Zimmer NexGen Knee: Patients Are Not Appliances

Washington, DCThere are certain sectors that require, by their very nature, a higher standard. Law enforcement. Government officials and members of the judiciary. Religious leaders. Surgeons. Any entity that manufactures medical devices such as Zimmer NexGen Knee Replacement. ANY manufacturer of a drug or medical device that can impact an individual’s health in a positive or negative way.

Sadly, that is often not the case. And it seems to be getting worse.

Zimmer is not the lone villain here. Other manufacturers of medical devices have been the subject of lawsuits following the failure of devices well ahead of their intended life expectancy. Artificial knees and hips, for example, have traditionally encompassed an expected life span of 15 years. In other words, a patient could reasonably expect a minimum of 15 years’ service from the artificial joint under normal conditions (a marathon runner, for example, might reasonably expect an artificial hip or knee to fail early).

It should be noted that a 15-year life expectancy stemmed from older, more traditional devices fashioned from more common materials. Updates to these devices were expected to be better, stronger and last longer.

But this has not proven to be the case for a growing number of patients. To that end, a recent Zimmer Knee Replacement NexGen lawsuit was filed in early March by a New Hampshire couple who alleged serious injury and inconvenience following the alleged failure of a NexGen knee two years after initial surgery.

Specifically, the action filed March 4 in New Hampshire District Court (Case No. 1:2014cv00095) spells out the situation that befell the plaintiff after receiving a Zimmer NexGen Knee Replacement in her right knee in 2011. Two years later, in 2013, the plaintiff required revision surgery following complications and the alleged failure of the device.

Two years is a far cry from 15. Further Zimmer lawsuits related to the Zimmer knee replacement recall have been consolidated in Zimmer Multidistrict Litigation (MDL 2272, US District Court for the Northern District of Illinois).

Is FDA 510(k) clearance help or hindrance?

What doesn’t help is a loophole observed by the US Food and Drug Administration (FDA) that allows for the fast-tracking to market of new devices that are of similar design to devices already on the market and accepted as safe and effective. Under normal circumstances, a medical device requires substantial vetting through clinical trials. If there are any serious problems, those setbacks involve only a small number of trial participants who have given permission to be used as a “guinea pig” for the purpose of furthering medical science. They also are provided with an honorarium for their service.

A clinical trial spares the greater population at large from suffering a similar fate.

However, the FDA 510(k) clearance allows manufacturers to circumvent the clinical trial process due to a perceived similarity of the item up for approval, when compared with a device already on the market: an artificial knee or hip of similar design as existing products but fashioned from, say, more modern materials.

The assumption is that the updated device will function in similar fashion to older, heritage devices. And while the 510(k) protocol brings promising products to market sooner, experience has proven that assumptions are increasingly misguided when unforeseen problems with materials come to the fore. Sadly, such problems are exacerbated across the entire population, rather than a smaller population of clinical trial participants.

When a Zimmer NexGen Knee or any other artificial medical device from any other manufacturer fails early, it’s not quite the same as running that defective dehumidifier back to the big box retailer for a refund or replacement. Nor is it quite the same thing as waiting in the service area for your car to be repaired.

The allegedly defective device is now a part of your anatomy, for which you took time off from work and other responsibilities for the surgery and necessary healing time. That can take months, in some cases. But a worthwhile investment, in exchange for 15 years of additional mobility.

Not.

Instead, plaintiffs embroiled in Zimmer NexGen litigation and lawsuits involving other defendants are incensed because within just a few years (or less) following initial surgery and convalescing, they are required to go through the pain and inconvenience of yet another surgery to undo the problem. What’s more, revision surgery is often more complicated than the initial procedure. Thus it can take longer to heal.

That means more time away from a career and other responsibilities.

Little wonder that plaintiffs are filing lawsuits. Patients are not cars. It’s not quite so easy to climb under the hood to swap out an allegedly bad knee such as the NexGen Knee. But manufacturers, and even the FDA, don’t seem to get it…