The first federal trial over DePuy Orthopaedics Inc.’s metal-on-metal hip replacement device, which is the subject of about 10,000 lawsuits across the country, is scheduled to begin on September 9 in Cleveland.

The case, brought by a woman in Rochester, N.Y., who claims to have a dislocated hip and was forced to undergo surgery to remove her ASR XL hip implant, will be the first bellwether proceeding to face jurors of nearly 8,000 cases coordinated in multidistrict litigation before U.S. District Judge David Katz. Prospective jurors are expected to be brought in on Tuesday.

Ellen Relkin of New York’s Weitz & Luxenberg, co-lead counsel for the plaintiffs’ steering committee in the ASR multidistrict litigation against DePuy, said the trial team will include committee member Eric Kennedy, managing partner of Weisman, Kennedy & Berris in Cleveland; Michelle Kranz of Zoll, Kranz & Borgess in Toledo, Ohio; and local counsel Stephen Schwarz, managing partner of Faraci Lange in Rochester, N.Y.

“We believe this is an appropriate case for bellwether trial since there is a concerning number of re-revisions among ASR patients resulting from injury to the tissue and muscle from metal debris and the two prior trials did not involve re-revisions,” Relkin wrote via email.

"The company will defend itself against the plaintiff's allegations and believes the evidence will show that the design of the ASR XL was not responsible for the plaintiff's hip arthroplasty failure and that the company's actions concerning the ASR XL were appropriate," wrote DePuy spokeswoman Mindy Tinsley in an email to The National Law Journal.

Jurors in state court cases in California and Illinois rendered the first verdicts over the ASR device this year. On March 8, a 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, but rejected his bid for as much as $179 million in punitive damages. DePuy has appealed that verdict to California’s Second District Court of Appeal.

A Chicago jury on April 16 issued a verdict for DePuy in a case brought by Carol Strum, who had the device implanted in 2008 but claimed she was forced to have surgery to replace it three years later. That trial was the first of 300 actions pending before Cook County, Ill., Circuit Judge Deborah Mary Dooling, who had asked lawyers to designate certain cases as representative.

Another trial in state court in Florida is scheduled for November 8. In California, where San Francisco Superior Court Judge Richard Kramer is overseeing about 2,000 cases, the first bellwether trial is scheduled for October 15. And in New Jersey, where DePuy’s parent company, Johnson & Johnson, has headquarters in New Brunswick, Bergen County Superior Court Judge Brian Martinotti has scheduled the first trial of more than 600 cases for October 21.

DePuy, based in Warsaw, Ind., pulled the device from the market on August 24, 2010, but plaintiffs allege the company knew about its problems long before that and failed to warn doctors. Those problems, they claim, include pain, grinding or clicking 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.

More than 93,000 ASR devices have been implanted in patients. DePuy also faces more than 4,000 lawsuits over its Pinnacle hip device, and similar litigation has been filed against other manufacturers.

DePuy, which has been hit the hardest over metal-on-metal hip implant devices, has fought vigorously to include 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 the federal case, plaintiff Ann McCracken had moved to exclude the evidence, claiming that the FDA’s clearance of the device was irrelevant to whether it was safe. DePuy attorney Robert Tucker of Tucker Ellis in Cleveland insisted the evidence would explain that his client wasn’t selling an unregulated product. Earlier, DePuy said: “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."

In a July 26 ruling, Katz, who 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,” he 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.”

McCracken has moved for clarification of that order, which DePuy opposed on Thursday.

The same issue surfaced in the multidistrict litigation over transvaginal mesh products pending before U.S. District Judge Joseph Goodwin in Charleston, W.Va. But in that case, Goodwin, who oversaw the first two bellwether trials this month, granted a motion to exclude from the cases any evidence that C.R. Bard Inc.’s device had been cleared for sale through the FDA’s 501(k) process. Bard, which lost a $2 million verdict in the first case and settled the second, unsuccessfully has sought reconsideration of Goodwin’s order or, in the alternative, to certify the issue for interlocutory appeal to the U.S. Court of Appeals for the Fourth Circuit.

Contact Amanda Bronstad at abronstad@alm.com.