This article is a further report on the People’s Republic of China (PRC) Tort Liability Law, specifically focusing on medical tort. The earlier, general introduction to this new law, entitled “New Tort Liability Law: Ramifications for Companies Doing Business in China”, was published recently. Please click here for more information.
As one of the most eye-catching chapters of the new Tort Liability Law, Chapter 7 of this law specifically provides for liabilities relating to medical tort. To provide some background in this area, in recent years China has witnessed a number of notorious medical disputes. These disputes harm, and to some extent even break up, the relationship between patients and medical institutions. It is expected that such depressing situations can be cured after the application of the new law, which will become effective 1 July 2010. From a medical institution’s perspective, in particular, the following developments merit special attention.
Proving and the Presumption of Fault
Article 54 of the Tort Liability Law clarifies that liabilities for medical tort shall be based on fault. However, the law is silent on which party shall bear the burden of proof for verifying the fault and the causes of fault. According to one existing judicial interpretation regarding evidence in civil litigation, such burden is on the medical institution. It is said that the medical institution shall be liable if it fails to prove that there is no fault in its medical treatment or that there is no relationship between the fault and the harm to the patient.
In particular, Article 58 sets out three circumstances under any one of which presumption of fault will be applied:
1. Violating the laws, administrative regulations or rules, or any other provision on the procedures and standards for diagnosis and treatment
2. Concealing or refusing to provide the medical records related to a dispute
3. Forging, tampering or destroying any medical records
According to this provision, if any of the above have occurred, the medical institution will be presumed to have fault.
Exemptions for Liability
In order to prevent the abuse of medical disputes against medical institutions, Article 60 of the Tort Liability Law provides that medical institutions shall not be liable for compensation under any of the following three circumstances:
1. The patient or his/her relatives fail to cooperate with the medical institution in the diagnosis and treatment of the medical condition, in line with the procedures and standards established for diagnosis and treatment
2. The medical staff have fulfilled the duty of reasonable diagnosis and treatment in the case of an emergency such as rescuing a patient in a critical condition
3. Diagnosis and treatment of the patient is difficult due to the medical conditions at the time
It should also be noted that under Item 1 of the above, the medical institution shall assume the corresponding compensatory liability if it is also at fault.
Liabilities for Defective Medical Products
The existing laws and regulations entitle consumers harmed by defective products to make a claim against either manufacturers or sellers, which is reiterated in the Tort Liability Law. However, the relevant PRC laws were silent on whether the patient harmed by using the defective medical products can sue the medical institution prior to the promulgation of the law. Now, the defective product liability is also applicable to medical institutions under the new law.
Article 59 of the new law provides that, if a patient suffers damage due to defective drugs, disinfectants and medical devices, or transfusion of blood that does not meet the standards, he or she may seek compensation from the manufacturer or blood-supplying organizations as well as from the medical institutions. After compensating the patient, the medical institution is entitled to claim reimbursement from the manufacturer or blood-supplying organization liable for the damage. It is assumed that the new law requires medical institutions to inspect their medical products more cautiously to mitigate their risk of exposure to defective product liabilities.
Notification, Documentation and Privacy Protection
Under the Tort Liability Law, medical institutions shall provide to their patients an explanation of their health conditions and the medical measures taken during the course of diagnosis and treatment. If surgery, a special examination or special treatment is required, medical institutions shall explain to their patients, or to the relatives of the patients, if applicable, the medical risks and alternative treatments in a timely manner and obtain their written consent, unless the opinion of the patients or their relatives cannot be consulted due to emergency. If medical institutions fail to fulfill such obligation of notification and subsequently cause damage to the patients, the medical institution shall be liable for compensation.
Further, Article 61 of the new law provides that medical institutions shall duly complete and ensure the safekeeping of medical records and shall assent to the requests of their patients to access and duplicate medical records relating to their cases. Although the new law is silent on the penalty in case of failure to perform the documentation obligation, is should be noted that, by failing to provide medical records as required by the patients, the medical institutions would be assumed at fault as mentioned above.
In line with the new law’s overall aim to establish a comprehensive legal framework of privacy rights, Chapter 7 of the Tort Liability Law specifically obligates the medical institutions to treat the private data of a patient with extreme confidence and prohibits any disclosure of such information without the consent of the patient.
Application of Medical Malpractice Regulations
According to the existing laws and regulations, there are two kinds of medical tort: medical tort caused by medical malpractice (Medical Malpractice) and medical tort caused by reasons other than medical malpractice (Other Medical Tort). The former is applied according to the Regulations on Handling Medical Malpractice (Medical Malpractice Regulations) and the latter is applied in terms of the General Provisions of Civil Law and the Supreme Court’s relevant judicial interpretations. Unfortunately, just as the classification of medical tort is itself somewhat unclear, the practices conducted pursuant to these provisions are likewise confusing. Generally speaking, and in common-sense terms, Medical Malpractice always causes heavier damages than Other Medical Tort. However, the Medical Malpractice Regulations provide for lower liabilities. As a result, in current legal practice, one patient will get less compensation if the medical tort is judged to be a result of Medical Malpractice compared to that which is the result of Other Medical Tort.
Given this situation, it is anticipated that the Medical Malpractice Regulations will be covered by the new law. However, as the law is silent on this issue, further clarification or interpretation from the competent authorities is required.
Conclusion
In brief, the purpose of the Tort Liability Law is to balance protection of the rights of both patients and medical institutions (including medical staff) in liabilities for medical tort. To mitigate potential legal risks, medical institutions must maintain a higher compliance standard and medical institution investors should stay alert to any developments in the interpretation or enforcement of the Tort Liability Law in China. Assistance from applicable legal professionals should be sought in this complicated medical arena.
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