2011 A Relatively Quiet Year for Zimmer, but NexGen Lawsuits Remain

January 18, 2012, 8:00AM. By Gordon Gibb

Washington, DCAs years go, 2011 was a relatively quiet one on the Zimmer Knee Replacement front. A bid to add to the existing Zimmer Multi District Litigation (MDL) for pending NexGen lawsuits didn't go through—and Zimmer has taken the offensive toward critics of its products by actually launching a lawsuit of its own against a legal firm in Ohio that represents one of the plaintiffs currently suing Zimmer.

Aside from that, 2011 was uneventful, save for those patients having to deal with an allegedly defective Zimmer NexGen Knee Replacement component, and the impact such a failure is having on their lives.

The medical devices industry has been hammered in the last several years with reports of defective products or devices that are failing extremely fast. Knee joints, for example, which are designed to last upwards of fifteen years or more with normal use, are instead experiencing failures after just a few years.

At the same time, a loophole in FDA regulations that govern pre-market testing of products substantially similar to those already on the market only serves to exacerbate the problem.

In the case of the NexGen knee, things began to unravel in 2010 after Zimmer severed its ties with an accomplished surgeon who, at one time, had worked in concert with Zimmer and had trained surgeons on the minimally-invasive surgical techniques inherent with the Zimmer NexGen system.

That all ended when Dr. Richard A. Berger began getting reports that Zimmer NexGen knees, which he and other surgeons had painstakingly installed, were failing prematurely. According to a report from The New York Times in June 2010 (06/19/10), Berger went public with a study that supported his findings. Zimmer, at the time, blamed the problems on bad surgical technique.

That article, together with another report that ran in The New York Times the day prior, served as the basis for a letter to Zimmer from Senator Charles E. Grassley, a tireless champion and advocate of patient rights.

In his letter to Zimmer, dated July 29, 2010, Senator Grassley requested of Zimmer certain responses relating to reports and allegations of failed Zimmer devices dating back to 2008.

Laterally, the United States Judicial Panel on Multidistrict Litigation heard an application this past August to include additional Zimmer products as part of the Zimmer NexGen Knee implant products liability litigation. However, that application was vacated by The Panel, noting that the Zimmer product in question was initially designed and developed by a Zimmer competitor, and, thus, represented a sufficient number of differences that warranted "a substantial amount of unique discovery."

While there has been a Zimmer knee replacement recall of some knee replacement components, some are crying out for a recall of the NexGen CR-Flex Porous Femoral component, specifically.