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Legal: Vacuum extractor during C/S causes brain damage

A 39-year-old woman who would have had a hard time delivering vaginally, had an elective C/S, and a vacuum extractor was used to deliver the head.

A 39-year-old california woman was pregnant in 2003 and elected to undergo a cesarean section for the delivery of her first child. The pregnancy was complicated by advanced maternal age, pregnancy-induced hypertension, and gestational diabetes. The woman claimed the decision to have an elective C/S was made because her obstetrician told her that she had a narrow pelvis and she would have difficulty delivering vaginally. The day prior to the C/S, the patient and her husband met with the obstetrician for a preoperative exam and consent discussion. A neonatologist and nursery nurses attended the delivery. A vacuum extractor was used during the C/S to deliver the head. The neonatologist examined the baby, found no problems, and gave Apgar scores of 9 and 9. No injury, bruising, or swelling of the head was noted, but the nurses documented the presence of bruises on the newborn's chest and right hip. About 6 to 7 hours later the infant became fussy, would not breastfeed, and appeared pale and cold. He was transferred to the NICU at approximately 15 hours of age and the neonatologist was called. Intracranial hemorrhaging and disseminated intravascular coagulopathy (DIC) were diagnosed and blood products were immediately administered. He was then transferred to another hospital, where massive subgaleal and intracranial bleeds were diagnosed, resulting in severe brain damage. The infant survived but about 75% of his brain is damaged, he is blind, and will probably never speak or walk. He will require 24-hour care for the rest of his life.

The parents sued the hospital and obstetrician. They claimed that the physician was specifically told that the mother was choosing the cesarean to avoid any injury to the baby and more specifically, that he was not to use any forceps or vacuum during the delivery, and that he told them that he did not use those devices. They argued that the bleeding was caused by the vacuum and that in 1998 the FDA had issued an advisory that subgaleal bleeds and intracranial hemorrhages had been associated with the vacuum extractors, and that extreme caution in their use and postdelivery observation of the newborn was required. The parents alleged the infant's bruising was abnormal for a C/S in a nonlaboring scenario and required monitoring and follow-up. The patient also claimed that when she asked the doctor if he had used a vacuum, he did not answer her. They maintained that there had been no indication for the vacuum, that obviously the uterine incision was inadequate to deliver the baby and should have been extended.

The hospital reached a $3.5 million settlement prior to trial and the case went forward against the obstetrician. He claimed the patient wanted a C/S from the beginning of her care because she was afraid of a vaginal delivery for the pain involved and the possibility the baby's head would be injured coming through the pelvis and birth canal. He denied that any conversation involving forceps or vacuum took place during the pre-op or any other visit. He further claimed that while he did not use forceps, he did use a vacuum if needed to assist in deliveries and that if a patient refused to allow him to use a vacuum, he would have referred her to another physician.

LEGAL PERSPECTIVE Even though this case was successfully defended as to the physician, it was problematic because neither the doctor's operative report nor the nurse's notes reported the use of the vacuum during the delivery of the infant. The physician later amended his dictated note by hand and then again by another dictation to reflect using the vacuum and what he then believed the pressure that was used. The nurse amended the patient's chart and L&D records to also reflect the use of the vacuum, but she noted a higher pressure setting than the doctor's note. The patient alleged that the failure to document the use of a vacuum in the chart potentially compromised the care of the baby.

As is usual in these cases, the issues are the informed consent for using the device and the indication for its use. The parents alleged that when they mentioned concerns about the vacuum, the physician should have discussed the possibility of its use and the complications associated with a vacuum prior to the operation. Since the damage was probably caused by the device, the indication for the use of the vacuum extractor during C/S became the major issue, and the lack of documentation was a challenge for the defense. The fact that the infant had an abnormal bleeding/clotting disorder, which most likely exacerbated the injury, probably aided in obtaining a defense verdict for the obstetrician.

Department editor DAWN COLLINS, JD, is an attorney specializing in medical malpractice in Long Beach, CA. She welcomes feedback on this column via e-mail to dawncfree@gmail.com