Informed Consent: The Legal Angle

In this post, we'll look at the legal angle of informed consent. It’s important to start with a key distinction in law: statutory law and common law. Statutory law refers to laws that are created by legislation (i.e. state legislatures or Congress), and there is usually little room for interpretation in statutes. Common law, on the other hand, refers to legal precedents that are formed from jury rulings and court decisions. That’s why it’s sometimes called case law. While there aren’t any laws or statutes (that I'm aware of) which dictate the content of an informed consent discussion, there are two landmark court cases which point us in the right direction. Since these court decisions have been recognized as precedent for many decades, one should expect them to be referenced in any litigation which involves the issue of informed consent between a physician and a patient (informed consent for human subjects research is a different subject).

The first case is Salgo v. Leland Stanford University Hospital (1957). Mr. Salgo was 55 years old when he underwent an aortogram for lower extremity claudication. Contrast was injected into the patient’s back, and the patient woke up with lower extremity paralysis (for reasons that are unclear). Salgo claimed he hadn’t been told that paralysis was a possible outcome of this procedure. Believe it or not, in the mid-20th century it was not uncommon for physicians to not disclose the risks of invasive procedures. There were various reasons for this, including a paternalistic style of medical practice, the belief that disclosing risks was not in the patient's best interest, and the thought that disclosing risks would cause psychological distress to the patient. However, the Salgo case was a major turning point, and even though Salgo didn’t win the case, the “informed” aspect was added to the concept of “consent” and the term “informed consent” was coined. 

The other influential case was Canterbury v. Spence (1972). Mr. Canterbury was 19 years old when he underwent a thoracic laminectomy for back pain. Postoperatively, he fell out of his hospital bed and subsequently became paralyzed. Canterbury stated that the surgeon, Dr. Spence, had not informed him about the possibility of paralysis associated with the surgery. Canterbury lost the case, but he appealed it, and the appellate court reversed the lower court’s decision and ordered a re-trial. Canterbury subsequently lost the retrial, but his case cemented the necessity of informed consent for medical procedures.

The appellate court ruling from this case contains several passages which have become de facto precedent regarding informed consent for surgical patients: 

“We now find, as a part of the physician's overall obligation to the patient, a similar duty of reasonable disclosure of the choices with respect to proposed therapy and the dangers inherently and potentially involved.”

"[a] risk is thus material when a reasonable person, in what the physician knows or should know to be the patient's position, would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forego the proposed therapy." (emphasis added)

“There is no bright line separating the significant from the insignificant; the answer in any case must abide a rule of reason.”

Notice the word "reasonable" plays a critical role. “Reasonable” is a word we frequently find in medicolegal dealings; legal writings often reference the "reasonable person standard", a standard which can be applied to either a patient or physician. But “reasonable” leaves plenty of room for interpretation. Take our recent experience with the covid pandemic. Is a person who refuses the covid vaccine a reasonable person? How about a person who insists their family member be treated with ivermectin? Or a person who refuses blood transfusions because they don't want to receive blood from someone who's received the covid vaccine (all real-life examples that I’ve encountered). Do we consider these people to be "reasonable"? What’s unreasonable for most might be reasonable for some…and when a jury is composed of 12 random people, you never know what outcome you’re going to get.

Therefore, a lot is left to the individual clinician to determine what a “reasonable” person would consider “significant” in an informed consent discussion--there are no hard and fast rules. In my upcoming posts, I’ll discuss some tips that will hopefully make this discussion as meaningful as possible. 

References:

 https://en.wikipedia.org/wiki/Salgo_v._Leland_Stanford_Jr._University_Board_of_Trustees

 https://en.wikipedia.org/wiki/Canterbury_v._Spence

https://biotech.law.lsu.edu/cases/consent/canterbury_v_spence.htm