First Hip Replacement Trial Set to Begin

The first federal bellwether trial against Johnson & Johnson's DePuy orthopaedics is about to begin.  The company faces design defect product liability allegations because it avoided full FDA pre-marketing review thanks to an exception for products that are the "substantial equivalent" of a product on the market before 1976.  Here the change was that the hip implant was all metal.  FDA's lax policies allowed that to be seen as an insubstantial change.  The design caused a high rate of problems due to metal-on-metal friction which released microscopic particles.
J& has been reported ready tosettle - after a series of test case rials known as bellwethers have given both sides a sense of the strengths and weaknesses of a sampling of cases.
The limited FDA review allowed plaintiffs to escape the Supreme Curt's federal preemption bar on design defect cases in Riegel v. Medtronic.  In an opinon by Antonin Scalia the Court spared medical device manufacturers who submitted devices for broader pre-market FDA review. - GWC
First Hip Replacement Trial Set to Begin:
by Amanda Bronstad - National Law Journal

Ellen Relkin - Weitz Luxenberg

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.****

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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.

Read more: http://www.law.com/jsp/nlj/PubArticleNLJ.jsp?id=1202617543405&First_Hip_Replacement_Trial_Set_to_Begin#ixzz2dpgUD3tW

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