The State Claims Agency has published a report revealing the most common clinical incidents in Ireland and the cost of settling clinical negligence claims.
The report – National Clinical Incidents, Claims and Costs – covers the period between 2010 and 2014. Its purpose, according to lead author Dr Dubhfeasa Slattery, is to help improve patient safety by analysing national data on clinical incidents in Ireland, and studying the results in order to develop a “learning health system” that provides safer care.
More than 206,000 clinical incidents in Ireland were reported to the State Claims Agency over the five year period – not all of which were attributable to medical negligence, and therefore not all resulting in clinical negligence claims. The incidents were divided into five main categories – Medicine, Surgery, Maternity Services, Disability Services and Care of the Elderly.
In the Medicine category – the category in which most clinical incidents were reported – the most common adverse outcomes were attributable to a delay or failure to diagnose and treat (most often in the emergency room), the incorrect medicine or dosage of medicine being prescribed or administered, and serious soft tissue damage – typically caused by bed sores due to a lack of nursing care.
Among the most common surgical clinical incidents in Ireland, the delay or failure to treat was again the leading cause of adverse outcomes. However the high percentage of adverse outcomes attributable to faulty equipment and missing or misplaced clinical records was also a cause for concern – both in the Surgery category and the Maternity Services category.
The leading clinical incidents in Ireland in the Maternity Services category were post-partum haemorrhages and perineal tears, while medication issues and serious soft tissue damage dominated the clinical incidents in the Disability Services and Care of the Elderly categories. A further 66,000 medical incidents were reported to the State Claims Agency during the period being investigated that were not regarded to be of a clinical nature.
In relation to the number of clinical negligence claims made during the period and the cost of settling them, the figures quoted in the report (2,873 claims and €288 million in settlement costs) are misleading as they included claims made during the period not settled during the period, and pre-2010 claims settled between 2010 and 2014. They were also inflated during 2012 by DePuy hip replacement claims, the Lourdes Redress scheme, and by the volume of claims made for unnecessary symphysiotomy procedures.
The twice-postponed DePuy ASR hip replacement court case has been put back in date again – this time after a change of plaintiff and a ruling about referring to the DePuy recall as evidence.
The first Federal DePuy ASR hip replacement case was delayed again last week after the parties in McCracken -v- DePuy (Case No 1:11 dp 20485) were allowed additional time by U.S. District Judge David A. Katz for discovery to take place and to deal with other legal matters.
The first `Bellwether` DePuy ASR hip replacement case has now been rescheduled for September 24th, and will revolve around the hip dislocation sustained by Ann McCracken (57) from Rochester in New York, which is alleged to have been due to metal particles displaced by her DePuy ASR XL Acetabular Hip Replacement System causing the soft tissues around her hip to decay.
Ann had a DePuy ASR XL Acetabular Hip Replacement System implanted in August 2009, but had to undergo revision surgery in January 2011 after she had suffered her dislocated hip. In October 2011, Ann had to undergo further surgery to insert a device restricting the movement of her hip, which has reduced her mobility and will result in her present hip replacement system wearing out quicker – resulting in another hip replacement operation in the future.
The latest delay is due to Judge Katz agreeing that the worldwide recall of the DePuy hip replacement systems should not be referred to in court – not only because the DePuy ASR hip replacement case to be heard on its individual merits, but DePuy´s lawyers successfully argued that any reference to the DePuy recall at trial might prevent other companies from voluntarily withdrawing potentially dangerous medical devices because of the legal consequences.
One of the purposes of this first ‘Bellwether’ DePuy ASR hip replacement case is to evaluate the relative strengths and weaknesses of the plaintiffs´ claims and DePuy Orthopaedic´s defence. If Ann´s case – and others still to be scheduled among the `Bellwether’ trials – results in a yardstick for compensation settlements, DePuy Orthopaedics are likely to negotiate settlement offers with the 7,800 plaintiffs also attached to this DePuy ASR hip replacement case through the consolidated multidistrict litigation (MDL).
If no compensation yardstick is established by the juries in each of the trials – or if there are both positive and negative verdicts returned – all of the remaining DePuy ASR hip replacement cases will be referred back to the US District Courts in which they were originally filed – each to be heard individually and prolonging the how long it will take for each plaintiff to receive a fair settlement of DePuy hip replacement injury compensation.
This second scenario would also have an impact on plaintiffs in Ireland who have made a claim for DePuy hip replacement injury compensation, as each DePuy ASR hip replacement case in Ireland would then have to go through the court process.
A Californian judge has upheld the DePuy hip replacement settlement of $8.3 million awarded by a Los Angeles jury to Loren Kransky and denied the company their request for a new trial.
Loren Kransky (65) from South Dakota was awarded the DePuy hip replacement settlement after a hearing at the Los Angeles Superior Court in March this year, in which the jury had found DePuy Orthopaedics negligent for supplying the plaintiff with a faulty ASR XL Acetabular hip replacement system and awarded the former prison office $8.3 million compensation for a faulty hip implant.
DePuy Orthopaedics´ parent company – Johnson & Johnson – appealed the decision and requested that a new trial be held on the grounds that “the court did not let the company tell the jury about the Food & Drug Administration’s review and clearance of the device”. However, Judge J. Stephen Czuleger upheld the jury´s verdict and said that the plaintiff had provided enough evidence during the original trial to establish that the products were defective in design.
The judge´s decision to deny DePuy Orthopaedics a re-trial has prompted Johnson and Johnson to delay the Multi District Litigation (MDL) being heard in Ohio, by filing a motion requesting that any DePuy hip replacement settlements awarded in the case are based on typical injury compensation awards in the company´s home state of Indiana – where compensation settlements are much lower than the national average.
Johnson and Johnson are also preparing to defend a second MDL in Texas; where more than 4,000 claims brought by plaintiffs complaining of defects in DePuy´s Pinnacle hip replacement system have been brought together in one action. The first of the DePuy Pinnacle hip replacement compensation claims is scheduled to be heard in September 2014.The company recently announced that it would discontinue manufacturing and selling the allegedly faulty Pinnacle hip replacement system from August this year.
DePuy Orthopaedics has announced that it will cease to produce and sell metal-on-metal Pinnacle hip replacements systems from August 2013
The company´s decision to stop producing and selling Pinnacle hip replacement systems is believed to coincide with the United States´ Food and Drug Administration (FDA) closing the ‘510(k) process’ loophole which allowed the faulty DePuy ASR hip implants onto the market in the USA without clinical testing first being conducted (the company claim that demand for the implants from orthopaedic surgeons has declined).
Although the Pinnacle hip replacement systems passed the FDA´s clinical testing standards in 2000 when they were first launched in the USA, the ASR hip implants which were recalled in August 2010 were given FDA clearance on the grounds that they were “similar to an existing product” – in this case the DePuy Pinnacle metal-on-metal hip replacements.
After the worldwide recall of the ASR hip implants, the Food and Drug Administration asked DePuy Orthopaedics to conduct further clinical tests on the Pinnacle hip replacement systems to ensure that the same problems did not exist as with the recalled ASR hip implants. DePuy declined and, in January 2013, new legislation was passed in the States to force all manufacturers of metal-on-metal hip implants to prove through retrospective clinical studies that their products were safe.
The announcement to halt the production and sale of DePuy Pinnacle hip replacement systems also coincides with the scheduled start of the Multi District Litigation being heard at the US Northern District Court in Ohio (DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation – MDL 2197) in which more than 7,500 plaintiffs are attempting to recover compensation for injuries caused by the DePuy ASR Articular Surface Hip Replacement System and the DePuy ASR XL Acetabular Hip Replacement System.
A jury has now been sworn in for the court case, but a delay to proceedings has been caused by solicitors representing DePuy Orthopaedics putting forward a motion that any award of compensation for injuries due a faulty hip replacement system should be based on compensation levels in the company´s home state of Indiana – where personal injury compensation settlements are significantly lower than Ohio.
Since the class action against DePuy for the ASR hip implant recall began, a second MDL class action has been started in the States against DePuy Orthopaedics in which more than 3,300 plaintiffs allege that they have suffered an injury due to the DePuy Pinnacle hip replacement systems. In the UK meantime, an investigation by the British Medical Journal revealed that recipients of the DePuy Pinnacle hip implants were at serious risk of system toxicity, while at home there have been calls for the Health Service Executive to initiate a DePuy Pinnacle hip replacement recall in Ireland.
The first DePuy ASR hip replacement claim to be heard in court has resulted in an award of $8.3 million being made to a former prison officer.
The claim made by Loren Kransky (65) from South Dakota was brought forward ahead of the Multi District Litigation (MDL) due to be heard in Ohio in May, as the claimant is terminally ill from diabetes, heart disease and kidney cancer.
Solicitors at the Los Angeles Superior Court claimed that Kransky had to undergo a second hip replacement operation – causing him pain and suffering – due to high levels of chromium and cobalt in his bloodstream caused by metal-on-metal friction within his ASR XL Acetabular hip replacement system.
They claimed that Johnson and Johnson – the parent company of DePuy Orthopaedics – marketed the faulty hip replacement products knowing that the ASR systems were defective, effectively accusing them of fraud in addition to negligence which would have entitled Kransky to qualify for significant punitive damages.
Johnson and Johnson disputed that they knew the ASR hip replacements were faulty in 2007 – the year in which Kransky underwent his original hip replacement surgery – and contested Kransky´s claim for DePuy ASR hip replacement compensation on the grounds that Kransky´s pain and suffering was due to his pre-existing medical conditions.
The jury at the Los Angeles Superior Court found that Johnson and Johnson had not acted “with malice” by marketing their product in 2007, but agreed that the product was defective and awarded Kransky $8 million in settlement of his DePuy ASR hip replacement claim, with a further $338,000 to account for the medical expenses he has incurred to date.
Johnson and Johnson announced immediately after that the company intends to appeal the decision, as the precedent of $8 million in compensation for pain and suffering could be greatly inflated when claims for claimants who do not have a terminal illness are heard in the MDL action in Ohio.
The first Multi District Litigation (MDL) DePuy faulty hip replacement cases – which will establish a benchmark of how much compensation for a faulty DePuy hip replacement many thousands of plaintiffs should be entitled to receive – have been set to be heard in May and July.
The announcement that the first “Bellwether” trial of Faye Dorney-Madgitz v DePuy Orthopaedics (MDL2197) will be heard in May at the Ohio Northern District Court in Cleveland was made by Judge David A. Katz; who also revealed that a secondary case – Ann McCracken v DePuy Orthopaedics – will be scheduled for July 2013 in the event that the Dorney-Madgitz v DePuy faulty hip replacement case is settled before it goes to trial.
The setting of the two trial dates is expected to increase DePuy Orthopaedics´ attempts to negotiate a settlement with plaintiffs in the Multi District Litigation (MDL), after the company successfully settled three DePuy revision surgery claims in Nevada for approximately $200,000 each. If the “Bellwether” Dorney-Madgitz v DePuy faulty hip replacement case proceeds to court, future settlements of DePuy faulty hip replacement compensation could be influenced by the verdict of the jury.
Whereas a low trial settlement of the DePuy faulty hip replacement case would be advantageous to DePuy Orthopaedics and their parent company Johnson & Johnson, should the jury in Cleveland award substantial damages in the case against Faye Dorney-Madgitz, this would set a benchmark for all future claims against DePuy for faulty hip replacements and painful revision surgery.
It may not be too late to initiate DePuy faulty hip replacement claims for compensation in Ireland if you have undergone revision surgery within the past two years or suffered any form of injury due to the recalled DePuy ASR hip replacement systems. Call our 24-hour helpline for more information.
The State Claims Agency has forecast that compensation claims against the State for hospital negligence could increase by more than a quarter in 2012.
Writing in the Clinical Indemnity Scheme newsletter, Ciaran Breen – Director of the State Claims Agency – commented that “It appears that people, injured as a result of a medical negligence event, are more likely to sue doctors, dentists and hospitals in these more difficult economic times” after attributing the increase on the economic downturn.
Mr Breen´s comments were in complete contrast to those made by Patricia Byron – Chief Executive of injuriesboard.ie -after the Injuries Board Interim Report was released last month, which saw only a 4.1 percent increase in claims over the first six months and not the “recessionary spike” that had been predicted. However, both public officials mentioned that there had been a significant increase in claims related to the DePuy hip replacement recall.
As 345 compensation claims were made against the State in the first six months of 2012 (as opposed to 542 in the whole of 2011), and the Statute of Limitations expired in August 2012 for many victims of the DePuy hip replacement recall, Mr Breen´s outlook may appear unjustifiably depressing. However, some compensation claims against the State are finding their way to court long after they might previously have been time-barred.
In July this year, the Supreme Court upheld a High Court judgement in favour of Olivia Kearney who, forty-three years beforehand, had undergone a symphysiotomy procedure which the High Court determined was “entirely unjustified and unwarranted”. Should the remaining two hundred survivors of the symphysiotomy procedure be allowed to make compensation claims against the State, Mr Breen´s forecast could be very conservative indeed.
Compensation claims against the State for hospital negligence represent a small number of claims managed by the State Claims Agency – the majority are for public liability and employer liability – but account for almost 90 percent of the value of claims each year. In 2011, the value of the 542 compensation claims against the State for medical negligence amounted to 860 million Euros.
Three DePuy revision surgery claims – intended to be the first cases to be heard by a jury relating to the recalled ASR hip replacements – have been settled out of court in Nevada.
The three plaintiffs – Annelise Rundle (74), Martha Bender (69) and Katherine Guy (60) from Las Vegas in Nevada – all required revision surgery after being recipients of failed DePuy ASR hip replacement systems in the past six years. It is reported that each has receive a settlement of approximately $200,000 – although this has not been confirmed by either the plaintiffs or by DePuy Orthopaedics Inc.
In their combined claim for DePuy revision surgery compensation, evidence had been made available to DePuy Orthopaedics Inc which revealed permanent bone damage caused by the devices and – in the case of Annelise Rundle – other health issues had developed which were attributable to the metal filings which had been displaced from the faulty hip replacement.
The settlement of the DePuy revision surgery claims came as no surprise as DePuy have a substantial number of claims scheduled against them and will wish to save the court costs of defending the claims made against the company or arguing for a limited assessment of damages. However, how much compensation for DePuy revision surgery was agreed upon has surprised some industry observers.
Professor Eric Gordon, a pharmaceutical industry expert from the University of Michigan, said “J&J [Johnson & Johnson – DePuy Orthopaedics´ parent company] should have expected to pay in the $200,000-to-$500,000 range per case” and he believes that the company will have been satisfied with the outcome of the DePuy revision surgery claims settlement, considering that there are more than 2,000 claims outstanding in the States of California, Maryland and Nevada, and 6,000 more consolidated into a Multi District Litigation (MDL) scheduled to commence in the spring of 2013.
Johnson and Johnson would not comment on whether they were intending to settle future DePuy revision surgery claims prior to other scheduled court hearings.
It may not be too late to initiate claims for DePuy revision surgery compensation in Ireland if you have undergone revision surgery within the past two years or suffered any form of injury due to the recalled DePuy ASR hip replacement systems. Call our 24-hour helpline for more information.
People suffering from the consequences of the recalled DePuy hip replacement system in Ireland had their plight highlighted on last night´s RTE current affairs and news report program, Prime Time.
The 20 minute feature about the DePuy hip recall on RTE Prime Time focused on the reasons behind the systems´ recall, how the failure of the DePuy hip replacements systems has affected innocent peoples´ lives and why so many questions about the DePuy hip replacement system recall in Ireland have remained unanswered.
The Background to the Story
DePuy Orthopaedics Inc – an American subsidiary of Johnson and Johnson – recalled their ASR XL Acetabular Hip Replacement System and the ASR Articular Surface Hip Replacement System in August 2010 following worldwide reports of a “higher than expected” failure rate. Expected to last for more than fifteen years, the DePuy hip replacement systems were failing after much shorter periods; resulting in patients experiencing hip fractures, the misalignment of joints, inflammation and the risk of infection from high levels of chromium and cobalt released into the bloodstream.
The DePuy Recall in Ireland
Affecting more than 3,000 Irish patients since 2003, DePuy Orthopaedics came to an arrangement with the Health Service Executive to cover the costs of monitoring patients who had a DePuy hip replacement system implanted in Ireland and revision surgery where necessary. Doctors and hospitals who had performed orthopaedic surgery in the previous seven years, started a program of x-rays and blood tests to identify which patients had a faulty implant and made arrangements for the revision surgery to take place. While DePuy offered to cover an individual´s expenses relating to travel, accommodation prior to an operation, child care costs if necessary and time off work for check-ups and surgery where required, no mention was made of compensation for the pain and suffering experienced by those found to be suffering from DePuy´s faulty products.
The DePuy Victims´ Tales
The report on the DePuy hip recall on RTE Prime Time focused on a number of cases – perhaps none more poignant than that of Antoinette Power from County Cork, who is now on her third hip replacement after the first DePuy ASR Articular Surface Hip Replacement System implanted in 2006 caused such damage to her pelvic region that the second (non-DePuy) hip replacement also failed.
John Hand from County Kildare described how his DePuy hip replacement had become misaligned and, while he is waiting for revision surgery, there is a click from his hip with every step he takes. He is concerned that with every click a little piece of the faulty DePuy hip replacement system is breaking away and entering his bloodstream – potentially affecting his liver, kidneys, brain and heart.
The story of Walter Hartrey from County Waterford highlighted the disruption to people´s lives by the DePuy hip replacement recall in Ireland. Mr Hartrey has two DePuy hip replacements and needs to have both replaced. He will be unable to work for up to a year while recovering from his surgery and speaking from experience he said “It takes a good while to get back onto your feet”.
Tommy Cussen from County Meath and Stewart Gray from County Waterford were two patients who had been given the all clear from the x-rays taken by their doctors, only to find out that extremely high levels of chromium and cobalt were present in their blood tests. “I have a poisonous level of cobalt in my body” said Mr Gray, “and what these toxins are doing to my liver and other organs in my body? I just do not know”.
The Lack of Straightforward Answers to Questions about the DePuy Hip Recall
Mr Gray´s question was just one of many which victims of DePuy´s failed hip replacement systems cannot get straight answers to. In the RTE Prime Time studio, Cathriona Molloy – representing the organisation Patient Focus – commented that the biggest fear facing the thousands of DePuy patients still being monitored was that they knew that their DePuy hip replacements were going to fail, but did not know how long they would have to wait for revision surgery. Ms Molloy stated that there was a lack of information and that people felt that they were getting “fobbed off”.
Studio presenter, Miriam O´Callaghan, also failed to get straightforward answers from HSE representative Bill Curtain, who claimed it was impractical to make direct comparisons to the UK – where the DePuy hip replacement system failure rate is approaching thirty per cent – in relation to how Ireland is tackling the problem concerning the lack of information being provided to the victims of DePuy´s hip replacement recall. His comments on the failure rate in Ireland were contradicted during the documentary by Chief Executive of the Irish Medicines Board, Pat O´Mahony who acknowledged that there was a grave problem.
Mr Curtain – who is himself an orthopaedic surgeon – also circumnavigated the issue of whether high levels of cobalt and chromium in the blood could cause any permanent damage to other organs and failed to provide a satisfactory answer when asked why Irish surgeons continued to use the DePuy hip replacement systems for patients in Ireland, once research in Australia had shown that there was a higher than expected failure rate in 2009 and a “Field Safety Notice” had been issued by DePuy Orthopaedics in March 2010.
DePuy Hip Replacement Compensation
The report on the DePuy hip recall on RTE Prime Time also brought to viewers´ attention the lawsuits currently going through the courts in America where victims of the faulty DePuy hip replacement systems were suing the company for personal injury due to product liability (you can read the latest news on the DePuy litigation cases >> here <<).
Several Irish DePuy recall solicitors were interviewed for the program, and they seemed to be able to provide better answers about the issues that people faced than the surgeons themselves. One such Irish DePuy recall solicitor claimed that many victims of the DePuy hip replacement systems in Ireland were engaging solicitors at this time to establish that they were entitled to claim DePuy hip replacement compensation.
If you, or somebody close to you, has had any metal-on-metal hip replacement implant within the past eight years, it is in your best interests to discuss your entitlement to DePuy hip replacement compensation with a personal injury solicitor at the earliest possible opportunity.
In August 2010, DePuy Orthopaedics – a division of the major pharmaceutical company Johnson & Johnson – issued a worldwide recall of the DePuy ASR Articular Surface Hip Replacement System and the DePuy ASR XL Acetabular Hip Replacement System following reports of a “higher than expected” failure rate. It is estimated that as many as 93,000 people have had one of these two systems implanted into them since they were introduced onto the market in 2003 – 3,516 of them in Ireland.
DePuy´s Offer to Reimburse Costs
Inasmuch as the prospect of revision surgery is not a pleasant one for any of the 3,516 potential hip replacement patients in Ireland, DePuy Orthopaedics has offered to pay for the cost of monitoring patients´ health, blood tests, X-rays and surgery as required. However, revision surgery is far more painful than the original hip replacement operation and a longer rehabilitation period is required. The impact on people´s lives is substantial, and this is why many thousands of people worldwide are seeking legal advice on the possibility of making a DePuy Hip Replacement Recall Compensation Claim.
Latest News on the Hip Replacement Recall
Potential victims have also been concerned with the lack of developments in the class actions already launched against the company. While DePuy hip replacement systems continue to claim more victims, the latest news on the hip replacement recall has be slow coming, but now there is some movement in the States which will be of interest to anybody considering a DePuy Hip Replacement Recall Compensation Claim.
The Litigation Case in America
In December 2010, the US Judicial Panel on Multidistrict Litigation consolidated all compensation claims against DePuy Orthopaedics into one Multidistrict Litigation (MDL) case. This was in order to reduce the need for pre-trial discovery on identical issues up and down the country and to prevent inconsistent pre-trial rulings in individual cases by different judges. This case was assigned to US District Judge David A. Katz to be heard in the Us District Court for the Northern District of Ohio in Toledo.
Latest News on the Hip Replacement Recall in America
In September, Judge Katz issued Case Management Orders which required each claimant´s solicitor to submit a Fact Sheet and Medical Records Authorisation Form on behalf of their clients who have already undergone revision surgery. This basic information will provide DePuy Orthopaedics with details of each claimant and their injuries, and DePuy Orthopaedics will have 120 days to present the judge with detailed information about each faulty hip replacement system and any communication which took place between themselves, the claimant and DePuy´s public liability insurers -Broadspire.
Judge Katz has also scheduled a status conference with the six-member executive prosecuting committee (which comprises of the lead solicitor from each of the six legal firms to have filed class action lawsuits to date) on November 22nd to report on the progress of the Case Management Orders.
Individual Assessments Still Required
Despite the submission of Fact Sheets and Medical Records Authorisation Forms, each individual claimant will still have to establish their own claims against DePuy, as damages will be awarded based on the DePuy hip replacement problems that the specific claimant experienced. These will include suffering due to the initial faults in the DePuy ASR hip replacements systems, the prolonged pain and inconvenience of revision surgery and the consequences thereafter when considerable time is required away from work and when a victim´s quality of life suffers as a result.
DePuy Hip Replacement Compensation Settlements
The case against DePuy Orthopaedics is yet to be proven in court, but precedents exist which experts believe will result in Johnson and Johnson paying billions of dollars in damages. Swiss hip and knee replacement company Sulzer AG were fined one billion dollars in 2001 for supplying a defective product which required revision surgery. The claims against DePuy Orthopaedics not only include the elements of revision surgery mentioned above, but also damages for toxic metal exposure, necrosis of the soft tissues surrounding the hip due to metal shavings from the hip replacement system and an increase risk (as yet unproven) of tumours and cancer.
In Other News about the Hip Replacement Recall
In other news about the hip replacement recall, the once “face of DePuy” – Penny Brown – has joined a UK class action against DePuy Orthopaedics after learning that her DePuy ASR hip replacement system had failed. Penny, who used to promote the DePuy ASR hip replacement systems following her own implant in 2004, underwent painful revision surgery last month which has left her bed-ridden since. She feels that legal action is necessary as “I not only feel let down personally but also feel guilty that I might have encouraged others to have the ASR implanted.”
In Australia, the Blacktown Sun has reported that a resident of Glendinning, New South Wales, has been diagnosed with exceptionally high levels of cobalt toxicity in her blood due to a failing DePuy ASR hip replacement system. Although the victim is not keen to join the 350-strong class action already filed in Sydney, if the cobalt poisoning develops into metallosis she could require life-long care – something not provided for in the existing DePuy offer.
In the USA, four senators in the Energy and Commerce Department have called for an investigation into other metal-on-metal hip replacement devices – specifically the DePuy Pinnacle hip replacement system, which bypassed the Food and Drug Administration testing process in 2008 by showing that it was all but identical in design to the subsequently recalled DePuy ASR Articular Surface Hip Replacement System and the DePuy ASR XL Acetabular Hip Replacement System.
Keep up to date with theLatest News on Hip Replacement Recall
If you, or anybody close to you, have had a metal-on-metal hip replacement system implanted since 2003, it is in your best interests to speak with a solicitor at your earliest possible opportunity.
Almost a year ago (August 2010), DePuy Orthopaedics Inc. announced that it was recalling their ASR hip replacement systems due to a “higher than expected” failure rate. However, no DePuy Pinnacle recall was announced – this system being an almost identical metal-on-metal hip replacement system – despite similar injuries being sustained by patients who have received the alternative hip replacement system.
Only Minute Differences Between the Two Systems
The only possible reason for the lack of a DePuy Pinnacle recall is that minute differences exist between the recalled ASR hip replacement systems and the DePuy Pinnacle hip replacement system. However, arguments that the DePuy Pinnacle system has a modular design and a separate outer shell (whereas the ASR was of a monoblock design – i.e. a solid piece of metal) are outweighed by the fact that the DePuy Pinnacle device has one of the lowest articulation clearance levels in the industry. In fact, the only one lower is the DePuy ASR system!
Is This Enough For a DePuy Pinnacle Hip Replacement Recall?
Although the DePuy Pinnacle Hip Replacement system was only introduced in March 2008 (the ASR devices were introduced from 2003) doctors in the USA are already reporting the failure of the devices and the need for revision surgery. If this was not alarming enough, it was also revealed that the DePuy Pinnacle Hip Replacement system bypassed the USA´s Food and Drug Administration testing procedure by showing that the device was similar to those already in existence on the market. Known as the 501(k) process, DePuy got their Pinnacle Hip Replacement system on the market by showing it was similar to the ASR Hip Replacement systems!
No News is Bad News!
Quite possible a DePuy Pinnacle recall will only be made once the company has received a substantial number of failure reports, but in the same way as DePuy Orthopaedics failed to advise surgeons and medical practitioners about the failure rate of the ASR systems, there is a deafening silence in response to allegations that the DePuy Pinnacle system is also faulty. One would expect that the duplication of the injuries experienced by patients who received the DePuy ASR Hip Replacement systems should be enough to instigate a DePuy Pinnacle recall but, as yet, there is no sign of this happening.
Could the HSE Initiate a DePuy Pinnacle Recall?
The Health Services Executive (HSE) has already come under a lot of criticism for continuing to implant ASR Hip Replacement systems when indications from across the globe suggested that the devices were faulty. They also played down the consequences for patients who needed revision surgery – both in number and effect – and supported the DePuy Patient Consent Form process which potentially removed the right of victims to claim compensation.
Even if the company fail to initiate a DePuy Pinnacle Hip Replacement recall, surely the HSE should look at the reports coming in from surgeons all over the country showing that history is repeating itself so soon, and take positive action. The symptoms that caused the recall of the ASR devices are appearing once again in the DePuy Pinnacle devices, and it is time for a DePuy Pinnacle Hip Replacement Recall in Ireland.
DePuy Hip Replacement Recall – Further Information
If you have been implanted with either the DePuy ASR or DePuy Pinnacle Hip Replacement systems, and are concerned that they may be faulty, please read our comprehensive article by clicking here. Thereafter, should you have any medical concerns about your condition, please make an urgent appointment to see your family GP. If you have any legal questions about your entitlement to claim compensation you are invited to call us on 1-800 848 881.
The Health Service Executive (HSE) and the Independent Hospital Association of Ireland have revised their DePuy Patient Consent Forms following complaints from patients and their legal advisers. The demand from DePuy´s parent company – Johnson and Johnson – that they receive patient´s medical notes with the return of a faulty DePuy ASR Hip Replacement System has been dropped, however it is still advised that patients should not sign the DePuy Patient Consent Forms without professional legal advice.
On August 26, 2010, DePuy Orthopedics, Inc., a subsidiary of Johnson and Johnson, issued a worldwide recall for two of its metal-on-metal hip implant devices – the DePuy ASR XL Acetabular System and the DePuy ASR Hip Resurfacing System. These hip replacement systems were withdrawn due to a “higher than expected” failure rate, which meant that people who had them implanted were much more likely to experience pain or swelling in the hip, hip fractures, hip dislocations and metal poisoning from the microscopic metal debris created by the friction between the device´s joints.
Johnson and Johnson originally consented to cover the costs of monitoring patients´ health, and revision surgery where required, on the proviso that those patients signed DePuy Patient Consent Forms which permitted the return of the ASR hip replacement device to Johnson and Johnson – together with tissue and fluid samples plus a copy of the patient´s medical records. Although the company have now dropped the condition that medical records are disclosed, it is still recommended that patients DO NOT SIGN THE DePUY PATIENT CONSENT FORMS without first taking legal advice.
The signing of the DePuy Patient Consent Form potentially damages any future claim a patient may have for personal injury compensation as it still requires that the excised implant is returned to Johnson and Johnson, thus removing the opportunity for the implant to be examined by an independent expert. Furthermore, the latest DePuy Patient Consent Forms being circulated by the HSE and the Independent Hospital Association of Ireland have been drafted in such a way to protect the two parties involved against personal injury claims, with no consideration for the patient.
Both these organisations are still potentially negligent in sanctioning the use of DePuy ASR Hip Replacement Systems long after studies had shown that there was a problem with them. Fine Gael spokeswoman on older citizens, Catherine Byrne, asked the HSE at the time of the recall to clarify why the joint replacement part was not recalled sooner in light of reports coming out of America and Australia indicating that there was a problem with the devices – she is yet to receive an answer.
The HSE has also failed to introduce a comprehensive screening program for neurological injury due to metallosis and cobaltism and claim on their website that only 10-15 per cent of people implanted with the faulty DePuy ASR Hip Replacement Systems may need revision surgery, whereas research published by the British Orthopaedic Association indicates that as many as 49% of the DePuy ASR Hip Replacement Systems implanted in Ireland since 2003 could fail within the next six years.
The British Orthopaedic Association research also confirmed that revision surgery for the faulty DePuy Hip Replacement Systems can be more complicated than the initial implant surgery – with a higher risk of infection, longer rehabilitation period and the potential requirement for hip reconstruction surgery to repair the damage caused by the DePuy systems. Under the Liability for Defective Products Act 1991, victims of this defective product could potentially sue Johnson and Johnson for health issues they may experience for the rest of their lives. The DePuy Patients Consent Form harms a patient´s right to claim damages against the company, and this is why it is recommended that patients DO NOT SIGN THE DePUY PATIENT CONSENT FORMS without first taking legal advice.
Research published by the British Orthopaedic Association indicates that as many as 49% of the DePuy ASR Hip Replacement Systems implanted in Ireland since 2003 could fail within the next six years.
Orthopaedic surgeons at the British Hip Society Annual Conference in Torquay this month considered the topic of large diameter metal-on-metal –bearing total hip replacement systems, with particular attention to the DePuy ASR hip replacement recall.
In Ireland, 3516 people received the faulty hip replacement system and, in figures which contradict assurances given by the Health Service Executive, it was announced that new projected failure rates for the DePuy ASR hip replacement systems are 35% within four years and 49% within six years.
The surgeons also recommended that patients being monitored for potential hip replacement system failure should have MRI or CT scans to detect any collection of fluid around the hip area, or the presence of cobalt or chromium ions which can lead to neurosurgical problems.
The publication also confirmed that revision surgery for DePuy ASR hip replacement systems can be more complicated than the original implant when soft tissue damage has been sustained, and that specialist hip reconstruction surgery may be required in these instances.
These findings add further weight to lawsuits and class actions currently going through the courts in the United States, where over 500 people have already filed compensation claims against DePuy Orthopaedics Inc.
The Health Service Executive (HSE) has reported that the first revision surgeries for patients implanted with the recalled DePuy ASR Hip Replacement Systems have now commenced.
3,516 people in Ireland had received these faulty hip replacement systems between 2003 and their withdrawal from the market last year due to a “higher than expected” failure rate. Originally the HSE estimated that the failure rate in Ireland would be around 12% in total, however new research by the British Orthopaedic Association has suggested that the failure rate of DePuy ASR Hip Replacement Systems in Ireland could be as high as 49% within six years.
The HSE also claimed in their report that all affected patients had been contacted, and would have now had their initial recall appointment to x-ray the existing implant and have a blood sample taken to check for microscopic metallic wear debris. Some patients have also undergone MRI scans to check for neurological problems caused by cobaltism.
The vast majority of patients are not expected to need revision surgery straight away, but should continue to be monitored with annual reviews for the next five years. Clinical assessments and revision surgery are being provided free of charge, with hospitals recouping the cost of any treatment from DePuy Orthopaedics.
Questions are still being asked about why the HSE did not act sooner than August of last year to alert patients about the problems with the faulty DePuy hip replacement system, and legal test cases are still in progress in The States to determine whether DePuy should pay product liability compensation. The HSE also faces potential claims for medical negligence.
Despite assurances by the Health and Safety Executive (HSE) that the vast majority of people who had DePuy Orthopaedics hip replacements implanted will not need revision surgery, an expert professor from Newcastle has claimed that as many as 50% of Irish victims would need new hips within 6 years.
Dr. Thomas Joyce, a reader in biotribology at the School of Mechanical and Systems Engineering, Newcastle University, has stated during a conference in Dublin that, of the 3,516 DePuy hip replacement systems that have been implanted in Ireland since 2003, about 50% will need replacing within 6 years.
His claims are based on studies of over 500 DePuy hip replacement patients in the U.K. – more than half of whom have experienced a joint failure within this period due to the “metallic wear debris” that can cause tissue damage and weaken the bone surrounding the implant. DePuy Orthopaedics Inc has already acknowledged a “higher than expected” failure rate and recalled the faulty ASR Articular Surface and ASR XL Acetabular systems late last year.
However, the HSE states that it has already conducted blood tests and precautionary x-rays on 2,022 patients as a precautionary measure, and has found very few who currently require revision surgery. They intend to continue monitoring the patients over a five year period under an agreement with DePuy Orthopaedics Inc.
A new threat has been identified in the faulty DePuy hip replacement systems which were implanted in more than 3,500 patients in Ireland from 2003 until last year. According to an article published in the American “The Journal of Bone and Joint Surgery”, metal on metal devices such as the DePuy ASR hip replacement systems can lead to “Cobaltism” – a condition where minute particles of cobalt get into the bloodstream and travel to other organs of the body, specifically the brain and heart.
The author of the article, Dr. Stephen S. Tower, MD used his own experiences of metal on metal implants to provide the data for the claim and, although acknowledging that a much larger study than his would be required to define the exact prevalence of cobaltism among patients with faulty DePuy hip replacement systems, believes that the potential exists for neurological and cardiovascular issues.
This theory is not unique. Some American experts have also highlighted the negative impact of increased levels of metal ions in the blood on other organs, and have pointed to the well-known story of Erin Brokovich as an extreme example of side effects. In real life and in the film of the same name, Ms Brokovich fought for the residents of Hinkley, California, when they experienced higher levels of cancer due to their water supply being contaminated with very high levels of chromium.
The Health Service Executive (HSE) has announced that 3,516 patients in Ireland made need corrective surgery for faulty hip replacement device made by DePuy Orthopaedics, unit of Johnson & Johnson. There are nearly 100,000 people worldwide fitted with the device.
However, data from the UK reveals that about one in eight people using the device may have problems, which implies that perhaps about 400 patient may require corrective surgery in Ireland (replacement of the faulty device).
The specific products affected by the problem are ASR XL Acetabular System and the DePuy ASR Hip Resurfacing System, both of which are no longer manufactured.
DePuy Orthopaedics has already said it would cover the cost of corrective surgery in any patients affected in Ireland. However, DePuy Orthopaedics has attached conditions to the offer- providing full medical records and returning the removed faulty hip device (presumably for analysis).
There is still no indication of what type of compensation scheme DePuy Orthopaedics will be offering. Meanwhile, the HSE is also negotiating the issue of medical costs with DePuy Orthopaedics.
Any victim that needs to undergo corrective surgery would be very unwise to sign any sort of legally binding agreement with DuPuy Orthopaedics without first seeking independent legal advice. It would be unwise to sign an agreement that puts the key medical evidence under the control of DuPuy Orthopaedics prior to any potential compensation litigation.
It should be pointed out that the HSE is clearly not responsible for the faulty products, which it used in good faith. It is highly unlikely that any court would find any surgeons or HSE-owned hospital guilty of medical negligence.