New Court Order to Preserve Evidence Contracted During Patient Revision Surgeries May Impact DePuy Pinnacle Litigation
A new federal court order for preserving tissue samples and components of the DePuy Ultramet liner—which was utilized in all metal-on-metal hips involved in the DePuy Pinnacle litigation—has been issued to ensure the integrity of evidence contracted during patient revision surgeries.
The Explant Preservation Order, which will set the protocol for the preservation of evidence retrieved in the DePuy Pinnacle revision surgeries plaintiffs say they were forced to undergo after suffering complications stemming from the hip implant, includes the initial receipt of procedures as well as the decontamination, photography and storage of related items. Issued on Jan. 23, 2013, this action may impact the thousands of DePuy Pinnacle hip lawsuits filed in the federal multidistrict litigation currently underway in the U.S. District Court for the Northern District of Texas. (In re: DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation – MDL No. 2244)
DePuy Pinnacle Hip Lawsuits Pending in Federal Court
There are currently 3,000 DePuy Pinnacle hip lawsuits pending in this MDL. Thousands of lawsuits filed after the DePuy ASR recall of August 2010 are also pending in courts around the U.S. Patients who received this metal-on-metal hip replacement allegedly suffered early failure rates, metallosis (metal ion poisoning) and other side effects, forcing them to undergo painful and risky revision surgeries to remove the device.
Thankfully, the rising number of claims brought by patients who allegedly sustained injuries stemming from the DePuy Pinnacle metal-on-metal hip replacement and similar devices has not gone unnoticed by the U.S. Food and Drug Administration (FDA). In June 2012, the agency held a communication with its Orthopaedic and Rehabilitation Devices Advisory Panel to discuss the effectiveness and safety risks related to metal-on-metal hip implants. Included in the panel were patients, physicians, international regulatory agencies, researchers, professional societies and manufacturers.
According to the FDA’s website, the group discussed failure rates and modes, metal ion testing, patient risk factors and considerations for follow-up after surgery, imaging methods and other issues pertaining to metal-on-metal hip implants.
The agency has taken an active approach to investigating the safety of these devices since then. On Jan. 17, 2013, it proposed new guidelines for metal-on-metal hips that would require all manufacturers to receive premarket approval on their products before they can be sold. Right now, some metal-on-metal hip implants have been allowed to enter the marketplace by way of the agency’s 510(k) process, which allows a product to be sold if its maker can prove it to be substantially similar to one already on the market.
How to File a DePuy Pinnacle Hip Lawsuit
If you suffered side effects stemming from a metal-on-metal hip implant, you be eligible to file a DePuy Pinnacle hip lawsuit. Call an attorney at Bernstein Liebhard LLP at (877) 779-1414 for more information.