FDA’s 510(k) Program to Blame for Zimmer Hip Replacement Problems?
Earlier this summer, the Institute of Medicine (IOM)—an independent nonprofit organization—urged the FDA to replace its much-criticized 510(k) program, stating that the agency’s resources would be better invested in developing a new program for the purpose of evaluating the safety of so-called “Class II” medical devices. Critics point to the 510(k) as being the reason why many products, like the Zimmer Durom Cup, have been found to have higher failure rates than expected once released on the market.
A Zimmer hip lawyer is likely to figure the 510(k) program into his or her argument that Zimmer failed to adequately test for possible Zimmer hip replacement problems prior to launch. What is the 510(k), what’s wrong with it, and how might reports such as this affect a possible Zimmer hip settlement?
510(k) requires no tests for Zimmer hip replacement problems
The FDA has basically two programs through which new medical devices can attain approval. One is called the “premarket notification,” which is often referred to as the “510(k) process,” and the other is called “premarket approval (PMA).”
Premarket approval requires a product to demonstrate safety and effectiveness through adequate and well-controlled clinical trials. PMA is used to evaluate Class III devices, which are those that support and sustain human life, are important in preventing impairment of human health, present a potential unreasonable risk of injury, or are new with unknown safety risks.
Premarket notification, however, or 510(k), requires no clinical trials. It is used to approve a device that is “substantially equivalent” to another device already on the market. The device can be technologically advanced, however, and doesn’t have to be manufactured from the same materials or even perform its intended purpose using the same technology. Manufacturers just have to prove that it has “roughly” the same safety and effectiveness characteristics as the predicate device to which it’s being compared.
The Zimmer Durom Cup received its FDA approval through the 510(k) process, a fact used in part to explain why it’s been the source of so many Zimmer hip replacement problems leading patients to seek a Zimmer hip settlement.
A Zimmer hip lawyer might refer to 510(k) as a “loophole”
It’s not uncommon for a Zimmer hip lawyer to refer to the FDA’s 510(k) process as a “loophole” that allows companies like Zimmer to release unproven products like the Zimmer Durom Cup onto the market without clinical trials.
For example, one of the complaints with the Durom Cup is the possibility for Zimmer hip replacement problems like metal poisoning, caused when the metal components rub against one another and deposit shards of cobalt and chromium into surrounding tissues. When the Durom Cup was approved, the FDA’s 510(k) process didn’t consider the effects of the new materials in the implant—namely, the cobalt and chromium. Since the new product doesn’t have to be made with the same materials as the old, the Durom Cup sailed through approval even though the metal-on-metal design later proved dangerous.
Will criticism of 510(k) encourage a Zimmer hip settlement?
Though the FDA is considering changes to the program, so far it has not released any information as to the extent of those changes. Can plaintiffs expect a larger Zimmer hip settlement because of this “loophole?” It remains to be seen, though several federal cases in 2009 were settled in a Zimmer hip settlement out of court.