Federal Trial over DePuy ASR Hip Implants Set to Start Next Week (OrthoSpineNews)
The first federal trial over DePuy Orthopaedics Inc.’s metal-on-metal hip replacement device, is set to begin on September 9 in Cleveland. These product liability lawsuits involve the DePuy ASR Metal on Metal hips, which were recalled in August 2010.
The New York plaintiff alleges to have a dislocated hip and was forced to undergo surgery to remove her ASR XL hip implant. This New York case, will be the first bellwether trial of nearly 8,000 cases coordinated in multidistrict litigation before U.S. District Judge David Katz.
DePuy ASR 2013 Verdicts
On March 8, a California jury in Los Angeles County Superior Court awarded $8.3 million to Loren Kransky, a retired prison guard who had the device implanted in 2007.
An Illinois jury in Chicago on April 16, rendered a verdict for DePuy in a case brought by Carol Strum, who had the device implanted in 2008 and she was forced to have replacement surgery three years later.
Another trial in state court in Florida is scheduled for November 8. San Francisco Superior Court is overseeing about 2,000 cases, the first bellwether trial is scheduled for October 15. New Jersey State Court has scheduled the first trial of more than 600 cases for October 21.
DePuy Recall
DePuy, recalled the artificial hip device from the market on August 24, 2010. The plaintiffs allege the company knew about its problems long before that and failed to warn doctors.
Plaintiffs allege that they have suffered injuries, including pain, grinding in the hips and a high metal content in blood tests. On May 6, 2011, the U.S. Food & Drug Administration, which regulates medical devices, ordered 21 manufacturers of metal-on-metal hip implants to conduct surveillance on their products and to assess their safety.
DePuy claims that “ASR XL was properly designed, the product was thoroughly and appropriately reviewed and cleared by the FDA, and the company informed of the product’s known risks.”
FDA 501 (k) Regulatory Process
DePuy, which has been hit by the metal-on-metal hip implant device lawsuits, has included in trials evidence that the FDA cleared the ASR for sale under its 501(k) process, which allows a manufacturer to sell a product that is “substantially equivalent” to a device already on the market. Such evidence was not part of the Kransky trial, but DePuy was allowed to introduce it in the Strum case.
In a July 26 ruling, the court which is overseeing the trial, allowed the evidence. “The Court is persuaded that Defendants are entitled to present evidence of the 501(k) clearance as it represents the process by which the device came to be on the market and is, therefore, relevant,” Judge Katz wrote.
“Despite Plaintiff’s protestations, the probative value outweighs the danger of unfair prejudice or jury confusion and this evidence will also be a subject to a special jury instruction.”