Judge Grants Motion to Bar DePuy ASR Hip Recall Evidence from Bellwether Trial
The judge overseeing multidistrict litigation against DePuy Orthopedics in Ohio has granted a motion by the defendant to exclude evidence of a voluntary DePuy hip recall that took place in 2010. U.S. District Judge David A. Katz has determined the recall evidence is inadmissible under federal rules. This ruling could impact how DePuy ASR hip lawsuits are handled in the future as well.
Bellwether trial scheduled to begin in September
In July, 2013, Judge Katz identified McCracken v. DePuy as the first bellwether trial for the federal MDL. The case is scheduled to begin trial on September 9, 2013 and replaced the complaint originally identified as the first bellwether trial, since a series of setbacks had pushed the trial date for the original complaint back a number of months.
Judge Katz noted in his recent order that evidence related to the voluntary recall by DePuy of the ASR hip implant was inadmissible in this case, because McCracken’s original hip replacement surgery took place prior to when the recall was issued. Judge Katz determined the recall to be a “subsequent remedial measure,” which would have prevented harm if it had occurred prior to the plaintiff’s initial surgery.
The judge also denied a motion by the plaintiff to exclude evidence of the FDA’s 510(k) clearance process of the device. Although the plaintiff stated in her motion that the evidence was “irrelevant and prejudicial,” Judge Katz noted that the 510(k) process was the way in which this particular device arrived on the market. He ruled the defendants should be allowed to present the 510(k) process as evidence, as all parties involved would understand this is a clearance process based on an equivalency standard and not a “stamp of approval” by the FDA for the safety of the device.
Judge Katz issued the motions in limine, which means the rulings were made at the beginning of the trial process. These motions can bar certain evidence prior to the trial going before a jury. Although it is most common in criminal proceedings, it may be used in civil proceedings like this as well. The judge did note in his order that rulings on motions in limine could be changed, if the circumstances of the trial warranted such a modification.
DePuy ASR hip lawsuits growing in U.S. District Court
Judge Katz is currently overseeing coordination of DePuy ASR hip lawsuits in U.S. District Court for the Northern District of Ohio. Multidistrict litigation was established for complaints against DePuy regarding the ASR hip replacement system in 2010, amid a growing number of lawsuits. That same year, the company issued their voluntary DePuy hip recall for the ASR system. According to the FDA, at the time the recall was issued, the failure rate of the ASR implant was estimated at around 13 percent after five years.
Those who have filed complaints have cited a number of complications associated with the hip replacement device, including high failure rates and dangerously high levels of metal particles in tissue surrounding the treated joint. Many who have suffered complications have been forced to undergo revision surgery, which carries additional risk due to removal of the current device and possible bone damage in the joint.
Since the MDL was established, more federal cases have been transferred to the coordinated proceedings. Currently, DePuy is facing more than 10,000 complaints involving their ASR devices in courtrooms nationwide. In addition to the Ohio MDL, cases involving the ASR have also been coordinated on a state level in California and New Jersey.
- United States District Court, Northern District of Ohio, MDL No. 2197 http://www.ohnd.uscourts.gov/home/clerk-s-office-and-court-records/multidistrict-litigation-cases/mdl-2197/
- American Academy of Orthopedic Surgeons, Joint Revision Surgery – When do I Need It? http://orthoinfo.aaos.org/topic.cfm?topic=A00510
- FDA, Medical Devices Recalls http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/Implantsan