Friday, May 6, 2011

UPDATE: Zimmer NexGen High-Flex Knee Replacement Litigation

Starting late last year, individuals implanted with a Zimmer NexGen High-Flex knee replacement system begin filing lawsuits alleging injury as a result of their implanted devices.  To date, we believe that at least eleven products liability cases have been filed claiming that the NexGen High-Flex family of knee replacements are defectively designed and that its manufacturer, Zimmer, Inc., failed to warn patients of the likelihood that the devices would become loose and require a revision surgery. 
Plaintiffs have filed lawsuits against Zimmer in federal courts around the country, including: three in the District of Minnesota; two in the Northern District of Illinois; one in the District of Nevada; one in the Eastern District of Michigan; one in the District of Kentucky; one in the Middle District of Tennessee; one in the District of New Jersey; and one in the Eastern District of Wisconsin.  While all cases are in the beginning stages of litigation, Sizemore v. Zimmer Inc., et al. (D. Nev. 2:10-cv-01979) appears to be out in front where both parties have entered motion practice regarding disputed discovery issues. 
In the past several years, Zimmer’s NexGen High-Flex knee replacement product line has been the subject of several peer reviewed studies documenting alarming failure rates.  For example, a study published in The Journal of Bone and Joint Surgery (British Edition) in 2007 reported that 38% of knees implanted with a NexGen High-Flex knee system became loose within 2 years after implant.  That study is startling considering knee replacement systems are reported to typically have a success rate of 85-90% up to ten years after implant.  In addition, some studies show that high-flex designs do not offer any statistically significant added degree of flexion compared to standard knee replacement systems, and may even be more prone to loosening than standard systems. 
In 2010, Dr. Richard A. Berger and Dr. Craig J. Della Valle – two prominent orthopedic surgeons from Rush University in Chicago, Illinois – made a podium presentation at the American Association of Orthopedic Surgeons reporting that 36% of the Zimmer’s NexGen High-Flex knees studied showed signs of loosening, and 9% required revision surgeries within one year of implant.  That same year, Dr. Steven Weeden and Dr. Steven Ogden reported that certain components within the NexGen Knee Replacement line were failing at a rate of 24%.  Following the reports, Zimmer sent an “Urgent Device Correction” letter to orthopedic surgeons alerting them of potential defects associated with the NexGen knee replacement.  Based in part on this analysis, the FDA issued a Class II Recall in September 2010.  Later in 2010, the FDA issued a second Class II Recall for additional NexGen High-Flex devices. 
All eleven cases filed name Zimmer as a defendant, involve the NexGen High-Flex knee system, and share the same theories of liability.  In addition, several more cases are expected to be filed in the near future as the current litigations continue to build awareness of the issue.  Keep checking back with us as we will continue to provide you with the latest update in litigations involving the Zimmer NexGen High-Flex knee replacement system. 

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