A jury was selected last week in a case in the DePuy Pinnacle multidistrict litigation (MDL). The MDL—IN RE: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation—(MDL 2244) is being heard in the Northern District Court, Northern District of Texas.
A Second Mandamus was also filed this Saturday evening concerning the Court’s Satellite Transmission Order and a Motion to Quash was filed this week for a deposition that is currently being taken in England. The Motion was considered and denied. Meanwhile, opening statements begin next Monday.
U.S. District Judge Ed Kinkeade, who is presiding over the trial and the MDL, ruled earlier this year that five cases chosen for bellwether trials had sufficient issues in common that they would be consolidated for trial. All five plaintiffs underwent similar implantation surgeries, their doctors received similar warnings, and the patients alleged similar injuries, according to the judge’s ruling, Law360 reported.
The MDL was consolidated in May 2011. At that time, the U.S. Judicial Panel on Multidistrict Litigation centralized three actions and identified 54 potential tag-along actions. To date, there are over 8,000 cases in the MDL, all brought over Pinnacle devices that are constructed with sockets constructed with metal, ceramic, or polyethylene lining, according to court documents, wrote Law360.
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 have 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.
A variety 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.