DePuy Trying to Avoid Paying for ASR Hip Implant FixesNov 1, 2010 | Parker Waichman LLP
Is DePuy Orthopaedics shirking its responsibility to victims of the recalled ASR XL Acetabular Hip Replacement System? According to a report from NBC Chicago, DePuy’s recent conduct indicates the device maker may be trying to avoid paying for revision surgeries needed by people who are suffering because of the defective hip implant.
According to the NBC Chicago report, statements on the DePuy ASR XL Acetabular Hip Replacement System recall website state that “bills for services should first be submitted to your insurance company or payer (public or private) in the usual manner.” It’s pretty clear from that statement that DePuy feels that the bill for revision surgeries should be footed by insurance, including taxpayer funded programs like Medicare.
In answers to lawsuits filed by victims of the ASR Hip Replacement, DePuy is pretty clear about its intentions to avoid liability. In one such answer detailed by the NBC Chicago report, the device maker has the audacity to state that the plaintiff “was negligent, careless and at fault and conducted herself so as to contribute substantially to her alleged injuries and damages.”
Those injuries “were not legally caused by the product at issue.” Instead, DePuy points the finger at six possible causes – allergic reaction, an idiosyncratic reaction, an idiopathic reaction, an unforeseeable illness, an unavoidable accident or a preexisting condition. The company has filed identical answers in several other lawsuits, NBC Chicago said.
In August, DePuy issued a worldwide recall of the ASR XL Acetabular System, a hip socket used in traditional hip replacement, and the ASR Hip Resurfacing System, a partial hip replacement that involves placing a metal cap on the ball of the femur. Only the ASR XL Acetabular System was approved for use in the US. The 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 recalled devices had to undergo revision surgery within five years of receiving it. A hip implant should last for 15 years or so.
DePuy was already phasing out the ASR hip implant system when it finally acknowledged in March 2010 that the device was prone to early failure. By that time, the US Food & Drug Administration (FDA) had received hundreds of reports describing premature failure of the DePuy ASR hip implant system. Still, it would be months before the DePuy ASR hip implant system was finally recalled.
Why is the DePuy ASR Hip Replacement prone to early failure? Some suspect it’s metal-on-metal design, which includes a hip socket made out of cobalt chrome. According to a report published earlier this year in The New York Times, metal-on-metal hip implants have been used in about one-third of the approximately 250,000 hip replacements performed annually in the US. However, many of the nation’s leading orthopedic surgeons have reduced or stopped use of these devices because of concerns that they can cause severe tissue and bone damage.
The cause of the problem isn’t entirely clear, but studies in recent years indicate that in some cases all-metal devices can quickly begin to wear. This creates a large amount of metallic debris that is absorbed into a patient’s body. The metallic debris can cause inflammatory reactions that lead to pain in the groin, death of tissue in the hip joint and loss of surrounding bone. These metal particles can infiltrate organs and tissues, and may even create large, painful cysts. The limited studies conducted so far on metal-on-metal hip implants estimate that 1 to 3 percent of implant recipients could be affected by the problem.