CHAPTER 42 Medicolegal and Ethical Aspects
Informed consent
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 recent 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 (Foy, 2003b; Watts, 2005). Parker’s parents were undecided about the right course of treatment for their son and wanted to seek a second opinion (Foy, 2003a). 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 (Foy, 2003a). A battle ensued between Parker’s parents and the state of Utah; the end result was that kidnapping and child neglect charges were filed against Parker’s parents (Foy, 2003a). Parker’s opinion was not nearly—if at all—as highly publicized.
Background
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” (Schloendorff v. Society of NY Hosp, 1914). 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 (McNeil v. Brewer, 1999*; Syoboda et al., 2000). 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 (Syoboda et al., 2000). The requirement of consent primarily protects the patient’s bodily integrity (Syoboda et al., 2000).
Informed Consent
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 (Schlam and Wood, 2000). “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” (Schlam and Wood, 2000).
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 (Schlam and Wood, 2000). 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 (Altman et al., 1992; Schlam and Wood, 2000). In other words, the patient must know for what he or she is giving consent (Syoboda et al., 2000). Informed consent is the “autonomous authorization of medical intervention … by individual patients” (Beauchamp and Faden, 1995; Syoboda et al., 2000). 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” (Schlam and Wood, 2000). 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 (Schlam and Wood, 2000).
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 (Syoboda et al., 2000). “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” (Syoboda et al., 2000). 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 (Syoboda et al., 2000). In short, physicians must disclose all material information; i.e., 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” (Arato v. Avedon, 1993; Syoboda et al., 2000).
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” (Syoboda et al., 2000). That a decision be made competently requires physicians to assess whether a patient can both understand the relevant medical information and make a rational decision based on that information (Syoboda et al., 2000).
The voluntariness requirement simply protects the patient’s right to make health care decisions free from manipulation or undue influence (Syoboda et al., 2000). 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 (Syoboda et al., 2000).
Background: Consent by Minor
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 (Syoboda et al., 2000). 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 (Watts, 2005). That right of 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 (Watts, 2005). 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 (Watts, 2005). 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 health care 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 (Watts, 2005). 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 (Schlam and Wood, 2000). Before that time, children had no rights, and parents reared their children without government restraint (Schlam and Wood, 2000). The Supreme Court has articulated several justifications for total parental autonomy (Parham v. JR, 1979; Watts, 2005). 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 (Parham v. JR, 1979; Watts, 2005). Since that time, however, the Supreme Court has modified the notion of absolute parental autonomy in order to account for the interest of minors, particularly in the arena of health care decisions (Watts, 2005). The idea is that there are better means for protecting parental autonomy than disregarding the desires of the children (Hawkins, 1996; Schlam and Wood, 2000). Jurisdictions vary in the deference given to parental autonomy over a child’s health care (Watts, 2005).
Typically, the current view is that for most treatment provided to children, informed consent is provided by parents or guardians (Health L Prac Guide, 2008). 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 (Secretary, Dept Health and Comm Ser v. JWB and SMB, 1992; Syoboda et al., 2000). 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 (Syoboda et al., 2000). 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 (Syoboda et al., 2000). 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 (Syoboda et al., 2000). 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 (Vukadinovich, 2004). 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” (Vukadinovich, 2004). Secondly, 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 (Vukadinovich, 2004).
The Mature Minor
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 (Health L Prac Guide, 2008). Then when they reach yet another, older age, they are given sole decision-making power over their own health care; at this point, they are no longer considered minors.
The law does recognize the “mature minor doctrine,” which 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” (Schlam and Wood, 2000). 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 (Kreichman, 1989*; Schlam and Wood, 2000). Even if 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.
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, as well as how to be assured that they have properly communicated with and obtained knowing and intelligent medical decisions from competent minor patients (Kreichman, 1989; Schlam and Wood, 2000). The Supreme Court has not been particularly helpful in offering guidance to physicians attempting to determine the maturity of a minor (Schlam and Wood, 2000). It did, however, hold in Planned Parenthood of Central Missouri v. Danforth, 428 US at 52-53, 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 (although it does not appear that any court has granted a patient younger than 14 years of age the right to consent), maturity, intelligence, and the nature and risks of the proposed treatment (Schlam and Wood, 2000). 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 refuse treatment (Schlam and Wood, 2000; O’Connor, 1994). 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 (Bishop v. Shurly, 1926; Gulf and SIR Co v. Sullivan, 1928; Younts v. St. Francis Hosp and Sch of Nursing, 1970; Cardwell v. Bechtol, 1987; Schlam and Wood, 2000). However, ethicists agree that the ordinary indicia of competence should be balanced against the risks of treatment (Schlam and Wood, 2000). The mature minor doctrine has been consistently applied in cases in which the minor is nearing the age of majority, usually 15 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 (Schlam and Wood, 2000). 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” (Schlam and Wood, 2000). 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 (Schlam and Wood, 2000).
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 (Health L Prac Guide, 2008). 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 (Health L Prac Guide, 2008).
The Emancipated Minor
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 (Schlam and Wood, 2000). 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 health care 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 (Vukadinovich, 2004). The emancipated minor doctrine broadly conveys to the minor the right to consent to or 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 (Vukadinovich, 2004). 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” (Schlam and Wood, 2000).
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 (Vukadinovich, 2004). Accordingly, with few exceptions, when treating an emancipated minor, the health care provider must deal with the minor as if that patient were an adult (Vukadinovich, 2004).
Informed Consent and HIPAA
The ability to authorize disclosure of health information usually goes hand in hand with the right to give informed consent, as discussed above (Health L Prac Guide, 2008). 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 health care related information (Health L Prac Guide, 2008). 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 (Health L Prac Guide, 2008).
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 (Health L Prac Guide, 2008). 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:
Medical malpractice litigation
A health care professional is not liable to a patient merely because the care rendered produced a bad result, because a bad result was brought about by an error in judgment, when there is a reasonable doubt or difference of opinion as to the patient’s condition or proper course of treatment, and when the physician acts with reasonable care in exercising judgment (Roach v. Hockey, 1981; McClellan, 2005). There are four theories of medical malpractice under which a plaintiff may be able to recover: breach of contract, negligence, lack of informed consent, and respondeat superior (McClellan, 2005). Negligence cases compose most of the medical malpractice actions against individual health care providers (Mastroianni, 2006). Informed consent cases are particularly relevant to pediatric physicians and pose a set of unique issues, as discussed previously. Accordingly, this chapter focuses on those types of actions. As stated, however, it is important to note that this chapter is intended to provide only an overview of malpractice actions; in reality, such litigation is incredibly complex, and the burdens of proof and type of evidence required to meet that burden are governed more specifically by each individual state’s law.
Negligence
Most medical malpractice actions are based on a negligence theory. In negligence-based malpractice actions, the plaintiff is essentially taking the position that the conduct in question “falls below the standard established by law for the protection of others against unreasonable risk of harm” (Mastroianni, 2006). Stated another way, the plaintiff is arguing that the professional did not possess or employ the degree of skill or knowledge required of a professional rendering such care under the circumstances (Incollingo v. Ewing, 1971; Shilkret v. Annapolis Emergency Hosp Assoc, 1975; McClellan, 2005). In such cases, the plaintiff, who is typically either the patient or the patient’s family (in the event the patient is incompetent or has died) must prove four elements of malpractice: duty, breach of standard of care, injury, and causation.
Duty
First, the plaintiff must establish that the defendant—typically the physician or the institution with which the physician is affiliated—had a legal duty to the plaintiff (Mastroianni, 2006). In the context of medical malpractice actions, the “duty” can include any number of obligations that health care professionals incur on entering into a physician–patient relationship, including duties mandated by state or federal statute, either implicitly or explicitly (Mastroianni, 2006). Generally during the physician–patient relationship, the physician has a duty to exercise the degree of care, diligence, and skill that physicians of reasonable and ordinary prudence would exercise under the same or similar circumstances (Shandell et al., 1981).
Courts have held that this duty may include any of the following actions:
Breach of Standard of Care
The very existence of the physician’s duty imposes on certain responsibilities to exercise due care, and the plaintiff must establish that the defendant breached that standard of care (Mastroianni, 2006). Stated differently, the plaintiff must establish that the physician undertook a form of treatment that a reasonable, prudent member of the medical profession would not have taken under the same or similar circumstances (Shandell et al., 1981). The standard of care, then, is what is reasonable under the circumstances (Shandell et al., 1981).
The first step for any plaintiff, after proving the existence of a duty, is to establish the appropriate medical standard of care (Shandell et al., 1981). Generally, a plaintiff must show that the defendant deviated from a standard of care and skill possessed by reasonably prudent physicians practicing in the same field of medicine. If the physician who renders the medical care to a patient in question specializes in a particular branch of medicine, that physician is required to use the care and judgment of a reasonably prudent person engaged in that specialty (McClellan, 2005). To be clear, a health care provider is not required to provide the highest degree of care possible—only the ordinary degree of skill and care exercised by his or her peers (Shandell et al., 1981). In order to establish the standard of care, the plaintiff must identify the person with whom the professional is being compared. There are jurisdictional differences as to the requirements of a geographic similarity and specialty training (McClellan, 2005). It appears that the current trend is to apply a national, rather than a local, standard to determine the standard of care required of a physician (Naccarato v. Grob, 1970; Shildret v. Annapolis Emergency Hosp Assoc, 1975; Bruni v. Tatsumi, 1976; Zeller v. Greater Baltimore Med Cntr, 1986; McClellan, 2005).
Injury
The plaintiff must also establish that he or she suffered a “compensable” injury—or one for which it is possible to be compensated for the actual harm suffered, including pain and suffering, with a monetary award. In most negligence cases, only compensatory damages are awarded. However, in cases where the defendant’s actions is deemed to have been “reckless” or an “extreme departure from the standard of care” (gross negligence), some states do allow a plaintiff to recover punitive damages as well (Mastroianni, 2006). A bad result alone, however, cannot be equated with malpractice and typically does not create a presumption of negligence (Shandell et al., 1981).
Causation
Finally, the plaintiff must establish that the defendant’s actions were the cause of the injury (Mastroianni, 2006). The fact that a physician erred does not necessarily warrant the conclusion that the error was the cause of the plaintiff’s injury. In other words, the physician may have erred, and the patient may have suffered, but unless the error caused the injury, the physician may not be liable (PLI, Med Malpractice). The plaintiff is required to establish that the physician’s departure from the standard of care was more likely than not to have been the proximate cause of the plaintiff’s injury (PLI, Med Malpractice). It need not, however, be the sole cause—only a substantial factor in bringing about the injury (PLI, Med Malpractice). Typically, the plaintiff will establish the causation element through expert testimony, primarily because a jury must struggle to understand scientific processes that are unfamiliar and involve inherent uncertainty (Practicing Law Institute, 2009; Shandell et al., 1981).
Malpractice Resulting from Lack of Informed Consent
If certain requirements are met, a plaintiff may bring a cause of action against a physician for lack of informed consent. As previously stated, an action for lack of informed consent is an action for medical malpractice in which the practitioner failed to inform the patient of the alternatives to the proposed treatment or diagnosis and the reasonably foreseeable risks and benefits involved, such that the patient can make a knowledgeable evaluation (Practicing Law Institute, 2009). Generally, even when the physician adheres to the requisite standard of care in performing a procedure or conducting an examination, the patient may recover for injuries suffered as a result of the procedure or examination if the physician failed to obtain informed consent (Armstrong v. Brookdale Univ Hosp and Med Cntr, 2005).
An action for informed consent has the same four elements as any other action for medical malpractice: duty, breach, injury, and causation. The difference in an informed consent action is in the nature of the breach; that is, the physician was negligent in explaining the procedure rather than performing it. More specifically, in order to establish medical malpractice based on lack of informed consent, a plaintiff typically must establish that the medical procedure carried a specific risk that was not disclosed, the physician violated the applicable standard of disclosure, the undisclosed risk materialized, and the failure to disclose the information caused the patient’s injury (Mastroianni, 2006).
It is important to note that the court distinguishes a lack of informed consent case from a case of battery, which lies against one who “intentionally touches another person, without that person’s consent, and causes an offensive bodily contact…. The intent required for battery is intent to cause a bodily contact that a reasonable person would find offensive” (Jeffreys v. Griffin, 2003; Armstrong v. Brookdale Univ Hosp and Med Cntr, 2005). In other words, in New York, a completely unpermitted touching by a medical practitioner is a battery, as distinct from a Section 2805-d claim (Jeffreys v. Griffin, 2003; Armstrong v. Brookdale Univ Hosp and Med Cntr, 2005). New Jersey also distinguishes a lack of informed consent case from a battery cause of action, reasoning that because physicians ordinarily lacked the intent to harm normally associated with the tort of battery, courts examining the nuances of the physician–patient relationship realized that conceptually a cause of action based on lack of patient consent fits better into the framework of a negligence cause of action. Accordingly, the framework for New Jersey’s lack of informed consent cause of action can be characterized as a negligence type of action rather than an intentional tort (Robinson v. Cutchin, 2001; Howard v. Univ of Medicine and Dentistry of New Jersey, 2002).
In New Jersey, a patient seeking to recover for lack of informed consent must prove that the physician withheld pertinent medical information concerning the risks of the procedure or treatment, the alternatives, or the potential results if the procedure or treatment were not undertaken (Perna v. Pirozzi, 1983; Howard v. Univ of Medicine and Dentistry of New Jersey, 2002). The information a physician must disclose depends on what a reasonably prudent patient would deem significant in determining whether to proceed with the proposed procedure (Largey v. Rothman, 1988; Howard v. Univ of Medicine and Dentistry of New Jersey, 2002). The plaintiff must also prove that a reasonably prudent patient in the plaintiff’s position would have declined to undergo the treatment if informed of the risk that defendant failed to disclose (Largey v. Rothman, 1988; Howard v. Univ of Medicine and Dentistry of New Jersey, 2002).
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* For example, 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.
* Discussing mature minor doctrine and the capacity to understand the treatment as the primary concern with minor’s consent to the proposed treatment.
