Both Sides Digging In for Pending Zimmer NexGen Lawsuit

Warsaw, INThe continuing controversy surrounding Zimmer Knee Replacement is destined for the courts, with the first bellwether NexGen lawsuit expected in 2014. And while Zimmer continues to hold that NexGen total knee replacement systems are reliable and some of the most widely used, the existence of a sizable product liability case serves to temper that notion.

As reported by Modern Healthcare (5/6/13), plaintiffs in the NexGen product liability case - lawsuits for which having been consolidated in federal court in Chicago - allege that various components associated with Zimmer NexGen Knee Replacement have a tendency to fail too soon, often causing severe pain and mobility issues. In many cases, revision surgery has been required to replace the allegedly faulty device. Revision surgeries are thought to be more complex than initial insertion, requiring additional healing time and often removing patients from the workplace for an extended period of time.

Both sides are digging in, with legal representatives for the plaintiffs alleging Zimmer put profits over safety by capitalizing on the availability of a fast-track-to-market option maintained by the US Food and Drug Administration (FDA), and aggressively marketing largely untested components.

Zimmer, on the other hand, told its investors in 2012 that it takes issue with plaintiff allegations. “We believe the plaintiffs’ allegations are not consistent with the record of clinical success for these products,” Zimmer said in a filing with the Securities and Exchange Commission in 2012.

Zimmer appears to have some ammunition to back that up. In countries that maintain device registries, studies have supported Zimmer’s claim of reliability. A 2010 Swedish study found that 14,440 Zimmer NexGen patients were at 0.5 percent risk of having a revision surgery - the lowest rate for a widely used total-knee device in the registry. In England and Wales, NexGen held a middle-of-the-pack position, with 29,730 devices showing a 1.9 percent revision rate after three years.

Dr. Mark Pagnano, professor of orthopedic surgery at the Mayo Clinic and one of the authors of a study documenting the failure rate of another Zimmer product, said in comments published in Modern Health that while researchers were surprised at the “relatively uncommon cause of failure in the short term” after cement used to bond Zimmer’s LPS 3-degree tibial tray was “debonding,” Pagnano added, “to keep it in perspective, the vast majority of these knee replacements are still working well at five years.”

Conversely, there appears to be plenty of evidence they are not. Dr. Richard Berger, a former paid Zimmer consultant, publicly criticized Zimmer for the high failure rates. And in September 2010, a NexGen knee replacement recall was undertaken by the FDA for one of the three NexGen components identified in the multi-district litigation.

Artificial knees, akin to hips, are historically supposed to last upwards of 15 years under normal use. In many cases, the devices in question have begun to fail in a matter of months, often requiring a patient suffering from Zimmer knee replacement problems to undergo revision surgery. In the process, the patient is subjected to additional pain and discomfort, and often requires additional time off work to heal from a subsequent surgery having come so soon after the initial placement.

At zimmerfacts.com, it is stated, “NexGen knees record the best or among the best survivorship rates in national joint replacement registries from around the world.” The debate over various Zimmer NexGen knee products will continue in federal court in Chicago, in 2014. Zimmer multidistrict litigation is MDL No. 2272.