John M. Lynch on DePuy Hip Recall Update
As John Lynch celebrates 30 years in business this year, this month we will review areas of law and cases that have been particularly topical in 2013. John, last week you spoke on the show about cases you have worked on over the years that have opened the floodgates. One example of this in recent years is the DePuy ASR hip implant recall.
Most listeners will be aware that we act for many clients who have suffered as a result of the worldwide recall by DePuy Orthopaedics Inc. on the 26th August 2010 of two of its hip replacement devices.
To recap, how many people in Ireland were fitted with the DePuy devices?
As matters stand, 3,282 patients in Ireland were fitted with the defective DePuy ASR hip implants.
It is estimated that nearly half of all DePuy ASR hip implants could fail within 6 years and require revision of the primary surgery.
Many of our clients have already undergone this revision procedure and experienced the difficulties of undergoing a second surgery.
We are more than surprised at the accelerating rate of revisions required since we started to work with people who have had DePuy implants.
As well as revision surgery DePuy patients will need annual blood checks for metal ions for the rest of their lives following an investigation by the British Medical Journal and BBC Newsnight in September 2012. The report outlines that metal on metal hip implant patients will need annual blood tests due to the issue of metal particles dislodging from the implant.
Were the devices recalled in other countries before the Irish recall?
The problems with the two DePuy devices were known long before the recall.
In Australia, the National Joint Replacement Registry (NJRR) reported in 2007 that data for the previous year showed that these devices had twice the risk of failure in comparison to similar devices.
In 2008, the NJRR re-confirmed that these devices had a much higher than expected failure rate. Again, in 2009, the NJRR found the same failure results.
In December 2009 DePuy Orthopaedics withdrew from the Australian market and in March 2010 DePuy issued an alert about the ASR implants.
Despite these developments many Irish patients continued to be implanted with the DePuy devices until the recall of the device in Ireland in August 2010.
What stage are the cases now at?
Many of our files against DePuy are now at an advanced stage.
In these cases the legal team for DePuy has reviewed the extensive medical records that we have supplied.
DePuy have admitted responsibility in some of the cases and have even asked us to meet with them to discuss settlement.
In these cases we are updating our medical reports so that we have a full picture of the current medical situation and can advise clients on the appropriate level of compensation.
Has the HSE reacted to the DePuy hip recalls?
Arising out the DePuy ASR debacle, the Heath Service Executive is to order a major review of all patients fitted with metal-on-metal artificial hips.
An estimated 6,500 of the devices have been fitted to Irish patients. This figure includes the 3,500 DePuy ASR hip devices and a further 3,000 which were made by other manufacturers, many of which are still being used. The move follows a similar investigation, which was launched by the UK’s medical devices regulatory agency, the MHRA, last year.
A new Irish national database of all knee and hip joint replacement surgeries is due to log its first patients.
Do databases exist in other countries where the DePuy devices were recalled?
Similar registries exist in the UK, Sweden, Australia and New Zealand and were credited with detecting issues with the DePuy ASR hip device prior to its recall. The plan is that the Register will not only monitor the performance of medical devices, but it will also monitor the activity of medical professionals who fit the devices as well as the institutions in which the hip replacement procedures are carried out.
It is our hope and aspiration that the work that we have done in the conduct of our cases for our clients has resulted in the changes that have been made to a system that was in serious need of an overhaul.
It should not have taken litigation to ensure that we had a Joint Register, an automatic retention of devices for forensic purposes, or a more thorough pre vetting of such devices before they are released onto the market.
We look forward, over the next number of months, to bringing any of the cases that we are involved in to a satisfactory finish for our clients.