American Journal of Law & Medicine

Reconceptualizing Consent for Direct-to-Consumer Health Services

The market for direct-to-consumer (DTC) health services continues to grow rapidly with former patients converting to customers for the opportunity to purchase varied diagnostic tests without the involvement of their clinician. For the first time a DTC genetic testing company is advertising health-related reports "that meet [Food and Drug Administration] standards for being clinically and scientifically valid." Ethicists and regulatory agencies alike have recognized the need for a more informed transaction in the DTC context, but how should we classify a commercial transaction for something normally protected by a duty of care? How can we assure informed agreements in an industry with terms and conditions as varied as the services performed? The doctrine of "informed consent" began as an ethical construct building on the promise of beneficence in the clinical relationship and elevating the principle of autonomy-but in the DTC context should we hold providers to legal standards of informed consent and associated medical malpractice liability, or contractual obligations where consumers would seek remedy for breach?

This Article analyzes the fine balance that must be struck in an industry where companies are selling services for entertainment or non-medical purposes that possess the capacity to produce serious and disquieting medical information. It begins by reviewing current standards of consent in the clinical setting from both a legal and ethical perspective and then lays forth current standards for DTC consent using two currently controversial case studies: that of keepsake fetal ultrasound and genetic testing.

DTC keepsake ultrasound and genetic testing providers attempt to de-medicalize the devices used for these procedures from their intended medical uses to non-medical uses. But while keepsake ultrasound is marketed as "intended for entertainment purposes only, " it can provide medical information as an incidental finding. 23andMe currently purports to be the only DTC genetics service that "includes " reports that meet FDA qualifications, despite disclaimers of intent to "provide medical advice. " The attempted de-medicalization of these devices, therefore, has not been fully transformative, and DTC providers should have more robust ethical and legal duties than the average goods and services seller.

This Article delineates these responsibilities, beginning with ethical duties surrounding marketing, entering into, and providing DTC services. It then turns to the legal paradigms necessary to enable, or at least allow for, DTC providers to meet these ethical obligations. While it argues that contractual, as opposed to fiduciary, requirements are most appropriate and that waivers of liability will likely be upheld, it also advocates for a heightened expectation of disclosure during contracting.

  I. INTRODUCTION
 II. CONSENT TO MEDICAL SERVICES IN THE CLINICAL SETTING
     A. Informed Consent to Medical Services in the Clinical Setting
        1. Ethical Considerations Regarding Informed Consent to
           Medical Services in the Clinical Setting
        2. Legal Paradigm of Informed Consent to Medical Services in
           the Clinical Setting
     B. Contracting for Medical Services in the Clinical Setting
        1. Arguments in Support of the Use of Contracts for Medical
           Services in the Clinical Setting
        2. Arguments Against the Use of Contracts for Medical
           Services in the Clinical Setting
III. CONSENT TO SERVICES IN THE DIRECT-TO-CONSUMER SETTING
     A. Introduction to Direct-to-Consumer Services
     B. Purchasing Direct-to-Consumer Services Through a Trained
        Intermediary: A Case Study of Keepsake Fetal Ultrasound
        1. Introduction to Keepsake Fetal Ultrasound
        2. Medical and Ethical Concerns Regarding Keepsake Fetal
           Ultrasound
        3. Current Consent Standards for Keepsake Fetal Ultrasound
        4. Legal Responses Relevant to Keepsake Fetal Ultrasound
     C. Purchasing Direct-to-Consumer Services from a Manufacturer: A
        Case Study of Genetic Testing
        1. Introduction to Direct-to-Consumer Genetic Testing
        2. Scientific and Ethical Concerns Regarding
           Direct-to-Consumer Genetic Testing
        3. Current Consent Standards for Direct-to-Consumer Genetic
           Testing
        4. Legal Responses Relevant to Direct-to-Consumer Genetic
           Testing
IV.  RECONCEPTUALIZING CONSENT FOR DIRECT-TO-CONSUMER
     SERVICES
     A. Ethical Models for Reconceptualizing Consent for
        Direct-to-Consumer Services
        1. Introduction to Integrative Social Contracts Theory
        2. Introduction to the Partial Entrustment Model
     B. Ethical Duties of Providers of Direct-to-Consumer Services
        1. Ethical Obligations of Selling Direct-to-Consumer Services
        2. Ethical Obligations of Entering into the
           Direct-to-Consumer Services Relationship
        3. Transactional Duties Acquired during the Direct-to-Consumer
           Relationship
     C. Applying Legal Paradigms to Consent for Direct-to-Consumer
        Services
        1. Contracting Versus Providing Informed Consent for
           Direct-to-Consumer Services
        2. Waivers of Liability for Direct-to-Consumer Services
        3. Legal Disclosure Obligations while Contracting for
           Direct-to-Consumer Services
        4. Why Direct-to-Consumer Trained Intermediaries Do Not Rise
           to the Level of Learned Intermediaries
V.   CONCLUSION

I. INTRODUCTION

The market for direct-to-consumer (DTC) health services continues to grow rapidly with former "patients" converting to "customers" to purchase varied diagnostic tests without the involvement of their clinician. (1) For the first time, a DTC genetic testing company is advertising that its product "includes reports that meet [Food and Drug Administration (FDA)] standards for being clinically and scientifically valid." (2) Tests available DTC include genetic risk assessments, fetal ultrasounds, blood tests, and full body scans either directly from device manufacturers or through intermediaries with related training. (3) Ethicists and regulatory agencies alike have recognized the need for a more informed transaction in the DTC context, (4) but how do we classify a commercial transaction for something normally protected by a duty of care? How can we assure informed agreements in an industry with proffered consents, waivers, terms and conditions, and contractual obligations as varied as the services they perform? The doctrine of "informed consent" began as an ethical construct building on the promise of beneficence in the clinical relationship and elevating the principle of autonomy. (5) But in the DTC context, should we hold providers to legal standards of informed consent and associated medical malpractice liability, or to contractual obligations where consumers would seek remedy for breach?

Government committees, scholars, and the public have begun to call for enhanced communication surrounding what these DTC companies are, and are not, offering to consumers. For example, in 2014, FDA issued a public warning strongly discouraging the use of fetal ultrasound for the sole purpose of keepsake photography as it provides "no medical benefit" while risking unknown long-term effects. (6) In 2013, FDA sent the popular genetic testing company 23andMe a Warning Letter because of concerns about "the public health consequences of inaccurate results," shutting down DTC access to genetic information for two years while the company worked through the clearance process. (7) The U.S. Presidential Commission for the Study of Bioethical Issues ("Bioethics Commission") released a report the same year highlighting the need for "industry-wide best practices" for the DTC model as there is no "coherent framework for regulating these enterprises." (8) As these government entities point out, while there are federal quality standards for these medical devices, some companies provide DTC services outside of regulatory boundaries (and even against expert advice). (9) But should a free market exist for such services? And what types of information do consumers need to make informed choices about what is safe, effective, and a good bargain?

To begin answering these questions, Part II of this Article revisits current standards for consent to medical services in the clinical setting. It reflects on the foundational ethical principles upon which the doctrine of consent is founded and presents a brief history of how this ethical ideal has been translated into case law. It then compares arguments that have been made in favor of and against the use of contracts for clinical medical services, including case law prohibitions on waivers of physician liability. (10)

After establishing an understanding of how the ethics and legalities of the doctrine of informed consent interplay in the clinical setting, Part III will turn to consent standards for services in the DTC setting. As there is not a comprehensive standard for what DTC consent should entail here, this Part will instead ask what the current norms are and present new empirical data on the topic. It will use two contested DTC services, keepsake ultrasound and genetic testing, to introduce the industry, layout medical and ethical concerns, and highlight the limitations of current regulatory response.

As example products, this Article argues that DTC keepsake ultrasound and genetic testing providers attempt to de-medicalize their devices from their intended medical uses to non-medical uses. But while keepsake ultrasound is marketed as "intended for entertainment purposes only," (11) it can provide medical information as an incidental finding. (12) 23andMe's current DTC genetic testing product returns 36 carrier status reports, generally recognized as health information, (13) despite disclaimers that it "do[es] not provide medical advice." (14) The attempted de-medicalization of these devices (15) has not been fully transformative and this Article argues that DTC providers have more robust ethical and legal duties than the average goods and services seller. Thus, Part IV of this Article analyzes the ethical obligations at play in the DTC industry and the legal paradigm capable of supporting and enabling them. It will lay forth several ethical conceptualizations of potential use, such as Thomas Donaldson and Thomas Dunfee's Integrative Social Contracts Theory, Henry Richardson's Partial Entrustment Model of research ethics, and the Bioethics Commission's DTC analysis in its recent report on incidental findings. It will then use the history of informed consent in the clinical setting, as well as current DTC practices, to propose a more robust ethical foundation for DTC providers with moral duties surrounding advertising, contracting with consumers, and providing DTC services.

From an ethical perspective, this Article argues that the marketing for DTC medical devices should not be false or misleading and that DTC products used outside of the clinic should be no more risky than those used in the clinical context. In addition, before entering into the DTC relationship, providers have the obligation to ensure that:

* Intermediaries are trained in the safe use of the device;

* A clinician willing to answer related questions is available to consumers; and

* Pre-intervention disclosure includes:

** a clarification that consumers are entering into a contract for goods and services rather than providing clinical informed consent,

** material risks of the procedure,

** limitations on the accuracy and reliability of data,

** any limitations on the capacity of the trained intermediaries, and

** whether regulatory agencies or professional organizations have come out against using the device for DTC purposes.

After the DTC relationship has been established, transactional ethical duties acquired by the DTC provider include the responsibility of alerting the consumer to any recognized incidental medical findings that come to their attention, within reasonable limitations. Providers do not have to be able to answer all consumer questions themselves, but if DTC providers plan to refer consumers to their personal clinicians for further information, they must confirm that consumers have a clinician and provide any relevant data or imagery collected.

Part IV then turns to the legal paradigms necessary to enable, or at least allow for, DTC providers to meet these ethical obligations. It argues that contractual, as opposed to fiduciary, obligations are most appropriate in an industry where a duty of loyalty has not been recognized, consumers are generally not vulnerable (at least compared to patient counterparts), and because there are distinctive advantages to enabling consumers to contract for diagnostic services outside the clinical setting. While waivers of liability will likely be upheld, this Article argues for a heightened expectation for standard of disclosure because these medical devices cannot be fully transformed from their clinical usage. Last, this Part clarifies that while DTC providers and manufacturers will likely be liable for injury caused during the provision of services, they are unlikely to be considered "learned intermediaries." (16)

II. CONSENT TO MEDICAL SERVICES IN THE CLINICAL SETTING

To inform this inquiry into consent in the DTC context, Part II examines the original ethical underpinnings of the doctrine of informed consent to medical services in the clinical setting and how those ethical ideals are translated into law. It will then give a brief background of the circumstances under which contracting for clinical services has, and has not, been supported by case law.

A. INFORMED CONSENT TO MEDICAL SERVICES IN THE CLINICAL SETTING

While "informed consent" itself is a description of a legal doctrine, (17) medical ethics forms the foundation for enabling patients to make autonomous decisions in their best interests, as defined by the patient. Because of its already exhaustive treatment in published literature, (18) this Part will only briefly revisit the original ethical impetus of consent that is fully informed. It will then analyze the current standards and their translation into an enforceable legal paradigm.

1. Ethical Considerations Regarding Informed Consent to Medical Services in the Clinical Setting

"The heart of issues about informed consent is moral, not legal[,]" (19) but the heart of the moral inquiry has had a wandering eye. What began in medical ethics as the steady beat of a commitment to beneficence broadened in the 1970s to a focus on enabling patient autonomy, within limitations. (20)

From the original Hippocratic Oath forward, historical foundations of a physician's obligations vis-a-vis their patients were focused on duties of beneficence, (21) Bioethicists now understand the modern conception of beneficence to be made up of four widely recognized obligations:

"One ought not to inflict evil or harm" (or "nonmaleficence");

"[O]ne ought to prevent evil or harm;"

"[O]ne ought to remove evil or harm;" and

"[O]ne ought to do or promote good." (22)

These obligations were the focus of U.S. medical ethics through the beginning of the twentieth century. (23) The 1970s, however, represented a turning point with an increasing focus on the importance of promoting patient autonomy, or respecting the decision-making capacities of rational individuals. (24) Currently, to respect patient autonomy, clinicians must obtain consent that is fully informed before performing medical interventions. (25) The need for informed consent, in turn, has enhanced the importance of communication with patients in a way that facilitates these reasoned medical decisions. (26) Today, the main goals of the informed consent process include the ideal of patient autonomy in addition to considerations of beneficence. (27) But creating systemic procedures to achieve and enforce the ideal balance between these sometimes conflicting principles has proven complex.

2. Legal Paradigm of Informed Consent to Medical Services in the Clinical Setting

While the ethics realm was still focused on the primary obligation of clinician beneficence, the legal construct of informed consent actually began where the ethical inquiry ended up--with a focus on the right of "self-determination" ("the legal equivalent of the moral principle of respect for autonomy"). (28) In the 1914 case of Schloendorff v. Society of New York Hospital, a New York court held that where a patient had a hysterectomy performed during an exploratory surgery without consent, an act of trespass, "not merely negligence," had been committed. (29) During trial, the defendant surgeon did not attempt to claim that informed consent had been secured, but simply that the patient had never explicitly objected. (30) The court utilized the rhetoric of autonomy in explaining that "every human being of adult years and sound mind has a right to determine what shall be done with his own body...." (31) This application of the crime or intentional tort of battery, (32) of which trespass is one specification, helped found the concept of the legal need for consent. (33) If a patient could demonstrate that the act of touching involved was "unconsented and offensive," liability for damages could be established. (34)

This trespass conception of consent remained intact until Natanson v. Kline found that unauthorized surgery was distinguishable from battery if "the physician [wa]s acting in relatively good faith for the benefit of the patient." (35) An assault and battery case, the court found, should be reserved for a defendant "acting for the most part out of malice or in a manner generally considered as 'antisocial.'" (36)

In order to secure such formal consent, the paradigm of "informed consent" began to form as "a process of shared decision making based upon mutual respect and participation...." (37) The first legal use of the term "informed consent" appeared in 1957 in the California case of Salgo v. Leland Stanford Jr. University Board of Trustees. (38) Like Schloendorff, Salgo invoked a right of self-determination, but the Salgo court extended the self-determination requirements from a duty to secure consent to a duty to disclose relevant information to secure consent that is informed (39) This disclosure had to cover facts "necessary to form the basis of an intelligent consent ... to the proposed treatment." (40)

The Salgo court also recognized a limitation on this disclosure requirement via the affirmative obligation of physician discretion: "the patient's mental and emotional condition is important and in certain cases may be crucial ... in discussing the element of risk a certain amount of discretion must be employed...." (41) Salgo was thus the first case to bring together the interests of beneficence and autonomy in a duty of disclosure (which elevated autonomy) tempered by physician discretion (meeting beneficence obligations). (42) However, Canterbury v. Spence later clarified that this discretion did not include nondisclosure "simply because divulgence might prompt the patient to forego therapy the physician feels the patient really needs," as such a paternalistic stance would rob patients of their autonomy. (43)

In addition to the disclosure obligations regarding a patient's health, courts have also found that physicians owe fiduciary obligations (44) that require physicians divulge information regarding personal interests that might affect their judgment. (45) Unlike a negligence standard, fiduciary obligations focus on loyalty. (46) While this doctrine was founded to protect beneficiaries from trustees, it has since been extended to apply to other cases where someone is trusted and expected to act in the best interests of another. (47) Thus, fiduciary obligations can arise in other contexts where the fiduciary possesses "superior knowledge and related skills," and the beneficiary is in a position of relative vulnerability and trust. (48)

The oft-cited case regarding clinical fiduciary obligations is the 1990 Moore v. Regents of University of California, (49) Moore was a patient who had undergone treatment for cancer but later sued his physician for using his cells in "lucrative medical research without his permission." (50) Because the physician knew that he intended to use Moore's cells in research when he advised Moore to submit to clinical testing/biospecimen collection, Moore alleged a breach of fiduciary duty and lack of informed consent. (51) The Moore court found the physician did indeed owe fiduciary obligations to Moore and that informed consent should include disclosure of "personal interests unrelated to the patient's health, whether research or economic, that may affect the physician's professional judgment...." (52)

A last area of clinician disclosure obligation (for the purposes of this Article) is embodied by the learned intermediary doctrine. Under general products liability, if products injure alleged victims have the option to sue the manufacturer directly for defects including a failure to warn about the risks of the product. (53) But when clinicians are prescribing a drug or medical device, (54) they are generally held responsible for adequately warning the patient. (55)

Devices are cleared or approved by FDA based on their "intended use" or the "objective intent of the persons legally responsible for the labeling of devices." (56) "[A] manufacturer or anyone in the chain of [device] distribution" cannot suggest that their product can or should be used for non-FDA approved uses. (57) But even though FDA only approves medical devices for specific indications, and even though manufacturers cannot promote their products for anything but those approved indications, once the device has been approved by FDA for something clinicians are generally free to prescribe that product as they deem fit. (58) Pursuant to what is sometimes referred to as the "practice of medicine doctrine" (59) clinicians are thus allowed to prescribe devices for both their intended approved use or for an "off-label" use. (60) However, on the margins, what qualifies as the "practice of medicine," or what constitutes a protected "legitimate health care practitioner-patient relationship," (60) is largely undefined. (61)

The other side of the coin of this enhanced prescribing power is enhanced responsibility. The learned intermediary doctrine creates a safe-harbor for manufacturers where the manufacturer has a duty to warn the clinician about risks, and the clinician adopts the duty to warn the patient. (62) This doctrine assumes that a clinician is in the best place to balance the particular risks and benefits of treatments for a particular patient and act as an informed intermediary between the manufacturer and the patient. (63) "[A]ll fifty states [adhere to] some [version] of the learned intermediary doctrine." (64) However, disclosure of the current regulatory status of the device is generally not considered necessary because on-label or off-label status does not affect the nature of the treatment and is not considered a "risk, benefit, or alternative." (65)

Therefore, while the legal paradigm of informed consent has significantly changed conceptually over the past century, today all states have recognized a duty to secure informed consent in a doctor-patient relationship, (66) focusing on risks that are "material," "substantial," "probable," or "significant." (67) In addition to these disclosure obligations, fiduciary and learned intermediary requirements make the doctor-patient relationship a heavily litigated area of law.

B. CONTRACTING FOR MEDICAL SERVICES IN THE CLINICAL SETTING

The basis of ethical and legal obligations between a physician and a patient is a consensual transaction, and an express or implied contract that creates the doctor-patient relationship. (68) While a contract is generally enforceable by law, (69) courts can find contracts voidable under certain circumstances, (70) including "public policy" reasons. (71) In these cases a court can decide that the best interests of society outweigh the fundamental interest in freedom of contract. (72) This Part will give a brief introduction to how these rules and limits of contracting apply to medical services in the clinical setting in order to set the stage for understanding the potential strengths and weaknesses of their use in the DTC setting.

1. Arguments in Support of the Use of Contracts for Medical Services in the Clinical Setting

Under tort law, patients carry the "risk of injury" and providers carry the risk of liability. (73) Case law delineates the standards by which these injuries and liabilities are judged. (74) Theoretically, under contract law, patients and providers could re-negotiate such standards, tailoring them to their personal risk preferences. (75) Patients might elect to negotiate, for example, for enhanced access to the healthcare team (sometimes known as "concierge medicine") or a deviation from the standard of care in exchange for limitations on damages. (76) Under this paradigm, state law would not be involved in the delineation of the standard of care, but would only need to enforce otherwise valid contractual agreements. (77)

Indeed, one of the major criticisms of the current negligence conception of informed consent is that it focuses on the "uniform abstraction" of what the "prudent patient" would need to know--as opposed to the individual patient sitting in front of the clinician. (78) Such an objective standard applied generically across clinician-patient relationships can miss the micro-level preferences of the individual that might otherwise be captured by contractual bargains. (79) In addition, while patients might not be able to comprehensively evaluate the quality of care they are receiving, they are uniquely situated to perform an autonomous analysis regarding their own medical decisions (80) when they receive adequate information to evaluate and understand their choices. Theoretically, no one can make the autonomous decision of what is best for patients as well as the competent patients themselves.

2. Arguments Against the Use of Contracts for Medical Services in the Clinical Setting

The bulk of legal scholarship and case law regarding contracts for medical services in the clinical setting has focused on arguments against them. Most support the premise that while contractual principles establish the doctor-patient relationship, ongoing interactions do not meet the qualifications necessary for a fair and effective private contract. (81) This Part will analyze some of the arguments against medical contracts in the clinical setting and explore in particular how contracts have been stymied in the waiver-of-liability context.

a. Inequity of Bargaining Power and Comprehension

When patients go to see their practitioners, it is most often because they feel unwell or are otherwise concerned about their health. Far from the traditional arms-length transaction over a tangible good, patients are often in the position of being "under-informed, vulnerable, distracted, or anxious...." (82) Although access to medical information and literature has expanded from the proliferation of the Internet, patients still go to see specialized clinicians to guide their decision making , and many types of interventions require clinician prescriptions. (83)

In order for a patient and clinician to contract on equitable footing, some argue the clinician would have to communicate the level of "information necessary to enable [the patient] to maximize her own welfare," a process at least one scholar, Maxwell Mehlman, has termed "fiduciary contracting." (84) Mehlman argues that the disclosure required for fiduciary contracting would entail the details of the bargain (85) (e.g., an agreement to arbitrate in exchange for lower fees) and possible alternatives (e.g., that with another practice the patient could sue for their injuries under tort, but their co-pays would be higher). Both of these types of disclosures could be required under contract law, but at the very least represent the limits of the doctrine in this application. (86)

It is unlikely, however, that disclosure of this type could put a patient on equal footing with a clinician. First, most patients are generally too far behind in their knowledge base to catch up through a simple negotiation. (87) Patients seek clinical services for the very purpose of receiving the clinician's professional advice and input, a skill set the practitioner spent years building. Even patients who are competent to make important decisions in other areas of their lives generally lack the level of health literacy required to fully comprehend the implications of medical information and ask relevant follow-up questions. (88)

Second, even if patients attempt negotiation for disclosure of certain information and fully comprehend that information when they receive it, they would not know what kind of information to bargain for in the first place. …

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