Augustus Cullen Law are currently acting for Clients who have experienced adverse outcomes following use of the DePuy ASR systems in their hip replacement surgery. Our investigations are still at an early stage. The background to the problem is beginning to emerge.
As of the 26th August 2010, DePuy Orthopaedics Incorporated have issued a worldwide recall of two hip replacements systems, the ASR XL Acetabular System and the DePuy ASR Hip Resurfacing Platform. This decision is based on data obtained from the National Joint Registry of England and Wales which demonstrated a relatively high percentage (12-13%) of 5 year revision or secondary hip surgeries where these systems were used. This means that patients implanted with these devices required premature replacement in approximately one in eight cases.
It is estimated that up to 93,000 people worldwide have been implanted with the affected products. This figure includes in or about 3,500 patients in the Republic of Ireland since the products first went on the Irish Market in 2004. Based on the number of incidents reported in the United Kingdom, more than 400 Irish patients could require corrective procedures, including repeat surgery, to remedy problems experienced with the product. Noted difficulties with the ASR Devices include loosening parts, infections, fractures, dislocation, metal sensitivity, and pain. It is understood that the recalled products were more often used on younger patients in need of hip resurfacing rather than older patients requiring a complete hip replacement. It was felt that they may benefit from the stability of the device, thereby limiting the chance of repeated dislocation. The risk for revision surgery was highest with ASR head sizes below 50mm in diameter and among female patients.
The HSE issued a statement on the 27th August 2010 wherein they advise that they became aware of the field safety notice from DePuy on the evening of the 26th August. They immediately notified management and staff, including Consultant Orthopaedic Surgeons, in all of the hospitals where orthopaedic surgery is carried out. Hospitals were advised that this product should not be used in any hip replacement surgeries with immediate effect. The Irish Medicines Board have assured the HSE that all devices affected by the recall have been removed from circulation. The HSE is currently identifying all patients who may have received this device as part of their hip replacement and hospitals will be contacting all affected patients directly.
According to a statement released by the Irish Medicines Board on the 27th August 2010, the manufacturer of the recalled systems has confirmed that all stock has been removed from Irish Hospitals. They further state that 12 incidents involving the ASR Hip System have been reported to the Irish Medicines Board since its introduction to the Irish Market in 2004.
Implications for those affected
The people affected by this worldwide recall are those who have been implanted with either of the systems since they were placed on the Irish Market in 2004. Patients who have been implanted with the affected devices will be contacted in the coming weeks for review by Orthopaedic Surgeons. Those called for review may be subject to a clinical examination, blood tests, and an MRI scan, to determine how the replaced joint is functioning. Some patients may require further surgery using a different type of joint replacement.
The President of DePuy Orthopaedics Incorporated, David Floyd, released the following statement following the recall of their Hip Replacement Systems;
"We regret that this recall will be concerning for patients, their family members and surgeons. We are committed to assisting patients and health care providers by providing information through multiple channels and paying for the cost of doctor visits, tests and procedures associated with the recall".
According to their website, DePuy intends to cover reasonable and customary costs of monitoring and treatment if services are required in association with the recall of ASR. However, this offer does not cover redress for the pain, anxiety, and suffering experienced by patients who have been implanted with a faulty system, and who are now receiving this news, awaiting further investigations, and having to undergo treatment or surgery which would not have been necessary had correct devices been inserted at the outset. Furthermore, if revision hip replacements are required, these procedures are generally more complicated with the outcomes not being as good as for the first hip replacement.
In a Field Safety Notice issued from DePuy to all Clinicians on the 24th August 2010, reimbursement in respect of any follow-up treatment was stated to be subject to the patient consenting to provide DePuy with x-rays, explants (removed devices), and any other requested medical information after the revision surgery.
If you have been undergone a hip replacement operation involving either of the systems recalled, you may have a case in Product Liability against the manufacturer and/or supplier of the Defective Product. Proceedings may be issued relying on a number of causes of action, to include common law and the Defective Products Act 1991. In its simplest form, to succeed in a claim in common law, you must show that the manufacturer/supplier owed you a duty of care, and this duty was breached. The Defective Products Act 1991, refers to dangerous defective products, and incorporates the principal of strict liability in a claim. Once you are satisfied with the identity of the manufacturer, and it is proven that the product was defective, and you suffered damage because of this defect, the manufacturer must then attempt to defend this.
The DePuy ASR is a metal-on-metal hip replacement system, which has increasingly been of concern to health care professionals as they can shed metal particles into the body causing damage to soft tissue, inflammatory reactions, and bone loss. It has been reported that the company admitted it was aware of “issues” surrounding the products for some time, and the ASR was withdrawn from Australia in December 2009, and the US last March. The EC (General Product Safety) Regulations 2004 also provide that recalls should only take place “as a last resort”, which may give some indication of the seriousness of the situation.
It is extremely important that you contact the office if you have any concerns over a hip replacement you have undergone since 2004. Whilst the primary concern must be further medical treatment, Statutory time limits are in place which limit the time within which you can issue proceedings. We would therefore suggest if you are affected or concerned, and require further legal advice, that you contact us as soon as possible. We would also ask that you refrain from signing any “consent” or “information release” forms from DePuy Orthopaedics Incorporated until we have consulted with you. We have already received instructions in respect this matter and have commenced our investigations. We are therefore well placed to address any concerns you may have.
If you have any further queries, please contact any of the following from our Medical Negligence Group: Michael Boylan, Partner; David McKechnie, Associate Solicitor; or Ian Lavelle, Associate Solicitor.
08 September 2010