DePuy ASR Hip Resurfacing System Sold Abroad After FDA RejectionFeb 15, 2012 | Parker Waichman LLP
According to a just-published report in The New York Times, DePuy Orthopaedics was selling its now-recalled ASR Hip Resurfacing System in Europe and elsewhere overseas, even after the U.S. Food & Drug Administration (FDA) rejected the company’s application for the same implant in 2009. While the FDA rejected the device on grounds that DePuy's studies and clinical trials were inadequate, it does not appear that the company, a division of Johnson & Johnson, bothered to inform patients, doctors, or investors about the agency's concerns regarding the ASR Hip Resurfacing System.
The DePuy ASR Hip Resurfacing System, along with the ASR Acetabular System, were both recalled in August 2010, amid an increasing number of reports that both implants were failing within just a few years of patients receiving them. Only the ASR Acetabular System was sold in the U.S., approved in 2003 via the FDA's 510(k) clearance process, which does not require human trials if a device is similar to another already on the market.
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 FDA did require human trials for the hip resurfacing system because at the time, the resurfacing procedure was relatively new.
The FDA never publically released the 16-page letter detailing the reasons behind its refusal to approve the ASR hip resurfacing system. This is normal for the agency, the Times said, because such letters may include confidential business information.
For its part, DePuy did not let European regulators know about the FDA rejection, but the law there usually does not require device makers to do so. However, the Times could not find any information suggesting DePuy notified investors, patient or doctors, which is somewhat unusual. 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.
When the FDA passed on approving the ASR hip resurfacing system, doctors in the U.S. and abroad, as well as some overseas regulators, were growing more and more worried about early failures reported with both ASR devices. DePuy, however, insisted the hip implants were safe. But just month after the FDA decision on the resurfacing device, the company began to formulate a strategy to phase out both ASR devices. That phase-out was announced in late 2009, but attributed to slowing sales
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. Finally, in August 2010, DePuy finally recalled both ASR hip implant systems, as the number of premature failure reports continued to increase.