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Defective Medical Devices - Overview

The legal definition of a defective product is a product that, when used in its intended fashion, causes injury or death to a person as a result of a defect in the design, manufacturing, application, or due to faulty labeling. Annually, there are roughly 22,000 deaths and over 29 million personal injuries in the United States as a result of defective consumer products. A high percentage of these personal injuries are a result of defective medical devices.

Several high profile defective medical devices have recently made the headlines, such as hip and joint replacements, heart valves and breast implants. Breast implants have been especially high profile, with a successful class action lawsuit against the manufacturer, Dow Corning, by women who have suffered varying degrees of health complications due to leaking silicone implants. This is a good example of a successful defective medical device lawsuit.

The Food and Drug Administration’s (FDA) sub-division, the Center for Devices and Radiological Health (CDRH), oversees medical devices and in some cases will intervene to either warn patients of potential hazards or take the drastic step of actually forcing the manufacturer to withdraw a defective device from the market. Annually, the CDRH received over 90,000 claims due to defective medical devices.

In most cases concerning defective medical devices, numerous people are affected by its defect and it makes most sense to try to either launch or join a class action lawsuit or tort case. This is because proving medical cases is extremely difficult and can become costly for an individual.

 
 

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