Thaddeus Mason Pope, JD, PhD
Informed consent is an important part of delivering quality cancer care. Traditional ethical and legal rules require clinicians to disclose three types of information: (1) the patient’s diagnosis; (2) the nature of the proposed intervention and its intended benefits, risks, and adverse effects; and (3) medically reasonable alternatives and their benefits, risks, and adverse effects.1 Recently, however, these traditional informed-consent rules have been expanding also to include nonmedical information. Increasingly, clinicians must disclose personal information, such as their training and experience.
Clinician Experience Improves Outcomes
In many areas of medicine, physician experience is positively correlated to better outcomes and improved quality of care.2,3 Several studies demonstrate the same relationship in oncology. Cancer treatment with more experienced clinicians is associated with more guideline-adherent therapy, reduced hospitalizations, and improved survival.4
For example, Boero et al found that patients receiving intensity-modulated radiation therapy for head and neck cancer had improved outcomes when treated by clinicians with a higher-volume practice in the procedure.5 Other studies show similar improvement with other cancers.6 And children with advanced cancer experience less fatigue when treated by more experienced oncologists.7
Traditional Informed-Consent Rules
This growing literature on the relationship between experience and outcomes has been reshaping informed-consent rules. Most states follow one of two dominant disclosure standards: the malpractice standard and the material-risk standard.8 About 25 states follow the malpractice standard. The other 25 states follow the material-risk standard. A growing number of states that observe the material-risk standard have been requiring clinicians to disclose their experience under some circumstances.
Cancer treatment with more experienced clinicians is associated with more guideline-adherent therapy, reduced hospitalizations, and improved survival.— Thaddeus Mason Pope, JD, PhD
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The malpractice standard requires physicians to provide patients with only that information a hypothetical reasonably prudent physician would disclose in the same circumstances. Since physicians do not customarily discuss their clinical experience with their patients, there is no duty to have such discussions in these states.8
Although the malpractice standard is physician-defined, the material-risk standard is patient-defined. It requires physicians to provide all the information that a hypothetical reasonable patient would consider important or significant in making a treatment decision.8 This disclosure duty is broader than the malpractice standard and increases the burden on physicians. After all, a reasonable patient may deem information important even if medical professionals do not customarily discuss that information.9
Before 2000, a handful of appellate courts in states adhering to the material-risk standard held that patients are “entitled to information concerning the treating physician’s experience with the particular procedure.”10-12 But these cases were outliers. Most courts have held that physicians do not have a duty to disclose physician-specific characteristics in obtaining a patient’s informed consent.13 They maintained that the doctrine of informed consent requires disclosure of only treatment-related facts and that expanding the doctrine would impose potentially significant burdens on physicians.14
Trend Toward Greater Disclosure of Personal Information
Since 2000, the trend has been toward greater disclosure of personal information. This is largely because data pertinent to the skill and experience of individual clinicians have been more routinely collected.15 An increasing number of courts and legislatures have held that physicians must disclose their experience and training when such information would be material to a reasonable patient’s decision about whether to undergo a proposed procedure.16-19 That 20-year trend has accelerated over the past 2 years.20-25
A growing number of states that observe the material-risk standard have been requiring clinicians to disclose their experience under some circumstances.— Thaddeus Mason Pope, JD, PhD
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For example, in 2017, the Superior Court of New Jersey imposed a duty to disclose experience.21 The defendant physician in that case severed the patient’s ureter while performing a robotic hysterectomy. While it is generally accepted that it takes 20 such procedures to become proficient and to minimize intraoperative injuries, the physician had performed only 3. The physician did not tell the patient about his lack of experience or the increased risk that it created.
In 2018, the Iowa Supreme Court held that there is a duty to disclose personal characteristics, such as experience and training.22 The patient in that case underwent a procedure to replace a flawed section of artery next to his heart. At the time, the surgeon did not have any experience or training in performing that procedure. The resultant complications included the patient being in a coma, undergoing a second heart surgery, and having a heart transplant.
Since 2000, the trend has been toward greater disclosure of personal information.— Thaddeus Mason Pope, JD, PhD
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The court concluded that a physician’s duty to disclose turns on whether a reasonable person in the patient’s position would consider the information to be material to the decision of whether to undergo the proposed treatment. The court further held that a physician’s experience or training with the proposed treatment can be information that is material to a reasonable person’s decision. Whether such information is material depends on the facts and circumstances of each case and is for the jury to decide.
These two cases are only illustrative. Over the past 2 years, courts in other jurisdictions have similarly held that physicians have a duty to disclose their experience and training. This is part of a broader trend in states adhering to the material-risk standard. Courts in these states increasingly recognize that nonmedical information, such as the physician’s health status, may be important to the patient’s decision.23-27
Here are three takeaway lessons for physician communication: First, never affirmatively overstate your experience.28 That risks not only liability, but also medical board discipline.29 Second, respond accurately to patient questions. Even when informed-consent rules do not require disclosure, you may never make misrepresentations. Third, only physicians in material-risk standard states must disclose their experience and training. Even these physicians have such a duty only when their lack of experience quantifiably and substantially impacts the relevant risk to a degree that the reasonable patient would find material. ■
Law and Ethics in Oncology explores the legal and ethical issues oncologists must be aware of in this era of precision medicine and changing health-care policy, both to protect patients’ rights and to safeguard against potential legal jeopardy.
Dr. Pope is Director of the Health Law Institute and Professor of Law at the Mitchell Hamline School of Law in Saint Paul, Minnesota (www.thaddeuspope.com).
Editor’s Note: The Law and Ethics in Oncology column is meant to provide general information about legal topics, not legal advice. The law is complex, varying from state to state, and each factual situation is different. Readers are advised to seek advice from their own attorney.
Disclaimer: This commentary represents the views of the author and may not necessarily reflect the views of ASCO or The ASCO Post.
DISCLOSURE: Dr. Pope reported no conflicts of interest.
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15. McWhirter R: Informed consent and performance data: Clinician experience as a material risk. University of New South Wales Law Journal 566. Available at http://classic.austlii.edu.au/au/journals/UNSWLawJl/2017/21.html. Accessed February 27, 2019.
20. Crane M: Lawsuit if you don’t disclose your lack of expertise? Medscape. October 30, 2018. Available at www.medscape.com/viewarticle/902188_3. Accessed February 27, 2019.
21. Forrest v Bonfield, No. CUM-L-83-11 (Superior Court of New Jersey Law Division–Civil Part, Cumberland County, January 19, 2017) (Geiger, J.) (Opinion).
27. Ginsberg MD: Informed consent: No longer just what the doctor ordered? Revisited. Akron Law Review. January 2019. Available at https://ideaexchange.uakron.edu/cgi/viewcontent.cgi?article=2446&context=akronlawreview. Accessed March 4, 2019.
28. Banja JD: Disclosure of experience as a risk factor in informed consent for neurosurgery: The case of Johnson v Kokemoor. Virtual Mentor 17:69-73, 2015.