Mass Tort Update- |
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Mass Tort Update
Problems in Informed Consent
Identifying adverse effects
Adverse effects may be well known to physicians; however, it is not safe to assume that patients have this same knowledge. When a suit is filed against a physician for not informing the patient of a particular adverse effect (eg, gustatory sweating after a parotidectomy), the physician may say that the suit is frivolous.
Analysis of suits filed suggests that frivolous suits (ie, suits that are based on complete lack of science) are extremely rare. An example of a frivolous suit may be the well publicized suit filed a few years ago in which a person complained that MRI scans performed after a head injury deprived her of her psychic abilities. However, suits such as impotence resulting after radical prostatectomy or sterility after bilateral oophorectomy are not frivolous if the patient was not warned about these effects prior to the surgery and was unaware that these effects could potentially occur. Patients cannot be held to the same level of medical knowledge as physicians.
What to disclose
The initial formulations of the level of disclosure needed for an informed consent require a physician to make those disclosures that a reasonable medical practitioner would make under the same or similar circumstances.
The disclosures that meet the standard are determined at trial by expert testimony. Under such a rule, which is followed in approximately half of the states, the level of required disclosure is largely determined by local practice.
In some states, decisions regarding informed consent are being incorporated into law. In California, for example, 9 separate procedures have informed-consent requirements, and accompanying state-prepared documents, that must be used if a suit is to be valid.
The rationale of limited disclosure
The courts attempt to further differentiate the risks required to be disclosed by referring to them as material risks. The definition of a material risk is a risk or adverse effect that is important to the patient; information that would affect the decision-making process of a reasonable person. The courts have sometimes quantified risks in the form of a percentage.
Risks that may be trivial but are common and risks that may be rare but are severe must be disclosed. A risk that is severe but rare is the risk of death. That the risk of death be disclosed in all cases seems reasonable; however, many physicians object to such disclosure, stating that everyone knows that the risk of death is present. They emphasize that knowledge of the risk may interfere with physician-patient rapport and patient healing and recovery.
Some physicians and many malpractice defense attorneys object vigorously to "laundry-list" consents. They have support in the law.
The Kansas Supreme Court stated that the requirement for reasonable disclosure "does not mean that a doctor is under an obligation to describe in detail all of the possible consequences of treatment." This may "so alarm the patient that it would...constitute bad medical practice." The court concluded that, if the physician was "motivated only by the patient's therapeutic best interests," the physician's judgment as to what is disclosed should be respected if it is in agreement with the practices of other physicians in the community.
Usually, defense lawyers argue that a written statement by the physician that "all risks were discussed, all questions answered, and an informed consent given" covers all eventualities. They insist that, no matter what complication or untoward outcome results, the physician can claim that the patient was warned. Conversely, the patient can insist that the complication was never mentioned. The explicit rationale in this instance is that, in such a conflict of assertions, a jury will believe the physician.
The rationale of full disclosure
Otolaryngologists are familiar with the parent or the patient responding with disbelief when they explain that numerous deaths occur in the United States every year from tonsillectomy.
Not everyone knows that tonsillectomy may result in death. Once informed, some patients or parents decide to forego tonsillectomy. For them, even the smallest risk of death is sufficient grounds to delay or avoid elective surgery. Others proceed with surgery, acknowledging the risk.
When such different reactions to the threat of death are observed, attempting to determine which of the numerous other risks or adverse effects would be material to the patient opens the physician to later questioning of his judgment. Furthermore, the same risk or adverse effect that would be dismissed as inconsequential if disclosed prior to the event becomes a major concern after the disaster occurs.
A 10% chance of gustatory sweating is naturally dismissed (preoperatively) when faced with the removal of a potentially malignant pleomorphic adenoma of the parotid gland; however, postoperatively and without warning, this same problem may be elevated to a major social handicap when the pathologist reports a benign lesion.
A patient warned preoperatively that the ear is likely to be permanently numb after parotidectomy may be intensely unhappy but will not sue as a result of the numbness. However, if the patient is informed after surgery that the numbness was expected and is normal, he may well react with disbelief and a conviction that such an explanation is offered merely as an attempt to avoid malpractice litigation.
The simple solution to this is to disclose everything. Those opposed to laundry-list disclosures are appalled by this suggestion. However, both ethical and statistical considerations support the idea of total disclosure.
First, it is not the physician's province to determine what risks or adverse effects each patient considers important. Physicians frequently react with disbelief when patients explain their reasons for refusing a recommended therapy, because they understand how small the risk is in actuality or because the patient's fear is so unrealistic. Yet, patient autonomy means that the values that lead to the patient's decision must be respected.
Second, when the most complete disclosure list possible is created, only the most obscure possibilities are excluded. A conscientiously prepared list excludes only a few risks that are highly unlikely and occur in fewer than 1 per 100,000 cases. Therefore, the chances of such an event both occurring and being absent from the list is much less than 1 per 100,000 cases.
Should the event occur, no jury would likely believe that such a remote possibility was included under the "all risks discussed" umbrella, leaving the physician at the mercy of the jury. In this instance, with an injured patient in the court, the jury would have to decide in retrospect whether the risk was a material one that should have been disclosed. Conversely, the lengths to which the surgeon has gone to inform the patient will make it clear to the jury that every good faith effort was made to convey that information and that this risk was truly unlikely and unpredictable.
Total disclosure is the best technique to avoid second-guessing and postdisaster revisionism.
Obtaining the Informed Consent
The responsibility for informed consent remains with the physician, even though physicians may delegate the duty of educating patients to auxiliary staff, and the auxiliary staff presents the informed consent document to the patient for signature. Therefore, the statement "My nurse forgot to tell Mrs. Smith that voice changes can result from thyroid surgery" is not an acceptable defense to an allegation of failure to disclose that risk.
Informed consent is not a piece of paper with a patient's signature at the bottom. In a nation where a substantial number of adults have limited ability to read, further explanation and teaching must occur before the patient signs the paper. The piece of paper documents a process, just as a signed contract provides written evidence of a process of negotiation that has led to an agreement. The agreement comes before the decision is made to put the agreement in writing. Therefore, informed consent implies patient participation in medical decision making. Enough information must be provided to patients in terms that they can understand to assure that their right to self-determination can be exercised effectively.
Informed consent is implicit in the codes of conduct of medical professional organizations, such as the Principles of Medical Ethics of the American Medical Association.
Ethical care leads to informed consent because it requires a process of providing the patient with the following:
Again, the document signed at the end of this process is merely evidence of the process that preceded the signing.
Informed consent and minors
Generally, minors may not give consent for their own medical care. Both legal precedents and legislation have modified this in many ways. A minor emancipated by a court or through a legal marriage may give consent for care to the same extent as an adult. In most states, special provisions have been made for minors to receive reproductive services. Prescription of birth control medications, fitting of diaphragms, abortion, and labor and delivery services are among the matters covered by such legislation.
Because the rules differ from state to state, any physician engaged in that form of medical practice should seek assistance from a local medical society or experienced attorney to ascertain the local rules before proceeding.
Informed consent and the (possibly) mentally incompetent
No special issues arise when a court of competent jurisdiction has declared a person in need of medical treatment incompetent and has appointed a guardian. The guardian stands in loco parentis and can give consent to the same extent as a parent could give consent for a child and can give consent in place of the incompetent person. A physician, who provides the same informed consent information to the guardian as would have been given to the competent adult, stands on firm legal ground.
However, problems arise when the person in need of treatment has not been declared incompetent beforehand. He or she may be of perfectly sound mind except for the incapacity of the illness at hand. Therefore, the physician is faced with the risk of being questioned not only by courts or family but also by the patient.
When physician and family are in agreement that a particular treatment should be provided, proceeding with the informed consent process with all responsible family members is generally considered safe. When the physician and family do not agree, protection of a court order should be sought if time permits.
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