Law & Medicine

Question: A 15-year-old boy develops excruciating testicular pain from torsion of the testis. The family internist urged emergency surgery as recommended by the urologist, but the parents refused. Which of the following accurately describes the issue of consent?

A. Even if the boy nods in assent, this would be invalid consent as he is a minor.

B. Acquiesce to the parents, as they have the legal authority to decide.

C. Try to persuade the parents that surgery is in the boy’s best interests, but operate even if they continue to insist on withholding consent.

D. Request a court hearing and treat the boy conservatively in the meantime.

E. Consent is deemed unnecessary in most cases so long as a second independent doctor documents his or her agreement.

Answer: C. This hypothetical raises the issue of doing what’s best for a minor in the face of parental refusal of beneficial medical treatment. Here, the boy’s assent may constitute indicia of consent, and should be strongly considered given the surgical indication and the urgency of the circumstances; a two-signature practice merely documents peer agreement and does not constitute legal permission to proceed. Because there is insufficient time to obtain court-sanctioned approval, the doctor should rely on the principle of necessity, which vitiates consent, to do what’s in the best interests of the patient. Thus, C is the best choice under the facts.

Consent is unnecessary in an emergency only if it cannot be readily obtained, and a delay places the patient in jeopardy. The treatment need not be life saving, so long as the potential harm to the patient is significant. This exception is typically provided for in state statutes on informed consent. For example, Hawaii Revised Statutes Section 671-3 (d) stipulates: "Nothing in this section shall require informed consent from a patient or a patient’s guardian when emergency treatment or emergency surgical procedure is rendered by a health care provider and the obtaining of consent is not reasonably feasible under the circumstances without adversely affecting the condition of the patient’s health." This comports with the policy of the American Academy of Pediatrics, which emphasizes the treatment of minors with an identified emergency medical condition regardless of consent issues. Such treatment should never be withheld or delayed because of problems with obtaining consent.

All adults of sound mind are presumed to be competent to give informed consent. But for a minor, the doctor must usually obtain permission from the parents or guardian unless the minor is emancipated, i.e., conducting himself or herself as an adult and no longer under the support or control of the parents, or is a "mature minor." The latter category defines the minor who is able to understand the nature and consequences of treatment. In fact, many adolescents are thought to have medical decisional skills that virtually match those of adults. In commonwealth jurisdictions, the term "Gillick competence" is used to describe a minor under the age of 16 who is deemed to have legal capacity to consent to medical treatment if there is sufficient intelligence and maturity to understand the nature, implications and consequences of treatment.

The mature or emancipated minor, like the adult, is entitled to the constitutional right to accept or forgo medical treatment. In general, courts have respected the minor’s judgment even in the face of parental objections. For example, a court held that a 14-year-old boy should decide whether he wanted his cleft palate and harelip repaired, regardless of his father’s objections to the operation. In another case, the court ordered treatment for a 12-year-old arthritis victim whose parents relied on faith healing, where there was uncontested medical testimony in favor of treatment. In yet another case, a 13-year-old boy was placed under state supervision for purposes of receiving chemotherapy and surgery that was estimated to have a 65% of curing his cancer. The court ruled that the information given by his father regarding the preference for and effectiveness of herbal therapy was wrong, and the minor’s refusal of consent was not an informed one.

Physicians have an ethical and legal obligation to obtain parental permission to undertake recommended medical interventions. In many circumstances, physicians should also solicit a patient assent when developmentally appropriate. In cases involving emancipated or mature minors with adequate decision-making capacity, or when otherwise permitted by law, physicians should seek informed consent directly from patients. Occasionally, a doctor faces the dilemma of parents refusing to give permission for a proposed effective treatment. One should always respect parental values, but the doctor has to look out for the patient’s best interests as well. In situations where the intervention is burdensome or its effectiveness limited, one might ethically acquiesce to parental wishes. However, where the intervention is highly effective or lifesaving with few risks, then the doctor may be obligated to pursue legal means in the face of continued parental resistance. Parental rights over their children’s health care should, in general, be respected, unless there is clear and convincing evidence that the parent’s approach is harming their child. The U.S. Supreme Court has famously said: "Parents may be free to become martyrs themselves. But it does not follow they are free, in identical circumstances, to make martyrs of their children." On the other hand, even a mature minor does not have an unfettered right to refuse treatment, especially where such refusal is against medical advice. For example, a 16-year-old was forced, against her will, to accept tube feedings to treat her condition of anorexia nervosa.

Finally, special rules apply in certain areas such as family planning, sexually transmitted diseases, alcohol and drug abuse, and psychiatric conditions. Many states statutorily allow teenagers to give consent for these types of medical services without parental approval.

Question: A 15-year-old boy develops excruciating testicular pain from torsion of the testis. The family internist urged emergency surgery as recommended by the urologist, but the parents refused. Which of the following accurately describes the issue of consent?

A. Even if the boy nods in assent, this would be invalid consent as he is a minor.

B. Acquiesce to the parents, as they have the legal authority to decide.

C. Try to persuade the parents that surgery is in the boy’s best interests, but operate even if they continue to insist on withholding consent.

D. Request a court hearing and treat the boy conservatively in the meantime.

E. Consent is deemed unnecessary in most cases so long as a second independent doctor documents his or her agreement.

Answer: C. This hypothetical raises the issue of doing what’s best for a minor in the face of parental refusal of beneficial medical treatment. Here, the boy’s assent may constitute indicia of consent, and should be strongly considered given the surgical indication and the urgency of the circumstances; a two-signature practice merely documents peer agreement and does not constitute legal permission to proceed. Because there is insufficient time to obtain court-sanctioned approval, the doctor should rely on the principle of necessity, which vitiates consent, to do what’s in the best interests of the patient. Thus, C is the best choice under the facts.

Consent is unnecessary in an emergency only if it cannot be readily obtained, and a delay places the patient in jeopardy. The treatment need not be life saving, so long as the potential harm to the patient is significant. This exception is typically provided for in state statutes on informed consent. For example, Hawaii Revised Statutes Section 671-3 (d) stipulates: "Nothing in this section shall require informed consent from a patient or a patient’s guardian when emergency treatment or emergency surgical procedure is rendered by a health care provider and the obtaining of consent is not reasonably feasible under the circumstances without adversely affecting the condition of the patient’s health." This comports with the policy of the American Academy of Pediatrics, which emphasizes the treatment of minors with an identified emergency medical condition regardless of consent issues. Such treatment should never be withheld or delayed because of problems with obtaining consent.

All adults of sound mind are presumed to be competent to give informed consent. But for a minor, the doctor must usually obtain permission from the parents or guardian unless the minor is emancipated, i.e., conducting himself or herself as an adult and no longer under the support or control of the parents, or is a "mature minor." The latter category defines the minor who is able to understand the nature and consequences of treatment. In fact, many adolescents are thought to have medical decisional skills that virtually match those of adults. In commonwealth jurisdictions, the term "Gillick competence" is used to describe a minor under the age of 16 who is deemed to have legal capacity to consent to medical treatment if there is sufficient intelligence and maturity to understand the nature, implications and consequences of treatment.

The mature or emancipated minor, like the adult, is entitled to the constitutional right to accept or forgo medical treatment. In general, courts have respected the minor’s judgment even in the face of parental objections. For example, a court held that a 14-year-old boy should decide whether he wanted his cleft palate and harelip repaired, regardless of his father’s objections to the operation. In another case, the court ordered treatment for a 12-year-old arthritis victim whose parents relied on faith healing, where there was uncontested medical testimony in favor of treatment. In yet another case, a 13-year-old boy was placed under state supervision for purposes of receiving chemotherapy and surgery that was estimated to have a 65% of curing his cancer. The court ruled that the information given by his father regarding the preference for and effectiveness of herbal therapy was wrong, and the minor’s refusal of consent was not an informed one.

Physicians have an ethical and legal obligation to obtain parental permission to undertake recommended medical interventions. In many circumstances, physicians should also solicit a patient assent when developmentally appropriate. In cases involving emancipated or mature minors with adequate decision-making capacity, or when otherwise permitted by law, physicians should seek informed consent directly from patients. Occasionally, a doctor faces the dilemma of parents refusing to give permission for a proposed effective treatment. One should always respect parental values, but the doctor has to look out for the patient’s best interests as well. In situations where the intervention is burdensome or its effectiveness limited, one might ethically acquiesce to parental wishes. However, where the intervention is highly effective or lifesaving with few risks, then the doctor may be obligated to pursue legal means in the face of continued parental resistance. Parental rights over their children’s health care should, in general, be respected, unless there is clear and convincing evidence that the parent’s approach is harming their child. The U.S. Supreme Court has famously said: "Parents may be free to become martyrs themselves. But it does not follow they are free, in identical circumstances, to make martyrs of their children." On the other hand, even a mature minor does not have an unfettered right to refuse treatment, especially where such refusal is against medical advice. For example, a 16-year-old was forced, against her will, to accept tube feedings to treat her condition of anorexia nervosa.

Finally, special rules apply in certain areas such as family planning, sexually transmitted diseases, alcohol and drug abuse, and psychiatric conditions. Many states statutorily allow teenagers to give consent for these types of medical services without parental approval.

Question: A 15-year-old boy develops excruciating testicular pain from torsion of the testis. The family internist urged emergency surgery as recommended by the urologist, but the parents refused. Which of the following accurately describes the issue of consent?

A. Even if the boy nods in assent, this would be invalid consent as he is a minor.

B. Acquiesce to the parents, as they have the legal authority to decide.

C. Try to persuade the parents that surgery is in the boy’s best interests, but operate even if they continue to insist on withholding consent.

D. Request a court hearing and treat the boy conservatively in the meantime.

E. Consent is deemed unnecessary in most cases so long as a second independent doctor documents his or her agreement.

Answer: C. This hypothetical raises the issue of doing what’s best for a minor in the face of parental refusal of beneficial medical treatment. Here, the boy’s assent may constitute indicia of consent, and should be strongly considered given the surgical indication and the urgency of the circumstances; a two-signature practice merely documents peer agreement and does not constitute legal permission to proceed. Because there is insufficient time to obtain court-sanctioned approval, the doctor should rely on the principle of necessity, which vitiates consent, to do what’s in the best interests of the patient. Thus, C is the best choice under the facts.

Consent is unnecessary in an emergency only if it cannot be readily obtained, and a delay places the patient in jeopardy. The treatment need not be life saving, so long as the potential harm to the patient is significant. This exception is typically provided for in state statutes on informed consent. For example, Hawaii Revised Statutes Section 671-3 (d) stipulates: "Nothing in this section shall require informed consent from a patient or a patient’s guardian when emergency treatment or emergency surgical procedure is rendered by a health care provider and the obtaining of consent is not reasonably feasible under the circumstances without adversely affecting the condition of the patient’s health." This comports with the policy of the American Academy of Pediatrics, which emphasizes the treatment of minors with an identified emergency medical condition regardless of consent issues. Such treatment should never be withheld or delayed because of problems with obtaining consent.

All adults of sound mind are presumed to be competent to give informed consent. But for a minor, the doctor must usually obtain permission from the parents or guardian unless the minor is emancipated, i.e., conducting himself or herself as an adult and no longer under the support or control of the parents, or is a "mature minor." The latter category defines the minor who is able to understand the nature and consequences of treatment. In fact, many adolescents are thought to have medical decisional skills that virtually match those of adults. In commonwealth jurisdictions, the term "Gillick competence" is used to describe a minor under the age of 16 who is deemed to have legal capacity to consent to medical treatment if there is sufficient intelligence and maturity to understand the nature, implications and consequences of treatment.

The mature or emancipated minor, like the adult, is entitled to the constitutional right to accept or forgo medical treatment. In general, courts have respected the minor’s judgment even in the face of parental objections. For example, a court held that a 14-year-old boy should decide whether he wanted his cleft palate and harelip repaired, regardless of his father’s objections to the operation. In another case, the court ordered treatment for a 12-year-old arthritis victim whose parents relied on faith healing, where there was uncontested medical testimony in favor of treatment. In yet another case, a 13-year-old boy was placed under state supervision for purposes of receiving chemotherapy and surgery that was estimated to have a 65% of curing his cancer. The court ruled that the information given by his father regarding the preference for and effectiveness of herbal therapy was wrong, and the minor’s refusal of consent was not an informed one.

Physicians have an ethical and legal obligation to obtain parental permission to undertake recommended medical interventions. In many circumstances, physicians should also solicit a patient assent when developmentally appropriate. In cases involving emancipated or mature minors with adequate decision-making capacity, or when otherwise permitted by law, physicians should seek informed consent directly from patients. Occasionally, a doctor faces the dilemma of parents refusing to give permission for a proposed effective treatment. One should always respect parental values, but the doctor has to look out for the patient’s best interests as well. In situations where the intervention is burdensome or its effectiveness limited, one might ethically acquiesce to parental wishes. However, where the intervention is highly effective or lifesaving with few risks, then the doctor may be obligated to pursue legal means in the face of continued parental resistance. Parental rights over their children’s health care should, in general, be respected, unless there is clear and convincing evidence that the parent’s approach is harming their child. The U.S. Supreme Court has famously said: "Parents may be free to become martyrs themselves. But it does not follow they are free, in identical circumstances, to make martyrs of their children." On the other hand, even a mature minor does not have an unfettered right to refuse treatment, especially where such refusal is against medical advice. For example, a 16-year-old was forced, against her will, to accept tube feedings to treat her condition of anorexia nervosa.

Finally, special rules apply in certain areas such as family planning, sexually transmitted diseases, alcohol and drug abuse, and psychiatric conditions. Many states statutorily allow teenagers to give consent for these types of medical services without parental approval.

Question: A 15-year-old boy develops excruciating testicular pain from torsion of the testis. The family internist urged emergency surgery as recommended by the urologist, but the parents refused. Which of the following accurately describes the issue of consent?

A. Even if the boy nods in assent, this would be invalid consent as he is a minor.

B. Acquiesce to the parents, as they have the legal authority to decide.

C. Try to persuade the parents that surgery is in the boy’s best interests, but operate even if they continue to insist on withholding consent.

D. Request a court hearing and treat the boy conservatively in the meantime.

E. Consent is deemed unnecessary in most cases so long as a second independent doctor documents his or her agreement.

Answer: C. This hypothetical raises the issue of doing what’s best for a minor in the face of parental refusal of beneficial medical treatment. Here, the boy’s assent may constitute indicia of consent, and should be strongly considered given the surgical indication and the urgency of the circumstances; a two-signature practice merely documents peer agreement and does not constitute legal permission to proceed. Because there is insufficient time to obtain court-sanctioned approval, the doctor should rely on the principle of necessity, which vitiates consent, to do what’s in the best interests of the patient. Thus, C is the best choice under the facts.

Consent is unnecessary in an emergency only if it cannot be readily obtained, and a delay places the patient in jeopardy. The treatment need not be life saving, so long as the potential harm to the patient is significant. This exception is typically provided for in state statutes on informed consent. For example, Hawaii Revised Statutes Section 671-3 (d) stipulates: "Nothing in this section shall require informed consent from a patient or a patient’s guardian when emergency treatment or emergency surgical procedure is rendered by a health care provider and the obtaining of consent is not reasonably feasible under the circumstances without adversely affecting the condition of the patient’s health." This comports with the policy of the American Academy of Pediatrics, which emphasizes the treatment of minors with an identified emergency medical condition regardless of consent issues. Such treatment should never be withheld or delayed because of problems with obtaining consent.

All adults of sound mind are presumed to be competent to give informed consent. But for a minor, the doctor must usually obtain permission from the parents or guardian unless the minor is emancipated, i.e., conducting himself or herself as an adult and no longer under the support or control of the parents, or is a "mature minor." The latter category defines the minor who is able to understand the nature and consequences of treatment. In fact, many adolescents are thought to have medical decisional skills that virtually match those of adults. In commonwealth jurisdictions, the term "Gillick competence" is used to describe a minor under the age of 16 who is deemed to have legal capacity to consent to medical treatment if there is sufficient intelligence and maturity to understand the nature, implications and consequences of treatment.

The mature or emancipated minor, like the adult, is entitled to the constitutional right to accept or forgo medical treatment. In general, courts have respected the minor’s judgment even in the face of parental objections. For example, a court held that a 14-year-old boy should decide whether he wanted his cleft palate and harelip repaired, regardless of his father’s objections to the operation. In another case, the court ordered treatment for a 12-year-old arthritis victim whose parents relied on faith healing, where there was uncontested medical testimony in favor of treatment. In yet another case, a 13-year-old boy was placed under state supervision for purposes of receiving chemotherapy and surgery that was estimated to have a 65% of curing his cancer. The court ruled that the information given by his father regarding the preference for and effectiveness of herbal therapy was wrong, and the minor’s refusal of consent was not an informed one.

Physicians have an ethical and legal obligation to obtain parental permission to undertake recommended medical interventions. In many circumstances, physicians should also solicit a patient assent when developmentally appropriate. In cases involving emancipated or mature minors with adequate decision-making capacity, or when otherwise permitted by law, physicians should seek informed consent directly from patients. Occasionally, a doctor faces the dilemma of parents refusing to give permission for a proposed effective treatment. One should always respect parental values, but the doctor has to look out for the patient’s best interests as well. In situations where the intervention is burdensome or its effectiveness limited, one might ethically acquiesce to parental wishes. However, where the intervention is highly effective or lifesaving with few risks, then the doctor may be obligated to pursue legal means in the face of continued parental resistance. Parental rights over their children’s health care should, in general, be respected, unless there is clear and convincing evidence that the parent’s approach is harming their child. The U.S. Supreme Court has famously said: "Parents may be free to become martyrs themselves. But it does not follow they are free, in identical circumstances, to make martyrs of their children." On the other hand, even a mature minor does not have an unfettered right to refuse treatment, especially where such refusal is against medical advice. For example, a 16-year-old was forced, against her will, to accept tube feedings to treat her condition of anorexia nervosa.

Finally, special rules apply in certain areas such as family planning, sexually transmitted diseases, alcohol and drug abuse, and psychiatric conditions. Many states statutorily allow teenagers to give consent for these types of medical services without parental approval.

Dr. Tan is emeritus professor at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at [email protected].

Question: A 15-year-old boy develops excruciating testicular pain from torsion of the testis. The family internist urged emergency surgery as recommended by the urologist, but the parents refused. Which of the following accurately describes the issue of consent?

A. Even if the boy nods in assent, this would be invalid consent as he is a minor.

B. Acquiesce to the parents, as they have the legal authority to decide.

C. Try to persuade the parents that surgery is in the boy’s best interests, but operate even if they continue to insist on withholding consent.

D. Request a court hearing and treat the boy conservatively in the meantime.

E. Consent is deemed unnecessary in most cases so long as a second independent doctor documents his or her agreement.

Answer: C. This hypothetical raises the issue of doing what’s best for a minor in the face of parental refusal of beneficial medical treatment. Here, the boy’s assent may constitute indicia of consent, and should be strongly considered given the surgical indication and the urgency of the circumstances; a two-signature practice merely documents peer agreement and does not constitute legal permission to proceed. Because there is insufficient time to obtain court-sanctioned approval, the doctor should rely on the principle of necessity, which vitiates consent, to do what’s in the best interests of the patient. Thus, C is the best choice under the facts.

Consent is unnecessary in an emergency only if it cannot be readily obtained, and a delay places the patient in jeopardy. The treatment need not be life saving, so long as the potential harm to the patient is significant. This exception is typically provided for in state statutes on informed consent. For example, Hawaii Revised Statutes Section 671-3 (d) stipulates: "Nothing in this section shall require informed consent from a patient or a patient’s guardian when emergency treatment or emergency surgical procedure is rendered by a health care provider and the obtaining of consent is not reasonably feasible under the circumstances without adversely affecting the condition of the patient’s health." This comports with the policy of the American Academy of Pediatrics, which emphasizes the treatment of minors with an identified emergency medical condition regardless of consent issues. Such treatment should never be withheld or delayed because of problems with obtaining consent.

All adults of sound mind are presumed to be competent to give informed consent. But for a minor, the doctor must usually obtain permission from the parents or guardian unless the minor is emancipated, i.e., conducting himself or herself as an adult and no longer under the support or control of the parents, or is a "mature minor." The latter category defines the minor who is able to understand the nature and consequences of treatment. In fact, many adolescents are thought to have medical decisional skills that virtually match those of adults. In commonwealth jurisdictions, the term "Gillick competence" is used to describe a minor under the age of 16 who is deemed to have legal capacity to consent to medical treatment if there is sufficient intelligence and maturity to understand the nature, implications and consequences of treatment.

The mature or emancipated minor, like the adult, is entitled to the constitutional right to accept or forgo medical treatment. In general, courts have respected the minor’s judgment even in the face of parental objections. For example, a court held that a 14-year-old boy should decide whether he wanted his cleft palate and harelip repaired, regardless of his father’s objections to the operation. In another case, the court ordered treatment for a 12-year-old arthritis victim whose parents relied on faith healing, where there was uncontested medical testimony in favor of treatment. In yet another case, a 13-year-old boy was placed under state supervision for purposes of receiving chemotherapy and surgery that was estimated to have a 65% of curing his cancer. The court ruled that the information given by his father regarding the preference for and effectiveness of herbal therapy was wrong, and the minor’s refusal of consent was not an informed one.

Physicians have an ethical and legal obligation to obtain parental permission to undertake recommended medical interventions. In many circumstances, physicians should also solicit a patient assent when developmentally appropriate. In cases involving emancipated or mature minors with adequate decision-making capacity, or when otherwise permitted by law, physicians should seek informed consent directly from patients. Occasionally, a doctor faces the dilemma of parents refusing to give permission for a proposed effective treatment. One should always respect parental values, but the doctor has to look out for the patient’s best interests as well. In situations where the intervention is burdensome or its effectiveness limited, one might ethically acquiesce to parental wishes. However, where the intervention is highly effective or lifesaving with few risks, then the doctor may be obligated to pursue legal means in the face of continued parental resistance. Parental rights over their children’s health care should, in general, be respected, unless there is clear and convincing evidence that the parent’s approach is harming their child. The U.S. Supreme Court has famously said: "Parents may be free to become martyrs themselves. But it does not follow they are free, in identical circumstances, to make martyrs of their children." On the other hand, even a mature minor does not have an unfettered right to refuse treatment, especially where such refusal is against medical advice. For example, a 16-year-old was forced, against her will, to accept tube feedings to treat her condition of anorexia nervosa.

Finally, special rules apply in certain areas such as family planning, sexually transmitted diseases, alcohol and drug abuse, and psychiatric conditions. Many states statutorily allow teenagers to give consent for these types of medical services without parental approval.

Dr. Tan is emeritus professor at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at [email protected].

Question: A 15-year-old boy develops excruciating testicular pain from torsion of the testis. The family internist urged emergency surgery as recommended by the urologist, but the parents refused. Which of the following accurately describes the issue of consent?

A. Even if the boy nods in assent, this would be invalid consent as he is a minor.

B. Acquiesce to the parents, as they have the legal authority to decide.

C. Try to persuade the parents that surgery is in the boy’s best interests, but operate even if they continue to insist on withholding consent.

D. Request a court hearing and treat the boy conservatively in the meantime.

E. Consent is deemed unnecessary in most cases so long as a second independent doctor documents his or her agreement.

Answer: C. This hypothetical raises the issue of doing what’s best for a minor in the face of parental refusal of beneficial medical treatment. Here, the boy’s assent may constitute indicia of consent, and should be strongly considered given the surgical indication and the urgency of the circumstances; a two-signature practice merely documents peer agreement and does not constitute legal permission to proceed. Because there is insufficient time to obtain court-sanctioned approval, the doctor should rely on the principle of necessity, which vitiates consent, to do what’s in the best interests of the patient. Thus, C is the best choice under the facts.

Consent is unnecessary in an emergency only if it cannot be readily obtained, and a delay places the patient in jeopardy. The treatment need not be life saving, so long as the potential harm to the patient is significant. This exception is typically provided for in state statutes on informed consent. For example, Hawaii Revised Statutes Section 671-3 (d) stipulates: "Nothing in this section shall require informed consent from a patient or a patient’s guardian when emergency treatment or emergency surgical procedure is rendered by a health care provider and the obtaining of consent is not reasonably feasible under the circumstances without adversely affecting the condition of the patient’s health." This comports with the policy of the American Academy of Pediatrics, which emphasizes the treatment of minors with an identified emergency medical condition regardless of consent issues. Such treatment should never be withheld or delayed because of problems with obtaining consent.

All adults of sound mind are presumed to be competent to give informed consent. But for a minor, the doctor must usually obtain permission from the parents or guardian unless the minor is emancipated, i.e., conducting himself or herself as an adult and no longer under the support or control of the parents, or is a "mature minor." The latter category defines the minor who is able to understand the nature and consequences of treatment. In fact, many adolescents are thought to have medical decisional skills that virtually match those of adults. In commonwealth jurisdictions, the term "Gillick competence" is used to describe a minor under the age of 16 who is deemed to have legal capacity to consent to medical treatment if there is sufficient intelligence and maturity to understand the nature, implications and consequences of treatment.

The mature or emancipated minor, like the adult, is entitled to the constitutional right to accept or forgo medical treatment. In general, courts have respected the minor’s judgment even in the face of parental objections. For example, a court held that a 14-year-old boy should decide whether he wanted his cleft palate and harelip repaired, regardless of his father’s objections to the operation. In another case, the court ordered treatment for a 12-year-old arthritis victim whose parents relied on faith healing, where there was uncontested medical testimony in favor of treatment. In yet another case, a 13-year-old boy was placed under state supervision for purposes of receiving chemotherapy and surgery that was estimated to have a 65% of curing his cancer. The court ruled that the information given by his father regarding the preference for and effectiveness of herbal therapy was wrong, and the minor’s refusal of consent was not an informed one.

Physicians have an ethical and legal obligation to obtain parental permission to undertake recommended medical interventions. In many circumstances, physicians should also solicit a patient assent when developmentally appropriate. In cases involving emancipated or mature minors with adequate decision-making capacity, or when otherwise permitted by law, physicians should seek informed consent directly from patients. Occasionally, a doctor faces the dilemma of parents refusing to give permission for a proposed effective treatment. One should always respect parental values, but the doctor has to look out for the patient’s best interests as well. In situations where the intervention is burdensome or its effectiveness limited, one might ethically acquiesce to parental wishes. However, where the intervention is highly effective or lifesaving with few risks, then the doctor may be obligated to pursue legal means in the face of continued parental resistance. Parental rights over their children’s health care should, in general, be respected, unless there is clear and convincing evidence that the parent’s approach is harming their child. The U.S. Supreme Court has famously said: "Parents may be free to become martyrs themselves. But it does not follow they are free, in identical circumstances, to make martyrs of their children." On the other hand, even a mature minor does not have an unfettered right to refuse treatment, especially where such refusal is against medical advice. For example, a 16-year-old was forced, against her will, to accept tube feedings to treat her condition of anorexia nervosa.

Finally, special rules apply in certain areas such as family planning, sexually transmitted diseases, alcohol and drug abuse, and psychiatric conditions. Many states statutorily allow teenagers to give consent for these types of medical services without parental approval.

Dr. Tan is emeritus professor at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at [email protected].

Question: A woman developed primary pulmonary hypertension (PPH) 4 years after she had stopped using the prescription weight-loss drug, fenfluramine. The drug is known to cause valvular heart lesions as well as PPH. In a wrongful death lawsuit, her estate won a jury award of $1 billion in compensatory and exemplary damages. The defense appealed the size of the award, and argued that there are no studies demonstrating an association between fenfluramine and an increased risk of PPH that long after cessation of use. Which of the following is incorrect?

A. This is a products liability case.

B. The plaintiff can advance legal theories against the manufacturer based on warranty, negligence, or strict liability (that is, fault-free liability).

C. This can be a stand-alone case or part of a class action lawsuit.

D. The decision will definitely be overturned on appeal.

E. Such cases are frequently settled for a much smaller sum.

Answer: D. When a person is injured by a defective product, be it a car or a prescription drug, he or she can file a cause of action against the manufacturer or others who have placed that item into the stream of commerce. The law governing this general area of product-related injuries, broadly termed products liability, covers more than one specific tort, and the injured plaintiff can recover damages under a number of legal theories. Essentially, the claim is that the product was defective and unsafe, and the injury suffered by the plaintiff was a foreseeable consequence. In the medical field, patients treated with medications can sustain serious, even fatal, complications. Medical devices such as pacemakers and operating room equipment may malfunction and injure. And mass vaccinations do give rise, if rarely, to neurological sequelae and fatalities.

The above hypothetical is taken from an actual Texas case that was settled, presumably for much less than $1 billion, to avoid the unpredictability of an appellate outcome. Although this was a stand-alone case, such cases are frequently part of a class-action suit.

There are three legal theories in a products liability claim: negligence, breach of warranty, and strict products liability. The latter is the most favored, as there is no need to prove fault or warranty. The legal doctrine had its genesis in Greenman v. Yuba Power Products Inc. Mr. Greenman was injured when he used a power tool that was given to him as a gift. He sued the manufacturer, although there was no direct contract of warranty between him and the manufacturer as he did not make the purchase himself. The California Supreme Court went beyond the law of contracts to find the manufacturer liable, and in the process introduced the notion of strict liability, which goes beyond simple negligence, centering instead on whether a product is defective.

The strict liability approach has been adopted, in some cases with modifications, in virtually all jurisdictions. The theory holds that a professional supplier who sells a product that is both defective and unreasonably dangerous is strictly liable to foreseeable plaintiffs. "Defective" is usually defined as product quality that is less than what a reasonable consumer expects. "Unreasonably dangerous" is a conclusion that the risks that result from its condition outweigh the product’s advantages. Strict liability is not about negligence or fault, but about a social policy that shifts to the manufacturer the cost of compensating the injured consumer. To prevail, the plaintiff must show proximate cause, and assumption of risk is still a valid defense.

Manufacturers or suppliers of products that are unavoidably unsafe however, would be exempt from strict liability. In Hines v. St. Joseph’s Hospital, the plaintiff received blood transfusions and contracted hepatitis. The defendants were Blood Services Inc., the supplier of the blood, and St. Joseph’s Hospital, where the transfusions were ordered and given. In ruling for the defendants, the Court held that the product, blood in this case, was unavoidably unsafe and therefore not unreasonably dangerous. However, in Snyder v. Am Ass’n of Blood Banks, the Supreme Court of New Jersey found the trade organization liable for failing to recommend routine HIV testing of the nation’s blood supply in the early 1980s. The Court reasoned that the Association breached its duty of due care as it had projected itself as the guardian of blood safety and therefore ought to have recommended HIV testing even though the data were inconclusive at the time.

If a doctor fails to warn the patient of a medication risk, the patient may have a claim against the doctor but usually not the drug manufacturer. This is termed the "Learned-Intermediary" doctrine. The justification is that the manufacturer can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through its sales representatives and in its package insert. The treating doctor, in turn, is expected to use professional judgment to adequately warn the patient, as it is not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship. Occasionally, a court would side-step the doctrine, for example, where a manufacturer knows that the drug will reach the consumer without the intervention of a physician such as over-the-counter preparations. Another situation is where extensive advertising of a drug to the public has taken place. Manufacturers may also be liable if they have failed to disclose all known risks, as alleged in the litigation surrounding rofecoxib (Vioxx) and rosiglitazone (Avandia).

Hospitals usually escape liability for adverse drug reactions, with courts tending to shield them against implied warranty (hospitals are not merchants) or strict liability. In a case where the plaintiff alleged that sepsis resulted from the infusion of contaminated dextran, the Court ruled that the hospital was not a manufacturer of patient-care products, and therefore was not liable under strict liability or implied warranty rules (Shivers v. Good Shepherd Hospital). Similar approaches, though not universal, have been applied in injuries associated with the use of medical devices such as surgical needles, pacemakers, and spinal implants.

Question: A woman developed primary pulmonary hypertension (PPH) 4 years after she had stopped using the prescription weight-loss drug, fenfluramine. The drug is known to cause valvular heart lesions as well as PPH. In a wrongful death lawsuit, her estate won a jury award of $1 billion in compensatory and exemplary damages. The defense appealed the size of the award, and argued that there are no studies demonstrating an association between fenfluramine and an increased risk of PPH that long after cessation of use. Which of the following is incorrect?

A. This is a products liability case.

B. The plaintiff can advance legal theories against the manufacturer based on warranty, negligence, or strict liability (that is, fault-free liability).

C. This can be a stand-alone case or part of a class action lawsuit.

D. The decision will definitely be overturned on appeal.

E. Such cases are frequently settled for a much smaller sum.

Answer: D. When a person is injured by a defective product, be it a car or a prescription drug, he or she can file a cause of action against the manufacturer or others who have placed that item into the stream of commerce. The law governing this general area of product-related injuries, broadly termed products liability, covers more than one specific tort, and the injured plaintiff can recover damages under a number of legal theories. Essentially, the claim is that the product was defective and unsafe, and the injury suffered by the plaintiff was a foreseeable consequence. In the medical field, patients treated with medications can sustain serious, even fatal, complications. Medical devices such as pacemakers and operating room equipment may malfunction and injure. And mass vaccinations do give rise, if rarely, to neurological sequelae and fatalities.

The above hypothetical is taken from an actual Texas case that was settled, presumably for much less than $1 billion, to avoid the unpredictability of an appellate outcome. Although this was a stand-alone case, such cases are frequently part of a class-action suit.

There are three legal theories in a products liability claim: negligence, breach of warranty, and strict products liability. The latter is the most favored, as there is no need to prove fault or warranty. The legal doctrine had its genesis in Greenman v. Yuba Power Products Inc. Mr. Greenman was injured when he used a power tool that was given to him as a gift. He sued the manufacturer, although there was no direct contract of warranty between him and the manufacturer as he did not make the purchase himself. The California Supreme Court went beyond the law of contracts to find the manufacturer liable, and in the process introduced the notion of strict liability, which goes beyond simple negligence, centering instead on whether a product is defective.

The strict liability approach has been adopted, in some cases with modifications, in virtually all jurisdictions. The theory holds that a professional supplier who sells a product that is both defective and unreasonably dangerous is strictly liable to foreseeable plaintiffs. "Defective" is usually defined as product quality that is less than what a reasonable consumer expects. "Unreasonably dangerous" is a conclusion that the risks that result from its condition outweigh the product’s advantages. Strict liability is not about negligence or fault, but about a social policy that shifts to the manufacturer the cost of compensating the injured consumer. To prevail, the plaintiff must show proximate cause, and assumption of risk is still a valid defense.

Manufacturers or suppliers of products that are unavoidably unsafe however, would be exempt from strict liability. In Hines v. St. Joseph’s Hospital, the plaintiff received blood transfusions and contracted hepatitis. The defendants were Blood Services Inc., the supplier of the blood, and St. Joseph’s Hospital, where the transfusions were ordered and given. In ruling for the defendants, the Court held that the product, blood in this case, was unavoidably unsafe and therefore not unreasonably dangerous. However, in Snyder v. Am Ass’n of Blood Banks, the Supreme Court of New Jersey found the trade organization liable for failing to recommend routine HIV testing of the nation’s blood supply in the early 1980s. The Court reasoned that the Association breached its duty of due care as it had projected itself as the guardian of blood safety and therefore ought to have recommended HIV testing even though the data were inconclusive at the time.

If a doctor fails to warn the patient of a medication risk, the patient may have a claim against the doctor but usually not the drug manufacturer. This is termed the "Learned-Intermediary" doctrine. The justification is that the manufacturer can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through its sales representatives and in its package insert. The treating doctor, in turn, is expected to use professional judgment to adequately warn the patient, as it is not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship. Occasionally, a court would side-step the doctrine, for example, where a manufacturer knows that the drug will reach the consumer without the intervention of a physician such as over-the-counter preparations. Another situation is where extensive advertising of a drug to the public has taken place. Manufacturers may also be liable if they have failed to disclose all known risks, as alleged in the litigation surrounding rofecoxib (Vioxx) and rosiglitazone (Avandia).

Hospitals usually escape liability for adverse drug reactions, with courts tending to shield them against implied warranty (hospitals are not merchants) or strict liability. In a case where the plaintiff alleged that sepsis resulted from the infusion of contaminated dextran, the Court ruled that the hospital was not a manufacturer of patient-care products, and therefore was not liable under strict liability or implied warranty rules (Shivers v. Good Shepherd Hospital). Similar approaches, though not universal, have been applied in injuries associated with the use of medical devices such as surgical needles, pacemakers, and spinal implants.

Question: A woman developed primary pulmonary hypertension (PPH) 4 years after she had stopped using the prescription weight-loss drug, fenfluramine. The drug is known to cause valvular heart lesions as well as PPH. In a wrongful death lawsuit, her estate won a jury award of $1 billion in compensatory and exemplary damages. The defense appealed the size of the award, and argued that there are no studies demonstrating an association between fenfluramine and an increased risk of PPH that long after cessation of use. Which of the following is incorrect?

A. This is a products liability case.

B. The plaintiff can advance legal theories against the manufacturer based on warranty, negligence, or strict liability (that is, fault-free liability).

C. This can be a stand-alone case or part of a class action lawsuit.

D. The decision will definitely be overturned on appeal.

E. Such cases are frequently settled for a much smaller sum.

Answer: D. When a person is injured by a defective product, be it a car or a prescription drug, he or she can file a cause of action against the manufacturer or others who have placed that item into the stream of commerce. The law governing this general area of product-related injuries, broadly termed products liability, covers more than one specific tort, and the injured plaintiff can recover damages under a number of legal theories. Essentially, the claim is that the product was defective and unsafe, and the injury suffered by the plaintiff was a foreseeable consequence. In the medical field, patients treated with medications can sustain serious, even fatal, complications. Medical devices such as pacemakers and operating room equipment may malfunction and injure. And mass vaccinations do give rise, if rarely, to neurological sequelae and fatalities.

The above hypothetical is taken from an actual Texas case that was settled, presumably for much less than $1 billion, to avoid the unpredictability of an appellate outcome. Although this was a stand-alone case, such cases are frequently part of a class-action suit.

There are three legal theories in a products liability claim: negligence, breach of warranty, and strict products liability. The latter is the most favored, as there is no need to prove fault or warranty. The legal doctrine had its genesis in Greenman v. Yuba Power Products Inc. Mr. Greenman was injured when he used a power tool that was given to him as a gift. He sued the manufacturer, although there was no direct contract of warranty between him and the manufacturer as he did not make the purchase himself. The California Supreme Court went beyond the law of contracts to find the manufacturer liable, and in the process introduced the notion of strict liability, which goes beyond simple negligence, centering instead on whether a product is defective.

The strict liability approach has been adopted, in some cases with modifications, in virtually all jurisdictions. The theory holds that a professional supplier who sells a product that is both defective and unreasonably dangerous is strictly liable to foreseeable plaintiffs. "Defective" is usually defined as product quality that is less than what a reasonable consumer expects. "Unreasonably dangerous" is a conclusion that the risks that result from its condition outweigh the product’s advantages. Strict liability is not about negligence or fault, but about a social policy that shifts to the manufacturer the cost of compensating the injured consumer. To prevail, the plaintiff must show proximate cause, and assumption of risk is still a valid defense.

Manufacturers or suppliers of products that are unavoidably unsafe however, would be exempt from strict liability. In Hines v. St. Joseph’s Hospital, the plaintiff received blood transfusions and contracted hepatitis. The defendants were Blood Services Inc., the supplier of the blood, and St. Joseph’s Hospital, where the transfusions were ordered and given. In ruling for the defendants, the Court held that the product, blood in this case, was unavoidably unsafe and therefore not unreasonably dangerous. However, in Snyder v. Am Ass’n of Blood Banks, the Supreme Court of New Jersey found the trade organization liable for failing to recommend routine HIV testing of the nation’s blood supply in the early 1980s. The Court reasoned that the Association breached its duty of due care as it had projected itself as the guardian of blood safety and therefore ought to have recommended HIV testing even though the data were inconclusive at the time.

If a doctor fails to warn the patient of a medication risk, the patient may have a claim against the doctor but usually not the drug manufacturer. This is termed the "Learned-Intermediary" doctrine. The justification is that the manufacturer can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through its sales representatives and in its package insert. The treating doctor, in turn, is expected to use professional judgment to adequately warn the patient, as it is not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship. Occasionally, a court would side-step the doctrine, for example, where a manufacturer knows that the drug will reach the consumer without the intervention of a physician such as over-the-counter preparations. Another situation is where extensive advertising of a drug to the public has taken place. Manufacturers may also be liable if they have failed to disclose all known risks, as alleged in the litigation surrounding rofecoxib (Vioxx) and rosiglitazone (Avandia).

Hospitals usually escape liability for adverse drug reactions, with courts tending to shield them against implied warranty (hospitals are not merchants) or strict liability. In a case where the plaintiff alleged that sepsis resulted from the infusion of contaminated dextran, the Court ruled that the hospital was not a manufacturer of patient-care products, and therefore was not liable under strict liability or implied warranty rules (Shivers v. Good Shepherd Hospital). Similar approaches, though not universal, have been applied in injuries associated with the use of medical devices such as surgical needles, pacemakers, and spinal implants.

Question: A woman developed primary pulmonary hypertension (PPH) 4 years after she had stopped using the prescription weight-loss drug, fenfluramine. The drug is known to cause valvular heart lesions as well as PPH. In a wrongful death lawsuit, her estate won a jury award of $1 billion in compensatory and exemplary damages. The defense appealed the size of the award, and argued that there are no studies demonstrating an association between fenfluramine and an increased risk of PPH that long after cessation of use. Which of the following is incorrect?

A. This is a products liability case.

B. The plaintiff can advance legal theories against the manufacturer based on warranty, negligence, or strict liability (that is, fault-free liability).

C. This can be a stand-alone case or part of a class action lawsuit.

D. The decision will definitely be overturned on appeal.

E. Such cases are frequently settled for a much smaller sum.

Answer: D. When a person is injured by a defective product, be it a car or a prescription drug, he or she can file a cause of action against the manufacturer or others who have placed that item into the stream of commerce. The law governing this general area of product-related injuries, broadly termed products liability, covers more than one specific tort, and the injured plaintiff can recover damages under a number of legal theories. Essentially, the claim is that the product was defective and unsafe, and the injury suffered by the plaintiff was a foreseeable consequence. In the medical field, patients treated with medications can sustain serious, even fatal, complications. Medical devices such as pacemakers and operating room equipment may malfunction and injure. And mass vaccinations do give rise, if rarely, to neurological sequelae and fatalities.

The above hypothetical is taken from an actual Texas case that was settled, presumably for much less than $1 billion, to avoid the unpredictability of an appellate outcome. Although this was a stand-alone case, such cases are frequently part of a class-action suit.

There are three legal theories in a products liability claim: negligence, breach of warranty, and strict products liability. The latter is the most favored, as there is no need to prove fault or warranty. The legal doctrine had its genesis in Greenman v. Yuba Power Products Inc. Mr. Greenman was injured when he used a power tool that was given to him as a gift. He sued the manufacturer, although there was no direct contract of warranty between him and the manufacturer as he did not make the purchase himself. The California Supreme Court went beyond the law of contracts to find the manufacturer liable, and in the process introduced the notion of strict liability, which goes beyond simple negligence, centering instead on whether a product is defective.

The strict liability approach has been adopted, in some cases with modifications, in virtually all jurisdictions. The theory holds that a professional supplier who sells a product that is both defective and unreasonably dangerous is strictly liable to foreseeable plaintiffs. "Defective" is usually defined as product quality that is less than what a reasonable consumer expects. "Unreasonably dangerous" is a conclusion that the risks that result from its condition outweigh the product’s advantages. Strict liability is not about negligence or fault, but about a social policy that shifts to the manufacturer the cost of compensating the injured consumer. To prevail, the plaintiff must show proximate cause, and assumption of risk is still a valid defense.

Manufacturers or suppliers of products that are unavoidably unsafe however, would be exempt from strict liability. In Hines v. St. Joseph’s Hospital, the plaintiff received blood transfusions and contracted hepatitis. The defendants were Blood Services Inc., the supplier of the blood, and St. Joseph’s Hospital, where the transfusions were ordered and given. In ruling for the defendants, the Court held that the product, blood in this case, was unavoidably unsafe and therefore not unreasonably dangerous. However, in Snyder v. Am Ass’n of Blood Banks, the Supreme Court of New Jersey found the trade organization liable for failing to recommend routine HIV testing of the nation’s blood supply in the early 1980s. The Court reasoned that the Association breached its duty of due care as it had projected itself as the guardian of blood safety and therefore ought to have recommended HIV testing even though the data were inconclusive at the time.

If a doctor fails to warn the patient of a medication risk, the patient may have a claim against the doctor but usually not the drug manufacturer. This is termed the "Learned-Intermediary" doctrine. The justification is that the manufacturer can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through its sales representatives and in its package insert. The treating doctor, in turn, is expected to use professional judgment to adequately warn the patient, as it is not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship. Occasionally, a court would side-step the doctrine, for example, where a manufacturer knows that the drug will reach the consumer without the intervention of a physician such as over-the-counter preparations. Another situation is where extensive advertising of a drug to the public has taken place. Manufacturers may also be liable if they have failed to disclose all known risks, as alleged in the litigation surrounding rofecoxib (Vioxx) and rosiglitazone (Avandia).

Hospitals usually escape liability for adverse drug reactions, with courts tending to shield them against implied warranty (hospitals are not merchants) or strict liability. In a case where the plaintiff alleged that sepsis resulted from the infusion of contaminated dextran, the Court ruled that the hospital was not a manufacturer of patient-care products, and therefore was not liable under strict liability or implied warranty rules (Shivers v. Good Shepherd Hospital). Similar approaches, though not universal, have been applied in injuries associated with the use of medical devices such as surgical needles, pacemakers, and spinal implants.

Question: A woman developed primary pulmonary hypertension (PPH) 4 years after she had stopped using the prescription weight-loss drug, fenfluramine. The drug is known to cause valvular heart lesions as well as PPH. In a wrongful death lawsuit, her estate won a jury award of $1 billion in compensatory and exemplary damages. The defense appealed the size of the award, and argued that there are no studies demonstrating an association between fenfluramine and an increased risk of PPH that long after cessation of use. Which of the following is incorrect?

A. This is a products liability case.

B. The plaintiff can advance legal theories against the manufacturer based on warranty, negligence, or strict liability (that is, fault-free liability).

C. This can be a stand-alone case or part of a class action lawsuit.

D. The decision will definitely be overturned on appeal.

E. Such cases are frequently settled for a much smaller sum.

Answer: D. When a person is injured by a defective product, be it a car or a prescription drug, he or she can file a cause of action against the manufacturer or others who have placed that item into the stream of commerce. The law governing this general area of product-related injuries, broadly termed products liability, covers more than one specific tort, and the injured plaintiff can recover damages under a number of legal theories. Essentially, the claim is that the product was defective and unsafe, and the injury suffered by the plaintiff was a foreseeable consequence. In the medical field, patients treated with medications can sustain serious, even fatal, complications. Medical devices such as pacemakers and operating room equipment may malfunction and injure. And mass vaccinations do give rise, if rarely, to neurological sequelae and fatalities.

The above hypothetical is taken from an actual Texas case that was settled, presumably for much less than $1 billion, to avoid the unpredictability of an appellate outcome. Although this was a stand-alone case, such cases are frequently part of a class-action suit.

There are three legal theories in a products liability claim: negligence, breach of warranty, and strict products liability. The latter is the most favored, as there is no need to prove fault or warranty. The legal doctrine had its genesis in Greenman v. Yuba Power Products Inc. Mr. Greenman was injured when he used a power tool that was given to him as a gift. He sued the manufacturer, although there was no direct contract of warranty between him and the manufacturer as he did not make the purchase himself. The California Supreme Court went beyond the law of contracts to find the manufacturer liable, and in the process introduced the notion of strict liability, which goes beyond simple negligence, centering instead on whether a product is defective.

The strict liability approach has been adopted, in some cases with modifications, in virtually all jurisdictions. The theory holds that a professional supplier who sells a product that is both defective and unreasonably dangerous is strictly liable to foreseeable plaintiffs. "Defective" is usually defined as product quality that is less than what a reasonable consumer expects. "Unreasonably dangerous" is a conclusion that the risks that result from its condition outweigh the product’s advantages. Strict liability is not about negligence or fault, but about a social policy that shifts to the manufacturer the cost of compensating the injured consumer. To prevail, the plaintiff must show proximate cause, and assumption of risk is still a valid defense.

Manufacturers or suppliers of products that are unavoidably unsafe however, would be exempt from strict liability. In Hines v. St. Joseph’s Hospital, the plaintiff received blood transfusions and contracted hepatitis. The defendants were Blood Services Inc., the supplier of the blood, and St. Joseph’s Hospital, where the transfusions were ordered and given. In ruling for the defendants, the Court held that the product, blood in this case, was unavoidably unsafe and therefore not unreasonably dangerous. However, in Snyder v. Am Ass’n of Blood Banks, the Supreme Court of New Jersey found the trade organization liable for failing to recommend routine HIV testing of the nation’s blood supply in the early 1980s. The Court reasoned that the Association breached its duty of due care as it had projected itself as the guardian of blood safety and therefore ought to have recommended HIV testing even though the data were inconclusive at the time.

If a doctor fails to warn the patient of a medication risk, the patient may have a claim against the doctor but usually not the drug manufacturer. This is termed the "Learned-Intermediary" doctrine. The justification is that the manufacturer can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through its sales representatives and in its package insert. The treating doctor, in turn, is expected to use professional judgment to adequately warn the patient, as it is not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship. Occasionally, a court would side-step the doctrine, for example, where a manufacturer knows that the drug will reach the consumer without the intervention of a physician such as over-the-counter preparations. Another situation is where extensive advertising of a drug to the public has taken place. Manufacturers may also be liable if they have failed to disclose all known risks, as alleged in the litigation surrounding rofecoxib (Vioxx) and rosiglitazone (Avandia).

Hospitals usually escape liability for adverse drug reactions, with courts tending to shield them against implied warranty (hospitals are not merchants) or strict liability. In a case where the plaintiff alleged that sepsis resulted from the infusion of contaminated dextran, the Court ruled that the hospital was not a manufacturer of patient-care products, and therefore was not liable under strict liability or implied warranty rules (Shivers v. Good Shepherd Hospital). Similar approaches, though not universal, have been applied in injuries associated with the use of medical devices such as surgical needles, pacemakers, and spinal implants.

Question: A woman developed primary pulmonary hypertension (PPH) 4 years after she had stopped using the prescription weight-loss drug, fenfluramine. The drug is known to cause valvular heart lesions as well as PPH. In a wrongful death lawsuit, her estate won a jury award of $1 billion in compensatory and exemplary damages. The defense appealed the size of the award, and argued that there are no studies demonstrating an association between fenfluramine and an increased risk of PPH that long after cessation of use. Which of the following is incorrect?

A. This is a products liability case.

B. The plaintiff can advance legal theories against the manufacturer based on warranty, negligence, or strict liability (that is, fault-free liability).

C. This can be a stand-alone case or part of a class action lawsuit.

D. The decision will definitely be overturned on appeal.

E. Such cases are frequently settled for a much smaller sum.

Answer: D. When a person is injured by a defective product, be it a car or a prescription drug, he or she can file a cause of action against the manufacturer or others who have placed that item into the stream of commerce. The law governing this general area of product-related injuries, broadly termed products liability, covers more than one specific tort, and the injured plaintiff can recover damages under a number of legal theories. Essentially, the claim is that the product was defective and unsafe, and the injury suffered by the plaintiff was a foreseeable consequence. In the medical field, patients treated with medications can sustain serious, even fatal, complications. Medical devices such as pacemakers and operating room equipment may malfunction and injure. And mass vaccinations do give rise, if rarely, to neurological sequelae and fatalities.

The above hypothetical is taken from an actual Texas case that was settled, presumably for much less than $1 billion, to avoid the unpredictability of an appellate outcome. Although this was a stand-alone case, such cases are frequently part of a class-action suit.

There are three legal theories in a products liability claim: negligence, breach of warranty, and strict products liability. The latter is the most favored, as there is no need to prove fault or warranty. The legal doctrine had its genesis in Greenman v. Yuba Power Products Inc. Mr. Greenman was injured when he used a power tool that was given to him as a gift. He sued the manufacturer, although there was no direct contract of warranty between him and the manufacturer as he did not make the purchase himself. The California Supreme Court went beyond the law of contracts to find the manufacturer liable, and in the process introduced the notion of strict liability, which goes beyond simple negligence, centering instead on whether a product is defective.

The strict liability approach has been adopted, in some cases with modifications, in virtually all jurisdictions. The theory holds that a professional supplier who sells a product that is both defective and unreasonably dangerous is strictly liable to foreseeable plaintiffs. "Defective" is usually defined as product quality that is less than what a reasonable consumer expects. "Unreasonably dangerous" is a conclusion that the risks that result from its condition outweigh the product’s advantages. Strict liability is not about negligence or fault, but about a social policy that shifts to the manufacturer the cost of compensating the injured consumer. To prevail, the plaintiff must show proximate cause, and assumption of risk is still a valid defense.

Manufacturers or suppliers of products that are unavoidably unsafe however, would be exempt from strict liability. In Hines v. St. Joseph’s Hospital, the plaintiff received blood transfusions and contracted hepatitis. The defendants were Blood Services Inc., the supplier of the blood, and St. Joseph’s Hospital, where the transfusions were ordered and given. In ruling for the defendants, the Court held that the product, blood in this case, was unavoidably unsafe and therefore not unreasonably dangerous. However, in Snyder v. Am Ass’n of Blood Banks, the Supreme Court of New Jersey found the trade organization liable for failing to recommend routine HIV testing of the nation’s blood supply in the early 1980s. The Court reasoned that the Association breached its duty of due care as it had projected itself as the guardian of blood safety and therefore ought to have recommended HIV testing even though the data were inconclusive at the time.

If a doctor fails to warn the patient of a medication risk, the patient may have a claim against the doctor but usually not the drug manufacturer. This is termed the "Learned-Intermediary" doctrine. The justification is that the manufacturer can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through its sales representatives and in its package insert. The treating doctor, in turn, is expected to use professional judgment to adequately warn the patient, as it is not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship. Occasionally, a court would side-step the doctrine, for example, where a manufacturer knows that the drug will reach the consumer without the intervention of a physician such as over-the-counter preparations. Another situation is where extensive advertising of a drug to the public has taken place. Manufacturers may also be liable if they have failed to disclose all known risks, as alleged in the litigation surrounding rofecoxib (Vioxx) and rosiglitazone (Avandia).

Hospitals usually escape liability for adverse drug reactions, with courts tending to shield them against implied warranty (hospitals are not merchants) or strict liability. In a case where the plaintiff alleged that sepsis resulted from the infusion of contaminated dextran, the Court ruled that the hospital was not a manufacturer of patient-care products, and therefore was not liable under strict liability or implied warranty rules (Shivers v. Good Shepherd Hospital). Similar approaches, though not universal, have been applied in injuries associated with the use of medical devices such as surgical needles, pacemakers, and spinal implants.

Question: A physician injected silicone into a patient for purposes of breast augmentation, but used a preparation that was labeled "not for human use." The patient experienced inflammation, burning and discoloration, and subsequently developed chronic cyst formation in the breasts. In a lawsuit against the doctor, which of the following best describes the legal consequences?

A. Assuming negligence is proven, she will be awarded both compensatory and punitive damages.

B. Punitive damages are also called hedonic damages.

C. An award for pain and suffering is an example of punitive damages.

D. Punitive damages are frequently bundled with compensatory damages in medical malpractice lawsuits.

E. In order to be awarded punitive damages, the plaintiff typically must prove that the defendant was grossly negligent, exhibiting wanton and reckless disregard of the risks.

Answer: E. Punitive damages, also called exemplary damages, are uncommon in medical malpractice actions. They are awarded only in situations where there is gross or aggravated negligence and not in ordinary negligence, where compensatory damages constitute the usual remedy. Punitive damages should not be confused with damages for pain and suffering, which are common in medical malpractice lawsuits. The latter belong in the category of non-economic or general compensatory damages, as are hedonic damages that address the value of a life lost or truncated. The above hypothetical is taken from an actual case where punitive damages were allowed by the courts because of the egregious nature of misconduct.

Punitive damages are awarded where the conduct complained of merits punishment, hence the quantum, typically large, is added onto compensatory damages. Although punishing the tortfeasor is not a stated objective of the tort system, the use of punitive damages is justified where there is a reckless, willful, or wanton disregard of the obvious risk of harm. The term "gross negligence" is sometimes used to describe this type of misconduct.

For example, evidence that a defendant had prescribed an excessive number of birth control pills (over 1,000 pills within a time period when less than 200 were sufficient) with resulting liver complications was deemed sufficient to raise the issue of gross negligence (Jackson v. Taylor). Punitive damages are typically invoked in products liability actions against large corporations, in which awards may reach the multi-million range. However, some jurisdictions statutorily disallow punitive damages altogether (for example, under the Federal Torts Claim Act).

The U.S. Supreme Court has advanced a three-prong test to determine whether punitive damages are excessive. They are the degree of reprehensibility of the defendant’s conduct; the ratio between the plaintiff’s compensatory damages and the amount of punitive damages; and the difference between the punitive award and the civil or criminal sanctions that could be imposed for comparable misconduct. In BMW of North America, Inc. v. Gore, the litigants were embroiled in a controversy over a repainted BMW car that was sold as a new vehicle without due notice to the purchaser. The jury awarded $4,000 in compensatory damages, and $2 million in punitive damages, but the U.S. Supreme Court ruled that the punitive amount was grossly excessive.

It is not always easy to predict whether an appellate court will allow punitive damages, reduce the amount (termed a remittitur), or disallow them altogether. In Noe v. Kaiser Foundation Hospitals, the Supreme Court of Oregon disallowed punitive damages where the defendants (a medical resident and supervising staff physician) were judged to be negligent for performing a circumcision without parental authorization, but did not act in an aggravated disregard for their professional duties. In Manning v. Twin Falls Clinic & Hospital, Inc., punitive damages were allowed to stand against a nurse who moved a patient with terminal chronic obstructive lung disease without providing portable oxygen. However, the hospital was not liable for the punitive damages as there was insufficient evidence to indicate that it ratified the nurse’s conduct.

Other court decisions have upheld punitive damages in medical malpractice actions. For example, a $2 million award was not considered excessive or disproportionate to the loss of life caused by a gastric bypass surgical procedure that was complicated by postoperative infection (McKowan v. Day). In another situation, the court allowed the case of a doctor who caused his patient to become addicted to narcotic drugs to reach the jury on the question of punitive damages (Los Alamos Medical Center Inc. v. Coe). In yet another, the jury awarded $125,000 in punitive damages in addition to compensatory damages because of the doctor’s wanton failure to provide follow-up care for a child who developed fever and gangrenous toes following foot surgery (Dempsey v. Phleps).

One important practical point: Punitive damages may not be a covered benefit in some professional liability insurance policies (for example, Medical Insurance Exchange of California), which means the practitioner’s personal assets may then be at risk.

Question: A physician injected silicone into a patient for purposes of breast augmentation, but used a preparation that was labeled "not for human use." The patient experienced inflammation, burning and discoloration, and subsequently developed chronic cyst formation in the breasts. In a lawsuit against the doctor, which of the following best describes the legal consequences?

A. Assuming negligence is proven, she will be awarded both compensatory and punitive damages.

B. Punitive damages are also called hedonic damages.

C. An award for pain and suffering is an example of punitive damages.

D. Punitive damages are frequently bundled with compensatory damages in medical malpractice lawsuits.

E. In order to be awarded punitive damages, the plaintiff typically must prove that the defendant was grossly negligent, exhibiting wanton and reckless disregard of the risks.

Answer: E. Punitive damages, also called exemplary damages, are uncommon in medical malpractice actions. They are awarded only in situations where there is gross or aggravated negligence and not in ordinary negligence, where compensatory damages constitute the usual remedy. Punitive damages should not be confused with damages for pain and suffering, which are common in medical malpractice lawsuits. The latter belong in the category of non-economic or general compensatory damages, as are hedonic damages that address the value of a life lost or truncated. The above hypothetical is taken from an actual case where punitive damages were allowed by the courts because of the egregious nature of misconduct.

Punitive damages are awarded where the conduct complained of merits punishment, hence the quantum, typically large, is added onto compensatory damages. Although punishing the tortfeasor is not a stated objective of the tort system, the use of punitive damages is justified where there is a reckless, willful, or wanton disregard of the obvious risk of harm. The term "gross negligence" is sometimes used to describe this type of misconduct.

For example, evidence that a defendant had prescribed an excessive number of birth control pills (over 1,000 pills within a time period when less than 200 were sufficient) with resulting liver complications was deemed sufficient to raise the issue of gross negligence (Jackson v. Taylor). Punitive damages are typically invoked in products liability actions against large corporations, in which awards may reach the multi-million range. However, some jurisdictions statutorily disallow punitive damages altogether (for example, under the Federal Torts Claim Act).

The U.S. Supreme Court has advanced a three-prong test to determine whether punitive damages are excessive. They are the degree of reprehensibility of the defendant’s conduct; the ratio between the plaintiff’s compensatory damages and the amount of punitive damages; and the difference between the punitive award and the civil or criminal sanctions that could be imposed for comparable misconduct. In BMW of North America, Inc. v. Gore, the litigants were embroiled in a controversy over a repainted BMW car that was sold as a new vehicle without due notice to the purchaser. The jury awarded $4,000 in compensatory damages, and $2 million in punitive damages, but the U.S. Supreme Court ruled that the punitive amount was grossly excessive.

It is not always easy to predict whether an appellate court will allow punitive damages, reduce the amount (termed a remittitur), or disallow them altogether. In Noe v. Kaiser Foundation Hospitals, the Supreme Court of Oregon disallowed punitive damages where the defendants (a medical resident and supervising staff physician) were judged to be negligent for performing a circumcision without parental authorization, but did not act in an aggravated disregard for their professional duties. In Manning v. Twin Falls Clinic & Hospital, Inc., punitive damages were allowed to stand against a nurse who moved a patient with terminal chronic obstructive lung disease without providing portable oxygen. However, the hospital was not liable for the punitive damages as there was insufficient evidence to indicate that it ratified the nurse’s conduct.

Other court decisions have upheld punitive damages in medical malpractice actions. For example, a $2 million award was not considered excessive or disproportionate to the loss of life caused by a gastric bypass surgical procedure that was complicated by postoperative infection (McKowan v. Day). In another situation, the court allowed the case of a doctor who caused his patient to become addicted to narcotic drugs to reach the jury on the question of punitive damages (Los Alamos Medical Center Inc. v. Coe). In yet another, the jury awarded $125,000 in punitive damages in addition to compensatory damages because of the doctor’s wanton failure to provide follow-up care for a child who developed fever and gangrenous toes following foot surgery (Dempsey v. Phleps).

One important practical point: Punitive damages may not be a covered benefit in some professional liability insurance policies (for example, Medical Insurance Exchange of California), which means the practitioner’s personal assets may then be at risk.

Question: A physician injected silicone into a patient for purposes of breast augmentation, but used a preparation that was labeled "not for human use." The patient experienced inflammation, burning and discoloration, and subsequently developed chronic cyst formation in the breasts. In a lawsuit against the doctor, which of the following best describes the legal consequences?

A. Assuming negligence is proven, she will be awarded both compensatory and punitive damages.

B. Punitive damages are also called hedonic damages.

C. An award for pain and suffering is an example of punitive damages.

D. Punitive damages are frequently bundled with compensatory damages in medical malpractice lawsuits.

E. In order to be awarded punitive damages, the plaintiff typically must prove that the defendant was grossly negligent, exhibiting wanton and reckless disregard of the risks.

Answer: E. Punitive damages, also called exemplary damages, are uncommon in medical malpractice actions. They are awarded only in situations where there is gross or aggravated negligence and not in ordinary negligence, where compensatory damages constitute the usual remedy. Punitive damages should not be confused with damages for pain and suffering, which are common in medical malpractice lawsuits. The latter belong in the category of non-economic or general compensatory damages, as are hedonic damages that address the value of a life lost or truncated. The above hypothetical is taken from an actual case where punitive damages were allowed by the courts because of the egregious nature of misconduct.

Punitive damages are awarded where the conduct complained of merits punishment, hence the quantum, typically large, is added onto compensatory damages. Although punishing the tortfeasor is not a stated objective of the tort system, the use of punitive damages is justified where there is a reckless, willful, or wanton disregard of the obvious risk of harm. The term "gross negligence" is sometimes used to describe this type of misconduct.

For example, evidence that a defendant had prescribed an excessive number of birth control pills (over 1,000 pills within a time period when less than 200 were sufficient) with resulting liver complications was deemed sufficient to raise the issue of gross negligence (Jackson v. Taylor). Punitive damages are typically invoked in products liability actions against large corporations, in which awards may reach the multi-million range. However, some jurisdictions statutorily disallow punitive damages altogether (for example, under the Federal Torts Claim Act).

The U.S. Supreme Court has advanced a three-prong test to determine whether punitive damages are excessive. They are the degree of reprehensibility of the defendant’s conduct; the ratio between the plaintiff’s compensatory damages and the amount of punitive damages; and the difference between the punitive award and the civil or criminal sanctions that could be imposed for comparable misconduct. In BMW of North America, Inc. v. Gore, the litigants were embroiled in a controversy over a repainted BMW car that was sold as a new vehicle without due notice to the purchaser. The jury awarded $4,000 in compensatory damages, and $2 million in punitive damages, but the U.S. Supreme Court ruled that the punitive amount was grossly excessive.

It is not always easy to predict whether an appellate court will allow punitive damages, reduce the amount (termed a remittitur), or disallow them altogether. In Noe v. Kaiser Foundation Hospitals, the Supreme Court of Oregon disallowed punitive damages where the defendants (a medical resident and supervising staff physician) were judged to be negligent for performing a circumcision without parental authorization, but did not act in an aggravated disregard for their professional duties. In Manning v. Twin Falls Clinic & Hospital, Inc., punitive damages were allowed to stand against a nurse who moved a patient with terminal chronic obstructive lung disease without providing portable oxygen. However, the hospital was not liable for the punitive damages as there was insufficient evidence to indicate that it ratified the nurse’s conduct.

Other court decisions have upheld punitive damages in medical malpractice actions. For example, a $2 million award was not considered excessive or disproportionate to the loss of life caused by a gastric bypass surgical procedure that was complicated by postoperative infection (McKowan v. Day). In another situation, the court allowed the case of a doctor who caused his patient to become addicted to narcotic drugs to reach the jury on the question of punitive damages (Los Alamos Medical Center Inc. v. Coe). In yet another, the jury awarded $125,000 in punitive damages in addition to compensatory damages because of the doctor’s wanton failure to provide follow-up care for a child who developed fever and gangrenous toes following foot surgery (Dempsey v. Phleps).

One important practical point: Punitive damages may not be a covered benefit in some professional liability insurance policies (for example, Medical Insurance Exchange of California), which means the practitioner’s personal assets may then be at risk.

Question: A physician injected silicone into a patient for purposes of breast augmentation, but used a preparation that was labeled "not for human use." The patient experienced inflammation, burning and discoloration, and subsequently developed chronic cyst formation in the breasts. In a lawsuit against the doctor, which of the following best describes the legal consequences?

A. Assuming negligence is proven, she will be awarded both compensatory and punitive damages.

B. Punitive damages are also called hedonic damages.

C. An award for pain and suffering is an example of punitive damages.

D. Punitive damages are frequently bundled with compensatory damages in medical malpractice lawsuits.

E. In order to be awarded punitive damages, the plaintiff typically must prove that the defendant was grossly negligent, exhibiting wanton and reckless disregard of the risks.

Answer: E. Punitive damages, also called exemplary damages, are uncommon in medical malpractice actions. They are awarded only in situations where there is gross or aggravated negligence and not in ordinary negligence, where compensatory damages constitute the usual remedy. Punitive damages should not be confused with damages for pain and suffering, which are common in medical malpractice lawsuits. The latter belong in the category of non-economic or general compensatory damages, as are hedonic damages that address the value of a life lost or truncated. The above hypothetical is taken from an actual case where punitive damages were allowed by the courts because of the egregious nature of misconduct.

Punitive damages are awarded where the conduct complained of merits punishment, hence the quantum, typically large, is added onto compensatory damages. Although punishing the tortfeasor is not a stated objective of the tort system, the use of punitive damages is justified where there is a reckless, willful, or wanton disregard of the obvious risk of harm. The term "gross negligence" is sometimes used to describe this type of misconduct.

For example, evidence that a defendant had prescribed an excessive number of birth control pills (over 1,000 pills within a time period when less than 200 were sufficient) with resulting liver complications was deemed sufficient to raise the issue of gross negligence (Jackson v. Taylor). Punitive damages are typically invoked in products liability actions against large corporations, in which awards may reach the multi-million range. However, some jurisdictions statutorily disallow punitive damages altogether (for example, under the Federal Torts Claim Act).

The U.S. Supreme Court has advanced a three-prong test to determine whether punitive damages are excessive. They are the degree of reprehensibility of the defendant’s conduct; the ratio between the plaintiff’s compensatory damages and the amount of punitive damages; and the difference between the punitive award and the civil or criminal sanctions that could be imposed for comparable misconduct. In BMW of North America, Inc. v. Gore, the litigants were embroiled in a controversy over a repainted BMW car that was sold as a new vehicle without due notice to the purchaser. The jury awarded $4,000 in compensatory damages, and $2 million in punitive damages, but the U.S. Supreme Court ruled that the punitive amount was grossly excessive.

It is not always easy to predict whether an appellate court will allow punitive damages, reduce the amount (termed a remittitur), or disallow them altogether. In Noe v. Kaiser Foundation Hospitals, the Supreme Court of Oregon disallowed punitive damages where the defendants (a medical resident and supervising staff physician) were judged to be negligent for performing a circumcision without parental authorization, but did not act in an aggravated disregard for their professional duties. In Manning v. Twin Falls Clinic & Hospital, Inc., punitive damages were allowed to stand against a nurse who moved a patient with terminal chronic obstructive lung disease without providing portable oxygen. However, the hospital was not liable for the punitive damages as there was insufficient evidence to indicate that it ratified the nurse’s conduct.

Other court decisions have upheld punitive damages in medical malpractice actions. For example, a $2 million award was not considered excessive or disproportionate to the loss of life caused by a gastric bypass surgical procedure that was complicated by postoperative infection (McKowan v. Day). In another situation, the court allowed the case of a doctor who caused his patient to become addicted to narcotic drugs to reach the jury on the question of punitive damages (Los Alamos Medical Center Inc. v. Coe). In yet another, the jury awarded $125,000 in punitive damages in addition to compensatory damages because of the doctor’s wanton failure to provide follow-up care for a child who developed fever and gangrenous toes following foot surgery (Dempsey v. Phleps).

One important practical point: Punitive damages may not be a covered benefit in some professional liability insurance policies (for example, Medical Insurance Exchange of California), which means the practitioner’s personal assets may then be at risk.

Question: A physician injected silicone into a patient for purposes of breast augmentation, but used a preparation that was labeled "not for human use." The patient experienced inflammation, burning and discoloration, and subsequently developed chronic cyst formation in the breasts. In a lawsuit against the doctor, which of the following best describes the legal consequences?

A. Assuming negligence is proven, she will be awarded both compensatory and punitive damages.

B. Punitive damages are also called hedonic damages.

C. An award for pain and suffering is an example of punitive damages.

D. Punitive damages are frequently bundled with compensatory damages in medical malpractice lawsuits.

E. In order to be awarded punitive damages, the plaintiff typically must prove that the defendant was grossly negligent, exhibiting wanton and reckless disregard of the risks.

Answer: E. Punitive damages, also called exemplary damages, are uncommon in medical malpractice actions. They are awarded only in situations where there is gross or aggravated negligence and not in ordinary negligence, where compensatory damages constitute the usual remedy. Punitive damages should not be confused with damages for pain and suffering, which are common in medical malpractice lawsuits. The latter belong in the category of non-economic or general compensatory damages, as are hedonic damages that address the value of a life lost or truncated. The above hypothetical is taken from an actual case where punitive damages were allowed by the courts because of the egregious nature of misconduct.

Punitive damages are awarded where the conduct complained of merits punishment, hence the quantum, typically large, is added onto compensatory damages. Although punishing the tortfeasor is not a stated objective of the tort system, the use of punitive damages is justified where there is a reckless, willful, or wanton disregard of the obvious risk of harm. The term "gross negligence" is sometimes used to describe this type of misconduct.

For example, evidence that a defendant had prescribed an excessive number of birth control pills (over 1,000 pills within a time period when less than 200 were sufficient) with resulting liver complications was deemed sufficient to raise the issue of gross negligence (Jackson v. Taylor). Punitive damages are typically invoked in products liability actions against large corporations, in which awards may reach the multi-million range. However, some jurisdictions statutorily disallow punitive damages altogether (for example, under the Federal Torts Claim Act).

The U.S. Supreme Court has advanced a three-prong test to determine whether punitive damages are excessive. They are the degree of reprehensibility of the defendant’s conduct; the ratio between the plaintiff’s compensatory damages and the amount of punitive damages; and the difference between the punitive award and the civil or criminal sanctions that could be imposed for comparable misconduct. In BMW of North America, Inc. v. Gore, the litigants were embroiled in a controversy over a repainted BMW car that was sold as a new vehicle without due notice to the purchaser. The jury awarded $4,000 in compensatory damages, and $2 million in punitive damages, but the U.S. Supreme Court ruled that the punitive amount was grossly excessive.

It is not always easy to predict whether an appellate court will allow punitive damages, reduce the amount (termed a remittitur), or disallow them altogether. In Noe v. Kaiser Foundation Hospitals, the Supreme Court of Oregon disallowed punitive damages where the defendants (a medical resident and supervising staff physician) were judged to be negligent for performing a circumcision without parental authorization, but did not act in an aggravated disregard for their professional duties. In Manning v. Twin Falls Clinic & Hospital, Inc., punitive damages were allowed to stand against a nurse who moved a patient with terminal chronic obstructive lung disease without providing portable oxygen. However, the hospital was not liable for the punitive damages as there was insufficient evidence to indicate that it ratified the nurse’s conduct.

Other court decisions have upheld punitive damages in medical malpractice actions. For example, a $2 million award was not considered excessive or disproportionate to the loss of life caused by a gastric bypass surgical procedure that was complicated by postoperative infection (McKowan v. Day). In another situation, the court allowed the case of a doctor who caused his patient to become addicted to narcotic drugs to reach the jury on the question of punitive damages (Los Alamos Medical Center Inc. v. Coe). In yet another, the jury awarded $125,000 in punitive damages in addition to compensatory damages because of the doctor’s wanton failure to provide follow-up care for a child who developed fever and gangrenous toes following foot surgery (Dempsey v. Phleps).

One important practical point: Punitive damages may not be a covered benefit in some professional liability insurance policies (for example, Medical Insurance Exchange of California), which means the practitioner’s personal assets may then be at risk.

Question: A physician injected silicone into a patient for purposes of breast augmentation, but used a preparation that was labeled "not for human use." The patient experienced inflammation, burning and discoloration, and subsequently developed chronic cyst formation in the breasts. In a lawsuit against the doctor, which of the following best describes the legal consequences?

A. Assuming negligence is proven, she will be awarded both compensatory and punitive damages.

B. Punitive damages are also called hedonic damages.

C. An award for pain and suffering is an example of punitive damages.

D. Punitive damages are frequently bundled with compensatory damages in medical malpractice lawsuits.

E. In order to be awarded punitive damages, the plaintiff typically must prove that the defendant was grossly negligent, exhibiting wanton and reckless disregard of the risks.

Answer: E. Punitive damages, also called exemplary damages, are uncommon in medical malpractice actions. They are awarded only in situations where there is gross or aggravated negligence and not in ordinary negligence, where compensatory damages constitute the usual remedy. Punitive damages should not be confused with damages for pain and suffering, which are common in medical malpractice lawsuits. The latter belong in the category of non-economic or general compensatory damages, as are hedonic damages that address the value of a life lost or truncated. The above hypothetical is taken from an actual case where punitive damages were allowed by the courts because of the egregious nature of misconduct.

Punitive damages are awarded where the conduct complained of merits punishment, hence the quantum, typically large, is added onto compensatory damages. Although punishing the tortfeasor is not a stated objective of the tort system, the use of punitive damages is justified where there is a reckless, willful, or wanton disregard of the obvious risk of harm. The term "gross negligence" is sometimes used to describe this type of misconduct.

For example, evidence that a defendant had prescribed an excessive number of birth control pills (over 1,000 pills within a time period when less than 200 were sufficient) with resulting liver complications was deemed sufficient to raise the issue of gross negligence (Jackson v. Taylor). Punitive damages are typically invoked in products liability actions against large corporations, in which awards may reach the multi-million range. However, some jurisdictions statutorily disallow punitive damages altogether (for example, under the Federal Torts Claim Act).

The U.S. Supreme Court has advanced a three-prong test to determine whether punitive damages are excessive. They are the degree of reprehensibility of the defendant’s conduct; the ratio between the plaintiff’s compensatory damages and the amount of punitive damages; and the difference between the punitive award and the civil or criminal sanctions that could be imposed for comparable misconduct. In BMW of North America, Inc. v. Gore, the litigants were embroiled in a controversy over a repainted BMW car that was sold as a new vehicle without due notice to the purchaser. The jury awarded $4,000 in compensatory damages, and $2 million in punitive damages, but the U.S. Supreme Court ruled that the punitive amount was grossly excessive.

It is not always easy to predict whether an appellate court will allow punitive damages, reduce the amount (termed a remittitur), or disallow them altogether. In Noe v. Kaiser Foundation Hospitals, the Supreme Court of Oregon disallowed punitive damages where the defendants (a medical resident and supervising staff physician) were judged to be negligent for performing a circumcision without parental authorization, but did not act in an aggravated disregard for their professional duties. In Manning v. Twin Falls Clinic & Hospital, Inc., punitive damages were allowed to stand against a nurse who moved a patient with terminal chronic obstructive lung disease without providing portable oxygen. However, the hospital was not liable for the punitive damages as there was insufficient evidence to indicate that it ratified the nurse’s conduct.

Other court decisions have upheld punitive damages in medical malpractice actions. For example, a $2 million award was not considered excessive or disproportionate to the loss of life caused by a gastric bypass surgical procedure that was complicated by postoperative infection (McKowan v. Day). In another situation, the court allowed the case of a doctor who caused his patient to become addicted to narcotic drugs to reach the jury on the question of punitive damages (Los Alamos Medical Center Inc. v. Coe). In yet another, the jury awarded $125,000 in punitive damages in addition to compensatory damages because of the doctor’s wanton failure to provide follow-up care for a child who developed fever and gangrenous toes following foot surgery (Dempsey v. Phleps).

One important practical point: Punitive damages may not be a covered benefit in some professional liability insurance policies (for example, Medical Insurance Exchange of California), which means the practitioner’s personal assets may then be at risk.

Question: A physician injected silicone into a patient for purposes of breast augmentation, but used a preparation that was labeled "not for human use." The patient experienced inflammation, burning and discoloration, and subsequently developed chronic cyst formation in the breasts. In a lawsuit against the doctor, which of the following best describes the legal consequences?

A. Assuming negligence is proven, she will be awarded both compensatory and punitive damages.

B. Punitive damages are also called hedonic damages.

C. An award for pain and suffering is an example of punitive damages.

D. Punitive damages are frequently bundled with compensatory damages in medical malpractice lawsuits.

E. In order to be awarded punitive damages, the plaintiff typically must prove that the defendant was grossly negligent, exhibiting wanton and reckless disregard of the risks.

Answer: E. Punitive damages, also called exemplary damages, are uncommon in medical malpractice actions. They are awarded only in situations where there is gross or aggravated negligence and not in ordinary negligence, where compensatory damages constitute the usual remedy. Punitive damages should not be confused with damages for pain and suffering, which are common in medical malpractice lawsuits. The latter belong in the category of non-economic or general compensatory damages, as are hedonic damages that address the value of a life lost or truncated. The above hypothetical is taken from an actual case where punitive damages were allowed by the courts because of the egregious nature of misconduct.

Punitive damages are awarded where the conduct complained of merits punishment, hence the quantum, typically large, is added onto compensatory damages. Although punishing the tortfeasor is not a stated objective of the tort system, the use of punitive damages is justified where there is a reckless, willful, or wanton disregard of the obvious risk of harm. The term "gross negligence" is sometimes used to describe this type of misconduct.

For example, evidence that a defendant had prescribed an excessive number of birth control pills (over 1,000 pills within a time period when less than 200 were sufficient) with resulting liver complications was deemed sufficient to raise the issue of gross negligence (Jackson v. Taylor). Punitive damages are typically invoked in products liability actions against large corporations, in which awards may reach the multi-million range. However, some jurisdictions statutorily disallow punitive damages altogether (for example, under the Federal Torts Claim Act).

The U.S. Supreme Court has advanced a three-prong test to determine whether punitive damages are excessive. They are the degree of reprehensibility of the defendant’s conduct; the ratio between the plaintiff’s compensatory damages and the amount of punitive damages; and the difference between the punitive award and the civil or criminal sanctions that could be imposed for comparable misconduct. In BMW of North America, Inc. v. Gore, the litigants were embroiled in a controversy over a repainted BMW car that was sold as a new vehicle without due notice to the purchaser. The jury awarded $4,000 in compensatory damages, and $2 million in punitive damages, but the U.S. Supreme Court ruled that the punitive amount was grossly excessive.

It is not always easy to predict whether an appellate court will allow punitive damages, reduce the amount (termed a remittitur), or disallow them altogether. In Noe v. Kaiser Foundation Hospitals, the Supreme Court of Oregon disallowed punitive damages where the defendants (a medical resident and supervising staff physician) were judged to be negligent for performing a circumcision without parental authorization, but did not act in an aggravated disregard for their professional duties. In Manning v. Twin Falls Clinic & Hospital, Inc., punitive damages were allowed to stand against a nurse who moved a patient with terminal chronic obstructive lung disease without providing portable oxygen. However, the hospital was not liable for the punitive damages as there was insufficient evidence to indicate that it ratified the nurse’s conduct.

Other court decisions have upheld punitive damages in medical malpractice actions. For example, a $2 million award was not considered excessive or disproportionate to the loss of life caused by a gastric bypass surgical procedure that was complicated by postoperative infection (McKowan v. Day). In another situation, the court allowed the case of a doctor who caused his patient to become addicted to narcotic drugs to reach the jury on the question of punitive damages (Los Alamos Medical Center Inc. v. Coe). In yet another, the jury awarded $125,000 in punitive damages in addition to compensatory damages because of the doctor’s wanton failure to provide follow-up care for a child who developed fever and gangrenous toes following foot surgery (Dempsey v. Phleps).

One important practical point: Punitive damages may not be a covered benefit in some professional liability insurance policies (for example, Medical Insurance Exchange of California), which means the practitioner’s personal assets may then be at risk.

Dr. Tan is an emeritus professor at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk." For additional information, readers may contact the author at [email protected].  

Question: A physician injected silicone into a patient for purposes of breast augmentation, but used a preparation that was labeled "not for human use." The patient experienced inflammation, burning and discoloration, and subsequently developed chronic cyst formation in the breasts. In a lawsuit against the doctor, which of the following best describes the legal consequences?

A. Assuming negligence is proven, she will be awarded both compensatory and punitive damages.

B. Punitive damages are also called hedonic damages.

C. An award for pain and suffering is an example of punitive damages.

D. Punitive damages are frequently bundled with compensatory damages in medical malpractice lawsuits.

E. In order to be awarded punitive damages, the plaintiff typically must prove that the defendant was grossly negligent, exhibiting wanton and reckless disregard of the risks.

Answer: E. Punitive damages, also called exemplary damages, are uncommon in medical malpractice actions. They are awarded only in situations where there is gross or aggravated negligence and not in ordinary negligence, where compensatory damages constitute the usual remedy. Punitive damages should not be confused with damages for pain and suffering, which are common in medical malpractice lawsuits. The latter belong in the category of non-economic or general compensatory damages, as are hedonic damages that address the value of a life lost or truncated. The above hypothetical is taken from an actual case where punitive damages were allowed by the courts because of the egregious nature of misconduct.

Punitive damages are awarded where the conduct complained of merits punishment, hence the quantum, typically large, is added onto compensatory damages. Although punishing the tortfeasor is not a stated objective of the tort system, the use of punitive damages is justified where there is a reckless, willful, or wanton disregard of the obvious risk of harm. The term "gross negligence" is sometimes used to describe this type of misconduct.

For example, evidence that a defendant had prescribed an excessive number of birth control pills (over 1,000 pills within a time period when less than 200 were sufficient) with resulting liver complications was deemed sufficient to raise the issue of gross negligence (Jackson v. Taylor). Punitive damages are typically invoked in products liability actions against large corporations, in which awards may reach the multi-million range. However, some jurisdictions statutorily disallow punitive damages altogether (for example, under the Federal Torts Claim Act).

The U.S. Supreme Court has advanced a three-prong test to determine whether punitive damages are excessive. They are the degree of reprehensibility of the defendant’s conduct; the ratio between the plaintiff’s compensatory damages and the amount of punitive damages; and the difference between the punitive award and the civil or criminal sanctions that could be imposed for comparable misconduct. In BMW of North America, Inc. v. Gore, the litigants were embroiled in a controversy over a repainted BMW car that was sold as a new vehicle without due notice to the purchaser. The jury awarded $4,000 in compensatory damages, and $2 million in punitive damages, but the U.S. Supreme Court ruled that the punitive amount was grossly excessive.

It is not always easy to predict whether an appellate court will allow punitive damages, reduce the amount (termed a remittitur), or disallow them altogether. In Noe v. Kaiser Foundation Hospitals, the Supreme Court of Oregon disallowed punitive damages where the defendants (a medical resident and supervising staff physician) were judged to be negligent for performing a circumcision without parental authorization, but did not act in an aggravated disregard for their professional duties. In Manning v. Twin Falls Clinic & Hospital, Inc., punitive damages were allowed to stand against a nurse who moved a patient with terminal chronic obstructive lung disease without providing portable oxygen. However, the hospital was not liable for the punitive damages as there was insufficient evidence to indicate that it ratified the nurse’s conduct.

Other court decisions have upheld punitive damages in medical malpractice actions. For example, a $2 million award was not considered excessive or disproportionate to the loss of life caused by a gastric bypass surgical procedure that was complicated by postoperative infection (McKowan v. Day). In another situation, the court allowed the case of a doctor who caused his patient to become addicted to narcotic drugs to reach the jury on the question of punitive damages (Los Alamos Medical Center Inc. v. Coe). In yet another, the jury awarded $125,000 in punitive damages in addition to compensatory damages because of the doctor’s wanton failure to provide follow-up care for a child who developed fever and gangrenous toes following foot surgery (Dempsey v. Phleps).

One important practical point: Punitive damages may not be a covered benefit in some professional liability insurance policies (for example, Medical Insurance Exchange of California), which means the practitioner’s personal assets may then be at risk.

Dr. Tan is an emeritus professor at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk." For additional information, readers may contact the author at [email protected].  

Question: A physician injected silicone into a patient for purposes of breast augmentation, but used a preparation that was labeled "not for human use." The patient experienced inflammation, burning and discoloration, and subsequently developed chronic cyst formation in the breasts. In a lawsuit against the doctor, which of the following best describes the legal consequences?

A. Assuming negligence is proven, she will be awarded both compensatory and punitive damages.

B. Punitive damages are also called hedonic damages.

C. An award for pain and suffering is an example of punitive damages.

D. Punitive damages are frequently bundled with compensatory damages in medical malpractice lawsuits.

E. In order to be awarded punitive damages, the plaintiff typically must prove that the defendant was grossly negligent, exhibiting wanton and reckless disregard of the risks.

Answer: E. Punitive damages, also called exemplary damages, are uncommon in medical malpractice actions. They are awarded only in situations where there is gross or aggravated negligence and not in ordinary negligence, where compensatory damages constitute the usual remedy. Punitive damages should not be confused with damages for pain and suffering, which are common in medical malpractice lawsuits. The latter belong in the category of non-economic or general compensatory damages, as are hedonic damages that address the value of a life lost or truncated. The above hypothetical is taken from an actual case where punitive damages were allowed by the courts because of the egregious nature of misconduct.

Punitive damages are awarded where the conduct complained of merits punishment, hence the quantum, typically large, is added onto compensatory damages. Although punishing the tortfeasor is not a stated objective of the tort system, the use of punitive damages is justified where there is a reckless, willful, or wanton disregard of the obvious risk of harm. The term "gross negligence" is sometimes used to describe this type of misconduct.

For example, evidence that a defendant had prescribed an excessive number of birth control pills (over 1,000 pills within a time period when less than 200 were sufficient) with resulting liver complications was deemed sufficient to raise the issue of gross negligence (Jackson v. Taylor). Punitive damages are typically invoked in products liability actions against large corporations, in which awards may reach the multi-million range. However, some jurisdictions statutorily disallow punitive damages altogether (for example, under the Federal Torts Claim Act).

The U.S. Supreme Court has advanced a three-prong test to determine whether punitive damages are excessive. They are the degree of reprehensibility of the defendant’s conduct; the ratio between the plaintiff’s compensatory damages and the amount of punitive damages; and the difference between the punitive award and the civil or criminal sanctions that could be imposed for comparable misconduct. In BMW of North America, Inc. v. Gore, the litigants were embroiled in a controversy over a repainted BMW car that was sold as a new vehicle without due notice to the purchaser. The jury awarded $4,000 in compensatory damages, and $2 million in punitive damages, but the U.S. Supreme Court ruled that the punitive amount was grossly excessive.

It is not always easy to predict whether an appellate court will allow punitive damages, reduce the amount (termed a remittitur), or disallow them altogether. In Noe v. Kaiser Foundation Hospitals, the Supreme Court of Oregon disallowed punitive damages where the defendants (a medical resident and supervising staff physician) were judged to be negligent for performing a circumcision without parental authorization, but did not act in an aggravated disregard for their professional duties. In Manning v. Twin Falls Clinic & Hospital, Inc., punitive damages were allowed to stand against a nurse who moved a patient with terminal chronic obstructive lung disease without providing portable oxygen. However, the hospital was not liable for the punitive damages as there was insufficient evidence to indicate that it ratified the nurse’s conduct.

Other court decisions have upheld punitive damages in medical malpractice actions. For example, a $2 million award was not considered excessive or disproportionate to the loss of life caused by a gastric bypass surgical procedure that was complicated by postoperative infection (McKowan v. Day). In another situation, the court allowed the case of a doctor who caused his patient to become addicted to narcotic drugs to reach the jury on the question of punitive damages (Los Alamos Medical Center Inc. v. Coe). In yet another, the jury awarded $125,000 in punitive damages in addition to compensatory damages because of the doctor’s wanton failure to provide follow-up care for a child who developed fever and gangrenous toes following foot surgery (Dempsey v. Phleps).

One important practical point: Punitive damages may not be a covered benefit in some professional liability insurance policies (for example, Medical Insurance Exchange of California), which means the practitioner’s personal assets may then be at risk.

Dr. Tan is an emeritus professor at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk." For additional information, readers may contact the author at [email protected].