Parker Waichman LLP is representing 13 plaintiffs in personal injury lawsuits involving various components in Zimmer Orthopaedic’s NexGen Knee Implant line. The lawsuits were all filed on March 5, 2012 in the multidistrict litigation currently pending U.S. District Court, Northern District of Illinois (RE: Zimmer NexGen Knee Implant -Products Liability Litigation – MDL No. 2272).
The Zimmer NexGen Knee Implant lawsuits name a number of components, including the Zimmer NexGen CR-Flex Component and the Zimmer NexGen LPS-Flex Component. The 13 plaintiffs have allegedly suffered injuries as a result of the named Zimmer NexGen Knee device(s) manufactured by the Defendants. In some cases, they have had to undergo revision surgery due to their failed knee replacement. All of the plaintiffs seek compensatory damages for pain and suffering and emotional distress and for economic loss as well as punitive damages.
Currently, well over 100 lawsuits are pending in the Zimmer NexGen Knee Implant MDL. Lawsuits pending in the litigation involve allegations that various Zimmer NexGen Knee Implant components, including the Zimmer NexGen LPS-Flex, Zimmer NexGen CR-Flex, Zimmer NexGen GSF LPS-Flex, Zimmer NexGen GSF CR-Flex, and Zimmer NexGen MIS Tibial components.
Zimmer obtained approval for the NexGen knee replacement components through the U.S. Food & Drug Administration’s (FDA) controversial 510(k) approval process. As we’ve reported in the past, this approval protocol allows devices to be cleared without human testing if they are shown to be “substantially equivalent” to one already on the market. Over the past year, the 510(k) process has attracted quite a bit of scrutiny. Over the summer, the Institute of Medicine called on the FDA to scrap the 510(k) process, saying it offered patients no assurance of safety. In June, , the Archives of Internal Medicine published a review that found that of 113 medical devices recalled between 2005 and 2009 because they could cause serious health problems or death, 80 had undergone 510(k) approvals. Many of those devices were recalled because of concerns the product could kill or seriously harm a patient.