DePuy ASR, Pinnacle Lawsuit, Settlements. Some 500,000 Americans have undergone hip replacement surgery and may have received a device that is known as a metal-on-metal hip device, such as Johnson & Johnson’s DePuy ASR hip implant or Pinnacle hip implant. The popular hip replacement devices have been the focus of thousands of lawsuits. The DePuy ASR has been the focus of a massive DePuy ASR hip recall in August 2010. DePuy Orthpaedics is a subsidiary of Johnson & Johnson.
The DePuy ASR hip implant has also been the subject of a large DePuy ASR settlement for patients who underwent a hip revision (replacement) surgery since March 2015. For patients who received a DePuy ASR hip replacement and underwent a hip revision surgery since March 2015 over one of the following issues, you may have a legal claim:
- Cobalt poisoning
- Degenerative heart disease, including cardiomyopathy
- Dislocated hip.
- Failure of the metal-on-metal hip implant device, requiring early device replacement.
- Loss of bone strength or structure which may cause bone fractures
- Metallosis (metal poisoning) due to chromium or cobalt particles from the hip implant shedding into area tissue or the bloodstream
- Non-cancerous tumors or pseudotumors near the hip implant
- Release of toxic substances in your bloodstream from the hip implant such as chromium or cobalt
- Tissue death surrounding the implant
Metal-on-metal hip replacement systems, including the DePuy ASR and Pinnacle hip implant devices have been associated with reports of severe and debilitating complications that may include:
- Increased risk of cancer due to toxic substances leaking from metal-on-metal implants
- Degenerative heart disease; cardiomyopathy
- Non-cancerous pseudotumors surrounding the hip implant site which may lead to pain, swelling, inflammation, and severe discomfort
- Premature failure of the hip implant that requires revision surgery, ideally with a metal-on-plastic or metal-on-ceramic design
The U.S. Food and Drug Administration (FDA) announced on August 23, 2010, a voluntary DePuy ASR recall of 93,000 DePuy ASR hip implants worldwide. This included 37,000 in the United States. The recall followed then-newly released data from the United Kingdom joint registry that discovered that 13 percent of DePuy ASR hip implants required hip revision surgery to correct incapacitating complications.
DePuy ASR hip replacement complications are similar to the metal-on-metal hip implant side effects reported by patients who were implanted with the DePuy Pinnacle metal-on-metal hip replacement and other all-metal hip implants. The Pinnacle device has not been recalled.
Today, Johnson & Johnson faces nearly 8,000 metal-on-metal hip implant lawsuits over its DePuy ASR XL Acetabular System and DePuy Pinnacle Acetabular Cup System. Both devices are popular metal hip replacement devices that have been used in thousands patients in the United States. To date, Johnson & Johnson has agreed to settle the first lawsuits brought over its DePuy ASR XL Acetabular System. In August 2012, Johnson & Johnson announced it would pay a combined $600,000 to settle three DePuy ASR hip implant lawsuits that were filed on behalf of plaintiffs who were implanted with a DePuy artificial hip and had to undergo revision surgery to remove the device after the alleged experiencing pain, bone damage, and other metal hip implant side effects. Each of the plaintiffs received $200,000 from the DePuy ASR lawsuit settlement, which is on the lower end of what Johnson & Johnson is expected to pay. Metal hip implant class action experts estimate that the settlement range should be in the $200,000 to $500,000 range. A settlement offer is also in place for hip implant recipients who underwent hip revision surgery involving the DePuy ASR after March 2015.
The product liability attorneys at Parker Waichman LLP have decades of experience representing clients in medical device litigation, including litigation involving metal-on-metal hip devices. The firm continues to offer free legal consultations to individuals with questions about filing a metal-on-metal hip replacement lawsuit.
Background: Metal-on-Metal Hip Replacement Devices
Revision surgeries are typically more complicated than initial metal-on-metal hip implantation surgeries. Revision surgeries are more challenging because there is often less bone to work with and the surgeries take longer to complete than original hip surgeries. Revision surgeries are also associated with an increased rate of complications and are typically more painful. A faulty device must be surgically removed and replaced with a different device; these two surgical procedures must often be handled separately, which leaves patients bed-bound in the interim.
A loophole in U.S. Food and Drug Administration (FDA) regulations known as the 510(k) enabled DePuy to be “able to market the Pinnacle Device with virtually no clinical … trials or FDA review of the implant for safety and effectiveness,” according to at least one complainant’s allegations. Allegations also include that, had the Pinnacle Acetabular Cup system undergone clinical trials, the manufacturer would have known about the “high percentage of patients developing metallosis, biologic toxicity, and an early and high failure rate due to the release of metal particles … implantation of the Pinnacle Device results in nearly immediate systemic release of high levels of toxic metal cobalt-chromium ions into every hip implant patient’s tissue and blood stream,” according to the complaint.
DePuy took advantage of the controversial FDA 510(k) process for its ASR metal-on-metal hip devices. Under this process, device makers are able to bypass clinical testing of their products if a device is found to be substantially similar to an already-approved device. While the DePuy ASR devices were released to market under the 510(k), studies reveal that metal-on-metal devices failed far more frequently than similar, but non-all-metal devices.
Metal-on-metal hip implants are constructed of all-metal surfaces. When first released, the metal devices were promoted as being a stronger and better choice for younger, more active patients when compared to traditional hip replacement devices. Because not all medical devices underwent safety testing prior to their release, which is an issue that has long been debated and is at the center of increasing controversy, especially because many metal-on-metal hip devices were approved using the federal 510(k) route, a more rapid way in which to clear medical devices in the United States. A number of consumer advocates consider the 510(k) route a lax way in which to release a medical device to market because the route enables device manufacturers to receive FDA clearance with no clinical testing if the manufacturer is able to prove that its device is substantially similar to a previously approved device. Under this loophole, device makers must only file paperwork and pay a fee to federal regulators.
In fact, many lawsuits allege that metal-on-metal hips were never clinically tested before they were approved. In August 2015, the agency sought to change the rapid clearance process, mandating devices makers follow a stricter process when seeking approval to release metal-on-metal hips. Johnson & Johnson stopped the sales of its metal-on-metal version of the Pinnacle device when the FDA’s decision was announced.
Filing a DePuy ASR or Pinnacle Metal-on-Metal Hip Implant Lawsuit
If you or someone you know suffered injuries related to the use of a DePuy Pinnacle or ASR metal-on-metal hip implant device, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, please call 1-800-YOURLAWYER (1-800-968-7529).