PHILIP A. BRIMMER, District Judge.
The Court presided over a trial to the court in this Federal Tort Claims Act case, involving alleged medical malpractice in the birth of a child, from April 9 to April 24, 2012. The evidence and arguments of counsel raise three principal issues — whether the physician who delivered plaintiff D.R.G. violated the standard of care; if so, did such violation of the standard of care cause D.R.G.'s cerebral palsy; and, if that is the cause, what damages are D.R.G. and plaintiff Maria Gallardo entitled to receive. Pursuant to Federal Rule of Civil Procedure 52(a)(1), the Court makes the following findings of fact and conclusions of law.
1. On February 11, 2007, plaintiff Maria Gallardo, age 32, was admitted to Memorial Hospital in Colorado Springs, Colorado, complaining of reduced fetal movement. She was 40 weeks and three days pregnant with D.R.G.
2. Ms. Gallardo was placed on an electronic fetal monitor ("EFM") at approximately 3:00 p.m. that afternoon, which provided the medical staff with a continuous read out, or "strip," indicating the fetal heart rate as well as the strength and frequency of uterine contractions. Ms. Gallardo's attending physician and nurses monitored the EFM strip until D.R.G. was born at 2:22 a.m. on February 12, 2007.
3. Dr. Michael L. Hall, an obstetrician with nearly thirty years of experience, testified on behalf of the plaintiffs regarding the standard of care. As part of his testimony, he provided definitions for the various events one can see on an EFM strip. The experts in this case did not dispute these definitions. The most important aspects of an EFM strip, as described largely, though not exclusively, through the testimony of Dr. Hall, are the following:
4. Four experts, Dr. Hall, Dr. Jeffrey McCutcheon, Dr. Michael Ross, and Dr. Robert Gore, referred to herein collectively as "the experts," offered their opinions regarding the standard of care in this case.
5. Dr. McCutcheon was the obstetrician attending to Ms. Gallardo that day and who performed the delivery of D.R.G. Dr. McCutcheon, who has approximately seventeen years of clinical practice experience as an obstetrician, testified regarding the care he provided in this case, including his interpretation of the EFM strip.
6. As noted above, Dr. Hall is an obstetrician who testified on behalf of the plaintiffs regarding the standard of care.
7. Dr. Michael Ross also testified as an obstetrical expert on behalf of the plaintiffs, offering his own interpretation of the EFM strip. Dr. Ross is a highly experienced obstetrician and gynecologist who also specializes in maternal fetal medicine, which focuses on high risk pregnancy. He has clinical and research experience in obstetrics and maternal fetal medicine.
8. Defendants called Dr. Robert Gore, an obstetrician with approximately thirty years of clinical experience, to offer his opinions regarding the care provided in this case.
9. Shortly after Ms. Gallardo was placed on the EFM at about 3:00 p.m., Dr. McCutcheon identified a deceleration in fetal heart rate. Some contractions were already occurring. Dr. McCutcheon decided to admit Ms. Gallardo to the hospital to augment labor. Dr. McCutcheon opted to use Pitocin to do so, a decision with which no expert has taken issue.
10. The various experts in this case generally agree that there were no indications on the early EFM strip that D.R.G. was in distress. However, Dr. McCutcheon and Dr. Gore explained why the strip was not sufficiently reassuring to justify sending Ms. Gallardo home.
11. A deceleration took place at approximately 6:00 p.m. that evening.
12. Dr. McCutcheon had Pitocin turned back on at approximately 6:30 p.m.
13. Through 7:25 p.m., Dr. Michael Ross, one of plaintiffs' obstetrical experts, interpreted the EFM strip as looking good. Dr. Hall interpreted the strip as remaining reassuring through 8:00 p.m.
14. Shortly after 8:00 p.m., Dr. McCutcheon added an internal uterine monitor, which is a pressure catheter that provides more accurate information than the external monitor regarding contractions and the level of uterine tone. The monitor revealed hyperstimulation and hypertonus.
15. Despite the amnioinfusion, the EFM strip continued to show some minor variable decelerations as well as hyperstimulation and hypertonus.
16. The recurring mild variable decelerations continued after 8:51 p.m., but the baby appeared to be tolerating them well through at least 10:50 p.m., according to Dr. Ross.
17. At approximately 11:00 p.m., Ms. Gallardo's cervix was four centimeters dilated and 75% effaced, which refers to the thinning and shortening of the cervix. A "complete" cervix, ready for delivery, is dilated ten centimeters and is 100% effaced. The baby was still at a negative station, meaning still relatively high in the pelvis.
18. A prolonged deceleration commenced at approximately 11:00 p.m.
19. Dr. Hall described the EFM strip at 11:10 p.m. as "bizarre" and difficult to assess. Dr. Ross, however, testified that, as of 11:15 p.m., he would not have taken any additional interventions.
20. Another prolonged deceleration occurred shortly after 11:30 p.m. At this point, the cervix was five centimeters dilated, 90% effaced, and the baby remained at a negative station.
21. At around midnight, Dr. McCutcheon saw good variability and a baseline of 140, with one mild early deceleration, five contractions in 10 minutes, and a good maternal pulse. Dr. McCutcheon thought this was a reassuring strip.
22. Through approximately 12:30 a.m., Dr. McCutcheon testified that the strip showed a baseline of 140, with an acceleration around 12:25 a.m. According to Dr. McCutcheon, this was followed by a period where he identified decelerations with contractions but also continued variability, though some of the variability was marked. Dr. McCutcheon also identified an acceleration after a contraction, which reassured him.
23. At approximately 12:35 a.m, there was a prolonged deceleration. Dr. McCutcheon examined Ms. Gallardo and discovered that her cervix had completely effaced, which he testified is often associated with such a heart rate response. Dr. McCutcheon monitored the heart rate and saw that it started to climb back up and showed good variability.
24. At 12:40 a.m., the cervix was fully dilated and 100% effaced, but the baby was still at a negative station. Dr. McCutcheon decided to have Ms. Gallardo start pushing. He expected, upon doing so, that delivery would happen relatively quickly as Ms. Gallardo had previously given birth naturally to two children, had a "roomy" pelvis, and there were no indications that the baby was especially big.
25. The first push occurred at 12:42 a.m. on February 12, 2007 and was followed by a prolonged deceleration. All the experts agreed that such a deceleration is concerning.
26. As a result of the prolonged deceleration, Dr. McCutcheon had Ms. Gallardo stop pushing for a few contractions. Dr. McCutcheon monitored the EFM strip and interpreted it as showing the heart rate was recovering and maintaining good variability.
27. Dr. McCutcheon testified that, during the pushing phase, he identified deeper late decelerations, tachycardia, and some variability. Furthermore, he recognized both hyperstimulation and hypertonus. Dr. McCutcheon did not view the contractions as interrupting the heart rate from reaching a baseline. Rather, Dr. McCutcheon identified points he believed the heart rate reached plateaus, such as in the minutes just after 1:00 a.m., which marked the baseline heart rate at approximately 160 beats per minute.
28. At 1:45 a.m., Dr. McCutcheon had Ms. Gallardo stop pushing because he was seeing deeper late decelerations and the baby had not been delivered as rapidly as he expected. The baby responded with a tachycardic heart rate between 180 and 190 beats per minute. Dr. McCutcheon stated that he believed the heart rate was slowly descending, which he interpreted as a sign that the baby was recovering from the normal stresses associated with the effort of pushing and the resulting maternal fever. During this period when no pushing took place, Dr. McCutcheon identified minimal to moderate variability with no decelerations during contractions. Dr. McCutcheon testified that babies can tolerate 180 beats per minute but he did not consider giving Terbutaline because it can cause the heart rate to go up.
29. Dr. McCutcheon identified a late deceleration with a contraction at 1:59 a.m., while Ms. Gallardo was still resting. In response, Dr. McCutcheon examined Ms. Gallardo, found that the baby had rapidly descended, which he said can cause such late decelerations.
30. In light of the rapid descent, Dr. McCutcheon decided to have Ms. Gallardo start pushing again at approximately 2:01 a.m. He testified that, in the end stages of labor, babies are under significant stress and become somewhat hypoxic, which can result in strips looking like the one in this case. Dr. McCutcheon could not tell how hypoxic the baby had become, but indicated that babies usually recover. In light of this strip, therefore, Dr. McCutcheon knew he did not have much additional time to have Ms. Gallardo continue with the plan of care for a vaginal delivery.
31. D.R.G. was delivered at 2:22 a.m. Blood was drawn from the umbilical cord for testing, among other things, the acid/base status of D.R.G. These cord blood gases indicated that D.R.G. was severely acidotic at the time of delivery. Later brain scans revealed swelling and damage throughout many regions of the brain, which experts testified indicated a hypoxic-ischemic
32. Throughout the labor, Dr. McCutcheon considered the possibility of a C-section. As labor progressed, Dr. McCutcheon testified that the risks associated with a C-section correspondingly increased. Dr. Gore testified that the risk of maternal death in a C-section is, overall, approximately 40 per 100,000 women, but that he believed the risk increases in unplanned C-sections. Dr. McCutcheon and Dr. Gore stated that C-sections also pose risks to internal organs, though they did not quantify this risk. Dr. McCutcheon said that there are also greater risks with heavier and shorter patients, like Maria Gallardo. In regard to whether a C-section at 2:00 a.m. would have made sense, Dr. McCutcheon said he probably could have done a C-section in 10-20 minutes, but he stated it is hard to predict how long it would actually take.
33. In summary, the experts each interpreted the EFM differently and disagreed regarding certain actions that should have been taken at various points in the labor.
34. ACOG issued clinical guidelines for the use of EFM in December 2005. See ACOG Practice Bulletin No. 70, "Intrapartum Fetal Heart Rate Monitoring" ("ACOG No. 70"), Ex. B-37. ACOG No. 70 discussed the widely varying interpretation of EFM strips and their limited predictive value. For example, ACOG No. 70 notes that different obstetricians interpret the same EFM tracing differently. See ACOG No. 70 at 4 ("There is a wide variation in the way obstetricians interpret and respond to EFM tracings. When four obstetricians . . . examined 50 cardiotocograms, they agreed in only 22% of the cases. Two months later, during the second review of the same 50 tracings, the clinicians interpreted 21% of the tracings differently than they did during the first evaluation.") (endnotes omitted).
35. Dr. Hall testified that a non-reassuring strip is predictive of hypoxic ischemic injury. ACOG No. 70 has a different view, noting that there is greater interpretive agreement among obstetricians "if the tracing is reassuring." Ex. B-37 at 4. Moreover, ACOG No. 70 states that "[t]here is an unrealistic expectation that a nonreasuring FHR tracing is predictive of cerebral palsy." Id. at 3 ("The false-positive rate is extremely high, at greater than 99%.").
36. Dr. Hall testified that, in his view, reassuring strips have moderate variability and accelerations along with small variable decelerations and early decelerations. If there is moderate variability without accelerations, the strip would still be "more reassuring than not." Docket No. 182 at 27, l.17. Dr. Hall stated that the term "non-reassuring" refers to "everything else," such as diminished variability, late decelerations, moderate to severe variable decelerations, and prolonged decelerations. If the EFM strip lacks variability and has an unstable baseline, it is ominous or preterminal, according to Dr. Hall. Dr. Hall testified that an obstetrician should not let an EFM strip stay in a non-reassuring state indefinitely.
37. According to ACOG No. 70, when faced with a "persistently nonreassuring FHR tracing," an obstetrician should evaluate potential causes. Ex. B-37 at 6. "Initial evaluation and treatment may include:
Ex. B-37 at 6. ACOG No. 70 also notes that "[m]aternal oxygen commonly is used in cases of a persistently nonreassuring pattern." Ex. B-37 at 6.
38. "Often, the nonreassuring FHR patterns persist and do not respond to change in position or oxygenation." Ex. B-37 at 6. When such is the case, using a medication such as Terbutaline "to abolish uterine contractions and perhaps avoid umbilical cord compression" "has been suggested." Ex. B-37 at 6. However, ACOG No. 70 states that, "although [anti-contraction medication] appears to reduce the number of FHR abnormalities, there is insufficient evidence to recommend it." Ex. B-37 at 6.
39. ACOG No. 70 states that, "[w]hen the FHR abnormality is recurrent variable decelerations, amnioinfusion to relieve umbilical cord compression should be considered." Ex. B-37 at 7.
On account of being employed by a federally funded clinic, Dr. McCutcheon is deemed to be an employee of the Public Health Service. See 42 U.S.C. § 233(g). As such, the physician is covered under the Federal Tort Claims Act ("FTCA"), 28 U.S.C. § 1346(b) and §§ 2671-80, pursuant to which the Court exercises jurisdiction over this case. The FTCA provides that the United States may be held liable for "the negligent or wrongful act or omission of any employee of the Government while acting within the scope of his office or employment, under circumstances where the United States, if a private person, would be liable to the claimant in accordance with the law of the place where the act or omission occurred." 28 U.S.C. § 1346(b)(1).
Because D.R.G. was born in Colorado Springs, Colorado, the Court applies Colorado law in this case. In Colorado, "[a] medical malpractice action is a particular type of negligence action." Day v. Johnson, 255 P.3d 1064, 1069 (Colo. 2011) (citing Greenberg v. Perkins, 845 P.2d 530, 534 (Colo. 1993). "Like other negligence actions, the plaintiff must show a legal duty of care on the defendant's part, breach of that duty, injury to the plaintiff, and that the defendant's breach caused the plaintiff's injury." Id. at 1069-70 (citing Greenberg, 845 P.2d at 533).
In Colorado, "the law implies that a physician employed to treat a patient contracts with his patient that: (1) he possesses that reasonable degree of learning and skill which is ordinarily possessed by others of the profession; (2) he will use reasonable and ordinary care and diligence in the exercise of his skill and the application of his knowledge to accomplish the purpose for which he is employed; and (3) he will use his best judgment in the application of his skill in deciding upon the nature of the injury and the best mode of treatment." Id. at 1069 (citation omitted). "And, if he possesses ordinary skill and exercises ordinary care in applying it, he is not responsible for a mistake of judgment." Bonnet v. Foote, 107 P. 252, 254 (Colo. 1910) (citations omitted); see Day, 255 P.3d at 1070 (citing, inter alia, Bonnet and Foose v. Haymond, 310 P.2d 722, 727 (Colo. 1957) ("To avail himself of the defense of a mistake of judgment, it must appear that the physician used reasonable care in exercising that judgment.").
Plaintiffs contend that Dr. McCutcheon, as the "captain of the ship," is responsible for any and all negligence that may have occurred during the care of Ms. Gallardo and D.R.G., including any negligence by the nurses. Plaintiffs rely upon Ochoa v. Vered, 212 P.3d 963 (Colo. App. 2009), in support of their argument that Dr. McCutcheon can be held responsible for all acts of the nurses who assisted D.R.G.'s delivery. Ochoa does not stand for such a sweeping proposition. Ochoa stated that the "captain of the ship doctrine, which is grounded in respondeat superior, imposes vicarious liability on a surgeon for the negligence of hospital employees under the surgeon's control and supervision during surgery." 212 P.3d at 966. The cases the Ochoa court cites, Beadles v. Metayka, 311 P.2d 711, 713-14 (1957), and Young v. Carpenter, 694 P.2d 861, 863 (Colo. App. 1984) (involving liability of doctor supervising a resident during the delivery of a baby), both stand for a more limited proposition.
For example, the Beadles court held that the following jury instruction was not improper: "`You are instructed that in the operating room the surgeon is master, and has exclusive control over the acts of the orderly and nurse, and is responsible for the negligence, if any, of the orderly or nurse, during the time the patient is being prepared for the operation in the operating room in accordance with the instructions of the surgeon, and in the presence of the surgeon.'" 311 P.2d at 714. The Beadles court proceeded to note that, outside the context of the specific facts of the case (where an anesthetized patient was injured upon being repositioned by an orderly at the direction of the surgeon) this instruction might indeed overstate things somewhat. However, the "personal presence of the physician and the actions of the orderly in response to the directions of the surgeon limits the instruction to this particular case and was not prejudicial." Id.
In support of its "captain of the ship" theory of liability, plaintiffs offered the testimony of Dr. Patricia Fedorka on the issue of whether the nurses were negligent in this case. There is no indication, however, that the nurses negligently performed any act that Dr. McCutcheon ordered while he was in the delivery room or out. See Young, 694 P.2d at 863 ("A crucial determination in establishing the applicability of the doctrine is the time when the surgeon assumes supervision and direction in the operating room."); see also O'Connell v. Biomet, Inc., 250 P.3d 1278, 1283 (Colo. App. 2010) ("Several Colorado appellate opinions have specifically stated that `[o]nce the operating surgeon assumes control in the operating room, the surgeon is liable for the negligence of all persons working under the surgeon's supervision.'") (citations omitted).
The Court finds that an obstetrician with a reasonable degree of learning and experience in February of 2007 would have been familiar with ACOG guidelines, including ACOG No. 70, which was issued in December 2005. The ACOG guidelines summarize the state of the research on certain issues at the time of their publication and offer obstetricians guidance on the implication of such research. The experts agreed that the ACOG guidelines were not prescriptions for care in specific circumstances, but rather provided general guidelines for clinical practice.
ACOG No. 70 informs obstetricians of the widely varying interpretations of EFM strips and their limited predictive value. See supra Finding of Fact No. 34.
Obstetricians with extensive learning and experience can reach various conclusions when reading the same EFM strip, as was demonstrated in this case. For instance, although Dr. Ross and Dr. Hall both believed that Dr. McCutcheon should have taken an alternative course, they disagreed regarding both the nature and timing of such alternatives based on their individual interpretations of the EFM strips. Dr. Hall interpreted the prolonged deceleration at 11:00 p.m. as a sign that the baby's condition was worsening and, therefore, would have conducted a C-section at that point or, in the absence of improvement, within 20 minutes. See supra Finding of Fact No. 18.b. As of 11:10 p.m., Dr. Hall believed the EFM strip was "bizarre." See supra Finding of Fact No. 19. Dr. Ross, however, when describing the strip at 11:15 p.m., testified that he did not believe there was any reason for Dr. McCutcheon to take any additional steps. See supra Finding of Fact No. 19.
Dr. Hall testified that a prolonged deceleration after 11:30 p.m. that evening was a sign of increasing hypoxia. See supra Finding of Fact No. 20.b. Dr. Ross, however, did not testify that he had any significant concerns regarding the baby's status at that point in the labor. Dr. Hall was troubled by reduced variability around midnight that evening, but Dr. Ross was not. Dr. Ross described reduced variability at around 12:20 a.m. as a sign that the baby was going through quiet and active sleep stages which was not a sign of fetal distress. See supra Finding of Fact No. 21.b.
Dr. Hall identified both hyperstimulation and hypertonus before the commencement of pushing and believed Dr. McCutcheon should have done something to address these issues. Dr. Ross, however, did not believe that either the hyperstimulation or hypertonus, prior to pushing, required any additional interventions. Furthermore, ACOG No. 70 does not provide specific advice regarding how or whether an obstetrician should address hyperstimulation and hypertonus.
Dr. Hall believed the baby had been having difficulty long before the commencement of pushing at 12:40 a.m. and, therefore, concluded that Dr. McCutcheon should not have proceeded with a planned vaginal delivery. See supra Finding of Fact No. 24.a. Dr. Ross did not take issue with Dr. McCutcheon's decision to have Maria Gallardo start pushing (although he criticized Dr. McCutcheon's decision to continue pushing in light of prolonged decelerations), interpreting the strip as indicating that the baby was tolerating labor well prior to commencement of pushing. See supra Finding of Fact No. 24.b.; cf. Finding of Fact No. 26.b.
The Court concludes that Dr. McCutcheon, who interpreted the EFM strip in this case as presenting a "persistently non-reassuring FHR tracing," Ex. B-37, ACOG No. 70 at 6, used reasonable and ordinary care in responding to such tracing and in proceeding with a vaginal delivery. At 11 p.m., Ms. Gallardo's cervix was four centimeters dilated and 75% effaced, with the baby at a negative station. The baby remained at a negative station at 11:30 p.m., by which time the cervix was five centimeters dilated and 90% effaced. The cervix was fully dilated and effaced by 12:30 a.m., just prior to pushing. As of 1:59 a.m., the baby had rapidly descended. Dr. McCutcheon identified at least minimal variability through the labor, an interpretation that the Court cannot conclude was unreasonable.
Based on the questionable interpretative and predictive reliability of EFM strips, particularly those that are non-reassuring or indeterminate,
Although Dr. Hall believes the EFM strip in this case required early operative intervention, no expert agreed with him on that point. Dr. Hall testified that a fetus cannot be left in Category II non-reassuring status for an indefinite period of time, a conclusion informed by his belief that the EFM strips are reliable predictors of fetal health.
Dr. Ross testified about the effect of pushing and the need to slow labor down in order to permit the baby to rest. As discussed above, see supra Finding of Fact No. 27.b., his testimony was based in part on a different interpretation of the EFM strip during the pushing phase. Unlike Dr. Hall and Dr. McCutcheon, Dr. Ross indicated that no baseline heart rate could be determined during the pushing phase. That conclusion was based on a close reading of the definition of "baseline variability," a term defined in ACOG No. 106, which was published two years after D.R.G.'s birth. Moreover, Dr. Ross recounted advice he had been given about the need to slow labor down in the face of non-reassuring strips of this sort. While that may be good practice, he did not provide any basis for the Court to conclude that it is generally accepted and therefore would define the applicable standard of care in this case.
The Court concludes that Dr. McCutcheon identified the EFM strip events discussed in ACOG No. 70, demonstrating his reasonable degree of learning, and responded to them in a fashion that was consistent with the standard of care in his medical specialty. After the fact, different obstetricians interpreted various points in the labor differently and reached different conclusions regarding appropriate plans of care. The standard of care in the face of persistently non-reassuring EFM strips in February 2007 could include such a wide range of approaches. In sum, plaintiffs have not demonstrated by a preponderance of the evidence that a reasonably cautious obstetrician in 2007 would have been required to either slow down labor through administration of Terbutaline or through additional rest of Ms. Gallardo, or perform a C-section before 2:22 a.m. Consequently, plaintiffs have not shown that Dr. McCutcheon's decisions, based upon his interpretation of the EFM strip and clinical assessment of Ms. Gallardo at various points in the labor, constitute failures to diligently provide reasonable care or to exercise his best judgment in light his interpretation of the EFM strip and the entire clinical presentation.
The brain injuries suffered by D.R.G. are profound and have deprived her of the hallmarks of a normal life. Moreover, her condition has placed many burdens on D.R.G. and her family, especially Mrs. Gallardo, who the testimony showed to be an extraordinarily dedicated and caring mother. Nevertheless, because the Court finds that there was no breach of the standard of care, defendant cannot be held liable for any damages suffered by D.R.G. regardless of when her injuries occurred and how such injuries might have been caused. Therefore, it is
