Father changed after surgery, given controlled drugs, never came home

Misfortune arrived all at once. On the afternoon of April 13, 2015, around 2:30 p.m., a man identified as Mr. A was found collapsed with blood coming from his left ear — a situation suggesting serious brain damage or head trauma. He was rushed to the emergency room at Yangsan Pusan National University Hospital at 2:34 p.m.

Doctors diagnosed him with, among other conditions, a left occipital epidural hemorrhage — a pooling of blood in the epidural space between the skull and the dura mater at the back of the head. The condition can cause symptoms of elevated intracranial pressure such as headaches and vomiting, and if the bleeding is severe enough to raise that pressure significantly, it can lead to loss of consciousness, limb paralysis and even death.

The hospital performed surgery to remove the epidural hemorrhage, beginning at 5:18 a.m. the following day and concluding at 8 a.m.

The procedure went smoothly. Immediately after Mr. A came out of anesthesia, he was administered Ultiva, an opioid analgesic. When he began trying to pull out the urinary catheter and IV lines connected to his body, midazolam was added to his regimen.

Midazolam is the sedative most commonly used in hospitals to sedate or calm patients.

Apart from showing signs of anxiety and agitation, Mr. A appeared to be recovering physically. The hospital transferred him from the intensive care unit to a general ward on April 20.

The problem emerged just two days after the transfer. Around 4:40 p.m. on April 22, Mr. A stopped breathing spontaneously and lost consciousness. He then developed cyanosis — a condition in which the skin, lips and fingernails turn bluish due to a lack of oxygen in the body.

Just over a month after he had been admitted, Mr. A died at 8:48 p.m. on May 15, never to return to his son's side.

Mr. A's son raised objections to the hospital's use of Ultiva and midazolam.

According to the medical community, Ultiva — whose active ingredient is remifentanil — is an ultra-short-acting opioid analgesic that is metabolized extremely rapidly in the body. It can cause life-threatening side effects, including sudden respiratory arrest and a sharp drop in blood pressure. For this reason, it is considered safe to use only in operating rooms or intensive care units where a patient's breathing and pulse can be monitored in real time.

Midazolam can also cause respiratory depression, and that effect is amplified when the drug is administered alongside an opioid. Both drugs therefore require strict adherence to prescribed dosages and administration protocols.

Despite this, Mr. A's family said the hospital administered excessive doses of both drugs beyond recommended guidelines without adequately accounting for his condition. They added that the hospital administered midazolam multiple times a day, causing Mr. A to suffer acute respiratory arrest and ultimately die.

The family further said the hospital failed to fulfill its duty of observation even as it administered high doses of Ultiva and midazolam to Mr. A over an extended period.

Their argument was that despite giving Mr. A prolonged high-dose treatment with both drugs — while he was showing organic brain abnormalities following surgery — the hospital discovered his respiratory arrest too late to prevent his death.

The Eighth Civil Division of the Busan District Court, presided over by Judge Lee Jae-deok, rejected all of Mr. A's son's claims.

The court acknowledged that physicians have a duty of care — an obligation to take precautions against harm based on a patient's symptoms and circumstances — but said that duty must be measured against the clinical standard of care prevailing at the time, citing a Supreme Court precedent (ruling 2004Da13045, handed down Oct. 28, 2005).

The court first declined to find fault in the administration of Ultiva and midazolam.

It cited three factors in reaching that conclusion: the recommended midazolam dose is 2 to 2.5 milligrams for adults under 60, with a total-dose ceiling of 5 milligrams, and the amount given to Mr. A did not exceed that limit; there is no established medical standard requiring that midazolam administered intravenously after Ultiva must be less than 3 milligrams; and the hospital had taken midazolam's half-life into account when timing each dose.

"Mr. A suffered from severe post-operative anxiety and delirium and was agitated, pulling at the urinary catheter, IV lines and monitor lines connected to his body and touching the surgical site with his hands," the court said. "The hospital had a clinical need to sedate him in order to provide appropriate treatment."

The court added that "Mr. A's anxiety and agitation persisted even while Ultiva was being administered and subsided only after midazolam — which takes effect rapidly — was given," and that "there was a need to administer additional midazolam to prevent the risk of harm to the patient himself, his guardians and the medical staff."

On the specifics, the court noted that "midazolam has a half-life of approximately three hours, and the hospital administered it to Mr. A only after intervals of six hours or more, for a total dose of about 3.75 milligrams." It also found that the timing and intervals of Ultiva administration "were adjusted in accordance with Mr. A's anxiety and agitation, his physical condition, and whether other medications were being used."

The court also sided with the hospital on the question of its duty to monitor Mr. A's condition.

In reaching that ruling, the court weighed three considerations: that Ultiva and midazolam can cause respiratory depression as a side effect, meaning both must be administered in a setting equipped for artificial respiration and cardiopulmonary resuscitation; that both drugs carry a significant risk of side effects when administered; and that respiratory arrest following drug administration requires monitoring given the patient's condition, potential drug interactions and the possibility of adverse reactions.

The court in particular acknowledged the following sequence of facts: that hospital staff administered 3 milligrams of midazolam intravenously to Mr. A, who was already receiving Ultiva, at around 8:45 a.m. on April 22, 2015; that after measuring his vital signs and oxygen saturation at 3:40 p.m. that day, staff measured only his vital signs at around 4 p.m.; and that it was not until around 4:40 p.m. that staff discovered Mr. A had stopped breathing spontaneously, lost consciousness and was showing signs of cyanosis.

Even so, the court dismissed the negligence claim, noting that "the hospital assigned Mr. A to a room directly in front of the nurses' station so his condition could be observed, and measured his level of consciousness and vital signs every hour." It added that "while continuous monitoring was necessary, it was difficult to pinpoint the specific window in which an adverse reaction to the drugs might occur, and no warning signs had appeared in his blood pressure, pulse, temperature or oxygen saturation readings."

The court further said it was "difficult to conclude that hourly checks of the deceased's condition rendered the monitoring inadequate by clinical standards," noting that "Mr. A was found unresponsive and without spontaneous breathing 40 minutes after the 4 p.m. vital-signs check, and the hospital immediately began cardiopulmonary resuscitation and other emergency measures."

Attorney Cho Jin-seok of law firm O'Kims said that intermittent checks such as vital-signs measurements alone make it difficult to detect respiratory depression early — suggesting there is room to contest the hospital's duty of observation.

He also expressed regret that the case had not more thoroughly examined whether the medical staff's actions fell short of the clinical standard referenced in the Supreme Court precedent the court applied.

"Ultiva was being continuously infused even after Mr. A was transferred to the general ward, and on the day of the incident, midazolam was administered repeatedly at hourly intervals without continuous oxygen-saturation monitoring," Cho said. "Respiratory depression can precede changes in vital signs such as blood pressure and pulse, making it difficult to detect early through intermittent checks alone."

He added that "the need for continuous oxygen-saturation monitoring in patients receiving a combination of opioid analgesics and sedatives deserves closer examination."

Cho also said the ruling "confirms that in medical malpractice litigation, whether a physician breached the duty of care is judged against the clinical standard at the time of treatment," and stressed the importance of how parties respond during the medical-record appraisal stage.

He advised that the litigation strategy should focus on establishing that the medical staff's actions fell short of clinical standards, through specific lines of inquiry: whether the continuous infusion of Ultiva in a general ward is permitted under the drug's approved indications or generally accepted clinical practice; and what level of monitoring — such as continuous oxygen-saturation measurement or end-tidal carbon dioxide monitoring — is required when midazolam is administered repeatedly during an ongoing opioid infusion.

Cho added that "the '5-milligram total-dose' ceiling for midazolam that the court cited as one basis for its ruling is a standard primarily designed for short-term sedation before and after procedures," and that "a medical review is needed to determine whether that same standard can be applied when midazolam is given repeatedly over several days during a continuous opioid infusion."

He also said "it is necessary to examine through appraisal whether the respiratory arrest was caused by the drugs, or by a change in the patient's physical condition or some other cause unrelated to the medication."