Although some oncologists may have fears about potential litigation associated with active surveillance in cancer care, new data on malpractice claims should instill confidence. A search for active surveillance–based lawsuits in the United States spanning 32 years found no successful claims. The findings were recently published in the Annals of Surgery.
Samuel Chang, JD, with Athene Law LLP in San Francisco, and coauthors searched Westlaw Edge and LexisNexis Advance databases from 1990 to 2022 for all U.S. malpractice cases involving active surveillance related to thyroid, prostate, kidney, or breast cancers or lymphoma. The search included jury verdicts, unpublished cases, trial orders, and administrative decisions.
“Our study canvassed widely across five common cancers, searching for cases where active surveillance led to medicolegal entanglements if cancers progressed – and we know that in a small percentage of cancers, they do progress. Yet no cases have yet come to light, despite an extensive search,” coauthor Allen S. Ho, MD, with the Samuel Oschin Comprehensive Cancer Institute at the Cedars-Sinai Medical Center in Los Angeles, told OBR.
The researchers identified only five cases that involved active surveillance as the point of allegation. All involved prostate cancers, and all were dismissed. Two cases centered on incarcerated patients with Gleason 6, very-low-risk prostate adenocarcinoma managed by urologists with active surveillance. In both cases, the patients alleged that active surveillance constituted cruel and unusual punishment and thus violated their 8th Amendment rights. No metastases or spread had occurred in either case. In both cases, the court determined that active surveillance was performed in line with “sound clinical judgment” and “accepted medical practices.”
The other three cases were brought because active surveillance was not presented or recommended as an option.
Those cases may offer a cautionary tale, said Daniel Barocas, MD, MPH, professor and executive vice chair of urology at Vanderbilt University Medical Center in Nashville. Over the course of the past two decades, leaders in urology have been trying to get the word out about the safety of active surveillance for low-risk cancers, he said, “so it is distressing that people are not recommending it in the appropriate settings.” He added that educating providers is key “to avoid the type of regret that the plaintiffs are expressing by suing doctors who didn’t recommend active surveillance.”
Dr. Barocas, who was not part of the study by Dr. Chang and colleagues, has participated in separate research that found a sharp rise in patients with low-risk prostate cancer choosing active surveillance. Use of the strategy increased from 16% in 2010 to 60% in 2018.
“Active surveillance is a crucial strategy to help people avoid overtreatment of low-risk cancers,” Dr. Barocas explained. “We really lament overtreating these low-risk cancers, because patients can end up with side effects and poor functional outcomes without real benefit.” Prostate cancer therapies may affect urinary and sexual function, and in the case of radiation, may also impair bowel function, he noted.
“Now, not only does the medical literature support the use of active surveillance, but it seems that the legal literature supports it as well. I’m relieved about that,” he added.
The authors of the malpractice study acknowledge that “the absence of evidence is not evidence of absence.” The databases do not contain all filed decisions made by a state regulatory agency, such as a medical board. In addition, not all federal and state decisions are published, and closed claims databases are not available.
Still, Timothy J. Daskivich, MD, also with the Oschin Institute, hopes that the findings bring some relief. “Hopefully, our study will help to eliminate this barrier to wider adoption of active surveillance,” he said.
Dr. Ho, Dr. Daskivich, and Dr. Barocas reported no relevant financial disclosures.
