A patient walks into the hospital on their own in the morning — and is brought home cold by the afternoon. For families, it is almost impossible to accept.
So they begin a fight that seems nearly unwinnable. Savings accounts are drained, homes are sold, and the money goes toward answering one question: why did their loved one die? Yet proving a medical institution's liability is extraordinarily difficult for patients and their families, largely because of the deep information asymmetry between them and the healthcare system.
In South Korea, medical disputes are handled mainly through two channels: mediation and arbitration via the Korea Medical Dispute Mediation and Arbitration Agency, which receives an average of about 2,100 cases a year, and civil litigation, which accounts for an average of about 1,000 cases annually, according to research by the Korea Insurance Research Institute. More than 3,000 medical disputes play out every year — a David-versus-Goliath struggle in each case.
The Herald Business, in partnership with law firm O'Kims, is analyzing medical dispute rulings to explore how the underdog can prevail. We hope to help patients and their families survive the "Medical Survival Game." The series runs twice a month, on alternating Tuesdays. [Editor's note]
Patient A thought all she had to do was get through chemotherapy. She was wrong. Four rounds had already pushed her to her limits — the fifth would prove catastrophic.
When she visited Seoul National University Hospital on April 23, 2020, the session did not go as the previous ones had. Unlike the four treatments she had received over the preceding three months, the nurse assigned to her was unable to secure a vein for catheter insertion. After several failed attempts, the nurse asked a colleague to administer the intravenous injection for the anticancer drug. Patient A was then given the chemotherapy drug adriamycin.
There was no swelling at the injection site, but redness appeared on the skin. Later that same day, the anticancer drugs docetaxel and cyclophosphamide were administered sequentially through an IV in her right leg.
The problems began the following day. From Monday onward, severe pain and swelling developed at and around the adriamycin injection site.
A doctor at Seoul National University Hospital diagnosed a suspected extravasation injury — meaning the chemotherapy drug had leaked out of the vein and into surrounding tissue — and prescribed steroids (oral medication and ointment) along with antibiotics to control the inflammation. In such cases, the damage can go beyond simple inflammation and lead to skin necrosis.
Patient A's condition steadily worsened. The pain and swelling spread to her shoulder, arm and leg. An MRI of her right wrist revealed cellulitis accompanied by extensor tenosynovitis.
Extensor tenosynovitis is inflammation of the tendons responsible for extending the fingers or toes. A joint consultation between the oncology and infectious disease departments concluded that the infectious disease physician believed Patient A's symptoms were most likely caused by drug-induced inflammation. The physician also raised the question of whether plastic surgery should be consulted for incision and drainage.
Patient A was ultimately diagnosed with complex regional pain syndrome (CRPS) type 2 — a rare, intractable condition in which direct nerve damage causes extreme, persistent pain so severe that even the lightest touch feels like a knife wound.
Patient A claims medical team violated duty of care and informed consent
A protracted legal battle between Patient A and Seoul National University Hospital followed. Patient A argued that the hospital's medical staff had violated their duty of medical care and their duty to provide informed consent, and on that basis sought 470 million won ($350,000).
On the duty of medical care, she challenged the extravasation of the chemotherapy drug through the IV insertion and the resulting skin necrosis. Her position was that a physician should personally administer chemotherapy intravenously, and that if a nurse performs the procedure, a doctor must be present to monitor the patient throughout the infusion.
She also said the assigned nurse's four failed attempts to insert the IV should have been reported to a physician, who should then have given detailed instructions before the injection and drug administration proceeded. In practice, a different nurse — asked by the assigned nurse — ended up administering the drug, and Patient A received the injection into a vein in her wrist, a site that had not been used in previous sessions.
Particularly regarding the redness that appeared at the injection site immediately after the drug was administered, Patient A said this should have been reported to a physician. Despite signs of possible extravasation, no follow-up measures were taken — such as removing residual drug — and she subsequently required treatment across oncology, dermatology, infectious disease, plastic surgery and rehabilitation medicine. She argued that inadequate and delayed treatment caused her condition to deteriorate.
On the failure to provide informed consent, Patient A cited the absence of any explanation about the risk of developing CRPS type 2. She also challenged the failure to inform her that the IV could be administered in the leg, arguing this denied her the right to choose the injection site.
Court rejects all of Patient A's claims
The Seoul Central District Court, presided over by Judge Lee Yu-bin, rejected all of Patient A's claims, finding no violation of either the duty of medical care or the duty of informed consent.
The court found no merit in any of the three specific grounds Patient A raised: the requirement for physician presence, the IV insertion process, and the response to the extravasation.
On physician presence, the court said there was no medical basis for requiring a doctor to insert the IV or to be present at the site during chemotherapy administration. It found, to the contrary, that monitoring a patient's progress during drug infusion falls within the scope of nursing duties.
On the IV insertion process, the court said that multiple failed attempts to secure a vein did not in itself establish a breach of the assigned nurse's duty of care. It also found no violation in the decision to have a colleague nurse perform the insertion.
On the response to extravasation, the court found that the assigned nurse and other staff were not under a duty of care requiring them to suspect adriamycin extravasation and take specific action on that basis — effectively rejecting the very premise of Patient A's duty-of-care argument.
The court explained that if the IV had been inserted outside the vein, significant pain along with redness and swelling would have appeared shortly after the infusion began, and the rate of drug infusion would have slowed or stopped. The implication was that the needle had not been misplaced outside the vein.
The court also noted the possibility that the extravasation had not resulted from an incorrectly placed IV at all.
"Extravasation of chemotherapy drugs is a common side effect, occurring in as many as 1 to 60 out of every 1,000 patients," the court said. "Even when a catheter is correctly inserted and properly maintained within the vein, a completely sealed state cannot be guaranteed, and no standard clinical guidelines have been established for preventing extravasation."
"The mere fact that extravasation occurred cannot be used to presume a breach of the medical team's duty of care," the court added.
On the failure to provide informed consent, the court found that the medical team had fulfilled its duty to explain the chemotherapy treatment, thereby protecting Patient A's right to self-determination; that there was insufficient reason to require an explanation of the specific IV insertion site; and that the development of CRPS type 2 from chemotherapy-related extravasation was not reasonably foreseeable.
Attorney Cho Jin-seok: ruling reaffirms basic principles of medical malpractice litigation
Cho Jin-seok, an attorney at law firm O'Kims, analyzed the ruling as a reaffirmation of the legal principles governing medical malpractice litigation.
The mere fact that Patient A developed CRPS type 2, he said, is not sufficient to establish negligence on the part of the medical team. He noted that if the challenge had extended beyond the fact of extravasation to the adequacy of the medical team's response, a formal medical record review would have been even more critical.
"This case involves a court rejecting claims of negligence and causation by the medical team in connection with chemotherapy drug extravasation during cancer treatment and the alleged resulting CRPS type 2, and dismissing Patient A's claim in its entirety," Cho said.
"The court held that the occurrence of extravasation alone cannot give rise to a presumption of negligence by the medical team," he added. "This reaffirms the fundamental principle of medical malpractice law — that the worst outcome a patient suffers is not automatically attributed to negligence by the medical staff."
"The court denied the physician's duty of care on the grounds that IV insertion, drug administration and progress monitoring are standardly within the nursing scope of practice," Cho said. "It is a judgment that takes into account the division of labor in highly specialized clinical settings and the realities of medical practice."
On the informed consent finding, he said: "The court found that a comprehensive explanation had been given before chemotherapy — including the risk of skin tissue necrosis from extravasation — and that the patient's right to self-determination was substantively protected. The ruling on CRPS type 2 also followed the legal principle that the duty to inform is limited to risks ordinarily foreseeable from the medical procedure in question."
He added that for Patient A, going beyond the mere fact of extravasation would have required establishing two things: first, through a medical record review, that the medical team's monitoring and response at the time of the extravasation fell short of clinical standards; and second, also through a medical record review, whether a medical causal link existed between that negligence and the development of CRPS type 2.
ko@heraldcorp.com
