Dallas Defective Medical Device Attorney

Nearly every medical device in the United States has to be approved by the Food and Drug Administration (FDA) before it can be distributed and used by consumers. There are three classes of devices that require inspection and approval by the FDA in the United States.

1. Class I Devices: These are considered low-risk devices that are not invasive. This includes items such as:
   • Bandages
   • Walkers
   • Wheelchairs
   • Basic surgical instruments
2. Class II Devices: These are considered intermediate-risk devices. This can include items that are moderately invasive but are not necessarily implanted inside a patient’s body. Some common Class II devices include:
   • Insulin pumps
   • CT scanners
   • IV infusion pumps
3. Class III Devices: This level of the device is considered high-risk and will undergo the most extensive inspection and testing by the FDA. These devices are typically invasive and implanted inside a patient’s body for life-sustaining reasons. Some of the most common Class III devices include:
   • Pacemakers
   • Spinal cord stimulators
   • Deep-brain stimulators
   • Heart valves

Medical devices, even those that have been rigorously tested, can become defective. Studies have shown that defective medical devices caused more than 80,000 deaths in this country from 2008 to 2018.

Victims who have been injured due to a defective medical device must often undergo extensive medical procedures and corrective treatments in order to repair damage to their bodies. Unfortunately, many medical device errors are not discovered until after a patient passes away, leaving family members picking up the pieces.

In Texas, the medical malpractice statute of limitations is two years from the date the medical mistake occurred. When it comes to defective medical devices, discovering the date the injury actually occurred can be difficult. It is important to work with a skilled Dallas defective medical device lawyer as soon as possible so an investigation into the case can begin.