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 16, 2006

Seoul Eastern District Court Decision 2004Gahap8263 Delivered on December 1, 2005

1. Of the judgment of the court of first instance, the part against the plaintiffs of the money ordered to be paid next shall be revoked.

The defendants shall pay to each of the plaintiffs the amount of money stated in the "amount of prize in the attached Form 1 (1)" and each of them shall be 5% per annum from May 1, 2004 to December 14, 2006, and 20% per annum from the next day to the date of full payment.

2. All remaining appeals by the plaintiffs against the defendants and appeals by the defendants against the plaintiffs are dismissed.

3. The total costs of the lawsuit shall be ten percent, and three percent shall be borne by the plaintiffs, and the remainder shall be borne by the defendants.

4. The portion to be paid with the amount under paragraph (1) may be provisionally executed.

1. Purport of claim

The defendants jointly and severally pay to the plaintiffs each amount of money stated in the "amount of claim" in the attached Form 1 sheet, and each amount of money calculated by 5% per annum 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.

2. Purport of appeal

A. The plaintiffs

The part against the plaintiffs in the judgment of the court of first instance shall be revoked, and the defendants shall jointly and severally pay to the plaintiffs each amount of money stated in the "appeal amount" in the attached Form (1) No. 1, and each of them shall be paid 5% per annum 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 date of full payment.

B. The Defendants

In the judgment of the court of first instance, the part against the Defendants shall be revoked, and all of the plaintiffs' claims against the Defendants corresponding to the revoked part shall be dismissed.

1. Basic facts

The reason why a party member should explain this part is as stated in the corresponding part of the judgment of the court of first instance (as stated in the column 1.) except that the phrase " around November 4, 2004" in Part 6, No. 15 of the judgment of the court of first instance as " around November 4, 2003," and therefore, it is acceptable in accordance with Article 420 of the Civil Procedure Act.

2. The parties' assertion

The plaintiffs, first, through the method of publishing false facts on the homepage of Hana Hospital and defendant 1, Inc., Ltd. (hereinafter "the defendant company"), by deceiving the plaintiffs as if they were effective in the stem cell transplantation, entered into a medical contract on the stem cell transplantation of this case (hereinafter "the stem cell transplantation of this case"), and second, the stem cell therapy of this case constitutes a medicine prescribed by the Pharmaceutical Affairs Act, but the defendants performed the transplantation of this case without obtaining approval from the Commissioner of the Korea Food and Drug Administration in accordance with the relevant regulations, and third, the defendants performed the transplantation of this case without obtaining approval of clinical trial plan from the Commissioner of the Korea Food and Drug Administration. Since the defendants did not provide or explain information on the validity and stability of treatment (hereinafter "the plaintiff company, etc.") before the transplantation of this case, the plaintiff 6, and his family members, which caused the defendants to receive medical treatment of this case, as well as the defendant's personal rights and rights to receive medical treatment of the plaintiff 6, etc., as well as the defendant's personal rights and rights.

The defendants are not required to obtain approval for clinical trial before the procedure because the stem cell surgery does not constitute a drug under the Pharmaceutical Affairs Act, and the defendant's medical corporation's Medical Foundation ("the defendant Medical Foundation"), and the defendant 2 did not obtain approval for clinical trial before the procedure because the defendant's act of selling the transplant surgery of this case was somewhat exaggerated in the homepage of the defendant hospital or reported to the defendant's media. However, since the defendant's act of selling the transplant of this case was false or guaranteed the treatment effect of the transplant of this case, the defendant's act of selling it does not constitute an illegal act of the plaintiff's transplant of this case. Second, since the stem cell of this case does not constitute an illegal act of the plaintiff's 1, the defendant's act of supplying it to the plaintiff's et al. before the transplant surgery of this case, the defendant 2 did not have an explanation about the treatment effect of the plaintiff's stem cell as well as the defendant's act of supplying it to the plaintiff's 6 et al.

3. Judgment by issue

A. Existence of liability for damages

(1) Occurrence of damages liability

(A) Violation of the Pharmaceutical Affairs Act

(1) Relevant provisions

Regulations concerning marketing approval of the drug at the stage;

【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, related documents and other necessary materials 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.") which are not permitted for manufacture or import pursuant to Article 26 (8) or 34 (5) of the Act shall be as follows:

10. Items deemed necessary by the Commissioner of the Korea Food and Drug Administration for the public interest or international agreements, such as blood products, gene therapy, cell therapy products, cell culture therapy products: 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) A person who intends to obtain permission for items or permission for modification of items of drugs, etc., or to file a report on items or a 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, the Commissioner of the Korea Food and Drug Administration shall determine matters necessary for the management of non-clinical trials conducted to prepare detailed regulations on items subject to examination, summary of preparation of data, requirements for each data, scope of exemption, criteria for examination, etc., and data on toxicity and pharmacological action (hereinafter omitted):

【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 order to restore the functions of a cell and tissue, by living persons in the form of a group, like gengengens, or xengengen cells outside the body;

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 manufactured or imported under the Pharmaceutical Affairs Act, cell cultivation products, cell therapy products, gene therapy products, etc.: Provided, That the same shall not apply to medicines, re-cooperative medicines, and cell culture products, in which the kinds, specifications, and quantity of active ingredients (in cases of liquid agents, concentration) are identical with those of already licensed items, and the production cost of the final source is the same as those of the final source and the same as those of the final source amount.

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

(2) Judgment

According to the above facts and their adopted evidences, stem cells used for transplantation surgery for plaintiffs et al. and plaintiffs 6 were separated from cord blood stored in Seoul Cump Bank operated by the defendant company by using technological power of the defendant company, and reproduced and cultivated outside body for the purpose of treating diseases, such as stem cell transplantation surgery. In full view of the above cord blood storage relationship, stem cell extraction and reproduction process, these series of processes of treatment pursued, the above Pharmaceutical Affairs Act and its enforcement regulations, the purport of the above Pharmaceutical Affairs Act and its enforcement regulations, and the relationship between the above provisions and the two provisions, the stem cells of this case were operated by changing the original biological or functional characteristics of cells or tissues through cell proliferation, and thus, the stem cells of this case were operated by the defendant company's division of stem cells by using technological power of the defendant company, and were reproduced and cultivated outside body for the purpose of treating diseases, such as stem cell transplantation surgery, and thus, it constitutes a violation of Article 20 subparagraph 13 of the Pharmaceutical Affairs Act's provision for treatment of the plaintiff's stem cell cells and its enforcement regulations.

(B) Breach of duty to explain

(1) Experimental surgery and content of the duty to explain.

If a certain treatment method is not yet verified to the extent sufficient in the effect or stability of the treatment, and it does not reach an officially recognized medical science, the doctor in charge should first select a method with a high stability, unless there are special circumstances. Even if it is necessary to conduct a test for a more stable treatment, the effect and stability of the treatment should be sufficiently examined through both theoretical and practical aspects, and the implementation should be allowed only for medical institutions equipped with human and material facilities. In addition, in order to guarantee the right of self-determination to select the patient prior to its implementation, it is necessary to clearly obtain consent from the patient by clearly explaining the risk, effect and validity of the treatment, controversy over the method, legality of the procedure, and legality of the procedure.

(2) Facts recognized.

The following facts can be acknowledged by comprehensively taking into account the following facts: Gap evidence 1, 2-4, Eul evidence 5-1, 2-3, Eul evidence 12-14, Gap evidence 15, 17, 18, Gap evidence 16-1 through 7, Gap evidence 19-1 through 8, Eul evidence 16-2-39, Eul evidence 34-4, Eul evidence 42-4-5, Eul evidence 5-46, Eul evidence 6-40, Eul evidence 7-39, Eul evidence 8-40, Eul evidence 40-40, the testimony of non-party 4, the testimony of non-party 1-1, the result of the video tape verification at the court of first instance, and the purport of whole pleadings of the plaintiff himself from the court of first instance to the plaintiff himself.

i) The Plaintiff et al. 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.

ii) The Plaintiff et al. had a special interest in the treatment effect of the stem cell transplantation surgery, which was introduced as a new treatment method for livering symptoms at the time before determining whether to conduct an operation after consultation with Defendant 2, and discussed Nonparty 4 or Defendant 2, an exclusive nurse in charge of stem cell transplantation, on the treatment effect.

iii) Accordingly, Defendant 2 and the above Nonparty 4 may cause the plaintiff et al. to give blood transfusions, chlostosiss, and hemopic shocks due to the side effects of the operation. The stem cells were born on the part of the disease and were unable to present statistics on the treatment effect. Prior to the procedure, the plaintiff et al. prepared written written consent of the operation with the same contents.

iv) However, two patients known as successful in clinical treatment through the homepage of the Han Hospital or the relevant news report have been administered on or around September 2003 through around 10, 2003, which was 2 months prior to the Plaintiff et al.’s birth, and thus, there was a change in the number of injury and injury resulting from simple liver functions, and it is difficult to view it as a scientific meaningful clinical result due to the lack of continuous tracking and observation after the operation. The above non-party 2, who received the first procedure, died on May 2004.

v) Although there has been a recent study on medical treatment of incurable diseases using cord blood stem cells, even though there are industrial factors that may affect the treatment effect, such as the type of the relevant disease, the characteristics and condition of the patient, the technology of separating and cultivating stem cells, and the specific method of procedure, Defendant 2 did not systematically research about the disease.

vi) At the time, it was difficult to see that there was a clinical case where the treatment effect was confirmed, not merely to present statistics on the treatment effect, but it was difficult to see that there was a clinical case where the treatment effect was confirmed, Defendant 2 did not clearly explain such circumstance to the Plaintiff, etc.

(vii) In addition, although the Defendant Medical Foundation and Defendant 2 did not actively inform the patients making a report on the Korean Hospital website that they are different from the facts, they did not take measures to immediately delete such notices.

(viii) Although the method of treatment is widely recognized in the medical community as it is verified to the extent that clinical cases are accumulated for a considerable period of time, Defendant 2 has advantages in the operation method, cost, side effects, treatment effects, etc. of the instant transplant surgery which has not yet been verified to the Plaintiff, etc.

(ix) The plaintiff et al. introduced by the defendant 2 to purchase stem cells from the defendant company and asked the non-party 5 of the defendant company's staff member who dealt with the purchase contract with interest in treating the treatment effect. The above non-party 5 said non-party 5 said that the patient suffering from urology who was born to the plaintiff et al. after the stem cell procedure and the urology of urology as well as her head symptoms.

x) Plaintiff 6 decided to undergo a stem cell transplantation surgery on a newspaper, etc. after consultation with Defendant 4, and concluded a stem cell purchase agreement first, and thereafter, Defendant 2, like the Plaintiff, etc., entered Korea Hospital upon introduction by Defendant 4, sought an explanation as described in the above clause iii).

(xi) Defendant 2 and 4 did not inform the Plaintiff and Plaintiff 6 of the fact that they performed transplant operations using stem cell medicine, which is a medicine, without obtaining approval from the Korea Food and Drug Administration.

(xi) There was no case where the fact-finding survey or criminal punishment was conducted on the grounds that the Ministry of Health and Welfare and the Korea Food and Drug Administration conducted a fact-finding survey on cells, such as stem cells separated and cultivated from the Defendant Company, constitutes a cell therapy.

(3) Determination

This case's transplant surgery includes test elements and is likely to cause infection outside the body. It is necessary to provide the Plaintiff's medical staff with professional knowledge and research experience related to the stem cell surgery before the transplantation surgery and to provide the Plaintiff's 2 with an opportunity to extract stem cell cells at least once it is proved that there is no risk of infection outside the body. Thus, it is necessary to provide the Plaintiff's medical staff and their guardians with an opportunity to use the stem cell cells at least once it is proved that it is difficult to obtain treatment from the Plaintiff's 6-month treatment and treatment by using it. In addition, it is necessary to provide the Plaintiff's 2-month treatment facilities with an explanation of the possibility that the treatment would have been lost due to non-party 1's non-party 2's treatment and development, and to provide the Plaintiff's 4-month treatment facilities with no explanation of the possibility of non-party 2's treatment and development, and it is necessary to provide the Plaintiff's 2-month treatment equipment with no explanation of the remaining treatment effect.

(C) Sub-decisions

Therefore, the defendants' implementation of the transplant surgery of this case in violation of the Pharmaceutical Affairs Act without fulfilling their duty to explain properly constitutes tort under the Civil Act. The defendant 4's publication of advertisements on the homepage with joint reporters' opinions about the treatment effect of stem cells jointly with defendant 2 can be evaluated as not only as representative director of the defendant company, but also as an individual's act. Further, the defendant's exclusive supply and sale of stem cells to the defendant medical foundation is recognized as an objective common relationship in relation to the transplant surgery of this case, barring any special circumstance, the defendants are liable to compensate for property and mental damage suffered by each plaintiffs as joint tortfeasor.

(2) Determination by issue

(A) Whether there exists deception by false or exaggerated advertisements

In the advertisement of goods, if a false fact is notified in a manner that would be criticized in light of the duty of good faith as to important matters of transaction in the advertisement of goods, it constitutes a deception. However, it would be difficult to readily conclude that the defendants' publicity or advertisement was made in a way that would not be acceptable in light of the good faith principle with the intent of deceiving the plaintiffs, and further, it would be difficult to accept the plaintiffs' assertion in this part of the above part of the plaintiffs' assertion because the defendants, including the plaintiffs and the defendants, concluded the treatment contract of this case due to the false or exaggerated advertising or the defendants' fraudulent act, as long as it would be acceptable (see Supreme Court Decision 9Da55601, 55618, May 29, 2001, etc.).

(B) Whether the relevant provisions are effective

The concept of cell therapy is defined by Article 26 (8) of the Pharmaceutical Affairs Act, Article 21 (1) 10 of the Enforcement Rule of the Pharmaceutical Affairs Act, and the definition of cell therapy is delegated to the Commissioner of the Korea Food and Drug Administration under Article 2 of the Pharmaceutical Affairs Act, Article 2 of the Pharmaceutical Affairs Act, Article 21 of the same Act concerning the definition of medicines, Article 21 of the same Act concerning the item license for manufacture of medicines, and Article 26-4 (Article 26-3 of the same Act concerning the item license for clinical trials using medicines on the premise that it falls under a drug). In light of the legislative intent of the same Act, it can be known that cell therapy under the Pharmaceutical Affairs Act refers to the item that causes any operation through the process of cells or tissue for medical purposes, such as treatment, diagnosis, prevention, etc. of diseases, and therefore, this provision delegates the concept of cell therapy to the Korea Food and Drug Administration through the notification of detailed and technical matters meeting the current medical level and standards, therefore, it cannot be accepted.

(C) Whether the standard for calculating the insurance fees and illegality are denied

According to the evidence Eul evidence Nos. 23 and 24, among health insurance benefit act and its upper value points (Notice of the Ministry of Health and Welfare No. 2002-95 of the Ministry of Health and Welfare), the second act benefit list, commercial value point check and calculation guidelines, Chapter 5 Jeju feed, 2 blood and blood component specifications e-105-C. The "cord blood donation organ transplant" column is deemed to have the basis for calculating insurance fees with respect to cord blood collection and cord blood organ injection. However, according to the evidence Nos. 9-1 through 7 and Eul evidence Nos. 10-22, it is difficult to accept the above part of the stem cell as the blood cells of this case, since the stem cell subject to the transplantation surgery of this case means a stem cell which can be reproduced and differentiated only with blood, it is hard to accept the above part of the medical surgery as a legitimate basis for calculating the insurance fees.

(D) Existence of causation

Even if Defendant 2 and Plaintiff 6 knew of the fact that they did not obtain approval for the clinical trial plan, there is no evidence to prove that they agreed to the transplant of this case. Rather, if the Plaintiff et al. and Plaintiff 6 knew of the illegality, treatment effect, etc. of the transplant of this case, if they knew of the illegality, treatment effect, etc. of the transplant of this case, it is recognized that they would undergo a timely treatment, such as undergoing a simplified surgery, as seen earlier. Accordingly, the above assertion by Defendant Company and Defendant 4 on this part is without merit.

B. Limitation on liability

According to the above facts, Defendant 2 and 4 did not clearly recognize that the stem cell system constitutes a medicine and thus violated the Pharmaceutical Affairs Act. The existing disease of Plaintiff et al. and Plaintiff 6 on the ground of stem cell transplantation itself does not seem to have substantially deteriorated. The transplant surgery itself is a relatively simple operation required for 30 to 1 hour by anesthesia, and the above patient's health is not considerably unreasonable. Defendant 2 explained the side effect or treatment effect of the surgery with consent, and Defendant 2 and 4 did not actively conceal the existing treatment result. The above Defendants also attempted to develop new treatment method for incurable disease, and the above Defendants also committed such unlawful act in the process of seeking compensation for damages to Plaintiff 2, despite the absence of any significant treatment method at the present level, it appears that the treatment effect of the transplant surgery was not considerably unreasonable for the above patients, and it appears that Defendant 2 had no specific treatment effect of the transplant surgery at the time of the request of Plaintiff 2 and the above Defendants had no specific treatment effect of the transplant surgery.

C. Scope of damages

(1) Costs of purchase and treatment of stem cells

(A) Details: The amount equivalent to the purchase cost of stem cells and the treatment cost that the Defendants would have not borne if the Defendants were to conduct a stem cell transplantation surgery with approval from the Commissioner of the Korea Food and Drug Administration or notified the patients that they would have conducted a clinical trial under the Pharmaceutical Affairs Act without such approval.

(B) Amount and basis for recognition: as shown in the column of “total” in the attached Form (2) No. 2.

(2) Determination on the assertion of transportation expenses, etc.

The plaintiffs sought compensation for transportation expenses or food expenses incurred by the above patients in the course of their visit to Korea Hospital for consultation. However, even if the plaintiffs decided not to undergo proper information hearing and treatment, it is difficult to view this part of the plaintiffs' assertion as damages in proximate causal relation with the defendants' tort as expenses that can be spent during that process.

(3) Limitation of liability: as shown in the “amount recognized after limitation of liability” in the attached Form (2) table.

(4) Consolation money

(A) Reasons for consideration: Age, family relationship, the background and result of the transplant of this case, and all the circumstances revealed in the arguments.

(b) the amount determined;

deceased Non-party 1: gold 8,000,000

Plaintiff 1, 2, 3, 4, 5, 7: each gold of KRW 5,00,000.

Plaintiff 6: Gold 4,000,000

(5) Inheritance relations

(A) The deceased non-party 1's property loss and consolation money

gold KRW 32,443,602 (gold KRW 24,443,602 + gold KRW 8,000,000)

(b)the amount of inheritance;

Plaintiff 8: 13,904,400 won (gold 32,443,602 won x 3/7)

Plaintiff 9, 10: each gold 9,269,600 won (gold 32,443,602 x 2/7)

4. Conclusion

Therefore, with respect to each of the plaintiffs' money stated in the "Total" list of the amount in attached Form 3 (3) 3 with property and mental compensation, and with respect to each of the money stated in the "amount in attached Form 1 (1) 1 with respect to each of the above money after May 1, 2004 for which the plaintiffs seek after the date of tort, it is reasonable for the defendants to dispute as to the existence and scope of the duty of performance, and the amount in attached Form 1 (1) to December 1, 2005, the date of adjudication of the court of first instance to December 1, 2005, the date of adjudication of the court of first instance to which it is reasonable for the defendants to dispute about the existence and scope of the duty of performance, and the remaining part of the plaintiffs' appeal to the defendants are dismissed within the scope of 1% per annum of the above decision of the court of first instance to the extent of 20% per annum of the above plaintiffs' damages for delay. Thus, the defendants' appeal is dismissed as it is without merit.

[Attachment]

Judges Yyeong-Jungngng (Presiding Judge)