The first four bellwether trials involving claims against the DePuy Orthopaedics ASR metal-on-metal hip implants are set to begin sometime next year.
According to a report from MassDevice.com, U.S. District Judge David Katz has ordered both sides of the massive Multidistrict Litigation involving thousands of claims against the failed and recalled all-metal hip implant from the Johnson & Johnson subsidiary to select four cases which will serve as bellwethers for others already filed and potential future claims.
More than 97,000 people worldwide were implanted with the DePuy ASR metal-on-metal hip implant before it was recalled from the market entirely in the Fall of 2010. Excessive reports of early failures caused by either persistent pain and inflammation, failed revision surgeries, and/or a toxic accumulation of the metals cobalt and chromium eventually led to the recall of the devices.
The recall also touched off a whirlwind of lawsuits to be filed against the company behind the devices and also prompted a federal investigation into the safety of metal-on-metal hip implants altogether. Touted as innovative in that they allowed younger recipients of hip implants to go longer on a single device and requiring less replacement surgeries in a lifetime, metal-on-metal hip implants have served primarily as a means of exposing the flaws of the Food and Drug Administration’s 510(k) “fast-track” approval system.
The claims made of metal-on-metal hip implants appear to have been made based on hope rather than any scientific evidence. They were rushed by the FDA’s approval system without much pre-market testing, putting recipients into a class of guinea pigs who would eventually test the devices and soon learn of their numerous flaws.
Thousands received the ASR and other metal-on-metal hip implants and soon, people who weren’t normally candidates for a total hip replacement were receiving them, opting for the replacement over potentially years of pain caused by a failing natural hip.
Those who received the ASR hip implant were quick to learn that they were not as advertised. Pain and inflammation were common within months of relying on the failed devices. Many people suffered a total failure of the ASR hip implant when the neck of if popped out of the hip socket. Revision surgeries were painful and often did not allay all the problems the implant were causing. And all the while, the ASR and other metal-on-metal hips were also putting their recipients at greater risk of injury because they were depositing small metal fragments into the body from the site of the implant. Through normal use, the metal components rub against each other, shaving off small particles of cobalt and chromium and distributing them through the body, into the bloodstream, nearby tissue, muscles, and organs.
If unchecked, this metallic build-up could lead to muscle and tissue damage, as well as potential organ failure.
Studies on the safety of the ASR hip implant conducted after it had become apparent these hip implants were failing at abnormal rates showed they’ve failed after just five years in more than 13 percent of recipients, and up to possibly one-third. Thousands of people still rely on the ASR hip implant and could potentially join the still-growing MDL filed in U.S. District Court.