All medical devices must be approved by the FDA prior to use by doctors, however, most people don’t realize that there are two methods of approval, 1) pre-market approval (PMA), and 2) 510(k). With a PMA approval, the manufacturer must submit a lengthy application which details the design and test results of the product. However, with a 510(k) clearance, the manufacturer must merely show that the device has been approved by another manufacturer and is substantially similar. Surprisingly, no testing is required by the manufacturer or the FDA prior to the device being implanted in patients.
The significance is that a PMA approval provides certain protections to a manufacturer that a 510(k) clearance does not. Our firm has successfully litigated against device manufacturers with both types of approvals. These devices include spine stimulators, neuro-monitoring devices, and spinal fusion medical devices. In our investigations for clients, we have also uncovered kick-back schemes which involve doctors being paid to use certain devices. Patients are never informed of this lucrative scheme which can conflict with what is best for the patient.
Medical device litigation is complicated and dynamic with various courts around the country setting different rules and laws. Causes of action can include negligent manufacturing, design defects, failure to warn, and breach of warranty. Various statutes of limitations apply, some as short as one year. With our main office in Austin, Texas, our firm currently represents injured persons from coast to coast. If you have concerns that your medical device is not functioning or may have caused you injury, call us immediately for a free consultation.
We are currently actively investigating and litigating regarding the Medtronic RestoreSensor spine stimulator. Patients have reported issues which include a short battery life, spontaneously turning on, and injuries from the device being removed.