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Physicians are confronted with a variety of unique legal issues on a daily basis. It would be nearly impossible to cover all of them—even in broad strokes—in a single chapter. Accordingly, this chapter focuses on two issues that may be of specific importance to pediatric physicians: informed consent and related medical malpractice actions. It is important to note at the outset that this chapter is intended to provide only a broad overview of these issues; in most cases, the nuances of these issues are dictated by state laws. As such, the relevant state’s laws should be consulted for more specific legal authority on these issues. This chapter attempts, however, to lay out the variety of considerations at play when determining whether both an adult and a minor patient have provided their informed consent to accept or decline the relevant medical treatment. It also provides an outline of two specific types of medical malpractice actions: one based on informed consent and one based on a negligence theory, which constitutes the majority of malpractice actions in this country.
Issues specific to the use of opioids in minors are addressed as well. Because of the significance and social impact of the opioid crisis since the publication of the ninth edition of this text, additional legal issues relating to consent and long-term risks will be addressed.
Patient consent is one of the most prominent issues facing medical providers today. Consent becomes even more complicated when a patient is a minor. Recall the case of 12-year-old Parker Jensen, who was diagnosed with an extremely rare and aggressive cancer, Ewing’s sarcoma, after physicians removed a tumor from the soft tissue of his mouth ( ; ). Parker’s parents were undecided about the right course of treatment for their son and wanted to seek a second opinion ( ). Parker’s physicians, however, sought a court order to remove Parker from his home in order for him to begin 49 weeks of chemotherapy that they—not necessarily Parker—believed was the appropriate course of treatment ( ). A battle ensued between Parker’s parents and the state of Utah; the result was that kidnapping and child neglect charges were filed against Parker’s parents ( ). Parker’s opinion was not nearly—if at all—as highly publicized. The specific issues facing physicians are whose consent actually is required when the patient is a minor and what informed consent means for the practitioner.
The notion of consent itself can be traced back to the laws of battery and trespass. In 1914 Judge Benjamin Cardozo likened assault to trespass of the body. He wrote, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault, for which he is liable in damages” ( ). Thus began the legal analysis of the notion of consent.
The issue of consent—and the circumstances under which a patient may be said to have consented to certain medical treatment—is an important one for physicians. Without patient consent to treatment, physicians may be sued for battery: the violation of a person’s right to be free from unwanted touching ( ). (An example is finding that an inmate’s inclusion in a medical study did not constitute offensive conduct, an element of battery, when no blood was drawn without the inmate’s consent; .) Subject to certain exceptions, such as emergencies that pose threats to a patient’s life, any willful touching of another is unlawful without valid consent from the individual or another authorized to consent on that person’s behalf ( ). The requirement of consent primarily protects the patient’s bodily integrity ( ).
Consent, however, gives the physician a privilege that protects him or her against liability for this tort as long as the patient is informed of the nature and consequences of treatment and gives knowing and intelligent consent to the proposed treatment the physician intends to provide ( ). “Informed consent” is designed to protect the individual’s autonomy in medical decision making; in other words, it is a real-world application of the adage that “every person has the right to determine what is done to his own body” ( ).
In turn, physicians are obligated to provide the patient with a “reasonable amount of information” for the patient to be able to make an informed decision ( ). It is worth noting here that some jurisdictions reject this approach for one that shifts the focus to what a “reasonable patient would need to know,” a standard that does not require expert testimony and thereby eases a patient’s burden of proof ( ; ). In other words, the patient must know what he or she is consenting to ( ). Informed consent is the “autonomous authorization of medical intervention ... by individual patients” ( ; ). It can really only follow after a discussion regarding the “nature of the proposed treatment procedures, possible alternative treatments, and the nature and the degree of the risk and benefits involved in accepting or rejecting treatment.” Consent is then considered “informed” when it is given “knowingly, competently, and voluntarily” ( ). It is worth noting, however, that if a physician doesn’t provide enough information to make an informed treatment and the patient consents, the physician may still be liable for negligence ( ).
Knowingly means that the physician has a duty of disclosure to provide adequate information to the patient in a manner that the patient can comprehend ( ). Adequate means “the amount and kind of information that the average person in the patient’s position would want to have in reaching an informed decision” ( ). This usually means that the clinician must fully explain the proposed procedure, the expected short-term risks and long-term consequences, the available alternatives and their risks and benefits, and the consequences of declining or delaying treatment ( ). In short, physicians must disclose all material information; that is, all “information which the physician knows or should know would be regarded as significant by a reasonable person in the patient’s position when deciding to accept or reject a recommended medical procedure” ( ; ).
Competently means that the patient has the capacity, or ability, to understand “information relating to treatment decisions and to appreciate the consequences of a decision” ( ). If a decision is be made competently, physicians must assess whether a patient can both understand the relevant medical information and make a rational decision based on that information ( ).
The voluntariness requirement simply protects the patient’s right to make healthcare decisions free from manipulation or undue influence ( ). Because of the power imbalance between a physician and the patient and the sometimes vulnerable state of the patient, there is a great danger of undue influence; as such, the manner in which physicians present information can significantly influence the relative importance the patient may attach to certain information and could persuade the patient to favor the option emphasized by the physician. Accordingly, physicians have a duty to distance themselves from their personal preferences and allow their presentation of information to reflect an objective assessment of the various interests at stake for the patient ( ).
Interestingly, the Supreme Court of Pennsylvania has considered the issue of informed consent under Pennsylvania law, and specifically Pennsylvania’s Medical Care Availability and Reduction of Error (MCARE) Act, which states that, except in emergent situations, it is the duty of a physician to obtain informed consent from a patient before certain procedures (the administration of anesthesia is a covered procedure) ( ). The court concluded that a physician cannot delegate the duty to obtain informed consent to others, and rejected the notion that disclosure to a patient by someone other than a physician—in this case, the physician’s subordinate—satisfies the duty of informed consent. The court emphasized that the relationship between a physician and patient requires direct communication between them to secure valid informed consent, as it is only through this two-way exchange between the physician and patient that the physician can achieve confidence that the patient fully comprehends the “risks, benefits, likelihood of success, and alternatives.”
As outlined above, competent adults are entitled to make decisions regarding their medical care themselves. But the framework of consent changes if the patient is a minor ( ). The legal framework of consent highlights the courts’ recognition that the family must be protected by a broad right of privacy, limiting government interference in the intimate family workings ( ). That right to privacy, however, is balanced by the fact that the state is permitted, in certain circumstances, to make determinations about the best interests of the child ( ). When such a conflict arises—perhaps relating to the type, length, and necessity of medical treatments for a child—the question is about who possesses the ultimate right to make a child’s medical decisions ( ). When does a minor have the right to have a voice in medical decisions regarding his or her own well-being? Even if the minor has a voice, when is that voice determinative?
An analysis of a minor’s right to participate in his or her healthcare decisions reflects a huge variation from state to state over the amount, if any, of deference given to a minor to consent or refuse medical treatment ( ). Traditionally, the view was that parents had total autonomy over a child’s medical care. That idea can be traced back to a time when children were considered the property of their parents ( ). Before that time, children had no rights, and parents reared their children without government restraint ( ). The US Supreme Court has articulated several justifications for total parental autonomy ( ; ). Primarily, they rest in the presumptions that children lack the maturity, experience, and capacity to make appropriate decisions, and that the “natural bonds of affection” between parents and children will lead parents to act in the best interest of their children ( ). Since that time, however, the Supreme Court has modified the notion of absolute parental autonomy to account for the interest of minors, particularly in the arena of healthcare decisions ( ). The idea is that there are better means for protecting parental autonomy than disregarding the desires of the children ( ; ). Jurisdictions vary in the deference given to parental autonomy over a child’s healthcare ( ).
Typically, the current view is that for most treatment provided to children, informed consent is provided by the parents or guardians. Stated another way, parental permission for medical procedures on children, when appropriate and properly secured, constitutes an exception to the general requirement of personal consent to medical treatment ( ; ). In turn, parents are required to make decisions that are in the best interest of their children; they may not make decisions for their children that are likely to cause them physical harm or otherwise impair their healthy development ( ). Parents, therefore, should be viewed as agents for their children, required to make decisions regarding medical interventions for their children in a manner consistent with the child’s best interest. Medical professionals, in turn, owe a duty to their minor patients to assist parents in making decisions that conform to that standard ( ). According to Syoboda and colleagues, to assist “parents in making decisions that comport with their child’s best interest, medical professionals must satisfy the same requirements of informed consent that apply to decision making by adults,” as outlined above. In short, a minor has the right to consent to medical treatment without third-party involvement in two key situations. First, an unemancipated minor may consent to treatment of specific types of conditions for which either the state legislature or the courts have granted such authority ( ). Such authority applies to any minor who is capable of giving meaningful informed consent and who has one of the specified medical conditions—in other words, if the minor can be said to be a “mature minor” ( ). Second, a minor who qualifies as emancipated, either by court order or on other grounds, may consent to medical treatment as if he or she were an adult ( ).
Most state laws provide that when minors reach a specified age, they are empowered to provide informed consent for the diagnosis and treatment for specific conditions (usually involving mental health, substance abuse, pregnancy, and sexually transmitted diseases) without the knowledge or consent of their parents ( ). When they reach yet another, older age, they are given sole decision-making power over their own healthcare; at this point, they are no longer considered minors.
The law does recognize the “mature minor doctrine,” a form of patient rights that was developed to ensure treatment of minors when parental consent may cause intrafamily conflict or be difficult to obtain and to protect physicians who treat “mature minors” ( ). As a result of the mature minor doctrine, physicians may treat children even in the absence of parental consent or a court order, because it has become reasonable to assume that mature children are capable of providing informed consent pertaining to their own medical treatment in certain situations ( ). The primary concern with a minor’s consent to the proposed treatment is the minor’s capacity to understand what the treatment involves ( ). Even if the parents ultimately disagree with the treatment given, the physician should still be protected against liability by the doctrine, subject to any specific state law limitations that may apply. Many states expressly permit minors to legally consent to medical treatment without parental consent or over parental objections ( ).
Still, it is essential that physicians have a clear understanding of how to adequately determine and record indications of the maturity and decision-making competence of minor patients, and how to be assured they have properly communicated with and obtained knowing and intelligent medical decisions from competent minor patients ( ; ). The Supreme Court has not been particularly helpful in offering guidance to physicians attempting to determine the maturity of a minor ( ). It did, however, hold in that a minor does not need parental consent if he or she “is sufficiently mature to understand the procedure and to make an intelligent assessment of” his or her circumstances. Jurisprudence has generally concluded that minors may be recognized as competent based on a variety of factors, including age (however, few courts have granted a patient younger than 14 years of age the right to consent), maturity, intelligence, and the nature and risks of the proposed treatment ( ). Accordingly, legal privileges are extended to these minors by allowing minors “who can understand the nature and consequences of the medical treatment offered” the right to consent to or to refuse treatment ( ; ). That said, courts generally find children competent to consent or refuse treatment when the treatment has little risk, such as vaccinations, back pain, and cosmetic surgery ( ; ; ; ; ). However, ethicists agree that the ordinary indicia of competence should be balanced against the risks of treatment ( ).
The mature minor doctrine has been consistently applied in cases in which the minor is nearing the age of majority, usually 16 years or older; the minor displays the capacity to understand the nature and risks of the treatment; and the nature of the treatment is not serious ( Definitions, USLegal.com ; ). Courts will, however, generally protect physicians in their “non-negligent treatment of ... mature minor(s) who consent . . . to a procedure after discussion with the physician” ( ). In addition, all states have statutes that give physicians the authority to treat minors, regardless of parental consent, in a variety of situations to “prevent certain negative consequences resulting from lack of medical care,” including but not necessarily limited to the provision of care for emergency medical situations, to an emancipated minor, and if the minor seeks treatment for certain specific medical conditions, such as mental illness and sexually transmitted diseases ( ).
Notwithstanding any of the above, children’s hospitals recognize an ethical obligation to involve children in the informed consent process to the maximum extent appropriate to their level of maturity ( ). Where a minor expresses a reasonable desire to refuse offered care, an attempt is often made by the treatment team to reconcile the views of the child and the parents and to avoid invocations of any legal authority the parents may technically possess ( ).
Notwithstanding the application of the mature minor doctrine, all states have statutes that give physicians the authority to treat minors, regardless of parental consent, to “prevent negative consequences resulting from lack of medical care,” such as in emergency situations or if the patient suffers from certain medical conditions ( ). One such situation arises if the minor is considered an “emancipated minor.” Emancipation for purposes of consenting to medical treatment may take various forms. It may be accomplished by court order when a child reaches a certain age. In such a case, often the state department or division of motor vehicles issues the minor an identification card reflecting the emancipated status, which the healthcare provider may request to see. It may also be accomplished by marriage. When a minor marries, that minor is deemed emancipated for purposes of consenting to or refusing medical treatment. Finally, a minor who is on active military duty has the authority to consent to medical treatment ( ). The emancipated minor doctrine broadly conveys to the minor the right to consent to or to refuse medical treatment without the involvement of the minor’s parent, guardian, or other third party, obviously without regard to whether the minor has reached the age of majority ( ). The contours of each state’s emancipated minor doctrine varies, but generally it is intended to protect minors who are no longer dependent on their parents—those parents who have “relinquished control over their child’s behavior and personal affairs” ( ).
Generally, an emancipated minor may consent to any type of medical treatment and is afforded the same confidentiality rights as an adult, regardless of the manner in which the minor is emancipated ( ). Accordingly, with few exceptions, when treating an emancipated minor, the healthcare provider must deal with the minor as if that patient were an adult ( ).
The ability to authorize disclosure of health information usually goes hand in hand with the right to give informed consent, as discussed above ( ). Accordingly, where the law recognizes the parent as the appropriate individual to give informed consent on behalf of a child, the parent may also exercise the child’s rights to disclose healthcare-related information ( ). Likewise, where the minor is authorized to consent to medical care independently, only the minor has the authority to consent to the disclosure of such information ( ).
The Health Insurance Portability and Accountability Act (HIPAA) of 1996 and its implementing regulations, as a general statement, defer to state laws addressing the ability of a parent or guardian to obtain or otherwise disclose protected health information concerning a minor ( ). HIPAA does, however, specify the following three situations in which a parent does not function as the personal representative of the minor for the purpose of disclosing protected health information:
When state or other law does not require the consent of the parent or other person before a minor can obtain a particular healthcare service, and the minor consents to such service
When a court determines or other law authorizes someone other than the parent to make treatment decisions for the minor
When a parent agrees to a confidential relationship between the minor and the physician (CFR §164.502(g))
There is a paucity of guidance for the usage of opioids in the pediatric population, unlike that which exists for adults. In fact, the Centers for Disease Control and Prevention (CDC) acknowledges in its opioid prescribing guidelines that there is only limited data relating to the use of opioids in the pediatric population and specifically excludes children and adolescents from the guidelines. The Pediatric Pharmacy Advocacy Group (PPAG), recognizing that considerations of opioid use in the pediatric population are propelled, to some extent, by the opioid epidemic in the United States, published recommendations for the use of this class of medications in children and adolescents. This important organization promotes the concept of including pharmacists in the process of educating parents about the risks of opioid medications that are prescribed to their children. This supplemental discussion could serve to reinforce informed consent conversations about the risks and benefits of their use. These recommendations of the PPAG ( ) include:
Pharmacists should proactively engage licensed prescribers on the customized selection of opioids and other nonopioid alternatives.
Pharmacists should actively provide education on proper storage, disposal, and administration of prescription opioids to prevent misuse, overdose, or development of opioid use disorder.
Pharmacists should actively engage in education of patients, families, and local communities to increase public awareness of the dangers regarding opioid misuse.
Pharmacists should lead or actively participate in institutional efforts to implement opioid stewardship programs.
Pharmacists should advocate for universal use of electronic prescription drug monitoring programs by prescribers and “real-time” data submission of opioids dispensed at pharmacies.
Pharmacists should participate in the distribution of naloxone to individuals and organizations that meet state-determined criteria through standing orders, protocol orders, collaborative practice agreements, or pharmacists prescriptive authority.
Pharmacists should actively endorse the American Academy of Pediatrics policy statement to improve access to evidence-based treatment for adolescents and young adults with opioid use disorder and advocate for an expanded role of the pharmacist in detoxification and office-based pharmacotherapy.
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