U.S. District Judge David A. Katz, who is presiding over the DePuy ASR hip implant multidistrict litigation (MDL) in U.S. District Court, Northern District of Ohio, just replaced the plaintiff in the first bellwether trial in this matter.
A court order dated July 8 declared that the case of Dorney-Madgitz v. DePuy, which had been scheduled as the first bellwether trial, has been vacated, with McCracken v. DePuy taking its place. The trial date remains scheduled for September 9, 2013. The overall litigation is in this matter entitled In Re DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability Litigation (MDL 2197).
The plaintiff in the new bellwether trial, Ann McCracken, was implanted with the DePuy ASR metal hip on or around August 2009. She alleges that, as a result of the procedure, “she suffered and continues to suffer serious bodily injury and was forced to undergo revision surgery on or around January 17, 2011,” according to court documents. McCracken resides in Rochester, New York.
“It’s astonishing to think about how many people may have been injured by metal-on-metal hip implants,” said Gary Falkowitz, Managing Attorney with the national law firm, Parker Waichman LLP. “We are hopeful that, over time, justice will be served.”
Symptoms consistent with a failed metal-on-metal hip implant device may include:
- Early failure, the need for revision surgery
- Metallosis, high levels of metal ions in the bloodstream
- Difficulty walking, or a change in the ability to walk
The DePuy ASR and other metal-on-metal hip implants were approved without clinical testing for safety or efficacy due to the 510(k) approval route. The 510(k) exempts devices from clinical testing as long as the manufacturers are able show that their product is similar to a previously approved device. The U.S. Food and Drug Administration (FDA) reported on January 18, 2013, that it was attempting to change the 510(k) approval process; the agency has proposed that all-metal hip replacements go through pre-market approval, which would require device makers to prove that their products are safe and effective.
Johnson & Johnson, which owns DePuy Orthopaedics as a subsidiary, recalled 93,000 ASR hips in 2010, citing a failure rate of 12 percent in five years, according to Bloomberg News. In Australia, failure rates have exceeded 40 percent in seven years. At the time of the recall, DePuy officials said that, “more people than expected who received the ASR Hip System experienced pain and other symptoms that led to a second hip replacement surgery,” according to TheJournal.ie.
Metal-on-metal hip implants, as a class, have become the subject of safety concerns in the orthopedic community. Now, studies reveal that metal hip replacements tend to fail more often than other implants.
The all-metal hip implants were created for greater durability and longevity and with the intention that the seemingly stronger metal components would be far superior over their more traditional counterparts constructed with plastic or ceramic elements. In recent years, the metal devices have come under fire for failing at unexpectedly high rates and leaving patients with significant and, often, life long injuries.