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According to recent court filings, an agreement has been reached to settle all knee replacement lawsuits involving problems with certain Zimmer NexGen implants, potentially ending years of litigation.
Zimmer Biomet currently faces about 300 product liability lawsuits pending in the federal court system involving variations of the NexGen implant. At one point, the litigation included more than 1,300 claims, however, following prior court rulings, the number has been reduced.
Since August 2011, the federal Zimmer NexGen knee cases have been centralized as part of a multidistrict litigation (MDL), which is designed to reduce duplicative discovery, avoid conflicting pretrial rulings and to serve the convenience of parties, witnesses and the courts.
The Zimmer NexGen system was first introduced in 1995, with most components later approved without extensive trials or FDA investigation into their safety through the 510K fast-track approval program, which only requires that devices be “substantially equivalent” to medical devices already on the market to obtain marketing approval.
All of the complaints involve similar allegations that certain configurations of the Zimmer NexGen artificial knee system are prone to fail within a few years.
On February 12, Judge Pallmeyer issued a case management order (PDF), which indicates that the parties have reached a confidential settlement in principal, which will potential resolve all state and federal cases pending as of January 14. Therefore, the Court has stayed all proceedings to allow the lawyers to finalize and administer the knee replacement settlements, and encourage the full resolution of the litigation.
For any newly filed cases, or claims that do not settle, Judge Pallmeyer has indicated that the plaintiffs must have support from case-specific experts willing to testify at trial in their cases, providing various deadlines for submission of expert reports.
“Plaintiffs and Plaintiff’s counsel in any newly filed cases, or any cases that are not resolved as a result of the confidential settlement, who fail to serve the expert report required by [the] deadline to do so, or who voluntarily dismiss their cases after that deadline, shall be sanctioned,” according to the Order. “Such sanctions shall be set, at the court’s discretion, in an amount sufficient to deter noncompliance with Case Management Orders, and to remedy the costs associaed with any such noncompliance.”
Co-Lead Counsel for plaintiffs and the manufacturer have been directed to provide monthly updates to the Court on the status of the efforts to settle the knee replacement cases.
The agreement comes as a number of other manufacturers face a growing number of product liability complaints over alleged design defects with other, newer knee systems, including DePuy Attune knee implants, Exactech Optetrak knee systems, and the Arthrex iBalance knee.