By Eoin P. Campbell, LL.B., Solicitor
You may already have seen a lot of recent press coverage about an urgent recall of replacement hip systems manufactured by the American company DePuy Orthopaedics Inc. This recall is due to a “higher than expected” failure rate in two particular hip replacement models used in Ireland since 2003.
Although the recall affects a relatively small number of people who have received hip replacements in recent years, we feel there is a lack of clear and comprehensive information regarding the whole issue. This article aims to provide you with answers to the following questions:
- 1) Who is responsible for the DePuy ASR hip replacement recall in Ireland?
- 2) What are the problems associated with this recall?
- 3) Who is affected?
- 4) What should people who are affected by the DePuy ASR hip replacement recall in Ireland do?.
If you or a loved one are effected by the DePuy ASR hip replacement recall in Ireland, you should contact a solicitor for further advice. You can talk to one now on our free help line by calling 1-800 989 900.
Who Are DePuy Orthopaedics Inc?
DePuy Orthopaedics Inc is part of the world famous Johnson & Johnson pharmaceutical company, and have been manufacturing replacement hips and knees, shoulder joints and bone cement for over a hundred years. They are one of the largest global providers of orthopaedic products with sales last year in excess of $5.4 billion (€4 billion), but now faults have been found in two of their products prompting a DePuy ASR hip replacement recall in Ireland.
Being such a large company, it is not surprising that DePuy Orthopaedics Inc has previously hit the headlines for the wrong reasons. In the United States, the company has been on occasion investigated by the Food and Drug Administration and has been reported in the press to have allegedly found guilty of illegally marketing an unapproved knee replacement device. Among other recent recalls of its products are the AMK Knee Replacement System and three significant batches of Apex Hole Eliminators – the screws that connect the hip replacement systems to the recipient´s bone. However, it should be remembered that DePuy Orthopaedics is a highly reputable and succesfull company and problems are the exception rather than the rule. DePuy has made sizable compensation payments in the United States when there have been product recalls in the past so it can be expected that compensation payments in Ireland will also be significant.
Which DePuy Hip Replacement Models Are Faulty?
Two of the DePuy ASR hip replacement systems have been acknowledged as faulty and recalled in Ireland. These are the DePuy ASR Articular Surface System and the DePuy ASR XL Acetabular System that have both been recorded as returning “higher than expected” failure rates.
The problems associated with the two hip replacement systems will differ from patient to patient, but the main cause of the DePuy ASR hip replacement recall in Ireland is the rate at which the implants shed debris. All hip replacement systems will create a little friction between the implant and the bone and sub-microscopic particles are distributed throughout the body. The rate at which the DePuy ASR replacement hip systems wear away at the remaining hip structure can lead to inflammation and infection, possible loosening or dislocation of the hip implant, and the potential for a hip fracture around the implant.
What does a “Higher than Expected” Failure Rate Mean?
Most hip replacement systems are expected to last around 15 years and, as an industry guide, a failure rate of 5% within the first five years is considered acceptable. However, data collected in the UK showed a failure rate of 12% for the DePuy ASR Articular Surface System and 13% for the ASR XL Acetabular System.
To put these figures into the context of the DePuy ASR hip replacement recall in Ireland, there have been 3,516 DePuy ASR hip replacement systems sold in Ireland to date. If the failure rate in the UK was repeated in Ireland, it would mean that rather than 175 systems failing within the first five years, there would be 440. Although 50 extra hip replacement failures per year may not mean a great deal to somebody who has never experienced revision surgery, the pain and longer recovery rate of revision surgery would mean more than a great deal to any of those fifty who had to undergo it.
Hip replacement might now be considered routine surgery, but even if it is now relatively common, it is nonetheless major surgery that is extremely painful with a long recovery period.
Who is affected by the DePuy ASR Hip Replacement Recall in Ireland?
According to figures released by the HSE, approximately 70,000 hip replacements have taken place in Ireland since DePuy ASR hip replacement systems were first used in 2003. Obviously, this recall is going to cause quite a lot of consternation among anybody who has received a replacement hip during this period until such time as they discover what system they have been fitted with.
Hospitals are currently identifying patients who have had a DePuy ASR hip replacement system implanted, and they will contact patients in the coming weeks. Each patient affected will be given an appointment to visit their doctor and have a blood test to identify any micro-particles of the system which are present in the bloodstream: an X-ray will be taken to detect any physical faults. In the meantime, if you are experiencing symptoms that indicate you may have a problem with a replacement hip system, it is recommended that you visit your GP.
I Think I am Affected by the DePuy ASR Hip Replacement Recall in Ireland – What Should I Do?
As mentioned in the “Higher than Expected” section above, this problem should affect no more than a hundred people within the next twelve months, so there is no need to panic. Your first course of action, if you believe that you are affected by the DePuy ASR hip replacement recall in Ireland, is to visit your GP and be referred to have the blood test and X-ray procedures as mentioned above. Even if you do not notice any immediate problems, Johnson and Johnson is recommending that implant patients undergo yearly monitoring to check for problems which may require revision surgery.
The cost of ongoing monitoring and revision surgery is supposed to be covered by DePuy Orthopaedics. However, DePuy Orthopaedics have attached conditions to this offer that entails a patient relinquishing all medical records concerning the faulty hip replacement system and the faulty system itself – effectively removing from the control of the victim the evidence that there was ever a faulty hip replacement system implanted. DePuy Orthopaedics are also asking patients to sign a legally binding agreement before it will take responsibility for the costs of monitoring and revision surgery – holding the health service to ransom over the provision of basic health care.
Where Does the HSE Feature in This?
There are question marks surrounding the integrity of the Health and Safety Executive (HSE) in respect of the DePuy ASR hip replacement recall in Ireland. Whereas they have been foremost in publicising the recall, they are still referring visitors to the FAQ section of their web site onto the DePuy Web site – apparently advocating that people with DePuy ASR hip replacement systems forfeit their right to legal representation.
Furthermore, if it is proven that the Health and Safety Executive were aware of the problem before the “voluntary” recall by DePuy Orthopaedics, they too could face court action for medical negligence. Between 2006 and 2009 reports of problems with the DePuy ASR hip replacement system were published frequently in the New York Times. The Food and Drug Administration in the United States has received over 300 complaints about the product. In Australia, the products were withdrawn in 2009, and in March 2010 DePuy issued a letter to surgeons advising them of the “higher than expected” failure rate, particularly in patients of small stature – typically women and people with weak bones. The majority of these individuals required expensive and painful operations to remove the device.
It seems inconceivable that the Health and Safety Executive (HSE) were not aware of these issues and, if they continued to purchase the DePuy ASR hip replacement systems with even partial knowledge of the problems, they could well be guilty of medical negligence. Your solicitor will monitor the situation and be able to tell you if the HSE is likely to be found negligent.
Is there Legal Recourse for This Recall?
Yes – but you have to approach this in the right way. Irrespective of advice given to you by a family doctor, your hospital surgeon, or the HSE, DO NOT SIGN THE DePUY CONSENT FORM. DePuy Orthopaedics is currently offering to cover “reasonable and customary” costs of health monitoring and revision surgery, but make no mention of compensation for the trauma of going through another surgical operation.
Revision surgery is technically more difficult than the original hip replacement, takes longer to perform, places you at higher risk of complications and has a longer recovery period. Test compensation cases have already been filed in the United States against DePuy Orthopaedics, alleging that they manufactured a defective product, failed to warn patients and doctors of problems with the implant and were negligent in designing, manufacturing, and selling the product.
Further claims in the United States will no doubt follow, but the DePuy ASR hip replacement recall in Ireland will also entitle you to damages on the grounds of further pain and suffering, loss of earnings and out of pocket expenses as you attend hospital for monitoring or undergo revision surgery.
Further Information about the DePuy ASR Hip Replacement Recall in Ireland
It is not known what impact personal injury claims for compensation will have on the length of time DePuy Orthopaedics are prepared to pay for ongoing monitoring or revision surgery, or if they will reassess the conditions under which they are prepared to offer payment. However, once you are aware that you have been fitted with a DePuy ASR hip replacement system, you only have two years from the “date of knowledge” in which to file a claim for compensation. Although this may seem like a long time, a complex case of this nature may take a considerable time to prepare, and it is in your best interests to contact us as soon as possible.
Therefore, for further information on what, how and when you should claim compensation for your faulty DePuy ASR hip replacement system, please do not hesitate to get in touch with a solicitor.
We have a free advice line where you can talk to a solicitor about the DePuy hip replacement recall. Simply call 1-800 989 900 or fill in the form to request a solicitor call you back.
Summary
- The DePuy ASR hip replacement recall in Ireland is due to a higher than expected failure rate in the hip implant.
- More than three thousand people are affected by the DePuy ASR hip replacement recall in Ireland.
- People who believe they have had the DePuy ASR hip replacement implanted should get a blood test and have a hip x-ray.
- Revision surgery for DePuy ASR hip replacement systems is more complicated than the original surgery and requires a longer recovery period.
- If contacted by the HSE or DePuy Orthopaedics, do not sign the DePuy Consent Form before speaking with a solicitor as this removes your entitlement to compensation.
- Speak with one of our solicitors on our free advice service to find out the latest news on the DePuy ASR hip replacement recall in Ireland and your entitlement to claim compensation.
UPDATE – October 2012. In its most recent Interim Report, the Injuries Board revealed that all applications for assessment they had received in respect of DePuy hip replacement compensation had been “released to the courts” as no compensation benchmark has been established. The first cases against DePuy Orthopaedics are expected to be heard in court throughout the first quarter of 2013.
Copyright © 2009-2019 Eoin Campbell
About the Author
Eoin P. Campbell is an honours law graduate (LL.B) and qualified solicitor whose professional experience is in the area of litigation and in particular personal injury claims. Eoin P. Campbell is currently lecturing in law at two universities in Lyon, France.