Last week, BioNews reported on an ongoing Australian case in which an IVF mother is suing her consultant specialist for negligence concerning the birth of her healthy twins, on the basis of her express wish to have had only a singleton pregnancy and one child. The case has taken on the semblance of a 'wrongful birth claim' scenario. Clearly, it hinges on the consent given by the mother to the clinic in November 2003. Drawing on the key threads from the numerous reports in the Australian press, it seems that the mother gave initial consent for the use and transfer of two embryos during routine IVF treatment. However, it is alleged that on the day of embryo transfer, the mother verbally rescinded the consent just before the procedure. It is then alleged that unbeknownst to the specialist, the personnel in the laboratory either did not hear, or did not know that the patient had changed her mind on the matter of consent. Therefore two embryos, not one, were loaded and then transferred. From additional reporting, it then seems that the specialist realised almost immediately, but apparently it was then too late to take remedial action.
These reports may not entirely be accurate and to a great extent represent hearsay. However, there are a number of issues which are pertinent to every clinic in the way 'business' is conducted on a day-to- day basis. Here in the UK, the most high profile case to date regarding failure in consent concerned the High Court action where a mix-up at the embryo transfer stage produced black twins for a white couple. On this occasion the wrong embryos went to the wrong couple. Here as in the Australian case there was a failure in the standard clinic procedures relating to consent. Gaps in the protocol allowed a combination of checking errors to produce a 'mistake'. A secondary factor was poor communication between the laboratory, nurses and the clinicians. If this unfortunate event has a positive element, perhaps it serves as a timely reminder to us all that it is vital that clinics work as a well oiled machine, where there is good communication between all departments and with the patient. Good clinic protocols, allied to good quality audit systems (which involves regular assessment of risks in all the procedures), will help to avoid such errors. Although, without eternal vigilance by all involved, including patients, we may never say never. We are human and all good quality personnel know humans make mistakes.
Clinics, protocols and mistakes aside, what does the Australian situation amount to in legal terms? I am no lawyer. I have some experience in the High Court and Criminal Courts as an expert witness, but as a lay person who teaches medical ethics, law and social policy of reproduction at UCL in London, I believe it is possible to view the matter as a contractual dispute. The patient puts her trust in the specialist. The contract is initially for replacement of two embryos. At the last minute, the patient changes her mind and elects for a single embryo transfer; a perfectly reasonable thing to do. The specialist appears to agree, but apparently, because the patient is under or about to undergo deep sedation, the usual laboratory protocol is not carried out and they inadvertently load and transfer two embryos. It may be construed, however the mistake occurred, that there has been a breach of contract, negligence and a breach of trust.
The Australian press has subsequently had a real jamboree on the matter. Irrelevant side issues, such as the Australian Medical Association calling for amendment of the law to prevent 'litigation tourist destinations' have surfaced. A Herald Sun editorialist has accused the couple of immoral consumer culture values that contextualise kids as commodities and IVF as a business proposition. Still others have focused on the couple's homosexuality. In my opinion, spokespersons for the Justice system have clearly come out against such claims. They rightly, in my view, identify the case as turning on important legal principles such as a doctor's duty of care and patient trust.
So, it is right that the 'wronged' couple should have the right to present their case - but how will the Court view the matter? A mistake may have been made. The outcome at first sight looks to hinge on how the judge will view the evidence. Did the patient really change her mind and cancel the existing written consent? Was a verbal bargain struck and was there a binding consent for only one embryo to transfer? At present, it appears that the specialist is not contesting the fact that consent was verbally altered, but what was the state of mind of the patient? Was she compos mentis at that point in time to make the decision? Where was the partner? Did she participate in the decision? Does the consent need both to assent? The judge in this case will have much to consider.
Further arguments in the media have centred on an interesting phenomenon, that of the 'free gift'. In today's society, supermarkets believe we love the BOGOF (Buy one get one free). Does this case represent an IVF clinic BOGOF? Frivolous though this line of thinking might be, the Law generally does not view the birth of healthy baby(s) as a wrong. Let's look deeper into this question. For instance, after failed sterilisation operations resulted in a pregnancy (doctors had failed to tell the patients the sterilisation might not work) some Courts have formed the view that damages are available in such circumstances, but they have been careful not to reflect upon the worth of the child or whether they were wanted or unwanted, rather focussing on whether there had been a genuine act of negligence that should be compensated. There seem to be two angles. The first is a straightforward allegation of medical negligence like any other. The second confounding issue is that there has been the birth of healthy children. Traditionally, the Law has been happy to compensate for the birth of a child born unhealthy as a result of negligence, but circumstances are less clear here because of a popular perception that a healthy child's birth is always a blessing.
A personal viewpoint of mine (a social comment) is that these proceedings arise as a consequence of how we view children. In my book, 'Counselling in male infertility' (Blackwells, 1996), I argue for the existence of a cult of children. Some view reproduction as a lifestyle choice, so we really have developed a 'consumeristic mentality'- children as a commodity. Part of the sadness in this case is the apparent resentment arising, because a sibling is impinging on the lifestyle and the economic aspirations of the plaintiffs. The second child is being viewed as a burden rather than a blessing and a gift.
Cutting to the quick, the important question for the judge in my opinion is 'how important is verbal consent as measured against written consent?' This question of how many embryos to put back is important because twins and triplets are now considered undesirable, because of the risks to mother and baby(s). So most IVF clinics will obtain consent from patients and record it in writing signed by both the doctor and the patients. Most clinics will involve the embryologists to confirm the facts of the consent with the patient prior to the procedure. This constitutes good practice. It occurs to me that if the clinic had required a new signed consent before acting on the verbal change of consent, the mistake may not have arisen. Ultimately, if the judge finds for the plaintiffs, he/she will then have to consider the causation and offer the quantum (amount of damages). I suggest the quantum should be no more than £1 on the basis of causation: the couple did not wish to consider the offered remedy of a reduction on the basis they did not want to risk the health of the surviving baby. A healthy baby is a blessing.