By Yukiko Takanashi / Yomiuri Shimbun Staff WriterA case of malpractice involving anesthesia that resulted in the death of a 2-year-old boy in 2006 was settled in favor of the plaintiffs in July, with the court ordering a Tokyo hospital to pay about ¥32.4 million ($284,000). The case raises questions about how medical institutions can prevent critical incidents, and what are the appropriate measures when investigating and disclosing the details about such an event.
At a press conference held after the ruling on June 21, the boy’s father said he hoped the ruling would urge medical institutions to change for the better — and by doing so, keep his son’s death from being a waste.
The malpractice occured in September 2006 at the Sakakibara Heart Institute in Tokyo, when the boy, who had severe heart problems, went through cardiac catheterization to check the function of his heart. This is a medical procedure in which a thin catheter is inserted into a large blood vessel that leads to the heart.
The boy’s blood pressure dropped shortly after the pediatrician administered general anesthesia. With reduced blood supply to the brain, he suffered hypoxic ischemic encephalopathy, a type of brain damage caused by lack of oxygen. The boy died in December, never regaining consciousness. His parents filed a suit against the corporate entity of the medical institution at the Tokyo District Court in 2014.
The court’s ruling focused on the fact that the pediatrician, who administered inhaled anesthetic in a higher density than usual, which increases the risk of lowering blood pressure, never took any steps to reduce it. The court found the doctor had been negligent because they mismanaged the boy’s blood pressure, and did not even set up an intravenous drip to inject medicine in case of emergency.
The hospital told The Yomiuri Shimbun in a written statement that they took the legal decision seriously.
“The medical institutions in Japan aren’t aware enough that anesthesia itself involves risks,” said Katsuyuki Miyasaka, an affiliated professor at St. Luke’s International University who specializes in anesthesia safety. “They have to realize it’s a matter of life and death.”
Miyasaka, who has practiced medicine in North America, points out the tendency to overlook safety measures when handling anesthesia during clinical check-ups; presumably because doctors focus on the examination itself. And as it is not considered treatment, they pay less attention to potential perils.
Separate physicians needed
According to a study conducted by the Japan Pediatric Society (JPS) in 2010, nearly 20 percent of the responding hospitals said they experienced cases of respiratory arrest in children who were put to sleep with sedatives while undergoing MRI scans. They also found that the risk of complications extended to people who were only put under sedation, not general anesthesia.
Together with the Japanese Society of Pediatric Anesthesiology and the Japanese Society of Pediatric Radiology, JPS made a list of safety measures in 2013, asking institutions to assign specific doctors to monitor the patients during the procedure.
In a follow-up survey carried out in 2016, JPS found that while the number of serious cases of anesthesia complications had decreased, more than 20 percent of the hospitals still did not assign any doctors to monitor the procedure.
There is another issue: Since there are no regulations on who can administer anesthesia, it is being done by doctors with no special training.
The drug used in the boy’s case was Fluothane — known for its risk of causing an irregular heartbeat and lowering blood pressure. The drug was released in 1959 and stopped being sold in 2015.
“It was a matter of common sense to administer something new and less complicated, even in 2006,” an experienced anesthesiologist said. “The risk is higher for children with serious heart problems. It is extremely dangerous for a non-specialist to administer it.”
An investigation into a case at Tokyo Women’s Medical University Hospital in 2014, where a child died due to an overdose of sedatives, revealed that the otolaryngologist who was the primary physician had little knowledge on the risks of anesthesia.
Last year, there were several cases of malpractice involving anesthesia related to pain relief during birth, with obstetricians handling both delivery and the control of anesthesia.
“Fundamentally, anesthesia should be handled only by people with special training,” said Mamoru Takeuchi, professor of Anesthesiology at Jichi Medical University. “But the number of staff are completely insufficient, so hospitals have to reconsider their safety measures.”
Takeuchi, who is also a former chairman of the Japanese Society of Pediatric Anesthesiology, stated the need to add anesthesiology to residency training. “We need to review the medical education system,” he said.
In May 2006, four months before the malpractice involving the boy at the Sakakibara Heart Institute, the same pediatrician carried out cardiac catheterization under anesthesia on a girl with heart disease. She never regained consciousness and died in 2007.
Though the hospital opened an inquest in June 2006 that made recommendations to address the issues in a report, they were never implemented, resulting in the subsequent case in September.
It was for this reason the boy’s parents requested the hospital to disclose their case. When the institution was unresponsive, they took it to court eight years later.
During the trial, the Tokyo District Court recommended an out-of-court settlement in favor of the plaintiffs, which the boy’s parents declined, saying they wanted a ruling. “People will know about the topic if there is a ruling,” they stated. “We want to raise the public’s awareness, so that such cases never happen again.”
Masao Katayama, who pinpointed the problems as an external member of the inquest, said the boy’s case was a bitter, yet typical, example of errors made with no lessons learned. Katayama, a former director of the department of anesthesiology at St. Luke’s International Hospital, deplored the fact that his report ended up an empty shell. “Everyone in the medical field, including myself, should learn from this case,” Katayama said.
In June this year, several hospitals, including those of Chiba University and Yokohama City University, admitted overlooking possible cancer alerts pointed out in the reports made on a patient’s image diagnosis. Such revelations led medical societies to work on making recommendations for improvements.
A similar approach was taken by the Japan Society of Obstetrics and Gynecology after several cases of anesthesia malpractice during childbirth were made public through media reports. The society conducted a survey to analyze such cases; till then, not even the data were known. The Health, Labor, and Welfare Ministry established a study group to examine safety measures.
Yoshimasa Nagao, director of the department of quality and patient safety at Nagoya University Hospital, stressed the importance of medical institutions disclosing malpractice cases.
“If publicizing serious misconduct became a rule, hospitals would start reevaluating their roles and think carefully about how agonizing it is for the patients,” said Nagao, who has his own experience of revealing mishaps in his hospital where the staff ignored reports on the patient’s image diagnosis in 2016 and 2017.
“At the end of the day, their way of thinking and actions on safety measures will be corrected.”