September 5, 2012 by: Linda Grayling
DePuy agreed in January 2012 to stop manufacturing the custom devices after a warning letter from the FDA. In it, the agency said the implants were being sold without federal approval, which requires an application with the FDA and clinical trials. DePuy argued that the devices were exempt because they were already approved by the FDA and modified only by doctors’ prescriptions, which is permitted by law.
But the FDA disagreed: “Although the devices’ size and shape may vary with each patient’s anatomy, the standardized design characteristics do not vary among the devices manufactured. The fact that final specifications are tailored to match a patient’s anatomy does not preclude a clinical study or submission of a marketing application for the devices.”
The FDA also said DePuy used poor quality-control systems in the production of the 14 types of custom implants. It ordered the company to recall any implants that had been delivered to surgeons prior to the halt in manufacturing earlier this year. More than 8,300 customized DePuy implants have been sold since 1999, but the number of unused devices in the recall is unknown.
DePuy already is dealing with a massive global recall of 93,000 ASR hip-replacement and hip-resurfacing devices that was announced in August 2010. The defective metal-on-metal hip implants have been shown to fail within a few years, resulting in painful revision surgeries. Typically, all-metal hip implants are expected to last about 15 years.
In addition, the DePuy artificial hips produce metal shavings when the ball and socket components grind against each other, causing metallosis, or metal poisoning of the blood. One British study found that when the metal debris becomes embedded in surrounding tissues, it increases the patient’s risk of bladder and kidney cancers.
In the United States, more than 8,000 patients have filed lawsuits against DePuy over their dangerous hip implants. Of those, 6,000 federal cases are part of a multidistrict litigation (MDL) that is being overseen by Judge David A. Katz in the U.S. District Court for the Northern District of Ohio. The first case in the MDL is expected to go to trial in March or April 2013.
The remaining state cases are winding their way through the courts. The first three DePuy ASR lawsuits, which were scheduled to be tried together in Las Vegas, Nevada, were settled out of court recently. Bloomberg reported the plaintiffs each received about $200,000.