Legal Liability to Volunteers in Testing New Drugs

Scientists test new drugs by giving them to volunteers. In spite of every precaution, the drug may harm the volunteer. Under Canadian law, can he recover damages against any of the persons connected with the test? He cannot succeed against the scientist if the latter had made complete disclosure of the risks and had then obtained the volunteer''s free consent. Where the subject of a test is a child or one of unsound mind, the guardian''s consent probably does not protect the scientist from a possible claim by the subject. Where a married woman is a volunteer, her husband''s consent is unnecessary. The volunteer cannot succeed against his family physician who referred him to the scientist unless the physician took an active part in an experiment that was conducted negligently or without a proper consent. The volunteer cannot succeed against the maker unless he has negligently prepared the drug or given misleading information.     

Bioethics for clinicians: 12. Ethical dilemmas that arise in the care of pregnant women: rethinking "maternal-fetal conflicts".

When a pregnant woman makes a decision or acts in a manner that may be detrimental to the health and well-being of her fetus, her physician may be faced with an ethical dilemma. Is the physician''s primary duty to respect the woman''s autonomy, or to promote behaviour that may be in the best interest of the fetus? The controversial concept of "fetal rights" or the "fetus as a patient" contributes to the notion that the pregnant woman and her fetus are potential adversaries. However, Canadian law has upheld women''s right to life, liberty and security of the person and has not recognized fetal rights. If a woman is competent and refuses medical advice, her decision must be respected even if the physician believes that her fetus will suffer as a result. Coercion of the woman is not permissible no matter what appears to be in the best interest of the fetus.     

Prostate cancer: 1. The descriptive epidemiology in Canada

A 70-year-old woman who experienced a long period of depression after her first husband''s death from prostate cancer at the age of 63 has become increasingly anxious about her own health and that of her close family. A few years ago she married a man her own age; he is in good physical condition. Last year the family spent much of the winter in Florida, where the woman noticed several studies in the media suggesting that an epidemic of prostate cancer is occurring in North America and that because early detection can save lives men of retirement age should be checked by their physicians as soon as possible. In addition, 2 close friends recently diagnosed with prostate cancer. On his latest fishing trip her husband learned from a friend that 1 in 8 men get prostate cancer. He has not seen his family physician for several years, but his wife has booked an appointment for them to discuss their concerns.     

Genetic Counseling—A Health Department Service to Physicians

Questions about inheritance in all kinds of diseases and defects are commonly asked of nearly all physicians. In attempting to answer these questions, however, the physician is often hampered by lack of formal instruction in clinical genetics.Since the health department, if it is to carry out its epidemiologic function, must be as concerned over the increasing identification of genetic agents in disease as it is and has been over environmental disease agents, it should come to represent a source of assistance not now generally available to the physician. In short, as it carries out those activities by which its store of general genetic information is increased, and until other sources of genetic consultation become reasonably available, the health department can be of real service to physicians as a resource to which they may turn for help when dealing with families wanting genetic information.Such a service has been provided experimentally for the last two years by the Contra Costa County Health Department.This program calls for the taking of family pedigrees by public health nurses on families with questions of a genetic nature who are health department clients and on families who are referred by their private physicians for this service. An interpretation of each pedigree is made by the department''s physician in charge of the program and submitted to the family''s physician for his use in counseling the family. Evidence to date suggests the process can be a highly useful service to the practitioner and his patient.     

The confederation worm token.

To an increasing degree the psychiatrist is oriented to the community and general hospital either as consultant, therapist, or collaborator in overall patient management. In these new roles, he becomes a more comprehensive physician and also conveys psychiatric insights to his colleagues.Psychological factors and the patient''s personality “style” influence the development and course of every disease, complicating diagnosis and effective treatment. It is a basic requirement that a good working alliance be established between patient and physician. This is assisted by comprehensive history taking, which clarifies the lifesetting in which the illness began, the patient''s personality and his habitual reactions of emotional regression under stress. It will also point up errors introduced by the patient, omissions, and distortions in offering the subjective data which the physician must evaluate.Seven major personality types and appropriate physician responses are outlined: the dependent demanding oral patient, the orderly controlled obsessive, the dramatic seductive hysteric, the long-suffering masochist, the querulous paranoid, the overbearing narcissist and the aloof withdrawn schizoid.The non-psychiatrist can resolve complex and puzzling medical problems if he has an increased awareness of how emotional forces complicate illness and if he can exploit comprehensive history taking to the full.     

The Coordination of Dentists and Physicians in Managing Adverse Oral Effects of Drug Therapy–Report of a Case

Because people are living longer and older people generally use more medications than do the young, it is extremely important that the dentist be aware of the medications that are being taken by his/her patients as well as the reasons for the medications. Frequently, it may be necessary to consult with the patient's physician(s) in order to better understand the patient's medication history. This paper describes a case in which a patient was inappropriately following a long-term course of antibiotic therapy when only a short-term regimen had been intended by the patient's physician. The long-term antibiotic use eventually predisposed the patient to oral candidosis. The dentist contacted the physician and referred the patient back to the physician for an alternative medical regimen. This case report emphasizes that patients may incorrectly interpret physician or dentist instructions concerning medication use. The dentist may be in an excellent position to identify medication errors and should contact the patient's physician whenever in doubt.     

From Chattel to Consenter: Adolescents and Informed Consent: 2009 Grover Powers Lecture

Angela Holder was to give the Grover Powers Memorial Lecture at the weekly Grand Rounds conducted by the Yale Department of Pediatrics on Wednesday, May 27, 2009, but unfortunately, she died one month earlier, on April 22, leaving behind her prepared address, “From Chattel to Consenter: Adolescents and Informed Consent,” which she had regarded as the pinnacle of a remarkable career, much of it spent at Yale. As the Grover Powers honoree, the department’s highest honor, Ms. Holder was only the fourth woman of 46 recipients and the first who was not a physician. On the date scheduled for her address, tributes were presented by her son, John Holder, and her longtime colleague, Dr. Robert Levine, co-founder of Yale’s Interdisciplinary Bioethics Center. Their comments follow Angela Holder’s completed but undelivered Grover Powers address. — Myron Genel, MD, Professor Emeritus of PediatricsUnder the common law of England and in the early years of the United States, a minor (defined as anyone under 21) was a chattel or possession of his or her father [1-4]. A father had the right to sue a physician who treated his son or daughter perfectly properly but without the father’s permission because such an intervention contravened the father’s right to control the child. Beginning in the early years of the 20th century, by the end of World War II and into the 1950s, the notion that a 16-year-old was a legally different entity from a 6-year-old gradually became law in all states.¹ The first hospital unit for adolescents was created in 1951 at Boston Children’s Hospital, and the concept of “adolescent medicine” was born [5].As the law in this area currently defines “adolescent,” we are discussing someone 14 or older who may be (1) living at home with his or her parents; (2) Not living at home but still dependent on parents (i.e., a 16-year-old college freshman living in a dorm); (3) an “emancipated minor” who is married, emancipated by a court order, or a parent (other than in North Carolina), living away from home and self-supporting; or (4) a runaway or throwaway. At any time in this country, there are about 200,000 adolescents living on the streets with no adult supervision or involvement [6].Regardless of the age of the patient, informed consent consists of five elements: (1) An explanation of what will happen; (2) explanation of the risks; (3) explanation of the projected benefits; (4) alternatives (including doing nothing); and (5) why the physician thinks it should be done, which I interpret as a right to know one’s diagnosis. While the doctrine of “therapeutic privilege” means that in rare cases a physician may withhold some information from an adult patient if she or he believes the patient cannot “deal with the information,” there can never be any withholding of information from an adolescent. If the patient can’t deal with the information to be presented, then parents have to be involved and give permission to treat the adolescent.In some cases, when parents are involved, they do not want their adolescent to know his or her diagnosis. While this is usually not a good idea, it normally falls under the rubric of “professional judgment,” and the physician has every right to decide to follow the parents’ instruction if she agrees with it. In some situations, however, the adolescent must be told what his or her illness is, whether parents like it or not. For example, if a teenager is HIV positive, he or she must be told, must be instructed about safe sex, and must be asked to divulge the names of any sex partners. Parents who say, “Oh, no, don’t tell him, he would never do anything like that, so it doesn’t matter,” should be tactfully but firmly led to accept the fact that he may well have and if he hasn’t yet, he will certainly in the future. There has been at least one successful malpractice case in which the physician did not, at the request of the parents, tell his adolescent patient that he had HIV. The patient’s girlfriend caught it and sued the physician [7]. I feel sure there are many more cases like this that have been quietly settled and no one will ever hear about.Usually, questions about adolescents giving consent to treatments that their parents don’t know about involve outpatient treatment. In the first place, hospital administrators, who are much more interested in getting paid than they are in advancing the rights of autonomous adolescents, are not going to admit for a non-emergency problem a minor whose parent has not made some sort of financial arrangement to pay for it. Secondly, in most households, if Little Herman doesn’t show up for supper or throughout the evening, someone notices and a few telephone calls later discovers that Little Herman is in the hospital.     

PSYCHOTHERAPY—A Concept for the Nonpsychiatric Physician

Patients tend to repeat with their physician, as with other significant people in their lives, their earlier previous patterns of behavior. The physician as well as the patient is involved in the physician-patient relationship. He will tend to respond to his patients in accordance with his earlier life experiences and his characteristic repetitive behavioral pattern. For both physician and patient, the relationship between them extends beyond the immediate reality situation.Psychotherapy is the utilization of psychological measures in the treatment of sick persons and the deliberate utilization by the physician of the physician-patient relationship for the benefit of the patient. The kind of psychotherapy that is practical and utilizable by the nonpsychiatric physician is that which uses education, reassurance, support and the management of the patient''s problems either directly or indirectly or through the intermediary of other people or agencies.The symbolic aspect of the physician-patient relationship is based essentially on the fact that a sick person, because of his anxiety and because of the threat to his physical and psychic integrity, is more dependent and more anxious than he would be if he were well, and therefore he has a correspondingly greater need for the authoritative and protective figure he finds in the physician.Psychotherapy is not directed exclusively to the treatment of flagrantly or obviously neurotic or psychotic patients. It should be and is directed to all sick persons. Limitations in psychotherapy are set by various determinants, among which are the nature of the precipitating factor in the illness, the nature of the sick person, the skill, knowledge and abilities of the physician, and the nature of the physician-patient relationship. In psychotherapy, as in all medicine, the physician should not do anything which may disturb the patient if the disturbance is of no value or if it cannot be followed through with special skills.     

Cross-cultural issues in European bioethics

European biomedical ethics is often contrasted to American autonomy-based approaches, and both are usually distinguished as 'Western'. But at least three 'different voices' within European bioethics can be identified:
The deontological codes of southern Europe (and Ireland), in which the patient has a positive duty to maximise his or her own health and to follow the doctor's instructions, whilst the physician is constrained more by professional norms than by patient rights
The liberal, rights-based models of Western Europe, in which the patient retains the negative right to override medical opinion, even if his or her mental capacity is in doubt
The social welfarist models of the Nordic countries, which concentrate on positive rights and entitlements to universal healthcare provision and entrust dispute resolution to non-elected administrative officials     

If Unprofessional Conduct Is Charged by the California Board of Medical Quality Assurance

The right of a physician to practice his or her chosen profession must be balanced against the right of the public to be protected from unprofessional conduct by physicians. By providing notice and a hearing before imposing discipline, if any, on a physician for unprofessional conduct, the California Board of Medical Quality Assurance meets the basic requirements of procedural due process. However, although the constitutional rights of the physician may be protected in this way, the administrative disciplinary process itself is likely to be an arduous experience. A basic understanding of the nature and legal effect of such disciplinary proceedings may assist a physician in defending against the charges.     

Analysis of Your Professional Liability Insurance Policy

The most important lessons for the physician to learn in regard to his professional liability insurance coverage are the following:1. The physician should carefully read his professional liability policy and should secure the educated aid of his attorney and his insurance broker, if they are conversant with this field.2. He should particularly read the definition of coverage and carefully survey the exclusion clauses which may deny him coverage under certain circumstances.3. If the physician is in partnership or in a group, he should be certain that he has contingent partnership coverage.4. The physician should accept coverage only from an insurance carrier of sufficient size and stability that he can be sure his coverage will be guaranteed for “latent liability” claims as the years go along—certainly for his lifetime.5. The insurance carrier offering the professional liability policy should be prepared to offer coverages up to at least $100,000/$300,000.6. The physician should be assured that the insurance carrier has claims-handling personnel and legal counsel who are experienced and expert in the professional liability field and who are locally available for service.7. The physician is best protected by a local or state group program, next best by a national group program, and last, by individual coverage.8. The physician should look with suspicion on a cancellation clause in which his policy may be summarily cancelled on brief notice.9. The physician should not buy professional liability insurance on the basis of price alone; adequacy of coverage and service and a good insurance company for his protection should be the deciding factors.     

Informed Consent in California: Latent Liability Without `Negligence'

Informed consent is a legal obligation due from a physician to his patient, an obligation which may not be met by the physician''s skillful treatment of his patient. It may only be met by the treating physician obtaining from his patient knowing authorization for carrying out the intended medical procedure. The physician is required to disclose whatever would be material to his patient''s decision, including the nature and purpose of the procedure, and the risks and alternatives. The disclosures should be made by the physician to his patient, and not through use of consent forms which are not particular to individual patients. To minimize any subsequent claim by the patient that there was a lack of adequate disclosures, the physician should record in the patient''s chart the circumstances of the patient''s consent, and should not rely on the patient''s unreliable ability to recall those circumstances.     

The road to Wisconsin

In this article Lynne Sears Williams of Calgary describes her family''s decision to leave for the US, where her husband, Dr. Jim Williams, will pursue his career in family medicine. The decision was not made easily, she writes, but eventually a love for Canada was outweighed by her husband''s desire to practise medicine without the financial and other constraints facing physicians in Canada.     

Consultant physician to outpatients.

Analysis of the records of the last 450 outpatients referred to me showed that the basic disorder of at least one in three lay in the psyche, and there was a large emotional element in many of the others. None were put on a waiting list for admission. Not only should physicians be generalists most of the time (whether or not they have a special interest) but most medical problems are best dealt with by the GP. Only occasionally can the physician attach a precise diagnosis to a patient who has been an obscure problem to his GP, and the physician''s most important function is to reassure the patient and explain his symptoms. Routine investigations seldom benefit the patient. If there could be a more equitable distribution of GPs of high quality with good back-up facilities fewer general and many fewer specialist physicians would be needed.     

Epilogue: Luria's Psychological Symphony

A finely worked bronze dog has been standing on my desk for twenty years now. Aside from the books with their dedicatory signatures, it is the only material thing I have in memory of Aleksandr Romanovich Luria. A week after he died, Lana Pimenovna, his wife, asked if I could drop in to see her. I thought that the reason for her call—to ask me to enlarge, reproduce, and frame some photos she had made of Aleksandr Romanovich in various years during his lifetime—was only a pretext: the publisher's in-house photographer or any other photographer could have done this.     

THE HIGH SCHOOL FOOTBALL TEAM PHYSICIAN

Mutual confidence is necessary between the football coach and the team physician. The physician''s decision in the matter of a boy''s condition must always be final. The coach should also consider the physician''s advice in shaping his psychological appeals to the players in before-game and between-halves talks. The physician should be on his way to a man injured on the field as soon as the play is ended. It is up to him and not the trainer or coach to make the diagnosis. The physician must have the ability to make an immediate evaluation of the extent of injury and use appropriate measures to get the player off the field. To see a semi-conscious man with dangling head being half dragged off the field is far worse from the patient''s standpoint and from the spectator''s standpoint than removal by stretcher.     

WORK INJURY—A Second Look at the Doctor's First Report

Injured employees require medical care and, if disabled, compensation payments for subsistence. The law requires that the employer or insurance carrier supply these benefits promptly. In the absence of prompt and adequate information from the attending physician, these benefits are withheld. The necessary information required to process employee''s claim is that called for on the standard accident report form, commonly called the “pink slip.” Not to supply this minimum information may constitute a hardship on the employee. By supplying more elaborate information than that called for, the physician may be increasing his load of “paper work” immeasurably.     

Internet access

A 65-year-old man undergoes a routine checkup before retiring. His wife has urged him to have his prostate examined, because she has read about testing for prostate cancer and a friend has just died of this disease. During the rectal examination, the man''s physician discovers some firmness in the right lobe of the prostate gland. The patient has had no urinary symptoms and is in excellent general health. Sexual function is normal. There is no history of prostate cancer; his father died of a stroke at age 86 years. Testing shows that the patient''s prostate-specific antigen level is 9.3 ng/mL, and he is referred to a urologist. Transrectal ultrasound-guided needle biopsy reveals adenocarcinoma with a Gleason score of 7 (intermediate grade). At a follow-up meeting with his physician, the patient says, "I have been doing some research, and it appears that I should have treatment. However, what is less clear to me is what form of therapy is best--surgery or radiation treatment. Please tell me what you can about the state of the art with respect to surgery."