Late last year, the Food and Drug Administration announced that it would recall hip implants manufactured by DePuy Orthopedics, a division of pharmaceutical giant Johnson & Johnson due to an abnormally high number of hip implant failures, which some predicted could easily surpass 12,000. At the time, DePuy critics were quick to note that the ASR hip implant models hit the market without FDA oversight thanks to a loophole that greenlights a product if it is similar to a device already approved by the agency. Last month, the New York Times published a scathing report about DePuy and the FDA, showing just how easy it was for the J&J subsidiary to put a dangerous product on the market.
The result of this alleged FDA oversight and DePuy coverup has led to physical discomfort, and many premature hip implant failures, requiring additional surgeries. The issue is that the ASR models were designed with a metal-on-metal replica joint. If not installed perfectly, this part could send harmful shards of chromium and cobalt into the blood stream and local tissue, potentially causing deafness or even heart disease. For some patients, like Mary Ann Doornbos, the defective hip implant caused injuries far worse than the original hip failure. As the Times reports:
One patient, Mary Ann Doornbos, a former I.B.M. employee in Illinois, remains on disability and still walks with a cane, one year after her A.S.R. was removed and replaced.
Ms. Doornbos, 56, said that she could not stand up long enough to cook a meal because the pain was constant. “I have been told that I have to be prepared that it will be like this for the rest of my life,” she said.
Instead of receiving an implant that would improve comfort and agility, the Times reports that patients like Ms. Doornbos have become guinea pigs for DePuy, while the company continues to profit. “You are basically testing these devices in an uncontrolled way on a large number of people,” said FDA critic Sidney Wolfe, director of the Public Citizen’s Health Research Group. Unfortunately, the FDA’s oversight of the DePuy hip implants was riddled with errors:
An internal agency review released several months ago found numerous flaws with the process, and the F.D.A. is proposing changes to it. To win agency permission to market the A.S.R. in the United States, DePuy never had to perform any patient testing of it. Agency officials said the company cited clinical data it had used five years earlier to win F.D.A. approval to sell another all-metal hip implant called the Ultima. The Ultima, however, used a cup that had a totally different design than the one used with the A.S.R.
Some observers predict that DePuy’s problems go much deeper than avoiding an FDA investigation. Dr. Stephen Graves, who runs Australia’s orthopedic database, says implants in that country indicate that DePuy has attempted to conceal hip implant irregularities that occurred as early as 2008. “When it is clear to the orthopedic community that a company has not been honest, that is a problem,” he said. “I think that J& J has a major issue with DePuy.” As the federal Multi-District Litigation against DePuy continues to grow, new reports have indicated that the ASR models fail more frequently for female patients.
Read the entire New York Times story for more on the potential dangers of DePuy’s faulty hip implants, the FDA’s lax oversight, and the legal road forward for patients who were harmed by the defective implants.