Hip Device Phaseout Followed F.D.A. Data Request
By BARRY MEIER NEW YORK TIMES
Published: March 22, 2012
At the same time, the agency 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,” according to the F.D.A. letter, obtained by The New York Times under the Freedom of Information Act.Officials also wrote that reports from countries where the implant was then being used showed it was performing “somewhat more poorly” than data submitted by the company’s DePuy Orthopaedics unit indicated. By mid-2009, for example, data from 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 statements were contained in a so-called nonapprovable letter in which the agency confidentially notified DePuy in 2009 that it was turning down the company’s application to sell the device in the United States. The bulk of the letter focused on problems that agency reviewers found with study data submitted by DePuy to support its claim that the artificial hip was safe and effective.
In its letter, the agency also asked DePuy for added safety data if it wanted to pursue its application.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. 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.
It is not known how many patients got the hip model, known as an articular surface replacement and sold under the trademarked name ASR, during that year. In an eight-year period, some 93,000 patients worldwide received the model, about one-third of them in this country.In addition to to dealing with a high rate of premature failure, hundreds of patients who got an ASR have suffered crippling injuries caused by particles of metallic debris generated as the all-metal implant wears.
“We are almost out of ASR, and the few doctors still using ASR are threatening to leave DePuy anyhow,” a company executive wrote in an e-mail in May 2010, nine months after the Food and Drug Administration’s letter. Thousands of patient lawsuits are proceeding against DePuy in connection with the ASR, and the e-mail is among thousands of company documents gathered by lawyers.
DePuy executives have insisted that they acted appropriately in recalling the implant model when they did, saying that before August 2010 internal company data showed that the model was performing as well as competing implants. They have also repeatedly said that their decisiondecision to phase out the model was based on slowing product sales, rather than any factors related to the device’s safety or the Food and Drug Administration’s decision not to approve the device.
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. Mr. Ekdahl said any suggestion that the administration had concluded that the ASR had safety issues was “simply untrue.”
A DePuy spokeswoman, Mindy Tinsley, said the only conclusion the administration reached in its letter was that the data submitted by DePuy “was inadequate to evaluate the safety and effectiveness” of the device.
She also said comments made by company executives about selling the device’s inventories were simply part of a program to phase out the device and were not connected to safety issues.
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. A sister version of the device was used both here and abroad in traditional hip replacement. Both models were based on the same component, a metal cup replacing a patient’s hip socket, which experts say was flawed in design.
Unlike the model used in resurfacing, 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, data from patient registries in Britain indicates.
In another article published last month, The Times reported that a top DePuy executive, Pamela Plouhar, had told her colleagues in a 2009 internal e-mail that the resurfacing version of the implant was not approved for sale here because of its high rate of early failure, or “revision,” during clinical trials.
To phase out the device, DePuy executives started a so-called rationalization, essentially 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.
DePuy publicly announced that plan in November 2009, initially setting late 2010 as its completion date. But in the spring of 2010, a DePuy official wrote that the program would end not at a fixed date, but when all the ASR stocks “are depleted,” an internal e-mail indicates.