Liability Regarding Complementary and Alternative Medicine (Part I)
By Dr. Gary L. Deel, Ph.D., J.D.
Faculty Director, School of Business, American Public University
This is the first article in a 10-part series discussing the duties of American medical professionals to disclose complementary and alternative medical treatments to patients.
As humanity has evolved and improved its understanding of the human anatomy, the medical field has continued to grow accordingly. Today, conventional medical practice — known as allopathy — all but dominates typical practice in modern civilizations.
However, a growing trend in first-world countries is the use of Complementary and Alternative Medicine (CAM). According to the National Center for Complementary and Alternative Medicine (NCCAM), a federally created division of the National Institutes of Health (NIH), CAM is a group of diverse medical and healthcare systems, practices, and products that are “not typically part of conventional medical care or that may have origins outside of usual Western practice.”
Complementary medicine could be defined as care that is used together with conventional medical practices. Alternative medicine is care that is used in place of such conventional practices.
Many of these new and relatively uninvestigated treatments have emerged in recent years due to globalization and increased cross-cultural exposure. Through these exchanges, people learn about techniques in different civilizations for treating illnesses and ailments that have been passed down over many centuries.
But the degree to which each unique CAM technique has been tested and proven (or disproven) to provide relief or cure varies significantly. Some treatments have a strong history of efficacy; others have yielded only questionable results at best to date.
However, what is not questionable is the level of interest from the general public in these alternative remedies. A 2010 NIH study found that more than a third of American adults actively use some form of CAM. With a consistent and substantial demand firmly established, it is clear that CAM is not going away.
In response to this demand, alternative therapy clinicians have grown in number and access to such services have become more readily available for the general public. As a result, the body of medical and malpractice law faces a variety of concerns. These concerns include the most appropriate integration of these practices into conventional medicine, and more importantly, the manner in which the law is prepared to uphold such a shift.
Among a plethora of controversial CAM issues, one of the most pivotal for medical professionals is that of informed consent. Informed consent in medicine is the basic idea that, when a treatment is to be administered, the physician must first disclose to the patient the expected benefits, the possible risks of the recommended procedure, and any alternatives available. And the patient must consent to the treatment after considering all such information.
The Integration of CAM Treatments Raises Issues within the Realm of Informed Consent
This premise seems straightforward and fair on its face, but the integration of CAM treatments into conventional medical practice raises several issues within the realm of informed consent. Should doctors be required to disclose the availability of CAM as part of their informed consent discussion? What if a doctor is not knowledgeable about CAM treatments? (Indeed, most are not, as will be discussed in later parts of this series.)
Also, there are dozens of types of CAM treatments recognized by NCCAM. Which ones are worthy of disclosure? These are all gray areas that our courts have so far not sufficiently addressed.
This series will seek to address two important questions with respect to the relationship between CAM — more specifically the treatments of traditional Chinese medicine (TCM) — and the laws of informed consent:
1. Within the context of the doctor/patient dialogue establishing informed consent, should physicians have a legal responsibility to their patients to disclose the availability of CAM treatments and their foreseeable risks/benefits as alternative therapy to the conventional treatment under consideration?
There are many concerns about imposing such liability on allopathic physicians, including a lack of education, fiscal concerns, prejudices and more. Limited case law in this area has so far suggested that doctors have at least some duty to advise their patients about alternatives to conventional treatment that pass a certain level of legitimacy as recognized within the medical community.
So disclosure of CAM options that satisfy such standards is probably appropriate. However, the critical variable so far left undefined by our courts is the second question:
2. What standard should be applied to determine whether a particular CAM treatment is recognized as sufficiently legitimate to warrant its disclosure to a patient?
The courts have approached most disputes concerning disclosures in informed consent cases through the evaluation of relevance and materiality to the parties involved. Sadly, this has led to a major divide in our legal system. Approximately half of all U.S. courts view materiality of medical information from the perspective of the attendant physician; while the other half view legal disputes from the perspective of the patient.
Both approaches bear a multitude of biases and unappealing side effects. A third option, which has yet to be explored by our courts, is the use of controlled clinical trials to establish a standard of efficacy to warrant required disclosure. This may prove the fairest solution.
There is much controversy surrounding the integration of CAM into a medical industry built exclusively around traditional western medical practice. In this series, we’ll look at whether physicians not trained or licensed in CAM should have a legal responsibility within the context of informed consent to disclose to their patients the availability of alternative treatments and their accompanying risks and benefits.
Furthermore, provided that some level of responsibility ought to exist, we’ll also look at what factors should determine whether a particular CAM treatment is legitimate enough to warrant disclosure to a patient. There is much at stake here — including legal liability and potential harm to patients — and the optimal solution may require a fundamental rethinking of our current approach to fairness in this field.
About the Author
Dr. Gary Deel is a Faculty Director with the School of Business at American Public University. He holds a J.D. in Law and a Ph.D. in Hospitality/Business Management. Gary teaches human resources and employment law classes for American Public University, the University of Central Florida, Colorado State University and others.