U.S. District Judge David A. Katz has replaced the plaintiff in the first bellwether trial in the DePuy ASR hip implant multidistrict litigation (MDL) in U.S. District Court, Northern District of Ohio.
The original case, Dorney-Madgitz v. DePuy (Case No. 1:11 dp 20112), has been replaced with McCracken v. DePuy (Case No 1:11 dp 20485). The trial date remains September 9, 2013. The overall litigation is entitled: In Re DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability Litigation (MDL 2197). The outcome of bellwether cases is important in indicating trends in litigation and can provide a basis for negotiating a settlement.
Ann McCracken of Rochester, New York, the new plaintiff, received a DePuy ASR metal hip implant in August 2009, and her suit alleges that “she suffered and continues to suffer serious bodily injury and was forced to undergo revision surgery on or around Jan. 17, 2011,” according to court documents.
The DePuy ASR and other metal-on-metal hip implants received U.S. Food and Drug Administration (FDA) approval without clinical testing for safety or efficacy through the 510(k) approval route, which exempts devices from clinical testing as long as the manufacturers show that their product is similar to a previously approved device. Many of these devices have been recalled or removed from the market worldwide because of high early failure rates and complications. The FDA announced in January 2013 that it was attempting to change the 510(k) approval process so that all-metal hip replacement devices would go through premarket approval requiring the manufacturers to prove that their products are safe and effective.
The FDA advises hip implant recipients to consult their doctors if they experience pain, swelling, difficulty walking or change in the ability to walk, loosening of the joint, or squeaking or popping sounds.