By Stuart E. Hoffman, DC, FICA
In recent months, a high-profile debate on mandating specific terms for “informed consent” by doctors of chiropractic in Connecticut has been a very serious concern for many of us in the chiropractic profession. The roots of this debate go back to the activities of a small but heavily funded and well-organized clique of individuals and organizations with names like “Victims of Chiropractic Abuse” to use the media and also the public policy process to incorrectly frighten consumers into believing that chiropractic inherently puts people at risk for stroke. The impressive safety record of chiropractic, indeed the most impressive safety record of any health care profession, appears to mean very little to those organizations and individuals who have taken on the role of professional critics of our profession.
These blatantly anti-chiropractic organizations promoting the fear of stroke from upper cervical adjustments hit upon the informed consent issue as a means to showcase their issues. In four days of public hearings in January of this year before the Connecticut State Board of Chiropractic Examiners, played it for all the publicity they could get, the facts again, taking a complete backseat to the fear factor they were promoting. The research and actuarial records, and the failure to make anything but a casual or coincidental link between stroke and chiropractic services, did not seem to deter these people at all.
At these four days of hearings, the state’s chiropractic organizations, the Connecticut Chiropractic Council and the Connecticut Chiropractic Association, with the support of a host of national organizations, offered a reasoned, research and fact –based defense of the safety record of chiropractic procedures, arguing that informed consent was already well-established in the state but that a specific warning of stroke as a possible outcome for cervical adjusting was simply not supported by the research record. On the other side, a long list of critics of chiropractic, including some well-known professional anti-chiropractic advocates such as Murray Katz, MD who was such a feature in similar discussions in Canada, and the “organizations” active on the stroke issue offered emotion, and accusations, but no facts to support their position.
Without any doubt, the highlight of the chiropractic presentations at these hearings was the testimony presented by respected researcher and epidemiologist J. David Cassidy, DC, PhD, Dr.Med.Sc., who testified as an expert witness and consultant to the International Chiropractors Association (ICA). Dr. Cassidy addressed key facts and issues on the basis of the existing science and research record, to which he has been a significant contributor on the issue before the Board. The objective of his testimony was to bring the discussion on an emotional issue back to the science and the objective research record. Speaking in the context of the most recent research (Neck Pain Task Force Report of the Bone and Joint Decade 2000-2010, a United Nations & WHO sanctioned study), Dr. Cassidy stated in compelling and well-documented terms that “neck manipulation is safe and effective form of health care.” Despite several hours of aggressive cross-examination, Dr. Cassidy was able to keep the focus of the hearing on the scientific record and laid the foundations for the Board’s eventual fact-based decision.
On June 11, 2010, the Connecticut State Board of Chiropractic Examiners issued their declaratory ruling on the issue of a mandated informed consent policy requiring a specific stroke Warning. In a well-reasoned, carefully worded statement, the Board concluded:
An objective observer would think that this statement would put an end to the matter. This, regrettably, is not the case. The goal of the anti-chiropractic activists is not to deal with facts or real risks but to hurt the chiropractic profession. Sadly, we will have to continue to deal with the backwash of their campaign, since after the defeats in the legislature in Connecticut and at the hands of the Connecticut Board of Chiropractic Examiners, a class-action lawsuit against the chiropractic state associations in Connecticut has been filed by one of the “stroke” groups alleging harm because the members of those associations have not specifically been warning patients of a stroke risk. This is more of the same anti-competitive distortion, probably for the publicity it will generate because the facts do not support their allegations. Regardless of their destructive intent and deceitful ways and means they are employing, the chiropractic profession will need to come together to support our colleagues in Connecticut against this latest phase of harassment.
The Connecticut episode shows the degree to which informed consent has become the subject of growing attention as an element in risk management procedures, because the lack of it in malpractice cases has become a common and effective claim. Clever and aggressive lawyers have hit upon the informed consent issue as a means to strengthen otherwise weak claims of clinical misjudgment or injury, based on a number of landmark court decisions and trends in other professions. In a landmark 2005 Wisconsin case, the state court found:
“Chiropractors, like medical doctors, are health care professionals involved in the application of procedures and treatments to the human body. We see no reason why the scope of an individual’s right to be informed of the risk inherent in bodily intrusions via chiropractic treatment and procedures should be any different from his right to be informed of the risk inherent in bodily intrusions in medical treatment and procedures.”
Thus, the fact that chiropractic is non-invasive provides no additional margin on demands for informed consent according to the Wisconsin court, a position reaffirmed by an often cited 1999 New Jersey Supreme Court decision, which similarly held that: “…informed consent applies to both invasive and noninvasive procedures, holding that physicians must inform patients of the possible risks and benefits of all “medically reasonable” treatment options—including those he or she does not recommend. If that is not complicated enough, courts are regularly finding that during the course of care, patients must be updated throughout their course of care in terms of relative risks and alternate care choices, and that not telling a patient about other care pathways and their risks becomes an issue in itself.
In fact, actions based solely or largely on the lack of formal and written informed consent have emerged as a malpractice growth industry, even though such charges may have nothing to do with whether a chiropractor has actually committed an act or acts of malpractice as it has historically been understood.
The message here is clear: Be consistent and proactive in obtaining both written and verbal informed consent from every patient, in advance of both examination and the active delivery of care. Yes, get informed consent prior to care to cover your examination procedures, as well as in advance of delivering chiropractic adjustive care.
Informed consent starts with a standardized form. Your malpractice carrier is always a good place to obtain a model form, followed by your state or provincial association, with, as is almost always the case, close attention paid to any direction available from your state or provincial regulatory board. On this form, the key information needed will always include the patient’s name, address and of extreme importance, the date.
The exact nature of the form’s contents should reflect the requirements in your jurisdiction. This is why a visit to the regulatory board’s website or information from your local association is so vital. Different jurisdictions have different specifics on informed consent. You will need to comply with state and provincial directions as to the degree of specificity regarding risks inherent in the procedures you are about to apply.
In recent months, as more and more technology and especially mechanical devices are incorporated into chiropractic practice (from mechanical adjusting devices to spinal decompression units) it is becoming important to obtain separate informed consent forms for each new level of intervention applied by your clinic. A form for the adjustment, a form for traction, a form for mechanical spinal decompression, and a form for any procedure that can be argued to be separate and different, and not arguably covered by a general form, will serve you well. Remember also that the absence of such forms becomes a problem in and of itself.
In addition to the form itself, most legal advisors will encourage that a note be added to the patient’s file stating that the form was signed and that a verbal exchange took place, with you as the provider (not a member of the staff) highlighting the contents of the form. Indeed, some malpractice experts argue that the verbal exchange is the essence of informed consent, where the patient has the opportunity to question the doctor’s choice of procedures, and that without the verbal component, the written form looses much of its meaning.
Rather than look at the informed consent exercise as a burden, practitioners should look at the interaction with the patient on relative risk and informed consent as an opportunity to orient them to what they can expect from the adjustment process, especially if they are first-time patients. While most patients feel an immediate sense of relief from the adjustment, a frank discussion on possible temporary or short-term discomfort from a first adjustment, possible stiffness, etc., helps patients keep things in a much better and more realistic perspective, and positions you as the doctor in a position of both credibility with the patient, as well as defensibility should any unforeseen issue arise. Such frank and open dialogue can only strengthen the doctor-patient relationship and enhance the positive nature of their chiropractic experience.
In today’s litigation-happy (or many might argue litigation-crazy) society, even the best, most conscientious and responsible doctors of chiropractic, applying the highest standards and most established procedures and protocols, can still be named in a malpractice claim. When it comes to informed consent, a whole new dimension of malpractice reasoning comes into play, where patients and their attorneys regularly argue that if a patient was fully informed of all risks and possible negative outcomes, then they may have decided not to receive the care and would not, as a result, been injured. The proactive doctor of chiropractic will respond accordingly, with sound and well-researched forms and procedures, all consistently applied and included in the patient’s file. It pays to do the work and, consequently, minimize the risk.
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Hanumans v. Boyson, No. 2003AP1527, 2005 WL 1522624 (Wis. June 29, 2005).
Matthies v. Mastromonaco, 160 N.J. 26, 37, 733 A.2d 456, 462 (1999).
Schreiber v. Physicians Insurance Company of Wisconsin, 223 Wis.2d 417, 588 N.W.2d 26 (1999).