Medical devices are necessary to the survival of many patients throughout the U.S. Unfortunately, a mistake or oversight in the design, marketing or manufacturing process can lead to catastrophic injury.
Medical Device Failures Medical devices must be approved by FDA prior to use by doctors. What most people don’t realize, however, is that there are two methods of approval: pre-market approval (PMA) and “510(k)” approval, and they are very different.
With PMA approval, the manufacturer must submit a lengthy application to FDA, which details the design and clinical-test results of the product. The PMA approval process weighs the benefits of the device with the risks of using it. The manufacturer of the new device must strictly comply with any approval including the approved design, marketing, and manufacturing process.
With a 510(k) clearance, however, the manufacturer must merely show that the new device is substantially similar to a product that previously received PMA approval by FDA. Unbeknownst to patients, with a 510(k) approval, no testing is required by the manufacturer or FDA prior to the device being implanted in them. Companies strive to use this much easier (and less safe) pathway to FDA approval so they can get new products to the marketplace faster.
Whether the problem can be traced back to the design, manufacturing, or labeling of the product, our team will work to investigate every avenue of compensation available to you and your loved ones. Our attorneys are nationally-recognized for their work in record-setting and otherwise large cases. Together, they bring over 7 decades of legal experience to the table and are passionate about holding large medical device manufacturers responsible for the injuries they have caused.
Select an area and allow Heard Law Firm, PLLC provide you with the legal guidance you need and deserve during this time.
The attorneys at Heard Law Firm are continuously investigating new claims and lawsuits that surface. We are committed to learning the the facts and details of new claims to best present a case in a way that will secure the best possible outcome for our clients. Check back here regularly to see our updated claims investigations.
The Attune® Knee System manufactured by DePuy Orthopaedics has been named in a growing number of adverse event complaints with the Food and Drug Administration (FDA). Although knee replacements often last up to 20 years, knee replacement patients with the Attune® Knee System may require additional surgery due to early failure of the device.
Patients whose implants fail prematurely often require revision surgery. Revision surgeries for knee replacements are more invasive and usually more painful than first-time knee replacement surgery. In order to perform a revision surgery, surgeons typically must break the original device away from the bone and often have to cement the new implant into place.
If you or a loved one have had a revision surgery or a doctor recommended additional surgery for your knee replacement, contact us for a free consultation.
Filling out this form does not create an attorney-client relationship with Heard Law Firm. It is simply to put you in contact with our firm so that we can evaluate your potential claim. Do not provide any information that you consider confidential and would not want disclosed to third parties. If you would like to speak with us confidentially, please call us at 713-665-1100 or send an email to firstname.lastname@example.org.