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 man, who developed huge blisters on his feet due to high levels of a chemical irritant in the fabric of his shoes, has settled his product liability compensation claim with the American manufacturer.
Chris Heleine (51) from West Yorkshire had purchased the shoes from a trendy menswear shop in Leeds to wear while on holiday in Menorca, Spain in April 2009. However, within a day of wearing the shoes on his vacation, Chris´s feet developed painful blisters and he was taken to hospital by his wife.
The hospital in Menorca was able to lance the blisters and drain the fluid which had collected beneath the top layer of skin, but for a week, Chris had to return to the hospital on a daily basis to have the dressings checked and changed due to the high risk of infection.
On the return to his home town of Huddersfield, Chris – still experiencing severe sensitivity in his feet – sought legal advice and had the shoes analysed for their chemical content. It was discovered in the test that there was a high level of 2-Mercaptobenzothiazole in the fabric of the shoe – a known irritant which had caused the skin on Chris´s feet to react so dramatically to wearing the shoes.
Chris filed a product liability compensation claim against the American manufacturer of the shoes – Collective Brands – and after the negligent company conducted their own tests, they offered Chris a four figure out-of-court settlement which Chris agreed to.
The manufacturer of the Composix Kugel mesh hernia patch has agreed to pay 184 million dollars to settle outstanding lawsuits against the company following the recall of its product in December 2005.
C.R. Bard, and its subsidiary Davol Inc., first recalled the product when the US Food and Drug Administration (FDA) discovered that the patch´s memory recoil ring could fail once being inserted into a patient. The FDA determined that the failure of the recoil ring to spring back open after insertion could, in the most serious cases, cut into the surrounding tissue and potentially perforate the intestines or bowel – causing serious injury or even death.
In total, more than 2,700 product liability and personal injury claims were made against the company following the recall – claims which C.R. Bard refuted. The company stated that they had acted responsibly by ordering a recall at the first sign of a problem and, in the first test trial against them, a jury agreed.
However, when a North Carolina court found in favour of a plaintiff who had suffered injury due to the Composix Kugel mesh hernia patch, and awarded them 1.5 million dollars, the company was forced into a rethink.
The news that they have now decided to settle the remaining claims for personal injury compensation will come as a huge relief to those who have waited for years to be compensated for the injuries they have suffered.
A man, whose right leg was severed when it became trapped in a grain bin, has been awarded 1.6 million dollars in a product liability compensation claim against the designer of the grain bin – Ken Babcock Sales Inc. of Hiawatha, Kansas – and his employer – the Fredonia Cooperative Association of Fredonia, Kansas.
Sam Rollings (23), of Wilson County, Kansas, was sweeping out corn in the grain bin in January 2007, when he slipped and his right foot became entangled in the drag chain of the grain bin conveyor system. His leg was pulled into the machine and Sam suffered such severe injuries to his right foot and lower leg that surgeons could not save it.
In an action against the designer of the grain bin and his employer, it was claimed that there were no protective barriers or guard rails in the grain bin, and that no instructions or warnings were ever issued to employees working in the grain bin about the hazards which were present. Claiming personal injury due to product liability, the case was tried before District Court Judge David Rogers of the District Court of Wilson County, Kansas.
After seven hours of deliberation, the jury agreed with Sam that both Ken Babcock Sales and the Fredonia Cooperative Association were jointly responsible for his injuries, and awarded a total of 1.6 million dollars to cover a loss of earnings, past medical expenses and future medical care.
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 report published in the March/April 2011 edition of the American “General Dentistry” journal advises dentists against exposing patients to too excessive amounts of zinc by ensuring that their dentures fit correctly.
Zinc is a common metal used in dental products, and administered in the recommended quantities should not present a problem. However, too much zinc can result in a copper deficiency, neurological problems and anaemia.
The report gives as an example a tube of denture adhesive – such as Flexigrip – which should last denture wearers up to twelve weeks. Some patients, who have ill-fitting dentures, will use much more than is recommended to keep their dentures in place.
Lawsuits have been filed in America against the manufacturers of denture creams which contain zinc for not adequately warning about the risks associated with the product. GlaxoSmithKline has reportedly settled some lawsuits regarding the zinc toxicity of their denture adhesive, Poligrip.
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.
Half a billion eggs shipped to 14 states in the USA have been recalled over recent weeks due to a salmonella outbreak. Around 2,000 cases of salmonellosis have been reported, although with unreported cases the true number could be over 70,000.
The entire outbreak was linked to a very small number of farms, mainly due to the consolidation in US agriculture over the past few decades. The production methods of these massive farms have been called into question and there have been many calls for improvements in the way the Food and Drug Administration supervises the food industry.
Salmonella is the genus name for a large number (over 2,500) of types of bacteria. The most common disease associated with Salmonella is called Salmonellosis, which is gastroenteritis (food poisoning). The symptoms are nasea, vomiting, and diarrhea. Although food poisoning is usually mild, it does lead to about 500 deaths per year in the USA.
The most obvious way to avoid egg-based Salmonellosis is not to eat eggs, especially infants and elderly people. If you do want to eat eggs, then only eat fresh eggs and ensure that the are fully cooked. You should even take the precaution of washing all hands and all surfaces that come in contact with raw eggs (and raw chicken or meat for the same reason).
As might be expected, the crisis has resulted in multiple lawsuits from victims.
In a ruling that will have important implications worldwide for compensation cases, the US government has proposed a civil penalty of $16.4 million on Toyota because the company “knowingly hid a dangerous defect” that caused its vehicles to accelerate unexpectedly. Toyota was initially praised by US authorities for the way it handled recalls to repair faulty accelerator pedals on more than 8 million cars globally (including 2.3 million cars and trucks in the USA).
However, it later emerged that Toyota waited at least four months before reporting the faulty accelerator pedals to US regulators, in contravention to safety regulations that require safety defects to be reported in five business days.
Toyota is facing at least 177 consumer and shareholder lawsuits seeking class-action status and at least 56 suits claiming personal injuries or deaths caused by sudden acceleration incidents. The United States National Highway Traffic Safety Administration has estimated that 52 people have died in Toyota accelerator-related crashes. A much higher number of people have escaped death but been injured. On April 9th, 2010, the United States Judicial Panel on Multidistrict Litigation ordered all federal lawsuits related to the Toyota recall should be heard together at the Central District of California before Judge James Selna.
There is also an unusual case of a Toyota Camry driver who claimed he tried to stop his car but crashed into the back of another car, killing three people. The driver in the read end car accident was sentenced to eight years in prison. The conviction was unusual because the car was clearly out of control having dodged cars at an intersection prior to finally crashing, and the driver had family members in the car. The investigation at the time focussed on the brakes, which were found to be working correctly, rather than investigating the accelerator.
Toyota car owners in the USA are also suing for the reduced resale value of the cards due to the recalls. The claim is supported by various industry guides to the resale value of cars, such as Kelley Blue Book, which lowered the resale value of recalled Toyota cars by an average of 3.5 percent. The price reduction was up to $750 for a Toyota Sequoia. The lawsuits related to lost resale value are considered a much greater financial liability than the lawsuits related to crashes because there are millions of Toyota car owners that may be entitled to compensation. In a previous recall in the USA, Ford Explorer owners were given vouchers worth between $300 and $500 towards the cost of a new Ford car.
Toyota Recalls in Ireland
Toyota Ireland announced in February that it was recalling 26,000 cars in Ireland, although this number was later reduced to just over 18,000. There was immediate speculation that drivers whose car was subject to the recall but ignored the recall and any potential problems with their vehicles could be potentially liable in the case of an accident and even face charges related to negligence. Toyota Ireland issued a statement on the issue of legal liability: “A driver of a potentially affected vehicle could only be the subject of a charge under the Road Traffic Act if involved in an accident if he or she is aware that their vehicle is the subject of this recall campaign and that he or she is aware of the signs of wear and tear, symptomatic of the defect in the accelerator mechanism and they have become apparent, namely the accelerator sticking or becoming slow to return to idle, and they continue to drive the vehicle in this condition.”
Toyota is clearly exposed to product liability claims due to its faulty accelerators, and will no doubt be involved in many road traffic accident claims, as well as pedestrian accident claims, claims from passengers in car accidents, and most of all, claims for rear-end car accidents where the rear driver is driving a Toyota car.