Docs, here comes the judge: Don't worry about malpractice suits for recommending AS, but do worry about not recommending AS
What a relief: AS isn't cruel or unusual.
(Note: I don’t pretend to be a physician or play one on this substack newsletter. Now for another confession: Back in the 1970s, I considered becoming a lawyer. I was interested in practicing health or First Amendment/media law. A half dozen law schools accepted me. But, in the end, I concluded I could have a bigger impact—and more fun—as a news reporter.
(I covered major lawsuits and covered legal issues. Supreme Court Justice Thurgood Marshall presented me with an award for articles exposing abuse of patients institutionalized in mental hospitals. But I don’t pretend to be a lawyer, either. As a journalist, I am reporting below on a study showing that there is no malpractice case against active surveillance for patients with low-risk PCa.)
By Howard Wolinsky
A new study shows that Active Surveillance for low-risk cancer cannot only manages Grade Group 1 (Gleason 6) cancers but apparently helps urologists ward off malpractice suits.
Some urologists used to worry—maybe some still do—that they could be sued for malpractice if they put a lower-risk patient on AS and the cancer metastasizes and kills the patient.
However, a legal review of AS shows no support for this concern. In fact, it’s the Constitution, baby: Courts have rejected the arguments of prisoners that being put on AS was tantamount to violating the 8th Amendment of the U.S. Constitution, prohibiting cruel and unusual punishment. And not only that—urologists who don’t offer AS are open to malpractice suits.
Lead author Samuel Chang, JD, of Athene Law LLP in San Francisco, and medical colleagues from Cedars-Sinai Medical Center in Los Angeles report in the April issue of the Annals of Surgery on their review of the legal status of AS in prostate and several other cancers.
Across cancers surveyed in major legal databases, 201 cases were identified initially. Five low-risk prostate cancer cases related to active surveillance. No pertinent cases were found regarding active surveillance involving any other cancers.
Constitutional guarantees for prisoners
“Of the five prostate cancers, two cases involved incarcerated patients with Gleason 6 very-low-risk prostate adenocarcinoma managed with active surveillance by their urologists. In both cases, the patients alleged deliberate indifference, contending that their 8th Amendment right to be free from cruel or unusual punishment (ie, active surveillance) had been violated. No metastasis or spread had occurred in either case.
“In both cases, the court determined that management with active surveillance was performed in accordance with national standards of ‘sound clinical judgment’ and ‘accepted medical practices.’ The recommendation against prostatectomy was considered a difference in medical opinion rather than a lapse in judgment or substandard care.”
In contrast, three cases involved alleged physician negligence for not explicitly recommending AS as a treatment option after complications from surgery occurred. All cases showed documented informed consent for AS, leading to defense verdicts in favor of the physicians who documented informed consent for AS.
Methodology
Researchers looked through all state and federal U.S. civil trials involving medical malpractice and active surveillance for all cancer using Westlaw Edge (“Westlaw”) and LexisNexis Advance (“Lexis”), computerized legal databases covering case law.
The queries used the terms “active surveillance,” “watchful waiting,” “active monitoring,” or “observation” in conjunction with thyroid cancer, prostate cancer, kidney cancer, breast cancer, and lymphoma. Eligibility criteria encompassed any primary case involving the target cancer histologies and active surveillance as a reason for litigation. The lead and senior authors reviewed cases to determine relevance.
Constitutional issue? Or appropriate care>
Of the five prostate cancer cases pertaining to active surveillance, two involved “alleged deliberate indifference from AS as a management strategy but were ruled as following the appropriate standard of care.”
The authors note that AS “has emerged as a rational approach for tumors unlikely to be lethal or cause harm.” Active surveillance and variations, such as observation, active monitoring, and watchful waiting, are recognized as legit in NCCN (National Comprehensive Cancer Network) Guidelines for low-risk prostate, kidney, and thyroid cancers; standard of care for certain lymphomas such as chronic lymphocytic leukemia/small lymphocytic lymphoma; and are being explored in Stage 0 breast cancer.
Failure to mention AS triggering malpractice suits?
Chang et al. stressed: “Failure to discuss an NCCN-recommended approach as a treatment option with patients could be considered just as prone to litigation.”
They recommend strengthening patient communication and guarding against malpractice including thoroughly explaining active surveillance to patients, engaging with the institution’s compliance officers or legal counsel to develop standardized consent templates, and integrating patient preferences and personal values when proposing the treatment option.
(Timothy Daskivich, MD, Cedars-Sinai)
“This data should bolster physicians’ confidence in recommending active surveillance for their patients when it is an appropriate option,” said Timothy Daskivich, MD, co-author of the study and assistant professor of Surgery at Cedars-Sinai. “Active surveillance maximizes quality of life and avoids unnecessary overtreatment, and it does not increase medicolegal liability to physicians, as detailed in the case dismissals identified in this study. In fact, in some cases, physicians were sued because they didn’t offer active surveillance.”
‘Stubbornly haphazard’
The researchers note that AS adoption, even for prostate cancer with its 30-year history, has remained “stubbornly haphazard. Monitoring, rather than treating, an invasive malignancy can be unsettling for patients and counterintuitive to physicians.”
So it stands now that AS has made major gains in prostate cancer in recent years, with uptake now of 60% vs. 6-10% 13 years ago. But 40% still are treated. Yet places such as the state of Michigan, Sweden, and the U.K. show that 90% uptake of AS is possible.
MD worries about suits remain an AS barrier
The researchers note that a key barrier to the spread of AS is physicians’ “concern over the risk of AS-related malpractice stemming from unease that the window for cure may unexpectedly close. The inherent worry from a cancer diagnosis, coupled with the relative ease of intervention, poses practical challenges to physicians who wish to minimize exposure to litigation. Such a conundrum, especially in fields where AS is an emerging tool, could promote bias against AS and limit its implementation.”
With the emerging debate over whether Gleason 6 (Grade Group 1) cancer should be redefined as a noncancer, urologists again are expressing worries about patients abandoning surveillance and opening the door not only for risks for developing advanced cancers but also for malpractice suits. Could informed consent be a shield to protect urologists?
The authors conclude: “We find no evidence of successful malpractice litigation for active surveillance in cancer. Very few claims were identified, and all were dismissed, with court rationale serving as effective future precedent. For physicians, this should provide strong reassurance that recommending AS carries no outsized risk compared with upfront treatment. In fact, discussing AS as a robust treatment strategy may avoid decision regret and litigation related to informed consent.
“It is furthermore likely that medicolegal exposure is much lower with AS, given the lower chance of complications. The foundation of active surveillance rests upon factors identical to any intervention: proper counseling, judicious risk assessment, and realistic expectations. Our findings may help substantiate management recommendations based on medical judgment rather than medicolegal dread.”
Remember the Glee in Gleason Score Prostate Comedy Contest?
You may recall our contest last year. I’ve been reprinting some the jokes.
This time, I’ll share some quips from Gemini (formerly Bard AI) about low-risk prostate cancer with a Rodney Dangerfield-style spin.
"I went to the doctor and he said I had low-risk prostate cancer. I said, 'No respect!'"
"I tried to join a cancer walk, but they said my cancer wasn’t aggressive enough. No respect!"
"I'm so sick of people telling me I'm not a real cancer patient. I get no respect.”
Maybe, with time, AI jokes will improve?