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Pinellia 4.77 million compensation, "peng yu case" next?

2015年08月05日

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Pinellia 4.77 million compensation, "peng yu case" next?

 

Time: 2015-08-05

 

Source: China's traditional Chinese medicine to the author: butyl ocean for physicians prescribe the "40 grams of pinellia", on the grounds that the excessive use of traditional Chinese medicine pinellia cause the uremia patients with, will Beijing yong hall pharmaceutical chain co., LTD to court, court ruled that the defendant to assume full compensation of $4.77 million.

The doctor of traditional Chinese medicine since ancient times have "TCM is not the secret lies in the amount of." , the qing dynasty the acknowledgement Wang Qingren think "ingredients, all component is more important," visible dose the choice of the formulas to some extent determine the clinical curative effect of traditional Chinese medicine, fully explain the dosage in traditional Chinese medicine also because of the importance of the syndrome differentiation and treatment. Our current pharmacopoeia dose was originally a guidance contained dosage, so the state administrative department to the relevant provisions of the specially formulated the ultra dose.

In real life, as a result of the need of individualized treatment and considering the specific situation of the medicinal materials quality, beyond the pharmacopoeia dose of Chinese medicine of traditional Chinese medicine in the clinical widely exist, while the sky-high compensation to the traditional diagnosis and treatment of traditional Chinese medicine and Chinese medicine dose usage into the spotlight as never before. The case, has a profound influence on Chinese medicine industry, whether there will be a doctor can't cure or open only in order to get their no cure for the disease also can't save the life of "square"? Whether to exacerbate the current patients "medical"?

The expert thinks, industry of traditional Chinese medicine can be fully that the verdict in the case analysis and evaluation, negative and positive. On the one hand, to promote the legislation of traditional Chinese medicine as soon as possible, standardize the practice of medicine of traditional Chinese medicine system; Clearly established, on the other hand, in accordance with its basic principle and law of traditional Chinese medicine of traditional Chinese medicine health care evaluation system, including the evaluation and identification of medical accident treatment system, to protect the reasonable and legitimate rights and interests of Chinese medicine, healthy development, realize the major policies of the party and the country to promote the development of traditional Chinese medicine.

To recap:

"40 grams of pinellia" prescription disputes

Zhang Xi on October 25, 2011 patients with lung condition short fatigue, went to Beijing to the defendant wing hall pharmaceutical companies wangfujing clinic of traditional Chinese medicine treatment, doctors diagnosed zhang wei "liver blood deficiency, obstruction, heart kidney is not handed in", to achieve clear phlegm turbidity, eliminating phlegm to open bi, dive down nerves, nourishing blood run under the legislation, to open the 7 prescription, prescription contains 40 grams of pinellia tuber.

Zhang Xi 7 days after taking medicine, to yong hall for the second time, put forward in front of the pesticide effect is not obvious, zhang wei was diagnosed as "qi deficiency and qi stagnation, bosom condition, move is aggravating", prescribe the 3 only for its, and especially in the case records: "if doesn't work in a timely manner to the hospital seeing a doctor". Shown on the Chinese judicial documents published online in the civil judgment, taking drug withdrawal symptoms aggravated after the plaintiff Zhang Xi prosecution.

On November 15, 2011, the plaintiff Zhang Xi to Peking union medical college hospital, in complete blood analysis, kidney, heart, 3 test results show that low creatinine in patients with severe overweight, hemoglobin, serious. After seeing a doctor in hospitals, eventually diagnosed as chronic glomerulonephritis, chronic renal failure (uremia period).

Zhang Xi think, yonhap hall in knowing that the prescription of some Chinese traditional medicine toxic circumstances not fully informed on the patients, and on the premise of not to renal function tests, drug overdosage, this a series of fault behavior directly result in patients with renal damage, caused the adverse consequences of uremia. Then Zhang Xi will yong hall to court, a claim for medical treatment, lost wages, these payments, disability compensation, follow-up treatment, mental injury a total of about 6.5 million yuan.

The first-instance court entrusted Beijing and judicial authentication is the defendant to the plaintiff by the diagnosis and treatment behavior whether there is a medical fault, medical treatment fault and the plaintiff's injury consequence if there is a causal relationship and participation of appraisal, appraisal conclusion for prescriptions is a duty of care is not in place, there are some defects and shortcomings. Among them, "this decoction" for the toxic traditional Chinese medicine (TCM), and the dosage of 40 grams, its dosage within the prescribed scope, the drugs used in direct cause renal damage situation according to the current research results and related information according to owe good, not sure. But the burden of aggravating renal damage cannot be ruled out, there are some defects should be considered. About the causality between medical behavior and Zhang Xi injury consequence participation, by the surveyor Zhang Xi currently diagnosed as "chronic kidney disease and uremia period" (kidney failure).

Court of first instance in order that the defendant to assume full responsibility for the plaintiff uremia consequences, sentence the defendant wing hall to compensate the plaintiff Zhang Xi medical bills and lost wages, twenty years disability compensation and subsequent treatment, these payments of seven hundred and thirty thousand a total of about $three million to $seven hundred and thirty thousand, the defendant wing hall leads to appeal, the second instance court upheld the conviction.

Clinical doctor:

Chinese medicine high-dose medication has universality, identification of a departure from the traditional Chinese medicine pharmacology

The use of "pinellia compliance, I think should be on the basis of pharmacopoeia, Chinese medicine yinpian regulate procedures and the patient's condition to determine. The court for diagnosis and treatment behavior compliance judgment, should be the main reference for professional appraisal conclusion, field most experts recognized standard of diagnosis and treatment of traditional Chinese medicine and diagnosis standard and other factors." One expert thinks, Chinese academy of social sciences in the case of professional appraisal and review process, did not ask for traditional Chinese medicine experts and management department of traditional Chinese medicine in the field of expertise, is a possible defects.

It is understood that this decoction sexual flavour, temperature, toxic, spleen, stomach, lung. With dry wet phlegm, inverse anti-nausea and new fights, the effect of external use acetanilide detumescence. Clinical used in wet phlegm more cold, cough and gasp the phlegm, phlegm faint headache, dizziness, vomiting, nausea, that never sleeps XiongGe bilge full, carbuncle swollen needless, mei qi, scrofula phlegm. The pharmacopoeia of the People's Republic of China "recommended dose for 3 ~ 9 grams. In the eastern han dynasty by the physician zhang zhongjing recorded in treatise on febrile disease "this decoction soup" and "synopsis of the" fructus scallions white pinellia decoction ", the original party of pinellia doses are half a litre, modern dose equivalent of more than 100 grams.

Clinical TCM doctor qu ji shui tan hospital director of the Beijing university the fourth victory that zhang wei doctors prescribe prescription for wing hall, according to the relevant provisions of the "Beijing Chinese medicine yinpian dispensing regulations prescribe the Beijing city written as" pinellia ", should be "method of this decoction", is processed after the processing of pinellia, itself, non-toxic (pharmacopoeia 2010 edition).

Chinese scholars think, otherwise Zhang Xi actual is take after 16 kinds of Chinese herbal medicine formula decoction liquid form, not directly using pinellia tuber slices, and the identification of no should detect the plaintiff Zhang Xi actual them.42 I take toxicity, otherwise can't determine whether used in liquid form of pinellia tuber are resulted in the condition of Zhang Xi evolution, and the defendant zhang wei yong hall physicians based on the viewpoints and subtract from synopsis of prescriptions of 40 grams of pinellia dosage, French medicine is looking at the time of the disease, play a role of party the medicine in fujin made to cure together. Recommended dose not because more than pharmacopoeia that it must be the direct cause of kidney disease.

And the plaintiff Zhang Xi 20 days after taking the drug in chronic glomerulonephritis, chronic renal failure, and the course of the disease is characterized by a long, long period of asymptomatic urinary anomalies, and cannot be determined Zhang Xi is caused by taking medicinal broth of traditional Chinese medicines contain pinellia, its evaluation is only think worse kidney damage, the burden of "cannot be ruled out.

By the state administration of traditional Chinese medicine is reported that the Chinese traditional medicine prescription format and writing standards "(7) of article 9 of the regulation:" Chinese medicine yinpian usage and dosage shall conform to the "pharmacopoeia of the People's Republic of China" regulation, without compatibility taboo, have compatibility taboo and ultra dose when using, should be above the drug again signature."

Shougang Beijing university hospital regions retirement Sun Zheng of traditional Chinese medicine and in this case evidence before the court, he thinks that the law of the People's Republic of China pharmacopoeia notice stipulated in article 27: "[usage and dosage 】 yinpian, unless otherwise specified, fry, take orally with legal system refers to the water consumption refers to the commonly used dose a day, adults can according to need to take into consideration the increase or decrease when necessary". Sun Zheng and said, in May, according to need to increase dosage applied appropriately, traditional Chinese medicine (TCM) high doses of drugs is a common phenomenon in traditional Chinese medicine (TCM) clinical application.

Legal experts:

The defendant has fault, but "all" legal responsibility is still in doubt

Chinese academy of social sciences institute of law a scholars believe that the defendant wing hall pharmaceutical companies have a certain degree of wangfujing TCM clinic fault.

The plaintiff complained of chest condition, muscle weakness, but at the same time asked if kidney health. The defendant according to its, complained of "liver blood deficiency, obstruction, heart kidney is not handed in" diagnosis. According to the treatment of traditional Chinese medicine theory, the cardiovascular system damage can lead to chronic renal failure, the defendants have apparently noticed that kidney problems, but according to "first help, while preserving renal" whole regulation, system management concept of Chinese traditional treatment, prescribe the comply with the principle of treatment of traditional Chinese medicine prescription, like when all things. But, the defendant didn't diagnosis, fault is for defects. Of course, this also for the later can't be removed from the liability left a hidden danger.

As for prescription writing exist without specification, representation appraisal Suggestions are as follows: "on the basis of the existing appraisal data did not see writing prescriptions on examination the patient outpatient medical records, including clinical time, don't, TCM four diagnosis, physical examination and necessary auxiliary examinations, diagnosis, treatment, disposal, diagnosis, medical record collection is too simple, there is insufficient. Medication should suggest that includes relevant auxiliary examination, in order to further diagnosis or exclude related diseases, don't think the prescriptions have a duty of care in place, there are some defects and shortcomings."

Through the expert opinion, the prescriptions of just a duty of care deficiencies of defects. Referred to the defendant is not fault, but with the plaintiff's injury consequence there is no direct relationship. Writing is not compliance violation of patients' right to know only, but will not damage the health of the patient. Beijing and judicial authentication will reply issued by court said "it has certain causal relationship between zhang X damage consequences and cannot be ruled out, I have the evaluation opinions tend to have certain causality", that is to say, professional medical treatment fault identification agencies cannot judge the drugs led to renal damage in patients with causality.

The scholars said, in terms of medical tort, tort liability in need to meet at the same time: first, the damage to patients, damage factor is a clinical activities; Second, medical institutions and medical personnel in the process of implementation of the diagnosis and treatment behavior at fault; Third, medical institutions and medical personnel behavior and the diagnosis and treatment in patients with damage to some extent between the results of the cause and effect.

For judicial authentication opinions, don't think because the plaintiff Zhang Xi do kidney disease inspection in advance, so although there is a causality between medical behavior and damage result, however, "participation specific causal relationship is unable to assess". And the plaintiff Zhang Xiyou fault, so, yonhap hall shall bear legal responsibility.

However, as for the court to judge the defendant "all" legal responsibility, there are three places are still in doubt:

First, the judicial authentication institutions during the litigation reply and expert witnesses to appear in court when questioned, a causal connection between medical behavior and damage consequence, but was unable to confirm the participation, and participation is directly related to liability ratio. Participation in judicial authentication cannot confirm is the premise of the court to the identified results of 100% participation, also need to refer to other direct evidence, proof power and determine.

The second, more than a dozen Chinese medicine yinpian compound in the liquid form is composed of pinellia, but in a short period of time can cause kidney damage, should need identification. But expert opinion does not seem to be on the appraisal, the doubt.

Third, the plaintiff have to other institutions of medical treatment of kidney disease? Before the diagnosis and treatment of the defendant, the plaintiff kidney health? Whether the defendant is the only the infringer? It's a matter affecting the responsibility size also.

"Integrated the above three aspects, I think it is difficult to eliminate the liability ratio of suspects. In general, that power and responsibility must be integrated all the evidence, that the defendant at fault and its medical behavior and damage consequence there is a direct causal relationship, diagnosis and treatment behavior can't belong to the main factors and common factors, the secondary factors, indirect, or inducing factors of any kind of situation." The scholar said.

Therefore, he suggested, to reduce the risk of the practice of TCM personnel, shall be carried out according to the condition of patients complained of comprehensive inspection as soon as possible.

Scholars of traditional Chinese medicine:

Save the legal risks of TCM diagnosis and treatment, or a doctor can't cure

The state of the research group of Chinese medicine of the Chinese academy of social sciences scholars believe that the current legal system and in areas of traditional Chinese medicine industry development have an adverse. Chinese and western medicine are two different system, diagnosis and treatment methods exist great differences, but the current health medical disciplines and laws are based on western medicine diagnosis and treatment principle for the standard of western medicine. Because the two sets of diagnosis and treatment patterns in the diagnosis of concept, diagnosis record method, treatment method and process and so on can't butt, which makes the traditional Chinese medicine diagnosis and treatment behavior is legal risk. In the event of dispute, the description of the TCM diagnosis way hard to recognized, or will encourage "medical alarm" events or not as the behavior of the doctor.

"Existing rules of evidence and medical judicial appraisal system for the doctor of traditional Chinese medicine industry have some legal risk." Other scholars believe that the Chinese academy of social sciences in general, the prescriptions have proved that no causal relationship between the results of the medical behavior and damage the burden of proof, but the doctor of traditional Chinese medicine theory is difficult to in accordance with the standards of western medical theory put forward counterevidence, not rebut or disproving cannot make study in western discourse and public opinion environment, inter alia, the judge of the life, is inevitable.

And judicial authentication must confirm prescriptions whether there is a fault, there is causality between medical behavior and damage result, the accuracy of experimental and concepts of western medicine, treatment, theory of certainty, a conclusion can be descriptive is better than the traditional Chinese medicine, especially the western medicine also has a responsibility to patients and their families self-protection system; In the case of the identification process, the rules could not be ruled out the possibility of western medicine experts to identify the traditional Chinese medicine diagnosis and treatment behavior, please, and then can't rule out the possibility of deviation even identified errors. These institutional imperfect determines the treatment of traditional Chinese medicine behavior exist great risk of legal liability.

"This sentence if not influenced by social supervision, questioning, everywhere will likely produce linkage effect demonstration, so, the doctor still dare to see patients with cure? Chinese medicine as the main body part of medicine health system with Chinese characteristics, the occurrence of this case to our medical environment is a lot of damage and blow." A Chinese scholars worry that the compensation to the judgment of social influence will hinder the development of Chinese medicine, deteriorating reputation of Chinese medicine and the social public opinion environment, also may thus make practitioners in medical disputes that may occur at any time, to the viewpoints of traditional Chinese medicine by the introduction of inheriting, developing and protecting will also have a significant adverse effect. The doctor can't cure will also result in patients with no significant curative effect, increase patients' hospital "and" expensive ".

Inspiration:

Legal measures to guarantee practicing medicine in TCM

", now think that the drug is a chemical with western standards of traditional Chinese medicine, so the fleece-flower root can only use 3 g, astragalus can only use 60 grams. Take the root of remembranous milk vetch, hundreds of years ago doctors Wang Qingren fill with Yang five soup also saved a lot of people, he is using astragalus 120 g as the main medicine. And now is restricted to 60 grams." National physician master tie-tao deng thought, on the premise of implementing constitution spirit, review of traditional Chinese medicine experts must be studied traditional Chinese medicine. Must carry on the policy implementation situation of research of traditional Chinese medicine, Chinese medicine policy is not only to protect traditional Chinese medicine, more to the development of traditional Chinese medicine.

Other scholars of traditional Chinese medicine thinks, should promote effective TCM legislation as soon as possible. Lesson from the practice of Chinese medicine shows that development of traditional Chinese medicine face urgency, protective measures need to be validity, support and promote measures shall be operable. It is of practical significance for the set of measures to speed up is advantageous to the health of Chinese medicine, autonomous legislation and sustainable survival and development of traditional Chinese medicine.

In addition, should make clear the doctor of traditional Chinese medicine health care evaluation system, including the evaluation and identification of medical accident treatment. It is necessary to perfect the national pharmacopoeia, the organization leading experts on the safety of Chinese medicine yinpian, effectiveness and use methods to do comprehensive evaluation and revision, and the specific conditions of use, using standard, clinical adjust method and procedures.

Links:

"Gentian purging liver pills" event

In 2003, the media reports, including a writer, an associate professor at tsinghua university academy of fine arts, a dozen patients, Beijing chaoyang hospital urology department after renal biopsy, was diagnosed with aristolochic acid renal damage, most of these people, claimed that had taken gentian purging liver pills or long or short history of medicine. Reported, taking "gentian purging liver pills" of the leading causes of uremia is the compound preparations containing blindly called "also" in traditional Chinese medicine (TCM) can cause kidney damage.

The plaintiff to damages of Beijing chongwen district people's court litigation, request compensation for medical expenses 89117.21 yuan tong ren tang. Court made the first-instance judgment that cannot prove that the plaintiff was ate tongrentang gentian purging liver pills to illness, the plaintiff lost.