The Food and Drug Administration (FDA) protects the public from dangerous drugs and medical devices through a rigorous approval process. After a device hits the market, the FDA continues to play a role in monitoring ongoing safety issues.
Medical Device Reporting
Once a medical device is available to the public, the FDA conducts continuous monitoring of the product. The procedure, known as Medical Device Reporting, investigates claims that a medical device caused serious injury or death through a malfunction of the device. Medical Device Reporting is an important tool for a Reno defective medical device lawyer, because the reporting procedure brings the manufacturer under FDA scrutiny.
Impact On Medical Device Lawsuits
The FDA’s investigation into malfunctioning devices pulls data from healthcare professionals, users of the devices, and distributors who have first hand knowledge of potential issues with the device. Under FDA guidelines, manufacturers must also report any instances of malfunctions that cause serious injury or death, because the malfunction could reoccur and harm someone else.
When the FDA determines there are substantial problems with a device, they will issues a Class I, II or III recall. Class I recalls are the most dangerous and will require the assistance of a doctor and a Reno defective medical device lawyer. Class II and III recalls are for less serious, but still harmful problems. Patients with a complaint under any of the three categories must follow the recall guidelines or risk further injury.
A Reno defective medical device lawyer may gain access to the data gathered by the FDA in order to make the case that the manufacturer knew safety issues existed and put the public at harm anyway. In the lawsuit, a Reno defective medical device lawyer typically argues the manufacturer has liability for injuries on one of four grounds.
- The manufacturer did not properly warn patients and customer of the potential adverse side effects that may come with the use of the device.
- Manufacturing and quality defects caused product failure. This is an increasing concern, especially for hi-tech medical devices made overseas.
- Manufacturers did not provide adequate training and information for doctors or consumers about the proper use of the device.
- The device does not deliver the expected therapeutic results.
Through post-market oversight, the FDA maintains a measure of control over the medical device market and provides ongoing protections for consumers.