Plaintiff 1 and one other (Law Firm continental, Attorneys Shin Jae-young et al., Counsel for the plaintiff-appellant)

LLC et al. (Law Firm Gyeong & Yang, Attorneys Kim Yong-nam et al., Counsel for the defendant-appellant)

May 1, 2007

Seoul Central District Court Decision 2004Gahap68644 Decided December 13, 2005

1. All appeals filed by the plaintiffs are dismissed.

2. The costs of appeal are assessed against the Plaintiffs.

The judgment of the first instance court is revoked. The Defendants jointly and severally pay to Plaintiff 1 17,478,397 won, 73,839,445 won, and 20% interest per annum from December 9, 2003 to the service date of a duplicate of the complaint of this case, and 5% interest per annum from the next day to the full payment date.

1. Basic facts

The following facts are not disputed between the parties, or may be acknowledged by each entry of Gap evidence 1, Gap evidence 2-1, Gap evidence 4, and Gap evidence 11 through 14.

(a) The relationship between the parties;

Plaintiff 1 is the husband of the deceased non-party 1 (the age 41 and 9 months at the time of death by birth on March 6, 1961; hereinafter “the deceased”), Plaintiff 2 is the deceased’s father, and Defendant limited liability company (hereinafter “Defendant limited liability company”) is the manufacturer and seller of Contac 600’s contact Contac 60’s contact, which is a drug (herb "PPA") containing biphenyl propa propathnomine, (hereinafter “PPA”).

B. Circumstances of the deceased’s death

(1) The Deceased, along with Non-Party 2, operated a simple key point in the name of “(trade name omitted)” in Eunpyeong-gu Seoul, Seoul. On December 2, 2003, the Deceased had drinking alcohol on the new wall and used cerebral blood transfusion, and was first transmitted to Seoul Master Hospital (hereinafter “instant accident”).

After his arrival at the Master Hospital on December 2, 2003, the medical personnel of the above hospital performed an emergency rupture operation against the deceased, but due to severe cerebral transfusion and cerebral math, the deceased died on December 9, 2003.

2. The plaintiffs' assertion

A. The assertion on Defendant limited liability

(1) The Defendant Limited Liability Company, a manufacturer and dealer of pharmaceutical products, has the obligation to supply a product with safety within the expected range in light of the consumer expectation level, and even under the Pharmaceutical Affairs Act, the pharmaceutical products likely to cause harm to the public health are obligated not to be manufactured. In violation of this obligation, the Defendant Limited Liability Company manufactured and supplied 600 contact, a defective pharmaceutical product, 600.

In addition, Defendant Limited LLC has a duty to pay continuous attention to the safety of the drug supplied by it, and to give reasonable explanation and warning to consumers in order to prevent such danger if the risk of the drug is discovered, and to suspend the manufacture, sale, and manufacture alternative drugs in the case of other alternative drugs. On November 9, 200, the Korea Food and Drug Administration (hereinafter “Korea Food and Drug Administration”) received notification from the Korea Food and Drug Administration (hereinafter “Korea Food and Drug Administration”) to voluntarily suspend the manufacture, import, and sale of the drug contained in the PPA. Accordingly, even if the PPA knew that the occurrence of the PPA is increased, it was negligent that the PPA did not take appropriate measures against such risk.

As the deceased died due to the above negligence of the defendant Yang LLC, the defendant Yang Yang LLC was liable for tort, and even if there was no negligence, the manufacturer and the seller are responsible for the damage suffered by the deceased and the plaintiffs.

If the defect of goods, etc. provided to consumers causes or is likely to cause danger or injury to the life, body, etc. of consumers, the business operator under the Complement Consumer Protection Act was obligated to take necessary measures, such as removal, destruction, etc. of the relevant goods, etc., but the defendant limited liability, upon recognition of the risk of contact 600, which is a drug containing PPA, continuously manufactured contact 600 and did not remove or destroy contact 600. According to the consumer damage compensation standards under Article 12(2) of the Consumer Protection Act, the consumer protection law and the aforementioned compensation regulations do not require the business operator's intent and negligence. Thus, the defendant limited liability is liable for negligence, and the defendant limited liability bears the duty to compensate the damage suffered by the deceased and the plaintiffs.

【Defendant Yang LLC indicated that “this product may receive compensation pursuant to the public notice of the Ministry of Finance and Economy in the manufacture and sale of Contac 600.” According to the consumer damage compensation standards above, in the case of a side effect of a medicine, it shall be compensated for medical expenses, expenses, and wages. In the case of a side effect of a medicine, a guarantee contract was established between the plaintiffs and the defendant Yang LLC to guarantee that the purchase of Contac 600 marked as above does not do any harm if the Contac 600 normally uses the Contac 600. Thus, the defendant Yang LLC is liable to compensate for the damage suffered by the deceased and the plaintiffs pursuant to the above guarantee contract.

B. Claims against Defendant Republic of Korea

The Food and Drug Administration belonging to the Defendant Republic of Korea did not designate contact 600, a PPA-containing-containing-containing-containing-containing-containing-containing-containing-containing-related drug as “o- or abused-related drug.” In violation of Article 56 subparag. 11 of the Pharmaceutical Affairs Act prohibiting “manufacture of drugs, etc. that are likely to cause harm to national health,” and was negligent in manufacturing and selling contact 600, which is likely to cause harm to national health. In addition, in violation of the standards stipulated by the U.S. Food and Drug Administration (FDA; hereinafter “UFDA”), the Defendant’s Food and Drug Administration allowed distribution of contact 600, which does not exceed 100 g of maximum volume per day, in violation of the standards stipulated in the U.S. Food and Drug Administration (FDA; hereinafter “U.S.), thereby failing to perform its duty to prevent danger and injury to consumers under the Consumer Protection Act, and failing to take measures such as collecting and destroying contact 600, which is likely to cause harm to consumer life and body.

The Food and Drug Administration did not take appropriate measures with regard to contact 600, which is a reduction chemical containing PPA, after the research of the towing that PPA increases the risk of a stroke, and if the Food and Drug Administration took appropriate measures required by the Pharmaceutical Affairs Act and the Consumer Protection Act, the Deceased did not use contact 600, and so, the Deceased could not die due to stroke stroke.

The above violation of the Pharmaceutical Affairs Act and the Consumer Protection Act by the Food and Drug Administration constitutes "where a public official is in the course of performing his/her duties and causes damage to another person by intention or negligence in violation of the statutes" under Article 2 of the State Compensation Act, and the defendant Republic of Korea is liable for tort, and the deceased and the plaintiffs are liable for compensation

3. Determination on common issues with the Defendants

A. Whether the Deceased used contact 600 on December 1, 2003, which was around the time of the instant accident

갑 제10호증, 갑 제11호증, 갑 제21호증, 갑 제22호증, 갑 제27호증의 각 기재 및 영상에 의하면, 망인의 남편과 딸인 원고들이 망인이 2003. 12. 1. 저녁에 콘택 600 1정을 복용하였다고 진술하고 있는 사실, 2003. 12. 2. 망인에 대한 응급개두술을 시행한 명지병원 의사 소외 3은, 2003. 12. 17. 망인의 출혈은 자발성출혈로 판단되고 원인은 명확히 규명되지 않았으나 일시적 혈압상승이 관여하였을 것으로 추정된다는 소견을 밝혔고, 2005. 8. 31. 망인의 보호자가 내원하여, 망인의 수술직후 주치의가 수술중 피가 잘 멎지 않았다며 다른 약을 복용했냐고 질문한 데 대하여 음주와 감기약을 복용했다고 대답했다고 진술하는데, 당시의 상황에 대하여 정확히 기억나지는 않으나 방사선검사와 진료기록 등을 면밀히 검토하면 망인의 뇌출혈 양상이 혈액응고장애로 인한 출혈의 가능성이 있고, 수술기록에 의하면 출혈과 함께 심한 뇌부종 등이 있었다는 점 등을 고려하면, 망인의 보호자의 위 진술 내용이 충분히 적합한 내용이라고 사료된다는 소견을 밝힌 사실, 망인이 복용하였다는 콘택 600 캡슐에 사용기한이 2004. 9. 7.로 기재되어 있는 사실을 인정할 수 있는바, 위 인정사실에 콘택 600의 경우 일반의약품으로 우리나라 가정에서 코감기 등에 자주 사용하고, 한 통에 10캅셀이 들어있어 구입 후 사용하고 남은 콘택 600은 가정에 보관하고 있다가 나중에 사용하는 사정이 있는 점, 아래에서 보는 바와 같이 콘택 600에 포함된 PPA는 출혈성 뇌졸중을 일으킬 위험성이 있고, 망인도 출혈성 뇌졸중으로 사망한 점 등을 더하여 보면, 망인이 2003. 12. 1. 저녁에 감기로 콘택 600 1정을 복용하였다고 인정함이 상당하다.

B. Whether contact 600 is a defective drug

(1) The allegations of the parties

The plaintiffs asserted that Contac 600 was defective in light of the technical level and economic feasibility around December 2003, which was at the time when Contac 600 was used as Contac 600, which was the time when Contac 600 was used by the deceased.

The defendants asserts that all kinds of medicine have a permissible side effect, and the usefulness of contact 600 also has a side effect, so it cannot be deemed to be defective. Further, the result of the research conducted at the Geil University of the United States cannot be said to have a correlation between a cold medication containing a PPA of less than 100§¯ a day maximum intake and a stroke, and that there is a defect at least 600 when considering that the report on the research conducted under the direction of the Food and Drug Administration (the "Seoul University Research" was submitted to the Food and Drug Administration by the PPA as the responsible researcher of the PPA and the stroke, the correlation between the cold medication of PPA and the stroke, which were submitted to the Food and Drug Administration on June 2004, it cannot be said that there was a defect at the point of 600 when the deceased stroke 600 mar mar mar mar mar.

Dozed Facts

The following facts may be acknowledged in light of the evidence Nos. 4 through 6, Eul evidence No. 1, 2, Eul evidence No. 2-1, 2, Eul evidence No. 3-5, Eul evidence No. 5, Eul evidence No. 6-1, 2, Eul evidence No. 7 through Eul evidence No. 12, Eul evidence No. 17 through Eul No. 20, Eul evidence No. 17 through Eul evidence No. 13, Eul evidence No. 14-1, and Eul evidence No. 2, Eul evidence No. 14-2:

㈎ PPA의 약리학적 특성, 연혁 및 미국에서 PPA와 출혈성 뇌졸중과의 상관관계를 밝히기 위한 연구를 하게 된 경위

① The PPA acts to alleviate breathesis (a phenomenon in which the space inside the inside is narrower because the partitionss in noses and the inner walls are gradually cut off for many reasons) by directly stimulateing the sub-principal to the sub-principal organ with a synthetic chronic neutism, and shall act to suppress food motivation by stimulating neutism. The case holding that even in the case of PPA where the leutism and the leutic leutism were reported to the leutic leutic leutism, which are similar to the PPA, and the above ingredients can be used for the reduction medication as the sub-principal neutism, and the leutic leutic leutism and blood pressure increase. While the leutic leutic leutic leutic leutic leutical leutic leutism and the leutic leutic leutic leutic lephuss were reported to the PPA, the level of 10th and the lephic lein leus.

② The PPA was used as a pharmaceutical product developed in the 1940s. Korea was introduced in around 1966. Since 1979, at least 30 cases research reports were made on the outbreak of cerebrovascular after taking advantage of the PPA. Among them, most cases were using the PPA as a food suppression, and some cases were related to the PPA contained in the pPA.

③ In addition to the above case studies, epidemiological research was conducted between PPA and stroke in the United States on 1984, and this epidemiological research revealed that there was no relationship between PPA and stroke.

④ Since then, there was a suspicion that PPA may cause a strokeal brain stroke, the U.S. FDA agreed to study the correlation between PPA and brain strokes with the cooperation of the US pharmaceutical company on 1992 by integrating the results of the research conducted in relation to the existing PPA and the abnormal response report reported to the U.S. FDA. In accordance with the aforementioned research plan, the PPA requested a research conducted in accordance with the aforementioned request (hereinafter “PPA”) to the U.S. A. PPA’s department of PPA, and a report prepared on the results of the research.

⑤ From 192 to 194, the research plan was formulated by the research institute. At the time of the establishment of the research plan, the correlation between women who take the PPA as food suppressions and brain strokes with the pPA is being discussed, and the PPA's effects are examined first. The correlation between the pPA's clothes and strokes in male and female between the age of 18 to 49, and the correlation between the pPA's pPA's clothes and strokes, in the same target group inside the territory of Korea, the correlation between the PPA's products containing the PPA(s) and the strokestrokes, and the correlation between the women between the age of 18 to 49, the PPA's first pPA's strokes and brain strokes and strokes.

④ At 43 U.S. 43 hospitals, the research team consisted of 1,376 patients suffering from her propopa and 702 patients suffering from her brain-dead, and her 1,376 patients extracted from her brain without her intent, according to the telephone exchange bureau, gender, race, and age, and compared the group with her even number in statistical studies.

7. As a result of the foregoing statistical research, the research team of the TPA concluded that PPA would increase the risk of the outbreak of strokes, and submitted a preliminary report stating such results to the U.S. FDA around April 200, and the main contents of the said preliminary report are as follows.

In the case that the association is based on the entire target (referring to the whole target of research without distinction between South and North) of the research institute, the correlation between the stroke and the entire PPA (including both reduction medication and food bath suppressions) used within 3 days has been turned into 1.49 (95% trust section 0.84-2.64). The correlation between the reduction medicine in the PPA was found to be 1.23 (95% trust section 0.68-2.24) and the response risk with the response risk level 15.92 (reliance section 15.138-138.48).

In the event that a person is a female, the correlation between the entire PPA (including both the reduction of weather and the control of food bath) used for not more than three days and the blood stroke, was found to be the response risk level 1.98 (95% trust section 1.00-3.90), the response risk level is 1.54 (95% trust section 0.76-3.14) and the response risk level is 1.54 (95% trust section 0.76-3.14). The correlation between the pPA-containing-containing suppression is also 16.58 (95% trust section 1.5%) (1.51-182.21).

The correlation with the entire PPA, which takes place within 3 days from blood strokes and strokes, has been 0.62 (95% trust section 0.20-1.92). The correlation between the reduction of strokes containing PPA was 0.62 (95% trust section 0.20-1.92) and response risk was 0.62 (95% trust section 0.20-1.92) (in the case of south, the difference between the pPA uniforms is limited to the reduction of strokes), and the correlation with the pPA-containing-containings suppressions was not measured because there was no patient group and large group.

㉣ 대상자들의 기준일 복용량과 그 전날 복용량의 총합계의 중앙값은 75mg이고, 중앙값 이상을 복용한 경우에는 중앙값에 미치지 못한 경우보다 상대적으로 위험도가 높은 것으로 나타났다.

㈏ 예일대 보고서를 제출받은 미국 FDA의 조치

① On October 19, 200, the U.S. FDA convened an advisory committee (NDAC) on non-bruptive drugs that need to be prescribed by doctors on October 19, 200, and the members of the advisory committee determined that the PPA was related to the risk of strokeing stroke, when using the PPA as a food bath control system. There were many opinions that the PPA could not be determined more than the opinion that it is related to the risk of strokeing stroke.

However, it was finally concluded that the PPA is not safe to use it as an OTC preparation (over-the-counter drugs, over-the-counter-the-counter marketer's reduced drug) because there is a correlation between PPA and strokes.

② On November 3, 200, the U.S. FDA notified the manufacturers of the PPA of the result of its meetings of the PPA, took measures to remove the PPA from all pharmaceutical products on November 6, 2000, and requested all pharmaceutical companies not to market drugs containing the PPA, but did not take measures to enforce the reduction in the PA.

㈐ 예일대 연구 발표 이후 다른 나라의 조치

① At the time of August 200, the United Kingdom, Spanishs, and Japan had the maximum daily uniform capacity of PPA 100 g, which is used for a reduction drug, been 100 g below that of the United States and did not take measures of suspension of sale and recommended attention in use. Japan, around August 2003, ordered pharmaceutical companies to revise additional terms and conditions of caution in use, and to convert Schlage, which is known as more safe from PPA-containing drugs, into a drug containing Schlage.

② Malaysia, Mexico, Brazil, Austria, etc. suspended the sale of drugs containing PPA after the publication of the preliminary report, however, in Germany, Switzerland, and Italian, there was no prevention of the sale of drugs containing PPA (in particular, pPAs) until the date of closing argument in this case.

㈑ 우리나라 식약청의 조치

① On November 9, 200, the result of the foregoing preliminary survey reveals that the PPA’s correlation with stroke is unclear, and thus, the Food and Drug Administration recommends domestic manufacturers to temporarily suspend the manufacture and sale of the PPA-containing-containing-containing-containing-containing drugs. On July 25, 2001, the Food and Drug Administration prevented the use of a composite product, the maximum volume of which exceeds 100§¯ among the PPA-containing-containing-containing-containing-containing-containing drugs, and the maximum volume of which per day exceeds 10§¯.

② The Food and Drug Administration determined that it is difficult to view that the maximum volume per day does not exceed 100m of pPA-containings solely based on the results of a celebry-related research to have a correlation with strokes, and thus, it is difficult to view that there is a correlation between strokes and strokes, and under the direction of the Food and Drug Administration, determined to conduct an epidemiological investigation on the relationship between strokes in the PPA-containings and strokes used by professors of Seoul National University as a responsible researcher, with the participation of professors of the PPA-containings and strokes.

③ On June 25, 2004, the research team reported the results of the final research to the Food and Drug Administration. The results showed that for PPA clothes (limited to PPA contained in the cold medication in Seoul; hereinafter the PPA in Seoul as a result of the research, both PPA refer to the PPA contained in the cold medication) within 14 days, the response risk level for all subjects was 2.14 (95% trust section 0.4-4.84). The response risk level for men was 1.36 (95% trust section 0.45-4.84). Women's response risk level was 3.86 (95% trust section 1.08-13.80). The response risk level for the PPA was 5.36% (5% trust section 95%) in the case of uniforms within 30 days, 5.45% in the case of women's reliance and 95% in the total PPA, 5.75% in the case of women's reliance and 95.7.25% in the case of reliance.7.45.7.7.4.6.7.4.7

④ According to the results of the foregoing study, the Food and Drug Administration ordered the suspension of sale and the destruction of reduction drugs contained in the PPA on August 1, 2004 on the ground that the uniforms of the PPA increase the risk of strokeing strokes in statistical studies of the PPA and deliberation by the Central Pharmaceutical Affairs Council, and that there are alternative drugs.

㈒ 2000. 1. 31.경 피고 유한양행이 제조한 콘택 600의 사용설명서에 기재된 콘택 600의 효능, 성분 및 함량, 용법, 사용상의 주의사항, 부작용은 다음과 같다.

(1) Efficacy: Drugs developed by SmithKline Beecam of the United States, which have efficacy to alleviate the initial symptoms of the climate, such as reproductive, mustath, snow, and coding force.

(2) Ingredients: 40§¯ of Masan PPA, 3.2§¯ of Marain acid clurine (morum) and 0.2§¯ of Belgium, 0.2§¯ of Belgium.

(3) pact: Shall be taken once in adults, and then taken twice a day (supper, pupper).

(4) Cautions for use.

1. He/she shall not administer any other internal medicine containing the PPA to a patient who is administering other internal medicine (such as a cold medication, non-chloythy medication, spathy resistant medicine, etc.);

2. The patient with high blood pressure shall be prudently administered;

(5) Side effects.

1. Mental and new boundary: Dropical stroke;

㈓ 2001. 7. 25. 식약청의 지시에 따라 개정된 콘택 600의 사용설명서에 기재된 콘택 600의 사용상의 주의사항, 부작용은 다음과 같다.

(1) Cautions for use.

1. Warning;

As a result of the U.S. preliminary survey, it is believed that the use of biphenylpropers as a food bath control system may cause strokes from women, so this drug shall not be used for the purpose of food bath control.

2. Masc centimeters not to be administered for patients taking other internal drugs containing chlorinatedpropherpropers (pactaccine, non-chlorate drugs, sloakly resistant drugs, etc.), patients with stroke-stroke diseases, patients with high blood pressure, patients with heart disorders, and patients with functional disorder in the upper-board line;

(2) Side effects.

1. Mental and new boundary: Dropical stroke;

3. Interconnection: It shall not be taken together with the sun-dried spathy, and internal resistant drugs containing anti-sacrhydydydydydydydydys (pydydydydydydyd, sydydydyd, al

④ The treatment of excessive injection is deemed to be likely to increase the risk of strokes by means of excessive injection in a foreign country, so it shall not be taken into account as it is deemed that the risk of strokes is high.

【Judgment

㈎ 의약품의 결함 판단에 있어서의 특수성

As a general synthetic chemical, drugs are treating diseases by causing a chemical reaction within human body, while they are manufactured through a normal manufacturing process, there are essentially adverse effects on human body. Therefore, in the case of drugs, products with safety within the expected range in light of the level of technology, economic feasibility, etc. at the time of distribution should be manufactured, and if they fail to meet such safety, they should be evaluated as “defect.” In determining whether there is a defect, comprehensive consideration should be given of the risk of drugs, possibility of safe alternative medicines even if there exists the same effect, economic cost of alternative medicines manufacturing, awareness of the risk of using medicines, and possibility of avoiding risk.

㈏ 앞서 살핀 바에 의하면, PPA 성분이 출혈성 뇌졸중을 유발할 위험의 가능성이 있음은 이미 밝혀졌다고 할 것이고, 감기약 제조업자로는 PPA와 비슷한 효능을 가지는 슈도에페드린 성분으로도 감기약을 제조할 수 있으며 그러한 제조가 PPA 함유 감기약에 비하여 더 큰 비용이 필요한 것은 아닌 사실, 2000. 이후의 지식수준에서 살펴 볼 때 슈도에페드린 성분은 PPA 함유 감기약 보다는 보다 안전하다고 인정되는 사실을 인정할 수 있고, 이에 더하여 일반 소비자인 망인으로서는 PPA가 함유된 감기약이 출혈성 뇌졸중의 위험성이 3배 이상 증가시킨다는 사실을 알았더라면 PPA 함유 감기약을 복용하지 않았을 것이라는 점을 더하여 보면, 망인이 콘택 600을 복용한 시점인 2003. 12.경 콘택 600은 유통당시의 기술수준과 경제성 등에 비추어 기대가능한 범위 내의 안전성을 갖추지 못한 결함 있는 의약품이라고 할 것이다.

However, the negligence of the 600 manufacturer's Contact 600 manufacturer's negligence can not be found to be responsible for tort or product liability under the Product Liability Act, and the establishment of such liability shall be determined separately below.

(c) Difference between contact 600 and the deceased’s death due to cerebral blood.

According to Gap evidence No. 14, Gap evidence No. 21, Eul evidence No. 22, Eul evidence No. 24, Eul evidence No. 27, Eul evidence No. 14-2 and the court of first instance, according to the overall purport of the arguments on the fact that even if the PPA is taken out at a reduced amount of less than 100m of daily intake, the risk of stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke 60m and 15m of stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke ste.

As shown in the above facts, it was revealed that the pPA-containing drugs increase the risk of the stroke stroke stroke stroke stroke stroke stroke 600, and the deceased was stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke ss

The Defendants asserted that the Deceased had drinking at the time of the instant accident, and that there was no dispute between the parties to the instant accident, and that the Deceased appeared to drink until the new wall. In light of the fact that at the time of the instant accident, two the Deceased was absent for a long time, and that he was seen to have blood due to the mouth, the Deceased was under the influence of alcohol, and that there was a stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke, and the Deceased was under the influence of alcohol at the time of the instant accident, and the fact that stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke s No. 14.

4. Determination on the claim against Defendant limited liability

A. Determination as to general tort liability

(1) As a result of statistical research, it was revealed that PPA increased the risk in the case of women, especially brain stroke, and that Food and Drug Administration prohibited the manufacture and sale of reduction drugs containing PPA based on these results, it cannot be said that the Defendant limited liability manufacturing the reduction drug containing PPA constitutes tort. However, it cannot be said that the Defendants knew or could have known the risk of PPA in light of the level of technology at the time of manufacturing and selling Contac 600 in Contac 600, and only if the Defendants did not have expertise because they did not have expertise because they were able to substitute PPA as a safe substitute for the PPA, but did not have expertise, they constitute tort liability for Defendant limited liability for tort.

Whether there can be a correlation between the reduction of the chemical substance contained in PPA and the stroke of the stroke solely on the BPA research

The plaintiffs asserted that there was a correlation between the reduction of the PA-containing-containings and the stroke of the stroke, and that the U.S. FDA also recommended the suspension of manufacture and sale of medicines containing the PPA-containings on such premise.

The research team in the PPA concluded that the PPA had a correlation with the stroke-stroke, and the fact that the PPA was prohibited from manufacturing and selling medicines containing PPA in the U.S. FDA after the research in the PPA was conducted.

On the other hand, according to the fact-finding 6, No. 1, No. 2, No. 7 and No. 12, No. 17 and No. 2, No. 17 and No. 10, No. 8 and No. 13, No. 14, and No. 14 were found to be hard to recognize that there were no significant correlation between the PPA 10, No. 44444 and No. reliance on the PPA, and that there were no significant correlation between the PPA 10, No. 5 and No. 5, No. 14, No. 5, and No. 5, No. 14, No. 7, No. 5, No. 5, and No. 5, No. 5, No. 5, No.

Therefore, it cannot be said that there was negligence on the part of the defendant limited liability company, since it did not discontinue the manufacture and sale of contact 600 containing each PPA after the disclosure of the preliminary report.

• Whether the Defendants was negligent in failing to provide reasonable explanations, instructions, warnings, etc. to ordinary consumers in relation to Contac 600 products after the disclosure of the report of the Madern

In the manual of 600 of the deceased's clothes at the time of the accident of this case, it is difficult to recognize that the 60-day maximum intake of the PPA is 80§¯ because of side effects; the 600-day maximum intake of the deceased is 80§¯; the 600-day contact manual applied at the time when Contac 600 was covered by high blood pressure patients, stroke-stroke-stroke, stroke-stroke, and stroke-stroke-stroke, and that the 60-day container was not covered by other PPA-containing-containing-containing-related drugs, and that the 60-day warning of the 60-day general brain-related drugs was not given to the 60-day patient or stroke-stroke-stroke-stroke, and that the 60-day container's general brain-related risks were not known to the patient or stroke-stroke-stroke.

Finally, it is difficult to view that the defendant Yang LLC knew or could have known that 600, which is the reduction drug containing PPA, was at the time of September 7, 2001 (the video of the evidence No. 10, the contact 600, which the deceased took, was written on September 7, 2004, and that the use period was manufactured and supplied to the market around September 7, 2001) or around December 1, 2003, when the deceased took contact 60, which was used to cover the Contac 600, which is the reduction drug containing PPA, was negligent in failing to provide reasonable explanation, instruction, warning, etc. to ordinary consumers in relation to the Contac 600 product, and therefore, it is difficult to find that the plaintiffs' assertion that the defendant Yang LLC committed a tort against the defendant Yang LLC is without merit.

B. Determination on the liability under the Product Liability Act

(1) According to the Addenda to the Product Liability Act, the Product Liability Act enters into force from July 1, 2002, and the Product Liability Act applies to the product that was first supplied by the manufacturer after the enforcement of the Product Liability Act. Thus, there is no proof that 600 contact 600, which the Deceased manufactured and supplied after July 1, 2002, is a medicine that the Defendants manufactured and supplied. Rather, as seen earlier, 600 contact 60, which the Deceased recovered, appears to have been manufactured and supplied around September 7, 2001, and thus, the Plaintiffs’ assertion on the premise that the Product Liability Act applies to 600, which was made by the Deceased, is without merit.

Shebly, we judge the Product Liability Act on the premise that the Product Liability Act applies.

As seen earlier, it is difficult for the deceased to find the existence of the defect at the level of science and technology at the time of sale by manufacturing contact 600 as well. However, according to Article 4(1)2 of the Product Liability Act, if it is proved that the existence of the defect was not discovered at the level of science and technology at the time of supplying the product, the liability for damages under the Product Liability Act shall be exempted. Accordingly, the product liability of the Defendant limited liability shall be exempted.

As to this, the plaintiffs did not take appropriate measures to prevent damage caused by the defect (the duty to observe the small product) even though they knew or could have known the existence of the defect in Contac 600 after again supplied Contac 600. Thus, the defendant limited liability did not assert such exemption. However, there is no evidence to prove that the defendants knew or could have known the existence of the defect in Contac 600 when Contac 600 is recovered from Contac 600, and as seen above, after the Seoul Building Research Institute was published on July 28, 2004, the plaintiff knew or could not have known the fact that the defect occurred in Contac 600 when Contac 600 is recovered from Contac 60,000. Accordingly, the defendants could not have caused damage to the deceased and the plaintiffs by neglecting the duty to observe the product before July 28, 2004.

In addition, if 600 contact 600, which the deceased her clothes, was manufactured around September 7, 2001, the deceased shall take measures to compulsorily recover 600 contact 600 already sold in order to prevent the deceased from taking away 600 contact 600, and it is difficult to see that the level of knowledge on the PPA, which is the date of the accident in this case, was revealed that there was a risk to the extent of compulsory recovery of reduction of air drugs containing the PPA in relation to the PPA.

Secondly, the plaintiffs' assertion that the Product Liability Act applies to contact 600 that the deceased's uniform 600, is without merit, and even if the Product Liability Act applies, the defendants are exempted from liability. Therefore, the plaintiffs' assertion is without merit.

C. Determination of strict liability under the Consumer Protection Act

구 소비자보호법(2006. 9. 27. 법률 제7988호로 소비자기본법으로 전문개정되기 전의 것) 제12조 제2항 은 “국가는 소비자와 사업자간의 분쟁의 원활한 해결을 위하여 대통령령이 정하는 일반적 소비자피해보상기준에 따라 품목별로 소비자피해보상기준을 제정할 수 있다.”고 규정하고, 이에 따라 제정된 소비자피해보상규정 제1조는 “이 규정은 소비자보호법 제12조 제2항 의 규정에 의하여 소비자와 사업자간의 분쟁의 원활한 해결을 위하여 ‥‥품목별로 소비자피해를 보상할 수 있는 기준을 정함을 목적으로 한다.”고 규정하고 있을 뿐, 사업자의 무과실책임을 규정하고 있지는 않으므로, 피고 유한양행이 망인과 원고들에 대하여 무과실책임을 진다는 원고들의 주장은 이유 없다.

D. Determination on the liability for guarantee agreement

According to Gap evidence No. 32, although it is acknowledged that "this product may be compensated in accordance with the public notice of the Ministry of Finance and Economy" is stated on the packaging of contact 600, the above phrase alone is insufficient to recognize that the guarantee contract was established to the effect that the contract between the plaintiffs and the defendant limited liability company guarantees that no harm shall be inflicted upon the normal use of contact 600, as alleged by the plaintiffs, and there is no other evidence to acknowledge it. Thus, the above argument by the plaintiffs is without merit.

5. Determination on Defendant Republic of Korea

A. In general, when a public official exercises his/her authority, he/she bears an official duty to prevent damage to the people or to take into account the safety of the people. A public official’s duty to maintain order inside an administrative agency immediately without relation to the interests of the people among the duties imposed by the public official in performing his/her duties, or his/her official duty is not for the benefit of the people, but for the sole purpose of promoting the overall interest of the public, if the public official’s duty is not for the benefit of the people, but for the sake of promoting the overall interest of the public, the public official’s duty to compensate for damage to the people in violation of his/her official duty is not recognized. On the other hand, if the contents of his/her official duty were established entirely or incidentally in order to protect the safety and interest of the people of society, the State or local government is liable to compensate for damage suffered by the victim due to the public official’s violation of his/her official duty (see Supreme Court Decision 97Da36613

B. The provisions of the former Pharmaceutical Affairs Act (amended by Act No. 7148 of Jan. 29, 2004) and the former Consumer Protection Act are considered.

[Pharmaceutical Affairs Act]

Article 1 (Purpose) The purpose of this Act is to prescribe matters concerning pharmacists and to contribute to the improvement of national health by ensuring their propriety.

Article 56 (Prohibition of Manufacturing, etc.) Any of the following drugs shall not be sold, nor manufactured, imported, stored, or displayed for sales purposes:

11. Medicines falling under Article 69 (1) 4.

제69조 (허가취소와 업무의 정지등) ① 의약품등의 제조업자나 그 수입자 또는 약국개설자나 의약품의 판매업자가 다음 각 호의 1에 해당할 때에는 의약품등의 제조업자나 수입자에 있어서는 식품의약품안전청장이 ‥‥ 그 허가·승인·등록의 취소 또는 제조소를 폐쇄하거나 품목제조금지 또는 품목수입금지를 명하거나 기간을 정하여 그 업무의 전부 또는 일부의 정지를 명할 수 있다.

4. When he/she manufactures, imports, or sells drugs, etc. which caused or are likely to cause harm to the national health, and drugs, etc. which are deemed to have no efficacy;

【Consumer Protection Act】

Article 1 (Purpose) The purpose of this Act is to prescribe the duties of the State, local governments and enterprisers and the roles of consumers and consumer organizations in order to protect the fundamental rights and interests of consumers, as well as to prescribe fundamental matters for the comprehensive promotion of consumer protection policies, thereby improving and rationalizing consumers' lives.

(1) Where it is deemed that any defect in goods and services provided by a business operator causes or is likely to cause any danger or injury to the safety of consumers' lives, bodies and property, the head of a central administrative agency may order the removal, destruction, repair, exchange, or refund of the relevant goods, or the prohibition of manufacture, import, or sale thereof, or the prohibition of provision of the relevant services, or order the improvement of the relevant goods and services or other necessary measures: Provided, That where it is deemed that urgent and substantial danger or injury to the safety of consumers' lives, bodies and property causes or is likely to cause serious danger or injury, the procedures prescribed in the main sentence may be omitted.

C. Considering the purport, purpose, and purpose of the former Pharmaceutical Affairs Act, the former Pharmaceutical Affairs Act, the Consumer Protection Act, or the Framework Act on Consumers, and the duties borne by the public officials of the Food and Drug Administration or the public officials of the central administrative agency in charge of consumer issues, the former Pharmaceutical Affairs Act or the former Consumer Protection Act, which were in force at the time when the deceased Contac 600 was used, to promote the overall interest of the people by regulating the manufacture, sale, import, etc. of drugs that may pose a risk to the general public’s health, and by regulating goods or services that may pose a risk to the safety of consumers’ lives, bodies, and property, and cannot be deemed as a provision directly protecting the safety and

Therefore, even though public officials of the Food and Drug Administration or public officials of the central administrative agency in charge of consumer issues were dangerous drugs or consumption products, they did not regulate them, and the fact that if they were to regulate them, the people could not use the dangerous drugs or consumption products, the state does not bear the responsibility for damages to the people.

D. The plaintiffs claim that a public official of the Food and Drug Administration or a public official of the central administrative agency in charge of consumer issues, who did not regulate PPA-containing drugs, such as contact 600, is negligent. In the event that a state of imminent and serious danger has occurred or is likely to occur with respect to the people's life, body, property, etc., even if there are no grounds in the formal sense of law, the plaintiffs may recognize the State or the relevant public official

However, as seen earlier, it is difficult to see that the reducedest intake of less than 100§¯ of PPA per day is likely to increase the risk of running stroke, and there was a need to research whether there is a stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke.

E. Meanwhile, as long as the results of the study that when the PPA was used for taking not less than 75m or more of 75ms in the towing report, the plaintiffs published a relatively high level of risk of stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke stroke s to 75m or more unless there is a special reason, the KPA should be suspended from manufacturing and selling medicines using not less than 75m or stroke stroke 600m or less per day in the Food and Drug Administration. However, as seen earlier, the PPA was included 40m or more in the PPA stroke 600m or more, and there is no evidence to acknowledge the maximum risk of 10m or more of stroke stroke stroke stroke stroke stroke stroke stroke stroke s to the above 10m.

6. Conclusion

Therefore, the plaintiffs' claim of this case shall be dismissed in its entirety as it is without merit, and the judgment of the court of first instance is just, and the plaintiffs' appeal is dismissed in its entirety as it is without merit. It is so decided as per Disposition.

[Attachment]

Judges Lee Gyeong-Gyeong (Presiding Judge)