a vaginal delivery is safer than a cesarean 12 delivery. The morbidity and mortality is much less.” (Id. 388:6-8.) Dr. Hawkins 13 believed that a C-section was “absolutely not [medically] indicated [for Ms. 14 Valenzuela], and it would not have been appropriate to perform a cesarean section.” 15 (Id. 444:1-4.) Dr. Kingston agreed, and opined that if C-sections were ordered based 16 on similar tracings as FRV’s, more than 50% of deliveries would be cesarean rather 17 than vaginal. 18 Ms. Valenzuela and Ms. Cazares testified that Ms. Valenzuela expressed 19 concern to Dr. Hawkins about the fetal weight of FRV. Dr. Hawkins disputed that 20 such a conversation happened, because if it did, it would have been in her report, 21 and it is not. (See id. 404-408; see also Jt. Exs. 016, 018.) The Court, however, need 22 not make credibility determinations here, because even assuming the conversation 23 occurred, “a physician should not prescribe a procedure which is not medically 24 indicated simply because the patient desires it.” Vandi, 7 Cal. App. 4th at 1070. The 25 ACOG guidelines support Dr. Hawkins’ decision as the guidelines recommend 26 elective or prophylactic cesarean section on a diabetic patient if the estimated fetal 27 weight is greater than 4,500 grams (9 lbs., 14 oz.). FRV’s estimated fetal weight 1 delivered a child that weighed 9 lbs., 2 oz. Based on Ms. Valenzuela’s clinical 2 circumstances, Dr. Hawkins did not believe a C-section was medically indicated. 3 Dr. Kingston also noted that Ms. Valenzuela’s history of three natural births without 4 incident was very significant and made her “a great candidate to do it again.” (Trial 5 Tr. 751:5-13.) She testified that after reviewing Ms. Valenzuela’s case, if the 6 obstetrician had ordered an urgent C-section under the circumstances, she “would 7 be a little surprised[.]” (Id. 768:25-769:6.) 8 Plaintiffs recognize that “medicine is practiced in the real world in dynamic, 9 evolving situations,” particularly with labor and deliver, and medical providers must 10 “look at all of the clinical circumstances.” (Id. 1525:10-15.) Neither expert looked 11 at the fetal heart tracings in a vacuum, and both experts testified that such tracings 12 should be interpreted in the context of the entire clinical picture. Accepting 13 Plaintiffs’ theory of the case invites the Court to interpret the tracings through the 14 lens of hindsight. But an obstetrician “can consider only what is known at the time 15 he or she acts[,]” Vandi, 7 Cal. App. 4th at 1070, and the Court finds that the real- 16 time interpretations of FRV’s tracings by the nurses and Dr. Hawkins were 17 reasonable. 18 Dr. Phillips’ interpretations strayed from AGOG’s definitions from time-to- 19 time. For example, between 8:49 a.m. and 8:57 a.m., he identified what “might be 20 a late deceleration” in the absence of a visually apparent change in the baseline. That 21 opinion is inconsistent with AGOG 106 and the opinions of Drs. Hawkins and 22 Kingston, and Nurse Wildern who charted the tracing as a Category I. At 9:01 a.m., 23 Dr. Phillips identified a “suggestion of a late deceleration.” But as Dr. Kingston 24 noted, a “suggestion” is not accepted terminology, and the tracing at that time did 25 not reveal a visually apparent drop in fetal heart rate. She further opined that the 26 tracings at 9:01 a.m. simply appear to be variability because, per ACOG, variability 27 is a subtle change in the baseline. Dr. Phillips also identified a prolonged 1 the AGOG standard—i.e., that the fetal heart rate falls fifteen beats per minute below 2 the baseline for at least two minutes. As Dr. Kingston noted, there were no such 3 markers between 9:29 a.m. and 9:33 a.m., and thus there was an absence of criteria 4 indicating a prolonged deceleration. 5 Moreover, the existence of recurrent decelerations, i.e., decelerations 6 occurring with at least 50% of the mother’s contractions, can be an important 7 indicator that the fetus is not tolerating labor. The Court is unable to conclude that 8 the tracings at issue reveal persistent Category II tracings with recurrent 9 decelerations and minimal-to-absent variability. Because the interpretation of 10 FRV’s tracings is disputed, and Plaintiffs have not established those tracings, along 11 with the other clinical circumstances, indicated an urgent C-section at 11:30 a.m., 12 Plaintiffs have failed to prove by a preponderance of evidence that Dr. Hawkins’ 13 management of Plaintiffs’ labor and delivery fell below the standard of care. In 14 addition, Ms. Valenzuela previously delivered three children naturally without 15 incident, including one LGA baby. The sizing ultrasound and physical examination 16 also suggested fetal weight within manageable limits. The Court therefore finds Dr. 17 Hawkins exercised that level of skill, knowledge, and care in her diagnosis and 18 treatment of Ms. Valenzuela and FRV that other reasonably careful obstetricians 19 would have used in the same or similar circumstances. An undesirable outcome 20 invites second-guessing, particularly in a case like the present one which involves a 21 precious child and loving family. Nevertheless, despite the difficult outcome, the 22 Court finds Dr. Hawkins acted within the standard of care. 23 / / / 24 / / / 25 / / / 26 / / / 27 / / / 1 III. 2 CONCLUSION AND ORDER 3 For these reasons, the Court finds Defendant not liable. Accordingly, the 4 Clerk of Court shall enter judgment in favor of Defendant. 5 IT IS SO ORDERED. 6 Dated: August 17, 2023 7 _______________________________ Hon. Dana M. Sabraw, Chief Judge 8 United States District Court 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27