Settlement Expands Health Care Coverage for Eating Disorders
June 24, 2009Fabricantes de produtos inseguros protegidos por decisão da Suprema Corte
WASHINGTON, DC — March 6, 2008 — The Supreme Court ruled in favor of limiting lawsuits on product liability. It will now be difficult for individuals to sue faulty medical products that have been approved by the U.S. Food and Drug Administration (FDA). The Supreme Court based its ruling on the fact that the FDA approval process requires manufacturers to prove the safety and effectiveness of their product. The ruling means state lawsuits on product liability are now barred because they would impose safety and effectiveness requirements that are different from federal law. With the shield of the FDA‘s approval, manufacturers will not be held responsible for personal injuries even if their products are unsafe.
The case heard last week, Riegel v. Medtronic, involved a patient whose catheter burst during a medical procedure and wanted to sue the medical device manufacturer, Medtronic. The question before the court was whether or not the patient could sue Medtronic under state law for a medical device that had been approved by the FDA. The opinion, written by Justice Antonin Scalia, will now severely limit a consumer’s ability to seek compensation for injuries that are a result of a federally approved medical device.
Pelo menos uma juíza, a juíza Ruth Bader Ginsburg, não concordou com a opinião geral da Suprema Corte de colocar os interesses comerciais acima da segurança dos consumidores individuais. O juiz Ginsburg disse que o Congresso nunca pretendeu “uma redução radical das ações judiciais estaduais de direito consuetudinário que buscam compensação por lesões causadas por dispositivos médicos projetados ou rotulados de maneira defeituosa”. (Notícias WTOP, 20 de fevereiro de 2008)
O deputado Henry Waxman (D-Califórnia) declarou: “A decisão da Suprema Corte retira aos consumidores os direitos que eles tiveram durante décadas. Não foi isso que o Congresso pretendia, e aprovaremos legislação o mais rápido possível para corrigir esta situação absurda.” ( New York Times , 21 de fevereiro de 2008)
Aprovação de dispositivos médicos e FDA
To receive approval from the FDA under current federal law, all the manufacturer of a medical device must show is the product’s safety and effectiveness to the FDA. Over the past three months, federal regulators have responded to more than 100 issues regarding unsafe medical devices. Independent groups such as The Institute of Medicine and the Government Accountability Office, as well as the FDA‘s science board, have reported poor management and scientific shortcomings within the FDA. Due to these apparent weaknesses, the FDA may be unable adequately to protect individuals against dangerous and unsafe medical devices, drugs, and food. As far back as 1997, the FDA‘s chief lawyer wrote in a brief, “even the most thorough regulations of a product such as a critical medical device may fail to identify potential problems.” (News Analysis, New York Times, February 21, 2008)
Brayton Purcell e seu caso
If you have a legal problem, we are here to help. You may contact us through this website or at any of our offices. We can arrange a convenient interview time and advise you of your legal rights. There is no charge for an initial consultation. We have offices in Portland, Oregon, in Northern California, in Southern California, and in Salt Lake City, Utah. We have been helping personal injury clients for over 40 years.
