DePuy Comments at FDA Metal-on-Metal Hip Implant Hearing Prompt Strong ReactionJul 2, 2012 | Parker Waichman LLP
Comments made last week by a spokesperson for DePuy Orthopaedics regarding its line of metal-on-metal hip implants has drawn the ire of at attorney at the national law firm of Parker Waichman LLP, which represents numerous victims of these device’s defects.
Daniel Burke, Senior Litigation Counsel at the firm, said in response to comments offered to a Food and Drug Administration panel last week investigating the safety and future use of all-metal hips that the DePuy logic goes against the theories which rushed these devices on to the market.
Last week, DePuy’s director of biostatistics and data management told the panel that the safety of metal-on-metal hip implants can not be determined across a whole class. Instead, each device’s safety must be determined individually.
Not so fast, Burke says in a video statement issued shortly after the panel dismissed. It was that specific thinking that DePuy Orthopaedics and other manufacturers of metal-on-metal hips used to get their products into the hands of surgeons around the world in a more expedited fashion.
“It is ironic that when they file with the FDA for a 510k, fast-track approval, the manufacturers claim their new metal-on-metal hip implant is substantially similar to others on the market,” Mr. Burke says. “Now they say metal-on-metal hips should be individually evaluated when it comes to failures, without having subjected their own devices to more stringent analysis during the approval process.”
Metal-on-metal hip implants were mostly approved through the FDA’s 510(k) “fast-track” approval system. Manufacturers have used this loophole in the regulatory system to get life-saving drugs and devices on the market quicker in lieu of proper pre-market safety testing. This process is supposed to be reserved for drugs administered to patients suffering from terminal diseases, or for other products which have been on the market for a longer period of time and an updated version of it only makes minor changes.
These hip implants, the FDA is learning, likely should not have been rushed through the approval process as they’ve been the source of tens of thousands of adverse event reports worldwide. DePuy, itself, has been forced to recall its ASR model metal-on-metal hip implant as a result of the numerous defects and injuries it has caused.
And while the medical device maker claims that all these hip implants should be judged on their own safety merits, there are hallmarks of all-metal hips that suggests the entire range of devices poses similar dangerous risks. For instance, an all-metal hip is likely to shed small metallic particles into a recipient’s bloodstream, potentially leading to toxic build-up of the metals cobalt and chromium. Other reports of pain and inflammation or a failure of the hip implant appear to have no link to any specific device.
Had the FDA ordered proper pre-market testing, Burke says, thousands of people today would not be worried their hip implant could cause problems without warning.
Last week’s two-day hearing focused on the future of metal-on-metal hip implants, specifically the recommended treatment of people who rely on either the recalled metal hip implant or one that’s been associated with similar problems, essentially the entire class of the devices.
Last year, the FDA ordered 33 manufacturers of metal-on-metal hip implants to conduct thorough post-market safety testing on these devices to determine what, if any, benefit they serve over older hip implant models.