Cobalt chrome, cobalt levels, DePuy, DePuy ASR XL, DePuy Hip Recall Litigation, DePuy Orthopaedics, Food & Drug Administration, Gary Hooper, Hip recall, Hip Replacement, hip replacement failure, hip revision, Johnson & Johnson, joint replacement, Metal on metal hip, New Zealand, Total Hip Replacement, UNited States, US Food and Drug Administration
Kiwis can’t claim for faulty hip joint
More than 500 New Zealander’s have been implanted with a faulty hip joint that has spawned multimillion-dollar lawsuits around the world. In what has been described overseas as “one of the biggest disasters in orthopaedic history”, De Puy, a subsidiary of American giant Johnson and Johnson, recalled its ASR (articular surface replacement) hip prostheses last August. The recall could cost Johnson and Johnson more than a billion dollars to settle claims worldwide, a United States analyst has estimated, but ACC legislation covering personal injury precludes New Zealand patients from suing.
James Elliott holds up the hip joint he and others such as former World Cup goalkeeper Frank van Hattum had implanted. Photo / Natalie Slade.
The recall came amid claims that metal debris from wear on the implant led to a reaction that destroyed surrounding soft tissue and exposed patients to cobalt and chromium poisoning. Long-term effects are uncertain but the US Food and Drug Administration recommends that patients should be monitored for systemic effects, particularly cardiovascular, neurological, renal and thyroid symptoms. ABC programme Four Corners reported in May that high readings of cobalt and chromium had been recorded in some Australian recipients of ASR hip implants.
The ASR is a “metal on metal” hip the ball and the cup it fits into are made of cobalt chrome metal rather than ceramic or polyethylene. The metal implants were expected to have a longer life and were therefore considered by some specialists a better option for younger and more active people. More than 93,000 ASR joints have been sold around the world.
In New Zealand, 507 patients have them. Of these, 376 were implanted with the total hip device and 131 with the resurfacing device.
Twenty-eight of the patients who received the total hip replacement had had the ASR implant removed by the end of last year – a failure rate of almost four times the average. The known failure rate for the hip resurfacing product was not higher than normal. The failure rates in New Zealand are much lower than those overseas, with reports in Britain as high as 49 per cent for the total hip system and 26 per cent for the resurfacing system.
The 28 New Zealander’s whose ASR total hip system has had to be replaced with another product include former All White star Frank Van Hattum and James Elliott, who is co-ordinating a group of patients. Mr Elliott, a lawyer who until recently worked for Herald publisher APN , said Johnson and Johnson was offering New Zealanders whose hip devices had failed out-of-pocket expenses. “They have made it clear to me in correspondence that there is the ACC bar, that I can’t sue for pain and suffering.”
He said it would be “morally reprehensible” if a company the size of Johnson and Johnson did not offer “reasonable compensation”. “No one is advocating the removal of ACC, but a corporation this size should step up and do the right thing instead of putting it on taxpayers.”
Wellington lawyer John Miller said the ACC system effectively precluded New Zealand patients joining class actions against Johnson and Johnson in Australia or the US. Mr Miller, who is representing three patients, said the company hadn’t ruled out compensation for emotional trauma but it was likely to be a fraction of what patients in a position to sue would get. Patients here were relying on the company being a good citizen, Mr Miller said.
Of the ASR devices, he said: “It does seem that lots of people have ticking time bombs in them.”
Hip operations are regarded as among the most beneficial because of the greatly improved quality of life they usually deliver. The ASR system was introduced without any checks done here to approve it as fit for purpose. It makes up a small proportion of the 35,000 hip replacement operations carried out in New Zealand in the past five years. Orthopaedic Association president Gary Hooper said New Zealand had one of the best ratios of revisions (removal of implants) in the world.
Though he thought the magnitude of the ASR problem was much lower here, Mr Hooper did not rule out that the rate of revisions might increase as patients learned of problems flagged overseas and had follow-up tests. “We can’t be dogmatic about what is happening because we don’t obviously know,” he said. “The surgeons concerned have been advised to talk to the [ASR] patients and if the patients have pain or have concerns about their implants then they should contact their surgeons.”
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- Lawsuit Against DePuy Filed From Spain (earlsview.com)
- Hip-replacement recall hurts profits at Johnson & Johnson (earlsview.com)
- Dozens suing over DePuy hip replacement (earlsview.com)
- Australia – Hip surgery ruins lives (earlsview.com)
- Sadwin has a few other Pithy Points for the Orthopaedic “Big Guys”… (earlsview.com)