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J&J Marketing Executive Emailed DePuy ASR Safety Concerns Before Recall

Feb 12, 2013

One of the top marketing executives in charge of promoting the company’s hip implants said in a 2009 email that he was increasingly concerned about the safety of the DePuy Orthopaedics ASR metal-on-metal hip implant.

In an email from Paul Berman written on Sept. 18, 2009, the hip implant marketing boss at the Johnson & Johnson subsidiary wanted to “reiterate (his) concern” about the safety of the DePuy device. The timing of the email is important to the case of Loren Kransky, who has taken his case against the company to a jury trial in Los Angeles Superior Court. The email was entered into evidence during the testimony of Michael Rhee, one of the company’s hip implant marketing managers.

Kransky, 65, alleges that executives with DePuy Orthopaedics were well aware of the problems plaguing the ASR metal-on-metal hip implant for years while continuing to market it as safe and effective through the time of its recall in August 2010. The email presented at trial on Monday, according to a Bloomberg report, was sent from Berman to others at DePuy almost a year before the device was recalled from the global market amid widespread reports of serious injuries and widespread early failures among its recipients, like Kransky.

DePuy still contends that the decision to recall the ASR device was based on “clinical performance” and not due to any alleged failures or defects. As more evidence is entered into trial and executives and persons working on the ASR hip implant device testify before a jury in Los Angeles, it’s becoming apparent that many were aware of the problems impacting this specific metal-on-metal hip implant.

Bloomberg also reports that the Berman email in 2009 suggested that the company limit sales of the ASR hip implant to just 10 surgeons “because of failure rates with the broader universe.” He also wrote in this one seemingly condemning email that “If the company feels the safety profile of the platform is not acceptable among the majority of surgeons it seems we should consider recalling it altogether.”

Previous testimony offered at trial shows that other executives were acutely aware of the problems that caused an unusually high number of early failures among recipients of the device. An engineer previously testified that the company failed to conduct a wide range of safety testing on the device and that reports of high rates of metallic particles being shed during regular use of the device were largely ignored.

Surgeons have testified that they’ve seen early failure rates among recipients of the ASR hip implant at close to 40 percent.

Kransky is one of those victims and the first of more than 10,000 people in the U.S. to file a lawsuit against DePuy, alleging that the ASR hip implant is defective and caused them to suffer serious and disabling injuries and forced them to have a revision surgery to replace the device, to have his case reach a jury trial. Bellwether trials among claims consolidated in a federal Multidistrict Litigation are expected to begin later this year.

The trial in Los Angeles has entered its third week as lawyers for Kransky continue to question current and former executives at DePuy Orthopaedics on evidence they were aware of the defects of the ASR metal-on-metal hip implant. DePuy contends that internal emails and documents being presented at this trial are being misrepresented and taken out of context.

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