Zimmer Hip 510(k) Approval Faces Growing Challenge
A recent report by an independent nonprofit organization has recommended that the FDA throw out its flawed 510(k) medical device approval process and start over. In light of the many post-market recalls and mounting adverse event reports surrounding devices such as the Zimmer hip, which was approved through the 510(k) program, the organization’s conclusions are not necessarily surprising. What remains to be seen is whether or not the FDA will act on the recommendations, and how the report may affect a Zimmer hip lawsuit.
FDA’s 510(k) a factor in Zimmer hip lawsuits
Non-profit advocacy group Public Citizen has long blamed the FDA’s 510(k) for early device failures such as those claimed by plaintiffs in a Zimmer hip lawsuit. They say the process “has failed to keep dangerous and ineffective medical devices from the market.” Indeed, just a year after the Zimmer Durom Cup metal-on-metal hip implant was approved, reports started filtering in of early hip failure, hip implant loosening, metal poisoning, and other Zimmer hip side effects.
Devices approved through the fast-track process have only to show that they are “substantially similar” to another device already on the market. “The way the law is written,” stated the recent report by the Institute of Medicine (IOM), “it directs the FDA to determine…that the new product be substantially equivalent to the old product, not that the new product or the old product be safe and effective.”
Does 510(k) suppress innovation?
The FDA and medical device companies say the 510(k) process makes it easier and cheaper for companies to gain approval for new upgrades of older models, and helps get newer technologies to the public without years of red tape. A Zimmer hip lawyer can easily make the case, however, that the program, which requires no clinical trials, costs less than $5,000, and takes only 3-6 months to complete, is a substandard short-cut that leaves patients to suffer the consequences.
The IOM even challenged the idea that the 510(k) supports innovation by pointing out the fact that because it takes less time and money, most companies seek to use it for approval, and therefore are less likely to develop truly new products that would not meet the 510(k) standard of substantial similarity to an old one.
Fast-track approval contributed to 2008 “Zimmer hip recall”
The Zimmer Durom Cup was approved by the 510(k) process in 2006, and two years later, the company suspended sales of the device, a move mistaken by many to have been a Zimmer hip recall. While the device was not actually recalled, Zimmer did suspend sales of the Durom cup in order to conduct an internal investigation of the product.
Ultimately, Zimmer denied any link between the claims of adverse event reports and some sort of design flaw. The device was reissued again a few months later with additional surgical instructions.
Whether the new report by the IOM will influence a future Zimmer hip recall is not yet known. So far, defense lawyers for medical-device manufacturers are trying to discredit the report, stating the IOM panel included no officials from the industry or from the investment community, and was therefore biased in its findings. Zimmer hip lawyers will continue to maintain otherwise.