X v The Sydney Children's Hospital Network

Two preliminary points

1. It is necessary to begin with two important preliminary points. First, it must be recorded that the Parents are grateful for, and have acknowledged the excellence of, the care which Ryder has received. They have participated fully in all of his medical consultations and carefully listened to the advice they have been given. They are not to be criticised for the approach which they have taken to their present dilemma.
2. Second, as will become apparent, the reasons that the Parents do not wish to consent are rational and motivated by their concern for Ryder's quality of life. They do not object to chemotherapy in and of itself. However, to put it shortly, they do not want to put Ryder through more chemotherapy when there is presently no detectable cancer in his body.

Ryder's medical history

1. A convenient summary of Ryder's medical history is set out in a letter dated 28 May 2020 from the Hospital to the Parents, which I gratefully adopt with necessary redactions (emphasis added): "Ryder was referred to [the Hospital] on 21 June 2018, with a diagnosis of bilateral retinoblastoma. At the time he was 7 months of age. Investigations to determine extent of disease revealed tumours confined to his eyes without spread to his brain. He was considered to have useful residual vision in both eyes. After undergoing investigations to determine extent of disease within each eye, the following treatment plan was implemented: 1. Chemotherapy to shrink the tumours. 2. Local cryotherapy/laser hyperthermia subsequently after the tumours had decreased in size following chemotherapy. 3. Regular examination under anaesthetic to assess response and to guide any additional local therapy. Ryder completed 6 cycles of chemotherapy in October 2018. His disease was monitored with examinations under anaesthetic during and following chemotherapy. In February 2019 he was found to have new tumours in his left eye. He received cryotherapy intermittently for new lesions over the next 12 months. Treatment also included additional chemotherapy into his eye, to control local spread of disease in his left eye. In late February this year, the tumour in Ryder's left eye recurred. At this point he was considered for a specialised form of chemotherapy administration directly into the blood vessels supplying the eye. In consultation with ophthalmologists from [an interstate hospital], this approach was reviewed and considered to be unlikely to benefit Ryder. The difficult decision to recommend enucleation [removal] of the left eye was made, which you accepted. Ryder underwent enucleation of his left eye on 11 March. Ryder made a good recovery. Subsequent histological examination of the eye unfortunately revealed that there was extensive invasion of the choroid layer and also involvement of the front (anterior) part of the eye, by the tumour. This was an important finding, as if there is infiltration of the layers of the eye in significant quantities, commonly referred to as "massive choroidal invasion" and/or "invasion of sclera" and/ or invasion of the front part of the eye, this is regarded as locally extensive disease, carrying a high risk of spread beyond the eye to other organs such as the bones, brain and/or other tissues. Standard of Care I emphasise strongly that the results from the histologic examination of the eye placed Ryder in a higher risk of developing spread of the tumour outside the eye. In such settings the standard of care consists of treating patients with systemic chemotherapy, even if patients had received prior chemotherapy."
2. Pausing there, it is important to note that the present issue is not a question of preventing a tumour developing in Ryder's remaining eye. The evidence in relation to the treatment of Ryder's retinoblastoma, insofar as his remaining eye is concerned, was given by the Doctor on the last occasion: "Your Honour, there is currently no evidence that he has an active tumour in his remaining eye. He remains at risk of developing new tumours in that eye, not because we have failed to treat the existing tumour, but because he has a predisposition to develop new tumours because of the genetic, he has a familial inheritable form of the disease. So every part of the back of his eye potentially could form new tumours which is why the standard is to have him reviewed every 4 to 8 weeks under anaesthetic to see if any new tumours develop, so they can be treated with local therapy, either laser or cryotherapy, without resorting to chemotherapy."
3. The present issue is concerned with minimising the prospect of any microscopic cancer cells, which may have escaped from Ryder's enucleated eye, becoming florid cancers in other parts of his body. The Doctor referred to this in his evidence as "distant (systemic) disease recurrence".
4. The Parents declined to give their consent in the face of the Doctor's strong recommendation that Ryder should undergo further chemotherapy. A second opinion was obtained, as well as an opinion sought by discussion among a specialist interest group of oncologists. All recommended without hesitation that Ryder should urgently undergo the proposed treatment.
5. The matter came before me last Friday in the Duty List. What became apparent was that before Ryder could undergo the proposed treatment, if it were permitted by the Court, it would be necessary for him to undergo a PET-scan and an MRI as preliminaries to that treatment. During the course of the hearing last Friday, the parties agreed to my suggestion that he should have those tests. This was done on the basis that if, in the unhappy event those tests demonstrated that there was detectable cancer in other parts of Ryder's body, there was no question that the Parents would do anything other than consent to the proposed treatment or any other treatment that might be recommended by his doctors in the face of that new diagnosis. However, if those examinations did not disclose any detectable cancer, then the matter would have to return to Court for determination.
6. Since the last hearing, Ryder has undergone a PET-scan and an MRI. Much to the relief of all concerned, fortunately neither of those tests detected any cancer in his body. This means that the Court has now had to determine whether orders should be made which would permit the Hospital to administer the proposed treatment to Ryder in the face of his parents not being prepared to consent to that treatment.
7. The Doctor's latest opinion is conveniently summarised in his most recent affidavit: "Risks if systemic chemotherapy is not administered 17. If the recommended approach to commence chemotherapy is not followed, Ryder has a significantly enhanced risk of developing distant (systemic) disease recurrence. I estimate that without chemotherapy his risk of recurrence is up to 40%. This means a cure rate of about 60% without treatment. 18. The risk period for relapse is greatest within the first two years from date of enucleation (surgical removal of the eye)…. 19. Although Ryder remains well without evidence of recurrence four months after surgical removal of his eye, he remains at high risk of relapse. I estimate that if he did not receive therapy and he remained disease free, the risk or relapse would slowly fade to very low levels by 4 years. 20. I estimate that chemotherapy would reduce the risk of recurrence to around 10%. This means a cure rate of 90%. 21. Should Ryder develop distant spread, attempts at curative therapy will cause severe toxicity and a higher risk of treatment failure and death. …"
8. The Doctor's opinion was more fully explained in a supporting report, which included: "Scenario 1: Ryder does not have detectable disease (cancer) on clinical examination and on medical imaging scans (Magnetic Resonance Imaging (MRI) of brain and orbits and Positron Emission Tomography (PET) scan of his body). He is considered to be at substantial risk of having microscopic residual cancer based on analysis of surgically removed eye. The recommended treatment for Ryder following surgical removal and subsequent microscopic histological examination of his left eye is six (6) additional cycles of chemotherapy using the following agents Carboplatin, Etoposide and Vincristine. There is no evidence that the retinoblastoma has developed resistance to these agents. These cycles are identical to those he received when first diagnosed. The doses are adjusted based on age and his weight. These agents are regarded as standard of care in patients who do not have overtly detectable disease either on medical imaging scans, or on the basis of clinical symptoms or signs. In terms of toxicity, each cycle will cause a drop in blood counts which will result in the following 1, A low white cell count which will predispose him to infection. 2, Low haemoglobin (anaemia) for which he may require blood transfusions, 3, Low platelet count which will increase the risk of bleeding and for which he may require platelet transfusions. Platelets are an essential component of body's system to stop and prevent bleeding In addition other likely toxicities • Nausea and vomiting which will be relatively minor. • Vincristine may cause constipation, nerve/muscle weakness. • Carboplatin may damage his hearing. This is an unlikely complication. • Etoposide may cause an allergic reaction, the severest form of which may require urgent resuscitation. • He may develop mouth ulcers (and/or gastrointestinal ulcers) called mucositis for which he will require pain relief and he may require nutritional support. This is unlikely • He will lose his hair temporarily. I expect Ryder will make a full recovery from these … In terms of long term recovery of these side effects, I anticipate that this will be complete. I anticipate Ryder's chance of cure to be 90%.... Scenario 2a: Ryder has overt or obviously detectable disease (cancer) on clinical examination and on medical imaging scans (Magnetic Resonance Imaging (MRI) of brain and orbits and Positron Emission Tomography (PET) scan of his body). Such findings will need to be confirmed with biopsy of the abnormal area. In this situation, the risk of treatment failure and subsequent death is much higher. Cure is still achievable but requires a substantial increase in intensity and would require bone marrow transplantation (using Ryder's own bone marrow). Ryder would first receive a series of intensive chemotherapy cycles. There are a number of different treatment regimens that can be chosen to use in these cycles of chemotherapy. … I have used this particular treatment in this setting in our Cancer Centre within the last two years. It consists of four cycles of the following agents. • Vincristine • Cyclophosphamide • Etoposide • Cisplatin Provided his disease had responded to therapy (highly likely), Ryder would then have bone morrow collection (or harvest) prior to undergoing bone marrow transplantation (BMT). BMT requires that he first be treated with very high doses of chemotherapy to destroy any residual cancer This treatment also has the unintended and unavoidable side effect of destroying the normal bone marrow (which is why it is collected ahead of time). Following the high doses chemotherapy, the preserved bone marrow is then reinfused (administered). This then repopulates and restores normal bone marrow function (i.e. blood production and immune function). Radiotherapy may be required if after the above treatment there are isolated spots of residual cancer We would try to avoid radiotherapy as this substantially magnifies the risk of subsequent second or third cancers. Duration of therapy is about 8 to 12 months. The chance of cure is around 50%. The acute side effects of BMT are substantially greater in terms of risk of infection, blood product support, gastrointestinal toxicity (mucositis), nutritional requirements, pain, requirement for supportive care, risk of organ failure (kidney, liver, lung) number and duration of hospitalizations. There is a much greater risk of dying of these toxicities particularly in the immediate period following BMT-phase. The risk is about 5%. This risk is higher if we undertake BMT when the patient has pre-existing medical problems. There are substantial long term side effects which include infertility, increased risk of second cancers, hearing loss, cataracts, permanent hair loss, long term damage to other organs (heart, lung, kidney, thyroid). Scenario 2b: Ryder has disease that has spread to the brain. This is a very difficult situation to cure. It will require treatment as outlined in Scenario 2a…."

The concerns of the Parents

1. The Court has been assisted by submissions carefully prepared by the Mother and by an extensive exchange during today's hearing between the Court, the Parents and the Doctor (who I found to be a considered and impressive witness), in which questions were asked and explanations sought in relation to the matters which the Mother had raised in her submissions.
2. I will next set out the Parents' concerns and the Court's findings.
3. First, there was a concern about the effect of the proposed treatment on Ryder's long term growth and development. The Court accepts the Doctor's opinion that there is no appreciable adverse risk to Ryder in that regard.
4. Second, the Parents were concerned that the history of Ryder's treatment - in particular, the course of chemotherapy he underwent which, nevertheless, did not avoid the enucleation of his left eye - demonstrated that he had somehow become resistant to chemotherapy. Their concern was that such resistance would render the suffering that he would undergo in the proposed treatment futile.
5. The Court accepts the Doctor's evidence that what occurred in relation to the course of treatment of Ryder's left eye is not indicative of any resistance to chemotherapy that might inhibit the effectiveness of the proposed treatment.
6. Third, as a result of research undertaken by the Parents, they expressed their concern about the appropriateness of the drugs that it was intended to be used in the proposed treatment. The Parents tendered into evidence the approvals for those drugs by the Therapeutic Goods Administration ("TGA"). They submitted that it was not apparent from those approvals that the relevant cancer drugs were suitable for use on children. To use them on children was, they submitted, an "off label" use.
7. Again, I accept the Doctor's evidence that because children are not used in the testing of such drugs, the TGA approvals do not, in terms, deal with the suitability of those drugs for the treatment of cancers in children. Nevertheless, the Doctor, who is highly experienced over many years in dealing with cancers of this kind, gave evidence, which the Court accepts, that, in his experience, these drugs are suitable for the treatment of children such as Ryder and have resulted in good outcomes for many of his patients. In those circumstances, the Court is satisfied that there is no proper basis for concern about the suitability of the drugs proposed to be administered to Ryder.
8. Finally, and perhaps most importantly, the Parents' fundamental objection to the proposed treatment was their clear and understandable unwillingness to put Ryder through chemotherapy again when, at the moment, he has no cancer presently detectable in his body. They had no objection to him undergoing regular scans for detectable cancers.
9. The Parents' concerns were eloquently expressed in the Parents' written submissions prepared by the Mother: "10. To elaborate on this point, Ryder completed 6 cycles of chemotherapy at the end of October 2018. Prior to starting chemotherapy our preference for the management of Ryder's tumour was to remove his left eye, where the main tumour was located, but we were convinced by the doctors that administering six rounds of intravenous chemotherapy to Ryder was the best option. We were devastated when this chemotherapy failed to control the growth of new tumours, and following this, Ryder was subject to a good year of treatments including administering chemotherapy directly into the left eye. While we concede that the chemotherapy calcified the main tumour, it failed to control growth of new tumours and we were then left with no choice but to remove his eye. We cannot express how distressing it was to us to subject Ryder to this prolonged administration of ineffective toxic treatments when the outcome ended up being what we had suggested should happen in the first place. … 23. Even [the Doctor] acknowledges some of these side effects, although as I said before he seriously downplays them. During the previous chemotherapy, Ryder was screaming in pain, in the absence of anti-emetic drugs, he vomited, all of his hair fell out, he was feverish, had night terrors and had a number of viruses requiring 48hr intravenous antibiotics in hospital. … 25. Your Honour, there are not many things worse that parents can experience than a diagnosis of a malignant tumour in their young child. We simply do not want to subject Ryder to more debilitating treatments unnecessarily. We only want to do what is in his best interests, to ensure that he has the best possible quality of life."
10. I asked the Doctor to respond to the point raised by the Parents about the severity of the side effects Ryder might experience if he underwent the proposed treatment. I accept the Doctor's evidence that what Ryder did go through as described by the Mother was within the range of possible side effects for such treatment and was not to be considered unusual or out of the ordinary. However, I also accept the Doctor's evidence that there are good prospects that Ryder will suffer less (but not be free from) from such side effects during the proposed treatment because he is now a little older and bigger and will, therefore, be better able to tolerate the unavoidable toxicity of the proposed treatment.

Legal principles

1. The parens patriae jurisdiction is an extraordinary jurisdiction which, in a case such as this, has only one criterion: what is in the best interests of the child. I respectfully adopt the summary of the jurisdiction set out by Beazley P in X v The Sydney Children's Hospital Network [2013] NSWCA 320; (2013) 85 NSWLR 294: "2. The jurisdiction invoked in this matter was the parens patriae jurisdiction of the Court. As Basten JA has stated, the origin of the jurisdiction is ancient. In its modern application, it is an "essentially protective" jurisdiction: Secretary, Department of Health & Community Services v JWB & SMB (Marion's Case) [1992] HCA 15; 175 CLR 218 at 280 per Brennan J. In circumstances where the Court's concern is with the welfare of a child, the authorities are clear that whilst the Court's jurisdiction is a broad one, it should act cautiously. This was explained by Fitzgibbon LJ in In re O'Hara [1900] 2 IR 232 at 239-240 in the following way: "In exercising the jurisdiction to control or to ignore the parental right the court must act cautiously, not as if it were a private person acting with regard to his own child, and acting in opposition to the parent only when judicially satisfied that the welfare of the child requires that the parental right should be suspended or superseded." 3 These remarks have been endorsed by the House of Lords in J v C [1970] AC 668 at 695, 706 and 722 and by Brennan J in Marion's Case at 280."

Consideration

1. The core concern of the Parents may be summarised in the proposition that they did not want to put Ryder through chemotherapy when it was not apparently necessary at this time. For the following reasons I find on the basis of the Doctor's evidence that it is necessary for Ryder to undergo the proposed treatment as being in his best interests.
2. As I explained to the Parents, when exercising this jurisdiction the Court is not a substitute parent. The position of the Parents as parents in relation to the proposed treatment is entirely understandable. No parent wishes their child to suffer, even when the suffering is necessary, and especially when they are not satisfied that it is necessary. However, the role of the Court in exercising the parens patriae jurisdiction is to consider the evidence objectively and to apply only the test that I have referred to above, being what is in the best interests of the child.
3. While the Court feels deep sympathy and understanding for the emotional turmoil of the Parents, when faced with circumstances such as the present, the Court's jurisdiction is not exercised by reference to the emotional wellbeing of the Parents, other than to the extent that wellbeing may have an impact upon the child. In this case, although what may come will be difficult and upsetting for the Parents, I have no doubt on the basis of how they have conducted themselves in these proceedings that they will see it through with the same fortitude and care for Ryder that they did during his earlier chemotherapy.
4. On the evidence, the issue is straightforward. If Ryder undergoes the proposed treatment, then there is, the Court accepts, only a 10 per cent prospect of a distant recurrence of Ryder's cancer, that is to say a recurrence of the cancer in some other part of his body as a result of the travel of microscopic cancer cells from his left eye prior to its enucleation. The proposed treatment will be uncomfortable and will have side effects. However, I have also taken into account that it is likely, and much to be hoped, that his capacity to tolerate the proposed treatment will be better than it was during his earlier treatment.
5. On the other hand, if Ryder does not undergo the proposed treatment, there is a 40 per cent prospect of a distant recurrence of his cancer. It is not then simply a question of him suffering from a cancer. In that eventuality, any treatment will be longer and more toxic than the proposed treatment, including, depending on the site of the cancer, carrying significant risks to his long term health and development. To this must be added that, obviously enough, the treatment of a cancer has a lower chance of a successful outcome than dealing with microscopic cancer cells that have not yet developed into an active tumour.
6. It is not to trivialise, and I intend no disrespect, to say that in this case the choice is between some very real pain in the short term - which, I hasten to add, I do not in any way underestimate - to avoid the real and not insignificant prospect of something far worse in the long term. The Court will order that the proposed treatment be permitted because it is well satisfied that it is in Ryder's best interests to have that treatment now and minimise the significant risk of a far more intrusive treatment later with considerably less prospects of success.
7. However, I wish to emphasise that the conclusion to which the Court has come has not been reached lightly. I have firmly borne in mind that the Court must be cautious about any intrusion on the autonomy of parents to make decisions about their child. Nor has it been reached by the uncritical acceptance of expert opinions of statistically likely outcomes, persuasive as those opinions may be. I am fortified in the conclusion which I have reached because it is also obvious to the Court that Ryder will undergo the proposed treatment with the unfailing love and support of the Parents, and in the care of clinicians whose undoubted technical competence is matched by their compassionate concern to ensure the best outcome and quality of life for Ryder.

DISCLAIMER - Every effort has been made to comply with suppression orders or statutory provisions prohibiting publication that may apply to this judgment or decision. The onus remains on any person using material in the judgment or decision to ensure that the intended use of that material does not breach any such order or provision. Further enquiries may be directed to the Registry of the Court or Tribunal in which it was generated. Decision last updated: 14 July 2020