Medical Device Failure
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) approval.
With a PMA approval, the manufacturer must submit a lengthy application which details the design and test results of the product. The PMA approval process weighs the benefits of the device with the risks of using it. The manufacturer must strictly comply with any approval including the approved design, marketing, and manufacturing process.
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, with a 510(k) approval, no testing is required by the manufacturer or the FDA prior to the device being implanted in patients. The FDA can set limits on marketing, however, manufacturers may skirt these rules by misleading physicians or hiring them as consultants to encourage what is known as off label use.
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 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. With our main office in Austin, Texas, our firm currently represents injured persons from coast to coast. Various statutes of limitations apply, some as short as one year.
We have recently litigated claims involving defective spine stimulators from Medtronic, Eclipse Spinal Spheres from Medtronic, spine stimulators by St. Jude Medical, neuromonitoring by Nuvasive, pelvic mesh failures, and hip replacements by DePuy.
If you have concerns that your medical device is defective or may have caused you injury, call us immediately for a free consultation.