Posted in Defective Medical Devices on September 26, 2013
Metal-on-metal hip implant devices were once touted as a medical breakthrough. Now thousands of lawsuits are piling up against medical device manufacturers who once made billions from all-metal hip implants.
The first federal case against Johnson & Johnson’s DePuy Orthopaedics division was recently postponed due to the unavailability of experts. These experts are in high demand as thousands of hip implant patients are experiencing painful device failures and require revision surgeries.
U.S. District Judge David Katz is overseeing about 8,000 conslidated cases in a Cleveland federal court. The bellwether case is that of Ann McCracken, a 57-year-old single mother from Rochester, New York.
The first DePuy ASR case was tried in a California court by the law firm of Walkup, Melodia, Kelly & Schoenberger.
The Walkup firm, and most notably, partners, Michael Kelly, Matthew Davis, Khaldoun Baghdadi and Douglas Saeltzer, were among the first lawyers in the U.S. to file cases arising from metal-on-metal hip injuries, seeking to hold manufacturers responsible.
Michael Kelly of Walkup serves as liaison counsel for the California coordinated cases, all of which are before San Francisco judge Richard Kramer.
The Walkup firm’s metal-on-metal hip lawyers have worked with experts across the globe in identifying and proving what is wrong with the metal-on-metal concept, and demonstrating why metal-on-metal is a dangerous and failed technology.
“In addition to prosecuting ASR claims against DePuy and Johnson & Johnson, the Walkup team is also investigating and prosecuting claims against Stryker for injuries caused by its flawed Rejuvenate hip, also known as the ABG II,” Walkup partner Mike Kelly said. “Patients with the failed Stryker ABG II should contact the hip injury specialists at the Walkup firm if they have questions.”
A History of Lax FDA Oversight
Device manufacturers such as DePuy Orthopaedics and Stryker heavily promoted all-metal hip devices as a longer-lasting alternative to traditional hip implants that are made from both plastic and metal parts.
All-metal hip implants were not adequately tested before being released to the market however, and are now known to have failure rates many times higher than traditional hip implant devices.
The metal components in all-metal devices rub together during normal use, often sending dangerous metal debris into a patient’s body. Patients often experience tissue death, painful revision surgeries, and ongoing hip failures.
The subsequent massive recalls and patient injuries have brought increased attention on the U.S. Food and Drug Administration’s lax approval process and the willingness of manufacturers to promote devices that have not been fully tested.
An investigation by the Government Accountability Office found that the FDA approves medical devices such as all-metal hip implant without sufficient review and fails to monitor recalls when concerns arise during ht marketing process.
Marcia Crosse, the GAO’s director of health care, told lawmakers that the FDA should take steps to increase its standards or reclassify potential risky products like hip implants.
“It remains to be seen whether these actions will help ensure that medical devices marketed in the United States receive appropriate premarket review,” Crosse told the Senate Special Committee on Aging. “Gaps in FDA’s post-market surveillance show that unsafe and ineffective devices may continue to be used, despite being recalled.”