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DePuy ASR Hip Implant Designer and Surgeon would have Blocked Approval of Device if Aware of High Early Failure Rate

Feb 13, 2013

One of the designers of the DePuy Orthopaedics ASR metal-on-metal hip implant told jurors this week that he would have never agreed to approve the device had he been aware of an early failure rate in excess of 20 percent.

According to a Bloomberg report from the Los Angeles Superior Court trial in which a former Montana prison guard claims that DePuy was aware of the defects associated with the ASR hip implant but continued to market it as safe and that the implant caused him to suffer severe and life-changing injuries, the lead designer/surgeon involved in developing the ASR hip implant testified that he “would not have put the product on the market” if he would have known that so many people would suffer complications in the first few years after receiving the implant.

The incentives were rich for Thomas Schmalzried, however. Because of his role in developing the ASR metal-on-metal hip implant, he was due at least 2 percent of every sale of the device. From the time it was introduced in the U.S. in 2005 until its eventual global recall in August 2010, Schmalzried pocketed $3.6 million in royalty payments from DePuy generated by DePuy sales.

Schmalzried, a surgeon practicing in Los Angeles, said that 66 of his patients were fitted with the ASR metal-on-metal hip implant while it was available on the market. Soon, he saw the impact of his failed device. Of his patients fitted with it, 11 had developed complications within the first four years consistent with the thousands of others around the world who have complained that the device was responsible for causing severe pain, inflammation at the site of the implant, and that it was exposing them to dangerous levels of metallic ions due to a defective design that caused the metal component parts to shed metallic particles into their bloodstream.

The surgeon was one of two who helped design the ASR hip implant that testified via videotaped deposition on Monday. Schmalzried was preceded on the stand by Thomas Vail, also a surgeon who grossed royalties in excess of $2 million generated by sales of this specific metal-on-metal hip implant.

In this trial, Loren Kransky, 65, claims he suffered complications caused by the ASR hip implant in the first months and years after being fitted with it. His is the first case of more than 10,000 lawsuits filed across the country to reach a jury trial. The outcome of this trial could impact many other complaints against DePuy, a division of Johnson & Johnson.

As lawyers representing Kransky attempt to prove that executives at DePuy were aware of the problems plaguing the ASR hip implant for years while the company continued to deny these claims and tout that it was safe and effective for patients to receive in a hip replacement surgery.

A bellwether trial picked from more than 7,000 claims against the ASR hip implant consolidated in a federal Multidistrict Litigation is expected to begin later this year.

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