Consent, Refusal, and Waivers in Patient-Centered Dysphagia Care

Purpose of Tutorial

Review issues surrounding consent, refusal, and waivers in patient care.
Provide clinicians with knowledge of ethics and law to invigorate clinical practice.
The tutorial is for educational purposes only and does not offer legal advice.

Method

Uses a hypothetical case of a "noncompliant" individual to explore:
- Ethical and legal features of the patient-practitioner relationship.
- Elements of clinical decision-making capacity.
- Duty of disclosure and the right of informed consent or refusal.
- Relationship among noncompliance, defensive practices, and iatrogenic harm.
Addresses the legal question of whether waivers of liability are enforceable.

Conclusions

Health care providers, including speech-language pathologists, have ethical and legal obligations to patients.
Waivers of liability in the medical context are generally unenforceable as a matter of public policy because they shift liability for substandard care from providers to patients.

Introduction

Speech-language pathologists (SLPs) adhere to the American Speech-Language-Hearing Association (ASHA) Code of Ethics (2016).
SLPs embrace interdisciplinary teamwork and evidence-based practice.
Ethics and standards of practice are crucial when caring for patients with complex cognitive-linguistic, motor speech, and swallowing difficulties.
The desire to do what is best for patients may lead to overly cautious or defensive practices.
Some SLPs or institutions may ask patients to sign waivers when patients do not comply with dietary regimens.
Kaizer, Spiridigliozzi, and Hunt (2012) reported that up to 40% of patients do not follow SLP recommendations regarding dietary restrictions.
Competent individuals have the right to choose (accept or refuse) medical treatments, including life-sustaining interventions (In re Schiavo, 2005).
Terms like "noncompliant" or "nonadherent" can be pejorative when describing patients whose views differ from clinicians (Jonsen, Siegler, & Winslade, 2006).
When patients refuse recommended care, questions arise about:
- Clinical decision-making capacity.
- Scope of disclosure in informed consent.
- Whether waivers shield clinicians from malpractice lawsuits.
Defensive practices (e.g., waivers) are unlikely to shield clinicians from liability for harmful practices.

Definitions of Legal Terms

Waiver of liability is defined (with diet waiver mentioned as a colloquial phrase).
The tutorial defines the term "contract."
It will describe the difference between express and implied agreements.
It will explain the relationship between "assumption of risk" and "waiver of liability."

Waiver of Liability

A hypothetical waiver includes three elements:
- Patient affirmation of receiving education about risks.
- Exculpatory clause: provision protecting a party from liability arising from negligence (Black, 1990, p. 566).
- Waiver of a legal right: intentional relinquishment of a known right (Black, 1990, p. 1580).

Contract

The analysis includes determining whether the waiver is a legally enforceable contract.
A contract is "a promise or set of promises constituting an agreement between the parties that gives each a legal duty to the other and also the right to seek a remedy for the breach of those duties" (Black, 1990, p. 322).
A legally enforceable contract requires an exchange of something of value (valuable consideration).

Express Versus Implied

A contract, waiver of liability, or consent can be express or implied.
Express agreement: memorialized orally or in writing (e.g., signing a form to release a sport facility from liability).
Implied agreement: demonstrated by conduct (e.g., participating in a risky activity like riding a roller coaster).

Assumption of Risk

Associated with waivers.
A common law principle meaning that "one who consents cannot be injured (volenti fit non injuria)" (Roseman-Orr, 1999, p. 719).
A person who knowingly and voluntarily engages in a risky activity assumes the risk and waives liability for resulting harm.
The lawsuit outcome depends on whether the conduct was reasonable and whether either party breached a duty of care.

Ethical Requirements and Hypothetical Case

Ethical requirements of the patient-practitioner relationship, elements of clinical decision-making capacity, duty of disclosure, and the right of informed consent will be discussed.
The hypothetical case is intertwined to illustrate the relevance of these concepts to waivers of liability.

Patient-Professional Relationship

Guiding biomedical moral principles: respect for autonomy, beneficence, nonmaleficence, and justice serve as the framework for ethical reasoning
No single principle has priority; clinicians should consider all principles and specific professional ethics rules (Beauchamp & Childress, 2013; Horner, 2003).
The principles correspond to conduct expressed in the patient-professional relationship that is trustworthy (fiduciary in nature), competent (adherent to the standard of care and non-negligent), and respectful of patients’ right of self-determination
Fiduciary duty corresponds primarily to trustworthiness, loyalty, and beneficence. Patients are vulnerable and rely on care providers to respect their values.
Health care providers are ethically obligated to act in patients’ best interests.
Pellegrino and Thomasma (1993) explain that patient’s good extends beyond what is medically good, including patient’s own assessment of what is good given his values, age, sex, occupation, aspirations.

Duty of Reasonable Care

SLPs strive to adhere to best practices, including evidence-based interventions (Dollaghan, 2007).
SLPs have a "duty of reasonable care" (Morrison v. MacNamara, 1979).
Courts rely on professional standards and expert witnesses, but the legal duty of care is the decision of the court.
Helling v. Carey (1974) involved failure to perform a glaucoma test, the court rejected the customary practice standard, stating that the reasonable standard should have been followed

Definitions of Respect

Respect for autonomy means respect persons for their inherent worth; treat humans as ends, never as means.
- Essential elements: liberty and agency. "Virtually all theories of autonomy view two conditions as essential for autonomy: liberty (independence from controlling influences) and agency (capacity for intentional action)."
Beneficence means "Taking action by helping-preventing harm, removing harm, and promoting good."
- Utility requires that agents balance benefits, risks, and costs to produce the best overall results."
Nonmaleficence means "[I]ntentional avoidance of actions that cause harm."
Justice means "[F]air, equitable, and appropriate treatment in light of what is due or owed to persons."

Hypothetical case

Mr. S., a 78-year-old man, was admitted to an intensive stroke unit with right hemiplegia and language difficulty
Diagnosis was left hemisphere thromboembolic stroke in the region of the middle cerebral artery
Prior to admission, he lived at home with his wife, was independent in all daily activities, and was socially active with family and friends
He had been in good health with the exception of a medical history of hypertension and gastroesophageal reflux disease, both of which were managed with medication.

Status on Admission to Rehabilitation (3 Weeks Poststroke)

On admission to an inpatient rehabilitation facility, Mr. S. presented with right hemiplegia and moderate non-fluent aphasia consistent with Broca's aphasia.
A clinical examination revealed mild unilateral face and tongue weakness, reduced pharyngeal sensation, a moderately weak voluntary cough, a mildly weak reflexive cough, and an intermittently wet voice quality after trial liquid boluses.
The physician adopted the recommendations of the SLP and wrote orders for honey-thickened liquids and a mechanical soft diet.
The physician also directed the SLP and nursing staff to engage the patient in education and initiate aspiration precautions, reflux precautions, and close monitoring. Mr. S. followed the recommendations for 2 weeks without complaint or adverse consequences.

Reevaluation (5 Weeks Poststroke)

After 2 weeks of intensive therapy, Mr. S. was making good progress in physical, occupational, and language therapy.
Although his reflexive cough was more vigorous than at admission, the team was concerned that he coughed frequently while eating. Although his chest radiograph had not improved, his pulse oximetry was normal
Despite additional education and counseling about his aspiration risk, Mr. S. expressed disappointment and disagreement with his modified dysphagia diet. He said, "I do not like thickened liquids"; "I am thirsty"; and "I want water, juice, and coffee."
These factors led the physician to order consults to neuropsychology and speech-language pathology to assess Mr. S.'s clinical decision-making capacity.

Subsequent Sections

Subsequent sections of this tutorial review the elements of clinical decision-making capacity and the correspondence between the duty of disclosure and the right of informed consent or refusal.
Ethics is at the heart of our professional work; our ethics advise us about what we should do. In contrast, law is an important and informative resource that sets minimum standards of conduct. In complex cases, knowledge of both ethics and law is necessary.

Clinical Decision-Making Capacity

Before obtaining consent to interventions, health care providers should determine whether their patients have the clinical decision-making capacity to understand and act voluntarily on relevant medical information.
Respect autonomous agents by acknowledging their right to hold views, to make choices, and to take actions based on their values and beliefs
All adult individuals are presumed to have the legal capacity to make decisions affecting their lives, clinical decision-making capacity must be assessed.

The ABA Commission and APA Working Group

The American Bar Association (ABA) Commission on Law and Aging and the American Psychological Association (APA) Assessment of Capacity in Older Adults Project Working Group (2008; Moye, Marson, & Edelstein, 2013) identified several capacity domains.
These publications acknowledged that the terms competency and capacity have been used interchangeably or inconsistently in the past.

Medical Consent Capacity

To determine medical consent capacity (clinical decision-making capacity) when decisions about a particular surgical procedure or medical treatment arise, physicians must ascertain whether each individual patient can understand medical information, weigh treatment options, appreciate the consequences of a decision to accept or refuse, and communicate a decision.
SLPs typically rely on multiple assessment approaches, including structured or semistructured interviews with the patient; administration of standardized aphasia tests; use of alternative and augmentative communication approaches, including but not limited to pictures, gestures, writing, symbols, and yes/no boards; and repeated evaluations in different settings
Despite the potential advantages of using standardized capacity instruments, examiners should first ensure that patients have been given the information that is relevant to making an informed decision about their treatment.
In our hypothetical case involving Mr. S., the SLP supported his communication and he was able to demonstrate clinical decision-making capacity despite the presence of aphasia.
The next ethical step is to engage Mr. S. in a robust informed consent process.

Duty of Disclosure and Informed Consent

The right of self-determination and the right of bodily integrity have their origins in common law.
Informed medical decision making by patients or their legal surrogates is supported by the right of privacy found in state constitutional law and in federal constitutional law.
In the health care arena, these ethical and legal rights of self-determination, bodily integrity, and informed consent imply that all patients have the right to receive information about the benefits, risks of harm, and probability and magnitude of possible harm associated with the recommended treatment and reasonable alternative treatments before they decide whether to choose (or refuse) the treatment that has been recommended.

Right of Self-Determination

The doctrine of informed consent has its roots in the principle of respect for persons that is, the moral obligation to respect autonomous agents' right to determine for themselves how to live a good, worthwhile life.
The law recognized self-determination as early as the 1700s.

Right of Bodily Integrity

The U.S. Supreme Court has long maintained the right of voluntary consent to medical procedures.
In 1891, the Court recognized that an individual has a right to "control of his own person, free from all restraint and interference of others" (Union Pacific Railway v. Botsford, 1891, p. 251).

Duty of Disclosure

Early legal cases in the United States affirmed patients' common law rights of self-determination and bodily integrity.
By natural extension, the law grew to recognize patients' right to be informed and health professionals' corresponding duty to disclose material information.
To ensure that patients participate in decision making (Moulton & King, 2010), SLPs and all members of the medical team should facilitate each patient's autonomous interests by disclosing accurate information through an educational process tailored to the patient's circumstances

Legal Standards Governing Disclosure

According to N. M. P. King (2015), only one state-North Carolina-has a statutory requirement for both.
In Natanson v. Kline (1960), the standard for disclosure was set as a "reasonable physician" standard. That is, the adequacy of disclosed information was measured against what a reasonable physician would disclose in a similar situation considering current medical knowledge and standards of the profession.
The standard of disclosure shifted to a more patient-centered view following Canterbury v. Spence (1972), in which a young patient who was paralyzed following a laminectomy complained that he had not been informed of the risk of paralysis from this procedure.
The factors contributing significance to the dangerousness of a medical technique are, of course, the incidence of injury and the degree of harm threatened

Physicians Duty

Also in 1972, the Supreme Court of California explained that physicians have a duty of reasonable disclosure and breach of this duty is a form of negligence.

Truman vs Thomas

In Truman v. Thomas (1980), a young woman repeatedly refused to undergo a pap smear because of the cost and later died from cervical cancer at age 30 years. The court explained that the scope of the physician's duty to disclose is set by law, not by the customary practice of physicians, and that when a patient refuses a procedure, material risks must be explained to her.
Thus, the standard for disclosure is reasonableness, and the scope of disclosure, depending on the jurisdiction, is either the reasonable physician or the reasonable patient. In either case, the court is the ultimate arbiter of whether the duty of disclosure has been met.
The duty of disclosure-and patients' corresponding right to accept or refuse the choice(s) offered-applies to all patients whether or not medical practitioners agree that the decision is wise or unwise, or rational or irrational.

Mrs. Candura

For example, when an older individual, Mrs. Candura, refused an amputation that would save her life, her daughter and her physician questioned her ability to appreciate the consequences of her decision.
The appellate court in Massachusetts wrote:
- A person is presumed to be competent unless shown by the evidence not to be competent…. [T]he irrationality of her decision does not justify a conclusion that Mrs. Candura is incompetent in the legal sense. The law protects her right to make her own decision to accept or reject treatment, whether that decision is wise or unwise…. Mrs. Candura's decision may be regarded by most as unfortunate, but on the record in this case it is not the uninformed decision of a person incapable of appreciating the nature and consequences of her act.

Status of Hypothetical Patient (6 Weeks Poststroke)

At this point in our hypothetical case, at approximately 6 weeks poststroke, the reader may assume that Mr. S.'s SLP understood her ethical responsibilities and took appropriate measures to ensure the adequacy of informed consent.
However, when Mr. S. asked, "What are my chances of getting pneumonia?" the SLP was not able to provide an individualized risk assessment.
The SLP also assured Mr. S. that it was his choice to refuse thickened liquids and that the neurorehabilitation team would provide him their best care and advice throughout his stay in the facility. So, even though the SLP and other members of the neurorehabilitation team were concerned that Mr. S.'s refusal of thickened liquids was unwise, they understood his right to do so. Nevertheless, the SLP told Mr. S. that his signature on an institutional consent form was the only way for him to receive thin liquids. She then presented him with an institutional document titled "Release From Liability and Waiver of Right to Sue" (see hypothetical example in the Appendix).

Noncompliance, Defensive Practices, and Iatrogenic Harm

When patients make treatment choices that do not correspond to SLPs' recommendations, SLPs worry about legal liability for any harm that might ensue (e.g., aspiration pneumonia and the possibility of death from pneumonia).
In turn, SLPs are likely to characterize patients in the medical record as noncompliant, and/or the SLPs or their employers might use a waiver as a defense against future liability.

Defensive Practices

Defensive practices involve those designed "primarily to help protect the physician from liability rather than to substantially further the patient's diagnosis or treatment"
Patients “bear the brunt” of defensive practices because such practices are designed by clinicians to escape liability rather than to benefit patients
Defensive practices are very costly—as high as 45 billion annually.
Yet if defensive practices cause iatrogenic harm to patients, and this is proven by the plaintiff in a malpractice lawsuit, defensive practices ultimately offer little protection from liability
Das, Schwartz, and Derenzo (2003) explained that flaws in how clinicians and patients interact interpersonally bear an important relationship to defensive practices and to patients' inclinations to sue.
A related issue is iatrogenic harm, which refers to harm caused by the treatment itself.

Therapeutic Alliance

When a decision is preference sensitive (e.g., individuals' drinking and eating preferences), the benefits and risks are uncertain. In this context, it is especially important that the patient and health professional team establish a strong "therapeutic alliance" through ongoing communication and shared decision making
This literature review helps us understand why asking a noncompliant patient to sign a waiver of liability is a type of defensive practice. This fact is relevant to our analysis of whether or not the waiver is enforceable as a matter of contract law or negligence law or on public policy grounds.

Enforceability of Waivers of Liability

Waivers and Negligence Law
Waivers of liability are common in extreme sports.

Give Kids the World v. Sanislo

The appellate court upheld the release of liability because the language in the release was clear and unambiguous, the setting was recreational and did not occur in the "public utility or public function context," the parties had equal bargaining power, and the contract was clear enough to put Mr. and Mrs. Sanislo on notice about what they were "contracting away"

Atkins v. Swimwest

The court agreed and deemed the waiver unenforceable. The court found that the deceased did not have adequate notice that she was releasing the Swimwest Family Fitness Center from negligence, she had no opportunity to bargain, and the waiver was not clearly distinguishable from the rest of the form. Furthermore, as the law of torts makes clear, where the law expects a standard of care, a party with a duty of care cannot shield itself from liability for negligence that imperils others

Locke VS. lifetime Fitness

The court set aside the waiver because for waivers to be legally enforceable, they must be unambiguous, conscionable, and consistent with contract law, and parties may enter into such an agreement only when it does not infringe the law or contradict public policy.

Tancredi vs Dive Makai

The court found that both the charter company and Mr. Tancredi were legally responsible and were 80% and 20% contributorily negligent, respectively
These select cases illustrate that an assumption of risk (i.e., using a waiver of liability, whether express or implied) does not relieve either party of their duty to act reasonably and to avoid foreseeable harm.

Waivers and Contract Law

In the first part of the hypothetical waiver included attest the fact that he had received education about risks associated with his dysphagia.
The second part includes an exculpatory clause, effectively releasing the neurorehabilitation team members and the facility from liability.
The third is to waive his right to sue the facility or its employees.

To answer this question, we first explore whether the hypothetical waiver fulfills the requirements of a legally enforceable contract. As mentioned earlier, a contract involves an agreement between two or more parties. A legally enforceable contract entails an offer, an acceptance, bilateral promises made by individuals on equal footing who negotiate the terms, and an exchange of something of value by the respective parties.

Hypothetical Case Explanation

With this definition in mind, there are several reasons why the hypothetical waiver presented in our hypothetical case is most likely not a legally enforceable contract.
First,the parties to the hypothetical agreement do not have equal bargaining strength.
Second, when the SLP told Mr. S. that signing a waiver was a condition of his receiving permission to drink thin liquids, the waiver became a “take it or leave it” agreement (i.e., a contract of adhesion).
Third, an enforceable contract is unambiguous by its own terms.
Fourth, a legal contract involves an exchange of something of value from both parties; this is referred to as valuable consideration.
To further explain why using waivers of liability in a medical context is problematic, we now discuss important public policy considerations.

Waivers and Public Policy

Public policy refers to "that principle of law under which freedom of contract or private dealings is restricted by law for the good of the community"
With these public policy considerations in mind, private contracts (e.g., waivers of liability) undermine the deterrence value of negligence liability in the medical context because they immunize the professional from his or her own carelessness by asking the patient to assume the risk of substandard care.
If the patient were to later sue the professional team for harm allegedly resulting from negligent care, the professional or facility most likely would use the waiver as a defense (i.e., to bar the lawsuit).
In medical malpractice cases, most courts disfavor this legal maneuver.
Many courts have found waivers unenforceable when they are against the public policy of holding health professionals responsible for the care they provide and for the impropriety of shifting risk to the patient, who is not in a position to manage or avoid it

Tunkl v. Regents of California Explanation

In Tunkl v. Regents of the University of California (1963), the patient who was in pain, under sedation, and probably unable to read was required to sign a waiver of liability as a condition of receiving medical care at a charitable research hospital. The court identified six public policy factors that weighed against the enforceability of the waiver.

Emory University v. Porubiansky Explanation

Emory University v. Porubiansky (1981) relied on the Tunkl v. Regents of the University of California court's reasoning to deem a waiver of liability unenforceable as a matter of public policy.
Thus, the Supreme Court of Georgia refused to allow Emory University to use the waiver to bar Porubiansky's malpractice lawsuit.

Summary and Conclusions

In our hypothetical case, an older individual experienced poststroke dysphagia and was placed on thickened liquids, which he tolerated for a few weeks and then refused.
The case provided the opportunity to identify major biomedical principles, explain the ethical and legal duties intrinsic to the patient-practitioner relationship, distinguish legal and medical capacity, and discuss the ethical and legal bases for patient self-determination and the elements of informed consent. Through the lens of a hypothetical case, we have attempted to raise awareness that unintended harms may result from well-intentioned interventions.
To dispel uncertainties and defensive practices, SLPS have a number of affirmative strategies available to them, particularly when faced with challenging situations.
In conclusion, patients are entitled to receive care that adheres to ethically and legally defensible standards. One facet of this standard is to fully disclose the nature of the treatment, the risks of and alternatives to the proposed treatment, and the risks associated with the refusal of a proposed treatment.
Our analysis of the law demonstrates that professionals' adherence to a standard of care is a common law and statutory duty that cannot be modified by contract, and courts are unlikely to enforce waivers of liability used in medical settings because they are against public policy. From the perspective of professional ethics, waivers of liability undermine the relationship of trust that is essential to the patient-practitioner relationship by placing the professional's interests above the best interests of the patient―a violation of ASHA's first principle.