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I have had two hip replacements since 2011. Both have so far proved satisfactory, but implants and prosthetic devices are always a risk, and there is no process of recall where a device has been found to be faulty. Affected individuals just have to wear it. Literally. Around the world there have been many deaths from faulty implants. But implants do improve lives. My life was a misery before ‘I had my hips done’, but I also know of some hip cases where a total replacement of a replacement was necessary.
So what are you to do if your bionic hip or your pacemaker is malfunctioning? First: seek medical confirmation of the nature and seriousness of the problem: it’s better if you do this rather than your beneficiaries. In other words don’t delay; don’t just put up with it. Talk to the surgeon who installed it for you. Lodge a legal formal complaint with the manufacturer if you can identify and locate them. They are unlikely to be found in Australia. In 2018, a major international investigation found 170 Australians had died and more than 8,500 had been injured in the past decade due to potentially dangerous medical devices. An investigation found lax regulations and vested interests allowed dangerous and malfunctioning devices onto the market, putting patients’ lives at risk (Source: ABC).
“We have seen catastrophic failures in medical device regulation, breast implants, more recently surgical mesh, hip implants, heart valves,” Pain Australia CEO, Carol Bennett, said recently.
All of these devices, when they fail, have a huge impact on people’s quality of life and on their pain and suffering. In response, the federal government announced its intention to tighten the regulations, including a requirement for more scientific evidence for implants for the spine, heart, and circulation and central nervous systems, before they could be used in patients. Better tracking and monitoring of implanted devices would also be introduced.
But these reforms will be postponed until November 2021, except for changes to the regulation of pelvic floor mesh. The current legislation was introduced in 2002, and is now out-of-date. It favours manufacturers rather than aggrieved patients. In Australia, the safety of medical devices is loosely regulated by the Therapeutic Goods Administration or TGA. However, the testing of suspect medical devices is carried out, not here, but in Europe by for-profit
private certifiers called ‘notified bodies’. The success rate of such individual complaints is not, in the first instance, encouraging. The TGA does have a form for complaints about ‘events’ involving medical appliances, but the onus is on the individual complainant to prove an alleged malfunction.
As a consequence, over the last decade, we have seen the emergence of class actions in Australia. A class action – or ‘representative proceeding’ as it is formally known – is a court proceeding where the claims of a group or ‘class’ of persons are brought by one or a small number of named representatives. Over the last 25 years, there have been over 500 class actions filed in Australia, many to do with faulty medical implants and a large number that have resulted in substantial settlements. The development and availability of litigation funding, increased access to information, and the growing number of law firms willing to represent claimants have contributed to the continued growth of
There is a separate kind of class action: shareholder class actions rise when a financial entity fails to live up to what directors have promised. Whilst the government has deferred reforms that would benefit individuals, it is enthusiastic about protecting ‘directors and officers’ of companies which have underperformed. In a climate of insurer caution, it is happy to have litigation funding arrangements and financial relationships between funders and plaintiff lawyers examined by a parliamentary inquiry into the class action system. A spokesperson for a leading class action legal firm comments, “The parliamentary joint committee is designed to deliver the government the answers it wants. The government and vested interests, including the Australian Institute of Company Directors and the Australian Industry Group, are working together to deny access to justice to ordinary Australians.”
Abraham Lincoln in the Gettysburg Address promised that, “government of the people, by the people, for the people shall not perish from the face of the earth”. In today’s Australia, you have to wonder who the government is for: the people? Or the corporations?
John Fleming II
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