Healthcare giant Johnson & Johnson actively marketed and sold an artificial hip device in Europe and elsewhere that had been rejected in the United States. During nearly a decade on the market, the two devices were used in about 93,000 individuals worldwide, about a third of which were implanted on patients in the U.S. Both models were based on the same component, an all-metal hip socket many experts believe is defective in design.
DePuy Hip Update 1/23/13: Newly disclosed court documents have revealed that a 2011 internal investigation conducted by Johnson & Johnson on its much-troubled DePuy ASR hip implant estimated that the device would fail within five years in nearly 40% of recipients. For reasons still unclear, the company failed to make this information public while simultaneously downplaying the potential health complications associated with its metal-on-metal hip. Click here to learn more.
Free DePuy Hip Replacement Lawsuit Evaluation: If you or a loved one has suffered an injury after being implanted with an artificial hip device, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the artificial hip and we can help.
What’s the problem?
J&J subsidiary DePuy Orthopaedics began phasing out its ASR hip replacement devices in November 2009, and formally recalling them less than a year later amid numerous reports of patients showing they were failing prematurely at alarming rates.
But in a confidential letter, the U.S. Food & Drug Administration (FDA) told J&J in 2009 that company studies and clinical data submitted to gain approval in the United States to market the model available overseas were inadequate to determine the devices’ overall safety and effectiveness. The administration also told the company it would need more in-depth clinical data to gain approval, a time-intensive process that could take a year or longer. The FDA’s action came amid growing questions regarding the high failure rates of both models of the implant.
The administration’s rejection will likely deepen the much-beleaguered company’s financial problems. In January 2012, J&J took a special $3 billion charge, the vast majority of which was related to anticipated legal and medical expenses associated with the recall. Nationwide, there are currently about 5,000 lawsuits pending, including a high number from patients crippled by metallic debris shed by the devices.
The DePuy ASR hip implant devices rejected by the FDA were developed for use in a hip replacement procedure known as resurfacing, which has been hailed as a revolutionary alternative to standard surgery. DePuy began selling ASR devices in about 2003, but because resurfacing is an entirely new technique, the administration mandated that J&J conduct clinical trials before selling the device in the United States.
While the company was in the process of running the trials, it used a loophole to win approval for a version of the ASR that was based on the same metal hip cup used in conventional hip replacement surgery. Because the device was structurally similar to others already on the market, the FDA authorized the implant under the controversial 510 (k) approval process. Within weeks of receiving the FDA’s letter, DePuy reportedly began focusing on phasing out the ASR and shifting surgeons to other company implants. Three months later, DePuy publicly announced its decision to phase out the ASR, attributing the action to declining sales. The company also stated that it had withdrawn its pending application for the resurfacing device.
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The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in DePuy hip lawsuits. We are handling individual litigation nationwide and currently accepting new DePuy hip injury cases in all 50 states.
Free DePuy ASR Hip Lawsuit Evaluation: If you or a loved one has suffered an injury after being implanted with a DePuy hip, you should contact our law firm immediately. You may be entitled to compensation by filing a DePuy hip injury suit and we can help.