FDA Under Fire for Zimmer Fast Track Approval

Elise Kramer | March 29th, 2012

Plaintiffs who have filed lawsuits with the help of a Zimmer hip lawyer are criticizing the Food and Drug Administration’s 510(k) “fast track” device approval process that has allowed a number of devices that have since become involved in litigation based on side effects to pass through the FDA’s usually-strict approval process without as many clinical trials as would normally be in place due to their similarity to products that are already on the market. Plaintiffs have claimed a number of side effects associated with the Durom Cup hip replacement system, including loosening of the implant, metallosis, and the need for a Zimmer hip implant revision. Despite this, neither the FDA nor Zimmer have initiated a hip replacement recall.

The only requirement for a device’s approval through the fast track process is that the manufacturers prove that it is “substantially similar” to a device that is already on the market and has been approved by the FDA. The New York Times published a report a little over a year ago that criticized the FDA’s fast track process–although this article focused on the DePuy ASR hip replacement device, similar concerns have been brought up with the Durom Cup hip replacement system as it followed a similar clearance pattern.

Zimmer hip replacement recall: not yet initiated

Despite the growing number of complaints against the device manufacturer, many of which have turned into lawsuits that are trying to gain compensation from the device manufacturer for injuries that patients have experienced. Patients have reported problems including limited mobility and loosening of the implant parts, and although Zimmer did pull the device from the market for three months for evaluation, ultimately it was re-released with the claim that any problems were due to problems with the surgical technique used to implant the device and not the device itself or any design or manufacturing flaws. Neither Zimmer nor the Food and Drug Administration have chosen to initiate a Zimmer hip recall.

Zimmer complaints criticize FDA method

A number of lawsuits are citing the FDA’s fast track approval process as the reason for their complications–they assert that, had the Food and Drug Administration require more stringent testing of the devices, the potential complications may have been noticed and weeded out before it had a chance to put patients at risk. Unfortunately, this was not the case, and lawsuits continue to be filed across the country.