Medical software company Cerner must head to trial for a jury to decide whether its software contained design defects that caused brain damage to a 25-year-old who was undergoing surgery to remove his gallbladder.
In a 2-1 decision, the Fourth Circuit said that the lower court, the Eastern District of Virginia, erred when it sided with Cerner and did not find the software company at fault.
“On the record before us, a jury reasonably could conclude that Cerner’s software contained two design defects that did not comply with industry standards or satisfy reasonable consumer expectations,” Senior Circuit Judge Barbara Milano Keenan stated in the opinion published Tuesday in a decision from the Fourth Circuit Court of Appeals.
Cerner, based in Arlington, Virgina, develops and sells a software system that hospital staff use to enter medical orders for patient care.
The case started when the patient, Michael Taylor’s grandmother Ruby Lowe, filed a lawsuit against Cerner in 2019. In seeking $50 million in damages, she alleged that there were two design defects in Cerner’s software and that the company failed to warn users of those defects.
Those alleged defects were described in the opinion as having affected the doctor’s orders. The doctor’s orders were supposed to show that pulse oximetry should start immediately after the surgery but instead showed to start pulse oximetry at 10:00 a.m. the day after Taylor’s surgery.
According to the opinion, when the doctor — Alexandria Booth — performed surgery on Taylor at Virginia Hospital Center, she put in an order for him to receive continuous pulse oximetry to measure the oxygen levels in his blood. A pulse oximeter will send an alarm to alert hospital staff when a patient’s oxygen drops below a certain level so the staff can wake the patient.
However, Taylor’s oxygen levels were not monitored overnight and he suffered from hypoxia, or a lack of oxygen to his brain, causing damage. As a result, Taylor can no longer walk, bathe, or use the bathroom by himself.
“The parties do not dispute that if Taylor’s oxygen level had been monitored continuously, his resulting hypoxia and brain damage would not have occurred,” according to the opinion.
The question is who is at fault. And the Court of Appeals believes it’s possible to point the finger at Cerner.
In his dissent, Judge James Harvie Wilkinson wrote that because Taylor’s grandmother already reached a settlement with the hospital where the procedure was performed — Virginia Hospital Center — and with the doctor’s employer, the case seems to be about money only.
“There is one reason, and one reason only, that the manufacturer is a defendant in this suit. It has a deep pocket,” Wilkinson wrote.
He said that Lowe has failed to show that Cerner’s software was a probable cause for the brain damage Taylor suffered. He says that hospital staff are to blame for the tragedy that occurred.
Lawyers for Lowe and for Cerner did not immediately respond to requests for comment.
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