Zimmer Knee Replacement Lawsuit Joins MDL 2272
An allegedly defective NexGen GSF LPS-FLEX device is the subject of a Zimmer knee replacement lawsuit brought by a New York couple in federal court. Their complaint, which was filed on August 8, joins the Zimmer NexGen products liability MDL 2272 currently underway in the Northern District of Illinois. Plaintiffs Donna and Leo Carrea are demanding statutory, compensatory and punitive damages for the purported injuries, emotional trauma, economic losses and pain and suffering sustained by Donna after she was implanted with the Zimmer NexGen knee replacement. Her husband Leo seeks compensation for loss of spousal consortium.
Zimmer knee replacement lawsuit joins NexGen coordinated litigation
The Carreas, who reside in Yorktown Heights, New York, filed their case via short form complaint, which was approved by the MDL court. As such, the exact nature of her alleged Zimmer knee problems aren’t provided in court documents, but state that Donna Carrea suffered injuries as a result of implantation and explantation of the GSF LPS-FLEX device, manufactured by the defendant. The complaint says that Mrs. Carrea underwent knee replacement surgery on December 2, 2008 at Northern Westchester Hospital. In October of 2010, she experienced complications and injuries from the implant and underwent knee replacement revision surgery to remove the device on January 21, 2013 at The Hospital for Special Surgery.
Zimmer’s family of NexGen knee implants have been attached to controversy in recent years, as a growing number of patients have reported high failure rates and debilitating problems within just a few months of receiving the devices. The orthopedics manufacturer is being accused of negligently manufacturing, designing and selling a defective medical device and failing to conduct sufficient pre-market trials to confirm product safety. The NexGen system was cleared for sale via the FDA’s 510 (k) process that allows manufacturers to avoid extensive testing on a new product prior to sale, as long as it is substantially similar to another already on the market.
Concerns over unreasonably high failure rates and potential design flaws were raised in 2010 by prominent orthopedic surgeon, Dr. Richard Berger, who found, in a study presented in a non-peer reviewed report, that NexGen components were sometimes failing to properly fuse with the bone – leading in some cases to device loosening and the need for revision surgery within two years. Zimmer has defended allegations of defective design in lawsuits, and continues to promote the NexGen knee replacement system for active, young people who want increased flexibility and motion.
NexGen Zimmer knee problems alleged by thousands
The Carrea’s Zimmer knee replacement lawsuit will be consolidated with nearly 1,000 others in the U.S. District Court for the Northern District of Illinois, where Honorable Judge Rebecca R. Pallmeyer is managing all pre-trial proceedings.
Plaintiffs claim they’ve suffered life-altering complications from the NexGen line of implants, such as:
- Joint pain
- Difficulty walking and standing
- Diminished mobility
- Bone fractures
- Bone loss or bone disintegration
- Soft tissue and nerve damage
- Need for premature revision surgery
Zimmer faces several causes of action in this recent complaint, including:
- Strict liability –design defect
- Strict liability – failure to warn
- Strict liability – manufacturing defect
- Negligent misrepresentation
- Breach of express and implied warranties
- Unjust enrichment
- Violation of consumer protection statutes
- Loss of consortium
MDL Judge Pallmeyer expects the first Zimmer knee replacement lawsuit involving the NexGen device will be ready for trial in early 2015.