Regulatory Focus™ > News Articles > NYTimes: J&J Privately Jettisoned Hip Implant Line After FDA Raised Questions

NYTimes: J&J Privately Jettisoned Hip Implant Line After FDA Raised Questions

Posted 23 March 2012 | By Alexander Gaffney, RAC 

Life science manufacturer Johnson & Johnson (J&J) worked to privately phase out a now-controversial metal-on-metal hip implant product in 2009 after the US Food and Drug Administration (FDA) contacted the company with concerns about levels of metal ions in patients' blood test, reports The New York Times.

The report raises troubling questions about J&J's public response to FDA's nonapprovable letter, which stated FDA would not approve the device for sale in the US.

J&J would not recall its hip implant device-known as an articular surface replacement-or a companion model until a year after receiving the letter. Instead, it was working privately to "sell off its inventories" and phase out the device just weeks after receiving the letter, reported the Times.

"[Johnson & Johnson subsidiary] DePuy did not recall the device at issue, or a companion model that was used in this country, until August 2010, a year after it got the administration's letter," reported the Times. "But in September 2009, just weeks after the letter arrived, company executives started a strategy to phase out the devices while selling their remaining stocks for use in patients both here and abroad, company records show."

J&J said in a statement that the two events were not connected, and simply reflected standing plans to phase out the hip implant devices.

Read more:

New York Times - Hip Device Phaseout Followed F.D.A. Data Request

See All Regulatory Focus Articles on Johnson & Johnson

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