Personal injury Solicitor, James McNally, brings you the latest news
Johnson & Johnson now face another potentially expensive disaster: ASR’s successor, the Pinnacle MoM implant, is the subject of increasing controversy. Patients are reporting the now familiar symptoms of pain, swelling, reduced mobility, dislocation and fracture. In addition there is concern about the high levels of metal ions apparently found in the blood of those with the Pinnacle device.
The product is made by Johnson & Johnson’s Orthopaedic Unit, Depuy, which denies any link between the presence of cobalt and chromium ions in the blood and possible health risks. The metal debris which some experts believe is generated by the MoM implants rubbing together is thought to lead to soft tissue, muscle and bone damage, in addition to cardiovascular, thyroid, renal and neurological problems. Autopsies of patients with MoM implants have shown metal ions in the liver and spleen indicating that ions may be dispersed throughout the body.
Dr Mary O’Connor is an Orthopaedic surgeon at the Mayo Clinic in Florida. She doesn’t use MoM implants because she has been worried about the risk of metal ion toxicity for many years. In her opinion, “We’re simply seeing the tip of the iceberg with metal-on-metal failures”. According to current monitoring systems, doctors estimate that more than 10% of the Pinnacle hips will fail over the next two to three years.
We are told that there are 1,600 Pinnacle lawsuits pending in the USand according to the report by Reuters, Johnson & Johnson are preparing to defend themselves rigorously against these product liability injury claims. A spokeswoman for the company has confirmed that they are “very confident” about their product. A director at DePuy reiterated their belief that their product performs as well as or better than other brands of MoM implants.
It’s no surprise that Johnson & Johnson are taking this rather hard line: if the claims succeed, they stand to lose an estimated $5 billion paying for revision surgery alone. The fact that there is no system in place in theUS to monitor the performance of the hips after implantation may also considerably aid their case. Nonetheless some legal experts in theUnited States have expressed surprise at the position the manufacturers have adopted: and urge a more cautious approach, saying that they risk losing credibility if it turns out that the products are faulty.
There are two reasons why this may just be the tip of the iceberg. The first is that there are no concrete figures for Pinnacle’s failure rate. DePuy has not publicly disclosed the number of devices implanted and despite manufacturers being ordered by the FDA to conduct follow-up studies in cases of implant failure, more than a year later these study protocols – DePuy’s included – have yet to be finalised.
In March 2011 the British Orthopaedic Association and the British Hip Society published results of a joint study into the ASR implants. They identified a failure rate of 49% after six years which is a figure four times higher than that given by DePuy when it recalled the device. British Orthopaedic specialist, Dr David Langton, has been studying MoM hips for years. He forecasts an 80% failure in ASR devices at eight years.
Dr Langton is also monitoring a group of 1,000 patients atNorthTeesHospitalwho have been fitted with the Pinnacle implant. Based on his studies so far he says that the failure rate of these hips is 8% at five years, increasing to 16% after six and a half years.
The lower failure rate of Pinnacle devices compared to ASR might be explained by the different designs and also, crucially, that the Pinnacle implants have smaller femoral heads. The larger heads – 36mm or greater- are associated with higher failure rates. However, in Dr Langton’s opinion an increase in the Pinnacle device’s failure rate is inevitable and although the overall failure rate may be lower than that of ASR, many more people have Pinnacle hips.
A USlawyer believes that the Pinnacle failure rate will be “far above 10%” which means that 15,000 patients in the United Stateswill require revision surgery. Experts estimate that Johnson & Johnson could be facing compensation settlements of an astonishing $319,000 per revision, or just under $5 billion in total.
Meanwhile, here in Britain, we are keeping a watching brief on these developments. Our team are on hand to offer free legal advice and guidance, so if you have received a metal-on-metal hip replacement and would like friendly, no-obligation assistance about the possibilities of making a compensation claim then please call our free legal helpline on 0333 888 0408. Alternatively you can e-mail me at james.mcnally@sleeblackwell.co.uk or any of my specialist injury solicitor colleagues, whose details can be found on this site.
