Tipp FM Legal Slot – 14th February 2012
John M. Lynch on DePuy ASR Hip Implant & PIP Breast Implant Recall Updates[soundcloud id=’167085703′]
We represent a considerable number of clients who have been directly affected by the DePuy hip recall. We have a broad spectrum of clients – those who have had revision surgery, who are awaiting revision surgery, those who have significant symptoms together with high cobalt and chromium levels, those who have no symptoms but have high metal ion readings in their blood and those who have neither high readings nor symptoms and those who have normal blood readings, normal scans but still have symptoms.
How serious is the issue of Metallosis?
The issue of elevated chromium and cobalt in the blood is certainly one of grave concern. It is common knowledge that the hip devices in question here are metal on metal, therefore wear and tear and also friction caused by movement over time leads to metal ions being released into the blood. Under normal conditions this is to be expected and is tolerated by the body. What we are seeing in many cases however is that the levels of these ions released in some people are well above the recommended level for toxicity in the body. This can result in a build-up of metal debris and fluid around the hip device which can compromise the hip. It is hard to see how this could not be a danger as the body would not be accustomed to having large amounts of either cobalt or chromium in it generally and is not equipped to deal with these high levels.
What are the adverse effects of having these metals in the body?
It is difficult to say for certain what the effects of having these high levels of toxicity of metals in the body will be, particularly the long-term effects, given that there is as of yet no definitive research completed in the area. In our experience a lot of patients are being told that these raised levels are nothing to worry about – but obviously from a medical point of view more extensive testing and research need to be carried out. There is an alarming degree of ignorance out there concerning the effect metal on metal implants have on patients in the context of the effects of high levels of chromium or cobalt.
Could Metallosis have long-term effects?
This represents a significant cause of concern for all those who have metal on metal joints, whether they have symptoms or not. People are worried that the prolonged use of the joint could result in significant long terms effects and definitive information on the effects is paramount. This concern has been intensified over the last number of months because of the suspicions that have emerged as to the viability of the Pinnacle which is another DePuy device.
When is the closing date for DePuy patients to initiate proceedings?
The recall was announced in August 2010 and under the Statute of Limitations DePuy patients have two years from their date of knowledge to make a claim, so proceedings will have to be initiated at the latest before 26th of August 2012. a word of caution – the issue of the time limit is a very complex one and each case has to be examined on a one by one basis.
PIP Patients – Steps to Take Immediately
We are continuing to receive a high volume of new PIP implant compensation enquiries from all over Ireland. As uncertainty over the effects of the PIP implants increases, women who have had these implants have been seeking advice from us to see what they can do and whether they can claim PIP compensation.
What action must PIP patients take immediately?
In all cases we are advising Clients to immediately take the following steps:
1. Firstly we need to find out whether you have PIP implants. We can do this by requesting a copy of your records under the Data Protection legislation from the clinic where you had your implants. The operation records page in your records should identify the makers of your implants. We are assisting many Client at this stage is establishing whether they have had PIP implants.
2. If you have PIP implants we would suggest that you contact your GP or the clinic where the operation took place to request a scan. It may take some time to get your records so you might not wish to wait for these before you seek a scan. An MRI scan will enable your medical practitioner to assess whether your implants pose an immediate risk, i.e. whether they have ruptured. You must be persistent in this if your request is denied. From experience we are discovering that Clients are getting quicker referrals for scans through their GPS.
3. We are aware that many Clients have had difficulties in sourcing Clinics who will perform the appropriate scans. We are aware of a number of clinics that are presently performing these scans and are happy to assist our Clients in this regard.
What will the scan show?
Your Scan may reveal one of two outcomes:
- If there is an issue with the implant, you may wish to have them removed and will need to consider your options from a medical and legal point of view.
- If your scan shows that there is currently no sign of issues with the implant, you may like to keep your situation under review and will need to consider your options from a medical and legal point of view.
What is the present legal position?
We are presently investigating the legal position in the context of taking a case for breach of contract and negligence for the costs of monitoring each client’s case, the cost of investigating each case and the cost of undertaking corrective surgery and compensation for pain, suffering and psychiatric injury and mental distress.
This is a complicated area of litigation because of the parties involved and because there is so much conflicting evidence and opinion. New information regarding the PIP implants is emerging day by day and we are closely monitoring these developments.
“Patient Agreement Form”
In recent days it has come to light that Irish PIP patients are being asked by the Hospital Group to sign a “Patient Agreement Form” to waive their right to legal redress in order to avail of the free removal or reduced cost replacements. They would also have to make a declaration to the effect that they will not speak to the media.
The “Patient Agreement Form” states “I agree that my acceptance of such services shall stand in full and final settlement of any claims whatsoever.” and “Upon acceptance of such services I agree to discontinue any or all actions I may have, or as may be, commenced against THMG Ltd (The Hospital Medical Group) and/or the surgeons in relation to my PIP implant surgery.”
Under absolutely no circumstances should PIP patients sign the “Patient Agreement Form” hindering legal action to which they are entitled – comment on compensation for pain and suffering.
How soon must I bring a case?
Some of our clients have been concerned that they may be out of time to bring a PIP compensation claim because their surgery was performed several years ago. We need to assess all PIP claims on a case by case basis and if you have had PIP implants, please contact us without delay