Medical devices like artificial hips and pacemakers can save or extend lives, or improve the quality of life for many people. However, medical devices can also be poorly designed, break or fail. If the device is defective or poorly designed and causes injury, you may have a good case for either a defective product claim and/or medical malpractice. The legal basis for each is slightly different, but medical malpractice lawyers can help sort that out for you.
What’s a Medical Device?
The US Food and Drug Administration (FDA) has the responsibility to ensure medical devices are safe before they are released for marketing. Medical devices fall into three classes:
- Class I includes devices that are important to treatment, like scalpels and surgical gloves, but that are unlikely to cause serious injury if they break or fail.
- Class II includes devices that are important to treatment but that – if used correctly – are unlikely to cause serious injury, like surgical pumps or powered wheelchairs.
- Class III devices are the most important, as they support or sustain human life. They include pacemakers and bone implants. Failure of these devices may cause serious injury or death.
The FDA’s Role
The FDA finds out about defective medical devices in a number of ways. It may conduct its own investigation. A medical device manufacturer may notify the FDA directly. Reports from physicians may trigger an investigation. After the FDA conducts an investigation it may recall the device at the wholesale level to get it off the market. For more serious recalls, the FDA will recall the device from retail stores and notify patients as well. With implanted devices, this may mean the patient must have surgery to remove the defective device.
When a Device is Recalled
If you receive notice or otherwise find out your medical device has been recalled, you should contact your doctor, your insurance company and an attorney. Your doctor can help you decide whether the device should be removed and/or replaced. Sometimes the recall requires that a device be fixed rather than removed, or the risk of removing the device is greater than its potential failure. Your insurance company can help determine what is covered if you need additional surgery; you may have out of pocket costs. A malpractice lawyer can help determine whether you have a case against the device manufacturer and whether there is already a class action suit on file.
Medical Device Recalls
Any medical device might be recalled, sometimes years after it was originally released to market. People who have been injured by a defective medical device can bring suit individually or collectively in class action suits. In order to win the case, malpractice lawyers must prove that their clients were directly injured by the defective device or as a result of the defective device, that the device was defective in design or manufacture, or that the marketing was defective. Examples of marketing issues include such things as false advertising or implied warranties. Finally, the defective device or improper marketing must be proven to be the cause of the client’s injury.
The issue of medical device recalls is very complex. A good malpractice lawyer can help you sort through the various aspects of the case and determine whether the device has caused an injury. If there is already a class action suit filed, you can also contact the lawyers for that suit.