Mental health innovation vs. psychiatric malpractice: creating space for "reasonable innovation".

AuthorKapley, David

Innovation is essential in both the practice of medicine and of mental health. (2) Physicians frequently use novel approaches to treatment in an effort to help patients--a process essential for medical progress. (3) New approaches can be required to deal with the uniqueness of particular cases and may be preferred over established approaches when newness offers the potential for some advantage to the patient. In psychiatry, the use of such innovation is already widespread. Much change in psychotherapy is a result of innovation. For example, Aaron Beck's contribution to cognitive theory, which concerns how thinking can make a person vulnerable to depression, has led to novel therapy-based treatments for depression. (4)

Innovation is an even more dynamic force in psychopharmacology. In recent years, child psychiatrists have treated children with a variety of medications in novel ways for purposes not sanctioned by Federal Drug Administration (FDA), including: clonidine, guanfacine, and bupropion in the treatment of attention deficit hyperactivity disorder; antidepressants in the treatment of childhood depression; and valproic acid in the treatment of aggression in childhood. Similarly, the use of Depakote (valproic acid) to treat bipolar disorder, an illness in which the patient experiences mood swings, began as an innovated treatment. For years, psychiatrists prescribed Depakote to stabilize the moods of patients suffering from bipolar disorder, even though the FDA did not sanction that use. Eventually, studies demonstrated the efficacy of Depakote for bipolar disorder. At present, Depakote (5) and Depakote ER (6) are approved by the FDA for the treatment of mania associated with bipolar disorder. Depakote, however, is a medicine with serious risks, such as liver failure, a condition when the liver ceases to sufficiently perform functions necessary to sustain life. (7) The risk of death associated with Depakote existed whether its use was innovative or mainstream. Such cases raise crucial questions about the relationship between innovative interventions and malpractice liability.

At present, the use of Depakote to treat bipolar disorder is in the mainstream of psychiatry. A psychiatrist would not be liable for malpractice when a patient suffers fatal liver failure from Depakote if the psychiatrist was reasonable in diagnosing bipolar disorder, obtaining informed consent to use Depakote, and in diagnosing and treating or in referring treatment for the liver failure. Would the law of medical malpractice have reached a similar result if a fatal side effect had occurred during the early innovative use of Depakote to treat bipolar disorder? This article attempts to provide guidelines for lawyers, courts, and psychiatrists in such situations. At the same time, it argues that malpractice liability should not hinge upon the historical accident of when a patient suffers a life-threatening side effect from medication used for a mainstream or an innovative purpose.

This paper emphasizes the application of the proposed doctrine in the specialty of psychiatry. The goal is to create a model doctrine that can be fruitfully applied to non-psychiatric physicians, as well as to other mental health practitioners. This article is divided into three parts. Part I discusses the law of mental health malpractice with an emphasis on reasonable innovation. Part II advances a proposed doctrine of reasonable innovation. Part III applies the doctrine to specific innovations in the history of psychiatry.


  1. The Challenge of Innovation

    Innovation in medicine often creates tension with the law of malpractice. Judges and clinicians face the formidable task of how to allow for change and evolution in the practice of clinicians, while protecting patients from unsound practice and quackery. After all, standards of medical practice help to guide physicians and protect patients. Flexibility, not rigidity, is a virtue for such standards. Stability without flexibility leads to stagnation, and stagnation is in the interest of neither patient nor physician. Flexibility comes out of awareness that, more often than not, there are many differing, yet reasonable, approaches in the care of patients. In fact, the concept of "reasonableness" has been central to the law of medical malpractice. (8) At the same time, patients are entitled to protection from the charlatan who promotes change in medical practice that is unsound and prone to injure. The law of medical malpractice must find a way to allow for innovation while also protecting patients from practitioners whose activities are so extreme as to exceed the bounds of reasonable medical practice.

    At the beginning, the innovator may be a minority of one. At one point, the ideas of many great innovators were inconsistent with the prevailing notions of their day. (9) Moreover, some innovations are unsuccessful. Others become more popular, as more practitioners take up the new practice. Eventually, the majority of clinicians may practice the innovation. What was once new becomes mainstream. Still later, the once-innovative practice, now mainstream, may begin to fade, and another new approach may begin to replace the mainstream idea. There is a natural evolution in the birth, growth, and death of ideas of standards of care. Judges should not tinker too radically with this natural cycle. Courts should encourage, rather than eradicate, positive innovation. Such an approach emboldens progress in the treatment of patients. Yet some change is too foolhardy or too dangerous to be permitted by the courts. Thus, courts must be aware of their role to protect the public from quackery. (10) An innovation may be unreasonable when it is new, or may become unreasonable after the passage of time--even after the innovation becomes the practice of the majority of physicians. (11)

    The challenge is to balance competing interests. Courts must determine how to encourage reasonable innovation that may help patients while discouraging unreasonable innovation or quackery that may harm patients. A workable doctrine of reasonable innovation is meant to help the courts find the proper balance. This doctrine must complement, but not replace, the rule of the respectable minority. That rule, a staple of existing malpractice law, states that a practitioner does not commit malpractice by following the approach of a respectable minority, even though the majority of practitioners follow a different approach. (12)

    One approach to a standard for reasonable innovation argues that an innovation is not malpractice even if practiced by a minority of one so long as the innovation is "reasonable." The purpose of this article is to outline the balancing of interests that occurs when determining whether an innovation is reasonable, while also exploring the interaction of this proposed doctrine with existing malpractice law.

    Generally speaking, it is unusual for a successful innovation to be the subject of malpractice litigation. This is due in part to the fact that patients do not typically sue for malpractice when treatment has helped them. It would be an easy, but intellectually dishonest, process to retroactively brand the innovation as unreasonable. Hindsight, after all, is 20/20; Monday morning quarterbacking helps the malpractice judge no more than the football fan. The use of such an analysis would result in a malpractice judgment in nearly every instance when innovation has resulted in injury. In effect, any physician using innovation would be at risk for absolute liability if an injury resulted from a violation of the customary standard of care. This would have a stifling effect upon innovation and would be contrary to the philosophy of reasonableness--central to the law of malpractice.

  2. Medical Malpractice and Innovation in the Standard of Care

    In order to prove a cause of action for medical malpractice, the plaintiff must show: (1) a duty owed from the defendant to the plaintiff; (2) a breach of that duty; (3) actual injury to the plaintiff; and (4) legal or proximate cause. (13) In medical malpractice cases, it is critical to determine whether the actions of the defendant were below the required standard of care. (14) This is because the duty owed to the patient is generally determined by the standard of care, which is reflected in the actual standard of practice of physicians. (15) A physician is required to adhere to a standard of care that would be exercised by other reasonable practitioners in the field under similar circumstances. (16) Here, the physician is guided by a "collection of clinical policies." (17) Clinical policies usually evolve as the result of the individual acts of hundreds of physicians, which are registered in writing and oral communication. (18) Policies may also be influenced by organizations with legal or economic control or by third-party payers. (19)

    Expert witnesses in medical malpractice cases are hired to testify about objective professional standards. (20) But the practice of medicine often requires clinical judgment, which introduces a considerable amount of subjectivity. In medical malpractice cases, reasonableness can be understood best by review of the intricacies of each case. (21)

    The plaintiff bears the burden of proving that the conduct of the defendant physician fell below the standard of care. (22) Courts usually require that expert testimony establish the care of other reasonable practitioners. (23) However, there are exceptions to the rule requiring the plaintiff to produce an expert witness. In one famous case, the Court of Appeals of New York held that no expert was required to testify against a psychiatrist who, as part of the treatment, physically assaulted a patient suffering from schizophrenia--a serious mental illness that causes the patient to lose contact with reality. (24) The court found that assaults against the patient "bespeak improper treatment" and thus it was...

To continue reading

Request your trial

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT