Comparing the Law of Medical Accidents in China and the United States

1. Comparing the Lawof Medical Accidentsin China and the United States Dean M. Harris, J.D. Department of Health Policy and Administration School of Public Health University of North Carolina at Chapel Hill September 22, 2005

2. By Comparing the Lawof Medical Accidentsin China and the U.S. • We can gain a better understanding of Chinese health care law and U.S. health care law; and • We can identify the lessons that each country can learn from the other.

3. The Law of Medical Accidents Raises Important Issuesof Health Policy • The law of medical accidents is part of the effort to improve the quality of patient care. • But, legal liability can increase health care costs by encouraging “defensive medicine.” • And, the threat of liability might discourage doctors from disclosing medical errors.

4. Outline of This Presentation • The U.S. legal system for handling medical accidents • The Chinese legal system for handling medical accidents • What can each country learn from the other?

5. CRIMINAL LAW LAW CONTRACT LAW CIVIL LAW INTENTIONAL TORTS TORT LAW THE TORT OF NEGLIGENCE CATEGORIES OF U.S. LAW

6. CONSTITUTION LEGISLATIVE BRANCH EXECUTIVE BRANCH JUDICIAL BRANCH THE U.S. SYSTEM OF GOVERNMENT

7. National People’s Congress (and Its Standing Committee) Supreme People’s Court State Council Various Ministries (such as MOH) THE CHINESE SYSTEMOF GOVERNMENT

8. The U.S. Legal System for Handling Medical Errors • In the U.S. legal system, medical errors are handled as part of the system of tort liability. • A “tort” is a wrongful act that one person commits against another, without the need for a contract between the parties. • The injured person may sue for monetary damages under the civil law of torts.

9. These Are Very Old Principlesof English and American Law • The original 13 states of the United States had been colonies of England. • Therefore, U.S. law is based on English common law. • In 1375, an English court reasoned that a doctor should be liable for his negligence, just like a blacksmith would be liable for causing injury to a horse.

10. The Tort of NegligenceRequires Proofof Four Elements • Duty • Breach of duty • Causation • Damages

11. The Element of “Duty” • Doctors have a duty to their patients to provide the same level of skill and care as other doctors in similar circumstances. • This level of skill and care is called the “standard of care.” • Usually, the patient must use an expert witness to establish the standard of care.

12. The Element of “Breach of Duty” • The patient must prove that the doctor failed to meet the standard of care in treating the patient. • Usually, the patient will need a medical expert witness to prove that the doctor breached the duty.

13. The Element of “Causation” • The patient must prove that the doctor’s breach of duty was the cause of the injury. • If the injury or death would have occurred anyway, the patient cannot prove “causation.”

14. The Element of “Damages” • The patient must prove that he or she suffered damages. • Damages for medical negligence include: -economic losses (such as lost wages and medical expenses); and -non-economic losses (such as pain and suffering).

15. Hospitals May Be Held Liablefor the Negligence of Their Doctors • Under the legal doctrine of “vicarious liability,” a hospital may be held liable for the negligence of its medical employee. • However, most doctors in the U.S. who treat patients at hospitals are not employees of the hospital. • Therefore, it is hard for patients to hold hospitals liable on this basis.

16. Also, Hospitals May Be Held Liable for Their Own Negligence • Even if the doctor is not an employee of the hospital, the hospital may be held liable for its own negligence. • This legal doctrine is called “corporate negligence.” • For example, a hospital could be held liable for allowing a bad doctor to treat patients at the hospital.

17. The U.S. Lawof Medical MalpracticeHas Two Goals • Compensation (providing monetary damages to injured patients or their families); and • Deterrence (improving the quality of care by getting rid of bad doctors and causing other doctors to be careful).

18. Does the U.S. lawof Medical MalpracticeReally Accomplish Its Goals? • Does the law really provide fair compensation to patients and their families? • Does the law really deter negligence and improve the quality of care?

19. Are There Too Many Lawsuitsfor Medical Malpractice in the U.S.? • Newspapers report large damage awards in malpractice cases ($10 million or more). • Doctors in the U.S. are very worried about being sued for malpractice. • Premiums for doctor’s liability insurance have increased significantly. • Politicians make speeches about “frivolous litigation” in malpractice cases.

20. But, the Data Showsthat Very Few Injured PatientsEver File a Claim • The Harvard Medical Practice Study reviewed records of hospital patients in New York State. • Out of 30,775 patients; • 1,133 suffered an adverse event; • of which 280 were caused by negligence; • but only 8 patients filed a claim.

21. What Conclusions Did the Researchers Draw from That Data? • Most of the patients who are injured as a result of negligence are not compensated by the system of medical malpractice. • Most of the doctors who injured patients by their negligence are not identified or held accountable by the system of medical malpractice.

22. Also, the U.S. Systemof Malpractice LiabilityCauses Other Problems • The malpractice system increases health care costs, by causing doctors to practice “defensive medicine.” • Doctor’s liability insurance is very expensive and sometimes not available. • The process for resolving claims takes a long time and costs a lot of money. • The threat of litigation interferes with efforts to improve the quality of care.

23. In the U.S., this Is Called the“Medical Malpractice Crisis” • The U.S. system of medical malpractice liability does not accomplish its goals. • It is not an efficient way to resolve disputes. • It causes other serious problems for the cost and quality of health care.

24. Possible Reformsfor the U.S. Systemof Malpractice Liability • Put limits (or “caps”) on the damages that can be awarded in malpractice cases. • Increase the penalties for “frivolous litigation.” • Promote methods of “alternative dispute resolution” such as mediation, arbitration, or panels of experts. • Replace the current system with a system of “no-fault” compensation.

25. The Chinese Legal Systemfor Handling Medical Accidents • On February 20, 2002, the State Council of the People’s Republic of China (P.R.C.) adopted the Regulation on the Handling of Medical Accidents. • This new regulation became effective on September 1, 2002. • The 2002 regulation replaces the previous 1987 regulation.

26. The Historyof Medical Disputes in China • In the 1950’s, criminal penalties were often used for negligent doctors. • In the 1960’s, local administrative departments began to play a more important role in handling medical disputes.

27. During the Cultural Revolutionfrom 1966 to 1976 • Many cases of medical malpractice were mixed with political accusation, and many doctors were punished severely. • Laws were almost disregarded or abandoned in handling cases of medical accidents. • Even in the early days after the Cultural Revolution, the judicial system was still disorganized.

28. After the Cultural Revolution • Since 1978, local administrative departments have been involved in managing medical disputes. • Administrative regulations and measures were adopted at the local level for handling these cases. • But, local regulations led to local differences in decisions.

29. There Was a Needfor Uniformity Throughout China • The central government favored standardized laws and regulations, in order to maintain the order of the market and promote economic reform. • Medical care was part of that trend toward standardization of the law. • The State Council of the P.R.C. promulgated the Regulation on Dealing with Medical Incidents on June 29, 1987.

30. Thus, China Has Made a Major Transition in Medical Law Since the Cultural Revolution, China has made the transition from: • Essentially no law on medical accidents, to • Many local regulations, to • A single nationwide regulation in 1987.

31. But, There Were Problemswith the 1987 Regulation • The definition of “medical incident” was very limited and narrow. • The amount of economic compensation was very low and unfair. • The system of expert authentication was unreliable and unfair. • There were conflicts between the 1987 regulation and other laws or regulations.

32. Therefore, the State Council Adopted a New Regulation in 2002 • As in the U.S., Chinese lawmakers have combined reform of the liability system with efforts to improve the quality of care. • There are civil remedies, administrative punishment, and even criminal punishment in very serious cases. • The 2002 regulation includes a system of quality assurance, regulatory supervision, and compensation for injured patients.

33. The 2002 Regulation ProvidesSeveral Methodsfor Obtaining Compensation • These methods include negotiation, mediation, and civil litigation. • The parties are not required to use negotiation or mediation, and they may go directly to the people’s court. • However, filing a suit in the people’s court will terminate any efforts at mediation by the department of health.

34. Technical Authenticationfor Medical Expertise • The health department can obtain a technical authenticationby referring the case to the medical society. • Experts are selected from databases maintained by medical societies. • The regulation sets forth detailed procedures for performance of technical authentications by panels of experts.

35. The 2002 RegulationDefines the Term “Medical Accident” • A “medical accident” is a negligent act by a hospital or staff members in medical treatment that caused personal injury and violated legal requirements or standards of medical care. • Thus, the standard of liability is negligence. • The regulation uses a system of comparative fault, rather than denying all recovery in cases of contributory negligence.

36. The 2002 RegulationProvides a Broader Rangeof Compensation • Compensation can be awarded for both economic and non-economic damages. • Damages may include lost wages, disability living support, disability equipment, support for dependents, funeral expense, and spiritual injury.

37. Hospitals Are Requiredto Establish a Systemof Quality Control • Hospitals are required to develop plans to prevent medical accidents and limit the effects of injuries. • Hospitals are required to educate their staff members about legal requirements, standards of medical care, and professional ethics.

38. Hospital Workers and SupervisorsAre Required to ReportMedical Accidents • Workers must tell their supervisors when they observe a medical accident, a negligent act that could lead to a medical accident, or a treatment dispute. • Supervisors must make timely reports. • If a medical accident has occurred, the hospital must report to administrative authorities at the local health department.

39. The Regulation Also ImposesRules about Medical Records • Hospitals are required to keep case history materials, and may not alter materials. • Patients have the right to photocopy their medical records at their own expense. • The patient will be present during copying and the hospital will attach a seal to the copies.

40. The 2002 RegulationIs an Improvementover the 1987 Regulation • The 2002 regulation takes steps to reduce medical errors and improve quality of care. • The new regulation makes some improvements in the procedure for resolving medical disputes. • The new regulation increases the amount and fairness of compensation.

41. But, the 2002 Regulation Still Suffers from Some of the Same Problems • Like the old regulation, the 2002 regulation still raises conflicts with other laws. • The 2002 regulation uses a system of technical authentication that many patients would not consider to be fair. • Despite its improvements, the 2002 regulation has not yet created a system in which the people can fully place their trust.

42. The 2002 Regulation Still Has Conflicts with Other Laws Such as the GPCL • The Supreme People’s Court (SPC) has tried to solve the conflicts between the 2002 regulation and the GPCL and Civil Procedure Law. • The SPC released the Law (fa) (2003) No. 20 Notice to Local High People’s Courts and Military Courts on January 6, 2003. • However, the P.R.C. Constitution does not authorize the SPC to interpret laws, and the legal status of SPC interpretation is unclear.

43. There Are Conflictsabout Which Party Must Payfor the Authentication According to Article 34 of the 2002 regulation: - If technical authentication confirms occurrence of a medical accident, health care facilities shall pay the fee. - Otherwise, the party applying for authentication shall pay the fee. But, according to the Supreme People’s Court’s Law Interpretation (2001) No. 33: -Health care facilities would have to bear the costs of technical authentication, regardless of the outcome of the authentication.

44. There Are Also Conflicts and Confusion about the Burden of Proof • The 2002 regulation does not explicitly deal with the issue of assigning the burden of proof in medical accident cases. • However, the SPC's Law Interpretation (2001) No. 33 provides, as a practical matter, that health care facilities must bear the burden of proving their lack of negligence and lack of causation.

45. Many Patients Would NotConsider the Technical Authentication to Be Fair • Local medical associations arrange authentications, but most experts in local databanks have local connections. • Therefore, there are concerns about bias and professional protectionism. • Also, the close relationship between medical associations and health departments may lead to departmental protectionism.

46. The 2002 Regulation Has NotYet Created a System that People Fully Trust • Many patients and their families do not fully trust the legal system for resolving medical disputes. • There is a need for a credible system to deal with medical accidents and related problems in quality of care.

47. Is There a “Malpractice Crisis” in China? • China does not have a “malpractice crisis” of frivolous claims or excessive damages. • However, it appears that China has its own “malpractice crisis” as a result of the lack of trust in the system. • The solution is to develop a credible system to deal with medical accidents and related problems in quality of care.

48. What Can Policymakers in the U.S. Learn from Experience in China? • Some people in the U.S. want to replace juries with panels of experts, but Chinese experience shows the problems of using expert authentication committees. • Some people in the U.S. want more legal requirements to report medical errors, but doctors and hospitals might not comply. • Despite its faults, the medical malpractice system in the U.S. is a generally credible and relatively peaceful method of resolving disputes.

49. What Can Policymakers in China Learn from Experience in the U.S.? • Quality of care in China might be improved by giving hospitals and hospital managers more authority and different incentives. • Chinese hospitals bear legal liability for medical errors, but they have little practical ability to prevent those errors. • Managers of Chinese hospitals need to have the legal authority and practical ability to discipline or terminate doctors who fail to provide proper care.

50. U.S. Experience Also Showsthe Importance of Effective Government Regulation • Medical liability is only one part of a comprehensive legal structure to improve the quality of care. • Another necessary part is effective government regulation, including licensure of medical professionals and facilities. • China has adopted licensure laws and regulations for health care providers, but so far the implementation and enforcement of those legal requirements has been limited.