Rochester Woman's Struggles with DePuy ASR Hip Implant tabbed as Bellwether Case in Federal MDLJan 25, 2013
One New York woman’s ordeal with her defective DePuy Orthopaedics ASR metal-on-metal hip implant may have a profound impact for thousands more people in her situation.
According to a report from The (Rochester) Democrat and Chronicle, Ann McCracken’s lawsuit has been selected as a bellwether case against the medical device company DePuy, a division of pharmaceutical giant Johnson & Johnson, claiming its ASR metal-on-metal hip implant is defective and that it knowingly sold the device as safe and effective even though it was aware of its shortcomings.
McCracken received her DePuy ASR metal-on-metal hip implant during a 2009 procedure. At the time, she felt like a “poster child” for hip replacements, she told the news source, but soon afterward her fate turned like thousands of other recipients of this hip implant. Pain and inflammation were soon daily problems until they became “steady and intolerable.” After enduring months of pain that seemed endless, McCracken opted for surgery to remove the device long before she was told the ASR would have to be replaced and long before any other traditional hip implant should ever need attention.
Her case is common to thousands, perhaps tens of thousands of other recipients of this and other metal-on-metal hip implants. These devices were rushed through the Food and Drug Administration’s flawed 510(k) “fast-track” approval system over the last decade. This process grants access to the market for medical devices that show they’re similar in design to other already-approved devices without having to undergo extensive pre-market clinical testing to prove they’re either safe or effective.
That testing, McCracken and others believe, likely would have called attention to the many drawbacks of the DePuy ASR hip implant, including the chances a recipient would experience any number of complications that have become synonymous with these devices. Most notably among those defects is the link to toxic metal poisoning, metallosis, caused by the wearing together of the metal components of the metal-on-metal hip implant. This condition, if gone unchecked, can lead to far more serious trouble like organ and tissue damage and contributes to the overall early failure rate of these devices. It also increases the likelihood a recipient of a metal-on-metal hip implant will have to undergo costly, painful, and risky revision procedures to either correct or replace the hip implant years before they would have with a traditional hip implant.
McCracken’s case was chosen out of a pool of more than 7,000 lawsuits combined as part of the federal MDL against DePuy and Johnson & Johnson over the ASR hip implant. The ASR hip was recalled in August 2010 after its high early-failure rate was confirmed but not before tens of thousands of the devices had been implanted in patients who believed they were receiving a breakthrough technology that was supposed to be more durable and longer-lasting than those traditional hip implants that used ceramic or plastic components instead of all metal.
Though McCracken’s trial - expected to be moved to a Rochester court when it begins later this year - has been tabbed as a bellwether case in the DePuy ASR litigation, another trial involving the same device has begun this week in a California court.
In the run-up to that trial, internal documents have been released that show DePuy and Johnson & Johnson were aware of the defects of its product for years and that by 2011, the companies knew that 40 percent of the nearly 100,000 recipients of this device were likely to experience problems similar to McCracken’s.
The outcomes of these early cases will likely have a strong bearing on the fate of the other lawsuits facing other victims of ASR defects.