Today’s correspondent has questions regarding a
… video was posted on YouTube by …. In it, the presenter discusses and demonstrates how to disassemble an EpiPen to obtain a further three doses of adrenaline. Despite warnings in the title and throughout the video that this is for medical professionals only, I am concerned that these instructions would allow anyone to interfere with a medical device and access a drug which, if used incorrectly, could lead to adverse outcomes. This is in addition to ignoring hygiene protocols in potentially reusing a syringe multiple times. It fails to take into account the fact that in an “austere environment”, someone would be unlikely to have a hacksaw blade, sharps container, syringe bodies, drawing up needles or injecting needles.
Given the propensity for people to blithely ignore warnings, I can see that there is a risk of someone attempting this procedure “just because”. I would be curious to know your thoughts on the following:
1. Are there any legal issues in interfering with a TGA registered autoinjector?
2. Despite the warnings shown, would there be repercussions in a first aider accessing the contents of the auto injector without obtaining some form of clinical authorisation from, say, an Ambulance-service Clinical Officer via Triple Zero or a Doctor?
3. Would a first aider undertaking this procedure without seeking higher clinical authorisation be seen by the courts as acting beyond a “Good Samaritan”? (I appreciate that not all the facts could be known in this circumstance.)
4. Would a registered medical professional be placing their registration at risk by acting outside of the norms of their profession by undertaking or directing a lay person to undertake this procedure?
While the video makes for interesting viewing, from a certain perspective, I would have thought this might be entering dangerous liability territory for the video producer.
I thank you for your time in reading this and hope that it generates some important discussion around the liability of providing information to the public.
I have said, often enough, that this blog is not the place for specific advice, it’s a blog of general principles only. For that reason, I am not identifying the video or its author, but should anyone identify it nothing I write should be taken as either an endorsement nor a criticism of the procedures demonstrated in the video nor of the presenter or the company.
The video does give ample warning that the procedures demonstrated are contrary to the manufacturer’s instructions, dangerous, should only be performed by a health professional and ideally under guidance from a more senior clinician and only in last resort circumstances where there is no immediate aid, a person has not responded to an initial epi-pen dose and they are, without further care, expected to die. The presenter points out that even after use there is sufficient adrenalin in the EpiPen for up to 3 more doses.
Are there any legal issues in interfering with a TGA registered autoinjector? I’m not an expert on the relevant legislation but I cannot see any issue. There would be if the person was modifying an approved device and trying to sell it; but that’s not what is happening here.
The video says that people should seek advice from a more senior clinician. The question I’m asked is ‘would there be repercussions in a first aider accessing the contents of the auto injector without obtaining some form of clinical authorisation from, say, an Ambulance-service Clinical Officer via Triple Zero or a Doctor?’
I think the more interesting question is why anyone would think that ‘an Ambulance-service Clinical Officer via Triple Zero or a Doctor’ could or would give that sort of authority. It might be relevant if the person giving the treatment was an employee and was ringing a company superior in the medical team, but imagine a first aider ringing triple zero or a doctor and saying ‘can I do this?’ The only answer would be, given that the clinical officer or doctor isn’t there, cannot see the patient, doesn’t know the first aider and may not have watched the video is ‘no, don’t do it’. But even if the doctor said ‘yes go ahead’ so what, he or she still does not know anything about the patient or the person on the end of the ‘phone.
The clinical question is ‘should a person showing signs of anaphylaxis be treated with epinephrine?’ Answer ‘yes’. If you have done that and they are going to die without more, no doctor’s authority is going to make any difference (supervisor/employee relationship excepted) to any legal position. It’s up to the person on the scene to decide what they think is necessary based on their experience and training. If they know what an EpiPen is, when its use is indicated and have watched the video, they are in a better position to know whether to act than anyone on the other end of a phone. If you are going to do it, you back yourself, a doctor’s approval may be some evidence that the conduct was ‘reasonable’ but a doctor cannot give lawful authority to someone else (see Doctors delegating authority to carry drugs (August 20, 2014)).
‘Would a first aider undertaking this procedure without seeking higher clinical authorisation be seen by the courts as acting beyond a “Good Samaritan”?’ That question seems to imply an ongoing misconception that there is some limit to the good Samaritan legislation – but see Good Samaritan legislation and scope of practice (March 27, 2015). If we take the NSW law as an example, section 56 of the Civil Liability Act 2002 (NSW) says:
A “good samaritan” is a person who, in good faith and without expectation of payment or other reward, comes to the assistance of a person who is apparently injured or at risk of being injured.
Section 57(1) says:
A good samaritan does not incur any personal civil liability in respect of any act or omission done or made by the good samaritan in an emergency when assisting a person who is apparently injured or at risk of being injured.
There are no limits here other than one has to be acting ‘in good faith’ that is with the honest intention of benefiting the patient. There is no requirement to stick within one’s training or scope of practice, that’s the very point. Doctors and nurses (and then others) were afraid of getting sued as people may expect them to meet a certain standard of care when they knew that emergency care was not their normal practice but surely something was better than nothing? This legislation is intended to encourage people to ‘have a go’ when they don’t know what they are doing. Someone’s pinned by a truck – get in and move it and if you crush their legs in the process, at least you were trying (see American Good Samaritan protected by Ohio Statute (May 20, 2015).
I would think a person undertaking the procedures suggested would be considered exactly the sort of person the good Samaritan legislation is intended to protect. A person is at risk of dying, you have used the EpiPen, but they need more. You understand what an epi-pen is, there are no other resources, it’s this or nothing. That’s when the legislation applies – to protect you, the good Samaritan, even if you introduce infection or give an overdose if you are honestly trying your best to help the patient.
Would a registered medical professional be placing their registration at risk by acting outside of the norms of their profession by undertaking or directing a lay person to undertake this procedure? They might if the action were something that demonstrated a lack of skill or care in the practice of their profession but all the circumstances have to be taken into account including the emergency situation as well as the value of the information they are being given (see Doctors giving advice, not direction, to paramedics (October 23, 2019)). As noted above however all a doctor could really do is give some reassurance to the person that it sounds like the patient might benefit from the drug and reassure them that it’s worth trying something. They cannot give legal authority to the ultimate decision.
I own a car. A car has to be maintained to the motor vehicle standards and needs to be safe. There are licensed mechanics who I can pay to maintain my car. But I can also buy DIY books and watch videos that will tell me how to do all sorts of things. If I follow those videos and make my car dangerous, the video producer won’t be liable. And if I’ve watched a video on how to do an emergency repair if broken down in remote Australia the producer cannot be liable if I decide to use that repair even though holding the motor together with coat-hanger wire and gaff tape would never pass a roadworthy test but may save my life. Equally they won’t be liable if it doesn’t save my life or if I fail to get a proper repair at the first opportunity and insist on driving with a defective vehicle.
I cannot see that the video is ‘entering dangerous liability territory for the video producer’. A person who applied the techniques in the circumstances described would be exactly the sort of person good Samaritan legislation is enacted for. They would not be ‘acting beyond a “Good Samaritan”’ they would be the archetype of a good Samaritan.