Physician Legal Review & Commentary

Neonatal necrotizing enterocolitis case leads to $7.05 million verdict

By Jonathan D. Rubin, Esq.
Partner
Kaufman Borgeest & Ryan
New York, NY

Ericka Saint-Hilaire, JD, RN, MPH
Associate Attorney
Kaufman Borgeest & Ryan
Valhalla, NY

Leilani Kicklighter, RN, ARM,
MBA, CHSP, CPHRM, LHRM
The Kicklighter Group
Tamarac, FL

News: A female infant was transferred to the hospital's neonatal intensive care unit for airway management and prematurity after her birth on June 13, 2004. The infant was diagnosed with uncompensated metabolic acidosis. On June 21, 2004, the female infant was diagnosed with a perforated bowel. She was taken to surgery, but died during the operation on June 21, 2004, due to complications of severe necrotizing enterocolitis. A lawsuit was filed against the physician and the nurse practitioner, by the child's mother and father on her behalf. Following trial, the jury returned a verdict of $7.05 million.

Background: A female infant was transferred to the hospital's neonatal intensive care unit for airway management and prematurity after her birth on June 13, 2004. The supervising physician diagnosed her with uncompensated metabolic acidosis. The supervising physician and the neonatologist agreed to start feeding the infant.

The feeding was advanced per an order from the nurse practitioner. A nursing assessment was conducted, and the nurse practitioner and supervising physician were informed that the infant appeared pale. It was noted that the infant had symptoms of metabolic acidosis on June 20, 2004, at 11:20 a.m. The supervising physician and nurse practitioner ordered continued observations and additional workups for sepsis if symptoms occurred. The female infant's abdomen was continuously documented due to increase of her abdominal girth.

The infant was diagnosed with a severe combination of acidosis, respiratory failure, and shock. The infant was transferred to a children's hospital on June 21, 2004, for medical treatment. Decompressing of the infant's distended abdomen was conducted. The infant died due to complications of severe necrotizing enterocolitis.

A lawsuit was filed against the medical physician and the nurse practitioner, by the child's mother and father on her behalf. Plaintiff argued that the supervising physician and the nurse practitioner breached the standard of care when the failed to adequately diagnose and timely treat the infant's condition, failed to reduce the risk of developing necrotizing enterocolitis, failed to appropriately monitor the infant's condition, failed to report her condition, and failed to obtain informed consent.

The defense argued that there were no signs of infection of necrotizing enterocolitis until the evening of June 20, 2004, and that it was properly treated. The defense also argued that the infant's abdominal examinations revealed that the infant's abdomen were not consistent with a finding of necrotizing enterocolitis.

The case proceeded to trial, and the jury returned a verdict of $7.05 million. About $50,000 of the amount represented past pain and suffering. The remainder of the award represents past and future loss of consortium. The defense has indicated it will appeal the verdict.

What this means to you: The loss of a child for any reason at any age is a devastating tragedy.

Necrotizing enterocolitis is a devastating condition that often leads to the ultimate untoward outcome suffered by this newborn and her family. If the signs and symptoms were recognized and addressed on a timely basis, would the outcome have been different? That question remains unanswered in this matter. The eight days from birth to death shows how quickly this condition can progress.

This infant was born prematurely, showed respiratory problems requiring airway management, and was diagnosed with uncompensated metabolic acidosis, which necessitated transfer to the neonatal intensive care unit (NICU) on her birth day. These two conditions are symptoms of necrotizing enterocolitis that should have raised the flag to conduct more tests and evaluations to rule out or confirm the diagnosis. Timeliness of proper diagnosis and intervention is important in this situation. As time went by, this infant began to exhibit all the signs and symptoms of necrotizing enterocolitis. Why was it not at least picked up as a differential diagnosis? Several questions arise such as why it took seven days to recognize this infant needed a higher level of care and to transfer the infant to the children's hospital.

This case should be referred to peer review to determine why there was a delay in diagnosis and the implementation of the proper medical intervention. According to the facts, it is unclear if the physician and nurse practitioner were employees of the hospital or specialized in the applicable area of medicine (i.e., neonatology, pediatrics, and neonatology). Was the physician board-certified? Was the nurse practitioner certified? Is there a process to assess the competency of physicians and nurse practitioners as there is for employees on an annual basis? If not, should there be? Are the physician and the nurse practitioner provided through a contracted service? Was the risk manager involved in the review of this contract to assess the risk exposures and risk assumptions created by the contract? Are the contract insurance requirement and other liability protection language adequate to protect the hospital?

Depending on the parties to the contract, the insurance limits are normally $1 million per claim/$3 million in the aggregate, or less. In most claims, these limits would be adequate; however, in this case, these limits would not be sufficient. In this case, the physician and nurse practitioner were named as defendants and not the hospital.

In addition to the peer review, the risk manager should conduct a root cause analysis to determine the answers to some of these questions and others with the intent to prevent a recurrence of such an unfortunate outcome. Collaborating with the department of pediatrics, an inservice on necrotizing enterocoloitis should be developed and presented as mandatory for the pediatricians, neonatologists and neonatology intensivists, nurse practitioners, and newborn nursery and NICU nursing staff.

Working with the nursing leadership, the chain of command process should be readdressed with the nursing staff. Nurses are educated to recognize signs and symptoms of certain conditions to bring to the attention of physicians or covering allied health professionals such as physician assistants and nurse practitioners. When it appears the response is delayed or non-responsive, such a situation should be reported to the nursing supervisor and, if necessary, up the medical and administrative chain of command to the CEO and medical staff president, if necessary, to intervene to invoke the bylaws to secure appropriate care. It is shared that the nursing staff reported changes in this infant's condition. Had there been a process to voice nursing concerns up this chain of command, would the outcome have been different? Again, this issue should be addressed as a part of the peer review and the root cause analysis as a consideration for prevention of recurrence of this situation or similar ones.

Of course, as difficult as it will be, a disclosure discussion with the parents of this infant also should be conducted. While there may be hesitancy on having such a meeting for fear of it generating a lawsuit, such meetings should be corrdinated by risk management with input from legal counsel, if it is thought to be necessary. Many states have passed statues requiring such disclosures, and many states also have passed statutes that address the admissibility of apologies should a lawsuit be initiated. Risk managers should be familiar with these statutes in their state and follow those guiding principles in these meetings. In addition, it is an eithical issue that should be considered in dealing with patients and families who have suffered an untoward outcome as a result of a possible or confirmed preventable medical error. In addition, a standard from The Joint Commission governs disclosure of unanticipated untoward outcomes.

This case raises many questions that cannot be answered, according to the facts provided herein. However, the answers to these questions can assist in developing risk control activities and interventions to prevent such situations in the future.

Reference

Bellrose v. Janet S. Lloyd MD, et al. Superior Court of Massachusetts, Suffolk County. Case No. SUCV2006-02412.