In the wake of the U.S. Food and Drug Administration’s massive 2010 recall of the DePuy Orthopaedics ASR metal hip replacement systems there have been numerous accounts of startling high failure rates.
In its announcement, the FDA said that “there was a voluntary recall of the DePuy ASR TM total hip system because of new, unpublished data from the UK joint registry indicating the revision rates within 5 years were approximately 13 percent.”
Since then there have been tens of thousands of DePuy ASR lawsuits filed in which patients who had the systems implanted in their bodies are seeking huge amounts of damages from parent company Johnson & Johnson.
Many of these DePuy metal hip system lawsuits were consolidated in a federal multidistrict litigation being overseen by a federal judge in which Johnson & Johnson is now in the process of a multi-billion settlement process.
What has happened in the years since the 2010 recall is that lawyers for DePuy metal hip implant victims and the media have focused their attention on internal DePuy documents and other systems to reveal that DePuy ASR systems apparently failed at much higher rates.
The New York Times, for instance, reported that internal DePuy projections estimate that the ASR systems will fail in 40 percent of those patients in five years, a rate eight times higher than for many other hip devices.
As the Times reported:
“The A.S.R. hip was sold by DePuy until mid-2010, when the company recalled it amid sharply rising early failure rates. The device, which had a metal ball and a metal cup, sheds metallic debris as it wears, generating particles that have damaged tissue in some patients or caused crippling injuries.
“DePuy officials have long insisted that they acted appropriately in recalling the device when they did. However, internal company documents disclosed during the trial of a patient lawsuit this year showed that DePuy officials were long aware that the hip had a flawed design and was failing prematurely at a high rate.
“Many artificial hips last 15 years or more before they wear out and need to be replaced. But by 2008, data from orthopedic databases outside the United States also showed that the A.S.R. was failing at high rates in patients after just a few years.”
The Times also reported that “Problems with the design first came to light in Australia and England just a few years after its marketing began. But DePuy officials insisted for years to surgeons who complained about that device that patient problems reflected their surgical technique rather than the implant’s design.”