Liability Regarding Complementary and Alternative Medicine (Part X)

clinical trials alternative medicine

By Dr. Gary L. Deel, Ph.D., J.D.
Faculty Director, School of Business, American Public University

This is the final article in a 10-part series discussing the duties of American medical professionals to disclose complementary and alternative medical treatments to patients

The first question in this article series, addressed in previous articles, asked whether physicians should have a legal duty to disclose complementary and alternative medicine (CAM) options and discuss them with patients in their care. And there is case law to suggest that some duty does indeed exist.

The second question asked what standards should be applied to determine whether a particular CAM treatment is sufficiently relevant or recognized in the medical community to warrant mandatory disclosure by a physician to her patient.

In previous articles, we discussed how the materiality standard is problematic because it is inherently subjective and our courts are deadlocked over whose position the standard of materiality should be judged by.

However, another test is available to the courts: to establish an objective standard based upon the success of a particular CAM treatment in clinical trials. Clinical trials are very standardized. So it would not be too difficult for courts to decree a general standard of performance for all alternative therapies that must be met in order to warrant disclosure during informed consent conversations between doctors and patients.

A General Standard of Performance Would Create Fairness and Consistency for Disclosure

Because it removes the element of subjectivity and the ultimatum of choosing one side over the other as authority in the matter, a general standard of performance is arguably much fairer in nature. It would also serve to create a consistent standard that courts could employ to measure the relevance of disclosure in all cases involving CAM therapies.

By the same token, this practice would also work to inhibit some of the concerns discussed in previous articles about the logistical challenges of integrating CAM treatments into the conventional medical industry. A clinical trial standard could be established at a success level that would not be unreasonably out of reach for alternative medicines. But it would be high enough that a flood of alternative medicines would not instantly satisfy the requirement and be protected under laws of required disclosure.

This would serve two purposes. First, it would allow allopathic physicians a fair opportunity to educate themselves on approved CAM therapies at a moderate and sustainable rate.

Second, it would require that CAM therapies undergo vigorous testing before passing muster for integration into the required disclosure process. Holistically, this is the most beneficial approach for all parties involved.

In addition, courts reviewing future litigation on the subject should seriously consider abandoning the materiality standards in favor of a single, objective standard of clinical reviews for determining required disclosures of CAM treatment options in the informed consent process.

The Battle Over the Integration of Alternative Medicine Is Far from Over

The relationship between CAM therapies and the laws of informed consent in the American legal system have a long and complicated history, and the battles over proper integration of alternative medicines into our allopathic standard are clearly far from over. However, it seems from the limited common law established thus far that our courts have expressed a willingness to entertain the idea that unconventional medicine, under yet undetermined circumstances, could attain a level of credibility sufficient to warrant their required disclosure under medical malpractice law.

Courts have several options moving forward for determining such a standard, but it is evident that applying to this question the same subjective materiality tests of the past will always favor one side of litigation at the expense of the other. Rather, in looking to fairly balance the interests of both parties, it seems most prudent that an objective standard of success in clinical trials would offer the sought-after protection for patients’ rights while also not overburdening allopathic physicians with unrealistic expectations of education and limitless liability. If our courts open their minds to this consideration, it would most certainly lead to a better, safer and more effective medical industry for all Americans.

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.

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