Pinnacle Metallosis Lawsuits Added To Texas MDL
A new lawsuit has been filed against DePuy Orthopedics and Johnson & Johnson over an allegedly failed Pinnacle Acetabular Cup system. DePuy Orthopaedics is a unit of Johnson & Johnson. The Pinnacle metal-on-metal hip device consists of all metal parts, including a metal femoral head, a metal femoral stem, a metal cup, and a metal liner. The lawsuit was filed within multidistrict litigation (MDL) No. 3:11-MD-2244-K in the U.S. District Court for the Northern District of Texas, Dallas Division.
The Arizona woman alleges to have undergone a left hip replacement procedure in which a Pinnacle metal-on-metal device was implanted in place of her left hip. The surgery took place in mid-January 2007. She alleges that, “after the replacement surgery, friction and wear between the metal on metal parts caused large amounts of toxic cobalt-chromium metal ions and particles to be released into” her “blood and tissue and bone surrounding the implant,” according to the complaint. The woman’s physician recommended that the Pinnacle Acetabular Cup system be removed believing the device to be the cause of her “hip pain, disability, elevated metal levels” and other symptoms. She allegedly suffered significant pain in her left thigh and groin, as well as functional difficulties after she was implanted with the Pinnacle System. She is scheduled hip revision surgery for the end of January 2017.
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.
Recently, a husband and wife filed a DePuy Pinnacle hip implant lawsuit over allegations that its metal-on-metal hip implant device caused the wife serious injury. This lawsuit is also filed in the Texas MDL. The woman underwent total hip replacement in February 2005 due to osteoarthritis in her left lip. Post surgery she had no healing issues and X-rays confirmed that her hip replacement device was positioned correctly. In July 2014, she allegedly told her physician that she was “feeling terrible, hurting all over, and felt a ringing in her ear,” according to her lawsuit. An MRI was conducted, which revealed fluid collection. A few months later, she allegedly complained of left hip pain, tinnitus, hoarseness, and anxiety, which she believed was the result of metallosis (metal poisoning). Her doctor recommended revision surgery, which she underwent in December 2014. She alleges to still experience “systemic symptoms, including tinnitus, hoarseness, and anxiety” and her doctor continues to monitor her blood metal levels, according to the complaint. The lawsuit also alleges that, “At all relevant times, Defendants were aware that metal-on-metal Pinnacle Devices posed an unreasonably high risk of developing metallosis, biologic toxicity, and total hip failure, and Defendants were aware that the Devices resulted in unsafe release of toxic metal ions into the tissues and blood stream of the hip implant recipients.”
The release of metal into patients’ bodies occurs when the metal femoral head rotates within the metal liner. The friction causes cobalt and chromium particles to be released into the area tissue leading to a variety of serious side effects, including metallosis and pseudotumors. To date, the FDA has received more than 1,300 adverse event reports over the Pinnacle Acetabular Cup System and DePuy Orthopaedics and Johnson & Johnson are accused of marketing the Pinnacle system as a better hip replacement device “featuring TrueGlide technology, allowing the body to create a thin film of lubrication between surfaces, which enables ‘a more fluid range of natural motion,’” according to the complaint.
Promotional materials included a young woman trying on tennis shoes at an athletic shoe store. The words that the Pinnacle System was “uniquely designed to meet the demands of active patients like you—and reduce pain” accompanied the visual. The lawsuit accuses the drug makers of “negligently advertising and recommending the use of the Pinnacle Device despite the fact that Defendants knew or should have known of its dangerous propensities,” according to the lawsuit.
Metal-on-Metal Hip Replacement Background
Revision surgeries are generally more complex than initial implantation surgeries, typically because there is less bone to work with. Revision surgeries also typically take longer than the original hip surgery and have a higher rate of complications. Revision surgery is a painful, complex procedure in which a faulty device must be surgically removed and replaced with a different device. The two surgical procedures must often be handled separately, leaving patients bed-bound in the interim.
Meanwhile, a number of manufacturers have recalled their metal-on-metal hip implants due to safety issues such as a high risk of device failure and metal corrosion. One of the most publicized recalls took place in 2010, when Johnson & Johnson’s DePuy unit globally recalled its ASR hip device.
Due to a loophole in U.S. Food and Drug Administration (FDA) regulations known as the 510(k), DePuy was “able to market the Pinnacle Device with virtually no clinical … trials or FDA review of the implant for safety and effectiveness,” the complaint allegations indicate. Allegations also include that had the Pinnacle Acetabular Cup system undergone clinical trials, the manufacturer would have been aware of 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.
Metal-on-metal hip implants are constructed of all-metal surfaces. When first released, the devices were touted as being a more resilient and better choice for younger, more active patients when compared to traditional hip replacement devices. Not all medical devices undergo safety testing prior to their release, an issue that has long been debated and is the focus of mounting controversy, especially concerning metal-on-metal hip devices. Many metal-on-metal hip devices were approved using the federal 510(k) route, which is a quicker way to clear medical devices in the United States. A number of consumer advocates consider this a slack method in which to release a device to market. The 510(k) 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.
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 Pinnacle Metal-on-Metal Hip Implant Lawsuit
If you or someone you know suffered injuries related to the use of a DePuy Pinnacle 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).