Standardizing Autonomy, Medical Communication, Liability, and the Doctrine of Informed Consent

Standardizing Autonomy

Medical Communication, Liability, and the Doctrine of Informed Consent

Liza Edwards-Levin

Abstract

We analyze the reasoning behind several key legal decisions that influenced the development of medical informed consent law in the United States, beginning with (and continually referring back to) the landmark case of Canterbury v. Spence (1972). The paper discusses the complexity of at once upholding patients' autonomy and respecting physicians' professional expertise in the eyes of the law, through analyzing several widely-debated aspects of medical informed consent law (such as reasonable disclosure standards) that continue to be interpreted differently between and even within states.

I. Canterbury Sets the Stage

When 19-year-old Jerry Canterbury entered surgery to relieve pressure on his spinal cord in 1972, he could not have known what he was in for: a future disabled by urinary incontinence and partial paralysis from the waist down.1 Having complained of back and neck pain, Canterbury agreed to undergo a laminectomy (removing part of the vertebral bone) at the recommendation of neurosurgeon William Spence, who examined Canterbury to find evidence of a ruptured disk. When Canterbury’s mother inquired about the seriousness of the procedure, Dr. Spence described it as relatively low-risk, “not any more [serious] than any other operation.”2 Following the surgery, however, Canterbury slipped out of his hospital bed while attempting to urinate, after which his legs became numb and paralysis ensued. In the words of the D.C. Circuit Court of Appeals, today’s doctrine of medical informed consent law was precipitated by Canterbury’s “depressing tale” of medical practice gone wrong—and his “understandable search for reasons.”3 Canterbury v. Spence (1972) expanded the physician’s duty to care under medical malpractice law to include the obligation to disclose relevant information.4 In a landmark ruling that crystallized a new means of adjudicating informed consent, the Canterbury appeals court reversed the district court’s award of directed verdicts to the defendants (Dr. Spence and the hospital), ruling that sufficient evidence existed to establish that Dr. Spence violated his duty to disclose the operation’s risks.5 Unlike traditional medical battery law, which applied only to procedures performed without a patient’s authorization, Canterbury v. Spence established that in order to consent, physicians must inform their patients of a treatment’s material risks and alternatives: In this sense, a patient’s “lack of informed consent operates to negate [their] authorization for a procedure.”6 In addition to drawing on the doctrine of medical battery, the appeals court characterized Canterbury’s claim against Spence as one of negligence, stating, “[Canterbury’s] interest in bodily integrity commanded protection, not only against an intentional invasion by an unauthorized operation but also against a negligent invasion by his physician’s dereliction of duty to adequately disclose.”7 Canterbury v. Spence also marked a historic shift toward protecting patients’ autonomy—every adult’s fundamental “right to determine what shall be done with his own body”—over and above physicians’ expertise.8 The appeals court recognized that patients, typically lacking sophisticated medical knowledge, rely upon doctors to fulfill their “vital informational needs.”9 Further, Canterbury “judicially mandated” this doctor-to-patient information transfer by stating that physicians, not patients, are responsible for ensuring appropriate disclosure (that is, “describing the proposed treatment, its risks, benefits, complications and alternatives [including no treatment at all]”).10,11 Departing from precedent, the appeals court determined that doctors cannot be legally entrusted with judging the scope of adequate disclosure: such discernment should be left to the courts.12 Suggesting that

physicians may fail to align their professional standards with patient interests, the appeals court declared, “Respect for the patient’s right of self-determination on particular therapy demands a standard set by law for physicians rather than one which physicians may or may not impose upon themselves.”13 At the same time, not every doctor’s failure to inform could result in an informed consent claim. Besides demonstrating that their physician failed to disclose a procedure’s material risk, plaintiffs must also prove that a “reasonable patient [made aware of the risk] would more likely than not have opted not to undergo the procedure,” and that the undisclosed risk caused them to suffer a compensable injury.14 Furthermore, according to Canterbury, physicians are exempt from their duty to obtain informed consent in emergencies when the patient is “unconscious or otherwise incapable of consenting,” as well as in situations where risk disclosure would threaten the patient’s well-being.15 Yet, the very notion of informed consent is imbued with a certain degree of ambiguity. The Canterbury court adopted the novel “lens of reasonableness, rather than custom” to determine the materiality of a given risk, delineate physicians’ duty to disclose, and assess the validity of informed consent claims.16,17 However, assessing reasonableness—let alone standardizing it—has proven a challenging science. After all, individuals’ responses to, and interest in, the disclosure of specific risks may vary dramatically—posing the question: Is it possible to generalize the decision-making process of a mythical ‘reasonable’ patient? Even the Canterbury court acknowledged the delicate task of applying the standard in practice, stating, “There is no bright line separating the significant from the insignificant; the answer in any case must abide by a rule of reason.”18 Courts across the United States have since struggled to pinpoint the boundaries of reasonable disclosure. Wisconsin’s state courts interpreted Canterbury to justify the adoption of an excessively broad disclosure doctrine, leading state physician groups to protest against the harmful impacts of defensive medicine.19 While Canterbury has led some states to judge informed consent cases foremost according to the expectations of a reasonable patient (a standard that tends to favor plaintiffs in case outcomes), others defer to the reasonable physician’s expertise and instinct.20,21 In recent years, disclosure statutes enacted in Canterbury’s wake have required physicians to communicate information of varying medical accuracy to abortion-seeking patients in the name of women’s “right to know.”22 Today more than ever, patients are viewed as active consumers rather than passive recipients of healthcare, yet health literacy—patients’ ability to “acquire, understand, and use” medical information—varies widely across the population, rendering true informed consent unenforceable.23 Indeed, while an increasing majority of Americans seek out health information online, Americans’ self-reported dependence on healthcare providers to impart reliable information has not decreased as a result: patient-provider communication remains at the core of patients’ medical decision-making.24 Still, in the nearly 50 years since Canterbury v. Spence was decided, the doctrine of informed consent and its resulting policies have failed to chart a course toward Canterbury’s destination of greater patient understanding.

II. Knowledge is Power? Informed Consent and Full Disclosure

Where does reasonable disclosure end? Wisconsin’s courts wrestled with this question for decades following the state’s enactment of a 1981 statute mandating physicians’ “full disclosure” of risks beyond Canterbury’s scope. The statute, Wis. Stat. §448.30 (“Information on Alternate Modes of Treatment”), centered doctors’ duty to disclose around the patient’s condition rather than the physician’s diagnosis. Indeed, Wis. Stat. §448.30 required physicians to not only disclose information (risks and alternatives) relevant to their proposed therapy, but to additionally list the “benefits and risks” associated with “all alternate, viable medical modes” of treating the patient’s condition.25 Between Martin v. Richards (1993) and Jandre v. Physicians Insurance Company of Wisconsin (2012), the statute’s ambiguous use of the word “treatment” underwent intense scrutiny: Wisconsin’s legal definition of “treatment” expanded dramatically, then narrowed, as patients and physicians respectively defended their personal and professional judgment.26 While the political motivation behind Wis. Stat. §448.30 remains unclear, its legal implications for Wisconsin physicians proved substantial.27 In Martin v. Richards (1993), the Wisconsin Supreme Court interpreted the statutory meaning of “treatment” to encompass the conditional treatment of risks associated with the patient’s diagnosis, beyond the immediate treatment of the diagnosis at hand. After 14-year-old Cheryl Martin crashed her bike into the back of a truck, emergency room physician William Richards diagnosed her head injuries as a concussion, noting “the possibility of intracranial bleeding.”28 When Dr. Richards recommended to Martin’s family that she remain at Fort Atkinson Memorial Hospital (FAMH) for observation, he failed to mention that the hospital had no neurosurgeon on staff and thus would be incapable of treating a “neurological complication such as intracranial bleeding” should such a risk materialize.29 Martin did in fact suffer an intracranial bleed during her stay at FAMH, and a helicopter rushed her to the University of Wisconsin hospital in Madison where she underwent two emergency surgeries several hours later; her injuries left her a “partial spastic quadriplegic.”30 Martin and her family sued Dr. Richards for negligence, and the applicability of their informed consent claim was debated extensively as the case moved through Wisconsin’s courts. After the Jefferson County Circuit Court granted Dr. Richards’ motion to dismiss the informed consent claim, the Wisconsin Court of Appeals reversed the circuit court’s dismissal and remanded the case.31 The Wisconsin Supreme Court affirmed the appeals court’s decision on the basis of informed consent, finding Dr. Richards liable under the standard established by Wis. Stat. §448.30. Having considered the risk of an intracranial bleed, Dr. Richards claimed he did not believe Martin was bleeding at the time he diagnosed her concussion, and thus did not think she required care at a facility with a neurosurgeon. In his argument before Wisconsin’s Supreme Court, Dr. Richards posed the question, “Why should we inform the patient that we don’t think we should do something?”32 The supreme court responded by invoking the reasonable patient standard established by Canterbury, calling

that standard “the very point of [Wis. Stat. §448.30]”: The court stated, “Here the doctor was concerned about the possibility of an intracranial bleed. When a reasonable person would want to know about an alternative treatment or method of diagnosis such as a CT scan or hospitalization in a facility with a neurosurgeon, the decision is not the doctor’s alone to make.”33 As such, the court reasoned that Wisconsin physicians’ disclosure of “all alternate, viable medical modes of treatment” under Wis. Stat. §448.30 must include available treatment options (and their material risks) for potential complications related to the patient’s diagnosis. Indeed, rather than being selectively filtered through a physician’s professional judgment, Martin v. Richards established that a physician’s disclosure must contain all that a “reasonable person would [or could] want to know,” including treatments for statistically rare but serious complications like intracranial bleeding. Wis. Stat. §448.30 and the precedent set by Martin informed the Wisconsin Supreme Court’s decision in Jandre v. Physicians Insurance Company of Wisconsin (2012), which expanded physicians’ disclosure duty even further to include discarded diagnoses. Thomas Jandre was evaluated by emergency room physician Therese Bullis with symptoms of “drooling, slurred speech and one-sided facial droop, dizziness, and leg weakness”; after testing Jandre for multiple types of stroke events (hemorrhagic and ischemic strokes) and brain tumors, Dr. Bullis diagnosed him with Bell’s palsy, a “diagnosis of exclusion” dependent on ruling out all other possible conditions.34,35 Eleven days later, Jandre “suffered a full-blown stroke, [impairing] his physical and cognitive abilities.”36 A carotid ultrasound subsequently revealed a significant blockage in Jandre’s carotid artery, indicative of an ischemic stroke event. Unfortunately, Dr. Bullis had incorrectly ruled out the possibility of an ischemic stroke through “listening to Jandre’s carotid arteries with a stethoscope,” which she herself admitted to be a relatively unreliable screening method.37 In her examination of Jandre, Dr. Bullis had declined to order a carotid ultrasound—a more accurate diagnostic tool that could have detected the blockage. Jandre’s family sued Dr. Bullis for negligence, bringing forth claims of informed consent as well as negligent care and treatment.38 A trial court jury concluded that, although Dr. Bullis was not negligent in her diagnosis of Bell’s Palsy, she breached her disclosure duty under Wis. Stat. §448.30 when she did not inform Jandre of the option to conduct a carotid ultrasound test for ischemic strokes. This judgment was upheld by the Wisconsin Court of Appeals, and ultimately affirmed by Wisconsin’s Supreme Court in their review of the case.39 Citing Martin v. Richards and Wis. Stat. §448.30, the Jandre court found that a physician’s duty to disclose should be dictated by the patient’s condition (“the symptoms that the patient displays”), not limited to their diagnosis.40 Indeed, while intracranial bleeding was not part of Dr. Richards’ diagnosis of concussion but rather a possible complication of Martin’s injury, the Martin court held that Dr. Richards should have disclosed the potential for intracranial bleeding to develop (and the hospital’s ability or inability to treat it) in order for the Martin family to make properly informed decisions about their daughter’s medical care. In the case of Jandre, the supreme court applied its previous, condition-centered informed consent

standard to justify an even broader reading of Wis. Stat. §448.30, whereby “the distinction between conditions ‘related’ to the final diagnosis and conditions ‘unrelated’ to the final diagnosis finds no support in the statute or case law.”41 In other words, the court determined that a physician’s duty to disclose includes diagnostic procedures and treatments for conditions related to the patient’s symptoms, yet unrelatedto the physician’s final diagnosis— namely, conditions discarded by the physician in the diagnostic process.42 Further, the Jandre court asserted that a physician’s inadequate disclosure of information could be deemed negligent even when their diagnosis and treatment were not, marking a sharp divergence between the professional standard used to review medical care and the patient standard for adjudicating informed consent. The medical malpractice action filed against Dr. Bullis by Jandre included claims of negligent misdiagnosis as well as negligence with respect to informed consent. In their request for review, the Physicians Insurance Company of Wisconsin (PIC) contended that the inconsistency of the jury’s original verdicts rendered the informed consent claim invalid. Given that Dr. Bullis’ diagnosis of Bell’s palsy—though incorrect—was found not to be negligent by the professional standard applied to misdiagnosis claims, PIC argued that Dr. Bullis had no enforceable duty to inform Jandre about the carotid ultrasound, a diagnostic test for an unrelated diagnosis of ischemic stroke.43 Physician-defendant Dr. Richards made a similar argument in Martin, claiming that if his diagnosis and care was not negligent, then “as a matter of law” he could not be found negligent for “failing to discuss a diagnosis which he did not make.”44 However, as noted in Justice Roggensack’s dissenting opinion, while Fort Atkinson Hospital’s inability to treat intracranial bleeding (should it develop as a result of Ms. Martin’s concussion) could be construed as a risk inherent in Dr. Richards’ proposed treatment, in Jandre’s case ischemic stroke represented a separate diagnosis altogether—and a discarded one at that.45 The Jandre court justified this expansion of mandated disclosure of treatments and diagnoses under Wis. Stat. §448.30 by distinguishing the discrete legal standards applicable to Jandre’s respective claims of negligent diagnosis and negligent disclosure—maintaining that while physicians may rely on professional custom to adjudicate their treatment, care, and diagnosis, informed consent is governed by the reasonable patient’s desire for information “regardless of what disclosures may be customary in the medical profession.”46 In Jandre, these two standards appear at odds: Jandre’s (retrospective) wish to hear the full range of possible diagnoses, tests, and treatments related to his symptoms would have undermined Dr. Bullis’ diagnosis of Bell’s palsy. The Wisconsin Supreme Court’s refusal to delimit risk materiality at once obstructed and weakened physicians’ diagnostic prerogative. Despite insisting that its application of the reasonable patient standard would not impose strict liability upon physicians, the Jandre court’s unusually broad definition of materiality suggested otherwise. On the one hand, the court took pains to emphasize the limits of physicians’ disclosure duties, reassuring doctors that they had “no duty to provide information to patients about tests” that a reasonable patient would not consider material.47 At the same time, physicians could deem few

procedures definitively immaterial according to Jandre’s standard, whereby, “[f]rom the perspective of the patient, the materiality of risk has nothing to do with whether that risk comes from a potential condition that is related to the final diagnosis, as in Martin … or from a potential condition that the physician has eliminated, though not unequivocally, as in the present case.”48 According to Canterbury v. Spence, a risk is material when a reasonable person would consider it a significant factor in deciding whether to undergo the proposed treatment.49 With the legal definition of materiality expanded under Jandre to include all risks posed by discarded diagnoses, physicians faced an impossible decision: inundate patients with the details of virtually every possible diagnosis, test, treatment, and risk associated with their condition—relevant or not—or fear the specter of an informed consent lawsuit. This concern appeared in the Wisconsin Medical Society’s amicus brief, which predicted that the Jandre court’s interpretation of Wis. Stat. §448.30 would require physicians to tell their patients, “I believe in my diagnosis but if my diagnosis is wrong, here are all the other things you should consider,” thereby inviting patients to “[usurp] their professional judgment.”50 Jandre’s overbroad application of informed consent threatened to harm physicians and patients alike, leading Wisconsin’s Hospital Association and Medical Society to lobby in favor of amending Wis. Stat. §448.30. The state’s medical associations expressed concern that Jandre would drive Wisconsin doctors to practice defensive medicine, unnecessary procedures conducted so as to avoid future malpractice suits.51 Beyond the unsustainable economic costs imposed by defensive medicine, an average-length doctor’s appointment of 13 to 20 minutes simply would not afford enough time for physicians to disclose and explain the breadth of information required under Jandre’s reading of Wis. Stat. §448.30—let alone obtain their patient’s informed consent to proceed with treatment.52 Moreover, physicians have argued that “the very objective of the doctrine of informed consent [would] be undermined” by presenting patients with an inordinate amount of information surrounding alternate conditions beyond their diagnosis.53 After all, many patients lack health literacy, the ability to process and understand essential health information. Rather than resulting in more informed patients, Jandre-style disclosure—more information and more choices—may leave patients overwhelmed and confused.54 Indeed, psychological research has revealed that decision-makers become “rapidly overwhelmed by having to consider more than a few options,” and in situations perceived as risky, individuals often rely on emotional reactions (rather than objective facts) to drive their choices.55,56 Existing evidence does not suggest that receiving “an endless variety of choices and options” would equip patients to make maximally informed healthcare decisions.57 Further, more care has not been shown to produce better results. Though patients may gravitate toward the seeming security of “more aggressive medical care,” patients in regions favoring aggressive care tend to have poorer health outcomes and lower satisfaction rates.58 Fearing increased liability and anticipating disruptions to their professional practice, physician groups’ efforts to revise Wis. Stat. §448.30 succeeded when Wisconsin adopted a new informed consent statute in 2013. Abandoning its prior reasonable patient standard, the

updated statute instead deferred to the reasonable physician to determine informed consent, as well as clarifying that physicians must no longer disclose “information about alternate medical modes of treatment for any condition the physician has not included in his or her diagnosis at the time the physician informs the patient.”59 While professional custom may not reliably dictate the most effective means of risk disclosure, Wisconsin’s lawmakers ultimately agreed that a legal remedy was the wrong prescription: “judges and juries ought not [play doctor].”60

III: Whose Reason Rules: State by State, Divergent Standards

Since Canterbury v. Spence, two broad standards have emerged by which informed consent cases are adjudicated in the United States. Some states (about half) have privileged patients’ self-determination over professional tradition through adopting a version of Canterbury’s reasonable patient standard, gauging the adequacy of physicians’ disclosure based on what a reasonable patient would consider important to their medical decision.61,62 Meanwhile, other states have decided against the patient-centered standard, questioning its feasibility and fairness. Such states have determined that a physician-defendant’s disclosure should be judged against the customary practices of fellow doctors in the community, an approach known as the reasonable physicianor professionalstandard. The distinction between these standards appears to tangibly influence the outcomes of informed consent lawsuits: research has demonstrated that states with a reasonable physician standard are significantly less likely to rule in patients’ favor.63 Indiana is one such state. In the case of Culbertson v. Mernitz (1992), Patty Jo Culbertson’s cervix improperly adhered to the wall of her vagina following a bladder suspension and cryosurgery performed by Dr. Roland Mernitz, a complication for which Culbertson underwent subsequent surgery by another doctor. When Culbertson filed an informed consent suit against Dr. Mernitz claiming that he failed to disclose the surgery’s “inherent risks and complications,” Dr. Mernitz requested summary judgment based on a medical review panel’s assessment of the case.64 Despite acknowledging Dr. Mernitz’s lack of disclosure, the panel held that he did not violate “the appropriate standard of care” because cervical adhesion to the vagina “is not considered a risk of such surgery requiring disclosure to the patient.”65 Considering this finding alongside Culbertson’s lack of opposing expert testimony, the trial court entered summary judgment in Dr. Mernitz’s favor. However, the Fulton Circuit Court of Appeals went on to side with Culbertson, stating that the trial court jury had not addressed one key issue of fact—namely, whether the potential for cervical adhesion would pose a material risk to a reasonable patient.66 In reviewing the case, the Indiana Supreme Court affirmed the trial court’s original decision to grant summary judgment. The supreme court held that most informed consent cases would require expert medical testimony to ascertain what a “reasonably prudent physician would disclose” to

inform the patient’s choice of treatment.67 Rather than expect physicians to “peer into the brain” of a “hypothetical ‘reasonably prudent patient,’” the court reasoned that physicians’ disclosure should be evaluated according to the professional norms of fellow doctors— although patient-plaintiffs may believe their “right of self-decision” to be profoundly hindered as a result.68 Furthermore, the court maintained that laypeople (e.g. lay juries) lack sufficient medical knowledge to accurately comprehend the relative significance of risks accompanying the majority of medical procedures.69 Indiana’s decisive instatement of the professional standard in Culbertson v. Mernitz countered the Canterbury court’s assertion that laypeople’s reasonableness should override medical custom to judge informed consent. Hawaii’s legal history of informed consent tells a different story—one of patient as protagonist. In the state’s landmark case of Carr v. Strode (1995), when Robin Carr’s vasectomy failed, he alleged that Dr. Walter Strode had neglected to inform him of the risk of remaining fertile after the procedure. Had he been made aware of this risk, Carr testified that he would have decided against the surgery.70 Although a trial jury of Hawaii’s First Circuit Court upheld Carr’s informed consent claim against Dr. Strode, the circuit court judge entered a judgment notwithstanding the verdict (JNOV) in Dr. Strode’s favor based on the plaintiff’s lack of expert medical evidence, and conditionally granted Dr. Strode’s motion for a new trial pending the results of an appeal.71 Indeed, the Hawaii Supreme Court’s prior ruling on the issue of informed consent pointed in Dr. Strode’s favor, having required medical testimony to establish failure to disclose: two years prior to Canterbury, in Nishi v. Hartwell (1970), the supreme court validated informed consent as a tort cause of action yet affirmed a trial court’s dismissal of the case because plaintiff Nishi had failed to “adduce expert medical testimony” to prove the inadequacy of physician-defendant Dr. Hartwell’s disclosure.72 Faced with a similar case in Carr v. Strode, however, Hawaii’s Supreme Court embraced Canterbury to overrule precedent in light of recent norms surrounding informed consent, contrasting Indiana’s stubborn rejection of the patient standard that Canterbury sought to advance. Despite their pre-Canterbury application of the reasonable physician standard in Nishi v. Hartwell, Hawaii’s Supreme Court reversed the circuit court judge’s JNOV in Carr v. Strode and remanded the case for a new trial on the issue of informed consent, citing Canterbury’s reasoning as well as a “growing nationwide trend [reflected in Hawaii’s lower court decisions] favoring the patient-oriented standard.”73 In their comparison of the physician- and patient-oriented standards, the Carr court opined that both “seek to achieve the same goal” of “[ensuring] informed and intelligent” patient decision-making.74 Ideally, the scope of disclosure dictated by each standard would align in keeping with this shared aim. Still, acknowledging the significant difference between the two means of judging physicians’ conduct, the court explained its choice to adopt the patient standard in Carr v. Strode through arguing that the medical community’s concept of what a patient needs to hear is an insufficient metric by which to determine an individual patient’s informational needs.75 While expert testimony would still be required to demonstrate

the materiality of medical risk, following Carr v. Strode Hawaiian courts no longer invited medical professionals to establish the scope of reasonable disclosure on their patients’ behalf. Alabama’s case of Fain v. Smith (1985) illuminates the challenge of legally defining not only reasonable disclosure, but reasonable consent on the patient’s behalf—particularly in the wake of a distressing medical mistake. The Alabama Supreme Court heard the appeal of plaintiff Duncan Fain, whose heart was erroneously punctured during a pulmonary arteriogram. After Fain’s informed consent case against physician-defendant Dr. R. T. Smith was decided in Dr. Smith’s favor by a district court jury, on appeal Fain held that the jury had applied the wrong standard to assess proximate cause.76 While Fain and Dr. Smith concurred that the risk of heart puncture should have been disclosed prior to the procedure, the two parties disputed whether Dr. Smith’s inadequate disclosure actually caused Fain’s injury: if Fain had been properly informed, would it have altered his decision to undergo the diagnostic test? Fain argued that the district court should have employed the subjective standard, by which the plaintiff’s own testimony constitutes sufficient proof that “he would not have consented to the procedure had he been advised of the particular risk in question.”77 On the other hand, according to the objective standard,the jury must consider factors beyond the patient’s self-serving testimony to ascertain, more generally, how a “reasonable person in the patient’s position” would have responded to the disclosure of all material risks.78 Alabama’s Supreme Court affirmed the district court’s judgment and upheld the objective standard, deeming it “fairer to both plaintiff and defendant.”79 While it is true that a patient-plaintiff’s account of what they would have done is unavoidably shaped by 20/20 hindsight, Justice Jones and Adams’ dissenting opinions in Fain v. Smith raised the point that true objectivity in discerning causation may be virtually impossible.80 Indeed, given that prudent patients vary in their responses to risk disclosure, Jones found the so-called objective standard to be fundamentally subjectivewith respect to juries, essentially tasking “each juror … with subjectively determining what he or she would have done.”81 Furthermore, even under the objective standard, the Alabama Supreme Court stated that the factfinder in an informed consent case must surmise the decision of a hypothetical patient who shares the plaintiff’s “idiosyncrasies,” “religious beliefs,” and all other relevant traits.82 While Adams argued that a patient-plaintiff’s testimony alone should not conclusively dictate causation, he also claimed that no standard filtered so narrowly through the patient’s point of view can call itself “objective.” He wrote, “When we build into the standard, as we have done here, ‘all of the characteristics of the plaintiff,’ … we no longer have the reasonable person standard.”83 Finally, Jones contended, courts should not seek to honor the self-determination of “reasonable persons alone.” Despite its claims of objective fairness, Jones asserted that the informed consent doctrine advanced by Canterbury chiefly “[safeguards] the right of individual choice, even where it may appear idiosyncratic” or even unreasonable.84

IV: Where Will Canterbury Take Us?

Only a small fraction of the United States population possesses expert medical knowledge, yet we are almost all patients at some point, faced with medical decisions that weigh heavily on our lives. In the landmark U.S. Supreme Court case of Dent v. West Virginia (1889), which empowered states to regulate the medical profession, the Court described doctors’ ubiquitous influence, “Every one may have occasion to consult [a physician], but comparatively few can judge of the qualifications of learning and skill which he possesses.”85 The foundation of modern-day informed consent law, Canterbury v. Spence (1972) affirmed the principle that no individual should be expected to relinquish their claim to bodily autonomy upon entering the doctor’s office: “Every human being of adult years and sound mind has a right to determine what shall be done with his own body.”86 Within medical malpractice law, the doctrine of informed consent attempts to foster and protect informed patient decision-making. Ideally, informed consent law equips patients with the information they need to determine the direction of their medical treatment—without compromising physicians’ ability to provide quality care. Since Canterbury, however, the relationship between medicine and law has remained more adversarial than synergistic. In a dramatic tug-of-war that literally rewrote the state’s informed consent policy, Wisconsin’s courts and doctors spent decades haggling over the highly contested, inherently personal territory of what a reasonable patient needs to know. The Indiana Supreme Court’s refusal to cast physicians as mind readers in Culbertson v. Mernitz and Hawaii’s commitment to following the mores of patient autonomy in Carr v. Strode illustrate the nation’s split between physician- and patient-centered disclosure standards—seemingly, a question of whose rationale a state’s courts should champion. But, is the issue quite so simple? Should it be? Medical informed consent is, after all, a two-way street, encompassing both physicians’ disclosure of risk information and patients’ resulting treatment decisions. Fain v. Smith rested on whether the divulgence of an undisclosed material risk would have caused the patient-plaintiff to withhold consent, thus preventing his injury. The Alabama Supreme Court endeavored to determine who should be trusted to verify causation: Patients? Jurors? Doctors? Standardizing a patient’s hypothetical past decision-making is by no means an exact science. No metric, legal or otherwise, is capable of calculating the degree to which an individual’s medical choices would have been impacted by a risk unknown to them at the time. When the law of informed consent purports to know better than physicians and patients alike, the doctrine’s original goal is hindered. In the recent case of EMW Women’s Surgical Center, P.S.C. v. Beshear (2019), the U.S. Sixth Circuit Court of Appeals invoked Canterbury to justify upholding Kentucky’s Ultrasound Informed Consent Act (H.B. 2), a statute that required doctors to perform and display an ultrasound, explain the images in their own words, and play the fetal heartbeat out loud before obtaining an abortion patient’s consent.87 Although H.B. 2 mandated disclosing the consequences of abortion for the fetus— not the patient undergoing the procedure—the Sixth Circuit nonetheless affirmed the state’s

right to compel physicians’ divulgence of medical information deemed “truthful, nonmisleading, and relevant.”88,89 Citing Canterbury’s assertion that medical custom should not dictate the bounds of mandatory disclosure, the court went so far as to deem physicians’ qualms with the statute irrelevant.90 By “eviscerating physician discretion,” however, the court precluded physicians from respecting their patients’ autonomy, thereby undermining the very objective of informed consent.91 Beyond infringing on physicians’ professional expertise— about one-third of the information that abortion informed consent statutes force doctors to disclose is medically inaccurate—such an approach to informed consent also threatens to erode patients’ trust in medicine through inflicting needless emotional injury.92 One abortion patient subject to a Texas statute’s consent requirements recalled her nightmarish experience: “The description the doctor provided was perhaps the most devastating part because although our baby was profoundly ill, he had healthy organs too. So, the doctor was forced to describe – and I to hear – that he had a well-developed diaphragm … His words were unwelcome and I felt completely trapped.”93 In order to facilitate more effective patient-provider communication, informed consent law must recognize its own limits. Malpractice liability already exacts a high economic cost on the United States healthcare system: a 2010 study found that “medical liability system costs, including defensive medicine” comprise 2.4 percent of the nation’s total healthcare spending, upwards of $55.6 billion annually.94 If the doctrine of informed consent expanded to mandate the disclosure of treatment-adjacent information such as medical costs, financial conflicts of interest, and physicians’ personal and professional history (as some ethicists advocate), the already-blurry lines distinguishing material from immaterial and reasonable from unreasonable would dissolve, rendering a fair, efficient litigation model unachievable.95 Moreover, opening the informed consent floodgates in this way would regiment a clinical conversation that, like the idiosyncratic patient themselves, escapes standardization. As Sawicki suggests, patient- and physician-oriented disclosure standards need not be viewed in opposition; indeed, a patient’s “informational needs” cannot be isolated from the practices of their surrounding medical community.96 In an era of increasingly crowdsourced medical knowledge and widespread misinformation, providers should be held responsible for disclosing the baseline risks and alternatives associated with a procedure.97 Yet, physician disclosure does not guarantee patient understanding, nor does knowledge of medical risk ensure a positive outcome. True informed consent—awareness of the known, acceptance of the unknown—relies on legal questions, not legal answers.

Liza Edwards-Levin is a senior at Brown University studying Social Analysis and Research and English in the nonfiction writing track.

Notes

1 Roberts, “Jerry Canterbury, Whose Paralysis Led to Informed Consent Laws, Is Dead at 78.” 2 Canterbury v. Spence, 464 F.2d. 3 Canterbury v. Spence, 464 F.2d. 4 Bobinski, “Law and Power in Health Care: Challenges to Physician Control,” 616. 5 Bobinski, 614. 6 Kelly, “THE RISE OF MEDICAL BATTERY AND INFORMED CONSENT,” 22. 7 Canterbury v. Spence, 464 F.2d at 793. 8 Canterbury v. Spence, 464 F.2d at 780 (citing Schloendorff v. Society of New York Hospital (1914)). 9 Canterbury v. Spence, 464 F.2d at 782. 10 Ginsberg, “Beyond Canterbury,” 109. 11 Bobinski, “Law and Power in Health Care: Challenges to Physician Control,” 618. 12 Canterbury v. Spence, 464 F.2d at 786. (“The duty to disclose, we have reasoned, arises from phenomena apart from medical custom and practice. The latter, we think, should no more establish the scope of the duty than its existence.”) 13 Canterbury v. Spence, 464 F.2d at 780, 784. 14 Sawicki, “Modernizing Informed Consent: Expanding the Boundaries of Materiality,” 8–9. 15 Canterbury v. Spence, 464 F.2d at 788. (“Two exceptions to the general rule of disclosure have been noted by the courts. Each is in the nature of a physician’s privilege not to disclose, and the reasoning underlying them is appealing. Each, indeed, is but a recognition that, as important as is the patient’s right to know, it is greatly outweighed by the magnitudinous circumstances giving rise to the privilege…”) 16 Bobinski, “Law and Power in Health Care: Challenges to Physician Control,” 617. 17 Canterbury v. Spence, 464 F.2d at 785. (“We hold that the standard measuring performance of that [duty to disclose] by physicians, as by others, is conduct which is reasonable under the circumstances.”) 18 Canterbury v. Spence, 464 F.2d at 787. 19 Ginsberg, “INFORMED CONSENT AND THE DIFFERENTIAL DIAGNOSIS: HOW THE LAW CAN OVERESTIMATE PATIENT AUTONOMY AND COMPROMISE HEALTH CARE,” 371–72. 20 Sawicki, “Modernizing Informed Consent: Expanding the Boundaries of Materiality,” 10. 21 Studdert et al., “Geographic Variation in Informed Consent Law,” 120. 22 Daniels et al., “Informed or Misinformed Consent?,” 181–82. 23 Ginsberg, “INFORMED CONSENT AND THE DIFFERENTIAL DIAGNOSIS: HOW THE LAW CAN OVERESTIMATE PATIENT AUTONOMY AND COMPROMISE HEALTH CARE,” 392. 24 “The Great American Search For Healthcare Information,” 2, 11. 25 Wis. Stat. § 448.30, Information on alternate modes of treatment. 26 Jandre v. Physicians Insurance Company of Wisconsin, 813 N.W.2d at 672. (“‘Treat’ is not a defined term. The undefined term appears six times in different forms in Wis. Stat. §448.30.”) 27 Ginsberg, “INFORMED CONSENT AND THE DIFFERENTIAL DIAGNOSIS: HOW THE LAW CAN OVERESTIMATE PATIENT AUTONOMY AND COMPROMISE HEALTH CARE,” 361. (“There is nothing contained in the legislative history materials obtained from the Legislative Reference Bureau indicating why the proposed legislation was so broad. The proposed legislation

may have been a product of a political agenda unknown to this author. Whatever the motivation for the statute, it would become an enemy of Wisconsin physicians.”) 28 Ginsberg, 74. 29 Martin by Scoptur v. Richards, 531 N.W.2d at 74. 30 Martin by Scoptur v. Richards, 531 N.W.2d at 74. 31 Martin by Scoptur v. Richards, 531 N.W.2d at 75. 32 Martin by Scoptur v. Richards, 531 N.W.2d at 80. 33 Martin by Scoptur v. Richards, 531 N.W.2d at 80–81. 34 Ginsberg, “INFORMED CONSENT AND THE DIFFERENTIAL DIAGNOSIS: HOW THE LAW CAN OVERESTIMATE PATIENT AUTONOMY AND COMPROMISE HEALTH CARE,” 369. 35 Jandre v. Physicians Insurance Company of Wisconsin, 813 N.W.2d at 641. 36 Jandre v. Physicians Insurance Company of Wisconsin, 813 N.W.2d at 641. 37 Jandre v. Physicians Insurance Company of Wisconsin, 813 N.W.2d at 641. (“Dr. Bullis admitted at trial that listening to the carotid arteries for a bruit is a ‘very, very poor screening test for determining what shape the arteries are in.’”) 38 Jandre v. Physicians Insurance Company of Wisconsin, 813 N.W.2d at 686. 39 Jandre v. Physicians Insurance Company of Wisconsin, 813 N.W.2d at 627. 40 Jandre v. Physicians Insurance Company of Wisconsin, 813 N.W.2d at 627. (“The essence of the decision in Martin, Wisconsin’s informed consent doctrine, and Wis. Stat. §448.30 … is that when a reasonable person would want to know about an alternative treatment or method of diagnosis, the decision is not the doctor’s alone to make. It is the condition of a patient, that is, the symptoms that the patient displays, that drives the duty to inform, not the diagnosis.”) 41 Jandre v. Physicians Insurance Company of Wisconsin, 813 N.W.2d at 648. 42 Jandre v. Physicians Insurance Company of Wisconsin, 813 N.W.2d at 652. (“We apply the principle stated in Martin that it is Jandre’s condition, not Dr. Bullis’ diagnosis of Bell’s palsy, that drives the scope of Dr. Bullis’ duty to inform Jandre in the present case. Jandre’s symptoms indicated that he might be suffering from any number of conditions, of which a stroke seemed one of the most plausible and most capable of inflicting immediate, severe harm.”) 43 Jandre v. Physicians Insurance Company of Wisconsin, 813 N.W.2d at 649. (“PIC’s basic argument is that it is anomalous to impose liability for breach of the duty to inform the patient when, as in the present case, the physician was not negligent in her care and diagnosis of the patient.”) 44 Jandre v. Physicians Insurance Company of Wisconsin, 813 N.W.2d at 650. 45 Jandre v. Physicians Insurance Company of Wisconsin, 813 N.W.2d at 680. (“In Martin, the recommended treatment for Ms. Martin’s head trauma was to remain at Fort Atkinson Hospital for careful observation. However, the risk of that treatment, i.e., a significant delay in surgery if it became necessary due to an intracranial bleed, was not explained.”) 46 Jandre v. Physicians Insurance Company of Wisconsin, 813 N.W.2d at 649, 650. (“Under Wisconsin law, negligence in failing to abide by the professional standard of care and negligence in failing to obtain informed consent are two separate and distinct forms of malpractice, with two different standards of care. A failure to diagnose is one form of medical malpractice. A failure to obtain informed consent is another discrete form of malpractice, requiring a consideration of additional and different factors. There is nothing anomalous or inconsistent in holding that a reasonable patient may

want information about alternative diagnostic techniques when the physician was not negligent in using one of multiple alternative, non-negligent techniques. To hold otherwise would substantially undercut the reasonable patient standard.”) 47 Jandre v. Physicians Insurance Company of Wisconsin, 813 N.W.2d at 662. (“Physicians have no duty to provide information to patients about tests that would not be material to a reasonable patient. The holding in the present case does not give patients leave to request all conceivable tests. Nor do physicians have a duty to perform tests that are not medically reasonable.”) 48 Jandre v. Physicians Insurance Company of Wisconsin, 813 N.W.2d at 656. 49 Canterbury v. Spence, 464 F.2d at 772. (“A risk is material when a reasonable person, in what the physician knows or should know to be the patient’s position, would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forego the proposed therapy.”) 50 Jandre v. Physicians Insurance Company of Wisconsin, 813 N.W.2d at 674. (“No other area of human interaction embraces the proposition that a professional must give a layperson the choice of usurping their professional judgment. There is no practical guidance on how to meet this obligation.”) 51 Ginsberg, “INFORMED CONSENT AND THE DIFFERENTIAL DIAGNOSIS: HOW THE LAW CAN OVERESTIMATE PATIENT AUTONOMY AND COMPROMISE HEALTH CARE,” 392. 52 Ginsberg, 393. 53 Jandre v. Physicians Insurance Company of Wisconsin, 813 N.W.2d at 663. (“Both here and in Martin, the physicians argued that ‘extending’ the informed consent duty to include alternate modes of diagnosis unrelated to a non-negligent final diagnosis would unnecessarily inundate patients with more information than they can possibly manage. The physicians contend that in this way the very objective of the doctrine of informed consent will be undermined.”) 54 Ginsberg, “INFORMED CONSENT AND THE DIFFERENTIAL DIAGNOSIS: HOW THE LAW CAN OVERESTIMATE PATIENT AUTONOMY AND COMPROMISE HEALTH CARE,” 393. 55 Ubel and Loewenstein, “The Role of Decision Analysis in Informed Consent: Choosing Between Intuition and Systematicity,” 647. 56 Loewenstein et al., “Risk as Feelings,” 267. 57 Jandre v. Physicians Insurance Company of Wisconsin, 813 N.W.2d at 673. (“Once diagnosis is determined to come within treatment, we are likely to be confronted with an endless variety of choices and options, some of which will entail no bodily invasion whatsoever. Many states appear not to embrace diagnosis in their informed consent statutes or cases for this very reason.”) 58 Fisher et al., “The Implications of Regional Variations in Medicare Spending. Part 2: Health Outcomes and Satisfaction with Care.” 59 Wis. Stat. § 448.30, Informed consent. 60 Jandre v. Physicians Insurance Company of Wisconsin, 813 N.W.2d at 671. 61 Canterbury v. Spence, 464 F.2d at 787 (quoting Waltz & Scheuneman). (“In broad outline, we agree that ‘[a] risk is thus material when a reasonable person, in what the physician knows or should know to be the patient’s position, would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forego the proposed therapy.’”) 62 Sawicki, “Modernizing Informed Consent: Expanding the Boundaries of Materiality,” 9. (“In the United States, jurisdictions are more or less evenly divided between a patient-based standard and a physician-based standard for identifying the information that must be disclosed as part of the informed consent process.”)

63 Studdert et al., “Geographic Variation in Informed Consent Law,” 115–17. 64 Culbertson v. Mernitz, 602 N.E.2d at 99. 65 Culbertson v. Mernitz, 602 N.E.2d at 99. 66 Culbertson v. Mernitz, 602 N.E.2d at 99–100. (“The Court of Appeals agreed with the Culbertsons that the trial court had erroneously entered summary judgment on Counts II and IV because an issue of fact remained as to whether the risk of cervical adhesion to the vagina was a ‘material risk.’ The court further held that that issue was a question for the jury which does not require expert testimony as to materiality, although expert testimony might be required to establish the existence and extent of the risk.”) 67 Culbertson v. Mernitz, 602 N.E.2d at 100. 68 Culbertson v. Mernitz, 602 N.E.2d at 103. (“When viewed through the eyes of the physician, it is easy to see that a physician should not be required to guess or speculate as to what a hypothetical ‘reasonably prudent patient’ would ‘need to know’ in order to make a determination … From a physician’s viewpoint, he should not be called upon to be a ‘mind reader’ with the ability to peer into the brain of a prudent patient to determine what such patient ‘needs to know,’ but should simply be called upon to discuss medical facts and recommendations with the patient as a reasonably prudent physician would. On the other hand, from the patient’s viewpoint, the physician should be required to give the patient sufficient information to enable the patient to reasonably exercise the patient’s right of self-decision in a knowledgeable manner.”) 69 Culbertson v. Mernitz, 602 N.E.2d at 104. (“We therefore hold that, except in those cases where deviation from the standard of care is a matter commonly known by lay persons, expert medical testimony is necessary to establish whether a physician has or has not complied with the standard of a reasonably prudent physician.”) 70 Carr v. Strode, 904 P.2d at 502. (“Carr further indicated that he would not have undergone the first vasectomy procedure if he had known that it might fail or allow him to become fertile in the future.”) 71 Carr v. Strode, 904 P.2d at 491. 72 Carr v. Strode, 904 P.2d at 494. (“Because Nishi had failed to adduce expert medical testimony regarding what physicians in the community disclosed to their patients regarding the particular medical procedure, we affirmed the trial court’s dismissal of Nishi’s complain, and by so holding, adopted the ‘physician-oriented’ standard of disclosure for actions based on the doctrine of informed consent.”) 73 Carr v. Strode, 904 P.2d at 499. 74 Carr v. Strode, 904 P.2d at 498. (“Both standards, therefore, tempered by objectivity, seek to achieve the same goal, that is, to ensure that the patient’s decision to undergo a particular medical procedure is an informed and intelligent decision.”) 75 Carr v. Strode, 904 P.2d at 499. (“Moreover, not only should the patient’s decision remain at the forefront when assessing the physician’s disclosure to his or her patient in each case, but we also believe that, barring situations where the therapeutic privilege exception to the physician’s duty to disclose is applicable, what the medical community believes the patient needs to hear in order for the patient to make an informed decision is insufficient, without more, to resolve the question of what an individual patient reasonably needs to hear in order for that patient to make an informed and intelligent choice regarding the proposed medical treatment.”)

76 Fain v. Smith, 479 So. 2d at 1154. (“Plaintiffs contend in brief that the objective standard does away with consideration by the jury of the patient’s testimony concerning his thoughts.”) 77 Fain v. Smith, 479 So. 2d at 1152. 78 Fain v. Smith, 479 So. 2d at 1155. 79 Fain v. Smith, 479 So. 2d at 1154. 80 Fain v. Smith, 479 So. 2d at 1154. 81 Fain v. Smith, 479 So. 2d at 1159. (“If there is no one reasonable person, each juror is left with subjectively determining what he or she would have done (e.g., ‘Well, I’m reasonable, so what would I have done in this situation?’).”) 82 Fain v. Smith, 479 So. 2d at 1155. 83 Fain v. Smith, 479 So. 2d at 1164. 84 Fain v. Smith, 479 So. 2d at 1158 (citing Katz). 85 Dent v. West Virginia, 129 U.S. at 122. 86 Canterbury v. Spence, 464 F.2d at 780 (citing Schloendorff v. Society of New York Hospital (1914)). 87 EMW Women’s Surgical Center, P.S.C. v. Beshear, 920 F.3d at 423. (“Under [Roe v. Wade (1973)], a woman has the right to choose to have an abortion. To inform that choice, the Commonwealth of Kentucky directs a doctor, before performing an abortion, to ascultate (or make audible) the fetal heartbeat, perform an ultrasound, and display and describe the ultrasound images to the patient.”) 88 EMW Women’s Surgical Center, P.S.C. v. Beshear, 920 F.3d at 424. (“Thus, even though an abortion-informed-consent law compels a doctor’s disclosure of certain information, it should be upheld so long as the disclosure is truthful, non-misleading, and relevant to an abortion.”) 89 EMW Women’s Surgical Center, P.S.C. v. Beshear, 920 F.3d at 444. (“To give the patient more information that is truthful, non-misleading, and relevant to a medical procedure is the epitome of ensuring informed consent.”) 90 EMW Women’s Surgical Center, P.S.C. v. Beshear, 920 F.3d at 439. (“If the validity of an informedconsent law depended on whether doctors agreed with the law—or whether the law required disclosures that, with no law, the doctor would disclose anyway—there would be no need for the law to supplement custom.”) 91 EMW Women’s Surgical Center, P.S.C. v. Beshear, 920 F.3d at 447 (Donald, B., dissenting). (“Under the prevailing standard of care, informed consent requires respect for the patient’s autonomy and sensitivity to the patient’s condition. Physician discretion is vital, but H.B. 2 eviscerates physician discretion.”) 92 Daniels et al., “Informed or Misinformed Consent?,” 181. 93 EMW Women’s Surgical Center, P.S.C. v. Beshear, 920 F.3d at 458. 94 Mello et al., “National Costs Of The Medical Liability System,” 1569. 95 Sawicki, “Modernizing Informed Consent: Expanding the Boundaries of Materiality,” 26. 96 Sawicki, 16. 97 Swire-Thompson and Lazer, “Public Health and Online Misinformation.”

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