[1] The degree of and the standard for determining the burden of proof as to whether there exists a causal relationship between the defect in a blood product or negligence of a pharmaceutical company and the victim in a case where a patient infected with a virus claims that the pharmaceutical company is infected by the viral blood product contaminated with the virus against the

[2] The case holding that the causal relationship between the defect in the blood product manufactured by Company B and the H infection of Company B and Company A is presumed, in case where the issue was whether Company B, etc., a patient suffering from blood disease, was infected with the HIV due to the blood product manufactured and supplied by Company B

[3] In a case where it is difficult to predict how the locking period of infection would run or how the disease will run at any stage at the time of infection, the starting point of starting the extinctive prescription of a claim for damages caused by a tort

[1] In order to establish a liability for product liability of a pharmaceutical product, there must be a causal relationship between the defect of a pharmaceutical product or negligence of a pharmaceutical company and damage. However, the process of manufacturing a pharmaceutical product is only known to only an internal organ of the pharmaceutical company, and it is extremely difficult for the general public to prove that the act of manufacturing a pharmaceutical product requires high level of expertise. Therefore, in a case where a victim, who is a patient, claims for the cause of liability for damages that a blood product was infected by a viral blood product against a pharmaceutical company through a virus, there was no symptoms to suspect infection before the pharmaceutical company administered the blood product. If the pharmaceutical product proves that there was a probable probability that the viral infection was contaminated, and that the blood product was contaminated by a virus, the pharmaceutical company’s proof of the causal relationship between the defect of the blood product or the negligence of the pharmaceutical company and the victim is consistent with the principle of fair and reasonable burden for mitigation of the burden of proof by presumption of infection between the victim’s blood product and the pharmaceutical product’s infection, even if there was no clear natural proof, it is no medical link between the victim’s infection’s medical method and other factors.

[2] In a case where the issue was whether Party A, etc., who is a blood patient, was infected with HIV (human immunodeficiency virus and Impine Impcy Vus) due to the blood product manufactured and supplied by Company B, the case holding that the presumption cannot be reversed solely on the ground that Party A, etc.’s genetic information held by the person presumed to have provided infected blood and information about HIV’s gene information is not accurately inconsistent with HIV’s genetic information, or that some patients were infected with HIV’s genetic blood products or blood transfusions, for which there was no symptoms to suspect infection before Party A, etc. was administered with the blood product manufactured by Company B, and the infection was confirmed after Party A was administered with the blood product, and that the blood product was contaminated with HIV or has a significant possibility of being contaminated with HIV, and that there was a causal link between Party A’s defect in the blood product manufactured by Company B and Party B’s negligence and HIV’s infection infection’s infection’s genetic information.

[3] In the damage claim based on a tort, “the date when the tort was committed” as the starting point of the extinctive prescription under Article 766(2) of the Civil Act refers to the date when the harmful act was committed, rather than the date when the harmful act was committed. However, in cases where the diving period for infection is long, or where it is difficult to predict how the disease would run at any stage at the time of infection, the time when the damage is realized uniformly considered as the infected date, the victim may cause an unfair consequence that prevents the claim for future damage from being extinguished due to uncertainty at the time of infection and failure to claim for future damage at the time of infection. Therefore, in such a case, damage caused by the outbreak of symptoms or the progress of disease in addition to the damage caused by infection itself may occur, and such damage may be deemed to have practically occurred at the time when the symptoms were discovered or the disease occurred.

[1] Article 750 of the Civil Act, Article 288 of the Civil Procedure Act / [2] Article 750 of the Civil Act, Article 288 of the Civil Procedure Act / [3] Article 766 (2) of the Civil Act

[3] Supreme Court en banc Decision 77Da1894, 1895 Decided December 26, 1979 (Gong1980, 12526) Supreme Court Decision 2004Da71881 Decided May 13, 2005 (Gong2005Sang, 950)

Plaintiff 1 and 68 others (Law Firm Sejong & Lee, et al., Counsel for the plaintiff-appellant)

Green Cross Holdings Co., Ltd. and one other (LLC, Kim & Lee LLC, Attorneys Noh Young-soo et al., Counsel for the defendant-appellant)

Seoul High Court Decision 2005Na69245 decided January 10, 2008

The part of the judgment of the court below against Defendant Green Cross Holdings is reversed, and that part of the case is remanded to the Seoul High Court. The appeal against Defendant Green Cross Co., Ltd. (hereinafter “Defendant Green Cross”) that was merged with the Defendant by Green Cross Holdings Co., Ltd. (hereinafter “Defendant Green Cross”) is dismissed. The costs of appeal between the Plaintiffs and Defendant Green Cross are assessed against the Plaintiffs.

The grounds of appeal are examined.

1. As to the grounds of appeal against Defendant Green Cross Holdings Co., Ltd. by the Plaintiffs

A. In order to establish the liability for damages in product liability of a pharmaceutical product, there must be a causal relationship between the defect of the pharmaceutical product or the negligence of the pharmaceutical company and the damage. However, the process of manufacturing the pharmaceutical product is limited to only the internal organ of the major pharmaceutical company, and it is extremely difficult for the general public to prove the defect of the pharmaceutical product or the negligence of the pharmaceutical company completely.

Therefore, in a case where a patient asserts that the victim was infected by a virus against a pharmaceutical company, there was no symptoms to suspect infection before the pharmaceutical company administered the blood product, and prove that the blood product is highly likely to have been contaminated with the virus, the mitigation of the burden of proof to presume the defect of the blood product manufactured by the pharmaceutical company or the causal link between the negligence of the pharmaceutical company and the victim's infection accords with the compensation system that provides for the equitable and reasonable burden of damage. Here, the probability of being contaminated by a virus is more consistent with the compensation system that provides for the fair and reasonable burden of damage. The determination can be made by taking into account various circumstances, such as the time close to the use of the blood product and the use of the blood product, statistical relations, the manufacturing process of the blood product, the medical characteristics of the virus, the degree of accuracy of the methods of diagnosis of blood virus, etc., even if there is no clear proof on natural science.

Meanwhile, a pharmaceutical company may reverse the presumption by proving that the cause of infection of the victim is not derived from its blood product, such as the absence of any defect in its blood product. However, the presumption is not reversed merely on the ground that the victim was administered with a blood product manufactured by another company or received blood transfusion during the period when infection is presumed.

B. As to the grounds of appeal by Plaintiffs 1, 11, 21, 17, 28, and 32 and their families

(1) According to the reasoning of the lower judgment, the first instance court and the evidence duly admitted and examined by the lower court, there was no symptoms to suspect HIV infection (HV) before the said Plaintiffs were administered with FIE (FAne, hereinafter “the instant blood product”), and the said infected Plaintiffs confirmed HIV infection after the lapse of the ordinary period of mideation (HIV infection). Defendant Green Cross Holdings Co., Ltd. manufactured and distributed the instant blood product, which is a treatment product for infection B from the first half of 190, with a high risk of being infected with HIV infection in the form of a single blood-related infection test (hereinafter “the instant blood product”). The result of an epidemiological investigation conducted by the Defendant at least six months for blood disease-related patients, which is the only one of the patients infected with HIV infection in the form of a high risk of being infected with HIV infection in the form of a high risk of being infected with HIV infection infection in the form of a high 190-year infection infection, and the result of an epidemiological investigation conducted by the Defendant at least six months.

Furthermore, according to the reasoning of the lower judgment, the first instance court and the evidence duly admitted and examined by the lower court, the Defendant purchased blood from Nonparty 1 on a total of 21 occasions from around January 3, 199 to March 26, 190 for the purpose of using the above blood product. Nonparty 1 showed positive reaction with HIV tests around April 1990. The Defendant used the blood purchased on January 20, 190 and January 23, 190 for the purpose of manufacturing the instant blood product. The Defendant purchased blood from Nonparty 1 on a total of 83 occasions from around January 5, 198 to December 23, 198 for the purpose of using the above blood product, which was indicated on the 1stma No. 1 for which Nonparty 2 had no capacity to produce blood products. The Defendant appears to have purchased blood from Nonparty 1 for the purpose of using the above blood product as a blood product No. IV 1 for identification number 1 for the purpose of using it.

(2) Examining the above facts in light of the legal principles as seen earlier, it is presumed that there was a causal relationship between the defect of the blood product manufactured by the above defendant, the negligence of the above defendant and the infection of the above infection, since there was no symptoms to suspect infection before the above defendant was administered with the blood product, and the infection of the virus was confirmed after the above defendant was administered with the blood product manufactured by the above defendant, and the blood product manufactured by the above defendant is likely to have been contaminated with HIV.

On the other hand, even if the genetic information of HIV owned by the person presumed to have provided infections, such as Nonparty 2 and 1, and the genetic information of HIV owned by the Plaintiffs is inconsistent with those of HIV, or a part of the infections were obtained foreign blood products or blood transfusions, the presumption cannot be reversed solely on such circumstance.

(3) Nevertheless, the lower court determined that the causal link between the instant blood product manufactured and supplied by the said Defendant and the Plaintiffs’ HIV infection cannot be acknowledged. In so determining, it erred by misapprehending the legal doctrine on the burden of proof in a damages lawsuit against the manufacturer of the blood product, thereby adversely affecting

The ground of appeal pointing this out is with merit.

C. As to the grounds of appeal by Plaintiffs 1, 11, 21, 17, 28, 32 and their families

(1) Plaintiffs 1, 11 and their families

The lower court confirmed that Plaintiff 1 was infected with HIV on March 21, 1991, and confirmed that Plaintiff 1 was administered with the instant blood product on March 18, 191, and that Plaintiff 1 was infected with HIV on March 14, 1991, and that Plaintiff 1 was administered with the instant blood product on February 28, 191, but it was recognized that the instant blood product was administered on February 28, 191, but it was difficult to view that the said Plaintiffs’ infection was caused by the instant blood product in light of the period for the formation of the body of the aviation of HIV.

The lower court, at the request of the Defendants, acknowledged that Nonparty 3’s professor collected only B05, B06-19 (Plaintiff 11), among the autopsys of HIV infections, on the basis of the dynamic research report (No. 32 and No. 2710 pages) on HIV infections, and recognized the infection verification date as above. The part related to the above evaluation report is that “the report prepared by Nonparty 4 professor is the blood stored in a social welfare foundation, and requested an examination to the National Health Institute on August 25, 1993, which was determined to be trained on August 25, 1993 by Nonparty 3 to the National Health Institute.” Since the report prepared by Nonparty 4 was deemed to have been stored in B05, B06, B14 (Plaintiff 11) and B19 (Plaintiff 11), it was reasonable to recognize that the blood was stored in B19-14 and B19-19-19-19-19-13, respectively.

However, according to the evidence of the first instance court and the lower court, at the time of the investigation by the National Health Institute of Korea on December 1992, 192, Nonparty 5’s molecular epidemiological investigation report (2.2. recorded 612 pages) prepared by Nonparty 5 professors around February 1996, the date of Plaintiff 1’s infection discovery was stated on March 11, 1992. The date of Plaintiff 11’s discovery was stated on December 5, 1992. At the National Assembly’s request of the Health and Welfare Committee of 2002, the “The Blood Research Committee” was newly constituted on the 9th 19 B. 9 B. 196th 196th 196th 196th 196th 196th 196th 2. 9th 196th 196th 2. 9th 196th 196th 2. 196th 1992

Thus, each of the above reports prepared by Nonparty 4 and 5 professors is made by a public institution, and their credibility is high. Thus, the court below should have confirmed whether the above non-party 3 professor is a stored blood due to confusion with B14, B19, B16 listed in the above examination report prepared by Non-party 4 professor No. 2. The court below should have determined the credibility of each report by reviewing the reasons why the above contents are not reflected in the examination report prepared by Non-party 4 professor No. 3. 2. The court below confirmed whether it is a stored blood due to confusion with B08, B16, and urged that B14 and B19 respectively submit data confirmed by the president of the Korea Blood Foundation No. 4 and March 14, 191.

Nevertheless, the lower court recognized the date of identifying infection, contrary to the content of the above official report with high credibility on the sole basis of the documents submitted by the Defendants. Therefore, the lower court erred by misapprehending the legal doctrine on the probative value of documents or the limitation of free evaluation of evidence, thereby failing to exhaust all necessary deliberations, thereby adversely affecting the conclusion of the judgment.

(2) Plaintiffs 21 and their families

The lower court confirmed that Plaintiff 21 was infected with HIV on February 21, 1991, and received the administration of the instant blood product on February 9, 191, February 20, and February 21, 1991, and on February 20, and the 21st day of the same month, but comprehensively taking account of the entire purport of the oral proceedings with the statement of Plaintiff 65 and Nonparty 6’s testimony of Nonparty 6, the lower court determined that the said Plaintiff’s infection was difficult to view that the said Plaintiff’s infection was caused by the instant blood product.

However, according to the reasoning of the judgment below and the evidence adopted by the court below, Nonparty 6, the maker of the written opinion related to the above contents in the final report of the Committee on Safety Test of Blood Products and the epidemiological investigation report (B 65) testified in the court below to the effect that “the above written opinion that Plaintiff 21 had already been confirmed to be HIV infected before being in charge of the instant blood product,” and Non-Party 2 and the blood disease patients’ HIV gene information were analyzed and made by analyzing the HIV genetic information, and the hhyogengengengengengene was located most close to each other. Most of the blood disease patients registered with the Korea Blood Foundation on February 191, 191, they could not find any material that Plaintiff 21 had actually undergone the HIV test before being registered with the Korea Blood Foundation, and considering that Plaintiff 21 appears to have failed to have undergone the above HIV test prior to being registered with the Korea Blood Foundation, the testimony seems to have been justifiable.

Therefore, it cannot be deemed that Plaintiff 21 had already been infected with HIV before receiving the administration of the instant blood product. If there is no symptoms to suspect HIV infection at the time of administration of the instant blood product, a causal relationship can be presumed as seen earlier.

Nevertheless, the lower court determined that Plaintiff 21 had already been infected with HIV before being administered with the instant blood product, and thus, the lower court erred by exceeding the bounds of the principle of free evaluation of evidence. The ground of appeal assigning this error is with merit.

(3) Plaintiffs 17, 28 and their families

The lower court confirmed that Plaintiff 17 was infected with HIV on July 1, 1991, and confirmed that Plaintiff 28 was administered with the instant blood product on the same day, and that Plaintiff 28 was infected with HIV on February 21, 1991, and that the instant blood product was administered from February 19, 191. However, it is recognized that the said Plaintiffs’ infection was in accordance with the instant blood product, and there is no evidence to prove that Plaintiff 17 was administered with the instant blood product before infection. Thus, the lower court determined that the said Plaintiffs’ infection was difficult to view it as the instant blood product, on the grounds that there was no evidence to support that the said Plaintiffs’ infection was administered with the instant blood product before infection.

However, according to the reasoning of the judgment below, the first instance court, and the evidence adopted by the court below, the documents (A78) prepared by Nonparty 7 of the National Health Center of the Republic of Korea after investigating patients infected with HIV around the beginning of 1990 stated that "the plaintiff 17 was administered cryna on April 2, 198 and September 10, 198; the documents (A65) prepared on April 4, 1991 by the National Health Center A.I.D. and the public health; and the documents (A65) prepared on May 9, 190 that "the mother of the plaintiff 28 had been infected with the plaintiff 28 cryna, a green cryna; the documents (A78) prepared on May 11, 1991 by the defendant 2, which had already been analyzed in the form of the cryna product distributed by the plaintiff 17 cryna, etc. in the form of the cryna product.

In light of the above circumstances, the documents prepared by the public official of the Korea Health Institute are official documents prepared in the process of collecting information in order to find the cause of infections of the patients suffering from HIV infections, such as blood transfusion, domestically produced blood products, and foreign produced blood products. The provider of the above information seems to have no special reason to provide false information. In addition, since the distribution route of the instant blood product and the result of molecular biological research are supported by the authenticity of the contents indicated in the above documents, it is reasonable to deem that Plaintiff 17 and 28 were administered with Facination made by the above defendant before the date of confirming infections of HIV. In addition, if there is no symptoms to suspect infections of HIV at the time of administering the instant blood product, the causal relationship can be presumed as seen earlier.

Nevertheless, the lower court determined that Plaintiff 17,28 was not administered with the instant blood product manufactured by the said Defendant prior to the verification of HeIV infection. Therefore, the lower court erred by exceeding the bounds of the principle of free evaluation of evidence. The allegation in the grounds of appeal assigning this error is with merit.

(4) Plaintiffs 32 and their families

The court below confirmed that Plaintiff 32 was infected by HIV on February 26, 1991, and on the same day, it is recognized that Plaintiff 32 was administered with the instant blood product, but there is no evidence to prove that Plaintiff 32 was administered with the instant blood product before infection. Thus, the court below determined that Plaintiff 32’s infection was difficult to view it as being caused by the instant blood product.

However, according to the reasoning of the judgment of the court below and evidence adopted by the court below, the plaintiff 32 had been diagnosed by the plaintiff 1 to 8, 1987, to 3, 4, 5, 5, 5, 196, 8, 5, 196, 5, 196, 5, 5, 5, 196, 5, 5, 19, 5, 5, 6, 5, 5, 19, 5, 6, 6, 9, 5, 6, 9, 6, 8, 6, 6, 8, 6, 6, 5, 6, 8, 6, 9, 5, 6, 6, 9, 5, 6, 5, 6, 6, 9, 5, 5, 6, 9, 1,5, 6, 1,5, 6, 1,5, 1, 6, 6,

Therefore, the lower court should have deliberated more on the time when Plaintiff 32 administered the instant blood product at home, and determined whether Plaintiff 32 confirmed the infection after the administration of the instant blood product.

Nevertheless, the lower court determined that there was no evidence to acknowledge that Plaintiff 32 was administered with the instant blood product before infection. Therefore, the lower court erred by misapprehending the legal doctrine on the probative value of documents and the limitation of free evaluation of evidence, thereby failing to exhaust all necessary deliberations, thereby adversely affecting the conclusion of the judgment. The allegation in the grounds of appeal

D. Meanwhile, with respect to the claim for damages arising from a tort, “the date when the tort was committed” under Article 766(2) of the Civil Act is not the date when the harmful act was committed, but the date when the result of the actual damage occurred (see Supreme Court en banc Decision 77Da1894, 1895, Dec. 26, 1979; Supreme Court Decision 2004Da71881, May 13, 2005, etc.).

However, if it is difficult to predict the potential potential for an infection, or if it is difficult to predict how the disease will proceed to any phase at the time of infection, the time when the damage is realized is considered to be the date of infection, the victim is not able to claim the future damage because it is uncertain at the time of infection, and it may result in an unfair result that can not claim after the extinctive prescription is completed at the time of occurrence of future damage.

Therefore, in the above cases, damage may be caused by the outbreak of symptoms or the progress of illness in addition to the damage caused by infection itself, and such damage may be deemed as actual at the time of the outbreak of symptoms or the progress of illness.

According to the records, it is clear that the locking of A.I.S ( Acquired Imun Deficicy Syndrome) is about about 10 years, whether a patient is a A.I.S patient at the time of infection, it is unclear whether a patient was infected with A.I.S at the time of AIV infection, and that the damage that a patient was infected with A.S is distinguishable from that of A.S. and is actually infected with A.IV. There is room to deem that the damage that a patient was a patient with A.S has actually been infected with A.S. infection and actually caused the result of such damage. Accordingly, the lower court should also examine whether the extinctive prescription has expired by examining these points.

2. As to the plaintiffs' grounds of appeal against Defendant Green Cross Co., Ltd.

According to the reasoning of the judgment below, Defendant Green Cross Co., Ltd., a telegraphic transfer of Defendant Green Cross, can be found to have been established on December 10, 199, which was after the Plaintiffs were infected with HIV. Thus, it cannot be deemed that the cause of the infection caused by Defendant Green Cross to HIV was based on the blood product manufactured and supplied by Defendant Green Cross.

The judgment below to the same purport is just, and the ground of appeal on the purport that Defendant Green Cross Co., Ltd. manufactures and supplies the instant blood product jointly with Defendant Green Cross Holdings is without merit.

3. Conclusion

Therefore, the part of the judgment of the court below against Defendant Green Cross Holdings is reversed, and this part of the case is remanded to the court below for a new trial and determination. The plaintiffs' appeal against Defendant Green Cross is dismissed, and the costs of appeal between the plaintiffs and Defendant Green Cross are assessed against the losing party. It is so decided as per Disposition by the assent of all participating Justices on the bench.

Justices Park Poe-dae (Presiding Justice)