Defective Hip Implants & DePuy: A Synopsis
DePuy Orthopaedics, Inc., a subsidiary of the pharmaceutical giant, Johnson & Johnson, announced in August 2010 that it was recalling two specific hip replacement implant products, having already sold some 95,000 units worldwide.
The recall was issued after research released by the National Joint Registry (NJR) found high rates of hip replacement failure for the ASR XL Acetabular and ASR Hip Resurfacing systems: 12% for ASR Hip Resurfacing System and 13% for ASR XL Acetabular System. These compare to revision rates of between 3 and 6%, which were previously recorded.
The ASRXL and ASR Hip Implants were metal on metal components and since their arrival on the orthopaedic scene nearly 20 years ago, they were marketed as the latest advance in hip replacement and were targeted at young active patients who needed a hip that would last a whole lifetime.
People who had these implants suffered early wearing and loosening of the components of the implant, resulting in soft tissue damage and increased levels of Cobalt and Chromium ion levels in their blood.
Such metal ions can damage the bone and soft tissues around the hip replacement resulting in:
- Fluid retention often under high pressure causing pain
- Tendon rupture causing hip dislocation
- Bone death resulting in fractures around the implant
Multiple studies and research organisations have warned about the harmful potential of metal-on-metal hips and uncertainty surrounds the toxicology of metal ions in the body. It is arguable that such a level of uncertainty would not be acceptable in drug regulation.
Instead of alerting regulators and patients to their concerns, it seems that companies tweaked the design of their total hip implants. In 2004, in an effort to rationalise their product range and increase usage of their implants, they shortened the trunnion (or taper)—the part of the stem that inserts into the head—to allow a few degrees greater motion and added grooves so surgeons could use them with both ceramic and metal heads.
But these changes, coupled with bigger and bigger heads, had unforeseen consequences; namely, increased wear, high levels of metal ions in the tissues and blood, and higher rates of joint failure. Research shows that even a small change in design can have a substantial effect on long term outcome.
While this was a worldwide recall, about 3,300 Irish patients received these implants in Ireland, across 16 public and 14 private hospital sites nationwide since 2003.
DePuy High Court Litigation in Ireland
In Ireland, in 2015, High Court Judge Mr Justice Kevin Cross urged all those involved in legal actions over defective DePuy hip implants to find “innovative ways” to resolve them. At the time there were 73 cases pending hearing out of an estimated 1,000 cases in the Irish legal system and the concerns were that such cases would take up a significant portion of the Courts time if each were to be resolved individually at Trial.
In response to this DePuy set up an Alternative Dispute Resolution process which involved evaluations being made by independent evaluators. If either DePuy or the Claimant reject the evaluation within 45 days, the Claimant may continue with their existing proceedings through the Courts.
At Coleman Legal Partners we have been instructed by a multitude of claimants who have had faulty or defective implants inserted and we have achieved significant six figure settlements on behalf our clients. As a result, we are alive to the complicated and important factors that must be considered in each case in early course. Our experience in this area means that we understand the catastrophic effects such defects can have on the operation of the implant and the potential harmful domino effect they can have on people’s lives.