Does Informed Consent Trump Standard Of Care?

Allen Jacobs DPM FACFAS

I would like to raise the following question: Can something be legal but not ethical?

Informed consent is a powerful tool serving to protect clinicians from patients who claim they were not informed about their treatment. My question is whether true informed consent allows patient and clinician to bypass recognized standards of care for the patient.

Let me proceed with a recent example. A middle-aged woman sprained her right ankle and was on crutches for the treatment of this problem. Shifting her weight to the opposite foot, she developed heel pain in her left foot. Her primary care physician instructed her to ice her heel, take a nonsteroidal anti-inflammatory drug (NSAID), roll her foot on a bottle and see a podiatrist.

Several weeks later, her podiatrist evaluated her. She received an injection, low Dye strapping and was scheduled for surgery. Eight days later, she underwent an endoscopic plantar fasciotomy and “heel spur excision.” She developed rather serious complications from this surgery and subsequently required five revision surgeries. She has not returned to work since.

She sued for a lack of conservative care. The defense was simple: she signed a consent form. She was informed that non-operative care was an option. She agreed to surgery. She allegedly did so after being informed that non-operative care was an option but she waived such treatment. She therefore underwent surgery.

It is well known by the readers that plantar fasciitis is typically treated by non-operative care.

Absent compelling reasons to do so, my question is whether a patient becomes an acceptable surgical candidate if she or he is properly informed of and waives the option of non-operative care for such a condition. Does informed consent relieve the duty to provide standard of care treatment?

Comments

The answer is simple ... NO!

Amenability is not an indication for surgery. Patients should be able to reasonably rely on the surgeon to explain the risk/benefit analysis for a particular procedure and act accordingly. If, as in the case of plantar fasciitis, there is a 90% chance of a successful outcome without surgery, the surgeon has a duty to provide that treatment before surgery is performed. If the patient is amenable to surgery and refuses conservative care, that is not a reason to perform such surgery. Rather, it is an opportunity to say no.

In the example, this patient had plantar heel pain for about one month. The "standard of care" (ie., what a reasonably competent podiatrist would do under similar circumstances) would call for a minimum of three months of treatment before surgery. That being said, this only holds true if the conservative care is universally known to be effective. If this scenario was about hallux valgus or some other deformiy that does not respond to conservative care, then the answer is YES.

This is a can vs. should situation. With proper education and informed consent, sure, you CAN do a procedure on a patient, but the real question to consider is SHOULD you?

Some of our colleagues (some of which I trained with) will say that if the patient is adamant, then your job is to appease them. I don't follow this idiom at all. Patients who demand surgery the first time I see them generally get shown the door. I'm not that guy in most situations. There are exceptions to the rule of course, but especially with the case as mentioned above, it's conservative treatment to exhaustion before I will even discuss surgical intervention.

Can something be legal but not ethical? Yes, yet Tort Law varies by jurisdiction as do ethical frames of reference. There are numerous instances of exception in the legal literature.

Does informed consent relieve the duty to provide standard of care treatment? No, not from a professional's clinical judgment perspective. Standard of care abides but informed consent also takes into account the judgement of a “reasonable” informed patient.

The legal literature provides insight into the unresolved dilemma of informed consent:

From: Schuck, P.H., Rethinking Informed Consent, Yale Law Journal, V. 103: 899-959.

In most jurisdictions, the duty of disclosure is subject to certain exceptions.
These include situations in which: (1) complete and candid disclosure might
adversely affect the patient's physical or psychological well-being
("therapeutic"); (2) the patient is incapable of giving consent by reason of
mental disability or infancy ("incompetence"); (3) an emergency makes
obtaining consent impractical ("emergency"); (4) the risk is either known to
the patient or is so obvious as to justify a presumption on the physician's part
that the patient knows of it ("actual knowledge" and "common knowledge");
(5) the procedure is simple and the danger remote and commonly appreciated
to be remote ("known remote risk"); and (6) the physician does not know of
an otherwise material risk and should not have been aware of it in the exercise
of ordinary care ("physician's reasonable ignorance").

This is the essence of the informed consent doctrine. Many
physicians will surely find this summary of principles highly unrealistic.

I conclude that the problem of the informed consent gap is essentially
structural. In other words, it reflects the constraints imposed by human psychology,
the physician-patient relationship, the tort law system, and an increasingly cost conscious
health care delivery system — and that these constraints are largely
intractable.

From: King, J. S., et. al. Rethinking Informed Consent: The Case for Shared Medical Decision-Making, American Journal of Law and Medicine, 32 (2006): 429-501.

In law, with rare exception such as legislative action, change is
evolutionary and methodical. Unlike biomedical science in which a
breakthrough can quickly lead to dramatic changes in medical practice, legal
precedent is more adherent and must evolve either through the legislative
process or on a court by court basis in case law.

It would be very informative to have opinions rendered on the subject by our podiatry colleagues with legal degrees. It will also be interesting to see how tort law evolves in the courts of empathy and social justice.

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