An Arizona woman has filed a lawsuit against medical device maker DePuy Orthopaedics and it parent company Johnson & Johnson over a failed Pinnacle Acetabular Cup System hip replacement device.
The plaintiff had her left hip replaced in January 2007. The surgeon implanted a DePuy Pinnacle Acetabular Cup System device with a metal liner to replace her left hip.
After the replacement, the plaintiff suffered severe pain in her left thigh and groin, in addition to functional difficulties with the implant. According to the legal complaint, “friction and wear between the metal on metal parts caused large amounts of toxic cobalt-chromium metal ions and particles to be released into Plaintiff’s blood and tissue and bone surrounding the implant.” The woman’s doctor recommended removal of the Pinnacle hip, believing it was the cause of her “hip pain, disability, elevated metal levels” and other symptoms. She is scheduled to undergo revision surgery this month.
Parker Waichman notes that manufacturers of metal-on-metal hips including Stryker, Smith & Nephew, Zimmer, Biomet, and Wright Medical all face lawsuits over their metal hip devices.
Pinnacle Acetabular Cup System Not Pre-Market Tested
Because of provisions in FDA device clearance regulations, DePuy was able to bring the Pinnacle device to market with virtually no clinical trials or FDA review of the implant for safety and effectiveness.
The Pinnacle device came to market under the 510(k) clearance process, through which the manufacturer shows that a device is “substantially equivalent” to a device already on the market and “does not raise new questions of safety and effectiveness.” The problem with this standard is that even small differences in materials or design can make a major difference in how a device functions. Device makers did not anticipate the types of problems that have occurred with metal-on-metal hips. They expected metal-on-metal hips to last longer and function better than hips made of plastic and ceramic materials.
The woman’s lawsuit contends that if clinical trials had been conducted, the manufacturer would have known of the “high percentage of patients developing metallosis, biologic toxicity and an early and high failure rate due to the release of metal particles.” The lawsuit alleges that implantation of the Pinnacle hip “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.”
Metal ions are released when the hip’s metal femoral head rotates within the metal liner. This friction releases microscopic cobalt-chromium particles into the bloodstream and surrounding tissue. The FDA has received more than 1,300 adverse event reports in relation to the Pinnacle Acetabular Cup System.
Pinnacle System Promoted as Safe and Effective
DePuy and Johnson & Johnson have been accused of marketing the Pinnacle System as superior to older hip replacement devices. Pinnacle’s TrueGlide technology “allow[s] the body to create a thin film of lubrication between surfaces, which enables ‘a more fluid range of natural motion.’” DePuy promotional materials featured a young woman trying on tennis shoes at an athletic shoe store, accompanied by the words that described the Pinnacle System as “uniquely designed to meet the demands of active patients like you – and reduce pain.”
Though many people who undergo hip replacement are middle-aged or older, increasing numbers of younger people are undergoing hip replacement to alleviate pain and regain motion so they can fully participate in daily activities and pursue an active life. Older-generation hip implants generally last for about 15 to 20 years, meaning that younger hip recipients might need two or even three more hip replacements in a lifetime. Metal-on-metal hips came to market with the expectation that metal components would have greater durability, giving patients longer intervals between replacements. But the DePuy Pinnacle and other metal-on-metal devices have not met expectations, and, in fact, have often failed in five years or less after implantation.
In November 2016, a federal jury in Dallas ordered Johnson & Johnson and DePuy Orthopaedics to pay more than $1 billion to six plaintiffs who said they were injured by Pinnacle hip implants. The jury found that the metal-on-metal Pinnacle hip implants were defectively designed and that the companies failed to warn consumers about the risks. Fortune reports that J&J and DePuy face more than 8,000 lawsuits over hip implants.
Legal Help for Those Injured by a DePuy Pinnacle Hip Implant
If you or someone you know has been injured by a DePuy Pinnacle metal-on-metal hip device, you should contact the attorneys at Parker Waichman LLP for a free, no obligation evaluation of your case. To reach the firm, fill out the contact form or call 1-800-YOURLAWYER (1-800-968-7529).