The faulty hip replacement claims were made following a joint investigation by Newsnight and the British Medical Journal (BMJ) which alleged that “patients have been kept in the dark about their participation in what has effectively been a large uncontrolled experiment”.
The investigation revealed a long history of alleged cover-ups by the UK medical regulator – The Medicines and Healthcare products Regulatory Agency (MHRA) – claiming that an eight-person “expert” advisory group, established by the MHRA in 2006 to report on the carcinogenic potential of metal-on-metal hip implants, contained two paid DePuy consultants and the director of product development for Smith and Nephew – another metal-on-metal hip replacement system manufacturer.
The advisory group – it was claimed in the Newsnight/BMJ investigation – had the brief to determine the “risk-benefit context” of metal-on-metal hip replacements and although a recommendation was made that patients should sign a consent form “which sets out the fact that the risks associated with metal wear debris have been discussed, including the genotoxic risk and possible sequelae”, the risks and the recommendation were never communicated to orthopaedic surgeons and their patients.
It was also alleged that the MHRA ignored faulty hip replacement claims from the American Food and Drug Administration (FDA) that high levels of metal ions had been found in umbilical cords and the placental blood of women who had received metal-on-metal hip replacements. Indeed, the MHRA criticised the FDA for issuing a warning without conducting a full risk analysis, when no clinical trials had been conducted in the UK to establish the safety of metal-on-metal hip replacements.
In 2008, Dr Tony Nargol – a consultant orthopaedic surgeon from the University of North Tees – advised DePuy Orthopaedics that he was witnessing a high level of metal debris in patients implanted with the Pinnacle metal-on-metal hip replacement system – not only the ASR hip replacement system which was recalled in 2010 due to a higher than expected failure rate. He claimed on the Newsnight report that he was witnessing system toxicity levels of 20-50 times the permitted levels, with patients suffering inflammations, muscle necrosis and bone decay. This information should have been passed onto the MHRA by DePuy, but was not done so.
The program concluded that the MHRA – the government agency which responsible for ensuring that medicines and medical devices work, and are acceptably safe – had failed in its duty of care by allowing faulty hip replacements to be introduced in the UK without due diligence and had failed to monitor the performance and safety of the metal-on-metal devices. In response to the faulty hip replacement claims, the MHRA announced it was advising 49,000 patients in the UK with “large-head” hip implants to have annual blood tests for life to check for the presence of metal ions.
A former face of DePuy has launched a claim for faulty hip replacement compensation after her own DePuy ASR hip replacement system failed.
Penny Brown (51) of Bath, Wiltshire, is a former gymnast who, between 2004 and 2008, allowed her image to be used in DePuy´s marketing material following her own hip implant operation. In addition to Penny´s face appearing on posters and in literature promoting DePuy ASR hip replacement systems, Penny also supported patients about to have hip implant surgery and gave media interviews about the benefits of the ASR hip replacement systems.
However, in 2009, Penny noticed an aching pain in her groin and her hip replacement made a “clunking noise” whenever she walked. After seeing her doctor, Penny found out that the pain she was experiencing was attributable to her DePuy ASR hip replacement wearing out and releasing metal debris into her bloodstream which was causing an inflammation.
She was advised by her doctor that she would need revision surgery to replace the faulty hip replacement – an operation which she underwent six months ago, but has been bed-bound ever since because of complications caused by the faulty device. Penny told reporters, “I not only feel let down personally but also feel guilty that I might have encouraged others to have the ASR implanted.”
As she has been unable to work since her operation, Penny sought legal advice and made her own claim for faulty hip replacement compensation. Although Penny admitted that she had been initially delighted with how the hip device had removed the constant pain of osteoarthritis, she says her life has been devastated since the failure of her DePuy ASR hip replacement system.
New Zealand hip replacement patients, who have been implanted with the faulty DePuy ASR Hip Replacement Systems, have been told that they will not be allowed to join class action suits being filed against Johnson and Johnson in Australia and the USA due to laws governing compensation claims in New Zealand.
Under the Accident Compensation Act 2001, New Zealanders are not able to claim for pain and suffering in cases of this nature and, although able to sue for emotional trauma, are unlikely to get a fraction of the compensation potentially available elsewhere in the world.
James Elliott, an ex-lawyer and victim of a faulty DePuy ASR Hip Replacement System, had been in the progress of co-ordinating a group of 28 New Zealanders whose ASR hip system has had to be replaced with another product.
He claims that in a letter to him from Johnson and Johnson, he was advised that the Accident Compensation Commission bar would prevent him and others from suing the company and they offered him out-of-pocket expenses for any costs he had incurred during his hip replacement therapy.
Elliott will continue to fight for compensation for himself and his fellow victims. He said that a company the size of Johnson and Johnson should “step up and do the right thing”, claiming that it would be morally reprehensible if the company failed to offer reasonable compensation.
A West Virginia woman has filed a lawsuit against Johnson and Johnson, the manufacturers of the recalled DePuy ASR hip replacement systems, which includes a claim for biologic toxicity compensation.
Delores Hatcher, from Wheeling, West Virginia, underwent replacement hip surgery on her left hip in November 2009. Within months on having the Depuy ASR Hip Replacement System implanted, she started to experience severe pain in her hip which left her unable to walk for any length of time
In April 2011, Delores´ doctor found high levels of meta-cobalt and chromium-1 in her blood – factors which are known to cause neurological problems such as confusion, hand tremors, cognitive decline, headaches and cardiological dysfunction
In addition to suing for product liability, Delores contends that Johnson & Johnson concealed the defects of the hip replacements when marketing the products and also alleges unjust enrichment against DePuy and Johnson & Johnson, noting that the U.S. Attorney’s Office charged the companies for aggressively marketing the metal-on-metal implants by paying illegal kickbacks to doctors and medical facilities.
In the United States, preliminary disclosure has begun in the federal multi district litigation (MDL) against DePuy Orthopaedics Inc. following the company’s recall of the DePuy ASR hip replacement systems last year.
The significance of preliminary disclosure is that depositions are taken against three DePuy executives to examine the company’s retention policies, electronically stored information and corporate organisation. The information gained from these depositions will assist lawyers representing plaintiffs in the States, who have identified certain documents relating to the sale and distribution of the ASR hip replacement systems which will strengthen their clients’ cases.
The MDL process has been agreed upon by both lawyers representing clients throughout the United States and DePuy Orthopaedics Inc. to speed up the time in which product liability claims against DePuy can be resolved. The depositions against the three DePuy executives are scheduled to be concluded on April 28 2011 and pre-trial arguments will then commence before the Honourable Judge David A. Katz of the Northern District of Ohio.
When the MDL process reaches this stage, it is anticipated that the number of plaintiffs involved in the action against DePuy Orthopaedics Inc. will have risen to many thousands. Approximately 93,000 hip replacement patients are affected by the faulty DePuy ASR hip replacement systems in the United States.
Hip replacement patients, who have had faulty DePuy ASR Hip Replacement Systems implanted, are being urged to make independent claims for product liability and personal injury compensation, rather than rely on class actions.
The call comes from “U.S. Drug Watchdog”, a private company monitoring pharmaceutical and medical devices in the United States, as many class actions are in the process of being prepared.
Their fear is that individuals who suffer more acute complications during the revision surgery will be undercompensated for their pain and suffering and could lose up to 100,000 dollars in compensation.
Settlement of DePuy compensation claims in America may also be delayed by an ongoing investigation into doctors who received “incentives” to promote selected hip and joint replacements.
DePuy Orthopaedics were one of four companies who were recently fined 310 million dollars by the U.S. government following an investigation into Medicare fraud, and now the Justice Department’s U.S. attorney in Newark, Christopher Christie Jr., is looking into the role of the American Academy of Orthopaedic Surgeons in the promotion of faulty hip replacement systems.
A new class action lawsuit has been filed in Australia against DePuy Orthopaedics Inc – manufacturers of the faulty ASR and ASR XL Hip Replacement Systems – to add to the many already underway in the United States.
5558 people in Australia were fitted with faulty implants between 2003 and the systems’ recall in 2009, and now a legal team in Victoria has filed a group claim to compensate victims who will have to undergo painful revision surgery and risk lifelong health problems.
The lead applicant, Tammy Stanford (40) from Hobart, Tasmania, had her left hip replaced with a DePuy Hip Replacement System in 2005. Throughout 2009 her health deteriorated, and she sought medical advice.
In January 2010, a surgeon found that her hip joint was inflamed and the bone surrounding the implant had degenerated. Tammy’s condition will mean that she requires specialist hip reconstruction before her faulty implant is removed and replaced with a safe device.
Australian surgeons first started noticing problems with the DePuy Hip Replacement Systems in 2007, however they were not withdrawn until December 2009. The case is due to be presented to the Federal Court in Sydney.
More weight was given to the increasing number of class action suits being filed against DePuy Orthopaedics, with the release of a Public Health Statement by America’s Food and Drug Administration (FDA). The FDA is responsible for protecting and promoting public health throughout America, and regulates the provision and use of all medical devices in the United States.
In a statement posted on the FDA website, concerns are raised about the use of metal-on-metal hip systems, which are “known to have adverse events including infection and joint dislocation”. The statement lists many of these “adverse events” which include pain around the hip or groin, localised swelling or numbness, and a change in the patient’s ability to walk.
In addition, and reminiscent of the Erin Brokovich case, the FDA also highlights concerns about metal ions from the implant entering the blood stream. They cite cases where patients have developed a reaction to these ions and experienced medical problems relating to their nervous system, heart and thyroid gland.
The FDA statement comes months after the DePuy ASR Hip Replacement recall in Ireland, and class action lawsuits being filed in both the United States and Australia.
The Food and Drugs Administration (FDA) – the regulator of medical devices in the USA – has issued a warning that all metal-on-metal (MoM) hip replacements could be hazardous.
The FDA claims come six months after the DePuy ASR hip recall in Ireland which was due to a “higher than expected” failure rate, and identifies all MoM hip replacements as being capable of causing the same injuries as witnessed with the recalled DePuy hip devices.
The main concerns of the FDA are “adverse reactions to metal debris” which are attributable to microscopic metal particles released into the bloodstream when friction occurs between the metal ball and cup of the implant.
Typical symptoms of an “adverse reaction” include pain, rashes and inflammation around the area of the implant, but the FDA have recommended that recipients of MoM hip replacements pay close attention to their general health, with particular focus on changes in the following areas:-
The kidneys (a change in urination habits)
The heart (chest pains or shortage of breath)
The thyroid (fatigue, feeling cold and weight gain)
The nerves (numbness, weakness and changes in vision or hearing)
Advice issued by the FDA is that, as recipients of MoM hip replacements will be affected in different ways by the presence of metal particles in their blood, any changes in the health of somebody implanted with a MoM hip replacement should be brought to the attention of their doctor immediately.