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의료기기의 결함으로 인한 손해배상책임과 미국 연방법 우선 적용 이론에 관하여 (The Liability for Unsafe Medical Product and The Preemption Clause of Medical Device Act)

  • 김장한
    • 의료법학
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    • 제15권2호
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    • pp.63-89
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    • 2014
  • In 1976, the Dalkon Shield-intrauterine device injured several thousand women in U.S.A. which caused the changes of medical deivce regulation. The Medical Device Regulation Act or Medical Device Amendments of 1976 (MDA) was introduce. As part of the process of regulating medical devices, the MDA divides medical devices into three categories. The class II, and III devices which have moderate harm or more can use the section 510 (k), premarket notification process if the manufacturer can establish that its device is "substantially equivalent" to a device that was marketed before 1976. In 21 U.S.C. ${\S}$ 360k(a), MDA introduced a provision which expressly preempts competing state laws or regulations. After that, the judicial debates had began over the proper interpretation and application of Section 360(k) In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that manufacturer approved by the Food and Drug Administration (FDA)'s pre-market approval process are preempted from liability, even when the devices have defective design or lack of labeling. But the Supreme Court ruled in Medtronic Inc. v. Lora Lohr that the manufactures which use the section 510 (k) process cannot be preempted and in Bausch v. Stryker Corp. that manufactures which violated the CGMP standard are also liable to the damage of patient at the state courts. In 2009, the Supreme Court ruled in Wyeth v. Levine that patients harmed by prescription drugs can claim damages in state courts. This may cause a double standard between prescription drugs and medical devices. FDA Preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding Food and Drug Administration approved products. FDA Preemption has been a highly contentious issue. In general, consumer groups are against it while the FDA and pharmaceutical manufacturers are in favor of it. This issues also influences the theory of product liability of U.S.A. Complete immunity preemption is an issue need to be more declared.

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차량용 블랙박스와 운전자의 사생활 보호 : 미국에서의 사고기록장치(Event Data Recorder : EDR) 규제를 중심으로 (Car Black Box and the Protection of Drivers' Privacy : In Light of the Regulation on EDR(Event Data Recorder) in U.S.A.)

  • 이경규
    • 한국IT서비스학회지
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    • 제12권2호
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    • pp.171-184
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    • 2013
  • Frequently faced with dangerous situations, for evidentiary purpose in case of civil and criminal liability challenges, car drivers in Korea have been armed with so-called 'black boxes'; however, which are just video recorders in vehicles rather than real 'black boxes' that are equipped in the airplanes. In the United States, they are called EDRs(Event Data Recorders), more technically, which means that they record data of events happened while driving, such as velocity changes, airbags deployment, seatbelt wearing etc. just like in the airplanes. EDR technology is quickly becoming more advanced, more widely available, and less expensive; however, new concerns are emerging : the privacy of drivers. In U. S., vehicle manufacturers and insurance companies and the governmental agencies including the courts and legislatures are the main parties in terms of the EDR concerns. In order to determine the best way to regulate EDR, it is necessary to balance all the merits, such as safety, privacy, truth, justice and efficiency, to support a legal framework regulating the EDR concerns. This article, in light of the regulation of EDR and experience therof in the United States, examines EDR technology itself, particularly with respect to the automobile industry, describing its history, its current state, and trends that may change it in the future; and explains how the National Highway Transportation Safety Agency (NHTSA), legislatures, courts have approached EDR data. At the early stage of regulation on EDRs in Korea, examining U. S. legal framework and usages would help for successful establishment of legislation and regulation.

중재판정의 취소와 집행거부에 따른 실무상의 유의점 - 공서위반을 중심으로 - (Practical Implications in the Setting Aside and the Refusal of Enforcement of Arbitral Award - Focusing on the Public Policy -)

  • 오원석;김용일
    • 무역상무연구
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    • 제35권
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    • pp.101-124
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    • 2007
  • This paper purposes to examine the setting aside and the refusal of enforcement of arbitral awards and their implications for practitioners. The aim of challenging an award before a national court at the seat, or place, of arbitration is to have it modified in some way by the relevant court, or more usually, to have that court declare that the award is to be disregarded (i.e. "annulled" or "set aside") in whole or in part. If an award is set aside or annulled by the relevant court, it will usually be treated as invalid and accordingly unenforceable, not only by the courts of the seat of arbitration but also by national courts elsewhere. This is because, under both the 1958 New York Convention and the UNCITRAL Model Law, the competent court may refuse to grant recognition and enforcement of an award that has been "set aside" by a court of the seat of arbitration. The New York Convention set out various grounds for refusal of recognition and enforcement of an arbitration award. The provisions of the Model Law governing recognition, enforcement or setting-aside of awards are almost identical to those set out in the Convention. Especially, the New York Convention and the Model Law state that an arbitral award may be refused and set aside if a national court of the place of arbitration finds that the award is in conflict with the public policy of its own country. Each state has its own concept of what is required by its "public policy". It is possible to envisage, for example, a dispute over the division of gaming profits from a casino. In many states, the underlying transaction that led to the award would be regarded as a normal commercial transaction and the award would be regarded as valid. Indeed, it is a consistent theme to be found in the legislation and judical decision of many countries. If a workable definition of "international public policy" could be found, it would provide an effective way of preventing an award in an international arbitration from being set aside and refusal for purely domestic policy consideration.

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다수당사자중재의 문제점에 관한 고찰 (A Study on Some Problems in Multiparty Arbitration)

  • 김명엽
    • 한국중재학회지:중재연구
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    • 제13권1호
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    • pp.207-244
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    • 2003
  • There are many parties who connected with contracts like a contract for construction. Dispute arising from the two parties can be souled by themselves. but it grows the necessity of settlement at one effort. The meaning of multiparty arbitration is solution of mixed disputes without inconsistency through multiparty concerned. H the parses wish to settle the disputes by arbitration, they must come to an arbitration agreement. The arbitration agreement is necessary to resolve disputes autonomously, that may be in the form of a separate agreement or in the form of a clause in a contract. More ever it is resonable to view the arbitration agreement as a substantive contract in its legal nature enabling the authority for dispute resolution by the arbitrator. I had argument about who should appoint the arbitrator. That is to say, each party can appoint the arbitrator, otherwise the courts can appoint one. The basis of multiparty arbitration is focused on the factor that the courts may have the right to order the consolidation of arbitration proceedings without consent of the parties. The dispute can be settled by the arbitrators who are appointed. Appointing arbitrator is very important because it affects the party's equality. The right to appoint arbitrator shall be entitled each party in multiparty arbitration. Therefore they can appoint plural arbitrators by mutual agreement. for .reference to Rules of Arbitration of The International Chamber of Commerce, the Court shall appoint a sole arbitrator or three arbitrators in condition. The Arbitration Act of Korea dose not have the clause on multiparty arbitration including the arbitration rules. But if we have the clause enacted, it brings a situation in which both parties gain a benefit.

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미국 인터넷상표권 침해관련 법률의 변화에 관한 연구 (Evolution of Internet Trademark Infringement in the U.S.)

  • 강준모
    • 디지털융복합연구
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    • 제12권10호
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    • pp.61-71
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    • 2014
  • 인터넷의 등장에 따른 사이버스페이스의 확장이 많은 변화를 야기하고, 특히 법 영역에서 현실세계의 법체계와 충돌하면서, '사이버스페이스와 법'에 관련된 문제는 우리나라 뿐만 아니라 세계 각지에서 21세기의 가장 중요한 이슈 가운데 하나로 부상하고 있다. 인터넷이나 컴퓨터와 관련된 기술발전의 속도가 빨라지고, 디지털화와 그 결과물인 디지털콘텐츠의 중요성이 증대되고, 전자상거래가 현실세계의 거래에 버금가는 영향력을 갖게 되면서 지적재산권 관련분야의 환경도 급변하고 있다. 특허, 상표, 저작권 등 지적재산권 이용형태의 다양화와 정보 유통형태의 혁신적 발전은 더 많은 정보의 자유로운 이용을 요구하는 이용자와 그러한 환경변화에 부응하는 보호를 요구하는 지적재산권자간의 충돌을 야기하고 있으며, 새로운 유형의 정신적 창작물에 대한 보호와 규율에 대한 논의가 활발히 이루어지고 있다. 이런 상황에서 세계 정치, 경제, 법률을 이끌고 있는 미국의 지적재산권관련 법제의 전개상황을 면밀히 살펴보는 것은 우리의 이익을 지키기 위하여 필수 불가결한 활동이다.

Recognition and Enforcement of Arbitral Awards under England Arbitration Act

  • Sung, Joon-Ho
    • 한국중재학회지:중재연구
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    • 제31권3호
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    • pp.3-23
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    • 2021
  • England is a significant base for international trade in Europe, and dispute resolution through arbitration is active. Therefore, due to the geographical relationship with the European continent, the settlement of trade transactions and disputes with European countries is one of the most essential tasks. In this regard, arbitration procedures in England have been actively used for a long time. In England, dispute resolution methods through arbitration have been developed centered on merchant groups such as guilds from the 16th century and have been actively used until today. However, the arbitration procedure also had the characteristics of the common law because there was no legislation related to arbitration. Therefore, arbitration based on common law was carried out until the first half of the 19th century. In the 'Arbitration Act 1889', two types of arbitration systems, 'common law arbitration' and 'statutory arbitration' coexisted. However, in the arbitration procedure, according to the newly enacted 'Arbitration Act 1889', the arbitration agreement was binding from the time the arbitration agreement was reached. There was a way to select an arbitrator even if it was not explicitly stipulated in the arbitration agreement, and the arbitration award was quickly enforced. Arbitration under contract was preferred over common law arbitration, where withdrawal and revocation of awards were possible. However, in response to these provisions, the England courts considered the arbitration system to deprive the courts of jurisdiction, while a strengthened judicial review of arbitration procedures was done. In particular, England unified the arbitration-related laws, which had been scattered for a long time, adopted the model law, and enacted the 'Arbitration Act 1996'. Under the recognition and enforcement of arbitral awards in 'Arbitration Act 1996', Section 66 deals with the recognition and enforcement of arbitral awards and foreign arbitral awards. Section 2 of the 'Arbitration Act 1950' is inherited and used as it is. Second, it deals with the execution of arbitral awards under the New York Convention: Article 100 (New York Convention), Section 101 (Approval and Enforcement of Awards), Section 102 (Evidence Presented by a Party Seeking Recognition and Enforcement), and Section 103 (Provides Matters Concerning Rejection Recognition and Enforcement).

프랜차이즈 분쟁계약상 사전중재합의에 관한 법리적 검토 (Judicial Review on Pre-arbitration Agreement in Terms to Resolve Franchise Dispute)

  • 성준호
    • 한국중재학회지:중재연구
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    • 제29권1호
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    • pp.3-29
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    • 2019
  • A franchise business is a business in which the owners, or "franchisors," sell the rights to their business logo, name, and model to third party retail outlets, owned by independent, third party operators, called "franchisees." There are a number of features in franchising or terms in franchise agreements that may lead to disputes between franchisors and franchisees. These disputes may arise because of underlying risks in the franchise relationship, franchise agreement, or conduct of the parties. In this case, ADR is an effective way to resolve disputes in a quicker and often less costly way than having to go to court. If an agreement cannot be reached through mediation, then arbitration becomes the next step to resolving the differences. Whereas mediation is non-binding and focused on facilitating the parties to find a resolution that is acceptable to both, arbitration is binding and may result in a decision that is not acceptable to one of the parties. These situations can be resolved through experienced arbitration as arbitration allows franchisees to settle matters promptly and outside of the public eye. In addition, franchise dispute arbitration is usually less costly than going to traditional court. Considering all of these, reaching an agreement will also have typical clauses that address the issue of dispute resolution. It is again a more efficient process than going through the legal process and courts and is often less costly. By going through arbitration, the parties agree to give up their rights to pursue the dispute in the courts. However, there is a problem that the arbitration prior to the agreement and under the terms would be contrary to the restriction of jurisdiction under the "ACT ON THE REGULATION OF TERMS AND CONDITIONS" in Korea.

신용장발행은행의 독립지급의무의 실무적인 운용과 예외 (Exceptions and Practical Operations to Independent Payment Obligation of Issuer under L/C Transactions)

  • 김선옥
    • 무역학회지
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    • 제43권4호
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    • pp.89-110
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    • 2018
  • 본 연구는 신용장거래에서 은행의 독립지급의무 및 이 의무에 대한 예외적인 취급원칙과 방향에 대한 문제를 소재로 취급하였다. 독립원칙과 독립원칙에 대한 예외문제는 신용장의 본질에 관계되지만 국가마다 이러한 문제를 취급하는 태도에 차이가 존재한다. 본 연구에서는 영국에서의 태도를 분석하기 위해 독립원칙과 예외문제를 취급한 판례 중에서 지도적인 판례로 인정되는 사례를 중심으로 하여 독립원칙과 예외문제를 취급하는 영국의 입장을 분석하였다. 영국법원은 가능한 한 상인들 간에 형성되어 온 상관습을 존중하려는 입장을 취해 왔으며 독립원칙의 실무적인 적용에 있어서도 이러한 입장을 반영하여 독립원칙의 중요성을 강조하면서도 실질적으로는 개개의 사안마다 당사자의 형평을 고려하여 예외문제를 취급하여 왔다. 그러나 미국의 Sztejn 사건을 계기로 하여 영국에서도 독립원칙의 적용에 대한 태도의 변화를 보여 신용장거래에서의 사기뿐만이 아니라 기초계약에서의 사기도 독립지급의무에 대한 예외사유로서 인정하기 시작하였다. 그렇지만 독립원칙에 대한 예외의 운영방식에 따라 신용장제도의 존재의의가 상실될 우려가 있고 또한 발행의뢰인에 의해서 예외적용을 남용할 가능성도 있다는 문제점들을 감안하여 영국은 비록 사기적인 요소가 존재하지만 수익자 자신이 선의의 입장에 있는 경우에는 수익자를 보호하는 입장을 채택함으로써 예외인정과 예외의 남용문제 간의 조정을 도모하고 있다.

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외국중재기관이 중국을 중재지로 하여 내린 중재판정에 대한 중국 법원의 국적 결정기준에 관한 연구 (A Study on the Nationality Determination Criteria of Chinese Courts for Arbitral Awards Made by Foreign Arbitration Institutions in China as the Place of Arbitration)

  • 하현수
    • 한국중재학회지:중재연구
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    • 제33권2호
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    • pp.3-21
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    • 2023
  • Chinese law does not directly stipulate the criteria for determining the nationality of arbitral awards, and the Civil Procedure Law stipulates that arbitral awards are divided into domestic arbitral awards and foreign arbitral awards based on the location of the arbitration institution managing the arbitration cases. This indirectly classifies the nationality of the arbitral award based on the location of the arbitral institution. However, with regard to the nationality of eight arbitral awards in this paper made in China by the foreign arbitration institutions, the Chinese courts determined the nationality by arbitrarily selecting the criteria for the location of the arbitration institution and the criteria for the place of arbitration, except for arbitral awards made in Hong Kong. China's unclear attitude toward the criteria for determining the nationality of arbitral award has resulted not only obscures the country that can exercise the right to revoke arbitral award, but also obscures the laws and regulations applied to the approval and execution of arbitral awards. In other words, since the right to revoke the arbitral awards resides with the country of nationality of the awards, such an ambiguous attitude in China prevents the parties from responding to the cancellation lawsuit by predicting the nationality of the arbitral awards in advance. Furthermore, since China made a declaration of reciprocity reservations while joining the New York Convention, in cases where the criteria for location of the arbitral institution is applied, if the arbitration institution belongs to a contracting state, the it must apply the New York Convention to approve and execute arbitration decisions, but if it is not a contracting state, it must be approved and executed by mutual arbitration agreements or reciprocity principles. These results can lead to different results in approval and execution of the same arbitral awards depending on how the nationality is determined.

중국의 결원중재제도에 관한 실증적 연구 (An Empirical Study on the Truncated Arbitration System in China)

  • 하현수
    • 한국중재학회지:중재연구
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    • 제31권4호
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    • pp.51-70
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    • 2021
  • Chinese courts seem to be indifferent or ignorant of truncated arbitration. In other words, the Chinese court canceled the arbitration award made by truncated arbitration except for the Pingdingsan Case among the four arbitration cases related to the domestic arbitration award reviewed in this paper on the ground that it violated the composition of the arbitral tribunal or the arbitration procedure. A Chinese court has canceled the arbitration award by judging only based on the composition of the arbitral tribunal and the legal process of the violation of the arbitration procedure not by determining whether the domestic arbitration award made by the truncated arbitration meets the conditions for the application of truncated arbitration as stipulated in the Arbitration Rules. Moreover, it seems that the Chinese court made a serious error in the application of the relevant regulations in the Pingdingsan Case, which ruled that the truncated arbitration did not violate the legal process. In this case, the Chinese court admitted truncated arbitration under logic process that it was not necessary to wait until the final hearing to apply the truncated arbitraion because one arbitrator was absent before the final hearing, but the truncated arbitrator had already formed his/her opinion before the absence. However, in the case of Marshall Investment Corporation, a case related to foreign arbitration, the Chinese court rejected the approval and execution of the truncated arbitration award by strictly applying the laws and timing of the truncated arbitration. Since only one case has been identified in the main text, it is difficult to make a definitive judgment, but considering these cases, it seems to be that the Chinese courts apply different standards to domestic and foreign arbitration awards to determine the legality of truncated arbitration.