UK Faulty Medical Device Claims

DePuy to End Sales of Pinnacle Metal-on-Metal Hip Replacements

Posted on: June 4th, 2013 by Medical Negligence

DePuy Orthopaedics Inc has announced that they will terminate production and sales of its Pinnacle metal-on-metal hip replacements by August this year.

The announcement to halt the production and sale of DePuy Pinnacle metal-on-metal hip replacements coincides with the start of the Multi District Litigation being heard in Ohio (DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation – MDL 2197) in which more than 7,500 claimants are claiming compensation for injuries due to the company´s sister products; the DePuy ASR Articular Surface Hip Replacement System and the DePuy ASR XL Acetabular Hip Replacement System.

The company´s decision to stop producing Pinnacle metal-on-metal hip replacements is believed to follow the United States´ Food and Drug Administration (FDA) closing the loophole known as the ‘510(k) process’ which allowed the faulty DePuy ASR hip replacement systems onto the market in the US 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, the ASR hip replacement systems 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 withdraw of the ASR hip replacement systems in August 2010, FDA officials asked DePuy Orthopaedics to conduct further clinical tests on the Pinnacle hip replacements systems to ensure that they were safe medical products. DePuy declined the FDA´s request.

Since then a second MDL class action has been started in the States against DePuy Orthopaedics in which more than 3,300 claimants allege that they suffered an injury due to the DePuy Pinnacle hip replacement systems, while in the UK, a joint Newsnight and British Medical Journal investigation found that recipients of the DePuy Pinnacle metal-on-metal hip replacements were at risk of system toxicity and criticised the Medicines and Healthcare products Regulatory Agency (MHRA) for allowing the product onto the market using the same ‘similar product‘ criteria as the American FDA.

DePuy´s announcement to end sales of the Pinnacle metal-on-metal hip replacements overshadowed the scheduled start of the MDL court hearing in Ohio, where a jury has now been sworn in and will first be asked to deliberate on a motion argued by solicitors representing DePuy Orthopaedics that the size of any award of compensation for injuries due a faulty hip replacement system should be applied in relation to the company´s home state of Indiana – where personal injury compensation settlements are significantly lower than Ohio.

US Jury Awards $8.3 Million DePuy Hip Compensation Settlement

Posted on: March 28th, 2013 by Medical Negligence

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.

Recall Metal on Metal Hip Replacements Claims Research

Posted on: March 12th, 2012 by Medical Negligence

Researchers from the University of Bristol have published a report in The Lancet medical journal which, they claim, presents “unequivocal evidence” that all metal on metal hip replacements should be recalled.

The metal on metal hip replacements claims are supported by an analysis of more than 400,000 hip implant operations recorded on the National Joint Registry which show a 6.2 per cent failure rate in metal on metal hip replacements compared to a failure rate of 2.3 per cent for ceramic on ceramic hip replacements and 1.7 per cent for plastic on metal hip replacements.

The research confirmed previously held beliefs that younger women were more at risk from a failed metal on metal hip replacement, with researchers also identifying “wider head” metal on metal hip replacements as having a higher failure rate – as much as 2 per cent more for each 1mm increase in the head size.

Medical negligence solicitors will point to the conclusions drawn in the report which state that metal on metal hip replacements “should not be implanted”, even though the number of these “risky” devices being used has declined in recent years – from 8,072 in 2008 to 673 in 2011.

However, the UK Medicines Regulator – the Medicines and Healthcare products Regulatory Agency (MHRA) – is unmoved by the metal on metal hip replacements claims, with the MHRA Clinical Director – Dr Susanne Ludgate – stating that there will not be a widespread recall on metal on metal hip replacements.

Despite issuing new advice at the end of February that recipients of metal on metal hip replacements should undergo medical check-ups on an annual basis, Dr Ludgate stated that “We recognise that there is emerging evidence of increased revision rates associated with large head metal on metal hip replacements. But the clinical evidence is mixed and this does not support their removal from the market”.

BBC Suggests Hip Replacement Medical Negligence by MHRA

Posted on: February 29th, 2012 by Medical Negligence

A joint BBC/British Medical Journal investigation into metal on metal hip devices, has suggested that the UK medicines regulator – the Medicines and Healthcare products Regulatory Agency (MHRA) – may be guilty of hip replacement medical negligence.

The results of the investigation – as shown on yesterday evening´s Newsnight program – displayed a timeline of alleged incompetence, oversight and miscommunication in respect of the DePuy hip recall in the UK and the advice currently being provided to all recipients of metal on metal hip devices.

It was claimed in the Newsnight report that:-

  • No clinical trials were conducted on metal on metal hip implants before they were first introduced to the UK
  • The MHRA ignored a 2004 report published in the Journal of Bone and Joint Surgery that claimed “Caution still needs to be exercised [with metal on metal hip replacements] until longer term results are available.”
  • An advisory group, established by the MHRA to investigate the risks posed by metal-on-metal implants included two paid DePuy consultants and the product manager of another metal on metal hip replacement manufacturer – Smith & Nephew.
  • The MHRA ignored warnings from the U.S. Food and Drug Administration that high levels of chromium had been discovered in the placental blood and umbilical cords of women who had given birth after being implanted with a metal on metal hip replacement.
  • Despite the MHRA´s Committee on Safety of Devices recommending that patients should sign a consent form “acknowledging the risks associated with metal wear debris”, no alert was published to doctors or patients and no consent form ever produced.

The claims of hip replacement medical negligence were supported by an interview with an orthopaedic surgeon who stated that he was witnessing up to fifty times the normal level of chromium and cobalt in the bloodstreams of patients who required revision surgery, and the program raised the case of the DePuy Pinnacle metal on metal hip replacement system, which has not yet been recalled despite being virtually identical to the recalled DePuy ASR hip replacement systems and also introduced without any prior clinical testing.

In response to the hip replacement medical negligence claims, the Chief Executive Officer of the MHRA – Professor Sir Kent Woods – said that there were fundamental differences between the ways in which drugs and medical devices were introduced to the UK market and highlighted that the MRHA had just issued a new medical alert to 49,000 recipients of hip devices in respect of potentially faulty metal on metal hip implants.

The conclusion of the report suggested that commercialism had triumphed over patient safety as manufacturers rushed in to claim their share of a lucrative market, and that the MHRA were guilty of “regulatory failure” – effectively hip replacement medical negligence.

MHRA Revises Faulty Metal on Metal Hip Implants Advice

Posted on: February 28th, 2012 by Medical Negligence

The Medicines and Healthcare products Regulatory Agency (MHRA) has today issued new advice to surgeons and doctors with patients who are recipients of potentially faulty metal on metal implants.

In a new MHRA Medical Device Alert, the UK Medicines Regulator advises medical professionals that patients who have received a metal on metal hip implant with a “wide head” of ≥ 36mm should be monitored annually for the life of the implant to minimise the risk of complications should the patient have to subsequently undergo revision surgery.

This MHRA Medical Device Alert supersedes the Alert of April 2010 – four months prior to the DePuy hip recall in the UK – which recommended that patients were monitored for the first five years and is based on the recommendations of an expert advisory group, established by the MHRA to review the management of patients with soft tissue swelling associated with potentially faulty metal on metal hip implants.

Dr Susanne Ludgate, Clinical Director of the MHRA, said: “Clinical evidence shows that patients have a small risk of suffering complications from having metal-on-metal hip implants. These implants have in most cases completely transformed the lives of patients who in the past were subject to increasingly severe pain and progressive lack of mobility.”

Joe Dias, President of the British Orthopaedic Association (BOA) welcomed the recommendations of the MHRA, saying “The safety of our patients is always our first concern. The British Orthopaedic Association welcomes the publication of this updated advice from the MHRA. We will continue to work closely with the MHRA to provide further advice on this matter as new information becomes available.”

Inasmuch as the new guidelines may prevent painful and complicated revision surgery in the future, many medical negligence solicitors in the UK will be watching with interest this evening as the results of a joint BBC/British Medical Journal investigation into faulty metal on metal hip implants is revealed on the BBC´s Newsnight program.