UK Injury Compensation News

The first recalled ASR hip replacement claim to be heard in court in the USA has resulted in the jury awarding a former prison officer an $8.3 million DePuy hip compensation settlement.

Loren Kransky (65) from South Dakota made the recalled ASR hip replacement claim for compensation after his doctor attributed certain health problems he was suffering to metal ions which had entered Kransky´s bloodstream from a faulty ASR hip replacement implant fitted in 2007.

His claim for a DePuy hip compensation settlement was brought forward to be heard in the Los Angeles Superior Court, as Kransky is also suffering from diabetes, heart disease and kidney cancer, and under Californian law preferential treatment is given to claimants who are terminally ill.

Solicitors representing Kransky argued in court that elevated levels of cobalt and chromium released by friction within the faulty hip replacement had caused damage to bones and soft tissues and had resulted in their client requiring a further hip replacement.

DePuy argued that there was no medical consensus on what levels of metal being released into the system caused harm to patients and contested the claim on the grounds that Kransky´s pain and suffering was due to his pre-existing medical conditions.

Loren Kransky´s claim for a DePuy hip compensation settlement had asked for significant punitive damages – alleging that DePuy had failed to adequately warn of the risks associated with the ASR XL Acetabular hip replacement system.

However, the jury at the Los Angeles Superior Court found that the company did not act with malice – prohibiting Kransky from being awarded punitive damages – but agreed with his solicitors that the hip replacement system was faulty and that the “black pieces of metal [that] flaked off the implant and caused a type of poisoning that could have killed him”.

The jury awarded Loren Kransky $8 million for his pain and suffering plus a further $338,000 to cover his medical costs. DePuy intend to appeal the decision, as the precedent of $8 million in compensation for pain and suffering could be greatly inflated for claimants who do not have a terminal illness.

A further claim for a DePuy hip compensation settlement is to be heard this week in Illinois State Court, while the first two multi district litigation (MDL) cases are scheduled for May and July in Ohio.

The first Multi District Litigation DePuy hip implant case – which will establish a benchmark of how much compensation for a faulty DePuy hip implant many thousands of claimants should be entitled to receive – is set to be heard in May.

Judge David A. Katz announced that the “Bellwether” trial of Faye Dorney-Madgitz v DePuy Orthopaedics (MDL2197) will be heard in May at the Ohio Northern District Court in Cleveland, with a secondary case – Ann McCracken v DePuy Orthopaedics – to start in July 2013 should the Dorney-Madgitz DePuy hip implant case be settled before it goes to trial.

The setting of a date is expected to accelerate DePuy Orthopaedics´ attempts to negotiate a settlement with claimants in the Multi District Litigation (MDL), after the company successfully settled three ASR hip replacement claims in Nevada for around $200,000 each. If the “Bellwether” Dorney-Madgitz v DePuy hip implant case proceeds to court, future settlements of compensation for faulty DePuy hip replacements could be influenced by the verdict of a jury.

The only possible advantage of DePuy Orthopaedics proceeding to court is that, should the jury in Cleveland establish a low benchmark in the settlement of DePuy hip implant claims, the company would save hundreds of millions of dollars in future settlements. Whether or not this is a risk that DePuy Orthopaedics are willing to take prior to their May court date remains to be seen.

DePuy Orthopaedics recently settled a class-action suit in Australia for their recalled LCS Duofix Femoral knee implant which is expected to have cost the company more than AU$10 million and it has been estimated by Professor Eric Gordon, a pharmaceutical industry expert from the University of Michigan, that the total cost of settling the 6,000 outstanding DePuy MDL cases could exceed $2 billion.

Settlement of a class action suit, claiming compensation for faulty DePuy knee implants, has been approved by a judge in Australia´s Federal Court enabling compensation payments to commence.

The class action suit was started in March 2010 by Pamela Casey, who was just one of a number of claimants who had undergone revision surgery due to the failure of the DePuy LCS Duofix Femoral knee implant. The knee implant was subject to a worldwide recall in July 2009 after higher than anticipated failure rates were identified in Australia – possibly due to Alumina particles within the implant causing pain and swelling around the knee joint.

Under the terms of the settlement, DePuy are to pay A$30,000 to claimants who underwent one revision to the faulty knee implant but required no further surgery. Claimants who needed two or more surgical procedures following the initial revision surgery are to receive A$65,000, and claimants who have experienced significant complications or loss of amenity will have their claims for faulty DePuy knee implant compensation assessed on an individual basis.

Justice Robert Buchanan approved the compensation agreement – which had been struck in August in the Pamela Joan Casey v. DePuy International Ltd class action lead case – after reviewing 430 inquiries into the proposed settlement. He stated in his summing up that none of the few complaints he received gave reason not to approve the settlement of compensation for faulty DePuy knee implants.

More than 5,000 DePuy LCS Duofix Femoral implants were used in Australia prior to the product recall, and DePuy also face an ongoing Australian lawsuit over their recalled ASR hip replacement systems.

The three Nevada-based ASR hip replacement claims against DePuy Orthopaedics, which were scheduled to be the first jury cases to be heard against the company, have been settled out of court.

Annelise Rundle (74), Martha Bender (69) and Katherine Guy (60) from Las Vegas in Nevada had all undergone DePuy ASR hip replacement surgery within the past six years, and all three had to have revision surgery when their DePuy hip implants failed.

Medical tests on Annelise Rundle determined she had also had health issues associated with the metal filings which had been displaced from the faulty hip replacement, while doctor´s testing Martha Bender discovered evidence of bone damage from the device.

The three DePuy ASR hip replacement claims are reported to have been settled by DePuy Orthopaedics´ parent company Johnson and Johnson for approximately $200,000 each – lower than what might have been anticipated according to Professor Eric Gordon, a pharmaceutical industry expert from the University of Michigan.

Professor Gordon said “J&J should have expected to pay in the $200,000-to-$500,000 range per case” and the company will have been satisfied with the outcome of the settlement considering that there are more than 2,000 cases outstanding in the States of California, Maryland and Nevada, and 6,000 more consolidated into a Multi District Litigation which should commence in the spring of 2013.

Johnson and Johnson would not comment on whether they were intending to settle future ASR hip replacement claims prior to scheduled court hearings.

Following the latest status conference in Ohio between solicitors representing victims of the recalled DePuy Orthopaedics faulty hip replacement systems, the first DePuy hip replacement court cases are to be scheduled for December 2012.

However, this first round of DePuy court cases will not be filed by claimants in the multi-district litigation (MDL) but, in a coordinated plan between solicitors, by individual claimants in the States of Nevada (December 2012), Maryland (January 2013) and Illinois (February 2013).

Depending on the outcome of the initial litigation, “Bellwether Trials” – where claimants are randomly selected from the MDL – will commence in May 2013 and June 2013 at the U.S. District Court for the Northern District of Ohio, and be presided over by the Honourable David A. Katz.

It is hoped with this schedule of DePuy hip replacement court cases, settlement figures can be determined which will reflect the suffering of those who have received faulty hip replacement systems and which will adequately compensate for  the pain of revision surgery as well as account for loss of earnings, medical costs and travel expenses.

Unlike class action lawsuits – where a claimant receives a proportion of the total award – each individual claim for DePuy hip replacement compensation will be assessed on its own merits, with different amounts being awarded according to the level of physical pain and suffering which has been experienced, loss of amenity due to the receipt of a faulty hip replacement system and special damages for loss of earnings and other out-of-pocket expenses.

Should this series of DePuy hip replacement court cases deliver awards which are of acceptable value to the legal representatives of those making DePuy hip replacement compensation claims, no further court cases would be scheduled, and claimants would be approached with out-of-court settlement offers as early as next summer.

Over 6,200 claims for DePuy hip replacement injury compensation have now been filed in the US, with 4,200 included in the MDL and a further 2,000 independently filed with State courts. This number is anticipated to rise sharply in the coming months, as many States have a Statute of Limitations which disqualifies claims for DePuy injury compensation after two years (the DePuy ASR hip recall was announced in August 2010).

If you or a loved one have received any metal-on-metal hip implant, and would like to know if you are eligible for hip replacement compensation, you should discuss the circumstances of your injury with a solicitor at the earliest possible opportunity.

The Clinical Director of the Medicines and Healthcare products Regulatory Agency (MHRA) has stated that there will be no metal on metal hip implant recall following data published in the Lancet which demonstrated that as many as 6.2 per cent of all metal on metal hip implants will fail within the first five years.

Dr Susanne Ludgate made the announcement after researchers from the University of Bristol analysed more than 400,000 hip replacement operations recorded on the National Joint Registry since 2003, and published their findings in the world´s most respected medical journal.

The research showed that 6.2 per cent of all metal on metal hip implants had failed within the first five years, compared to 1.7 per cent of metal on plastic hip implants and 2.3 per cent of ceramic on ceramic hip implants.

A higher level of hip implant failure was identified in women – particularly younger women who may lead a more active lifestyle – and metal on metal hip implants with a “large head”, with the report stating that each 1mm increase in head size increased the risk of revision surgery by 2 per cent.

The refusal of the MHRA to recall metal on metal hip implants will come as no surprise to those who have been following the DePuy hip recall story. Only two weeks ago the MHRA was criticised on BBC´s NewsNight program for allowing metal on metal hip implants to be introduced into the UK without any clinical testing.

The MHRA response was to announce that all recipients of metal on metal hip implants should have annual testing for the life of the implant to ensure the integrity of the hip replacement system and to check against displaced metal debris entering the bloodstream. However, the growing volume of data which suggests that there should be a metal on metal hip implant recall has not swayed Dr Ludgate.

“We recognise that there is emerging evidence of increased revision rates associated with large head metal on metal hip replacements,” Dr Ludgate told reporters, “but the clinical evidence is mixed and this does not support their removal from the market”.

A BBC Newsnight report, prepared in conjunction with the British Medical Journal (BMJ), has made faulty hip replacement claims against the manufacturers of metal-on-metal hip replacement systems and accused the Department of Health of failing in its duty of care to almost 50,000 hip implant patients.

The program, which was aired last night on the BBC, claimed that problems with metal-on-metal hip implants had been known for many years, but no action had been taken to inform orthopaedic surgeons or patients, or to stop the use of faulty hip replacement systems in the UK. The report claimed that all “large head” (≥36mm) metal-on-metal hip replacement systems had a high failure rate due to friction between the ball and cup causing metallic ions to enter the blood stream and cause tissue necrosis and other complications.

Evidence of the claims was produced using the DePuy Pinnacle hip replacement system as an example, which was introduced into the country without any clinical tests, and that was producing test results as early as 2008 which indicated up to fifty times the normal level of chromium in the blood streams of patients having to undergo revision surgery. It was reported on the program that the Medicines and Healthcare products Regulatory Agency (MHRA) said on Tuesday around 49,000 patients in the UK were in a high-risk category due to potential system toxicity.

The MHRA – the Department of Health agency responsible for ensuring that medical devices work and are acceptably safe – was also attacked on the program for allowing the faulty hip replacements to be introduced into the UK without any clinical testing, and for accepting the recommendations of a benefit/risk assessment panel established in 2008 which included consultants and a director of product development from the faulty hip replacement manufacturing companies.

In response to the faulty hip replacement claims, Professor Sir Kent Woods – MHRA´s Chief Executive Office – said that there were fundamental differences between the way the drugs and medical devices were introduced into the healthcare market, and his agency would continue to work with the British Hip Society and British Orthopaedic Society to analyse the rate of wear of metal-on-metal hip implants according to the data collected on the National Joint Registry.

Concerns over “system toxicity” have caused more alarm among patients worried about the DePuy metal on metal (MoM) hip implant recall according to advisors to the Medicines and Healthcare products Regulatory Agency.

Experts such as Stephen Cannon, a consultant orthopaedic surgeon for the Royal National Orthopaedic Hospital, have warned that the damage done to the bone structure around the hip area and tissue necrosis – caused by metallic particles displaced by the recalled MoM hip implants – can make revision surgery more complicated for the surgeon and more painful for the patient.

There has already been a significant number of personal injury compensation claims made against Johnson and Johnson – the parent company of DePuy Orthopaedics – following the MoM hip implant recall in August 2010, but now claims for hip implant recall compensation are anticipated to increase following revelations that, even if the hip implant is operating as it should, the potential exists for particles of chromium and cobalt to enter the bloodstream and cause damage to the patient´s organs and neurological system.

The Medicines and Healthcare products Regulatory Agency are expected to release new guidelines for patients concerned about the MoM Hip Implant Recall – who are currently advised to undergo annual x-rays and blood tests to insure the integrity of their DePuy MoM hip implant. However, Professor Joe Dias – president of the British Orthopaedic Association – is concerned that only 41 per cent of patients who received the DePuy MoM recalled hip implant are registered as having received the recommended checks.

MoM hip implant systems have been present in the UK since the 1990s, when they were seen as a more suitable option than replacements than hip replacements using a metal ball and plastic socket. It is estimated that more than 40,000 patients in the UK have had MoM hip implants, of which 10,000 are known to have had the recalled DePuy metal on metal ASR hip replacement systems implanted.

DePuy ASR metal on metal hip implants were recalled in the UK in August 2010 following a “higher than anticipated” failure rate. The recall meant that many more people are having to undergo painful revision surgery than expected due to the failure of their original hip replacement. Compensation claims for unnecessary suffering and extended time away from work due to a lengthy rehabilitation period have already been made against Johnson and Johnson and DePuy Orthopaedics, however more MoM hip implant compensation claimants are now anticipated to come forward.

Despite not being included in the DePuy hip recall of August 2010, the number of DePuy Pinnacle injury compensation claims in the United States has grown so quickly that legislators have merged them into one class action suit – known as a “multi-district litigation” case (MDL).

Over three hundred DePuy Pinnacle injury compensation claims have been filed to date – an alarming figure considering that the DePuy Pinnacle hip replacement system was not introduced to the market until five years after the recalled DePuy ASR hip replacement systems in 2008 – with each claiming injuries similar to those experienced by patients affected by the DePuy hip recall.

One of the reasons for such a significant failure rate is that no clinical testing was performed on the DePuy Pinnacle hip replacement system prior to launch on the American market. A process known as 501(k) was used to introduce the faulty hip replacement system into the United States whereby DePuy were able to show that the Pinnacle hip replacement system was similar in design and function to an existing hip replacement product already being used in the United States – the subsequently recalled DePuy ASR Acetabular System!

The MDL for the DePuy Pinnacle injury compensation claims will be held at United States District Court, Northern District of Texas, Dallas Division under Judge Ed Linkeade at a date still to be determined.

UPDATE February 2010: The number of claimants who have joined the MDL for DePuy Pinnacle injury compensation claims has risen to over 900. Unfortunately, a similar “grandfathering” process was used to introduce the Pinnacle hip replacement system into the UK and current advice from the UK Medicines Regulator is for recipients of the faulty metal on metal hip replacement system to have annual blood tests to check for high levels of cobalt and chromium entering the blood stream.

A claim for blood poisoning injury has been made against DePuy Orthopaedics by a woman who received her DePuy ASR hip replacement system as recently as November 2009.

The claim, made by Delores Hatcher from Wheeling, West Virginia, follows the results of a blood test in April 2011 which indicated high levels of chromium-1 and meta-cobalt in her blood – known causes of cardiovascular injury and neurological conditions such as headaches, confusion and cognitive decline, and possibly carcinogens which could lead to the development of cancer.

Delores added her claim to the growing number of compensation claims following the DePuy hip recall of August 2010 after visiting her doctor complaining of pain around her left hip and difficulty in walking. Both Delores and her doctor were overcome by the outcome of the blood tests as the hip replacement was fitted in November 2009 and had failed in a short period of time.

 In her claim for blood poisoning compensation, Delores also accuses Johnson & Johnson – the parent company of DePuy Orthopaedics – of hiding known defects with the faulty hip replacement systems and alleges that they aggressively marketed the faulty hip replacement systems by paying kickbacks to medical supplies purchasers and orthopaedic surgeons.

Disclosure has begun in the multi-district litigation case against DePuy Orthopaedics on behalf of thousands of Americans who have made DePuy injury compensation claims following the recall of the DePuy ASR XL Acetabular and DePuy ASR Articular hip replacement systems last August.

During the preliminary disclosure, depositions will be taken from three DePuy executives to ascertain the company´s corporate organisation, retention policies and storage of electronic information. This information has been asked for by solicitors representing claimants making DePuy injury compensation claims in the United States, as they believe that there is incriminating evidence relating to the sale and distribution of the recalled ASR hip replacement systems.

It is hoped that these depositions will accelerate the multi-district litigation case investigating the DePuy hip recall and reduce the time it could take for so many DePuy injury compensation claims to be resolved. More than 93,000 recalled DePuy hip replacement systems were implanted in the United States between 2003 and 2010 and it is expected that many thousands more affected by the “higher than expected” failure rate will have joined the class action before it is resolved.

This first stage of disclosure is scheduled to be concluded by April 28th 2011, at which time pre-trial arguments on behalf of those making DePuy injury compensation claims will be heard by the Honourable Judge David A. Katz at the Northern Ohio District Court.

The Food and Drug Administration (FDA) – the United States agency responsible for the regulation of medical products – has issued an update to its warning for patients implanted with metal on metal hip devices.

Although primarily focusing on issues known to exist with the recalled DePuy hip replacement systems, the FDA has identified all metal on metal hip devices as having similar risks due to microscopic metallic particles released into the blood stream when friction occurs between the metal ball and cup of the implant.

In addition to the friction wearing down the metal on metal hip devices – necessitating the requirement for revision surgery when the hip replacement system becomes loose or starts to cause pain – the FDA has advised on “adverse reactions to metal debris” which manifest when particles of chromium and cobalt cause symptoms or illnesses in other parts of the body.

These symptoms and illnesses can relate to the heart, nervous system, thyroid gland or the bone and/or tissue surrounding the metal on metal hip device. It has already been established that tissue necrosis can lead to more complicated revision surgery with an extended rehabilitation period when further hip replacement surgery is required, and due to this possibility, the FDA have recommended that recipients of metal on metal hip devices pay close attention to their general health, with particular focus on any changes in the following areas:-

• The heart (chest pains or shortage of breath)
• The nerves (numbness, weakness and changes in vision or hearing)
• The thyroid (fatigue, feeling cold and weight gain)
• The kidneys (a change in urination habits)

The FDA has advised that people will react to the presence of metal particles in the blood in different ways and has recommended that if recipients of metal on metal hip devices experience any changes in their health which are not directly related to their replacement hip system they should consult a doctor at the first possible opportunity.

Although it will be necessary for an orthopaedic surgeon to confirm that irregularities in the blood are directly attributable to metal particles released from metal on metal hip devices, the FDA has recommended several tests to evaluate the symptoms including:-

• Special imaging tests (MRIs, Cat Scans and X-rays)
• Blood tests (to determine the volume of metal ions in the blood)
• Joint aspiration (where a needle removes fluid from around the hip replacement system for analysis)

In the UK, similar recommendations have been in place for almost a year. In April 2010 – four months prior to the worldwide DePuy hip replacement recall – the Medicines and Healthcare products Regulatory Agency (MHRA) issued a medical device alert which highlighted concerns with metal on metal hip devices and recommended that recipients of all such hip replacement systems should have annual check-ups for a period of five years to determine whether metallic ions had entered the blood stream.

For those who have suffered an adverse reaction or injury due to a faulty metal on metal hip device, the possibility exists to make a personal injury compensation claim on the grounds of product liability. However, in much the same way as the FDA acknowledges that people will suffer different reactions to the presence of metal particles in the blood; people in dissimilar situations will be entitled to varying amounts of failed metal on metal hip device compensation depending on their personal circumstances.