A local court has judged that even if a patient dies after administering immunotherapy, one cannot always predicate it as a side effect or medical workers' malpractice.

Andong Branch of Daegu District Court recently dismissed all claims for damages filed against a hospital by the bereaved family of a patient who died of esophageal cancer.

The deceased patient, identified as just A, was admitted to the hospital, known as only B, to receive esophageal cancer chemotherapy in June 2020. Since September of that year, A had been administered the immunotherapy, Opdivo (nivolumab) co-developed by BMS and Ono Pharmaceutical, but died of pneumonia caused by esophageal cancer two months later.

The patient had been diagnosed with esophageal cancer and received proton therapy at the National Cancer Center (NCC) for two months before being admitted to the hospital. Medical professionals at NCC recommended surgery and explained that the patient also needed combined chemoradiotherapy (CCRTx), but the patient rejected them all.

After he left NCC and moved to hospital B, the patient received treatment with standard anticancer drugs -- Cisplatin, Fluorouracil, and Opdivo – and was discharged without particular symptoms. However, he complained about the standard anticancer drugs’ side effects, forcing medical staff to shift to Opdivo alone. A gastroscopy on Sept. 23, 2020, confirmed that esophageal musical lesions and stenosis had improved.

A chest radiography check on Nov. 13, 2020, conducted after administering only Opdivo, also showed improvement in pneumonia symptoms. There were no abnormalities in the examination four days later. However, two days later, the patient showed fever symptoms before the endoscopy, and the medical staff discontinued the examination, injected antipyretics, and observed the progress. After the patient’s blood pressure and the temperature returned to normal, the hospital prescribed antibiotics and other drugs and discharged the patient on Nov. 21, 2020. However, the patient died about a week later.

The bereaved family claimed that the patient died of pneumonia due to the side effects of Opdivo. In demanding compensation, the family members said they had not been properly informed of the possibility of side effects by medical professionals. The hospital discharged the patient without taking appropriate measures after pneumonia had developed.

However, the court judged differently. It concluded there were no direct causal relations between the patient’s death and the immunotherapy. The court also said the hospital’s medical staff did not have to pay alimony for violating the duty of explanation, either.

“Comprehensively considering detailed treatment process and the opinions of those who appraised medical records by the commission, it is difficult to conclude there are considerable relations between the patient’s death and the anticancer drug based on presented evidence alone or recognize the hospital medical staff’s malpractice, and there is no other evidence to recognize it,” the court said.

The opinions of medical record appraisers also backed up the court.

“Immunotherapy, such as Opdivo, has fewer serious side effects compared to standard anticancer treatments,” said a hemato-oncologist at Chung Ang University Hospital. “In this case, too, the patient’s pneumonia has no correlation with the immunotherapy.” The appraiser also pointed out that there were no abnormalities after the final administration of Opdivo.

A pulmonary specialist at Soon Chun Hyang University Hospital also said, “According to chest CT on Nov. 27, 2020, two days before the patient's death, the pulmonary pleural effusion and white shading had improved compared to two months ago. The existing pneumonia was not so serious as to cause death, and the pneumonia that appeared on the CT of hospital B had also improved. Therefore, the patient did not die of lung disease.

A radiography specialist at Soon Chun Hyang said when hospital B began anticancer treatment, the patient already had had typical radiation pneumonia and fibrosis lesions that appeared after radiotherapy.

“The violation of the duty of explanation for which doctors should pay alimony is limited to invasive medical activities, such as surgery or actions predicted to have serious consequences, including death. Not all medical activities are included in the list,” the court said. “There is no room for the use of immunotherapy to become a problem for violating the duty of explanation, as it is not related to the patient’s death or the patient’s right to self-determination due to doctors’ invasive behavior.”

Accordingly, the court dismissed all of the bereaved family’s claims, saying there was no reason.