Australian appellate court upholds $7 million judgment in medical malpractice action against hospital for failing to disseminate recent amendments to cancer treatment protocol by United States study group and against estate of treating specialist for his failure to seek out such information
Monique Frances King (plaintiff) was 13 years old in 1989 when she received treatment for cancer at the South Eastern Sydney Area Health Service (SAHS) which operated the Prince of Wales Children's Hospital (defendant 1). Now 29 years old, she sued the SAHS and the estate of the late Professor Darcy O'Gorman-Hughes (defendant 2) for personal injuries suffered as a result of her treatments.
When a neurosurgeon had explored plaintiff's spine, he discovered a highly malignant tumor surrounding the right C-7 nerve root. The surgeon removed as much of the tumor as he could reach. Plaintiff then came under the care of Dr. Hughes for cancer treatments.
One of the treatment modes was intraspinal chemotherapy. This consists of administering three agents: methotrexate (MTX), cytosine arabinoside (Ara C) and hydrocortisone. The medical profession generally refers to this procedure as "triple intrathecal therapy" or TIT whether or not three agents are involved. After this treatment plan went into effect, the plaintiff began on or about July 21,1989 to show symptoms of myelopathy (damage to her spinal cord); which eventually led to her quadriplegia.
The heart of plaintiff's case was the charge that Dr. Hughes and the other pediatric oncologists at SAHS failed to live up to their professional duties to keep themselves informed as to recent U.S. developments in the management of the children's cancer from which plaintiff suffered.
The defendants do not deny that the plaintiff's quadriplegia resulted from the treatment she received. They blamed the combination of radiotherapy, the administration of Act D as part of the systemic chemotherapy, and TIT. They do deny that any breach of duty on their part relating to their treatment of the plaintiff was the cause of any compensable damage.
The evidence showed that Dr. Hughes took into account many published writings, plus his own substantial experience. The key issue in this case arose from the fact that his treatment plan rested in part on a protocol known in the U.S. as IRS II. In particular, Dr. Hughes followed the guidelines in the IRS II protocol in deciding to use TIT as part of the treatment plan. He also took those recommendations into account in deciding on the size and number of doses of MTX, Ara C and hydrocortisone to be given by way of TIT and of Act D to be administered by way of systemic chemotherapy.
A body called Intergroup Rhabdomyosarcoma Study Group (IRS Group) had published a relevant IRS II protocol (A rhabdomyosarcoma is a highly malignant tumor in children that typically occurs in the head and the neck.). The IRS Group mainly operates in the U.S.; it had regularly been carrying out studies of different types of treatment for malignant head tumors.
The protocol set forth the recommended dosages of chemotherapy agents and their frequency, and the amount of radiotherapy. An article in a medical journal suggested that patients had a substantially improved survival rate when treated with an intensive therapy which included TIT and that it might, with some modifications, also be of value in treating tumors in the spinal region.
The defendants had included TIT in the protocol specifically to prevent metastasis. They refer to it as "prophylactic" TIT. Physicians could also use TIT for "salvage" purposes, that is, to achieve survival in desperate cases. Prophylactic TIT was an experimental and controversial form of treatment. The defendants concede that it was radical.
Between 1984 and 1991, the IRS Group developed and put out a new protocol, known as IRS III, involving a different group of patients. On June 5, 1987, the Group published an important amendment to the protocol. This document dealt with the risk of neurological complications from combining radiotherapy with TIT.
Uncertain of what had caused these complications, the amendment advised (1) that physicians should cut back the doses of prophylactic intrathecal chemotherapy to levels now used for central nervous system (CNS) leukemia and (2) that they should strictly limit intrathecal therapy to 4 doses in 20 weeks. In addition, it advised that the "maximum' tolerance dose of radiation to the spinal cord should not exceed 4140 4200 cGy.
This information would have been of vital importance to the plaintiff. Her actual treatment differed substantially from that advised by the 1987 amendment to IRS III, and these differences lay at the heart of the respondent's case. For example, the dosages of Ara C given to plaintiff were each of 70 mg. This was less than recommended by IRS II, but much more than the 30 mg advised by the amendment to IRS III.
Dr. Hughes died before the trial in 2000. Nevertheless, a number of documents in evidence clearly show that he claimed not to have been aware of the relevant amendment made to the IRS III protocol. Moreover, he had no direct association with the IRS Group. On the other hand, Dr. Leslie White, one of the other pediatric oncologists on the staff of the Prince of Wales Hospital, was a "corresponding member" of a Children's Cancer Group in the United States, which itself belonged to the IRS Group.
In his trial testimony, Dr. White conceded that his membership was "for the hospital". The minutes of the Group's meetings were reaching him during the 1980s. He said that he usually saved these minutes as a useful source of general information. There was no restriction on sharing of the information he gained from the U.S. material, which included commentaries on the protocols. He admittedly was aware that defendant 2 had partially based his prescription for sarcoma patients on IRS II.
Dr. White turned over some documents he had received about a meeting of the Pediatric Oncology Group in Orlando, Florida, in April 1988. The minutes clearly informed any reader interested in the IRS II protocol that IRS III had taken its place and would have greatly reduced the quantities of chemicals given to plaintiff. The trial judge found in part that these doses and their frequencies of use had caused the plaintiff's injuries.
In his judgment, the lower court had inferred from Dr. White's evidence that he had failed to circulate the information in the Orlando minutes. "I would draw the same inference, as well as the further inference that it had not been circulated because the document had been a large one and Dr. White had not got around to reading it. Dr. White agreed that, had he been asked by Dr. Hughes whether he had any documentation in relation to the IRS II protocol, he would have searched through his documents and would have produced this document." [¶ 23].
At the end of trial, the judge entered a $7 million judgment against the hospital defendant but not against the estate of Dr. Hughes. Both sides appealed. The Court of Appeal of the Supreme Court of New South Wales affirms the judgment against the hospital but also finds against the estate.
"An important issue resolved by the judge concerned the circumstances in which Professor O'Gorman Hughes was unaware of the 1987 amendment to the IRS protocol. A reference to this amendment had been published before the [plaintiff's] treatment in a paper ... written by Frederick B. Ruymann, the Director of the Division of Hematology/Oncology at the Children's Hospital in the Ohio State University School of Medicine. He was a member of the IRS Group Committee at the time."
"The paper, which is said to have been written on behalf of the IRS Group, was included in a new medical journal, "Cancer in Children', dated December 1987. The paper stated that brain stem dysfunction in a small number of patients had prompted the amendment, which reduced TIT and avoided simultaneous TIT and radiotherapy. It identified in detail the reduced TIT as being administered in weeks 0, 6, 12 and 20 and then stopped ...." [¶ 26]
"The [trial] judge described the medical journal in which this paper had been published as "obscure' ... [and] not one Professor O'Gorman Hughes would have been expected to have seen. There was no evidence of any other published reference to the 1987 amendment to the IRS protocol prior to the respondent's treatment. ... A more detailed article concerning the amendment was published in the "Cancer' journal in 1992, after the [plaintiff] had received her treatment."
"The [trial] judge held that it was entirely reasonable' for Professor O'Gorman Hughes to expect that Dr. White would have been in a position to advise him of any relevant protocol changes which had occurred since IRS II, but that he had received no such advice from Dr. White." [¶¶ 27-28].
The lower court found that Dr. Hughes' ignorance of the amendment to the IRS [III] protocol did not result from negligence on his part. He concluded that Dr. Hughes had used a degree of diligence which would guarantee the prescription of treatment in accordance with the most current and considered guidelines available in the world.
The Court of Appeal first approves the finding of liability on the part of the hospital. "The judge held that Dr. White (for whose acts and omissions the hospital was vicariously responsible) had either failed to make himself aware of such information in the relevant Orlando document that the IRS protocol had been amended or he had failed to establish a system for the proper dissemination of such information throughout the department. That breach of his duty of care by Dr. White had materially contributed to the [plaintiff's] quadriplegia." [¶¶ 32-33].
"Dr. White was a pediatric oncologist in the pediatric oncology group. The clear inferences from all of the evidence are that he took part in at least the regular weekly meetings of that group, and that he knew that his colleagues in that group needed all of the relevant information he had gleaned from his overseas connections for the treatment of their patients, including Professor O'Gorman Hughes for the treatment of the respondent. Dr. White knew that Professor O'Gorman Hughes's protocol was based in part on IRS II, and that studies of the IRS Group were regarded as being studies of importance."
"When Dr. White did finally read the Orlando minutes, he realised the information they contained was significant to Professor O'Gorman Hughes's treatment of the respondent, as he drew this information to the attention of the defendants' legal advisers, and he agreed that, if he had been asked by Professor O'Gorman Hughes whether he had any information in relation to the IRS II protocol, he would have searched through his documents and would have produced these particular minutes; he also said that he would normally have circulated them when the document was received." [¶ 38]
"In my opinion, all of this material justified the judge's acceptance of a duty of care on the part of Dr. White in relation to the dissemination of the Orlando minutes to the members of the oncology department team. He did not find that Dr. White had a duty actively to seek out information from any particular overseas body; his implicit finding was merely that Dr. White had a duty to pass on information he had received from such bodies. I am not persuaded that the judge's conclusion that Dr. White had been negligent was erroneous. I would reach the same conclusion as the judge did for myself." [¶ 40].
The defendants next attack the judge's finding that, if Dr. Hughes had found out about the amendment to the IRS III protocol, he would have sought advice from members of the IRS Group as to the problems they had encountered by way of highly undesirable side effects from the chemotherapy being administered under the protocol. "The [defendants] submit that the judge should have accepted the evidence of their witness, Dr. Kellie, that in Sydney and Melbourne, it was very rare in oncological circles to seek advice from overseas in the initial stages of treatment but relatively common to seek assistance from overseas if unusual side effects are encountered in the course of the treatment." [¶ 41].
"The two situations are quite different. Where there has been no question of reliance on an overseas protocol involving a radical, experimental and controversial means of treatment, used rarely in the hospital, the practice described by Dr. Kellie may well be the usual one. In this case, however, the judge was fully entitled to conclude that Professor O'Gorman Hughes would have made inquiries once he knew that there had been an amendment to the IRS protocol on which he had in part relied in formulating his own protocol." [¶ 42].
"It was open to the judge to conclude that the treatment based in part on the earlier IRS protocol would not have been administered if Professor O'Gorman Hughes had been made aware of the amendment. My own conclusion is that Professor O'Gorman Hughes, after making inquiries of members of the IRS Group or others in relation to the amendment, would have adopted the advice given by the amendment, and the respondent would not have been rendered quadriplegic by the treatment administered to her. That, as I understand the judgment, is the effect of what the judge held. There was no error made by him in doing so." [¶ 47].
"The judge [also] held that Dr. White was negligent in failing either to make himself aware of the information in his possession relating to the amendment to the IRS protocol on which Professor O'Gorman Hughes relied or to establish a system for the proper dissemination of such information throughout the oncology department at the hospital. The judge then held that (1) the dosages and frequency of the chemotherapeutical agents administered by Professor O'Gorman Hughes at a higher level than those advised by the amendment to the IRS protocol had caused the respondent's myelopathy and consequent quadriplegia, and (2) if Professor O'Gorman Hughes had known of the relevant amendment, he would have modified the regime he had prescribed for the respondent." [¶ 50].
The appellate court, however, disagrees with the lower court as to the nonliability of Dr. Hughes. "I conclude that the system in place for sharing information in the oncology department of the hospital was insufficient for the treatment prescribed, that Professor O'Gorman Hughes was aware of the nature of the system in place, and that, by proceeding with the treatment of the respondent without ensuring that he had been placed in as good a position as if he had conducted a literature search and any necessary follow up inquiries himself, he failed in his duty to the respondent in the particular circumstances of this case to be in possession of all the necessary up to date information in relation to that treatment."
"I am satisfied that, if Professor O'Gorman Hughes had performed that duty, he would have become aware of the 1987 amendment to the IRS protocol, and that he would have modified the regime he had prescribed for the respondent. As the excessive dosages of Ara C by way of TIT and their frequency associated with the radiotherapy contributed to the respondent's myelopathy and thus her quadriplegia, causation is established as discussed earlier in this judgment." [¶¶ 71-72]
Citation: South Eastern Sydney Area Health Service v. King, [2006] N.S.W.C.A. 2; 2006 WL 496074 (New South Wales Ct. App. 2006).
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