A version of DePuy Orthopaedics’ ASR hip implant that was not approved by the U.S. Food & Drug Administration (FDA) in 2009 was marketed in Europe and elsewhere overseas, despite safety concerns raised by the company’s own studies. According to a report in The New York Times, the FDA’s issued a non-approval letter for the device as regulators and surgeons overseas, as well as some U.S. doctors, were raising serious concerns about both models of DePuy’s ASR Hip Implant.
In August of the following year, DePuy, a division of Johnson & Johnson, would issue a worldwide recall for both models of the hip implant – the ASR Hip Resurfacing System and the ASR Acetabular System. The massive hip implant recall was issued after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12%-13%) who had received the devices had to undergo revision surgery within five years of receiving it. At the time of the recall, DePuy had sold more than 93,000 units of the hip replacement devices.
Both DePuy ASR hip implant systems are metal-on-metal devices. Since they were recalled, safety concerns about these types of artificial hips have continued to mount. Last May, the FDA directed all makers of all-metal hip implants, including DePuy, to conduct post-market studies of their products to determine if they were shedding dangerous amounts of metallic debris in patients. It is believed that metal-on-metal hip implants can shed dangerous amounts of cobalt and chromium through wear, leading to tissue damage, premature device failure, the need for revision surgery, and even long-term health problems.
Only the DePuy ASR Acetabular System was sold in the U.S, having been brought to market here in 2003. According to The New York Times, the FDA had declined to approve DePuy’s application for the hip resurfacing system in 2009, saying the company’s studies and clinical trials were inadequate to determine the implant’s safety. A DePuy spokesperson would not tell the Times whether or not the FDA’s decision on the ASR Hip Resurfacing System was disclosed to doctors, patients or investors, but one researcher involved in the implant’s trial said he was not informed. The Times’ review of publicly available information also indicated that DePuy did not disclose the agency’s nonapproval letter in financial reports or in presentations to analysts while the device remained on the market.
Nothing the company did in relation to the ASR Hip Resurfacing System is illegal, as overseas regulatory standards are less stringent than those in the U.S., and usually do not require companies to provide notification when the FDA refuses to approve a product that is being used abroad, the Times said. One attorney who specializes in FDA regulation told the Times that, in general, drug and medical device usually disclose FDA nonapproval letters if they might have a material impact on a company’s finances, but there is no hard-and-fast rule about doing so. For its part, the FDA says it has a policy of not publically releasing nonapproval letters because they might contain confidential business information.
According to the Times, both the DePuy ASR Hip Resurfacing System and the DePuy ASR Acetabular System were based on the same component, an all-metal hip socket cup that experts say was faulty in design. The version that was approved by the FDA, the ASR Acetabular System, was cleared through the agency’s 510(k) protocols, a more streamlined process that does not require human testing if a device is shown to be substantially equivalent to products already on the market. The FDA did, however, require human clinical trials for the resurfacing system because resurfacing was a new procedure.
Around the time the FDA issued the non-approval letter for the ASR Hip Resurfacing System, doctors and others were starting to have doubts about both ASR hip implant devices, as more and more patients suffered early failures of the implants. According to The New York Times, just weeks after the FDA said no to the resurfacing system, DePuy began formulating a strategy to slowly phase out ASR sales. In November 2009 – three months after the FDA said no to the resurfacing system – DePuy announced the ASR phase out, citing slowing sales. The company also announced it was withdrawing its FDA approval application for the resurfacing device. However, the company continued to insist the devices were safe.
By March 2010, a New York Times investigation had revealed that the FDA had received 300 complaints related to early failures of the ASR Acetabular System. Almost all of the complaints involved patients who underwent revision surgeries following early failure of the implant. In a letter dated March 6, 2010, DePuy warned doctors that recently analyzed data from Australia suggested that the devices had a higher-than-expected failure rate when used in traditional hip replacement on certain types of patient, including women and patients with weak bones. Finally, in August 2010, DePuy recalled both ASR hip implant systems, as the number of premature failure reports continued to increase.
Since issuing the ASR hip implant recalls, DePuy and Johnson & Johnson have been named in more than 5,000 product liability lawsuits filed on behalf of people who allegedly suffered early failures of their implants. As we reported previously, Johnson & Johnson disclosed last month that it had set aside nearly $3 billion to deal with costs associated with the hip implant recall and litigation.