DePuy A.S.R. Hip Replacement Recall Shows Flaws In FDA Approval Of Medical Implants

DePuy ASR artificial hips.jpgAs underscored by a story in today’s New York Times, the recent recall of DePuy A.S.R. artificial hips shows how a hole in the FDA’s regulatory framework for medical implants endangers millions of Americans who receive medical implants.
DePuy A.S.R. artificial hips were touted as next generation of artificial hips – a new technology that would allow for hip replacement surgeries involving the removal of less of a patient’s thigh bone. The A.S.R. or Articular Surface Replacement technology, it was thought, would resurface portions of bone that were removed in conventional hip replacements. DePuy, a Johnson & Johnson subsidiary, also promoted the A.S.R. technology as likely to last longer than rival hip replacements – predicting a product lifetime of 15 years or more.
What steps did DePuy have to go through to bring the A.S.R. artificial hips to market? Were there years and millions of dollars spent double-blind randomized clinical trials before the FDA finally approved the DePuy ASR? No. In fact, because FDA regulations allow medical implants to be sold without clinical testing if they resemble devices already approved for use in patients, the DePuy ASR made it to market without clinical trials.

DePuy claimed the A.S.R. resembled another hip prosthesis that it had already brought to market called the Ultima. The Ultima, however, had a completely different cup design than the ASR. Despite the dissimilarities between the A.S.R. and the Ultima, the FDA regulations allowed the A.S.R. to be sold without testing.
Because of the absence of any clinical testing of the DePuy ASR, orthopedic surgeons who were implanting the ASRs had no data to go on about the ASR’s effectiveness. All they had were DePuy’s very compelling promotional materials – their advertising – which seemed to demonstrate that the ASRs were much more durable and longer-lasting than conventional hip replacements.
When the DePuy ASRs began being implanted in patients, problems almost immediately began cropping up. The grinding on metal-on-metal parts within the ASR released cobalt ions that killed tissue, causing pain and, in some cases, permanent disability.
But doctors had no idea how widespread the problems were with DePuy ASR artificial hips because FDA regulations do not require reports of problems relating to this type of implant to be maintained in any sort of central database. Orthopedic surgeons who reported problems with the A.S.R. to DePuy were told that the problem lay with their surgical technique and not with the implant.
As a result of the mounting complaints about the ASR, DePuy reportedly knew of its defects as early as 2008. However, DePuy did not recall the XL Acetabular Head System until late August of this year.
There are basically two frameworks for addressing the safety of medical devices. One is regulatory: government agencies insist on certain testing and safety precautions before a product can be brought to market. The other lies in tort: people injured by devices like the DePuy ASR hire trial lawyers to sue for their injuries. We’ve blogged before about how famous economists like Milton Friedman have favored robust tort remedies in protecting consumers. But it seems that increasingly we are moving to a regime that favors regulatory protections over tort rights.
Thankfully, those who were injured by DePuy ASR hip prostheses still have the right to hire lawyers to bring suit for the injuries they’ve suffered. If it were up to some people, however, injury lawyers would not be protecting the DePuy ASR victims, only a hollow patchwork of regulatory protections would be.

This blog is maintained by the Boston product liability lawyers at The Law Office of Alan H. Crede, P.C. The blog neither offers nor contains legal advice.