Re: Baby A
[2008] FamCA 417
•6 June 2008
FAMILY COURT OF AUSTRALIA
| RE: BABY A | [2008] FamCA 417 |
| FAMILY LAW – MEDICAL PROCEDURES |
| Family Law Act 1975 (Cth) |
| Secretary, Department of Health and Community Services v JWB and SMB (Marion's Case) (1992) 175 CLR 218 Minister for Immigration and Multicultural and Indigenous Affairs & B and B (2004) 219 CLR 365 |
| APPLICANTS: | Baby A’s parents |
| RESPONDENT: | Office of the Public Advocate |
| INDEPENDENT CHILDREN’S LAWYER: |
| FILE NUMBER: | MLC | 5105 | of | 2008 |
| DATE DELIVERED: | 6 June 2008 |
| PLACE DELIVERED: | Melbourne |
| PLACE HEARD: | Melbourne |
| JUDGMENT OF: | Dessau J |
| HEARING DATE: | 6 June 2008 |
REPRESENTATION
| COUNSEL FOR THE APPLICANTS: | Ms M.A. Hartley |
| SOLICITOR FOR THE APPLICANTS: | Lander and Rogers |
| COUNSEL FOR THE RESPONDENT: | Ms K. Nolan |
| SOLICITOR FOR THE RESPONDENT: |
| COUNSEL FOR THE INDEPENDENT CHILDREN'S LAWYER: | Ms S.C. Dowler |
| SOLICITOR FOR THE INDEPENDENT CHILDREN'S LAWYER: | Victoria Legal Aid |
Orders
That leave shall be granted to the applicants to amend their application filed 5 June 2008 by adding paragraph 5A as follows:
“In the alternative a declaration that it is lawful for the parents to consent to the treatment for their child.”
That the applicant parents are authorised to consent on behalf of their child BABY A born in May 2008 to the administration of drug X as treatment for her condition on a continuing basis subject to the medical opinion of the child’s treating medical practitioners from time to time.
That the administration of drug X to the child BABY A is authorised as treatment for her condition on a continuing basis subject to the medical opinion of the child’s treating medical practitioners from time to time.
That in the alternative I declare that it is lawful for the parents to consent to the treatment for the child BABY A by administration of drug X as treatment for her condition on a continuing basis subject to the medical opinion of the child’s treating medical practitioners from time to time.
There shall be liberty to apply on short notice.
That pursuant to s 65DA(2) and s 62B, the particulars of the obligations these orders create and the particulars of the consequences that may follow if a person contravenes these orders and details of who can assist parties adjust to and comply with an order are set out in the Fact Sheet attached hereto and these particulars are included in these orders.
That the appointment of the Independent Children's Lawyer shall be discharged.
That my reasons for judgment given this day shall be urgently transcribed and a copy made available to each party.
That the applicants shall have leave to serve a sealed copy of this order on all persons and/or organisations relevant to the advancement of the child’s interest.
IT IS NOTED
That the Southern Health Human Research Ethics Committee A approval for the treatment was given subject to the conditions as set out in paragraph 2.2 of the Minutes contained in Exhibit 8 to the affidavit of MS T sworn 6 June 2008.
That publication of this judgment under the pseudonym Re Baby A is approved pursuant to s 121(9)(g) of the Family Law Act 1975 (Cth).
| FAMILY COURT OF AUSTRALIA AT MELBOURNE |
FILE NUMBER: MLC 5105 of 2008
| BABY A’s PARENTS |
Applicants
And
| OFFICE OF THE PUBLIC ADVOCATE |
REASONS FOR JUDGMENT
INTRODUCTION
Baby A was born in May 2008. Within a day of her birth, it became obvious that she was seriously unwell. She was transferred to the neonatal intensive care unit at Monash Medical Centre. She was diagnosed as suffering an extremely rare and fatal metabolic disorder. At the moment, there is no effective cure or therapy. The life expectancy of infants with that disorder is weeks or months and tragically, death is inevitable.
Baby A’s parents have brought this urgent application. They seek various orders to enable the administration of an unapproved therapeutic drug, a substance known as drug X as a rescue treatment for Baby A.
The medical experts in charge of Baby A’s care and treatment are unanimous in supporting that course. Yesterday, Southern Health's Human Research Ethics Committee approved the treatment plan that had been approved the previous day by the Clinical Ethics Committee.
The HREC is the body approved by the National Health and Medical Research Council to approve research involving humans and the supply of as yet unapproved therapeutic goods. It is comprised of a combination of medical practitioners, allied health specialists, and laypeople.
Drug X has not yet been used in humans. There has been laboratory testing overseas. It has been shown to be effective in mice. A small quantity of it has been donated to and rushed into Australia for Baby A, under a scheme to import unapproved therapeutic goods known as the "Special Access Scheme", which permits such a substance to be brought into the country on compassionate grounds.
With each day that passes, according to the medical evidence, toxins build in Baby A’s body; toxins that are causing her progressive irreparable neurological damage. That accounts for the urgency of this application.
THE PARTIES
Yesterday I ordered the appointment of an Independent Children's Lawyer. I am grateful to Victoria Legal Aid for responding so promptly, and I am grateful to the ICL who, through counsel, has asked important questions today. I note that the ICL has supported the parents' application.
I invited the Attorney-General for the Commonwealth of Australia or his nominee to intervene in the proceedings, pursuant to s 91 of the Family Law Act 1975 as amended. I am advised, and have seen an email that satisfies me, that the Attorney-General has received notice of the order, and does not propose to intervene.
I also invited the Victorian Public Advocate or a nominee to intervene pursuant to s 92 of the Family Law Act. Ms Nolan has appeared on behalf of the Office of the Public Advocate today. I am grateful that she has stepped in at such short notice and like the ICL, she has offered genuine assistance by raising important questions.
Baby A’s parents were married in October 1998. Baby A’s mother, by way of an extraordinary twist of fate, is connected with a company, Y Company, which is a company involved in the research and development of pharmaceuticals here and overseas.
THE DOCUMENTS RELIED UPON
The applicants have relied upon the following:
·Their application filed on 5 June
·The parents' affidavits sworn on 6 June and filed today
·The affidavit of Ms T, the manager of the research directorate and corporate solicitor for Southern Health which was sworn yesterday and filed today
·The affidavit of Baby A’s treating doctor, consultant neonatologist at the Monash Medical Centre neonatal intensive care unit, Dr N. That affidavit was also sworn and filed today.
THE JURISDICTION AND THE POWER OF THE COURT
Baby A’s parents have equal shared parental responsibility. Parents can generally consent to a child's medical treatment as a part of their parental responsibility. However, certain medical procedures require the court's authorisation because they are beyond the ordinary bounds of such parental responsibility. They have become known as "special medical procedures" (see Secretary, Department of Health and Community Services v JWB and SMB (Marion's case) (1992) 175 CLR 218).
In Marion's case, the High Court held that authorisation is needed for a special medical procedure due to “the major invasive and irreversible nature of the procedure” - in that case sterilisation - the significant risk of making the wrong decision, and the grave consequences of a wrong decision.
This Court has jurisdiction to authorise special medical procedures by virtue of the welfare power in s 67ZC of the Act which provides:
(1)In addition to the jurisdiction that a court has under this Part in relation to children, the court also has jurisdiction to make orders relating to the welfare of children.
(2) In deciding whether to make an order under subsection (1) in relation to a child, a court must regard the best interests of the child as the paramount consideration.
The "welfare jurisdiction" of the Court is not at large. It is dependent upon a provision in Part VII of the Act, creating a "matter" to which the jurisdiction conferred in s 67ZC can be attached (see Minister for Immigration and Multicultural and Indigenous Affairs v B and B (2004) 219 CLR 365).
In this case, the decision to provide the proposed treatment to Baby A falls within the realm of parental responsibility described in s 61C(1) of the Act. Arguably, it not only falls within that realm, but is not even a special medical procedure, at least certainly not of the type contemplated in Marion's case. Although in one sense it throws up difficult ethical issues arising from the proposed use of treatment for which there has been no human trial, in another sense, given that no other treatment options exist for this baby, the ethical issues may not be so complex.
In addition though, there is the issue of what could be seen as a potential conflict of interest where, as it happens, it is Y Company that is likely to produce and supply this drug if it is used beyond the initial trial. In any event, even if, as may arguably be the case, these parents do have the legal capacity to make this decision without a court order, in the circumstances where the supportive treaters have evidently preferred the clarity and certainty of a court order, what this child urgently needs is not the discussion of a fine legal point so much as everything to be put into place in the clearest possible manner in an effort to save her life and/or relieve her symptoms.
Accordingly, I propose considering the matters to be taken into account as if Baby A’s treatment is a special medical procedure.
THE CONSIDERATIONS
Rule 4.09 of the Family Law Rules 2004 sets out the expert evidence that the court must consider and I will deal with each aspect.
First, I must deal with the exact nature and purpose of the proposed medical procedure. What is proposed here is a treatment regime whereby Baby A will be infused with a small amount of this substance. If she tolerates it - and she will be very closely monitored - infusion over about 30 minutes per day, or later every few days, will continue with the closest of monitoring. If deemed successful after 120 days, a decision will then be made as to how to continue. The precise detail of the treatment plan is set out on the parent information sheet exhibited to Ms T’s affidavit at exhibit 10.
There is currently stock of the drug available for several months of treatment. Thereafter, it will be available either directly from Professor Z, who developed the drug in Germany, and who has promised to provide it without cost to the parents, or if necessary, by its production through Y company. Given what I have referred to as the extraordinary coincidence of the mother's professional expertise, I can be satisfied that if needed, this drug will be obtained for Baby A in the longer term.
Next, I have to consider the particular condition of the child for which the procedure is required and I have already noted Baby A’s condition above. In layman's terms, the effect of that condition is that she is unable to process toxins in her body, and testing shows that they are at very high levels and mounting.
I have to consider the likely long-term physical, social and psychological effects on the child if the procedure is carried out, and if the procedure is not carried out. If this treatment is not administered, there being no other known treatment, Baby A will inevitably die. She is not expected to survive very long at all. If the treatment is administered, according to the evidence of Dr N (at paragraph 5):
Treatment with [drug X] ... offers a chance of life, a chance of great improvement in [Baby A’s] condition and a chance for her to reach adulthood if the research results of Prof [Z] in laboratory mice are repeated in human administration.
He later adds (at paragraph 11):
If the procedure is carried out, there is a possibility that it may halt progression of the child's condition and allow her the opportunity for ongoing life.
As to the risks, he says (at paragraph 12):
The nature and degree of any risks to the child from the procedure cannot be specified with any real degree of accuracy as the proposed procedure has not previously been performed on a human being. The proposed monitoring regime and my views in relation to adverse events or side effects are set out (the HREC papers).
In exhibit 10 to Ms T’s affidavit, the drug’s possible side effects are listed. That list is based on side effects seen with the use of another similar but unrelated and not strictly comparable medication. As noted by Dr N, no‑one can be sure. What I can be sure about though is that Baby A is being treated by experts in an excellent setting where I am satisfied she will be closely monitored and she will not be permitted to suffer or worsen without adequate safeguards for her overall medical well-being and comfort.
The Rules direct me to specifically consider the nature and degree of any risk to the child from the procedure. I have just done that in part, but further as to those risks, I am satisfied on the detailed material in the affidavit of Ms T and its exhibits, that this has been a central question that has exercised the minds of the treating neonatologists, experts from other hospitals here and interstate, the professor who has developed the drug, and ultimately the HREC that has given approval for the treatment plan or protocol.
At paragraph 14 of that affidavit, it is noted that Dr D, consultant chemical pathologist and medical administrator to the HREC, has formed the opinion that:
[Drug X] would be unlikely to be toxic and it is reasonable to consider that [drug X] would be absorbed by human cells.
Dr D also formed the opinion that:
The administration of [drug X] could have a favourable outcome on the metabolic pathway blockage in [Baby A].
The committee which considered the compassionate access application in relation to the therapeutic goods aspect, recommended a precise protocol with conditions set out at paragraph 2.2 in exhibit E to Ms T’s affidavit to provide appropriate safeguards. I am willing to consider incorporating those into my orders if requested.
I need to consider alternative and less invasive treatment, if it is available, and the reason why this procedure is recommended instead of the alternative treatments. I have made it plain that there is no alternative treatment in this case.
I need to consider that the procedure is necessary for the welfare of the child. Again, it is clear that without it, Baby A cannot survive. It is sadly that simple. It is her only chance.
I need to consider if the child is capable of making an informed decision about the procedure and if she is not, whether she is going to be able to develop sufficiently to make an informed decision. She is a newborn baby. Of course she cannot make her own decision. Again, sadly, without treatment, she will not survive long enough to mature to do so.
Finally, I need to consider whether the child's parents or carer agrees to the procedure. Baby A’s parents in this case are absolutely united in the decision to try this treatment. They are educated and intelligent. All the material supports that they have discussed and considered every relevant piece of information, expert, medical and legal, and other advice, in whole-heartedly agreeing to this procedure.
CONCLUSION
Deciding from a courtroom what is in any child's best interests is always an exquisitely difficult task. In one sense, it is all the more difficult in this case, involving as it does the heart-wrenching predicament for this family, with such a sick baby, and a dire prognosis at present. However, in another sense, the task is the easier for it being a genuine matter of life or death for baby A. It brings absolute clarity to where her best interests lie. Without the treatment sought by her parents, a treatment that is fully supported not only by the treating medical experts but also by the relevant ethics committees, as well as the ICL, with the riders that she has had to prepare urgently and not been able to obtain other information that would normally be obtained, supported (with similar riders) by the Office of the Public Advocate, there is no question in my mind that this baby would not have the chance of life that she deserves.
Baby A can only profit too from being nursed and loved by two parents who, amidst all the turmoil, can at least have the peace of mind that they have given it the very best possible shot on her behalf and who can have no regrets, knowing that they have done everything within human capacity to help her reach her full potential, whatever that turns out to be.
Finally, it is important to note that the parents' solicitor, Messrs Lander and Rogers, have acted pro bono on their behalf. It is obvious that they have had to prepare extraordinarily detailed material in urgent circumstances. That material in turn has been well presented by Ms Hartley of counsel and that has been very helpful to the court. The community generally, as well as the parents specifically in this case, are well served by such lawyers.
I propose granting the parents' application, as I have already said. I will hear submissions about the form of the orders.
I certify that the preceding () paragraphs are a true copy of the reasons for judgment of the Honourable Justice Dessau
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