CHOP has settled lawsuits filed by the families of 3 premature babies who died after viral infections

When a virus infected 23 premature infants at Children’s Hospital of Philadelphia, an internal team of investigators found traces of it on devices that had been used to examine the babies’ eyes.

But that didn’t explain how the infants got sick in the summer of 2016. Though the devices, called ophthalmoscopes, were unsanitized, they never came in contact with the babies’ eyes or skin.

Further investigation revealed the missing link: The eye doctors wielding the devices did not wear protective gloves, apparently transmitting the virus by touching the babies after using the germy scopes.

The hospital team wrote an article in a medical journal to describe how it cracked the case. But after three of the infants died, lawyers for CHOP fought to keep the details secret from their families in another forum: Philadelphia’s Court of Common Pleas.

More than six years later, the families of those three children have quietly settled lawsuits against the hospital.

The settlement amounts have not been made public. Lawyers for the families and the hospital, who sparred in court for years over whether the hospital was negligent, both declined to comment. But court documents offer an inside look at how the legal system balances competing interests when hospitals are accused of medical malpractice.

Patients or their surviving relatives have the right to seek copies of their medical records through the process of discovery — as the families did in this case, obtaining grim details of how the three extremely premature infants suffered respiratory distress and ultimately died. Yet lawyers for CHOP successfully argued that certain internal records about the viral outbreak were off-limits — citing laws protecting documents that were created for the sole purpose of improving overall patient safety and health-care quality.

In Pennsylvania and other states, the intent of such laws is to make doctors and nurses feel free to identify problems and solutions without fear of legal repercussion, said George Kontos, an adjunct professor at the University of Pittsburgh School of Law.

“You want to be able to have the medical providers figure out the root cause, to say ‘Here’s where we messed up, and here’s how we can do better so that this does not happen again,’” he said.

In their cases against CHOP, the families’ lawyers accused the hospital of claiming that privilege too broadly — wrongly labeling certain records as being part of the quality-review process as a ploy to keep them secret.

» READ MORE: 23 infants infected at CHOP after eye exams with contaminated equipment

But in November, ruling on all three cases at once, an appellate panel found mostly in favor of the hospital. Judges said the families were entitled only to two sets of internal records: emails in which a CHOP physician discussed the case with a colleague at the University of Pennsylvania, and postings on the hospital’s intranet site — one in August 2016 titled “CHOP Serious Safety Events,” and the other in February 2017, titled “Learning from our Safety Events.”

Hundreds of other documents, including PowerPoint slides from seven “safety huddles” at which CHOP physicians discussed their investigation, would remain off-limits.

Lawyers for the families had contended that the infections and deaths were the result of negligence by the hospital. Lawyers for CHOP argued the opposite, saying that the hospital’s discovery of how the virus was transmitted marked the first time that phenomenon had been described in the medical literature.

Four months after the appellate ruling, on March 20, the three families settled their lawsuits against the hospital. The terms were not disclosed.

What’s not in dispute is that the three babies were extremely fragile.

Two of them were girls who weighed less than 1.5 pounds at birth, both born during the 25th week of gestation. Babies born at that stage have a 70% to 80% chance of survival, according to a 2022 study in JAMA.

The other child, a boy who weighed just more than 2 pounds at birth, was born at 27 weeks. Babies born at that stage have a 90% chance of survival, on average.

The first sign that something was amiss came in mid-August 2016, when staff in CHOP’s neonatal intensive care unit (NICU) identified a cluster of infections with a virus called an adenovirus, according to a summary in the appellate ruling.

The cases were so unusual that they prompted an immediate investigation. No such infections had occurred in the NICU during the previous 12 months. By the end of the month, 23 out of 43 children in the unit had tested positive for the virus.

All 23 had respiratory symptoms. Five of them developed pneumonia, and 12 required increased breathing support, the hospital reported in its case study. Six employees and three parents also tested positive for the virus.

Hospital infection-control staff tested the ophthalmoscopes for the virus because the infants all had been given eye exams. Some of the infants also developed symptoms of infection in their eyes.

The two eye doctors who performed the exams did not sanitize the scopes in between patients, nor did they wear protective gloves, according to a court deposition by hospital epidemiologist Julia Sammons.

When asked why not, the doctors said gloves would decrease their dexterity, making it harder to position the babies’ heads for the eye exams, Sammons said in response to questions from Elia Robertson, one of the lawyers representing the families.

The doctors cleaned their hands before seeing each patient, but not in between touching the germy scopes and touching the babies, Sammons said.

Shanin Specter, another lawyer representing the families, declined to comment on the case when The Inquirer contacted him this month. But when he filed one of the lawsuits, in 2018, he called the practices “shocking,” especially given the delicate nature of the babies’ health.

“By definition, they are vulnerable to serious injury or death from getting an infection,” he said at the time. “And then you don’t wear gloves when you do an eye exam, and you don’t clean the ophthalmoscope?”

Ever since the outbreak, Sammons said in her deposition, the hospital has required the scopes to be disinfected in between patients, and the eye doctors must wear gloves.