In 2004, Mr. Alex Gorsky left the company to head the North American pharmaceuticals business at Novartis. He returned to Johnson & Johnson in 2008. In September 2009, he took over the medical device and diagnostic group.
It was a particularly tumultuous time for the company’s orthopedic unit, DePuy. Just a few weeks earlier, the Food and Drug Administration refused to let it sell one of its hip implants in this country because it had failed to meet regulatory standards. Meanwhile, complaints about that device and a companion version that was used in this country were mounting from doctors here and regulators abroad.
It is not known what role, if any, Mr. Gorsky played in DePuy’s decision not to disclose the F.D.A. action. But at the start of his tenure, DePuy decided to phase out the implants marketed as the ASR and shut a factory in England that made them.
DePuy recalled the ASR in August 2010, amid rising failure rates. But before then, DePuy executives repeatedly insisted that the ASR was safe. And Mr. Gorsky stated publicly in 2010 that the company had decided to drop it for business reasons, not safety concerns.
In a recently disclosed DePuy e-mail, a top executive wrote that the F.D.A. had refused to approve the device after seeing data showing it failing prematurely in significant numbers during company studies in patients.
Johnson & Johnson did not answer questions about whether Mr. Gorsky had known about the problems associated with the artificial hips. But his promotion to chief executive surprised Dr. Robert Hauser, a cardiologist and an advocate for improved safety of medical devices.
“I mean, come on. What is this?” Dr. Hauser said. “He’s been overseeing one of the major J.& J. quality issues and the board of J.& J. sees fit to name him the new C.E.O.”
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