Tipp FM Legal Slot – 31st July 2012
Gillian O’Mahony July 2012 Q&A Review[soundcloud id=’167071558′]
- DePuy Hip Implant Recall Deadline
- Family Law Courts Structure Reform
Over the past year or so both you and John Lynch have kept listeners updated on the DePuy Hip Implant Recall. Remind us again, when were DePuy hip implants recalled and how much time do patients now have left to lodge a claim?
There is now less than ONE MONTH REMAINING for those affected by the DePuy Hip Recall to lodge a claim.
As many people will be aware, on the 26th August 2010 DePuy Orthopaedics Inc., a division of Johnson & Johnson, announced a worldwide recall of two of its metal-on-metal hip replacement devices; the ASR XL acetabular total hip replacement and the ASR hip resurfacing system. Both hip implants were recorded as having “higher than expected failure rates”.
How many patients are affected in Ireland and what is the failure rate?
As matters stand, 3,282 Irish patients were fitted with defective DePuy ASR hip implants. Experts have found “unequivocal evidence” of high failure rates and the ASR total hip implant has now been shown to have a failure rate of up to 50% within six years.
How would DePuy patients know if the device is failing – what symptoms are they experiencing?
We represent many patients who received the faulty DePuy implants. Some patients have symptoms showing that the device they received has started to fail and have even had their revision surgery at this stage. Other patients, however, have no obvious symptoms at all.
Our experts have given us a list of symptoms, which show the failure of the device:
- Continuing hip, groin, leg, or low-back pain;
- Audible noises such as crunching, clicking, grinding, or metallic sounds coming from the ASR device;
- The sensation that one`s hip is not “in place,” especially when standing up or starting to walk;
- Loss of ability to perform physical activities, reduction in mobility and noticeable limp;
- Swelling in the affected hip area or generalised hip pain, discomfort, pressure or tenderness and;
- Loosening of the various components in the implant, necrosis or soft tissue damage and elevated cobalt and chromium levels in the blood due to exposure to metal.
We have identified common symptoms in patients with elevated blood ion levels:
- Rashes, skin patches and skin discolouration;
- Memory loss/difficulties;
- Eyesight deterioration;
- Changes in urine.
Despite recent research, there is still a lack of certainty as to the actual affect that these metal ions in the bloods can have.
What is metallosis and how is it affecting DePuy patients?
One of the greatest concerns for patients is what is called Metallosis and its relatively unknown effects. The DePuy hip devices are metal-on-metal, therefore wear and tear caused by movement over time can lead to metal ions being released into the blood and urine. This can lead to a build-up of metal debris around the hip device itself. There is an alarming degree of ignorance out there about the effect metal on metal implants have on patients where there are high chromium or cobalt readings.
In 2007, the Lancet medical journal said that the recommended levels of ions in the body had not yet been clarified. Five years on there is still no definite agreement in the medical profession.
Our experts have told us about the metal ion levels:
- Less than 1 ug/l – normal
- With metal on metal replacement – 2ug/l can be normal
- 2-5ug/l – grey area
- 5-10ug/l – suspicion of excess wear
- 10-20ug/l – Newcastle studies show that in patients with these levels 60% will have failure issues within 3 years
- Over 20ug/l – very excessive wear of joint – revision necessary
Since the recall of the DePuy devices has further research been carried out into metal-on-metal devices?
In two recent medical reports published in the British Medical Journal and the Lancet Medical Journal experts new findings indicate a necessity for patients with Metal-on-Metal implants to be monitored at least once yearly.
The BMJ report advises that metal ions can seep in to the local tissue can cause reactions which can destroy both muscle and bone and in turn result in long term disability. They can also seep into the bloodstream and are toxic to the lymph nodes, spleen, liver, kidneys and other organs as they pass through the body. The report warns of potential link between the release of metal ions into the body and the risk of developing cancer. The report also advises that levels of cobalt in the blood in excess of 7μg/L should be investigated.
The Lancet Report recommends that MoM implants should no longer be used and for those patients who have received MoM implants it is recommended that clinical and radiological reviews be carried out at least once per year for the lifespan of the implant to monitor metal ion levels in the bloods and changes in the implant.
When should patients contact you about lodging a claim?
Immediately! In most cases the deadline for lodging a claim seeking compensation is fast approaching and those affected by the recall need to take precautionary action before the 25th August 2012 to avoid the possibility of your case being out of time.
There is a lot of work involved in lodging a claim so the sooner DePuy patients start the better.
What is Symphysiotomy?
Symphysiotomy was first advocated in 1597. Symphysiotomies became a routine surgical procedure for women experiencing an obstructed labour. They became less frequent in the late 19th century after the risk of maternal death.
A symphysiotomy is a barbaric procedure where the obstetrician breaks a woman’s pelvis, cutting it into two to facilitate the delivery of her baby. This procedure was discontinued and replaced by a caesarean operation in the early part of the 20th century in the developed world, except in Ireland.
How many women had the symphysiotomy procedure in Ireland and when did the procedures take place?
1,500 Irish women were victims of symphysiotomy between 1944 and 1992.
Were the women aware that they were having a symphysiotomy, did they give their consent to the procedure?
These medical professionals abused their power by performing completely unnecessary and damaging procedures on women who were at their most vulnerable. In many cases the procedures were concealed, the women were not given information before or after the surgery and their consent was not sought or given. What is even more disturbing is that most of the women who underwent this procedure were not aware of it until several years later or until very recently. Last week a case came before our Supreme Court and the five-judge court said the procedure should never have been carried out on the lady in question particularly when she was unconscious and under anaesthetic.
Why is the area of symphysiotomy so topical at the moment?
Last week the Supreme Court upheld a High Court decision that a symphysiotomy carried out on an 18 year old in 1969 at Our Lady of Lourdes Hospital in Drogheda was “entirely unjustified and unwarranted”. The woman in this case did not know that she had a symphysiotomy until almost 33 years later when she heard a radio programme about it. She suffered chronic on-going pain, continuous back pain, incontinence and depression as a result of the symphysiotomy. The Supreme Court awarded compensation in the sum of €325,000.
Why did the procedures take place?
It has been suggested that the laws of the Catholic Church influenced the use of symphysiotomies in Ireland long after they were discontinued elsewhere. Symphysiotomy appears to have been heavily influenced by Catholic teaching forbidding contraception. It has also been claimed that many of the operations in Ireland after 1940 were carried out – without prior knowledge or consent – “mainly for religious reasons, by obstetricians who were opposed to family planning”.
The Organisation for Survivors of Symphysiotomy has claimed that obstetricians chose to perform a symphysiotomy instead of the far safer caesarean operation because the doctors viewed caesareans as a method of birth control because women can have no more than around four caesareans. For a doctor to carry out a Caesarean section on a woman was to limit the size of her family. Once a Caesarean, always a Caesarean: this was the medical view which meant that Caesareans were associated with family planning.
Were there long-term effects on the health of the women who had the symphysiotomy?
Women who have had a symphysiotomy suffered permanent damage as a result. Many women have suffered a life of pain and discomfort because of incontinence, chronic pain, prolapsed organs, neurological and psychological problems.
Family Law Courts Structure Reform
Last week John Lynch spoke to us about proposals for the reform of our Family Law Courts structure, tell us about this?
A major shakeup of the legal system has been drawn up by Justice Minister Alan Shatter and agreed by the Cabinet. As part of this system a new Family Court structure is proposed. The initiatives accepted by the Government will require the holding of a Constitutional Referendum and this have the potential to achieve significant changes to the courts structures which have remained largely unchanged since 1924.
What Family Law Courts System is currently in place?
The current family courts system is “fragmented” and “overlapping”. There are three courts — district, circuit, and high court — each dealing with separate family issues, ranging from maintenance applications and custody issues to child abductions.
One of the legal hallmarks of Irish Family Law is that there is a great deal of judicial discretion. In addition, Family Law cases present particular and special challenges which mean that a Family Law case could, potentially, require a Court to make a wide range of decisions on children, maintenance, family assets and finance, occupation of the family home, etc. Family Law cases may be psychologically complex, requiring family assessment by social workers, psychiatrists or psychologists, particularly where there are children involved. Cases can also be financially complex, especially in what have come to be known as “ample resources” or “big money” divorce cases where the assets (financial and property) may involve millions of euro and where pension splitting may also be in question.
Under the current system, family law cases generally first come before the District Court. Family cases are usually left until the end of the court list, to give those concerned as much privacy as possible. But as a result, families can be left waiting in the courthouse as prisoners and other criminals are ushered in and out.
None of the Courts have family law divisions and therefore people can be at the mercy of all the work that the Court has to do.
Matters are not improved by the poor listing system when people have to wait all day and then come back another day which may be month away.
The frequency with which family law cases are dealt with add to the stress – sometimes in the Circuit Court month can go by before family law cases are dealt with.
The other issue is the availability of suitable judges and different judges covering for the assigned judge – this all adds to the unpredictability of the system and outcome.
Some of the locations in District Courts with other business and lack of facilities heaps further stress on the people involved.
What new proposals have been put forward by the Minister for Justice, Alan Shatter?
The Justice Ministers proposals include to humanising the courts system and ensuring that the judges dealing with family law cases have the skills and training to do so.
He also hopes that the new system “should be more user friendly and should make things less costly”.
It is hoped that the new regime will prove less intimidating and a more welcoming environment for families in personal difficulties.
Are there any changes in the makeup of Judges in the proposals?
Under a reformed structure, the Justice Minister envisages entirely separate family courts, where just the parties involved, the judge and the court clerk are present. Judges with a specialisation in family law cases could preside over all proceedings, ensuring a level of compassion and understanding. Many judges dealt very well with family cases, but not all judges were trained in the area.
It’s important the judiciary have special skills, so when individuals go to family court, they know there’s going to be a degree of consistency of approach.
Are there any suggestions on the Back up services to the Family Courts?
It is hoped that the new system would also have the necessary back-up, including welfare services that would conduct assessments and mediation services that would provide alternatives to courts.
Is this a new concept being proposed by the Minister?
The restricting of the Family Law Courts is not a new concept. Specifically designated Family Courts and trained judges as was originally proposed in the 1996 Law Reform Commission Report on Family Courts. This report originally pointed out that: “Judges who deal with Family Law matters in Ireland are not by law required to have any special qualifications, training or experience in, or aptitude for, Family Law matters.” Since this report in 1996 there has been considerable and substantial growth of Family Law and, there have also been large increases in the number of Family Law cases coming before the courts. This reform will therefore be very important and will hopefully modernise our court system to reflect the realities of society.
Will our new system be similar to any other country?
The specifics of exactly what the Justice Minister is proposing are largely unknown. We do know that in March 2012 the Justice Minister visited the New South Wales Family Court in Australia where he discussed the workings of the Australian family court structure and its relevance to his commitment to establish an integrated Family Court in our jurisdiction. Following on from this visit he may decide to establish a dedicated Family Court structure similar to that which operates in Australia, where it is a separate entity with its own judges who are specially appointed for this work, as well as having distinctive procedures, personnel and appropriate support services to deal with Family Law matters. There is a comprehensive case management system and extensive support services such as counselling and mediation funded by the State.
Minister Shatter also attended a Family Law Conference in 2011 which included judges from the US and Canada where issues around improving the Irish system were discussed by Irish judges in collaboration with international judges who shared their experience. This experience was grounded in dedicated and specialised Courts, judges with support from experts and case management.
What will be the first step in reforming our system?
Perhaps as a first step towards a less radical restructuring of the court system in relation to Family Law matters, Minister Shatter may however decide that it could be possible to make improvements in our existing system by creating a distinctive Family Law Division which would include District, Circuit and High Courts and would have significant improvements in resources in staff and ancillary services.