Amidst Stryker Lawsuits, Calls to End FDA Fast-Track Loophole

Washington, DCWhen one considers that a full premarket approval (PMA) process for a new medical device is measured in years, the mere two months it took to get the Stryker Rejuvenate Modular Hip System approved for market seems remarkably short. This is especially true considering the relatively high failure rate and the subsequent voluntary recall of the Rejuvenate system by the manufacturer just a few short years after bringing the hip replacement system to market.

The issue is not unique to Stryker, in that other manufacturers have faced similar setbacks after modern hip replacements expected to outlast more traditional devices by decades are instead failing after just a few years and negatively impacting patients. Failures have been characterized by the unexpected loosening of components, fostering bone fractures and other issues related to bone health and stability.

The widespread adoption of metal-on-metal devices, again thought to foster longer wear for younger recipients, in reality resulted in metal toxicity, as minute metal particles were released into the bloodstream and caused inflammation of surrounding tissue.

According to most reports, it can take anywhere from three to seven years to bring a medical device from conceptualization to the market through a normal PMA that would also cost manufacturers millions in testing and clinical trials.

In contrast, the Stryker Rejuvenate Modular Hip System was approved by the US Food and Drug Administration (FDA) on June 3, 2008, less than two months after Stryker submitted the Rejuvenate Modular Hip under the now-controversial 510(k) Clearance, given that the Rejuvenate system was substantially similar to other devices currently on the market. This allowed Stryker - like all manufacturers granted a 510(k) Clearance for their medical devices - to skip the costly and time-consuming PMA process, including clinical and observational trials on volunteers before the products were released to the wider market.

“Most case studies show a hip implant is good for 27 to 44 months,” said attorney Ben Gordon, of the law firm Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor, P.A. in Florida, in comments to Online Legal Media’s Brenda Craig in April of this year. “Certainly there are people whose devices last five to seven years, but it is rare for these devices to last anywhere close to the 15 years that their predecessors got, much less the 20 to 40 years doctors were led to believe.”

Two years and two months after Stryker began marketing the Rejuvenate Modular Hip, the manufacturer found it necessary to issue an “Urgent Safety Alert” in April 2012. Stryker would issue a voluntary recall of the device some three months later.

“As it turns out, the metal-on-metal hip implant does not last longer,” says Gordon. “I have been representing clients for many years and what they have gone through is unnecessary,” he says.

To that end, there have been increasing calls from ethicists and the medical community to end the fast-track 510(k) Clearance, which was originally intended to serve the consumer by bringing promising products to market sooner. However, it seems the opposite has been true, given that products such as the Stryker Rejuvenate Modular Hip was not adequately tested through a full PMA before release to the market, thereby introducing unproven devices without a documented failure rate or history to the unsuspecting consumer. In July 2011, the Institute of Medicine called for the elimination of the 510(k) Clearance altogether.

In the meantime, thousands of Stryker Rejuvenate Modular Hip systems were implanted into patients during the two years it was on the market. With allegedly high failure rates, many patients will be facing needed revision surgery, which is usually more complex than the original procedure - and is not always 100 percent successful.

With a recalled hip implant that may have lasted a fraction of the expected lifespan, a consumer would have little choice but to pursue compensation through a Stryker Rejuvenate Modular Hip System lawsuit.