The HSE and DePuy Orthopaedics – a division of Johnson and Johnson – who recently issued a recall of two of its hip replacement products, may face thousands of lawsuits from affected patients.
The products which were recalled were the ASR Xl Acetablur System and the ASR Hip Resurfacing System. The ASR devise is a large diameter, monoblock hip resurfacing and replacement device.
The DePuy ASR Hip Resurfacing System was introduced in 2003 and is only approved for use outside of the USA. The ASR Excel Acetabular System was first launched in 2004 and has since been available worldwide. It is estimated that 93,000 of these devices have been implanted worldwide.
Shortly after the ASR Resurfacing System was introduced, DePuy Orthopaedics began receiving a number of complaints of problems and complications associated with early failure for the metal hip implants. The hip replacement can fail with only a few years of surgery, causing pain and leading to complicated and expensive replacement surgery. Most of these complications required additional surgery to replace the hip implants.
The DePuy ASR Acetabular Cup System is a metal- on- metal hip component. DePuy withdrew the ASR hip in the Australian market in December 2009 and indicated a plan to phase the devise out worldwide in 2010. It is believed that a design flaw with the DePuy metal hip implants exist which makes them difficult to implant at the proper angle. If the metal on metal hip replacement is improperly positioned, it can cause small particles of metal to cause inflammatory reactions, impacting the surrounding tissue in the hip joint and loss of bone. This can cause complications and leave patients with lasting problems and the surgery to remove the hip implant can be more complex.
Individuals with small statures, such as women and those with weak bones may be more susceptible to failure of the DePuy ASR hip implants.
The company will face legal claims for liability for manufacturing a defective product, failing to warn these patients and doctors of problems with the implants and negligence in the design, manufacture and sale of the product.
Approximately 70,000 hip replacements have taken place in Ireland since July 2003, when this product first became available in this Country. Approximately 5% of these may be affected by this recall, as figures from the company itself indicate that 3,516 implants were sold in Ireland. However, this figure has not yet been confirmed as accurate.
In March 2010, DePuy discontinued the cup and sent a letter to Doctors that month warning that data from the Australian Medical Device Registry showed a “higher than expected” failure rate than traditional hip replacement, especially in smaller patients and those with weak bones. These moves followed two years of reports that the implant was prone to early failure.
The HSE may also have a legal liability to compensate affected patients if it can be proven that they were aware of the defective nature of the implants but continued to use them in their hospitals. Since 2008 the problems with these implants had become apparent.
While the primary liability may be with the manufacturer in these cases, the HSE may also have a liability problem. If the HSE continued to purchase these devices from DePuy Orthopaedics during the period in which it was clear that these products were defective, then the HSE could be held partially liable and may end up paying millions of euro in compensation to effected patients.
Patients with hip replacements have reported that they have experienced pain and swelling of the hip, even mouths after the surgery. If the device becomes loose, it could potentially break some bones in the area around the hip socket. There have also been numerous patient complaints of crippling pain experienced following the implantation with this defective device.
Between 2006 and 2009, reports of problems with the DePuy model ASR hip replacement device rose sharply. Of the problems reported in 2009, over 90% required replacement.
The FDA has received approximately 300 reports of failure since 2008. The majority of these individuals required expensive and painful operations to remove the device.