South Korea: A Study On The Limitations Of Criminal Responsibility Of Medical Professionals In Medical Accidents: Focusing On Recent Decisions Of Korean Courts Regarding Professional Negligence And Causal Relations

According to the established precedents of the Supreme Court of Korea, in the case of a medical accident resulting in injury or death to a patient, the acknowledgment of professional negligence – a violation of the duty of care required for medical professionals' work – shall be determined with regards to whether the physicians were able to foresee and prevent the result in question.¹ The standard of care for determining negligence shall be the degree of prudence and caution provided by the average worker when executing the same work and duties. Other considerations shall include the general standards of medical practices at the time, the medical environment and conditions, the special characteristics of the medical practice, etc.

However, the Court also recognizes the execution of discretionary power in medical practice, decreeing that "when making clinical decisions, physicians have a wide discretionary space in choosing the most appropriate decision based on their professional knowledge, the state of medical practices, and his/her own knowledge and experience. Regardless of the outcome of the medical treatment, it cannot be said that only one type of treatment is justifiable and conducting any other treatment constitutes an act of negligence unless it deviates from a reasonable scope."² That is to say, if a physician chooses to perform a medical treatment that he/she believes is appropriate in a given circumstance after thoroughly considering the necessary measures and risks associated with the treatment, the Court considers this choice of treatment to be within the physician's discretionary power and does not recognize criminal negligence, unless the medical treatment in question is considered significantly deviant from medical principles or lacking in rationality.

Meanwhile, in terms of the burden of proof to prove medical malpractice, the Court maintains its position that prosecutors must strictly prove the malpractice of doctors based on the principle of in dubio pro reo, which is to rule in favor of the accused when in doubt. This is different from civil cases for damages. There are cases where a physician or hospital is found innocent in a criminal prosecution because the prosecutor failed to fulfill the burden of proof but is found liable for damages in a civil suit.

In the aspect of litigation practice, a high level of medical knowledge and expert assessments of the corresponding medical department are required to determine whether a physician's medical malpractice should be recognized in a lawsuit. Therefore, the presence of professional negligence is first determined by content from the examination of medical records and responses to factual inquiries by university hospitals, medical associations, etc. requested by investigation agencies or the court, or by statements of medical appraisers who are present at court as witnesses.

Next, concerning the causal relations between medical malpractice and undesirable results, a South Korean court ruled in a civil case concerning a medical malpractice the following: "In a case where a patient dies during medical treatment, if the victim proves that medical malpractice was committed in a series of medical care based upon common sense, and that no other cause could have intervened in the result other than the above series of medical care, for example, proving that the patient did not have any health problems that could have caused the above result prior the medical practice, and unless the medical personnel proves that the above result was not caused by medical malpractice but by a completely different cause, it is reasonable to presume the existence of a causal relation between the medical malpractice and the outcome and ease the burden of proof on the claimant."³ Thereby, South Korean courts allow a causal relation between a medical malpractice and the outcome to be presumed if the victim proves the presence of medical malpractice and that the patient did not have health problems. In contrast, criminal cases involving medical accidents require strict proof of causal relations as well as proof of medical malpractice.

Therefore, according to the precedents of South Korean courts, judgment on the presence of medical malpractice or the establishment of causal relations may differ between civil and criminal suits of the same case, as criminal suits follow the strict principle of legality and demand proof to the level that no reasonable doubt exists in accordance with the principle of in dubio pro reo.

In particular, for criminal cases where the presence of medical malpractice and causal relations were a major issue, the Supreme Court of Korea recently clarified its position that criminal malpractice and causal relations must be recognized based on extremely strict criteria by reversing a number of decisions of the original courts who had recognized medical malpractice and causal relations and found the accused physicians guilty of inflicting bodily injury or death by professional negligence.⁴

(1)Case Summary

The accused in this case are clinical professors, residents, and nurses who work in the neonatal intensive care unit ("NICU") of a university medical center and were in charge of prescribing and administering SMOFlipid (an injectable lipid emulsion) to the newborns as attending physicians, doctors in charge, or nurses in charge. Contrary to the product instructions, which indicate the use of one bottle per patient and the use of aseptic manipulation to avoid infection, medical professionals at the university hospital conventionally separated SMOFlipid into several syringes, stored them on trays in the injection preparation room and injected them to patients. On the day of the accident, all the newborns in this case, who were hospitalized in the NICU and had severely poor immunologic functions, developed clinical indications of sepsis and died the next day.

At the time, this medical accident, where several newborns died on the same day due to the failure of infection control at a large university hospital, caused the medical personnel and university medical center to receive widespread condemnation. The prosecutors indicted all medical staff, including the professors, residents, and nurses in charge of neonatal intensive care, for professional negligence, some of whom were even arrested.

(2) Decision of the First and the Second Instance

1. Concerning the existence of professional negligence, the first instance court recognized the medical malpractice of the six accused medical professionals, with the exception of one resident doctor, of splitting medications into several syringes, thereby increasing the risk of infection. The Court also recognized negligence in the duty of care for not preventing such acts. In other words, drugs usually have specific administration methods and precautions, and the medication in this case also had instructions as follows: Use immediately after removal from storage, use one bottle per patient, store admixtures at 2°C to 8°C for no longer than 24 hours, and perform aseptic manipulation in a bio-clean environment while repacking. Therefore, the accused had the professional duty of care to use one bottle per patient and perform aseptic manipulation or comply with infection guidelines to prevent the risk of infection while splitting the medicine. Violating the duty of care, the accused divided the medications and left them at room temperature for at least five hours, which was recognized as professional negligence. (Meanwhile, the second instance court determined that it is hard to determine the act of splitting itself to be a medical malpractice, holding a different view from the court of first instance).
2. In terms of the causal relations between professional negligence and the newborns' deaths, the court presupposed the cause of the newborns' deaths to be "septicemia due to Citrobacter" based on the testimonies and written opinions of experts. Therefore, the premise of this suit was that the malpractice in the process of splitting injections, which were collectively administered to the newborns in question, resulted in the occurrence of septicemia due to Citrobacter. In other words, a causal relation needed to be established between the faulty medicine distribution and the Citrobacter contamination of SMOFlipid injections. However, the court ruled that the causal relation between the medical personnel's malpractice in the injection division and the deaths of newborns were not clear in this case due to the following considerations:
   • Even if there was professional negligence in the process of dividing SMOFlipid injections, it is difficult to confirm that such malpractice undoubtedly caused contamination in the injections. (Other possible causes of contamination were suggested in detail in the second instance court).
   • The syringes were found connected to infusion sets in the medical waste bin and were mixed with other waste contaminants such as defecated diapers and blood when they were collected as evidence(specimen). Considering the fact that the bacteria and virus tests on the remaining injections of this case were conducted two days after the evidence was collected, it is possible that the samples were contaminated with Citrobacter in the sample collection process after the accident.
   • It is hard to conclude that the administration of injections caused the septicemia in newborns as non-specific symptoms of septicemia, which were the death cause of some newborns, had occurred the day before the injection.

Therefore, the first and second instance courts ruled that it is difficult to establish as a fact that the injections in this case were contaminated by Citrobacter due to the preparation procedure (division process) and that the newborns died of septicemia. In other words, the courts did not consider the causal relations between the medical malpractice and the deaths to be "proven beyond reasonable doubt," and acquitted all of the accused, including three professors, one resident doctor and three nurses. This decision was recently affirmed by the Supreme Court.

(3) Implications

The judgment of acquittal by the first and second instance courts in the case of the newborns' deaths clearly illustrates that even when the negligence of a medical professional is recognized, the causal relations between the negligence and each outcome must be decidedly proven to hold the medical professional criminally liable. In other words, unlike civil compensation suits where medical professionals may be held liable for monetary compensation under the legal principle of mitigating the burden of proof (Supreme Court Decision 93Da52402 Decided February 10, 1995, etc.), in criminal cases, medical professionals are only held criminally liable after exacting judgment on whether (i) professional negligence and (ii) causation are proven to the extent that there is no reasonable doubt.

This case reaffirmed the established legal principle of criminal trials in South Korea, which requires the finding of guilt to be based on reliable evidence that proves the veracity of the accused facts to the extent that the judge cannot raise reasonable doubts, and if there is no such evidence, the judge shall decide in the interest of the accused (Supreme Court Decision 95Do3081 Decided March 8, 1996, etc.).

As testimonies and written opinions of experts play a decisive role in determining medical malpractice and causal relations in medical disputes, it seems that the testimonies of a forensic medical examiner of the National Forensic Service and a pediatric infectious disease expert who conducted the autopsy and suggested that the syringes may have been contaminated with bacteria during the collection process afterward (i.e., opinions on the possibilities that other medical causes existed or intervened)⁶ played a crucial role in the court's determination of whether the causal relations held.