As reported in the New York Times, Johnson & Johnson executives in 2009 phased out their ASR hip implant and sold off their inventory just weeks after the Food and Drug Administration asked the company for added safety data about the implant.
At the same time, the federal regulators told the company that blood tests of some patients who got the all-metal hip showed a “high concentration of metal ions” that it found “concerning.” These concerns were highlighted in the F.D.A. letter, obtained by The New York Times under the Freedom of Information Act.
Officials expressed concern that reports showed that the ASR was performing “somewhat more poorly” than data submitted by the company’s DePuy Orthopaedics unit indicated. By mid-2009, data from the UK and Australia showed that the device was failing at high rates just a few years after implantation, rather than lasting 15 years as expected.
The Food and Drug Administration’s letter notified DePuy in 2009 that it was turning down the company’s application to sell the device in the United States.
DePuy did not recall the device at issue, or another model that was used in this country, until August 2010, a year after it got the administration’s letter. According to company records, in September 2009, shortly after the letter, company executives started a strategy to phase out the devices while selling their remaining stocks for use in patients both here and abroad.
After receiving the letter, Johnson & Johnson’s DePuy Orthopaedics started to phase out the ASR line, while trying to quickly sell remaining stock and convince doctors to begin using other DePuy products. At that time, the manufacturer denied that there were any safety concerns with the hip, and suggested that the product was being phased out because of declining sales. It is unknown how many patients got the hip model, known as an articular surface replacement and sold under the trademarked name ASR, during that year.
Hundreds of ASR patients have suffered crippling injuries caused by particles of metallic debris generated as the all-metal implant surfaces grind against each other. This medical condition is called metallosis.
Thousands of patient lawsuits are proceeding against DePuy in connection with the ASR.
Last month, after an article in The New York Times disclosed DePuy’s receipt of the administration’s letter, the company’s chief executive, Andrew Ekdahl, defended DePuy’s 2009 decision not to disclose the letter to doctors or patients.
The version of the device that the administration declined to approve for the United States was used abroad only in an alternative hip replacement procedure known as resurfacing. Both models were based on the same component, a metal cup replacing a patient’s hip socket, which experts say was flawed in design.
The version used in traditional surgery was cleared by the Food and Drug Administration in 2005 through a regulatory pathway that did not require it to undergo clinical studies. Today, that device is failing prematurely at even higher rates than the one the administration would not approve, according to data from patient registries in Britain.
To phase out the device, DePuy executives started a strategy to end the model’s production and to sell off its existing stocks while persuading orthopedic surgeons to switch to other implants from the company.