The James Esparza Law Firm
Medical Malpractice Lawyers
Salt Lake City, Utah
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Defective Medical Devices
In the United States, the use and sale of medical devices is governed by the FDA (Food and Drug Administration) whose aim is to provide "reasonable assurance of safety and effectiveness" for medical devices.
The FDA has divided medical devices into three different risk classes (I, II and III) and into seven categories. They test products before they are approved, and require reporting on the performance of the devices once they are on the market.
However, it is the equipment manufacturer that is held liable for defective products, like the defective shoulder pain pump, negligence, misrepresentation, breach of warranty, or for criminally withholding information, such as in the case involving the Ancure Aortic Graft.
People who have been injured by a defective medical device – and particularly if there has been criminal cover-up of the problems – are usually entitled to damages including medical costs, pain and suffering (mental and physical), loss of income, and in the case of death, surviving family members can bring a wrongful death suit.
