In 2009, a DePuy Orthopaedics’ hip replacement joint – called an articular surface replacement (ASR) Hip Resurfacing System – had not been approved by the U.S. Food and Drug Administration for sale in the U.S., but had been sold overseas by DePuy since about 2003. DePuy, a Johnson & Johnson company, apparently decided it was still okay to market and sell the ASR Hip Resurfacing System in Europe. Companies, such as Johnson & Johnson/DePuy, are not required to notify foreign countries when their products have not been approved by the FDA. At the same time, DePuy chose to sell a similar hip replacement device (ASR XL Acetabular System) in the U.S., which was not FDA-approved in the usual manner, but instead was marketed and sold through a regulatory loophole because it was "similar" to previously FDA-approved hip implants. Implants may be sold without certain kinds of testing and FDA approval if the device, such as an artificial hip, resembles an implant already approved and used by patients. Being similar to an already approved device, however, is often in the eye of the beholder. For example, many cars are similar, but some may suffer from design defects because of material – and unsafe – differences in certain design aspects.
In August 2009, the FDA sent DePuy/Johnson & Johnson a confidential letter noting problems with the clinical data and the devices concerning the ASR Hip Resurfacing System (already being sold overseas for about six years). The hip replacement devices contained an all-metal hip socket cup determined to be "faulty in design." By November 2009, DePuy began "phasing out both models of the device" according to an article by Barry Meier in The New York Times (February 14, 2012). Reports were received that the devices were failing at an unusually high rate. Meier’s article noted that "the two implants were used in about 93,000 patients worldwide, about one-third of them in the United States." DePuy's stated reason for the "phase out" in November 2009 (three months after the FDA letter), however, was that the the ASR was suffering from "declining sales."
In August 2010, the DePuy/Johnson & Johnson ASR hip implant devices were formally recalled – the ones that had gained "approval" through the regulatory loophole and were sold in the United States from about 2005 through 2010. According to the company’s recall announcement, "the ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System used in hip replacement surgery [was being recalled] due to the number of patients who required a second hip replacement procedure, called a revision surgery." There was no mention of a decline in sales at this time.
The company advised patients with an ASR device, which was marketed to younger and more active patients to last 15 years or more, to visit their surgeons for evaluation of their implant’s performance. It also recommended annual monitoring "to ensure the ASR hip replacement is functioning well, even in the absence of symptoms." Even without "symptoms", it turns out many ASR recipients had elevated cobalt and chromium, which are metals found in the ASR systems.
Also there was a noticeable disparity between the post-marketing clinical surveillance data and the actual revision surgery rates, where new unpublished 2010 data showed a five-year revision rate of approximately 12% for the ASR™ Hip Resurfacing System and approximately 13% for the ASR™ XL Acetabular System, which had been projected to be lower.
A larger issue emanating from this scenario is that the company did not disclose the contents of the FDA letter—which might have had a bearing on the health and safety of the companies’ clients and hospitals’ and doctors’ patients, not to mention the financial status of the company. Although there is no law requiring a company do so, one commentator noted that "in general, drug and medical device makers typically disclose non-approval letters if they might have a material impact on a company’s finances." Meanwhile, there await a thousands of lawsuits by patients who had the ASR systems implanted.