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Shezad Malik MD JD
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DePuy ASR Design Flaw Exposed in Metal Hip Implant Trial

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It is the $64,000 question, that is the lynchpin of the DePuy ASR product liability trial that is currently underway in Los Angeles, California; "What did DePuy know and when did they know it and if so did they fail to disclose that information." DePuy Orthopedics, the manufacturer of the DePuy ASRs is a subsidiary of Johnson & Johnson.

According to recently unsealed documents, Johnson & Johnson executives knew years before they recalled the DePuy ASR metal on metal artificial hip in 2010, that it had a critical design defect. Internal company documents confirm that the Johnson & Johnson company concealed that devastating information from doctors and patients.

36,000 US Patients Received the Metal ASR Implant.

DePuy Orthopedics had received many complaints from doctors about the Articular Surface Replacement (ASR) implant in 2005. According to documents, the ASR design defect caused the hip implant to release metallic debris after implantation. Furthermore the model failed an internal test in 2007 in which DePuy engineers compared it ASR performance to that of another of the company’s hip implants.

Plaintiffs’ lawyers revealed the documents in Los Angeles Superior Court during opening arguments in the first DePuy ASR lawsuit to go to trial. The DePuy Orthopedics company is under seige with more than 10,000 filed US lawsuits.

DePuy executives claimed before the ASR recall in 2010 that the implant was working well, and in 2009, the company announced plans to phase out the model but said it was doing so because of slowing sales, and not safety concerns.
According to DePuy’s internal estimates, the ASR metal on metal hip is projected to fail within five years in about 40 percent of patients who received one. That is eight times the failure rate of most orthopedic implants.

What is the Design Problem with DePuy ASR Hip?

According to the internal DePuy records, the problem was the design of the cup component that fit into a patient’s hip socket. The cup had an inside groove against which a surgeon pressed a tool to implant the component. The groove limited the surface area inside the cup in which the device’s ball could rotate as a patient moved. As a direct result, the ball was more likely to strike the cup’s edge, causing acclerated wear and tear leading to early failure.

"Smoking Gun" DePuy Internal Documents

“We will ultimately need a cup redesign, but the short-term action is manage perceptions,” one top DePuy sales official told a colleague in a 2008 e-mail. According to another document, DePuy executive, Andrew Ekdahl, who is now the unit’s president, was also told by a company consultant that the A.S.R. was flawed.

In 2009, the Food and Drug Administration rejected DePuy’s application to sell the resurfacing version of the ASR in the United States, saying it was concerned about, “high concentration of metal ions” in the blood of patients who received it.

So I ask again, "What did DePuy know and when did they know it, and if so did they fail to disclose that information" and the Los Angeles jury will soon make that determination.