Five months before Johnson & Johnson (JNJ:US)’s DePuy unit recalled 93,000 all-metal hips, the company addressed the concerns of a marketing executive who had been suggesting a recall, his boss told a California jury.
The boss, Randall Kilburn, testified today in state court in Los Angeles that he spoke to Paul Berman, a director of hip marketing, after Berman sent an e-mail on March 14, 2010, expressing his concern over the safety of DePuy’s ASR hip device.
Berman said in the e-mail that he had “an obligation as an employee of J&J and DePuy to make it known when I do not feel comfortable.” He also referred to four earlier e-mails he sent suggesting a possible recall.
Kilburn, testifying in the first of 10,000 lawsuits (JNJ:US) to go to trial over the ASR hips, said he talked to Berman after getting the March 2010 e-mail and discussed his concerns. Kilburn said he also made sure all of the complaints that Berman knew of about the hips were investigated internally.
When they were done talking, Berman “was comfortable that all of his input was heard and that the product was safe based on all the evaluations that were done,” Kilburn told jurors. Kilburn said he also printed out Berman’s e-mail and handed it to David Floyd, who was then president of DePuy.
The testimony came at the trial of a lawsuit by Loren Kransky, 65, a retired prison guard who claims DePuy defectively designed the ASR hip and failed to warn of its risks. J&J, the world’s largest seller (JNJ:US) of health-care products, denies that the design was defective or that it contributed to the health problems of Kransky, a Montana resident.
J&J attorney Michael Zellers questioned Kilburn today to try to show that DePuy took all ASR complaints seriously.
“I know the people, and I know I can look at every decision we made and they were the right decision,” Kilburn said. “I know that our processes are very robust. People are free to raise concerns. We have that open dialogue and debate. Our senior leaders have the best interests of patients in mind.”
Zellers asked if patient safety was important to Kilburn, if it had the highest priority at DePuy, and if the company was conscientious in its decisions. Kilburn said yes to each.
Kransky’s lawyers have sought to show that DePuy failed to test the ASR properly and ignored complaints by surgeons that the device was failing at increasing rates.
When J&J recalled the device in August 2010, it said 12 percent of the hips had failed, requiring replacement surgeries known as revisions. Jurors have heard that DePuy calculated the rate at 35.8 percent within 4.57 years, and that Australian data showed a failure rate of more than 40 percent last year.
J&J, based in New Brunswick, New Jersey, said today that it told doctors outside the U.S. to stop using its Adept hip implant after a higher-than-expected failure rate. A U.K. database found that 12 percent of patients needed revisions to fix the implant, which hasn’t been on the market since 2011, J&J said.
About 7,500 of the hips were distributed in 21 countries not including the U.S. Doctors were sent a safety notice about the product on Jan. 14.
J&J acquired the hips in 2009 from closely held U.K. device maker Finsbury Orthopaedics Ltd. J&J said patients who received the Adept implant should be followed according to local standards of care.
The case is Kransky v. DePuy, BC456086, California Superior Court, Los Angeles County (Los Angeles).
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