Lawsuit

#6        DATE AND DAY OF ACCIDENT AND   #7      TIME:

This MCA claim concerns the substandard medical care provided by agents, servants, and employees of the United States at the U.S. Naval Hospital in Naples, Italy to Finley Sissons, newborn infant of Lisa and Steve Sissons, on March 22, 2012 through March 24, 2012 resulting in his death on March 26, 2012.

#8        BASIS OF CLAIM:

This claim concerns the substandard medical care provided by agents, servants, and employees of the United States to Finley Sissons, newborn infant, born at the Naples U.S. Naval Hospital (USNH) including but not limited to delay in calling for a C-section due to non­ reassuring fetal heart tones and scenario indicative of cord compression from nuchal cord (head would descend to +2 station with pushing but then return to +1 station after contraction as well as late decelerations on FMS). Once an emergency C-section was called for, a delay of 1 hour, 20 minutes occurred until the C-section was performed. This delay was a breach of the standard of care. Had Finley been delivered timely, more likely than not he would not have required resuscitation. Following delivery, government providers failed to timely and properly resuscitate Finley, ultimately causing his death.

Lisa Sissons presented to USNH due to spontaneous rupture of her membranes at 22:50 on 3/22/12. She was 38 weeks, 2 days gestation and was dilated 1-2cm at the time of admission. She required augmentation due to no cervical change for several hours.

By approximately 17:02 on 3/23/12, Mrs. Sissons had dilated to 9cm. A review of the fetal monitor strip (FMS) showed significant abnormalities starting at approximately 17:15 with late decelerations into the 70’s. See  Exhibit 1,  FMS  3/23/12  17:15-21:15. At 18:18 Mrs. Sissons’ cervix was dilated to 10, however, she was still at station 0 (meaning the top of the fetal head was still even with the ischial spines). The U.S. Naval Hospital health care providers had Mrs. Sissons push for over 2 hours despite failure to descend evidenced by, “Head descends to 2+  with contraction and  pushing but returns to  1+  when not  contracting.” See  Exhibit 2, Physician Notes 3/23/2012. Nuchal cord/cord compression would have been strongly considered at this point by a prudent physician as the fetal monitor strip continued to show late decelerations indicative of fetal distress during contractions. The fetal heart rate also showed significant tachycardia into the 180s by 19:14.

Finally Dr. (name removed)’s note stated, “Will prep for C-section.” Id. Dr. (Name Removed) stated he called for the C-section at 20:17, Finley was not delivered for an hour and 45 minutes after the Dr. (Name Removed) said he called for the C-section despite the pre and post operation diagnosis of “IUP at 38 weeks with non-reassuring fetal rate tracing.See Exhibit 3, Immediate Postoperative Note 3/23/2012.It is unclear why the delay in the C-section occurred but it cost Finley valuable time that resulted in his needing to be resuscitated.

Finley was delivered at 22:00. The delivery note stated, “At 22:00 a viable male infant was delivered by C-section with Apgar 2 and 2. Arterial cord gas pH 7.205 with venous pH of 7.342. Initial heart rate was in the  70s. CPR was started.” See  Exhibit 4,  Delivery   Note 3/24/2012. On the 1 and 5 minute Apgar, Finley received a 1 of heart rate <100 and a 1 for color, body pink. At this point, although Finley had clearly suffered distress during the labor and delivery  process evidenced  by a 1 minute Apgar of  2 and a C-section should have been performed earlier, based on the objective evidence, if Finley had been properly resuscitated, more likely than not he would be alive today.

However, Finley was not properly resuscitated. Additional government negligence that ultimately cost Finley his life occurred following delivery, due to failure to properly resuscitate him. An investigation came to the conclusion that “umbilical cord wrapped around his neck, which starved his brain of oxygen” caused Finley to “succumb to perinatal asphyxia three days later and die from convulsions and cerebral edema.” See  Exhibit 5,  Special  Investigation Branch Royal  Military Police, 3/30/2012. However, based on the objective evidence, this is incorrect. The facts prove that Finley did not suffer perinatal asphyxiation due to the umbilical cord based on his cord gases of pH 7.205 arterial and pH 7.342 venous, heart rate in the 70s at birth and pink central color. Studies have shown a normal mean arterial pH for newborns is 7.24-7.27 and a normal mean venous pH for a newborn is 7.32-7.34. See Exhibit 6, Use of umbilical cord blood gas analysis in the assessment of the newborn, Achieves of Disease in Childhood: Fetal   &  Neonatal, 2007  November; 92(6):  F430-F434. Studies  have shown  “acidosis  is generally tolerated by the fetus without sequelae until it becomes very severe…Serious adverse sequelae in the newborn period are rare after birth with umbilical cord pH greater than 7.0.” ld. One study, Goodwin et al “found that hypoxic-ischaemic encephalopathy occurred in 12% of infants with cord pH <7.0.” Id. Therefore, 88% of infants in the study with pH <7.0 when timely and properly resuscitated, suffered no neurological injury. “In combination with other clinical information, normal paired arterial and venous cord blood gas results can usually provide a robust defense against a suggestion that an infant had an intrapartum hypoxic-ischemic event.” /d. With a normal mean venous cord blood pH, a near normal arterial cord blood pH (over 7.2), his heart still beating over 70 beats per minute and pink body color, the objective facts do not meet the criteria for a perinatal asphyxia event. The logical explanation based on the facts is that the irreversible hypoxic insult was suffered by Finley following delivery.

The U.S. Naval Hospital did not call a code blue for 10 minutes following birth, no epinephrine was administered for 10 minutes and Finley was not intubated for 30 minutes. Although a pediatrician, Dr. (Name Removed) was present at delivery, Dr. (Name Removed) failed to properly resuscitate him. Finley’s heart rate decreased from over 70 beats per minute at birth to 25 beats per minute and remained 25 beats per minute until he was intubated 30 minutes after birth. The normal heart rate for a newborn is 120-160 beats per minute. See Exhibit  7, Assessments for Newborn Babies, Lucile  Packard Children’s Hospital  at  Stanford, 2014. Due to the low heart rate, Finley was not being properly oxygenated. Most likely the decreased heart rate was caused by the delay of 30 minutes in intubating Finley as his heart rate went up to 150 beats per minute following intubation.

After this inexcusable delay in intubating Finley, even after he was finally intubated, he was not properly ventilated. The ventilation rate was set at 22 assisted ventilations per minute when the proper ventilation rate for a newborn is 40-60 assisted ventilations per minute. He was under-ventilated for a full hour until the transport team from a private Italian Hospital arrived and immediately increased the ventilation rate to the proper rate of 45 assisted breaths per minute. For the first few hours after birth, Finley suffered irreversible hypoxia at the hands of the USNH medical personnel, evidenced by the results of a blood gas done an hour and a half after birth that revealed severe hypoxia with pH 6.689 which was decreased from the cord gases of pH 7.205 arterial and 7.342 venous. The brain damage to Finley was too significant by the time he arrived at a private Italian Hospital. Finley died on March 26, 2012.

Dr. (Name Removed) wrote a letter to Lisa Sissons defending his position of not performing a C­ section earlier. See Exhibit 8, Dr. (Name Removed) Letter  with Attachments. Although we do not agree with his position and believe a C-section should have been performed sooner due to the FMS clearly showing fetal distress evidenced by repeated late decelerations, the letter does describe important facts that show Finley was resuscitable. Those facts include the venous and arterial cord blood pH were not indicative of significant acid-base imbalance, his heart rate in the 70s at birth with a FMS showing a baseline of 160 with beat to beat variability from 2140-2142 and Finley  born  with  a  pink  body  color.  None  of  these  facts  support  prenatal  asphyxiation specifically asphyxiation from which an infant would not recover. Additionally, Dr. (Name Removed)’s statement about the FHR tracing does not support perinatal asphyxiation. He stated, “The remaining part of the fetal heart rate tracing from the time the C-section was called at 20:17 until you were taken to the operating room at 21:23 shows the fetal rate in the 150-170s with an averaging in the 160s without variable decelerations.” Id.

The negligence following Finley’s birth was a travesty. Despite having a heart rate in the 70’s when born, because he did not receive proper oxygenation and chest compressions, his heart rate dropped to 25 and remained 25 beats per minute for 30 minutes until he was properly intubated. If a C-section is called due to non-reassuring fetal rate tracing, one must be prepared for the delivery of an infant requiring intubation and have experienced personnel in the OR. Once he was intubated, his heart rate went up to 150 beats per minute. However, at 22:54 the vent rate was set at 22 assisted breaths per minute and any opportunity for Finley to recover was lost as he was not properly oxygenated for the next hour until the “transfer personnel changed ventilator monitor rate from 22/min to 45/min.” See Exhibit  9, Delivery Data  3/23/2012. A newborn’s acid-base balance improves with resuscitation efforts if done properly. In Finley’s case his cord blood pH at birth was within the mean range of normal. Within that hour and a half following birth, his pH dropped to 6.689 indicative of an anoxic event caused by improper oxygenation. By the time the transfer personnel arrived, the ABG drawn at 00:06 was so low the results stated, “Unable to read in lab.” Id.

Finley was transferred to a private Italian Hospital on 3/24/12 at approximately 00:30. The note from U.O.C. Di Neonatologia E Terapia Intensiva Neonatale stated, “Upon arrival of Caserta Newborn Emergency Transport Service (at the time of23:40) the newborn was critical in a  severe convulsive state. First  loading dose  administered of  Phenobarbital and  NaHC03. Around 30 minutes later convulsive state still persistent and 2nd dose of Phenobarbital and NaHC03  due to metabolic acidosis.” See Exhibit  10, Clinical  Notes transcribed in English 1217/2012. Finley did not receive proper medications until the transport team arrived as USNH medical personnel failed to administer phenobarbital or NaHC03.  The note continued, “Transferred to our Department of Neonatology and Neonatal Intensive Care despite unavailability of hypothermia equipment, as it was being used for another patient, due to lack of suitable alternative within the region and in view of the gravity of the clinical situation. The transfer was carried out by the Caserta Newborn Emergency Transport Service using mechanical ventilation (IPPV RR 60/min, FIP 20 PEEP 4 Fi02 0.30).” Upon admission: B/P 63/47, HR 168, RR 40/min, very severe general clinical condition. Death occurred around 60 hours of birth due to repeat severe desaturation attacks and bradycardia that did not respond to prolonged resuscitation  measures.  Diagnosis:  Male  newborn  with  signs  of  acute  neonatal  asphyxia. Opinion: The problems presented by baby Finley Arthur are attributable to severe and acute neonatal asphyxia.” Id. Despite unavailability of hypothermia equipment, Finley’s last possible lifeline, he was still transported to the Italian Hospital. The hypoxia he suffered the first hour and a half after birth was too extensive for him to recover especially without hypothermic equipment.

U.S. Government health care providers were negligent in not timely recognizing and responding to the abnormal FMS indicative of hours of fetal distress. If a C-section had been performed earlier when the FMS showed repeated late decelerations, more likely than not Finley would not have begun to decompensate, would not have needed to be resuscitated and would be a healthy baby today. Additionally, Dr. (Name Removed) failed to perform the emergency C-section called due to failure to progress, fetal tachycardia and non-reassuring FHT within the standard of care of 30 minutes. However, despite suffering from distress during the second stage of labor and experiencing a nuchal cord, Finley had compensated for a long period of time. He was just starting to decompensate at the time of delivery. His cord pH, although slightly low was not near the <7.0 required for hypoxic ischemic encephalopathy and his heart rate was in the 70s with pink color to his body. It was the hour and a half following birth that cost Finley his life in which he did not receive proper medication such as epinephrine for 10 minutes, never received sodium bicarbonate, was not intubated for 30 minutes, had a heart rate of 25 despite ongoing CPR and had the vent set to 22 assisted breaths per minute instead of standard 45 breaths per minute. It is the responsibility of the U.S. Naval Hospital to have trained and competent personnel available at all times. Based on the records, it appears that U.S. Navy health care providers had limited experience in resuscitation of newborns and set the ventilator rate based on the requirement for an older child not a newborn. Had Finley been properly and urgently resuscitated, more likely than not he would have survived.

If Dr. (Name Removed) had called for a C-section at 20:02 when the FMS showed “fetal tachycardia and repetitive decelerations” and would have performed the C-section within the standard of care of 30 minutes, Finley most likely would not have required resuscitation and would be alive and healthy today. See Exhibit 8, Dr. (Name Removed) Letter with Attachments. However, if Dr. (Name Removed) was correct in not calling for a C-section earlier and the fetal heart rate tracing prior to delivery showed “reassuring variability” with “baseline 160s with beat to beat variability and an acceleration to 175 beats per minute,” then Finley was not experiencing life-threatening perinatal asphyxia from the umbilical cord and more likely than not, should have survived a proper resuscitation. Even if Dr. (Name Removed)’s assessment of the FMS was correct, at a minimum it was the improper resuscitation of Finley that caused his death and the Naples U.S. Naval Hospital health care providers cost Finley his life. Finley’s  parents have been devastated by the unexpected, tragic loss of their otherwise healthy baby. The emotional toll has been unimaginable. Additionally, Mrs. Sissons experienced significant hemorrhaging following the C-section preventing her from spending quality time with little Finley before he died which has impacted her grieving process. Had the U.S. Government healthcare providers timely delivered Finley and/or properly resuscitated him, his tragic death would have been prevented.