Even the most thorough process may not absolve you.

For each procedure we perform, either the physician, surgical counselor or both explains the risks, benefits and alternatives — including no procedure performed — to the patient and, if appropriate, the family or legal guardian. This conversation sometimes incorporates eye models, videos and illustrations to facilitate patient understanding. After that, once all questions are answered to the patient’s satisfaction, the consent form is signed and witnessed. These forms have been carefully vetted by legal and regulatory institutions and are either those provided by the AAO, ASCRS or the AMA or versions of those informed consent forms.

But does conscientiously performed process even matter? Patients can still sue physicians for complications that were explained as possibilities beforehand even after signing the informed consent form.

IT DOESN’T ELIMINATE LEGAL RISK

Per Edward Raab, MD, JD’s 2004 article in Transactions of the American Ophthalmological Society, “Informed consent begins with consideration of the tort of battery, one of the oldest forms of legally disfavored conduct.”

Battery is construed in several ways: procedures performed for which there was no consent at all, procedures that substantially differ from that described by the informed consent and the substitution of a procedure or the person performing the procedure. Unfortunately, according to Dr. Raab, “the patient’s consent distinguishes permitted from unpermitted treatment. Whereas this effectively precludes a claim of battery ... it otherwise is insufficient to eliminate all legal risk.”

HERE’S THE RUB

There is a distinct difference between medical negligence and a lack of informed consent. Cases built upon the concept of medical negligence assume that a proper informed consent is in place but that the physician is still responsible to perform a given procedure competently. In the case of Waller v Aggarwal, 16 Ohio App. 3rd 355, 1996, it was determined that “informed consent is not a defense to a physician’s failure to render appropriate and competent medical services.”

This often creates much confusion amongst jurors. The judge for the Waller case found, “The fact that the [plaintiff] consented to the procedure and was informed of its risks did not result in a ‘waiver of her rights.’ It did not grant consent for the procedure to be performed negligently, and it did not waive the [plaintiff’s] right to recourse in the event the procedure was performed negligently ...

“Knowledge by the trier of fact of informed consent to risk, where a lack of informed consent is not an issue, does not help the plaintiff prove negligence. Nor does it help the defendant show he/she was not negligent. In such a case, the admission of evidence concerning a plaintiff’s consent could only serve to confuse the jury because the jury could conclude, contrary to the law and the evidence, that consent to the surgery was tantamount to consent to the injury which resulted from surgery. In effect, the jury could conclude the consent amounted to a waiver, which is plainly wrong … and that no such evidence will be allowed.”

Again, according to Dr. Raab: “Almost all courts scrutinize the adequacy of informed consent under principles of negligence. Courts apply either of two standards for adequate disclosure, depending on the jurisdiction. Whether either one is breached is a question for the jury. One [standard] refers to what a reasonable physician would consider important to the patient’s decision (the ‘reasonable practitioner’ standard). The other is whether the physician has disclosed what a reasonable person in the patient’s position would want to know in order to make a considered decision (the ‘prudent patient’ standard).”

MUST ALL RISKS BE DISCLOSED?

The law requires disclosure only of material, not trivial, risks that are reasonably foreseeable. Disclosure should always include the possibility of no treatment and the anticipated consequences of that course. Per Waller v Aggarwal, any undisclosed treatment alternatives, or withholding the option to do nothing, can be construed as an imposition of the physician’s choices upon the patient’s power to decide.

FINAL THOUGHT

I am both frustrated and confused. We do our best to serve as our patients’ strongest advocates. We examine, diagnose, teach, answer questions and make recommendations for an appropriate course of action in our patients’ best interests. When a patient agrees and consents to a procedure that carries inherent risk, we are entering into a partnership of shared risk. We are both aware that every procedure may result in complication, and we collectively accept that risk as reasonable to proceed.

When a known complication occurs, however, patients often resort to a posture of either naïve confusion or outright blame, despite the normal risks of a given procedure or those uniquely attributed to that individual (ie, a traumatic cataract resulting in a crystalline lens dislocation).

Does our legal environment and ever-growing litigious society make us play defensive medicine? Of course it does. Does this add unnecessary health-care cost? Sometimes.

If informed consent does not represent agreed-upon shared risk, then what is its purpose other than to document the conversation (and avoid the penalties for not obtaining consent)? Even after researching this thoroughly in the medical and legal literature in preparation for this column, I am still confused. OM

Steven M. Silverstein, MD, FACS, is a cornea-trained comprehensive ophthalmologist in practice at Silverstein Eye Centers in Kansas City, Mo. He invites comments. His e-mail is ssilverstein@silversteineyecenters.com.