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Marketing executives at DePuy Orthopaedics discussed the potential

Feb 14, 2013

Marketing executives at DePuy Orthopaedics discussed the potential “backlash” the company could suffer from problems caused by its ASR metal-on-metal hip implants a full three years before a recall was issued on the devices.

DePuy, a subsidiary of Johnson & Johnson, maintains that its August 2010 recall on the ASR metal-on-metal hip implant was due to sluggish “clinical performance” out of the device and not because it was defective or flawed in design in any way.

According to a Bloomberg report, jurors in the ongoing trial of Loren Kransky were told that marketing executives at DePuy met in 2007 in Chicago and discussed the issues surrounding what were then growing reports of early failures among recipients of the ASR hip implant.

Kransky is a former Montana prison guard who claims the ASR hip implant he received several years ago was defective and that DePuy was aware of the problems plaguing the device but continued to market it as safe and effective. His is the first case among more than 10,000 lawsuits filed against the ASR hip implant to reach a jury trial.

Testimony has entered its third week and jurors are hearing evidence that is attempting to show that executives at DePuy were aware of the problems dooming the ASR hip implant, that the company failed to conduct proper testing on the device, and that the hip implant causes serious and disabling injuries for recipients that eventually lead to a revision surgery to either correct or remove the device entirely.

On Tuesday, two of those points were addressed directly during the testimony of Randall Kilburn, a marketing executive at DePuy who attended that 2007 meeting in Chicago, three years prior to the recall. During that meeting, a slideshow presentation discussed ten problems facing the company in the coming year and chief among them was “metal ion backlash,” according to the report.

Kilburn admitted that in 2007, “metal ion backlash” was among “many” concerns the company had and considered threats to the business. Those executives also discussed numerous other problems they called “red flags” surrounding the ASR hip implant.

This goes against the company’s mantra even through this trial that it never believed the ASR metal-on-metal hip implant to be defective. Kilburn also testified that he was party to data that showed numerous adverse event reports had already been filed against the implant, especially when it was “malpositioned” in a patient.

More than 10,000 people have filed lawsuits similar to Kransky’s in courts across the country and they all make similar claims, especially that the company was aware of the defects associated with the device and that it caused dangerous amounts of toxic metallic ions to accumulate in a recipient’s bloodstream, leading to organ and tissue damage. One surgeon even described that damage as “black hole” around the implant in testimony offered at the beginning of this trial.

If Kilburn’s testimony didn’t paint a bad enough picture for the company, striking another blow to the credibility of its claims, his actions a year later at a sales conference may be worse. As his time on the stand Tuesday continued, Kilburn also admitted to rallying the company’s sales force around the ASR hip implant in 2008, a year after that meeting he had attended. It was there that he touted rising sales of the metal-on-metal hip implant and pushed for more, leaving the crowd with the rallying cry, “Game on!”

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