Plaintiff 1 and 9 others (Attorney Lee principal-hoon et al., Counsel for the plaintiff-appellant)

Medical Corporations, the Korea Medical Foundation and 3 others (Attorneys Cho Jong-tae et al., Counsel for the defendant-appellant)

November 10, 2005

1. The defendants jointly and severally pay to the plaintiffs the amount of money stated in the annexed sheet "the amount of money" in the annexed sheet, and 5% per annum from May 1, 2004 to December 1, 2005, and 20% per annum from the next day to the day of full payment.

2. The plaintiffs' remaining claims against the defendants are dismissed.

3. 35% of the costs of lawsuit shall be borne by the Plaintiffs, and the remainder by the Defendants.

4. Paragraph 1 can be provisionally executed.

The defendants jointly and severally pay to the plaintiffs the amount of money stated in the "amount of claim" in the attached Form No. 1, 2004 to the service date of a copy of the application for modification of the claim of this case from May 1, 2004 to the service date of a copy of the application for modification of the claim of this case, and 20% per annum from the next day to the day of complete payment.

1. Basic facts

The following facts are not disputed between the parties, or there is no dispute between the parties, or there is no other evidence to reverse the evidence of Gap evidence 1 through 3 (including each number), Eul evidence 5 through 12 (including each number), Eul evidence 1 through 8 (including each number), Eul evidence 1, Eul evidence 6-1 through 7, Eul evidence 16-1 through 7, Eul evidence 20, 21, Eul evidence 26, Eul evidence 26, Eul evidence 26, each part of Eul evidence 7, witness non-party 4, and 5, each of the video tape verification results of this court's examination of plaintiffs 1 and 8, and there is no other evidence to reverse it.

A. Status of the parties

(1) The Defendant Medical Corporation, Korea Medical Foundation (hereinafter “Defendant Medical Foundation”) is a legal entity that employs medical professionals in Jeju Interconnection and establishes and operates Korea Medical Center, which is a general medical institution, and Defendant 2 is a doctor who administers the stem cell transplantation surgery of this case as the head of Korea Medical Center.

(2) Defendant hystop item (hereinafter “Defendant Company”) is a company established for the purpose of organization suitability testing, precision technology research and development business, and business of research and development of technology for culture and technology for culture and technology. The Defendant Company is a cord blood storage institution, and the said cord blood storage bank has been provided with 60,000 cord blood granted free of charge for the purpose of family-storage-type cord blood storage-type, 7,000 dogs and research and development. The Defendant Company has a special technology for raising stem cells separately from cord blood, and provides stem cells in clinical trials using stem cells. Defendant 4 is the representative director of the Defendant Company.

(3) While Plaintiff 6 was diagnosed with liver cryposis (a disease caused by nephal disorder in spine and caused symptoms such as crypology and urine disorder), Plaintiff 1, 2, 3, 4, 5, 7, and Nonparty 1 (hereinafter “Plaintiff 1, etc.”) were diagnosed with liver cryposis (liver cryposis), the patients who received the stem cell transplantation surgery with the stem cells supplied by the Defendant Company are patients who received the stem cell transplantation surgery. Meanwhile, the progress of crypology confirmed and determined by Hana Hospital around the stem cell transplantation surgery of this case is as follows.

Defendant 6’s name in the name of the tag contained in the main text does not occur. From May 2002 to March 2003, 2003, Defendant 6 received treatment from another hospital, such as stroke and stoptoptop, etc. In addition, on August 15, 2003, he received self-end blood stem cell transplantation, but did not obtain the effect.

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(4) Nonparty 1 died on May 28, 2004 due to the aggravation of the perjury. Plaintiff 8 is Nonparty 1’s wife, Plaintiff 9, and Plaintiff 10 are children between Nonparty 1 and Plaintiff 8.

(b) Announcement of the results of stem cell transplantation surgery for the liver patients of the oriental hospital;

(1) On September 3, 2003, Defendant 2 performed an operation to injecting and transplant the cord blood stem cells supplied by each Defendant company to Nonparty 2 (the age of 45 at the time, and Nonparty 3 (the age of 58 at the time, South, and the age of 58) of the same symptoms on October 8, 2003 (the age of 58) who is the patient suffering from liverlosis, into the part of the patient's disease in the part of the patient's body (the method of such operation by Defendant 2; hereinafter referred to as "the stem cell transplantation operation").

(2) On November 4, 2003, Defendant 2 announced that the process of the above operation was observed and opened a joint press conference with Defendant 4 on November 4, 2003, and that “the result of the implementation of the cord blood stem cell transplantation surgery with respect to the two livers patients was significantly favorable as a result of the implementation of the operation.”

(3) The defendant Han Medical Foundation published a letter on the homepage of Hana Hospital stating that "the technologies to treat liver cirrosis with stem cells separated from umbil blood have succeeded in the world's first clinical trials in Korea," and that "the above non-party 2 and the non-party 3 (non-party 2 included anonymous angles) have significantly improved the function of liver cirrosis as a result of various tests on administering patients, and in particular, although the non-party 2 was judged to liver cirrhosis, he completely cured the stem cell's efficacy at a rapid speed so that it can be recovered at the rapid speed," and that "the stem cell's efficacy has been proved by this success," while indicating the contact number (the telephone number and facsimile number) of "non-party 4 nurse" on the side of the Seoul Maa Hospital Bank's homepage, the defendant company also introduced the "the results of the first cirrative treatment of cirrosis cirrosis by applying stem cells extracted from umbil blood."

(4) Around November 4, 2004, this article was widely reported with the content of “the clinical tests of technology treating liveration by transplanting stem cells from umbilum cord blood have successfully succeeded” through various media, such as newspapers and broadcasting.

C. The details of the stem cell transplantation surgery for the plaintiff et al.

(1) The Plaintiff 1 et al. had contact with the implementation and clinical results of the liver stem cell transplantation surgery and the clinical results of the Mara Hospital through the contents of newspapers, broadcasting, posting on the Internet homepage, etc., and sought opinions about the possibility of surgery and treatment effects.

(2) The Plaintiff 1 et al., who met the hospital as follows, decided to undergo the procedure after consultation with Defendant 2 on the stem cell transplantation surgery, and discharged the stem cell transplantation surgery after being hospitalized.

Defendant 1 November 27, 2003 - November 28, 2003 - January 20, 2003, 204 - January 20, 2004 - Defendant 12, 204, 20. 3. 4. 12. 1, 203, 203, 20. 1, 204, 20. 1, 204, 20. 1, 204, 20. 1, 204, 20. 3. 1, 205, 204, 2. 1, 201, 3. 4. 1, 200, 204 - Defendant 1, 3, 201, 204 - 1, 206. 3, 2, 2004

(3) The stem cell used in the above alcohol was purchased by the plaintiff 1 et al. in direct contact with the defendant company's employees upon introduction. In other words, the plaintiff 2 et al. conducted genetic testing, etc. for the patient suffering from the defendant 2 and delivered the result thereof to the defendant company. The defendant company confirmed that the cord blood stored in the defendant company was suitable for transplantation and notified the patient through Hana Hospital. After that, if the plaintiff 1 et al. accepted that the patient et al. were to undergo an operation, the stem cell was directly concluded with the plaintiff 1 et al. to supply the stem cell and received the payment of KRW 30 million to KRW 33,00,000 to KRW 333,00.

D. The process of performing the stem cell transplantation surgery against the plaintiff 6

(1) On November 2003, Plaintiff 6 also meta Hospital and the Defendant Company’s report on stem cell transplantation surgery through broadcasting and newspapers, etc., and visited the Defendant Company to provide consultation around December 2003, and requested the Defendant 4 to provide consultation. The Plaintiff 6 requested genetic testing, etc. to the Defendant Company, and the Defendant Company confirmed that there was an organization suitable for transplantation. The said Plaintiff concluded the stem cell transplantation surgery with the Defendant Company first on December 30, 2003.

(2) After that, on February 2, 2004, Plaintiff 6, as the introduction of Defendant 4, applied for a stem cell transplantation surgery to Defendant 2. Accordingly, Defendant 2 gave advice to Defendant 2 to the effect that it did not have any clinical results with respect to a diverosis, and that Defendant 6 was already in the process of purchase and distribution of stem cells, and the Plaintiff 6 requested a strong procedure. Upon Defendant 4’s request to Defendant 4, the above Defendant recommended Defendant 2 to conduct the procedure with respect to Plaintiff 6 on several occasions.

(3) Ultimately, Defendant 2 decided to implement a stem cell transplantation surgery against Plaintiff 6, and the said Plaintiff was hospitalized on February 26, 2004 and received a transplant surgery on March 10, 2004, and discharged the Plaintiff on March 12, 2004.

E. After the operation, Plaintiff 1 and Plaintiff 6’s pre-sales service

(1) After the stem cell transplantation surgery, it was not observed that Plaintiff 1 and Plaintiff 6 had improved the existing illness or that the progress rate of the disease was alleviated on the ground of the above surgery. It was determined that the stem cell injected at the time of the above surgery was not divided into a normal tissue cell on the part of the disease.

(2) On the other hand, there is no circumstance to deem that the existing illness has deteriorated or any side effect has occurred due to the above surgery by Plaintiff 1, etc. and Plaintiff 6.

F. Criminal punishment against Defendant 4

(1) From March 2004, the Ministry of Health and Welfare and the Korea Food and Drug Administration launched the so-called “fact-finding survey on cell therapy,” and filed a complaint with the prosecution on the grounds that they conducted clinical trials using cell therapy without approval from the Commissioner of the Korea Food and Drug Administration.

(2) After that, Defendant 4 was prosecuted as a violation of the Pharmaceutical Affairs Act (Article 75(1)1 and Article 26-4(1) of the Pharmaceutical Affairs Act) on the criminal facts that Defendant 2 performed clinical trials by having 53 patients, including Plaintiff 1, in the Han Hospital without obtaining approval from the Commissioner of the Korea Food and Drug Administration, for a total of 53 patients including Plaintiff 1, Defendant 4 was convicted of having been sentenced to a suspended sentence of a fine not exceeding 2 million won in the court on January 13, 2005. The above judgment became final and conclusive as the appeal period.

2. Occurrence of liability for damages;

A. Grounds for liability

(1) The premise for judgment: As to the violation of the Pharmaceutical Affairs Act

(A) Provisions on marketing approval of drugs

【Pharmaceutical Affairs Act】

Article 2 (Definitions)

(4) For the purpose of this Act, the term "pharmaceuticals" means articles falling under any of the following subparagraphs:

1. Articles listed in the Korean Pharmacopoeia other than non-pharmaceutical drugs;

2. Articles used for the purpose of diagnosis, medical treatment, mitigation, treatment or prevention of diseases of human beings or animals, other than appliances, machinery or equipment;

3. Articles, other than appliances, machinery or equipment, used for the purpose of exerting pharmacological effect upon the structure or functions of human beings or animals.

Article 26 (License, etc. for Manufacturing Industry)

(1) Any person who intends to engage in the business of manufacturing medicines shall obtain permission from the Commissioner of the Korea Food and Drug Administration under the conditions as prescribed by the Ordinance of the Ministry of Health and Welfare, and any person who intends to engage in the business of manufacturing quasi-drugs shall file a report with the Commissioner of the Korea Food and Drug Administration, and shall obtain permission for items or file a report on items by item (hereinafter referred to as "items and medical appliances" in Article 6 (1) of the Addenda to the Medical Devices Act (Act No. 6909 of May 29, 2003) (the

(6) In cases of paragraph (1), where items to be permitted are new drugs or drugs designated by the Commissioner of the Korea Food and Drug Administration, test results, relevant documents and other necessary data concerning safety and effectiveness shall be submitted, as prescribed by Ordinance of the Ministry of Health and Welfare

(8) Matters necessary for the objects, standards, conditions, management, etc. of permission in granting permission for the manufacturing business and items of medicines, etc. under paragraph (1) shall be prescribed by the Ordinance of the Ministry of Health and Welfare.

【Enforcement Rule of Pharmaceutical Affairs Act】

Article 21 (Those Subject to Restriction on Permission for Manufacturing or Importing Drugs, etc.)

(1) Medicines or quasi-drugs (hereinafter referred to as "drugs, etc.") for which permission for manufacture or import is not granted pursuant to Article 26 (8) or 34 (5) of the Act shall be as follows:

10. Items recognized by the Commissioner of the Korea Food and Drug Administration as necessary for the public interest or international agreements, such as blood products, gene therapy, cell therapy products, cell culture therapy products, etc.: Provided, That any of the following cases shall be excluded:

(c) A gene therapy, cell therapy, cell cultivation medicine, etc. separately determined by the Commissioner of the Korea Food and Drug Administration;

Article 21-2 (Those Excluded from Product Licenses of Drugs, etc.)

Medicines, etc. falling under any of the following subparagraphs shall be excluded from those subject to the permission for manufacture and marketing under Article 26 (1) of the Act:

1. Drugs, etc. for clinical trials for which approval for a clinical demonstration plan has been obtained in accordance with Article 28 (1);

Article 27 (Examination of Safety and Effectiveness)

(1) Any person who intends to obtain permission for items or permission for modification of items of drugs, etc., or to report on items or report on modification of items pursuant to Article 23 (1), 26 (1), (6) and (8) or 34 (1), (4) and (5) of the Act shall undergo an examination of safety and effectiveness of the relevant items after meeting the following materials. In such cases, matters necessary for the management of non-clinical trials conducted to prepare detailed regulations on items subject to examination, methods of preparing data, requirements for each data, scope of exemption and criteria for examination, and data on toxicity and pharmacological action, etc. (hereinafter referred to as "non-clinical trials"), shall be determined by the Commissioner of the Korea Food and Drug Administration:

【Rules on Permission and Examination of Biological Chemicals, etc., No. 2003-26 of the notification of the Korea Food and Drug Administration on May 23, 2003】

Article 2 (Definitions)

The definitions of terms used in this Regulation shall be as follows:

13. The term "cell therapy" means a drug used for the purpose of treatment, diagnosis and prevention through a series of acts, such as propagating, screening, or otherwise changing the biological characteristics of a cell in the body of a living person in order to restore the functions of a cell and tissue;

Article 19 (Objects of Examination)

(1) The examination of safety and effectiveness under this Act shall be conducted with respect to biological preparations, re-cooperatives, medicines to be permitted to manufacture or import under the Pharmaceutical Affairs Act, cell culture products, cell therapy products, gene therapy products, etc.: Provided, That the same shall not apply to medicines that have already been permitted and the kinds, specifications and quantity of active ingredients (in cases of liquid agents, concentration) are the same as those of the final source, and biological preparations, re-cooperatives, and cell culture products, the production cost of which is the same as those of the final source.

Article 20 (Scope of Material to be Submitted)

(1) The kinds of materials to be submitted for the examination of safety and effectiveness shall be as follows, and the scope of materials to be submitted according to the characteristics of each drug shall be as specified in attached Tables 2 through 4:

(hereinafter referred to as each subparagraph omitted. The data number referred to in attached Table 3 below refers to the data to be submitted under the subparagraphs of this Article.

[Attachment 3]

Data to be submitted from a cell therapy;

본문내 포함된 표 구 분 ＼ 자료번호 1 2 3 4 5 6 7 8 가 나 다 라 마 바 가 나 다 가 나 Ⅰ. 자기유래세포치료제 ？ ？ ？ ？ ？ ？ ？ ？ ？ ？ ？ ？ ？ ？ ？ ？ 1. 세포를 증식시킨 경우 ○ ○ ○ △ △ △ △ △ △ △ △ △ ○ × △ △ 2. 세포를 조작하여 형질을 변화시킨 경우 ○ ○ ○ ○ ○ △ △ ○ △ ○ △ △ ○ × ○ △ Ⅱ. 동종유래세포치료제 ？ ？ ？ ？ ？ ？ ？ ？ ？ ？ ？ ？ ？ ？ ？ ？ 1. 세포를 증식시킨 경우 ○ ○ ○ ○ ○ △ △ ○ ○ ○ △ △ ○ × ○ △ 2. 세포를 조작하여 형질을 변화시킨 경우 ○ ○ ○ ○ ○ △ △ ○ ○ ○ △ △ ○ × ○ △ Ⅲ. 이종세포치료제 ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ × ○ ○ Ⅳ. 기타 ○ ○ ○ △ △ △ △ △ △ ○ △ △ ○ × ○ △

○: to submit data

△△△: It may be exempted from taxation because it is not intended or impossible to submit them based on individual medicines.

】 Materials exempted

Each State: In the case of a like-class cell therapy that falls under Class II, the following materials shall be attached thereto:

(i) the characteristics of the cell donor;

(ii)the biological characteristics of cells;

(iii) the medical history of a cell donor and the items to be examined for infection with pathogenic microorganisms;

(iv) the method and quantity of recovery of cells from a donor of a cell;

(b) Regulations on clinical trials

【Pharmaceutical Affairs Act】

Article 26-4 (Approval, etc. of Clinical Test Plans)

(1) Any person who intends to conduct clinical trials of drugs, etc. shall prepare a clinical trial plan and obtain approval therefor from the Commissioner of the Korea Food and Drug Administration. The same shall apply to any modification of the clinical trial plan (the same shall apply to any modification of the plan).

(4) Any person who intends to conduct a clinical test referred to in paragraph (1) shall explain details of the clinical test, details of and procedures, etc. for compensation for any health damage that may be inflicted on a subject during the clinical test to the subject and obtain consent of the subject.

(7) Matters to be included in the clinical demonstration plan referred to in paragraphs (1) and (4) and necessary matters concerning the details, timing, methods, standards for conducting clinical trials, etc. shall be prescribed by Ordinance of the Ministry of Health and Welfare.

【Enforcement Rule of Pharmaceutical Affairs Act】

Article 28 (Approval, etc. of Clinical Test Plans)

(1) Any person who intends to obtain approval of a clinical test plan or approval of a modification of a clinical test plan which has been approved pursuant to Article 26-4 (7) of the Act shall submit to the Commissioner of the Korea Food and Drug Administration an application for approval of a clinical test plan under attached Form 18 or attached Form 19, along with the following documents and materials (hereinafter

【Guidelines for Approval of Drug Clinical Test Plan No. 2002 - 65 of Notification of the Korea Food and Drug Administration on December 3, 2002】

Article 1 (Purpose)

The purpose of this Regulation is to prescribe the detailed matters concerning the guidelines, scope, requirements, scope of exemption, procedures and standards for approval for clinical testing plans for drugs under Article 26-4 (7) of the Pharmaceutical Affairs Act, Articles 28 and 29 of the Enforcement Rule of the same Act, and Article 32 (1) 4 of the Enforcement Rule of the Act on the Control of Narcotics, Etc. in order to ensure appropriateness in the affairs of approval for clinical testing plans for drugs.

Article 12 (Use of Drugs, etc. for Clinical Trials in Emergency Situation)

(1) Notwithstanding the provisions of Article 11, where a doctor intends to use medicines for clinical trials or medicines not licensed in the market under the responsibility of a doctor after obtaining consent from the patient concerned, based on a judgment of an emergency which seriously or imminently threatens life, he/she shall submit the following data and obtain approval for use from the Commissioner of the Korea Food

(C) Determination as to whether the Pharmaceutical Affairs Act violates the Pharmaceutical Affairs Act

According to the above facts and their adopted evidence, the stem cells used by Plaintiff 1, etc. and Plaintiff 6 can be seen as separating stem cells from cord blood stored at low temperature in the Seoul Baum Bank operated by the Defendant Company by using technical power of the Defendant Company, and spreading and cultivating stem cells outside the body for the purpose of treating diseases, such as stem cell transplantation surgery.

Considering the above cord blood storage relationship, the process of gathering, proliferating, and cultivating stem cells, the treatment purpose pursued by such a series of processes, the above Pharmaceutical Affairs Act and its Enforcement Rules, the purport, contents, and mutual relations between the publicly notified provisions of the Korea Food and Drug Administration, the above stem cell used is an operation that changes in the original biological or functional characteristics of cells or tissues through cell proliferation, and it becomes an operation that changes in the original biological or functional characteristics related thereto, and the above stem cell used constitutes a "cell cell therapy" as provided by attached Table 3 of Article 20 of the "Rules on Permission and Examination of Biological Products, etc." as provided by the notification of the Korea Food and Drug Administration under Article 2 subparagraph 13 of the Pharmaceutical Affairs Act and the Enforcement Rule thereof, which is delegated by the Korea Food and Drug Administration, and thus, constitutes a "pharmaceutical" as provided by Article 2 of the Pharmaceutical Affairs Act without obtaining approval from the Commissioner of the Korea Food and Drug Administration. Furthermore, if the above stem cell falls under the above drug, it does not constitute a legitimate operation or stem cell surgery as provided by the Korea Food and Drug Act.

Therefore, without the approval of the clinical plan of the Commissioner of the Korea Food and Drug Administration, practices using stem cells cultivated and reproduced as cell therapy violate the Pharmaceutical Affairs Act.

(D) Determination on the assertion by Defendant Company and Defendant 4

The above Defendants asserted that Article 21 (1) 10 (c) of the Enforcement Rule of the Pharmaceutical Affairs Act, which provides the basis for interpreting that cell therapy constitutes a medicine under the Pharmaceutical Affairs Act, and Article 21 (1) 10 (c) of the Regulations on the Permission and Examination of Biological Products, etc., notified by the Korea Food and Drug Administration, are not grounds for delegation under the Pharmaceutical Affairs Act, and the contents of the above notification are unclear. Thus, it is unreasonable to interpret that stem cells provided by the above Defendants constitute a medicine under the Pharmaceutical Affairs Act, and that Article 75 (1) 1 of the Pharmaceutical Affairs Act

In light of the legislative intent of the concept of cell therapy, it can be easily known that the definition of cell therapy is a matter delegated to the notification of the Korea Food and Drug Administration pursuant to Article 26(8) of the Pharmaceutical Affairs Act, Article 21(1)10 of the Enforcement Rule of the Pharmaceutical Affairs Act, Article 2 of the Pharmaceutical Affairs Act, Article 21 of the Act on the Definition of Drugs, Article 26-4 of the Act on the Product License for Manufacture of Medicines, and Article 26-4 of the same Act on the Clinical Test Using Drugs (Article 26-3 of the same Act on the premise that it falls under a drug). In light of the legislative intent, it is difficult to say that cell therapy under the Pharmaceutical Affairs Act refers to the system that causes any operation through the process processing of cells or organizations for medical purposes, such as the treatment, diagnosis, prevention, etc. of diseases. Accordingly, since this Act delegates the concept of cell therapy to the Korea Food and Drug Administration through detailed and technical matters meeting the current medical standards and the notification of the Korea Food and Drug Administration.

The above defendants' arguments are not accepted.

(2) Defendants’ liability for damages

(A) The fact that the Defendants supplied a stem cell to the Plaintiffs and performed a transplant surgery

The following facts may be acknowledged by comprehensively taking into account the aforementioned facts and the purpose of the entire pleadings.

① As seen earlier, Plaintiff 1, etc., etc. had been in progress to a considerable extent, and the life expectancy was predicted from 6 months to 5 years, and at the present medical level there was no particular treatment method except a simple surgery.

② The Plaintiff 1 et al. meta Hospital and decided whether to conduct the surgery after consultation with Defendant 2. The Plaintiff et al. sought special attention to the treatment effect of the stem cell transplantation surgery introduced as a new treatment method for the liveration, and sought advice on the treatment effect from Nonparty 4 or Defendant 2, who is the nurse in exclusive charge of stem cell transplantation.

③ Defendant 2 or Nonparty 4 may give the Plaintiff 1, etc. the blood transfusions, chromosomes, and hemical shock shocks due to the side effects of the surgery. Defendant 2 or Nonparty 4 notified the Plaintiff 1, etc. that it could not present statistics as to whether stem cells are born on the part of the disease and whether to treat the stem cell, and received the same written consent prior to the surgery.

④ However, since two patients, who are known as successful in clinical treatment through the homepage of the Han Hospital or the relevant news report, have undergone the procedure on September 10, 2003 or around October, 2003, the day before the time when the plaintiff 1 et al. al. left home, there was a change in the number of injury or disease caused by simple liver functions, but it is difficult to view it as a scientific meaningful clinical result due to the continuous tracking and observation after the operation (the non-party 2, who had undergone the first procedure, died after livering liver, and eventually died around May 2004). In addition, even though there was a recent medical research on the treatment of scam disease using cord blood cells, even if there was an industrial accident, there was no systematic research conducted by the defendant 2 as to the medical situation.

⑤ Accordingly, Defendant 2 did not clearly explain such circumstances to Plaintiff 1, etc., even though it was difficult to see that there was clinical cases where the treatment effect was confirmed, not merely to present statistics on the treatment effect at the time.

6) In addition, the non-party 2, who was administered at the Han Hospital, did not actively inform the patients who read and inquire about the notices, etc. on the homepage of the Hando Hospital of the fact, and did not take measures to delete such notices.

7) In addition, as a treatment method of liveration, a simple surgery was set up for a considerable period of time and became an academicly recognized medical practice. Defendant 2 explained the stem cell transplantation surgery, which is not verified to Plaintiff 1, etc., compared with a simple surgery on its operation method, expenses, side effects, treatment effects, etc., and even emphasized the advantages of the stem cell transplantation surgery.

④ Upon introduction by Defendant 2, Plaintiff 1, etc. purchased stem cells from the Defendant Company, and they asked Nonparty 5 to Nonparty 5 of the Defendant Company’s staff member who performed the purchase contract with interest in the treatment effect. Nonparty 5 also talked about the stem cell treatment method and treatment possibility known to them. Nonparty 5 concluded that a patient with a her her her her her her her her her her her her her her her her her her her her her her her her her her her her her her her her her her her her her her her her her her her

① As seen earlier, the Plaintiff 6 decided to undergo a stem cell transplantation surgery reported on a newspaper, etc. after consultation with Defendant 4, and concluded a stem cell purchase agreement first. The said Plaintiff, upon introduction of Defendant 4, transferred the stem cell purchase agreement to Korea Hospital, and sought an explanation as indicated in the above (3) through (5).

(10) Defendant 2 and 4 did not inform Plaintiff 1, etc. and Plaintiff 6 of the fact that they performed a transplant surgery using a stem cell which is a medicine without approval from the Korea Food and Drug Administration: Provided, That from March 2004 to March 2004, there was no case where the fact-finding survey or criminal punishment was conducted on the grounds that it constitutes a cell therapy, which is a medicine, with regard to preparations such as stem cells separated and cultivated from the Defendant Company, from the Ministry of Health and Welfare and the Korea Food and Drug Administration, until they entered the fact-finding survey on cell therapy. Therefore, Defendant 2 and Defendant 4 did not have a clear perception that the act of selling stem cells or transplant surgery was in violation of the Pharmaceutical Affairs Act until it is a question as seen above, and there was no other relevant administrative agency or legal expert about whether there was any procedure or regulation prescribed

(B) Legal evaluation of the defendants' provision of stem cells and procedures

According to the above-mentioned facts and the above-mentioned facts, the following facts may be inferred:

① Since the stem cells of Defendant Company did not obtain permission to manufacture the quality of drugs from the Commissioner of the Korea Food and Drug Administration, it cannot be used for the clinical test without obtaining approval for the clinical test, Defendant 4 provided the stem cells to Defendant 2 for the clinical test. Defendant 2 performed transplant surgery using that stem cells to Plaintiff 1 and Plaintiff 6.

② Since the above procedure is still in an early research stage that has yet to be established as an academicly recognized medical practice, it is reasonable to view that the doctor’s duty to explain the results of medical research, including accumulated clinical trials, possibility of treatment, side effects after the surgery, etc. is more aggravated than that of ordinary medical practice (Article 28 of the Enforcement Rule of the Pharmaceutical Affairs Act). However, according to Article 28 of the Enforcement Rule of the Pharmaceutical Affairs Act, documents necessary for approval of a clinical trial plan include “written consent form of examination”, “Rules on Compensation for Victims”, “standards for Medical Treatment and Treatment of Examinees after a clinical trial”, and “measures for the protection of the safety of examinees” as well as only providing information to the extent that it is impossible to present statistical data on the treatment effect in a timely manner, and obtained consent to the operation without sufficiently explaining the patient to decide whether to undergo the surgery.

③ Defendant 4 also announced the results of clinical therapy with Defendant 2, posted the same article on the homepage of the Seoul umba Bank. Unlike usual drug transactions, Defendant 2 could not make a careful decision in determining whether to conduct clinical therapy by having the patient, while selling a stem cell for surgery at a high price by directly contact with the patient, and by having the patient impliedly or in concert with the explanation of treatment effects, etc. (in particular, Plaintiff 6 entered into a contract with the above Plaintiff to supply stem cell prior to consultation with the doctor).

④ As a result, Plaintiff 1, etc. and Plaintiff 6 decided to undergo a stem cell transplantation surgery and received such surgery and subsequently disbursed various expenses, such as purchase of stem cells and hospitalization.

In light of these circumstances, the legislative intent of the provisions related to the Pharmaceutical Affairs Act to protect the subject's right to self-determination and to ensure the scientific validity and safety of clinical trials, each of the above acts committed by the Defendants is considered to be an unlawful infringement on the plaintiffs' right to self-determination and an objective co-ownership. Therefore, the Defendants are jointly and severally liable to compensate the plaintiffs for the damages suffered by the plaintiffs (However, the part of the plaintiffs' assertion that Defendant 2 and 4 actively accused the plaintiffs because the treatment effect of stem cell transplantation reaches 10%, is not acceptable as it is difficult to believe and there is no other evidence to acknowledge it).

B. Limitation on liability

According to the evidence adopted above, the following circumstances can be acknowledged.

① Defendant 2 and 4 did not clearly recognize that the procedure of the procedure was in violation of the Pharmaceutical Affairs Act because the stem cell line constitutes a drug.

② It does not seem that the existing diseases of Plaintiffs 1 and 6 have deteriorated due to stem cell transplantation itself until now.

(3) A transplant surgery itself does not seem to have become a group of health of the said patients as a relatively simple surgery which is required for over thirty minutes through one hour by national anesthesia.

④ Defendant 2, upon obtaining consent to an operation, provided an explanation to prevent the side effects of the operation or the treatment effects, and unlike Defendant 2 and 4, Defendant 2 and 4 did not actively conceal the existing treatment results.

⑤ In the process of trying to develop a new treatment method for incurable diseases, the said Defendants committed such illegal acts, and the patients also decided to perform stem cell transplantation procedures with the risk that there is no innovative treatment method different from the current medical level and the treatment effect of stem cell transplantation is uncertain.

⑤ In particular, even though Plaintiff 6 explained that Defendant 2 was unable to present any clinical result to Defendant 2, the Plaintiff requested the procedure to do so strongly. On August 15, 2003, the transfer of the instant procedure, he had already been in the Katool’s sexual stem cell transplantation procedure at the Katool’s sexual hospital, which had not obtained any particular effect at the time.

Therefore, it is reasonable to limit the Defendants’ liability for damages by taking account of the above circumstances in light of the ideology of the damages system that provides the fair and reasonable apportionment of damages as the guiding principle. The limitation ratio is reasonable to determine 1/3 and 2/5 against Plaintiff 1, etc. as 2/3 and 3/5 against Plaintiff 6 in light of the above circumstances and factual relations. Therefore, the Defendants’ liability is limited to 2/3 and 3/5, respectively.

3. Scope of damages.

(a) Scope of recognition;

The ordinary damages suffered by Plaintiff 1, etc. and Plaintiff 6 due to the Defendants’ tort are ① consolation money due to infringement of the above patients’ personal rights, such as the right to self-determination, and ② if Defendant 2 and 4 performed a stem cell transplantation operation with approval from the Commissioner of the Korea Food and Drug Administration, or the above Defendants notified the patients of the fact that they were conducting clinical trials under the Pharmaceutical Affairs Act without approval, it would be reasonable for the patients to bear the expenses for the purchase of stem cells and the expenses for hospitalization.

In addition, the plaintiffs seek compensation for transportation expenses or food expenses [the amount of KRW 1.4 million), KRW 2,00, KRW 500,000, KRW 500, KRW 5000, KRW 500,000), Plaintiff 6, Plaintiff 7 (gold KRW 1.00,000), KRW 3 (5,000), KRW 5,000, KRW 500, KRW 500), and Nonparty 1 (gold KRW 500,00), which is incurred by the above patients in the course of attending the Korea Hospital in order to obtain counseling. However, this part of the plaintiffs' assertion is without merit, since it is most difficult to view that there is a proximate causal relation with the defendants' tort even if they decided not to receive proper information and have received treatment.

B. Calculation of damages

(1) Consolation money

- Plaintiffs 1, 2, 3, 4, 5, 7, and Nonparty 1: each of the amount of KRW 1 million

- Plaintiff 6: 700,000 won

【Written Grounds for Witnesses】 The details, results, and other various circumstances of the stem cell transplantation surgery of this case

(2) Property losses

Defendant 2, Defendant 3, Defendant 2, Defendant 413, Defendant 2, Defendant 2, Defendant 35-13, Party A, Party 2, Party A, 35-14, 36, 2417, 24, 381, 236-13, 236-13, 36-13, 90, 296-13, 296-13, 90, 296-13, 296-13, 29, 365, 29, 365, 30, 296-1, 29, 365, 29, 306-1, 29, 365, 29, 306-2, 306, 309, 3303, 300-13, 305, 3003-14, 300

(3) Inheritance relationship

- The consolation money and property damage of the deceased non-party 1: Total 24,279,621 won

- Plaintiff 8: 10,405,51 won (=24,279,621 won x 3/7)

Plaintiff 9, 10: each gold 6,937,034 won (=24,279,621 won x 2/7)

4. Conclusion

Therefore, the defendants are jointly and severally liable for damages for tort against the plaintiffs, which is the sum of consolation money and property damages, and the amount of damages for delay calculated by applying the rate of 5% per annum as stipulated in the Civil Act from May 1, 2004 to December 1, 2005 and 20% per annum as stipulated in the Act on Special Cases concerning Expedition, etc. of Legal Proceedings from the following day to the date of full payment.

Therefore, the plaintiffs' claims against the defendants are accepted within the scope of the above recognition, and the remaining claims are dismissed as they are without merit. It is so decided as per Disposition.

[Attachment]

Judges Cho Yong-ho (Presiding Judge)