Improve legislation to reduce "birth defects" disputes
Errors in prenatal diagnosis caused birth defects
● With the increase of citizens’ legal awareness, there are more and more birth defect lawsuits in our country.
When a fetus is found to be suffering from congenital disease or death after birth, many citizens choose to appeal to the courts, requiring hospitals with prenatal diagnosis errors to bear the corresponding medical damage liability
● In recent years, there has been a gradual increase in obstetrics medical damage liability disputes, but there is a large gap between the understanding of their rights and obligations between doctors and patients.
The current legislation has not yet clearly stipulated this, leading to inconsistent trial practices.
Even if the same method of legal remedy is adopted, the scope and amount of damages in the courts of different regions vary greatly.
● It is necessary to further improve the establishment of liability for damage in prenatal diagnosis medical damage disputes, and the judgment standards for liability.
In addition, in view of the fact that there is no uniform compensation standard for birth defects in my country, legislation should be adopted as soon as possible to determine the scope of compensation for birth defects in order to standardize the judicial discretion of judges.
□ reporter Wang Yang
□ Our newspaper trainee reporter Bai Chuxuan
On September 7, Ms. Chang from Jingzhou, Hubei Province was sent to the hospital during term labor. The newborn suffered severe asphyxia after birth, causing pulmonary hemorrhage. Half an hour later, she died after being transferred to the hospital.
According to Ms. Chang, the doctor said that the newborn had congenital diseases, and her B-ultrasound and fetal heart sounds were normal before delivery.
As early as 2011, a pregnant woman in Foshan, Guangdong had 9 prenatal checkups, of which 4 B-ultrasound failed to detect fetal malformations, and was told that the fetus had no left foot 7 hours before birth.
Three months after the child was born, his parents took the hospital to court on the grounds that the hospital’s diagnosis and treatment were at fault.
During the interview, an expert told the reporter of "Rules of Law Daily" that every family is full of expectations for the arrival of the newborn, but if the fetus is found to be accompanied by congenital diseases or even die due to illness after birth, it will undoubtedly be a heavy blow.
After misfortunes occur, many people will choose to resort to courts. In recent years, the number of obstetric medical damage liability disputes has increased, and they also account for a large proportion of medical disputes.
At present, such cases in my country are gradually increasing, but there is a large gap between the understanding of their rights and obligations between doctors and patients.
Since the current legislation has not yet clearly stipulated this, the trial practice varies from place to place.
Even if the same method of legal remedy is adopted, the scope and amount of damage compensation in different local courts are quite different.
Therefore, the legislature should improve relevant laws and regulations on disputes caused by birth defects as soon as possible.
Prenatal checkup started late
Fetal defect detection rate is low
Birth defect, also known as improper birth or birth error, refers to the birth of a child with congenital disability due to the negligence of the maternity examiner's diagnosis or notification.
Relevant data show that my country is one of the countries with a high incidence of birth defects. On average, one child with a defect is born every 30 seconds, and 800,000 to 1.2 million children with a defect are born every year.
Among them, in addition to 20% to 30% of children who can get a better quality of life through early diagnosis and treatment, 30% to 40% of children die after birth, and about 40% will become disabled for life.
This means that every year hundreds of thousands of families will be involved in the vortex of life-long suffering.
In 2005, my country designated September 12 as China's Birth Defect Prevention Day.
Pre-pregnancy eugenic health check, also known as prenatal diagnosis, which is usually called "prenatal checkup", refers to the diagnosis of congenital defects and genetic diseases of the fetus, including corresponding screening.
Prenatal diagnosis technology projects include genetic counseling, medical imaging, biochemical immunity, cytogenetics and molecular genetics and other technical services.
Prenatal screening technical items include maternal peripheral blood biochemical immune screening, ultrasound screening of fetal body surface and important organs, and related prenatal consultation.
Prenatal diagnosis started late in our country.
In the 1990s, my country began to increase prenatal diagnosis projects and gradually introduced foreign databases and risk value calculation software.
On December 13, 2002, the former Ministry of Health announced the "Administrative Measures for Prenatal Diagnosis Technology."
Since then, our domestic pre-diagnostics have gradually standardized development.
Article 14 of the Maternal and Child Health Law stipulates that medical and health care institutions shall provide health care services during pregnancy and childbirth for women of childbearing age and pregnant women.
The implementation measures of the Maternal and Child Health Law also stipulate that prenatal diagnosis is one of the main items of technical services for maternal and child health care.
On December 25, 2019, the National Health Commission issued the "Notice on the Basic Standards for Prenatal Screening Technical Medical Institutions and the Basic Standards for Prenatal Diagnostic Technical Medical Institutions", from the main responsibilities, setting requirements, personnel capabilities, housing and venues , Equipment configuration, rules and regulations, quality control, etc., put forward clear requirements for medical institutions that carry out prenatal screening techniques and medical institutions that carry out prenatal diagnosis techniques.
The "Report on the Development of China's Maternal and Child Health Career (2019)" shows that the national prenatal care rate has steadily increased, from 83.7% in 1996 to 96.6% in 2018, and in rural areas from 80.6% to 95.8%.
From 2003 to 2014, the national infant mortality rate from birth asphyxia, neonatal asphyxia within 24 hours, and birth asphyxia within 7 days, decreased by 75.1%, 81.3% and 76.9% respectively.
The neonatal mortality rate, infant mortality rate and mortality rate of children under 5 years of age decreased from 33.1‰, 50.2‰, and 61.0‰ in 1991 to 3.9‰, 6.1‰ and 8.4‰ in 2018, respectively, a decrease of 88.2% and 87.8%. % And 86.2%.
The "Healthy China 2030" Planning Outline and the "National Comprehensive Birth Defect Prevention Program" clearly stated that it is necessary to build a birth defect prevention system covering all stages of marriage, pre-pregnancy, pregnancy, newborns and children, and provide fairness for the masses. Accessible, high-quality and efficient birth defect prevention services.
At present, it has become a general consensus to prevent birth defects and ensure the birth of healthy babies through prenatal diagnosis.
However, due to differences in medical conditions and technical levels, the prenatal diagnosis projects carried out by hospitals in various regions of our country are different.
In other words, there are very few genetic diseases or birth defects that can be diagnosed prenatally through prenatal diagnosis technology.
Data shows that there are thousands of single-gene genetic diseases that have been discovered, but far less than 10% of them can be detected by prenatal diagnosis methods. There are still many infants suffering from congenital diseases or deaths after birth each year. .
Hospital medical fault
Violation of patients' legal rights
The health of women and children is the cornerstone of the health of the whole people, a yardstick for measuring the progress of social civilization, and the basis and prerequisite for the sustainable development of mankind.
In recent years, with the continuous improvement of citizens’ legal knowledge and awareness of rights protection, medical disputes have shown a significant increase.
According to incomplete statistics from health authorities, obstetric disputes account for almost 40% to 50% of medical disputes.
With the development of science and technology and changes in social ethical concepts, disputes and lawsuits related to fetal malformations in our country are showing a clear upward trend.
It is understood that the Tort Liability Law has introduced the concept of birth defects and confirmed the liability for damages to birth defects.
Related infringements infringe on the legitimate rights and interests of patients to obtain appropriate prenatal health care services, resulting in a series of property damage and mental damage.
Liu Junhao is the son of Liu Shikun and Zhao Juan.
Starting from July 10, 2018, Zhao Juan began prenatal examinations at Xinmi Maternity and Child Health Hospital. All prenatal examination hospitals informed Liu Shikun and Zhao Juan that the fetuses were normal.
On February 14, 2019, Zhao Juan gave birth to a baby boy and was diagnosed with suspicious glaucoma.
Subsequently, Liu Shikun, Zhao Juan, and Liu Junhao filed suits as plaintiffs.
The People’s Court of Xinmi City, Henan Province, after trial, held that in accordance with the Maternal and Child Health Law and its implementation measures, doctors should perform the obligation of prenatal diagnosis, notification, and medical opinion when providing medical services to pregnant women. .
In this case, due to the negligence of Xinmi Maternity and Child Health Hospital and failing to perform these statutory duty of care, Liu Shikun and Zhao Juan lost the opportunity to terminate the pregnancy in time. The medical behavior of Xinmi Maternity and Child Health Hospital violated the plaintiff Liu Shikun and Zhao Juan’s right to know and reproductive choice.
On July 28 this year, the Xinmi City Court decided in the first instance that the Xinmi City Maternity and Child Health Hospital compensated Liu Shikun and Zhao Juan for medical expenses, hospital food subsidies, nutrition, nursing expenses, transportation expenses, mental damage comfort funds, identification fees, etc. More than 300,000 yuan.
According to Hu Gongqun, a legislative consultant to the Standing Committee of the Beijing Municipal People’s Congress, the current demand for prenatal examinations in society continues to expand and the requirements for the quality of prenatal examinations are greatly improved. The public has high expectations for prenatal diagnosis. However, prenatal diagnosis is subject to technical limitations. Limitations, it is impossible to detect all fetal diseases.
After disputes occurred, there was a big gap between doctors and patients in their understanding of their rights and obligations.
From October 2009 to April 2010, a pregnant woman in Guangdong went to a Maternal and Child Health Hospital in Foshan City for 9 prenatal system checks, 4 of which were B-ultrasound.
It was not until April 12, 2010, before the delivery, when the hospital performed a B-ultrasound examination of the patient that "unilateral lower limb dysplasia of the foot was missing".
Because the parturient is about to give birth, the patient chooses to give birth, the result of the baby's birth is "absence of the left foot."
The pregnant woman and her family believed that the hospital was at fault in the diagnosis and treatment, so they sued the court.
Finally, a district court in Foshan made a verdict of the first instance in this case, ruling that the hospital should bear 20% of the compensation liability and compensate the patients for various losses totaling more than 110,000 yuan.
The trial judge of the case stated in an interview: First of all, the purpose of the patient’s pregnancy examination is to understand the growth and development of the fetus, so as to take reasonable health care measures during pregnancy or decide whether to terminate the pregnancy. The patient has the right to know and understand the condition of the fetus. Reproductive options.
Secondly, there are medical faults in hospitals that fail to fulfill the duty of care and notification to the possible absence of the fetus’s distal limbs, which objectively violates the parents’ right to know and reproductive choices before the fetus is born.
Third, the absence of the baby’s left foot is caused by its own developmental abnormalities, not directly caused by the hospital’s fault, and the hospital should not take full responsibility.
Wuhan lawyer Chen Yong believes that the obligation of the hospitals involved in the above cases is the obligation of notification, which has clear legal provisions.
The "Detailed Rules for the Implementation of the Regulations on the Management of Medical Institutions" clearly stipulates that medical institutions shall respect the right of patients to know about their condition, diagnosis, and treatment.
When performing operations, special examinations, and special treatments, necessary explanations should be made to the patient.
If it is not appropriate to explain the situation to the patient due to the implementation of protective medical measures, the patient’s family shall be notified of the relevant situation.
"In this age of tension between doctors and patients, obstetricians and gynecologists must promptly and patiently communicate with patients while serving patients. Important notifications should be kept in written records."
Frequent cases of birth defects
The verdict is quite different
In recent years, with the enhancement of citizens’ legal awareness, there have been more and more “birth defects” lawsuits in our country.
After the fetus is born with congenital disease or death, many citizens choose to appeal to the courts, requiring doctors who have made mistakes in prenatal diagnosis to bear the corresponding medical damage liability.
A reporter from the Rule of Law Daily conducted a search on the Chinese Judgment Documents website using “prenatal diagnosis” and “medical damage” as keywords. In 2018, there were 335 first-instance cases in basic courts, and 329 first-instance cases in basic courts in 2019. In 2020 There have been 83 first-instance cases in basic courts so far.
If a fetus is found to be accompanied by congenital disease or even death due to disease after birth, it will be a heavy blow to every family.
Since the current legislation has not yet clearly stipulated this, the trial practice is different.
Medical damage compensation cases caused by birth defects have been affirmed in judicial practice.
However, in the frequent birth defect cases, different judges have different judgments on the same cause.
Recently, a reporter from the "Rules of Law Daily" entered the three key words "birth defect", "birth error" and "improper birth" on the Chinese Judgment Documents website, and respectively used the cause of "medical damage liability dispute" and "medical service contract dispute" in the search results. "The cause of inquiry.
The results of the inquiry showed that less than 10% of cases were based on "medical service contract disputes"; more than 70% of cases were based on "medical damage liability disputes".
On February 4, 2015, Huang Xiaoran performed a 3D/4D color ultrasound prenatal examination at the Maternal and Child Health Hospital of Lianping County, Guangdong Province. The contents described in the inspection report showed that the fetus was not abnormal, but Huang Xiaoran gave birth on May 5 Of the baby girl has a deformed right ear and no external auditory canal.
Huang Xiaoran believes that medical staff did not pay special attention when performing four-dimensional ultrasound examinations, violated diagnostic routines, and failed to detect the fetus with right ear malformations and no external auditory canal in time, which caused Huang Xiaoran to lose the right to know and the right to choose to terminate the pregnancy of the malformed fetus. Therefore, he filed a complaint to the court for compensation, and the court filed the case with a "medical service contract dispute".
The Guangdong Nantian Judicial Appraisal Institute issued an appraisal opinion after the forensic appraisal that the auricle deformity and atresia of the external auditory meatus of the child are congenital malformations, which are related to genetic and environmental factors.
Lianping County Maternal and Child Health Hospital has insufficient notifications, but there is insufficient basis for the causal relationship between the deficiency and the deformity of the child.
Accordingly, the court of first instance rejected Huang Xiaoran's request for compensation.
Huang Xiaoran refused to accept and appealed.
On March 14, 2017, the Heyuan Intermediate People's Court rejected Huang Xiaoran's appeal.
Zhang Yunshu, a professor at the Law School of Anhui University of Finance and Economics, believes that the complexity of birth defects is not only reflected in the legal level, but also involves moral, ethical and even philosophical issues.
In addition, public policy considerations are also very important.
“Only considering the fault factor cannot make a good balance between the fetus’s parents and the doctor. Therefore, the principle of proportionality should be more adopted, and the fetus’s parents and the doctor should be held accountable in proportion.”
On August 14 this year, the Intermediate People’s Court of Guangzhou City, Guangdong Province made a first-instance judgment on a dispute over medical damage liability between Luo Yaoyang, Lin Ren and the Southern Theater Air Force Hospital.
During the trial, Luo Yaoyang and Lin Ren claimed that the hospital had not fulfilled the diagnosis and treatment obligations corresponding to the medical level at the time during the obstetric examination of Luo Yaoyang, and failed to detect the child with congenital heart disease in time, which violated Luo Yaoyang and Lin Ren’s “eugenics”. Right to choose prenatal education, "right to choose informed" and other rights.
The hospital argued that the congenital heart disease of the child involved in this case does not belong to the scope of the disease that must be detected in the prenatal screening exercised by the doctor.
The child’s congenital heart disease does not belong to the six major deformities required by the Ministry of Health.
In addition, there is no causal relationship between the congenital heart disease of the child and the medical treatment.
The court of first instance held that the hospital’s notification of the consent for prenatal ultrasound examination was unclear and inadequate, and that there was a fault in failing to perform grade III prenatal ultrasound.
However, considering that the diagnosis of large vascular malformations of the fetus involved is technically difficult by prenatal ultrasound examination, and medicine is a specialized natural science, many medical problems are still under repeated exploration and verification, far from exhausting all medical truths. Although prenatal examination is widely used in modern clinical medicine, it has certain limitations. Therefore, in combination with the expert opinion, the court of first instance determined that the relevance of the wrongful act to the infringement of the rights of Luo Yaoyang and Lin Ren was 50%.
Accordingly, the court of first instance ruled that the hospital should pay more than 60,000 yuan in compensation.
Luo Yaoyang and Lin Ren appealed against them and were rejected by the court of second instance.
Guo Zeqiang, a professor at Zhongnan University of Economics and Law, told the reporter of Rule of Law Daily that compared with doctors, fetal parents have no professional experience at all and have to rely heavily on doctors’ testing technology and hospital testing equipment.
They belong to a vulnerable group and need special protection by law.
In cases of birth defects, the birth of a child with a congenital disability brings tremendous financial pressure to the family.
Ordering the negligent hospital to make appropriate compensation to the parents of the child can ease the financial pressure of the parents, facilitate the continued treatment of the child, and conform to the spirit of fairness and justice.
Guo Zeqiang said that for most judges who lack professional medical knowledge, in order to ensure the objective and fairness of the judgment when trying cases, the state should further improve the establishment of liability for damage in prenatal diagnosis of medical damage disputes and the judgment standards for liability.
In addition, in view of the fact that there is no uniform compensation standard for birth defects in our country, legislation should be passed as soon as possible to determine the scope of compensation for birth defects and standardize the judicial discretion of judges.