Medicolegal Sidebar: Informed Consent in the Information Age

Introduction The process of informed consent is essential to building the doctor-patient relationship, and also to shared decision-making, whereby patients and doctors actively work together to formulate treatment decisions. Traditionally, physicians had nearly exclusive knowledge and understanding of disease, its course, and available treatments and associated risks. This is changing. Every physician now is an educator; transfer of relevant information empowers patients, facilitates shared decision-making, and supports the concept of truly informed consent. Informed consent has a legal foundation as well. Under the legal doctrine of informed consent, a doctor must provide enough information to help the patient make enlightened healthcare choices. One premise of informed consent was that patients do not know enough, and that the doctor knows more; this asymmetry of information must be countered by physician disclosure of all relevant risks to the patient. The information age has had a profound impact on many industries, including healthcare. Patients now can find detailed medical information on the Internet, including forums where patients with similar conditions communicate about their diseases and even comment about their physicians. As such, the notion of informed consent, premised on the inherent imbalance of information in favor of the physician, may be changing rapidly. History of Informed Consent The legal doctrine of informed consent is contained in the Nuremburg Code, a set of guidelines drafted at the end of World War II, to prohibit medical experimentation on humans, in the name of science. Informed consent is grounded in the notion of human autonomy—every person has the legal right to determine what is done, or not done, to his or her body [8]. The seminal case that developed the doctrine of informed consent is that of Canterbury v Spence [2]. In this case, a young man who developed paralysis after a lumbar laminectomy sued, claiming that the surgeon did not disclose loss of motor function as a possible complication of the procedure. The injured patient further claimed that had he known about the risk, he would not have undergone surgery. The court agreed; the defendant doctor had an affirmative duty to disclose those risks associated with the procedure that a reasonable person would find significant in terms of deciding whether or not to undergo the procedure. Canterbury, and similar legal rulings that followed in the United States, led to the modern formulation of informed consent law that is summarized in nearly every standardized consent forms used in hospitals today. Rather than rely on community or professional customs to decide how much to tell the patient, Canterbury clarified that a physician must disclose information about: (1) the condition being treated, (2) the nature and character of the treatment or operation offered, (3) the expected outcomes, (4) the alternatives to the proposed treatment, including nontreatment, and (5) the known risks, benefits, and complications attendant to the proposed treatments, and alternatives. To this day, the requirements set forth by the Canterbury court remain valid in obtaining informed consent before surgery. How Much to Disclose Although modern consent forms are a standard in hospitals today, the question of how much information to disclose has vexed physicians. There is a balance between too much data, and not enough information. Legal rulings through the years have identified certain exceptions to full disclosure. One exception to full disclosure is the so-called “therapeutic exception,” a concept that was introduced in the 1970 legal ruling in a case called Nishi v Hartwell [5]. The Hawaii court ruled that a physician can withhold information from a patient if that information would psychologically harm the patient, thereby risking his or her physical health. In Nishi, an elderly dentist had undergone angiography with a severe complication—paralysis from an adverse reaction to the test. The physician-defendants agreed that they had indeed avoided discussing this risk, contrary to the requirements of Canterbury, because they feared that the patient would have been too frightened to undergo the procedure. The court agreed, stating that “the primary duty of a physician is to do what is best for his patient and that a physician may withhold disclosure of information regarding any untoward consequences of a treatment where full disclosure will be detrimental to the patients total care and best interest” [5]. Thus, the court held a “therapeutic exception” of the established medical standard that “a competent and responsible medical practitioner would not disclose information which might induce an adverse psychosomatic reaction in a patient highly apprehensive of his condition” [5]. The Nishi exception to informed consent was watered down considerably by later rulings, but its premise remains valid law—even later rulings did not completely void the concept of a therapeutic exception to full disclosure. For example, one legal case clarified Hawaii statutory law by stipulating, among other things, that the physician is required to disclose “all recognized serious possible risks of harm and complications that the physician knew or should have known of, plus other information” [4]. Exceptions to informed consent were refined even further to include when disclosing medical information would pose a threat to the patient. For example, if full disclosure risks making the patient so upset that rational decision-making would be impossible, courts generally have not required disclosure. Likewise, if full disclosure is likely to cause psychological harm to the patient, a physician is not required to disclose. However, none of these exceptions apply if a doctor withholds information merely because he or she believes that the information may cause the patient to refuse a specific treatment, as had been the standard established by the earlier Nishi ruling. To summarize, a physician must disclose all information that a sensible individual would want to possess for medical decision-making, even though that information could lead to refusal of care of a treatment the physician believes is in the patient's best interest [3]. Consumer Advertising The FDA requires drug manufacturers to divulge all of the chief risks associated with a drug, meet accuracy standards, and include a balanced depiction of the product's risks and benefits. Consumer-directed ads for medical devices, such as artificial knees and hips, however, are not subject to such monitoring. Proponents of direct-to-consumer marketing (DTC) claim that it is an effective way to educate patients about medical devices. Modern DTC marketing increasingly relies on new interactive communications tools designed to not only educate, but also empower and engage patients and physicians alike. For instance, virtual reality, 3-D-based tools, and mobile applications can help patients envision life after treatment, and newer sensor technologies can even track patient data and symptoms in real-time, empowering the patient to share this information with the doctor. Implantable devices, such as total hip and knee implants, have a physical presence, and are amenable to patient visualization, touch, and emotion. The orthopaedic industry recognizes that these attributes can lead to powerful brand affinity. Patients may not understand complex clinical data and may need the physician for interpretation of such, but a physical, implantable device can play to the public fascination with technology. Patients easily relate to devices that help heal, correct, or enhance the quality of life. One example of a successful DTC campaign has been the “GetAroundKnee” marketing effort by Stryker (Kalamazoo, MI, USA), an orthopaedic implant manufacturer [9]. Targeting arthritis patients directly, the advertising played the femoral component design profile of a circle (a shape that is supposedly natural to the human body) rather than the oval side-profile found in competing femoral components. The goal was to have patients go to their surgeons and ask for the Stryker knee. The integrated campaign entailed print ads, online ads, an online website, and social media promotion. It was successful; between May and December 2012 alone, the dedicated website attracted more than 500,000 unique visitors, according to statements made by the company. While the design had been on the market for 5 years before the campaign, sales figures showed a gain in revenue and market share after the advertising campaign [6]. As other industry vendors have targeted orthopaedic patients directly, some orthopaedic surgeons have expressed concern that DTC marketing offers a skewed view of the risks and benefits of medical devices. Bozic et al. [1] have reported that 74% of surgeon respondents to their survey believed that DTC medical device ads “negatively impacted their relationships with patients.” Authors also reported that 60% of patients surveyed reported that they had “formed an opinion about the type of treatment or device that was appropriate for them before consulting with a doctor.” In other words, DTC marketing was highly effective in informing patients, regardless of the accuracy or integrity of the information gained by the patient [1]. The risk in DTC marketing of a medical device, such as a total knee implant, whether promoted by an advocate surgeon, or the implant manufacturer, is legal liability arising from a claim of “defective marketing,” a legal theory that is part of product liability law. In the case of the Stryker knee product advertised directly to the public, for example, defective custom cutting guides were recalled after the FDA received 44 reports of adverse incidents related to their use [10]. Discussion Interested stakeholders in the medical industry should revisit legal requirements concerning informed consent in light of improvements in information technology, and in light of trends in DTC marketing. The pendulum has taken a complete swing: Where patients once had too little information, they now are awash in a sea of Internet data, vendors’ claims, and physician disclosures of potential risks in boilerplate consent paperwork that few patients read, and even fewer can understand. Informed consent is a cherished value in western societies, and courts have gone to great lengths to protect patient autonomy and decision-making, requiring physicians to comply with disclosure requirements that have been developed over many legal rulings. At the heart of our concept of informed consent is the fundamental right of the patient to know. Has the Internet made informed consent obsolete, given the frequency with which patients self-educate about medical conditions, their treatments, and attendant complications? Has DTC marketing altered the relationship between physician and patient? How can one logically apply the informed-consent doctrine when a patient comes to the physician requesting medical management from advertising that the physician has not contemplated? Finally, are some patients so frightened by full disclosure that they truly avoid necessary treatment? These are formidable questions facing courts today as they grapple with informed consent in a world of preinformed consumers who also happen to be patients. The informed consent doctrine was created with the assumption that patients came to the physician or surgeon tabula rosa (blank slate). In the contemporary world in which we live, that may be an unwarranted assumption. Perhaps a solution is to add a fourth element to the informed consent doctrine. That element would require that a physician or surgeon include in the informed consent process an inquiry into the patient's information or misinformation, perception or misperception of what the benefits and risks are of the procedure. It might include adding to the informed consent process something as simple as, “Before I talk to you about the proposed treatment, could you tell me what you know about the treatment and what you believe the treatment can do to benefit you, as well as what fears that you may have about the harm the treatment could potentially cause you?” At a much deeper level it may be important to understand how DTC marketing has influenced the patient's preconscious perceptions of the outcome. It has been well documented that DTC marketing suggests that not only will the medication and procedure address the patient's health care needs, but it will transform the patient's life or the patient's family's life, in a significant, positive way [7]. We know this is not always the case. Inquiries into the patient's perception of how the proposed treatment would impact the patient's life may prevent patients from developing unrealistic expectations as to the treatment outcome. Accordingly, a revised informed consent doctrine in the modern world of instantaneous information via the Internet and DTC advertising would have four elements: (1) discussing with the patient what their preexisting understanding is of the proposed treatment, (2) explaining the known, realistic benefits of the procedure, (3) discussing the risks of the procedure without unnecessarily alarming the patient, and (4) discussing alternative treatments.