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Jackie Fedeli
Jackie Fedeli
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Project Manager Attests To DePuy's Flaws During ASR Trial

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During one of the first DePuy Metal on Metal Hip Trials, a former Johnson and Johnson (J & J) project manager told jurors that the company failed to forecast key flaws that led to the 2010 DePuy recall.

Plaintiff Loren Kransky and his attorney Mike Kelly are alleging failure to warn, defective design and negligent recall in the pending lawsuit against J & J.

Magnus Flett who lead a design team at Johnson and Johnson’s subsidiary Depuy Orthopedics oversaw a group conducting a failure mode and effect analysis (FEMA) of a cup component of the device that was shallower than other cups.

Kransky alleges that the shallow design of the metal cups caused toxic debris of cobalt and chromium to enter his bloodstream. Kransky’s lawyers also claim the metal cups did not stimulate growing of surrounding bone which made them unstable in the hip.

Soon after DePuy began selling ASR Devices, doctors began reporting that the cup could be unstable and lead to the release of metal ions.

Flett advised the court that as Johnson and Johnson started to gather data, the company realized that devices placed at angles of 55 degrees or higher gave increased ion results.

Kelly displayed a document from DePuy dated September 27, 2007 that described how “massively increased wear” can occur when the cup is “oriented at a steep angle” The document also suggested that the company could “significantly redesign” the ASR device, but a 2008 e-mail from the head of U.S. marketing at DePuy said they will ultimately need to redesign the cup, but the short term action is to simply manage perceptions.

Johnson and Johnson knew their product was flawed if they had planned to significantly redesign the cup. But, they were not too concerned with the faulty products that were already on the market. Not until the DePuy ASR was recalled in 2010.

Flett advised that the plans for the redesigned ASR were scrapped due to financial restrictions

DePuy worked to keep the ASR redesign discreet, so that surgeons would not ask too many questions about the effectiveness of the first ASR. ASR 2 was later scrapped due to financial restrictions. Flett told the jury that DePuy never told surgeons that the ASR failed or that revision surgeries would be required at a higher rate than other company products.

Kransky’s case is the first of many DePuy trials. There are 10,000 more DePuy lawsuits filed against Johnson and Johnson.

For more information on this trial, please visit: http://www.bloomberg.com/news/2013-01-28/j-j-failed-to-forecast-flaws-leading-to-recall-jury-told.html