On the 26th August 2010 DePuy Orthopaedics, Inc. (which is a division of Johnson & Johnson) announced a worldwide recall of its ASR hip replacement system after recently publicised data showed that the five-year revision rate for the ASR articular surface systems was approximately 12% and for the ASR XL acetabular system was approximately 13%. The data also suggests that the risk of complications with these systems is greater where the ASR head sizes are below 50 milimetres in diameter and there would also appear to be a bias towards female patients. Although the recall in Ireland was only announced in recent days, DePuy has already had several cases for medical negligence and liability for defective products relating to the ASR systems commenced against it in the US.
In a statement on the day following DePuy’s announcement the HSE stated that it had become aware of the field safety notice on the evening of the 26th August and that it immediately notified management and staff, including consultant orthopaedic surgeons, in all of the hospitals where orthopaedic surgery is carried out, with hospitals being advised that this product was not to be used in any hip replacement surgeries with immediate effect.
On the 30th August 2010 the HSE followed up this initial statement confirming that approximately 70,000 hip replacements had taken place in Ireland since July 2003 when the DePuy ASR product first became available and that approximately 5% of these would be affected by the recall, with figures provided by DePuy indicating that 3,516 of these defective products were sold in Ireland. The HSE further indicated that hospitals would be contacting all affected patients directly and that they would take all steps necessary to ensure patients received appropriate follow-up treatment.
However, since that date there has been complete silence on the matter from the HSE, notwithstanding the fact that DePuy has in the meantime taken the wholly improper action of declaring that it will cover the cost of corrective surgery only if patients first of all consent to all of their medical records being supplied to the company and to the handing over of the removed faulty implant after completion of the surgery.
If you have undergone hip replacement surgery at any time between July of 2003 and the present, even if you have not yet been contacted the HSE, it would be advisable to ascertain whether an ASR device was used in your case by either contacting your GP or orthopaedic surgeon, particularly if you are experiencing pain, difficulty in walking or any other adverse symptoms.
If it is indeed the case that an ASR system was used in your case, your first priority should of course be to take medical advice to ascertain what remedial steps should be taken in your particular case. This will probably entail the taking of blood tests and MRI scans initially.
However, once you have received appropriate initial medical attention, we would strongly urge you at that stage to obtain independent legal advice from a solicitor practising in the area of medical negligence and under no circumstances to sign any documentation which is provided to you by DePuy before having done so. Failing to take these precautionary measures could mean that your prospects of successfully bringing a claim against DePuy for medical negligence and liability for defective products could be seriously prejudiced.
If you wish to discuss your case with a solicitor call John McCarthy now on 023 883 3348 or email him at firstname.lastname@example.org to arrange a free initial consultation to discuss your case.
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