42-Year-Old Woman in Aichi Prefecture Dies After COVID Vaccine as Investigation Committee Chair Faces Unexplained Dismissal Demand

On November 5, 2022, in Aisai City, Aichi Prefecture, a 42-year-old former nurse suddenly fell ill and died immediately after receiving the COVID-19 vaccine. To investigate the process leading to her sudden death, evaluate the case, and prevent recurrence, Aisai City organized the ‘Medical Accident Investigation Committee’ (hereinafter referred to as the Investigation Committee) with external experts starting in December of the same year. The committee has been holding regular meetings. On September 26 of last year, the committee announced its findings.

It has been revealed that the chair of the investigation committee was subject to a ‘motion for dismissal’ from the Tokyo Medical Association in May. A document titled ‘Request for Dismissal of Mr. Yoshimasa Nagao from Four Positions‘ was distributed through a newsletter published by the Medical Governance Society.

Mr. Yoshimasa Nagao (55), the Deputy Director of Nagoya University Hospital (hereinafter referred to as Nagoya University Hospital), is also the Director of the Patient Safety Promotion Department. He is known nationwide as a pioneer in ‘medical safety’ and has been featured on ‘Professional: Shigoto no Ryuugi’ (NHK).

On the other hand, the Tokyo Medical Association was established with the aim of ‘protecting the lives and rights of over 6,000 insured medical practitioners in Tokyo and improving public health and medical care.’ Mr. Nagao revealed this in an interview with the author.

“As for me, I believe it will be a matter of explaining the circumstances at the time and waiting for Nagoya University’s judgment. I do not believe the allegations that I acted illegally on my own are accurate. If what is being pointed out is indeed illegal, then considering the (10) press conferences held by the investigation committee, most of those decisions were made under the responsibility of Aisai City, and Aisai City would also be held accountable for any illegal actions.

Regarding the responsibility to explain to citizens and society, I feel it was the natural duty of the administration to carefully consider and make every effort to address the situation. Specifically, when there was no one at the city hall capable of providing a medical explanation during the final investigation results announcement (on September 26 of last year), the city meticulously planned to have all investigation committee members present at the city’s press conference to first hold an explanatory meeting, followed by the mayor holding a solo press conference. I believe this was a well-considered and innovative approach by the city.”

The accident investigation report is a detailed document extending to 77 pages, providing a multifaceted examination of the circumstances leading to the woman’s death, clarifying why her life could not be saved, and proposing measures to prevent recurrence.

The mayor of Aisai City also believed that an examination from the perspective of third-party experts was necessary, and established the Medical Accident Investigation Committee based on the Medical Care Act. He commented, ‘We take the contents of this report seriously and will work towards establishing a more desirable vaccination system and preventing recurrence so that those who wish to be vaccinated can do so safely and securely.’ Additionally, Eiji Ioka, the husband of the woman who died suddenly, told FRIDAY Digital, “I don’t think vaccines are bad, but I believe we must ensure a properly established environment for safe vaccination. If my wife’s death can lead to a safer environment being maintained, I want the contents of the report to be made public and utilized.”

So what exactly did the Tokyo Medical Association take issue with? Summarizing the contents of the 18-page request for dismissal, it comes down to this.

• The medical accident investigation system is not a system for the purpose of accountability but a system for the purpose of learning, and it must be de-identified to ensure that medical practitioners are not identified and held accountable.

• “Press conferences,” by widely reporting the incident to the media, make it easy to identify the individual medical practitioners involved, thus posing a high likelihood of violating personal information protection laws.

• The human rights and personal information of medical practitioners involved in medical accidents are damaged, leading to a potential recurrence of walk-away sabotage and subsequent medical system collapse.

• Mr. Nagao publicly announced at a press conference the medical assessment that the possibility that the patient could have been saved cannot be ruled out if appropriate treatment, such as the early administration of adrenaline, had been provided.

• According to reports, the bereaved family filed a civil lawsuit and a criminal complaint. This is an entirely unforeseen situation under the medical accident investigation system, and it undermines the very foundation of a system for the purpose of learning.

Based on the above five points, they argue that Mr. Nagao’s press conference was in violation of the law.

Point 3 refers to “walk-away sabotage,” which indicates the phenomenon where doctors leave hospitals or clinics in medical settings. This issue is a serious challenge in Japan’s medical system and is considered one of the causes of medical system collapse. Medical system collapse refers to a state where the provision of medical care becomes unstable and unsustainable.

As stated in points 1, 2, and 4, the Tokyo Medical Association claimed in the request for dismissal that the investigation committee’s public announcement of the investigation results—specifically, that the possibility that the patient could have been saved cannot be ruled out if appropriate treatment, such as the early administration of adrenaline, had been provided—has intensified the defamation against the concerned doctor. They seem to have taken this matter seriously and thus decided to request Mr. Nagao’s dismissal.

However, in the “Case Investigation Report” prepared by Aisai City, the purpose of establishing the investigation committee is described as follows: “Since Aisai City, the organization responsible for the establishment, did not have the medical or other necessary specialized knowledge required for the accident investigation, the committee was composed entirely of external members who conducted the investigation and made recommendations from not only a professional perspective but also an objective and neutral standpoint.”

Mr. Nagao was merely one of the members chosen by the city, and the chairperson was selected by mutual election among the six committee members. The management of the press conference after the investigation committee meetings, including details such as where the bereaved family could hear the content of the conference, was also led by Aisai City. If the Tokyo Medical Association is to hold Mr. Nagao accountable, there should similarly have been some form of protest directed at Aisai City. However, when Aisai City was questioned about this, their response was, “There have been no protests or other objections regarding the holding of the press conference from any organization.”

Furthermore, the Tokyo Medical Association stated in point 5 that the bereaved family filed a civil lawsuit and the case turned into a criminal complaint. However, upon re-interviewing the bereaved family and related parties, FRIDAY Digital found that the lawsuit was filed against Aisai City, not against medical practitioners. Additionally, the bereaved family has not filed a criminal complaint at this point, indicating that there is a factual error in the request for dismissal. Therefore, as stated in point 5, “this is not a situation entirely unforeseen by the medical accident investigation system, and it will not undermine the very foundation of the system.”

The Tokyo Medical Association’s request for Mr. Nagao’s dismissal from four positions, despite the fact that the factual investigation may be insufficient, reflects concerns about the significant damage that publicizing medical accidents can cause to medical practitioners.

The origin of this issue dates back to the “Ono Hospital Incident” that occurred on December 17, 2004. A patient who underwent a cesarean section at Ono Hospital in Fukushima Prefecture died, and the obstetrician who performed the surgery was arrested on suspicion of criminal negligence causing death and violation of the Medical Practitioners Act’s obligation to report unusual deaths. In 2008, the Fukushima District Court ruled the physician not guilty, but this incident led to a series of clinic closures in high-risk specialties like obstetrics and gynecology, a decrease in young practitioners entering these fields, and an increase in physician maldistribution, which accelerated medical system collapse. Additionally, media coverage of medical accidents heightened public distrust in the medical field and increased societal attention on medical accidents, with some arguing that it became a factor in the rise of medical litigation.

On the other hand, Mr. Nagao has consistently maintained a stance of “not running away, not hiding, not deceiving.” Even in his first year as a professor at Nagoya University Hospital, having moved from Kyoto University Hospital, he held external expert-led medical accident investigation committees for five cases of fatal accidents, such as “a case of death due to hemorrhagic shock from aortic injury” and “a case of death on the fifth day after undergoing robot-assisted laparoscopic antrectomy using the Da Vinci surgical system,” and publicly announced the results at press conferences.

Mr. Nagao explained:

“Establishing systems for improvement, anticipating medical accidents and ensuring transparency are fundamental responsibilities that hospitals should inherently possess. Therefore, it is our duty to provide accurate explanations to patients and society based on the facts” (from the Medical Safety Promotion Network).

And it is explained.

In fact, this stance has become the standard for medical safety worldwide. As evidence, Nagoya University Hospital was the first in Japan’s national university hospitals to receive certification from JCI (Joint Commission International), known as the most challenging certification body in the world, in 2019. It was recognized as a “hospital that meets international standards for medical quality and patient safety.”

By the way, Aisai City is said to have disclosed this to Mr. Nagao.

“After the accident investigation committee’s announcement, it seems that they regularly urged the local medical association to thoroughly implement measures to prevent recurrence. There has been significant improvement, and I have nothing but words of gratitude for the investigation committee, including Dr. Nagao.”

When a medical accident occurs, it is necessary to be mindful of the way the announcement and reporting are made to avoid promoting blame-shifting. However, if improvements are made by making the investigation results clear, it might be better to disclose them openly rather than concealing them.

◆ “Request for dismissal of Dr. Yoshimasa Nagao from four positions” by the Tokyo Association of Health Physicians

A case report prepared by Aisai City.