By Dr. JD, a plaintiff’s attorney, practicing in the Northeast
Consenting a patient is really the entering into of a contractual agreement that will govern the medical care that you will engage in and, as in all contracts, that process requires a meeting of the minds to be valid.
The document called a “consent” is, like a written contract, merely a legal formality that memorializes the end result of that process.
The only role it really plays in a medical malpractice action is when it is not there at all or looks so deficient on its face that it raises serious questions about the propriety of the care ( e.g.; the physician is not named, suggesting that there may have been “ghost surgery”, or the patient’s signature is a scrawl that suggests that they may not have been competent when they signed, or the document itself is post-dated, suggesting that it was only filled-in after the fact).
In fact, since a malpractice claim in which a patient is alleging “lack of informed consent” is actually the patient saying “I did not know something critical to my decision about my care because you did not tell me, and I would not have made the choice about my care that led to my present problem if you had told me what I needed to know”, a signed piece of legal boilerplate is no bar at all to that claim proceeding. At most, it creates a rebuttable presumption that the patient agreed as an informed person, but that simply moves the case forward to the presentation of evidence to provide that rebuttal.
Let’s therefore forget about the consent form other than to say that in the settings where it is required it should always be filled out fully and properly and maintained in the chart.
Let’s instead move on to the process of consenting to see how you can do it so as to limit your liability, using a few FAQ’s:
1. I know that consents are necessary for situations like surgery, but are they limited to such matters?
Actually, almost all your interactions with patients are consenting procedures in some form. You are usually proposing options and explaining them to the patient, and the patient is then asking questions and either accepting or disagreeing with your suggestion based on your answers to those.
Voila! An informed consent meeting every criteria for such has just been taken.
In fact, every time you prescribe a medication or break a patient’s skin with a syringe you need their informed consent. That is why you say “I’m going to switch you to X, but it can cause a rash in 10% of cases and I want you to discontinue it immediately and call me if that occurs. OK?” or “I’m going to need to draw some blood now. It might hurt a little. OK?”
In fact, you are doing so even if the patient is hospitalized and has already signed a general consent that covers all the minor procedures, like blood draws and IV’s, that will be necessary. If all that mattered were a signed piece of paper, you could just grab the patient’s arm and jam the syringe in, but you do not do so because there is an implicit understanding that the patient has the right to be involved in what happens to them medically.
Finally, it is why, even when you are certain that the patient’s choice is wrong and dangerous, or when the patient is not competent to make a decision at all, you cannot simply substitute your judgment for the patient’s and must instead get a surrogate, who will take the patient’s part in the consent discussion, involved.
In other words, the concept of informed consent runs throughout the day-to-day practice of medicine.
It is simply that in some settings that are deemed more inherently high risk, we formalize and document the process. However, that a separate form is signed does not change the fact that the underlying process is identical: explaining the matter to the patient and then getting permission from the patient to proceed.
This all having been said, we will be concentrating here on medically significant matters that do require a more complete discussion and may also require written proof of consent.
Some matters, like surgery, sedation and catheter insertion or contrast instillation are non-discretionary as far as a complete consenting procedure. Others, like an off-label use of a medication, may not carry mandatory requirements.
The wisest course to take if it occurs to you that a treatment might need a more extensive consenting procedure is to err on the side of caution. Frankly, no one facing a medical negligence allegation has ever regretted having a documented consenting procedure in their records.
2. Do I have to do it personally?
Simple answer: Yes
In fact, the discussion of alternatives and risks and benefits with the patient is considered a non-delegable duty.
Again, that is different from getting a consent form signed. Ideally, you should be doing that yourself when you actually have the discussion, but if that is not practical a surrogate, such as a resident, can do it for you.
However, there is simply no defense to an allegation of lack of informed consent if you never talked to the patient and left a doctor-in-training to be the sole information source for the patient.
The requirement that you be the physician who does the consenting process is actually of genuine medicolegal benefit for you because it permits you to set the stage for what will follow. A patient who feels that they have been given adequate information and treated with respect by their doctor is less likely to become a plaintiff if there is a less-than-optimal outcome later.
3. What do I have to tell the patient about the proposed treatment to make sure that his or her consent is really “informed”?
There are generally described to be three standards: what would a reasonable physician reveal, what would a reasonable patient want to know and what would this particular patient want to know.
However, in the real-life world of liability limitation these distinctions matter very little.
While most jurisdictions nominally eschew the overt paternalism of the Reasonable Physician standard in favor of the patient-centered Reasonable Patient standard, it is also clear that an actually reasonable physician should be evaluating what is necessary to be revealed in a way that comports with the principle that informed consent means telling the patient what he or she actually needs to know and so would, in essence, really be adhering to the Reasonable Patient standard. Similarly, it would never be reasonable to slavishly adhere to an abstract idea of what to tell a patient because different patients obviously have different concerns that will impact on their decision-making, and so any proper consenting process incorporates the Subjective Standard of what the particular patient should be told to make sure that their consent a valid one.
Therefore, if you want your consenting procedure to be defensible if it is later questioned, your actual standard should be that of a physician who fills in the gaps in his or her patient’s knowledge until that physician is certain that the patient is acting as an informed participant in their medical care, and who leaves that patient feeling that their concerns have been adequately addressed.
The specific points to be covered in this regard are the proposed treatment, the alternatives to it, and the relative risks and benefits of each option
The first element is straightforward. It is a description of the treatment in layman’s language.
The second element is pretty simple as well. It is a description of those alternatives in layman’s language and the citation, if available, of endorsed choices by the board or college of your specialty.
It is the third element that most physicians have serious concerns about because they see themselves as being caught between the need to cover every possibility so they cannot later be accused of leaving something out, while also not literally scaring the patient away from needed medical care.
The answer is that listing every single possibility is beyond the scope of the consenting process, but there must be a recognition of when the severity of a risk outweighs even a minimal possibility of it so that it must be mentioned.
The liability-limiting rule is therefore is that you should mention everything that is common, even if it is unimportant, and everything that is important, even if it is uncommon. After all, if you were the patient, wouldn’t you want to know if there was a very slight possibility that you could die as much as you would want to know that there was a 90% possibility that you would sneeze a lot?
The real issue, however, is to recognize that when you are dealing with the risks and benefits section of the consenting process you are not acting like a recitation machine. If all that was required was a bare listing of factoids, you could just hand the patient a list of statistical pros and cons and send them on their way.
Instead, what you are doing is providing clinical perspective, and this may come down to explaining why a tougher choice may be a better one and why bare statistics may not be the best criteria for that patient to evaluate their choice by.
More on this topic next week…