Defective Medical Devices Overview

Medical science is a field that continues to make substantial progress in many ways. Billions of dollars are spent on research and development of new medications, surgical procedures, rehabilitation protocols and technology. Specifically, these technological advances are used to develop new medical devices designed to help with a variety of inflictions. However, there is a risk involved with each new medical advance, and specifically in regards to medical devices, these risks can be quite high in nature. As such, defective medical devices can cause egregious harm to patients, and this harm can cause an exacerbation of the condition from which the patient already suffers, additional injuries and even death in certain circumstances. Below are two central issues regarding defective medical devices, but if you or someone you love has been injured by a medical device, contact an experienced attorney immediately for a consultation.

What makes a medical device defective?

Defective medical devices, in terms of litigation, fall under the standard test for products liability. There are two theories that can lead to the finding that a device is indeed defective:

1. Defective design: This theory of liability attaches when every machine of a certain type is designed in such a way that it is unreasonably dangerous when it is used.
2. Defective product: This theory is relevant when the design of a product is not dangerous, but when this particular device is not built properly, thereby causing it to be unreasonably dangerous.

The Role of the FDA in Handling Defective Medical Devices

The FDA oversees many products in the medical industry to make sure that they are safe for use on patients. These products include medications, medical supplies and medical devices. As part of their oversight duties, the FDA gathers reports on any problems regarding medical devices and issues public statements alerting the public to a device that may be problematic. The FDA may also require the manufacturer to issue a warning statement and, if necessary, to issue a recall of a particular product.

These recalls fall under a distinct set of classifications, which are described below: Types of Recalls:

Class I Recall

A Class I recall comes with the highest risk. The FDA issues a Class I recall when a device could reasonably cause serious injury or death. In this situation, the company in question must notify their customers who are expected to contact the end users of a device. The FDA may also issue a press release.

Class II Recall

A Class II recall is less serious than a Class I, as this situation generally arises when a device may cause temporary or reversible health complications or shows even a slight chance of causing serious injury.  The FDA usually does not issue a press release in this situation.

Class III Recall

This is the least serious recall. In this situation, the device most likely will not cause serious injury, but it does violate FDA law in some way. In a Class III recall, the company is not required to issue a press release. Overall, there are many things to consider in regards to defective medical devices. If you are suffering as a result of using a medical device that may be defective, contact an experienced trial attorney immediately.

 

^ Back To Top