By Dr. JD, a plaintiff’s attorney, practicing in the Northeast
4. Will including a documented discussion of a risk or complication protect me from a lawsuit if that problem actually then occurs, since the patient agreed to risk it?
No
Many doctors misinterpret a patient being informed of a potential problem and still electing to go ahead as an “assumption of the risk” situation that would then bar that patient from recovering for an injury incurred as a result. They believe the consent to be a “get out of being sued card”.
The actual fact is that just because something is a known complication or a possibility that was discussed, and which the patient indicated a willingness to risk in hopes of a greater benefit, does not mean that if that problem occurs that it was not the result of negligence. The fact that the patient was aware that it might happen is irrelevant because, in consenting, the patient accepted that sometimes even a perfectly done procedure may have a complication but did not thereby also consent to having the procedure performed negligently, causing the same complication.
Therefore, if the patient-turned-plaintiff can prove that the problem occurred as a result of a breach of the standard of care, that he or she knew that it might happen if the procedure were actually done perfectly does not restrict them from suing for damages that resulted from it.
5. How specific should I be ?
The consent that you obtain must leave you the room you need to maneuver clinically.
In emergency situations where the patient cannot speak for themselves and has no authorized proxy to speak for them, we assume that they would want what was necessary to be done. We therefore find “implied consent”.
However, when a patient gives consent for a treatment in advance, we return to the contract concept and apply the equivalent of the “four corners rule” of contract law: we only accept what is within the four corners of the written agreement, memorialized in the doctor’s note and the consent form itself, as having been actually agreed upon.
In practical terms, this means that a surgeon who only addresses Procedure X in the consenting process and has the patient sign a consent form referring only to Procedure X must actually then stop surgery if Procedure Y turns out to be preferable because while the patient did sign a surgical consent form that allows the surgeon to accommodate to an emergency, switching to Procedure Y is not an emergency.
In other words, even if Procedure Y is for the patient’s benefit, the surgeon was simply not authorized to do it by the patient.
The consenting procedure and the consent form should therefore both address any potential “springing” events that may require the physician to change plans while the patient is not in a condition to discuss the matter.
6. What should I put in my note to document the consent process?
This brings us back to the fact that the consent form or the patient’s signature under a note in your chart documents nothing other than the fact that something likely happened resulting in that signature being affixed to that piece of paper.
Relating what actually happened is up to you.
First, bear in mind that even the most honest patient relating the events years later to a jury or to a state medical board will simply not remember everything that you said.
Some doctors deal with that by recording consenting discussions. I regard that as excessive and, in many settings (states that do not permit such, consenting done in a hospital) it is not even possible.
A well-written note will suffice because intrinsic to being well-written is that it will be written in a way that conveys its veracity.
The first issue is therefore to avoid sounding self-serving. Using terms like “lengthy” and “complete” to describe the process are red flags to a later evaluator that that may be mere puffery, while, by contrast, “thorough” describes the process in terms of depth and will match the details that are then related.
Next, employ the dual rules of “If you do not write it down, it never happened” and ”If it is worth saying, it is worth writing down”. If your note says “The risks and benefits of the procedure were discussed” but not what those are, you have said nothing of any medicolegal worth and will be reduced to claiming that, well, you probably said X or Y but you can’t be sure – and when that is coupled to the patient swearing in the strongest terms that that they were never told, your case is over.
This brings us to the important fact that even though you will probably be using a template for your consenting documentation, it should never read like boilerplate.
Remember that the consenting process is one that is supposed to be geared to a specific patient making a decision and a note that sounds one-size-fits-all makes it very hard to later claim that you actually spoke to the patient with personalized attention.
Therefore, for example, do not just say “questions answered” or “concerns addressed”. Instead, say “”The patient asked about whether he would face any work restrictions after the procedure and was told that he needed to avoid any heavy lifting for at least two weeks” or “The patient’s concern that this treatment might affect her plans to start a family this year were discussed and she understands that it will likely require deferral of pregnancy for several months”.
You should also include any diagrams that you drew for the patient and append a copy of any educational materials you provided.
Remember that the longest time spent personalizing the documentation of a consenting procedure is far shorter than the shortest lawsuit or medical board inquiry.
If you have followed these simple rules, by the time that you reach the standard closing statement that “The patient indicated his/her understanding of the matters discussed and has agreed to the procedure”, that statement will seem to be just the obvious logical outcome of what you clearly and provably did.
There is no better defense than that.
This just confirms that it is not possible to do an adequate consent process. It would be so easy to be a plaintiff’s attorney. Second guessing, Monday morning quarterbacking, and suing for a lack of documentation. I can easily look back at almost any extensive medical chart where a complication occurred and find inconsistancies or contradictions that could be twisted to convice a jury (not of our peers) that a doctor was negligent.
This attorney said if its not written is isn’t done. And if its worth saying its worth writing down. It is not humanly possible to write down everything that is said and everything that is done. It would take far longer than the operations. And, this sort of defensive documentation takes AWAY from patient care. Spending time trying to write down everything that was said during a 45 minute discussion keeps the doctor from being with other patients and providing their care.
(Studies have shown that if you video the consultation and then later ask the patient if these topics were discussed most will say no …….. when they are clearly right there on the video.)
In my practice we do audio recordings of some consents. This is to avoid what I have heard patients say later (who were coached by their attorneys) “Oh yeah, I signed that, but I didn’t read it”.” I didn’t know that if my pets crawled around on my surgical site i could get an infection.”
In the audio we ask them if they have read all of the documentation and risks ? If their questions have been answered ? If they know that there are no guarantees ? And if they accept these risks and want to proceed.
Its possible that just knowing they made that recording may discourage legal action. Maybe ?
I really believe that probably all consents should be video’d and with cheaper storage this could happen. This avoids patients telling juries that the doctor didn’t explain something, or didn’t answer their questions. The “he said she said” of patient care can be avoided if there is video of exactly what was said by whom.
I am absolutely certain that a consent is as good a used toilet tissue. When administered by a physician, it could routinely take 2-4 hours to cover the topics present on a written and Board approved consent for elective surgery. The case itself might take 30 minutes at most. Then, when the routine attorney attacks begin, the claim will always be of insufficient knowledge to comprehend the consent, inadequate written material presented at least one week in advance or that the plaintiff did not get adequate time to review the material with an attorney.
I have audio and video taped all consents and consultations for the last 7 years. It doesnt stop the attacks, it merely shifts the emphasis to interpretation or the fact that a patient, despite consenting to proceed never “expected” this well known complication.
Almost all plaintiff’s attorneys allege “lack of adequate informed consent” in their lawsuits against you. It’s just standard practice, so much so that if plaintiff loses a case, not including this catch-phrase could be used as a form of malpractice charge against the attorney who lost the case.
The worst charge against any attorney would be missing the deadline for filing the suit. But included in that complaint would undoubtedly be a discussion of the filing itself, including anything relating to the consent. We all know it’s just business. (Vito Corleone would agree).
While procuring a knowledgeable consent is vital, I still think it means more to have the patient KNOW that you are actually listening to them. There are a number of ways to do this, which have to do with not having your staff interrupt you, to showing that you are paying attention to your patient.
For me, a striking method was to actually use my laptop in front of them to keep their medical records. Post-patient dictation is prone to missing important features. Even if you have your staff gather the details for you, it is not the same thing as your actually typing them in yourself.
This obviously requires excellent typing skills, which I have, but many of you do too. It is also possible to use some pre-written files that you use frequently and copy and paste them in. Classic examples would be ingrown nail surgeries for me, tonsillectomies and ear tubes for an ENT, and physical examination set-up files for internists.
Patients were fascinated by my use of the laptop. They thought that I was very much paying attention to them, especially if I asked them to repeat a phrase. To my amazement, this absolutely stopped any legal problems I had after I started doing this. Even in complex cases with less than a perfect result, nobody went after me.
I’m sure the laptop PC made a difference. It is impossible to quantify this, but everything bad just stopped. It has a lot of other advantages too, but this was by far its greatest value.
If some of you are interested, I can write a small article on this and put it in here. It is also possible to use some digital medical record systems to do this, depending on the vendor.
Michael M. Rosenblatt, DPM
I taught this material in law school for many years. Several points bear emphasis.
First, there are two types of consent – the simpler being the ordinary written consent that a patient gives upon entering a hospital facility or an implicit consent such as is given to a phlebotomist by the patient stretching out her arm for blood drawing. Failure to obtain this type of consent results in a claim of battery and might, under certain circumstances, be an intentional tort.
The second, informed consent, is somewhat of a misnomer and is actually something that the doctor does. It is the process of providing all the necessary information that a reasonable patient would want to know to make a knowledgeable decision. In some states it is what a reasonable physician would tell a patient to enable her to make a knowledgeable decision.
In neither case is the patient’s explicit verbal or written assent required and the focus is really on what was told to the patient. Failure to provide the necessary information may result in a claim for Lack of Informed Consent.
Although frequently filed, lack of informed consent is, for a variety of technical reasons, generally a difficult claim to prove, particularly under the reasonable patient standard.
Very few states permit the use of a subjective patient standard where the patient need only say (obviously in retrospect), “Oh, if I had known that could happen, I wouldn’t have had the operation.”
The real question is whether to provide a lengthy list of every possible complication or simply place in the notes an outline of what was discussed with only the most important points being mentioned. Having also practiced as a plastic surgeon and again for technical reasons, I prefer the latter approach.
I would just like to extend my thanks to Medical Justice and Dr. JD for providing articles of this nature. As a program director, I intend to refer my residents to this “blog” as the wisdom and experience that have been provided are very valuable.
I am hoping that Dr. JD will touch on the extreme importance of overall communication skills (including listening) in avoiding a lawsuit.
Thank you again for this fascinating series.
While I agree with Dr. Lehv that a “general” outline of risks and complications should be mentioned in the consent form, I think we are also getting closer to the need for consent formats based upon the age of the patient.
For example, a very real issue is occurring with POCD (Post Operative Cognitive Disorder-increase likelihood of dementia). And it’s not just the anesthesia, but also the trauma of the surgery itself. Over the years we have been seeing more heart surgery and certainly orthopedic surgery to try to improve bone and joint function during aging. Very few patients now die as a result of anesthesia, although some elderly patients do die from a mixture of post operative infection, and a misunderstood and strange phenomenon of “inability to tolerate the trauma.”
The bottom line is that our society is aging. Would patients knowingly undergo a major procedure if they understood that their possibility of experiencing POCD/dementia is 6-8% increased? Would you?
I still passed my ham radio license examination two years after experiencing a major procedure that required a general anesthesia, and (fortunately) I can still write. But I felt I had no choice back then, so I accepted the risk.
I knew about the possibility. I won’t mask the issue and say I was not concerned about it. I was. But I don’t think that most surgical patients (especially us old ones’) know about it. Do you think they should be informed?
Michael M. Rosenblatt, DPM
Obviously, an informed discussion has to be tailored to the patient, the procedure and the circumstances. For someone with a GSW to the chest an informed consent may not need to be anything more than “You need the surgery or you will die.” For a facelift, informed consent is everything under the sun.
My answer to the above question about POCD is “Yes” but others might disagree. That is why an informed consent claim for failure to preoperatively discuss POCD is likely to fail.
Under a reasonable physician standard the jury will hear both from expert physicians who do and who do not include it in their discussions. Invariably the jury concludes that it’s not mandatory and the patient loses.
Under a reasonable patient standard, the plaintiff is required to prove all of the elements of the tort of lack of informed consent. One element is almost always that, “a reasonable person in the position of the patient would have decided against the therapy had the material risks and dangers inherent and incidental to treatment been disclosed to him or her prior to the therapy.”
The problem here is that lots of reasonable persons undergo major procedures where they have been informed of the possibility of POCD. Therefore, the plaintiff will usually fail in her burden of proving that a reasonable person knowing of POCD wouldn’t have undergone the procedure.
This illustrates why informed consent cases are difficult to prove. They are, however, possible to prove but the circumstances are usually quite different, e.g., a physician who slightly misleads the patient about his experience with a particular type of brain surgery. A reasonable patient fully informed of the surgeon’s limited experience might very well decide not have the surgery with that particular surgeon. In such a case, the plaintiff will likely succeed.
I think Dr.Lehv’s response to the question: “Should an older patient be informed of the risks of POCD/dementia after elective surgery?” makes sense.
I think an important part of that argument is strictly temporal. I have a life-long DPM/JD friend who is now in his 70s. He still practices podiatric surgery actively, including ankle trauma surgery.
Throughout his life he has had very peculiar (unexplainable) mathematical and calculating abilities. Nobody, including he, knows how or why he can do them.
If he were to undergo an elective medical/surgical procedure and IMMEDIATELY come out severely compromised after it, he and his family would wonder why. I’m not saying they would sue, but many families who were not familiar, or were not exposed to the possibility of POCD, might very well, and be successful at it.
If Dr. X’s dementia occurred over a longer period of time, say 3-6 years, reasonable people could assume that if it had anything to do with the surgery, it was strictly tangential or even irrelevant.
Michael M. Rosenblatt, DPM