A recent Ontario medical malpractice decision highlights the importance of properly framing a doctor-patient relationship when trying to establish liability.
The case involved a cardiac patient who had participated in a research study and died as a result of a procedure performed during that study. The research physician running the study was found to have breached his fiduciary duty towards the patient by not informing him that certain elements of the study had changed; namely, that the number of study participants had decreased since the information was initially provided to the patient on a consent form.
The patient died on February 12, 2005, as a result of an angioplasty performed by one of the defendant physicians. After the patient’s death, his wife sued the two doctors for breach of their fiduciary duties and for negligence.
At the time of his death, the patient was 54 years old. He had been overweight and had non-insulin-dependent, Type II diabetes. He had been referred to a cardiologist who arranged for an angiogram to be carried out on June 7, 2004. The results of the angiogram revealed a 90% blockage (i.e. stenosis) in his left circumflex artery (a main artery to the heart). He was thereafter referred to have an angioplasty.
An angioplasty is a minimally invasive procedure in which a wire or catheter is inserted into an artery from the wrist or the groin and is moved, through the veins, to where a blockage has occurred (for example, in the heart).
The blockage is then stretched or pushed out of the way using an expandable balloon at the end of the wire/catheter or through the placement of a metal stent expanded into the artery (or both).
The so-called “STREAM Study” was granted three years’ worth of funding by the Heart & Stroke Foundation of Ontario in 2001. The purpose of the study was to determine whether “intensive control” of glucose levels using insulin would reduce stenosis, particularly in diabetic patients.
The study set out a number of specific parameters including:
- A sample size of 240 patients was required to ensure there were sufficient participants for the results to be statistically valid but would not risk more patients than necessary;
- A Data Safety Monitoring Board comprised of medical, ethical, and statistics experts would receive and review the data to monitor the safety of the trial;
- The patient consent form would include a policy statement of “full and frank disclosure of all information relevant to free and informed consent”, per the Tri-Council Policy Statement regarding ethical conduct for research involving humans (a necessary requirement for any study involving humans patients).
One of the two defendant physicians had participated in the development of the STREAM study (the research physician).
Patient Recruited into the STREAM Study
On the day of his angioplasty, the patient was recruited into the STREAM study by a registered nurse at the hospital on behalf of the research physician (who was the principal investigator for the STREAM study at that facility).
It was explained to the patient that, as part of the study, he would have to be prepared to self-inject insulin and to undergo a follow-up angiogram within 6 months. The consent form included the logo of the Heart & Stroke Foundation of Ontario and stated that:
- the patient would be part of a study of “about 240 patients similar to yourself”;
- participation was voluntary;
- the patient could withdraw at any time “without penalty”; and
- the patient’s doctor would inform the patient of any new information about the study that might influence the patient’s willingness to participate.
The patient was not told that in between when the original consent form had been drafted and when he had signed it:
- The study was having trouble finding qualified patients to participate;
- The Heart & Stroke Foundation had, for a variety of reasons including an inability to attract a sufficient number of patients, decided not to renew the third year of funding for the STREAM project;
- The research physician had continued to attempt to recruit patients even after funding for the study was not renewed;
- The research physician had not informed the hospital’s Research Ethics Board that he was going to continue to recruit patients even after low recruitment rates and withdrawal of the funding.
The research physician admitted at trial that the consent form should have changed to reflect the lower number of participants in the study but had not been changed before the patient had signed it and entered the study.
The court noted that a fiduciary duty can arise in a doctor-patient relationship, as recognized by the Supreme Court of Canada (SCC). While the SCC did not provide a framework as to how and when a fiduciary duty would arise, the court did note that “the most fundamental characteristic of the doctor-patient relationship is its fiduciary nature. All the authorities agree that the relationship of a physician to a patient also falls into that special category of relationships which the law calls fiduciary.”
A later SCC decision noted that “what is required [to establish a fiduciary relationship] is evidence of a mutual understanding that one party has relinquished its own self-interest and agreed to act solely on behalf of the other party.”
The Court’s Discussion on Fiduciary Duty in this Case
In discussing the facts at hand in this case, the court noted that the duty owed by a doctor to the patient was a fiduciary duty. Furthermore, this was a situation that involved medical research on a human where the patient-to-doctor relationship became a participant-to-researcher relationship. The obligation of a researcher to the participant where research involves humans is strict, with the following commentary from the SCC proving to be instructive:
…the doctor-patient relationship shares the peculiar hallmark of the fiduciary relationship- trust, the trust of a person with inferior power that another person who has assumed superior power and responsibility will exercise that power for his or her good and only for his or her good and in his or her best interest. Recognizing the fiduciary nature of the doctor-patient relationships provides the law with an analytic model by which physicians can be held to the high standards of dealing with their patients which the trust accorded them requires.
The Court’s Conclusions About Fiduciary Duty
On this basis, the court found that the research physician had a fiduciary duty towards the patient. This fiduciary duty was to comply with the terms set out in the consent form, which had been drafted in accordance with the principles set out in the Tri-Counsel Policy Statement, and which had been agreed to by the patient.
The consent form required the research physicians to inform the patient of any new information that would reduce the patient’s willingness to participate in the study. The research physician failed to do so.
In addition, it had been apparent, at the time of the patient’s participation, that the Heart & Stroke Foundation had contemplated the “closing” of the study, and that it would have to be resubmitted to the hospital’s Research Ethics Board.
The court noted that:
While the changes made in the STREAM study from when the consent form was drafted may not have been significant or changed the risk of harm to [the patient], it was not something for [the research physician] to decide. His obligation, or duty, was to pass on these changes to [the patient] (and to the Research Ethics Board) in order to permit them to re-evaluate their previous decision. This would have protected [the research physician] from liability.
The court went on to say:
[The research physician], by his action failed to give [the patient] the opportunity to consider, reflect and determine if he should ‘discontinue participation at any time during the study without penalty’. By not providing the information about the STREAM study which varied from the content of the consent form that was explained to [the patient] on [the day of his angioplasty] and to which [the research physician], as principal investigator at St. Michael’s hospital for the STREAM study agreed, [the research physician] breached his fiduciary duty.
The Benefits of Representation by a Dedicated Medical Malpractice Professional
Medical malpractice lawsuits are litigated much differently than most other personal injury lawsuits and involve extremely influential and powerful players including hospitals, large insurance companies such as Healthcare Insurance Reciprocal of Canada (HIROC), as well as the Canadian Medical Protective Association (CMPA).
Furthermore, there are specific and important limitation periods involved in medical malpractice lawsuits, numerous medical experts must be retained, and other procedural aspects must be met to be able to move successfully through the process. The stakes are enormous.
In addition to being highly technical, medical malpractice suits can take a significant amount of time, often even years, to resolve. All of this can significantly increase a family’s uncertainty, stress, and emotional turmoil following a medical injury, and contribute to their feelings of vulnerability and fear.
At Sommers Roth & Elmaleh we have successfully represented patients and the families of patients affected by medical negligence for more than 40 years. We have regularly been at the forefront of major developments in medical malpractice litigation, and have set a number of ground-breaking legal precedents. We have been recognized as being among the top medical malpractice firms in Canada, as demonstrated by the sheer number of medical malpractice cases we have successfully litigated.
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