DePuy Implants withdrawn from the market.
DePuy Implants withdrawn from the market. The DePuy ASR Hip Resurfacing System and the DePuy ASR XL Total Hip Replacement System were launched on the market in 2003. Research by the British Orthopaedic Association and the Australian Orthopaedic Association National Joint Replacement Registry, led to the world wide voluntary recall of this product by DePuy on the 26th August 2010, as concerns had been raised in relation to the unacceptably high numbers of patients who were experiencing problems with these artificial hips and requiring surgery to have the implants revised.
Contents:
1 DePuy Implants withdrawn from the market
2 Symptoms to be aware of in relation to implant failure
3 Time limit for taking action against DePuy
4 Who is going to pay for my revision surgery?
5 What if I have not undergone revision surgery?
6 The Alternative Dispute Resolution Process – the background
7 The Alternative Dispute Resolution Process – How does it work?
8 The Alternative Dispute Resolution – Criteria for eligibility
9 Proposed Amendments to the Alternative Dispute Resolution Process
10 High Court proceedings
11 What is happening in other jurisdictions?
12 Statistics
13 The Specialist DePuy Team at Malcomson Law
1. DePuy Implants withdrawn from the market
DePuy Implants withdrawn from the market. The DePuy ASR Hip Resurfacing System and the DePuy ASR XL Total Hip Replacement System were launched on the market in 2003. Research by the British Orthopaedic Association and the Australian Orthopaedic Association National Joint Replacement Registry, led to the world wide voluntary recall of this product by DePuy on the 26th August 2010, as concerns had been raised in relation to the unacceptably high numbers of patients who were experiencing problems with these artificial hips and requiring surgery to have the implants revised.
Complications of implant failure include the following:-
• Excessive cobalt and chromium ion levels due to the wear of the metal on metal device.
• Metallosis which is a type of metal poisoning or reaction.
• Tissue damage or bone damage, for example necrosis, pseudotumors and reaction to the metal debris.
• Loosening of the implants.
• Infection caused by metallosis.
2. Symptoms to be aware of in relation to implant failure may include:-
Orthopaedic advice is that any reports of pain should be taken seriously and that follow up reviews should occur regularly and in general on an annual basis, even if there are no physical symptoms as the wearing and loosening of the components of the implants can lead to soft tissue damages as well as pain. Furthermore, cobalt and chromium ion levels in the blood must also be monitored as these can be elevated without any physical symptoms. Regular radiology, such as ultra-sounds and MARS MRI scans, should be carried out to check for any abnormalities.
If you have any concerns in relation to your DePuy hip implant you should contact your treating orthopaedic surgeon. If you are not attending with an orthopaedic surgeon, your G.P. can refer you. There are a number of Orthopaedic Surgeons in the country who specialise in DePuy ASR related issues.
3. Time limit for taking action against DePuy
Admittedly certain aspects of a defective product action against DePuy are now out of time, for example the time limits for issuing proceedings have now expired:-
1. Under the provisions of the Defective Products Liability Act, 1991 (10 years from the date of the release of a product onto the market, therefore 2013)
2. Under the provisions of the Sale of Goods & Supply of Services Acts (6 years from the date the cause of action accrued)
3. Under the principles of Contract (6 years from the date of the Contract)
However, it is still possible, in certain circumstances, to take an action against DePuy under the rules of negligence. In this regard, the relevant time frame for taking an action in relation to the negligence of DePuy for manufacturing and distributing a defective product under the Statute of Limitations Acts is two years from the date of your knowledge that your DePuy implants had failed. Therefore, if you only became aware of the fact that your DePuy hip implants had failed within the last 2 years, it could still be possible for you to issue High Court proceedings against DePuy, which would not be statute barred.
In order to prepare for this, we would need to take up your medical records from your treating Orthopaedic Surgeon, to include radiology and blood test results, to establish when it became evident that your DePuy hip implants had failed.
4. Who is going to pay for my revision surgery?
DePuy will, for the main part, through their Loss Adjustors Thornton’s, reimburse or cover the costs of revision surgery, where the revision surgery takes place within 10 years of the initial hip replacement/hip resurfacing procedure. Furthermore, if you are within the requisite time frame, DePuy may also cover the cost of losses incurred by you which relate to the revision surgery, such as travel expenses, loss of earnings, convalescent care, etc. Furthermore, if you have private health insurance, your health insurer is obliged to cover the costs of your surgery.
Some clients have encountered difficulties where they are outside of the ten year period and neither their private health insurer nor DePuy will cover the costs of the surgery. In these circumstances, the health insurers are obliged to cover the costs of the surgery, under the terms of your insurance policy, and thereafter to seek reimbursement from DePuy, if possible.
We have successfully challenged health insurers in this regard in the past and secured the payment of costs associated with revision surgeries in circumstances where the health insurers have agreed to do so and seek reimbursement directly from DePuy.
5. What if I have not undergone revision surgery?
You should continue to attend with your General Practitioner and your treating Orthopaedic Surgeon for a regular annual review in relation to your DePuy implants. Sometimes, if a patient is unsymptomatic and there is no evidence of elevated metal ion levels in blood test results, these reviews can become bi-annual. However, if you are concerned about any physical manifestations of pain or stiffness, etc. you should schedule a review with your consultant orthopaedic surgeon for radiology and blood testing.
Elevated metal ion blood test results should be of concern to you as they can suggest that the implants have failed, even if there is not a physical manifestation of such a failure. Any symptoms should be treated seriously as the sooner revision surgery takes places once the implant has failed, the less permanent damage will be done.
6. The Alternative Dispute Resolution (ADR) Process – the background
In circumstances where over 1,100 High Court Personal Injury Summons have issued against DePuy, Mr Justice Cross, a High Court Judge who presides over applications and reviews in relation to general DePuy proceedings, has said in the past that, were all these cases to run in the High Court, it would take 12 years for them to be concluded, given the limited judicial resources in the High Court.
In these circumstances, for the last number of years, Malcomson Law has been involved in the formation of an Alternative Dispute Resolution (ADR) Process. This Process was approved by Mr Justice Cross in the High Court on 16th December by the Order made by Mr Justice Cross on that day.
7. The Alternative Dispute Resolution (ADR) Process – How does it work?
This process is an independent evaluation of a claim which is deemed to be eligible for the process. In other words, if you meet the qualifying criteria, your claim can proceed using a paperwork only process, whereby the details of your claim would be submitted to an independent Evaluator who would review your claim and evaluate the damages to which you are entitled. It is not a judicial or arbitrarial process and the Evaluators are retired Judges from the Supreme and High Courts or practicing Senior Counsel who have experience with personal injury actions.
You would not be obliged to appear before the High Court and all evidence would be provided to the Evaluator to which you are assigned, by way of a booklet containing High Court pleadings, expert reports, a statement taken from you and any other submissions which may be of assistance to your claim. Also details of any financial loss which you have suffered, which would be included in your claim.
8. The Alternative Dispute Resolution (ADR) Process – Criteria for eligibility
To be eligible for the process, a number of conditions must be satisfied:-
1. You must have had your revision surgery not less than 180 days but not more than 10 years following from your original hip replacement or hip resurfacing procedure.
2. Your revision surgery must have taken place within this jurisdiction.
3. Your claim must not be statute barred, in other words, proceedings must have been issued at the very least within 2 years from your date of knowledge of the failure of your DePuy implant which has caused a demonstrable personal injury. Before such proceedings can be issued, an application must be made to the Injuries Board. Furthermore, proceedings must be served on the Defendants within 1 year of the date that they are issued in the High Court.
As part of the agreed ADR process, certain criteria have been included which might exclude you from the ADR process. These would include claims where the revision surgery was exclusively necessitated by any of the following:-
- Dislocation;
- Trauma;
- Infection;
- A fracture of the femoral head;
- Any issue relating to the femoral system.
9. Proposed Amendments to the ADR Process
As it stands, many claims are currently deemed ineligible for the ADR process, for example if you have not yet undergone revision surgery or if your revision surgery was due to one of the exclusionary criteria. Our Managing Partner, Raymond Bradley, is currently proposing amendments, with the support of other claimant Solicitors in the country, which would increase the number of claimants who would be entitled to participate in the ADR process. These amendments include the following:-
1 Claimants who have not yet undergone revision surgery for certain reasons.
2 Claimants who have bi-lateral DePuy ASR implants but only one of them has been revised.
3 Provisions to be made for deceased Claimants.
4 Deletion of the exclusionary criteria
We have also proposed an Appeals process in relation to claims which are denied eligibility to the process by DePuy. These proposed amendments have not yet been accepted, however, we are in ongoing correspondence with the Chairman of the Evaluators, Mr Justice Iarfhlaith O’Neill, other claimants’ Solicitors and DePuy in this regard. Furthermore, there are ongoing reviews in the High Court in relation to the ADR process.
10. High Court proceedings
While the ADR process was being established and since its formation, a stay was placed on High Court proceedings which had been issued but not listed for hearing, prior to the establishment of the ADR Process. Effectively, this meant that proceedings were not allowed to progress before the High Court or to be listed for hearing if they had not already been listed before the stay was put in place. This stay was recently lifted by Mr Justice Cross in the High Court on 4th October 2016. This means that cases can now run to a hearing in the High Court.
There has been some recent publicity in the media surrounding cases which have been running in the High Court, having been listed for hearing before the stay on proceedings was put in place. However, until recently none of these hearings have run to a conclusion and all of them were compromised, or in other words settled, prior to the conclusion of the hearing. These settlements would all have been confidential and therefore, there has been no indication as to the level of liability of DePuy or the settlement amounts which were agreed on.
Recent High Court judgement
Very recently, the first High Court judgment was handed down by Mr Justice Kevin Cross. Malcomson Law did not act in this particular case but the judgement has been published and is available to view on www.courts.ie.
This case involved a Plaintiff who was 52 years of age at the time of the hearing. She had suffered from acetabular dysplasia, a congenital hip disorder, since childhood before eventually undergoing bilateral hip replacements in 2005 and 2006. The implants used were DePuy ASR products which subsequently failed and resulted in the Plaintiff having to undergo early revision surgery of both hips. Her cobalt and chromium levels had also been enormously elevated. On revision surgery, she was found to have ALVAL (caused by an adverse sensitive reaction to metal debris) and metallosis.
At the hearing, evidence was given on behalf of the Plaintiff by a Consultant Orthopaedic Surgeon which was substantiated by histopathology reports as well as evidence of a Clinical Neurophysiologist in relation to the permanent damage occasioned to the Plaintiff’s sciatic nerve during the course of one of her revision surgeries. Evidence was also given in relation to the fact that the Plaintiff was likely to undergo two further revision surgeries over the course of her lifetime, given her relative youth.
The Plaintiff’s evidence was accepted by Mr Justice Cross, despite contradictory evidence from the Defendant, DePuy International. He awarded the Plaintiff a sum of €704,209.60 which was broken down as follows:
Past care and travel expenses €51,040.11
Future revision and care costs €191,415
Future home care/aids and appliances €240,000
General Damages to date €200,000
General Damages into the future €100,000
Total €782,455.11
10% was then discounted from the award due to the conclusion that 90% of the Plaintiff’s problems were due to the consequences of her DePuy ASR implants having failed and the other 10% due to her pre-existing hip dysplasia. Therefore the net total award was €704,209.60.
11. What is happening in other jurisdictions?
Australia
Australia was the first jurisdiction in which the DePuy ASR products were withdrawn from the market and here, a class action system is in operation. On 29th June 2016, the Federal Court approved a settlement agreement of this DePuy ASR class action for $250 million. Approximately 2,000 people in Australia are currently registered as members of this class action.
The United States
The United States also operates a class action system and the class action against DePuy in relation to ASR hip implants is ongoing. However, some cases have been heard individually and the first of these was the case of Loren ‘Bill’ Kransky which was heard in 2013 when Mr Kransky awarded the sum of $8.3 million by a Los Angeles Jury. DePuy then went on to appeal this decision on a number of grounds and the appeal was eventually heard in the Court of Appeal of the State of California in July 2016. The Appeal was disallowed and the original judgement stood. In the USA, there are over 12,000 ASR hip implant Personal Injury or Wrongful Death actions filed against DePuy. It is estimated that the total cost of settling these claims in the USA will top $4 billion and it is likely to be one of the largest settlements of US claims involving a medical device in history. It is estimated that the average settlement in the USA will be in the region of $350,000 depending on age & medical condition, according to a report in the New York Times.
Class Actions in Ireland
In Ireland, there is no provision for a class action and the closest equivalent is the ADR Process which has been established. The benefit of this, is that each claim is viewed as individual and is judged on its own merits. Therefore there is no “pot to share” so to speak, as is the scenario in Australia and the USA, where all eligible claims are settled for a total figure, regardless of how many claimants are involved in the class action.
12. Statistics
- DePuy ASR implants were launched on the market in April 2003.
- The product was withdrawn from the Australian market by the Government in December 2009.
- Voluntary recall of ASR products by DePuy occurred on 16th December 2010. Approximately 3,300 Irish patients received these implants.
- Approximately 1,100 High Court proceedings have issued against DePuy and this number is rising.
13. The Specialist DePuy Team at Malcomson Law
Of the 330 claimants who would currently qualify for the ADR process, Malcomson Law represents 91 and rising. We also represent further claimants who have not yet undergone revision surgery. In total, Malcomson law are currently representing approximately 120 claimants who are either likely to require revision procedures and many of whom have already undergone such procedures as a result of being implanted with DePuy ASR products.
This type of litigation is extremely complex and difficult to advance. The Specialist DePuy Team at Malcomson Law is headed by Raymond Bradley, Manager Partner. Raymond has extensive experience of running health related cases in the Irish High Court, an unrivalled record of involvement in high profile cases in medical negligence and in representing victims of health scandals at public enquires and compensation tribunals. Also part of the team is Patricia Crosbie, who has extensive experience representing clients in personal injuries, defective medicines and defective device claims. Prior to practicing law, Patricia worked as a general theatre and paediatric nurse. Fiona Reynolds, Solicitor, and Rachel Hill, Solicitor, also form part of the team as well as our extensive support staff.
If you are experiencing any difficulty with your DePuy metal on metal hip implant please phone us at 01-8744422 or email us at help@mlaw.ie and a client care executive will be in contact with you.