Jury selection has begun in the third DePuy Pinnacle metal-on-metal hip device bellwether case in the 8,000-case multidistrict litigation (MDL) brought against Johnson & Johnson and its DePuy Orthopaedics unit.
The MDL has been organized in Dallas, Texas federal court, according to Reuters and contains at least 8,400 cases.
As the name suggests, metal-on-metal hip implants consist of all-metal surfaces. When the devices were first released to market, they were touted as being more durable and better suited for younger, more active patients. In recent years, the safety of metal-on-metal hip implants has been the subject of increasing controversy and there have been serious concerns that metal hip implants release metal debris when the device’s surfaces rub together during normal activities, such as walking.
An array of adverse reactions are allegedly associated with metal hip devices that include, for example, increased blood metal ion levels and metal poisoning; dislocations; pain; fracture; difficulty ambulating, rising, standing, and balancing; noise emanating from the joint; and pseudotumors. Some reports note that chromium and cobalt hip device debris has allegedly led to tissue death and increased blood metal ion levels.
Meanwhile, not all medical devices are tested for safety before being released to market. This is a long-discussed, well-known issue in the system that has given rise to increased controversy, especially concerning metal-on-metal hips.
Many lawsuits point out that metal-on-metal hips were not clinically tested before they were approved. In the United States, device makers may seek U.S. Food and Drug Administration (FDA) clearance through a 510(k) application if the device is substantially similar to a device that has been previously approved. Under this quicker clearance route, device makers are only required to file paperwork with the FDA and pay a fee.
In August 2015, the FDA sought to change this rapid clearance practice by mandating device makers go through a stricter process when seeking approval to release metal-on-metal hip devices. Johnson & Johnson halted sales of its metal-on-metal version of the Pinnacle device following this decision.
Meanwhile, J&J has previously faced litigation over another of its metal-on-metal hip implant devices, the ASR, which was recalled in August 2010. Federal regulators have also advised metal ion testing in some patients to determine if the implant has failed.