March 23, 2012 ~ This has not been a good week for Johnson & Johnson.
First word that it sold the transvaginal surgical mesh, ProLift, without getting any sort of FDA approval in advance (see background story here).
Now the New York Times (NYT) (here) is reporting that J&J began phasing out the DePuy defective metal hip in 2009, weeks after the U.S. Food and Drug Administration (FDA) began looking into safety concerns and a year before the company decided to voluntarily recall the defective device.
The company received a letter (here) that said the DePuy ASR (Articular Surface Replacement) Hip System could not be approved based on premarket approval application based on data submitted. In the letter said it was turning down the approval because of problems with the safety data submitted. Among the problems at the time, some patients implanted with the metal artificial hip showed a high concentration of metal ions in their blood and the agency was seeking additional safety data on the implant.
In February, the British Medical Journal (here) reported on metal toxicity being found among patients who were implanted with metal artificial hips.
The model sold in the U.S. was cleared by the FDA in 2005 through the 510(k) approval process and did not require clinical studies and data on safety and efficacy. The version that was declined for approval was sold overseas. A sister version was sold in the U.S. and abroad. The Times reports both models used a metal cup as a replacement for the hip bone socket.
The DePuy Orthopaedics hip recalled its metal hips (one for resurfacing, one for total hip replacement) in August of 2010 but not before 93,000 patients worldwide received the implant, with about 30,000 in the U.S. It is uncertain how many patients received the implant between 2009 and 2010.
“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,” the Times reports.
The NYT reports that DePuy admits the phase out of the device was based on sales not safety even though data was showing that it needed to be replaced well in advance of its predicted 15 year lifespan.
A DePuy executive defended the company’s decision not to alert doctors or patients about the FDA’s concerns or letter, in the NYT article.
DePuy says its “committed to addressing reasonable and customary costs of testing and treatment for reasons related to the recall, including revision surgery if necessary.”
FDA Letter to DePuy- Aug. 13, 2009
BMJ – February 2012, Ongoing Problems with Metal on Metal Hip Implants