Product liability in prosthetics: Changes in the law 2016

1区 医学 Q1 Medicine Journal of Bone and Joint Surgery Pub Date : 2017-06-01 DOI:10.1302/2048-0105.63.360531
M. Foy
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引用次数: 1

Abstract

The Consumer Protection Act (1987) (CPA) makes a producer strictly liable for personal injury, death or damage caused by a defective product. Although fault is not a requirement, the consumer (patient) must prove the defect, the injury and a causal link between them. This was tested in the medical field in the case of A vs National Blood Authority (NBA) in 2001.1 A total of 117 claimants brought an action for damages under the Act arising from their infection with hepatitis C as a result of blood transfusions received after March 1988. It was claimed that the infected blood was a “defective” product within the meaning of the Act and that they were entitled to receive blood that was free from infection. The NBA argued that as there was no test for hepatitis C until April 1991, the presence of the virus in the blood could not have been expected to be detected before that time. The court found in favour of the claimants in what was perceived to be a harsh decision at the time. In an 82-page judgement, it was argued under the Act and the European Union product liability safety directive, that the blood products were defective and that the public was entitled to expect that transfused blood should be free of infection, even though there was no reasonable means that the NBA could have used to identify the infection. After this case, it was generally accepted that it was much easier for patients to prove that a product was defective, and more difficult for manufacturers to escape liability by showing that they had done all that could be expected of them. This brings us on to consideration of the case of Wilkes vs DePuy International Ltd,2 a matter in the field of orthopaedics that …
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假体产品责任:2016年法律变更
《消费者保护法》(1987年)规定,生产者对缺陷产品造成的人身伤害、死亡或损害负有严格责任。虽然不要求有过错,但消费者(患者)必须证明缺陷、伤害以及两者之间的因果关系。2001年A诉国家血液管理局一案在医疗领域证实了这一点。共有117名索赔人因1988年3月以后接受输血感染丙型肝炎而根据该法提起诉讼,要求赔偿损失。据称,受感染的血液是该法意义上的"缺陷"产品,他们有权获得未受感染的血液。NBA认为,由于直到1991年4月才有丙型肝炎的检测,在那之前,血液中病毒的存在是不可能被检测出来的。法院做出了有利于原告的判决,这在当时被认为是一个严厉的判决。在一份长达82页的判决书中,根据该法案和欧盟产品责任安全指令,该公司辩称,血液制品存在缺陷,公众有权期望输血应该没有感染,即使NBA没有合理的方法可以用来识别感染。在这起案件之后,人们普遍认为,对于患者来说,证明产品有缺陷要容易得多,而对于制造商来说,通过证明他们已经做了所有可以期望他们做的事情来逃避责任要困难得多。这使我们考虑到威尔克斯诉DePuy国际有限公司一案,这是骨科领域的一件事……
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