Medical Research Under Scrutiny

On August 8 2006 Mr. Justice Browne of the Ontario Superior Court of Justice issued a decision with wide reaching implications for policy makers and researchers in the health care field. The relevant facts are:

The plaintiff was diagnosed with having Acute Lymphoblastic Leukemia when she was a young child.  In February 1995, the plaintiff was entered into a study referred to as protocol 9405 being a study of the Pediatric Oncology Group (“POG”).  It was alleged that she received chemotherapy treatment, which included the drug Methotrexate at a higher dosage than for all patients having a standard treatment or being treated at a lower dosage under a prior protocol and that as a result she sustained brain damage. An issue of informed consent arose as it was alleged that there was no information given by way of the consent form or otherwise as to the relative risk between treatment under this protocol, the prior protocol or standard treatment.  There was no issue that the drug dosage would increase toxicity. The pleadings allege that the chair of the POG group who was not involved in the care of the plaintiff was responsible for the POG treatment protocol 9405 and that she was negligent in failing to manage and supervise the development of the protocol; in failing to provide the research institution, the hospital, with adequate consent forms for the purpose of obtaining an informed consent to treatment, in failing to warn of all risks reasonably anticipated, specifically dealing with toxicity and brain damage and specifically, the increased likelihood of toxicity by a failure to warn of the relative increase in risk between the protocol use of Methotrexate and other treatments even using the same drug.  It was also pled that the chair of the POG was vicariously liable and that she had breached a contractual and a fiduciary obligation.

The court refused to strike the claim brought against the chair of the POG thereby allowing the issues to go to trial to be decided on a full evidentiary record. The ruling is significant as the court rejected arguments that the fact that the chair as a researcher and administrator not in a relationship of direct treatment and/or research vis a vis the particular patient was protected from liability. Indeed the court concluded that the bright light of day would be beneficial in an overall policy sense to researchers and the public generally in finding that the claim disclosed a recognized and reasonable cause of action. The full text of the decision may be found at

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