Each year, dozens of medical devices are recalled by manufacturers or the Food and Drug Administration (FDA). Patients and their family members might first learn of a recall by listening to the news or by perusing the FDA’s recall website.
Learning that you used a faulty medical device can be unnerving. It is perfectly natural to fear that the device will malfunction and injure you. But patients and their family members can protect themselves by taking some simple steps.
Step 1: Contact your Doctor
Devices get recalled when either the manufacturer or the FDA become aware of problems with the manufacture or design. Some devices pose immediate problems, while others may not. In fact, some devices are recalled even though they pose no real risk of injury. However, your doctor should have more information about whether the device is still safe to use.
Of course, you cannot immediately stop using all devices, such as an implant. But you need to discuss options with your doctor. Surgery itself carries risks, which might outweigh the risk of the faulty medical device. For that reason, call or schedule an appointment to talk about options with your doctor. You might continue to use the device but with heightened attention to problems. Or you might seek a replacement, including even surgery to install a new device.
Step 2: Document Your Symptoms or Side Effects
You might have a lawsuit if you are using a defective device and are injured in the process. For this reason, it is critical to carefully document any symptoms you are having. Write down how you are feeling and if you ever experienced pain or discomfort. For example, you might have been waking up with headaches even after using a CPAP machine that has been recalled.
Remember to discuss your side effects with a doctor. This can create the necessary documentation if you were actually injured by a defective device.
Step 3: Swap out the Defective Device, if Necessary
The device manufacturer might have contacted you about getting a new device. If the device you have is not an implant, then swapping it out might be as painless as sending your old device to the manufacturer in return for a newer model. There should be no charge for replacing a defective medical device. There are reputable suppliers where you can get new devices like a ResMed AirFit N20.
If you believe a device has injured you, however, hold onto it. You will want it as evidence as part of a product liability claim against the manufacturer. These claims are difficult to make when you have no documentation of which device you were using.
Step 4: Visit an Attorney
Each year, thousands of people are injured by defective medical devices. Some devices are not even recalled. They end up injuring people before the FDA or the manufacturer have a chance to pull the product from the market.
Under Pennsylvania law, a manufacturer and possibly others are legally responsible when someone is injured using a defective product. However, this type of claim is complex, and only a seasoned Philadelphia medical device attorney can fully understand the facts.