The ABC is reporting on defective medical devices including a defibrillator that has been widely used, and remains in use, even though it has been removed from the Australian market – see Alison Branley, Mario Christodoulou, Inga Ting and Sophie Scott, ‘The Implant Files reveal defibrillators pulled from market still being used in emergencies’ Background Briefing (Online) 26 November 2018.
Associate Professor Bonython from the School of Law & Justice at the University of Canberra is quoted as saying:
“They [ambulance services] are going to be liable if the device fails and costs a life or causes injury to either a paramedic or a patient,” Associate Professor Bonython said.
I appreciate that when being interviewed, much of what is said is omitted from the program or report, but as a simple statement I would disagree with it.
We’re told that the defibrillator in question ‘has been the subject of more than 100 “adverse events” since 2012 … such as failing to shock, turning off unexpectedly and trouble pacing heart rhythms’. It has been ‘has been linked to at least one death’ but we don’t know quite what that means. The TGA:
… pointed out that defibrillators were used in cases of heart failure, a situation where death was a high possibility.
“The reporting of an adverse event associated with the use of a medical device does not mean that the device in question caused the adverse event.”
The article also quotes Professor John Skerritt, the TGA’s deputy secretary, who:
… acknowledged there were issues with the device, but said the regulator had no choice but to work with Philips to phase out the device by 2022.
“[What] we’ve heard from the state ambulance departments was that if all those products just came straight off the market now, they wouldn’t be able to have defibrillators in many ambulances just because of the sheer costs,” he said.
On the question of liability, a plaintiff would have to prove that the failure of the device ‘caused’ their death. If they were in cardiac arrest proving that it is more likely than not (ie on the balance of probabilities) they would have survived had the machine worked would be virtually impossible. Defibrillators may improve the chance of survival, they don’t guarantee it.
If the defibrillator caused burns to the patient that may be a different matter but the mere poor outcome does not prove negligence.
As for injuries to the paramedic, workers compensation is a no fault scheme so naturally the service will be liable if a defibrillator or any equipment causes injury to a patient. But again that does not prove that it is negligent to keep the machines. In determining whether there is negligence a court must consider (Civil Liability Act 2002 (WA) s 5B(2)):
(a) the probability that the harm would occur if care were not taken;
(b) the likely seriousness of the harm;
(c) the burden of taking precautions to avoid the risk of harm;
(d) the social utility of the activity that creates the risk of harm.
So how likely is the machine to fail. What are the consequences remembering that if it fails to shock it’s not actually causing the patient harm, but it may fail to contribute to a better but unlikely outcome. If the only precaution is to remove the machine and that leaves the ambulances with no defibrillator that is a much higher risk and will be associated with many more adverse outcomes than having a machine that sometimes fails. And the social utility of having defibrillators in ambulances may be such that it is worth ‘the risk’.
The statement “They [ambulance services] are going to be liable if the device fails …” is far too simplistic to be accepted. It may be an edited version of what Associate Professor Bonython and it makes good press to reinforce urban myths about liability, but it is not necessarily correct.
A response to the ABC Story from the South Australia Ambulance Service can be found here:
Your statement that “If the defibrillator caused burns to the patient may be a different matter” is a bit concerning, in that it may discourage a Good Samaritan from attempting treatment at all. Are there any circumstances in which a Good Samaritan could become liable for less than perfect treatment? For example, let’s say someone has training in using a defibrillator, but in the urgency of treating someone, forgets to take a simple step, saves a life, but causes damage which could otherwise have been avoided, and which they had been trained to avoid?
You have to read that statement in context – it was talking about a potentially defective machine. The point was that if it failed to shock it would have hard if not impossible to say it ‘caused’ the person to die or ‘caused’ harm. But if it caused a burn it would be easy to say that ‘but for’ the defibrillator the burn would not have occurred. I said that because the exact nature of the risk posed by the machine was not clear in the story.
If a person uses a defibrillator and saves a life how could it be said that they caused harm when the alternative was that the person would be dead. It’s like breaking ribs during CPR – it is not in the circumstances, a harm.
In short there are NO circumstances in which a Good Samaritan could become liable for less than perfect treatment
“[What] we’ve heard from the state ambulance departments was that if all those products just came straight off the market now, they wouldn’t be able to have defibrillators in many ambulances just because of the sheer costs,” he said. Isn’t there some sort of obligation on the retailer/manufacturer if the product is not fit for purpose? I would have thought they would bear the cost of replacement not the various ambulance services.
Note that this story was based on a larger investigation into medical devices. I think the point of the story is that the TGA has not been an effective regulator and that in this case it was the manufacturer that removed the product from the market and not the TGA. And a spokesperson for Phillips ‘… rejected suggestions the product was pulled to avoid regulatory action. “The MRx is safe for their intended usage, for both patients and users of the device,” she said’. If the TGA aren’t taking action and if it was unsafe the ambulance service as a large consumer would have to do so and they may think its not worth the effort. There may have been 100 adverse events but how many times has the machine been used? Clearly whether the product is ‘fit for purpose’ is a contested issue.