Lawyers say the decision, which may be appealed, sheds light on the complexities involved in framing doctor-patient relationships in medical malpractice suits.
The deceased, David Stirrett, was participating in a research study that underwent changes before his angiogram, which had complications that were followed by death, the decision says. At the centre of the case is whether Strauss breached his fiduciary duty by failing to disclose those changes to the study, lawyers say.
“It just emphasizes the importance of all the possible ways of framing a medical malpractice lawsuit before starting it. It is a relatively complicated case from a legal perspective, which is why it’s fascinating,” says Paul Harte, a medical malpractice trial lawyer at Harte Law in Richmond Hill, Ont. who usually represents patients and victims of medical error but was not involved in this case.
Stirrett underwent an angioplasty in 2004 in Toronto, after a Scarborough cardiologist said there was a 90-per-cent blockage of one of Stirrett’s arteries, the decision said. Earlier on the day of his procedure, Stirrett, who was diabetic, was recruited at the hospital by a registered nurse to participate in a study called STREAM, led by Strauss, according to the decision.
In the study, one group of participants was trained on self-injecting insulin to better control blood sugar levels, while another group was encouraged to follow exercise and dietary recommendations, the decision said. A followup angiogram six months later would help researchers determine whether there was a change in the patients’ conditions, particularly a condition called restenosis, according to the decision.
The followup angiogram was not part of a “regular clinical practice” but was only for research purposes, and the procedure had a risk of one in 1,000 for complications such as heart attack, stroke or death, the decision said.
Cheema and Sheth, who were not involved in the STREAM study, performed a followup angiogram, when the inner and middle layers of the artery walls separated, blocking the blood flow in Stirrett’s heart, and he died a few days later, the decision said.
In 2003, the Heart and Stroke Foundation of Canada decided not to continue funding the study, and researchers reduced the anticipated number of participants to 100 moving forward, according to the decision. Additionally, Strauss told the court that a new, promising type of stent was invented and was being used in the years after Strauss started planning the STREAM study in 1999.
“Studies are really important to doctors in terms of academic success — getting published — and financial success, because doing studies attracts grants and creates revenue,” Harte says.
“The value of that study, in terms of the importance, was being greatly diminished.”
Despite the changes to the study, when Stirrett signed the consent form for the study in 2004, it listed a participation rate of “240 patients” and the Heart and Stroke Foundation funding was mentioned by the recruiting nurse, the decision said. Stirrett was not warned in advance of his angioplasty that he would be recruited for the study, nor was he told that the study was having difficulty finding qualified participants.
The results of the study were inconclusive, and Strauss’ work was published in 2012 and has been cited by other studies, the decision said.
“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 David Stirrett, it was not something for Dr. Strauss to decide,” Dow wrote in the decision. “His obligation, or duty, was to pass on these changes to David Stirrett.”
Because the case may be appealed, the lawyers involved declined to comment on particulars of the case.
“It is my belief that physicians have a duty to scrupulously adhere to a patient’s right to self-determination and autonomy,” says Richard Bogoroch, one of the lawyers representing the plaintiff.
William Black, a partner in the litigation group at McCarthy Tétrault LLP in Toronto and one of the lawyers that represented the defendants, says they are considering all the options, but they haven’t yet launched the appeal. He also notes that the case has raised “novel and interesting issues.”
One of the complexities of the decision was the distinction between the researcher-participant relationship and the doctor-patient relationship, says Elyse Sunshine, who practises at boutique health law firm Rosen Sunshine LLP in Toronto representing mostly health-care providers but who was not involved in this case.
“Unlike treatment, where we generally know risks and benefits and whatnot, the purpose, usually, of research is to answer a particular question,” Sunshine says. “The research itself benefits hopefully, ultimately, society. At that particular moment, it’s not necessarily going to benefit that particular individual. So, it’s thought there should be a higher obligation to make sure participants in research . . . [and] know all of those risks and benefits and the known and unknown and what we are trying to accomplish.”
The plaintiff in this case had separately made a claim of negligence, Dow wrote in the decision, but a jury found that while Strauss was negligent in several respects, the negligence was not the cause of Stirrett undergoing the angiogram.
Harte says the decision distinguishes between negligence and fiduciary duty, since in many cases the two claims will have the same result — but in this case, there is a distinction.
“The history of medical malpractice is littered with cases that failed on the basis of causation. The plaintiff was unable to establish that the error made a difference,” Harte says. “Let’s say, God forbid, you receive a delayed diagnosis of cancer — you find out when you are diagnosed that you could have been diagnosed a year earlier. It’s not easy to prove your outcome would have been different . . . If you had a 30-per-cent greater chance, you get nothing. You must be able to prove you had a better-than-50-per-cent chance of a better outcome.”
On the other hand, a breach of fiduciary duty involves a relationship where one party is so powerful and the other party is so vulnerable that “society holds them to a higher standard,” Harte says. A breach of fiduciary duty usually must be met with an “equitable remedy,” Harte says.
“Patients are easily exploited,” Harte says. “They want to give back. It was being sponsored by the Heart and Stroke Foundation, so it sounded credible and an important study. And [patients] are exposed to risk relative to marginal benefit to society. . . . This case gives another tool to attempt to get around the significant challenges associated with [showing] cause.”
One element of the case that may come up on appeal is whether the jury’s finding of negligence “mirrors” the claim of breach of fiduciary duty, says Valerie Wise, a lawyer at Wise Health Law in Toronto and Oakville, Ont. who represents health-care providers but was not involved in this case.
“The courts really look at how has the plaintiff framed the case,” Wise says. “If this is just about those [negligence] issues, and they are just repeated in the allegations of breach of fiduciary duty, that’s where I think it would be grounds to appeal to say, ‘Those allegations are mirrored.’”
Sunshine says that lawyers assisting health professionals involved in research may find the case helpful in understanding the obligations of research.
“If you’re not sure, err on the side of the patients’ interest or the participants’ interest,” Sunshine says.