Experts predict that the study, conducted by the hugely regarded Institute of Medicine, will advise stricter regulations for the approval of new implant devices. An experienced Zimmer knee lawyer must be conscious of the FDA’s “fast track” 510(k) medical device clearance process. For example, Zimmer’s NexGen CR Flex artificial knee device, a device facing allegations of early knee failure and knee revision surgery in a typical Zimmer knee lawsuit, was given industry clearance under the 510(k) normal 2005.

As opposed to the FDA’s alternative, more rigorous pathway to market approval, the 510(k) clearance approach does not need a device to undergo clinical tests, such as a pre-market Zimmer knee study. Rather, the device makers need only show that the artificial implant is “substantially equivalent” to devices currently on the industry.

Mixed reaction to FDA’s investigation

A pro-enterprise group attacking the upcoming 510(k) study claims that the assessment board appointed by the esteemed Institute of Medicine to oversee the report is unacceptably biased. Regardless of the fact that the 12-member evaluation board is not only composed of physicians and academics, but also lawyers who have worked in the past for device makers and consumer advocates alike, the protesting organization believes that the absence of representatives from the producers themselves, or their satisfied implant buyers, really should automatically invalidate the study’s conclusions.

Artificial joint makers have additional protested that stricter marketplace approval recommendations will have a negative impact on the health of patients, because innovative merchandise will take longer to get to the industry.

Not every person in the medical community agrees with attacks on the forthcoming report, however. The NY Times recently quoted a Yale medical professor expressing his displeasure with the device industry’s tactics: “We are trying to get to good policies, and the spin game does not help us.”

Zimmer knee lawyer in favor of FDA action

Like other advocates for patients harmed by related medical devices, a Zimmer knee lawyer may possibly allege that the 510(k) approach is inadequate. Medical devices cleared to market in this fashion expose patients to all kinds of risks as evidenced by various recalls and mounting lawsuits.

A Zimmer knee lawyer could agree that had the FDA conducted pre-market place trials to study implants such as the NexGenCR-Flex and related devices from other device producers, patients and doctors could make more informed choices about the devices chosen.

Find out how you can file a Zimmer Knee lawsuit