Appeal leaves questions about fiduciary duty in clinical trials

An appeal in Stirrett v. Cheema, 2020 ONCA 288, has resulted in success for the appellants, including a research physician. Lawyers at the appeal, and intervenors on behalf of various interested parties, have highlighted the significant policy implications of this case and what it clarifies about the duty clinical trial physicians owe their subjects.

The suit stemmed from the death of David Stirrett, a participant in a clinical research trial, who died of complications arising from an angiogram he underwent as part of the trial. His widow, Karen Stirrett, sued the two physicians who performed the angiogram, Asim Nazir Cheema and Tej Narendra Sheth as well as the researcher, Bradley Strauss.

At trial, the jury found that Strauss alone was negligent in failing to update the sample size of his study, from 240 patients to 100 patients, failing to set up a data safety monitoring board, and failing to submit any deviations in protocol to the research ethics board. But they found that this negligence did not cause Mr. Stirrett to undergo the angiogram, applying a ‘but-for’ test.

The trial judge, Justice Grant Dow of the Superior Court, found that Strauss owed an ad hoc fiduciary duty to Mr. Stirrett, and breached that duty in the negligence found by the jury. He agreed with plaintiff’s counsel, Richard Bogoroch and Toby Samson, that with such a duty owed, causation is removed from the analysis. He found Strauss liable.

The appeal was allowed, examining two questions: whether a fiduciary duty was owed and whether Dow erred in saying causation was removed from the analysis. The Court of Appeal found that Dow had erred on the latter issue but did not decide on the first issue. Lawyers involved in the case have different opinions on the ramifications of that decision.

“Now in Ontario, the only decision [on an ad hoc fiduciary duty in clinical trials] is justice Dow's decision,” says Gavin MacKenzie who, along with Brooke MacKenzie stood for the respondent at the appeal. “[The decision] was not reversed by the Court of Appeal. The Court of Appeal didn't affirm it either.”

MacKenzie says that in any future cases arising out of medical research on human subjects, Dow’s decision will be referred to. If that decision comes before the Court of Appeal again, it will have to decide whether a fiduciary duty is owed in certain circumstances.

William Black and Christine Wadsworth, who acted for the appellant, say their successful strategy at the appeal was to focus on the question of causation, rather than the fiduciary duty question. They noted, however, that the fiduciary duty question has key ramifications for clinical research in Ontario.

“I do think that that importance of clinical research is part of the factual makeup of the case and the court clearly has said now that there is no per se fiduciary duty in the context of clinical researcher and participant,” Wadsworth says. “Whether or not there will be an ad hoc duty in any particular case will be very fact dependent.”

They stressed, as well, that the ruling in Stirret has confirmed the application of a ‘but for’ test even where a fiduciary duty is owed.

MacKenzie, however, maintains that if a fiduciary duty is found then causation should be removed from the analysis and the burden should shift to the defendant to show that they, the person who breached their duty, should be relieved of the obligation to make the damage good. He says the issue requires further clarification by the Supreme Court of Canada.

The case saw two interventions on the appellant’s side from the Canadian Cancer Trials Group and the Canadian Cardiovascular Research Collaboratory, both of which focused on the potential chilling affect any finding of even an ad hoc fiduciary duty could have on clinical research. Barbara Legate, founding partner at Legate Personal Injury Lawyers, intervened on the respondent side on behalf of the Ontario Trial Lawyers Association. She says a fiduciary duty must be owed in circumstances where the REB has not fully approved changes in a clinical trial.

“If the question is whether something ought to have gone to the REB, then that's the only question for the court to determine,” Legate says. “Once that determination is made, then the researcher ought to bear the consequences of failing to go to the REB.”

At the time Stirrett underwent the angiogram, elements of the trial had not been approved by the REB. If Dr. Strauss had waited for the approval of the REB and had obtained appropriate consent Legate says, a finding of negligence would be difficult. In a situation where the REB hasn’t given approval, though, Legate says the case should not be a question of negligence, rather it’s a question of whether or not the researcher should have continued with the trial. She says courts should make that determination based on expert evidence.

Alexandra Shelley, associate at Torys LLP, intervened on behalf of the Canadian Cancer Trials Group. She says they were concerned about any chilling effect the establishment of a fiduciary duty could have on clinical research, an area made all the more sensitive by the ongoing COVID-19 pandemic.

“The Court of Appeal because of their finding on causation declined to decide that fiduciary duty issue, but they did provide some helpful commentary on the existence of a fiduciary duty and the research realm,” Shelley says. “I think that gives us at least a framework going forward on how to decide if fiduciary duty exists.”

Shelley says the concern about the trial decision was that it found on a limited underlying analysis that the research doctor owed a fiduciary duty to their subjects. Shelly says that limited analysis makes it difficult to determine the reasoning. The concern, she says, was that it imposed a novel obligation on all research doctors. She says the Court of Appeal was clear that no per se fiduciary duty exists and the presence or absence of such a duty will be determined on a case-by-case basis.

“They picked up on the intervenors argument and affirmed that establishing a fiduciary duty in a clinical trial requires that the plaintiffs show that the defendant undertook the duty…to act in the beneficiary's best interest,” Shelley says. “That requirement of an undertaking is consistent with the Supreme Court's precedent, and substantially raises the bar on establishing that the researcher owes a fiduciary duty to a participant in a clinical trial.”