FDA Fast Track Process Faces Scrutiny in Zimmer Hip Lawsuits
Zimmer hip implant lawsuit plaintiffs have questioned the FDA’s clearance process for artificial hip devices. The Zimmer Durom Cup hip, along with other metal hip implants, was cleared via the FDA’s “fast track” 510(k) medical device approval process. Despite claims from plaintiffs about premature device dislocation, neither the manufacturer nor the FDA has implemented a Zimmer hip replacement recall.
Devices approved through 510(k) do not undergo standard clinical testing required for other products. Instead, the manufacturer of the device has only to show the new device is “substantially similar” to another device already on the market.
A comprehensive report in the New York Times a little over a year ago questioned whether the FDA’s fast track clearance process was in the best interest of patients. Although this particular report was primarily focused on the DePuy ASR hip replacement device, the Zimmer Durom cup followed a similar clearance pattern, allowing Zimmer to avoid putting its new metal-on-metal hip implant through the rigors of pre-market clinical testing.
Despite growing complaints, no Zimmer hip replacement recall
Following the 510(k) clearance of the Durom Cup hip, Zimmer hip implant lawsuit plaintiffs reported problems with the device, such as early loosening of component parts, limited mobility, and the need for revision surgery.
Though no Zimmer hip replacement recall has been implemented, the company did temporarily remove the Durom Cup from the market for three months in 2008, to investigate Zimmer hip lawsuit allegations of early device failure. They returned the implant to the market, claiming that instances of device failure were due not to a design flaw, but to inadequate surgical technique.
Some patients who have filed a Zimmer hip implant lawsuit claim that metal shavings were shed by the device and entered the bloodstream and surrounding tissues, causing significant damage and discomfort.
Zimmer hip implant lawsuit complaints criticize 501(k)
While some plaintiffs filing a Zimmer hip implant lawsuit allege that Zimmer did not alert patients and the medical community to problems associated with their hip implant, the FDA 501(k) clearance process has also come into question.
This process was originally designed to speed the approval process for drugs and devices that could “treat serious diseases and fill an unmet medical need,” according to the FDA website. However, many medical associations, including the Institute of Medicine and the New England Journal of Medicine have recently called for an end to the “fast track” process, citing the number of defective and life-threatening devices that have hit the market as a result.
Although the FDA has not yet put an end to the 501(k) process (nor has it issued a Zimmer hip replacement recall), the increased scrutiny generated by injured plaintiffs across the country, including those who have filed a Zimmer hip implant lawsuit, may force the agency to take another look at their accelerated clearance methodology.