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…
Here’s from my book (dated, in part, as will be obvious from a few references, but still pertinent as regards informed consent):
INFORMED CONSENT
Once I know why I’m doing the study, I get informed consent from the patient or from the patient’s family or guardian. The four main things to talk about are the technique, indications, alternatives, and risks of the procedure. I describe the technique in a plain English, down to earth way without throwing around any complicated terms that I do not explain in the next breath. I don’t talk about catheters until I explain that they are thin tubes. I don’t usually mention guide wires at all since the word “wire” conjures up in a person’s mind not something as complex and elegant as a guide wire but something between an electrical wire and a coat hanger. I don’t want my patients to be thinking about either one–they are inaccurate and frightening.
Discussion of indications is important for two reasons. First it tells the patient why the procedure is being done. At least as important is a verification that the information I have been given is accurate. More than once I have gone to get consent from a patient, mentioned that the reason their other doctor [not a mistake: you’re one of the patient’s physicians, the referring physician is one of their other doctors] has asked us to do the examination is XYZ. The patient then says something like, “I don’t have XYZ, I have ABC.” I usually say something like, “Oh. Maybe I better get in touch with Dr. Smith. Be right back.” And I’m off to talk with Dr. Smith in a deep and meaningful way. Mistakes happen; we are all human. Either the patient didn’t know that XYZ was what Dr. Smith was thinking about or Dr. Smith gave me the wrong information, usually the former. I get back in with the patient and clarify the matter.
On rare occasion, I’ll get a referral from someone who should not have requested the exam. Wrong indication, no indication, a CT or MRI would be preferable, whatever. It then becomes a judgement call, but usually if I cannot find a good reason to do the exam, I’ll find a good reason not to do it.
Alternatives are important to consider, but in truth, when an angiogram is indicated, there aren’t a lot of alternatives to give the same information in as reliable and readable a format. The main alternative to angiography at this point in time is not having it. [footnote: Some say that MRA is a good alternative. I disagree. MRA is a cute way to visualaize some aneurysms and vascular anomalies. In its current state, 1/98, a negative MRA does not exclude dangerous lesions. I have seen many small aneurysms which would have been prospectively (i.e., before the angiogram or hemorrhage) undetectable with MRA which bled and killed patients. And a positive one always leads to a catheter angiogram. So why waste money on most MRAs?] And before I hear the patient’s wish about whether to do the study, I let them know that in the absence of the angiographic information, their doctor might not have enough information to treat them. I do not wait until they say that they don’t want the procedure to say those words since to do so would be to seem to be trying to talk a patient into an exam.
ABSOLUTE RULE:
I NEVER (read that again) TRY TO PERSUADE A PERSON TO HAVE AN ANGIOGRAM, NOR SHOULD YOU.
EVER.
FOR ANY REASON.
NOT EVEN IF THEY WILL CERTAINLY DIE IF THEY DON’T HAVE IT.
[Unfortunately, the fonts and stresses don’t copy here–it was all in large typeface, bolded, underlined, and italicized. Part was in military-looking stencil. You get the idea.]
Any questions about this point? People have the right to die and to refuse some or all medical care. It is an invasion of their privacy to coerce them, however subtly, to accept what you think is in their best interest. Don’t play God or even parent. Let the patient make up his or her own mind. [footnote: If one of my residents or fellows ever talked a patient into an examination after hearing me tell them not to I would fire them immediately. Period. No second chance. This has not yet come up and I hope it never does. I do think this is important.]
Last of all are the risks. Most patients will not ask you about risks spontaneously. I am sure that the overwhelming majority of people reading this book are thinking that THEY sure would ask questions and plenty of ’em. Well, most people who read this book will be in the medical field, and most of the world out there is not. Trust me: most won’t ask. You have to tell them.
The devil of it is: even when you tell people, most won’t hear. I have heard of a study of “informed consent” done elsewhere. I haven’t read it myself, but it sounds so right that I have no trouble believing it in detail. I understand that a group of physicians went in to obtain informed consents from patients for a study or operation that the patient was about to have. They then did whatever they had to do, and when it was all over, they went back to talk with the patient again. They discussed the risks in particular, asking the patient if they recalled that the risks were as they had previously discussed. They often did not, and some even went so far as to say that, if they had known, they would not have had the procedure. The researchers had taped the consent conversation and then played it back for the patient who typically believed the tape to be a forgery.
Because of its vagaries, ambiguities, and patient’s often serious lack of recall of the conversation, I do not go into painful detail about the risks unless asked. I do open the door, though. I always say the same thing, too, so that if someone asks me, a lawyer for example, I can answer honestly that I know what I said because it is always [yes, always] the same except for the name. I say, “Now Mr. Jones, for you to give informed [stress: “informed”] consent for this procedure, it is necessary for you to be informed [again stress: “informed”] that, although it is unlikely, it is nevertheless possible for complications, potentially serious or even life-threatening complications [stress: “life-threatening” and say it clearly and slowly] to result from this procedure, though, as I said, this is very rare. Do you understand?” Almost everyone will say that they do. “Do you have any questions?” is my next question to them.
In my experience, maybe one person out of twenty will have questions. The rest will either say that they have none, or will say something to the effect that they “have to have” the study. I never let a patient off like that. If they feel that they “have to have” the study, it is usually for the wrong reason–they feel that their referring doctor or I will be angry with them or some other irrelevant thing. If this comes up, I go back to the alternatives section of the conversation. And I keep at it until the patient figures out that they have to decide and I won’t decide for them.
The one exceptional person in twenty says something like, “Complications? What do you mean?” This person wants to know. They know that they do not “have to have” the procedure and they have real questions about it. I answer them in as much detail as the patient wants. In these cases, though, I always talk about, stroke which I describe as being “no different from any other kind of stroke and can result in paralysis, blindness, inability to speak or understand language, even in death.” I again ask if the patient has any questions. They rarely do, but if they do, I try to answer them as well.
I do not ask the patient if it OK for us to do the exam. To do so would imply that I want to do it and the patient has to be the willing guinea pig. That is not the case, and I do not want to lay down a verbal substrate that suggests it. I ask if they want me to do it. I believe that the doctrine of “informed consent” is intrinsically flawed. I spend a lot of time and effort making sure that the patient understands the issues. What I get is an informed request for me to do the study. And I tell the patients that that is what I want.
For interventional procedures, I do not offer the patient the option of not hearing the scary words mentioned. The risks are as high and the rate of complications is unavoidably higher. Short of an exsanguinating trauma emergency, everyone I embolize (or their relative, guardian, etc.) hears the scary words. I sometimes feel like a bully for saying some of the things that I say, but the legal system has forced that on us. I do not know whether things are better for it, but I always comply.
Now present day: This saved my bacon the one time I was sued and went to trial. (I’ve been sued a few other times, but it was always dropped–no settlement or admission: dropped.) This time, the PA in Hershey had been deposed by Mr. James Ronca of Philadelphia, who I seem to recall suggested to him that he–the PA–had gotten the consent signed. Tom Lemley, the PA (who had passed away before the case came to trial) was represented by a video in which he said “no, no! Dr. Horton is very particular and always gets his own consents.” There was a definite, audible silence after that answer–both on the video and in the courtroom.
By the way, the verdict was pure defense for both me and my co-surgical defendant as well as Hershey Medical Center. And both appeals–in the trial court and Pennsylvania Superior Court–were denied.
Dr JD is correct that it is not only surgery that requires a written informed consent. I know somebody who wishes he had had one, many years ago. He was an internist who routinely prescribed methotrexate for psoriatic arthritis. Although the literature states that the incidence of aplastic anemia (at least at 2010) is .08%, (out of 123,553 patients who took it) his patient hit the “jackpot” and died from it. During those years, written consents for potent drugs were not common. He had none. The author is quick to dispel the notion that only surgery requires a written informed consent. (Correctly, in my opinion).
Most of what I did was elective surgery. A lot of it was probably unnecessary. Period. That said, I’m sure it helped some people who had to work long hours on their feet, in order to keep their jobs. But there was always a risk for it. This explains why, as I got older, I cut way back on operations. That didn’t protect me from the paradoxical effect of NEW patients coming in and demanding surgeries, which happened with surprising regularity.
I found that when I discussed complications and risks, it would genuinely help if I could give a reasonable statistical discussion. Numbers are exceedingly difficult to find in podiatry. The best I could do is give a round-about discussion. Some things were obvious. Neuroma surgery failed roughly 30-40% of the time. Hex THAT one out.
Less obvious were certain “prophylactic” operations I recommended for so-called “pre-diabetics.” (We didn’t call them that then.) But they still were. There is real value in correcting anatomical defects prior to the time when a patient develops poor circulation and neuropathy.
All of this means a “heart to heart” talk. And I mean that. If you have a history of knowing your patient and treating them conservatively for say 6 months to 1 year, you start having a real doctor/patient relationship with them. Naturally you will execute a written consent. But that is actually less important than the relationship you have with your patient. (And dare I say, mutual trust).
Patients are at an enormous disadvantage in making serious medical choices. It’s improved (with the Internet), but some extremely talented and brilliant people are medically quite ignorant. My own father was, and made some bad choices, maybe resulting in dissemination of his CA.
Consent is a two way street, for sure. You must inform your patients of the risks involved in your treatment. But you also have an ethical obligation to inform them the risks of AVOIDING it.
Michael M. Rosenblatt, DPM
One other thing to include in informed consent processes: the natural history w no intervention vs the range of outcomes possible with intervention.
The answer to my question
May be in the article, but I am tired, worn out, and have spent too much of my day dealing with regulations in medicine, and i can’t stand reading anything else today. My question about obtaining consent… So u can’t delegate the duty, but can you create videos of yourself that a patient can watch for 10-20 minutes or however long etc…. And will that suffice? Scenario…” Mr. Talley Whacker, u are having a radical prostatectomy today. (Tomorrow etc) and here is a video I want u to watch that I personally created. It is about a 15 minute video discussing the risks, benefits. Side effects and details of the surgery so u can make an informed consent. I will be back after i round on a few more patients to see if you and Mrs. Tally Whacker and your brother Mr. Johnson have any questions. Ok?”
Is THAT allowed?
I was an Emergency Physician for 12 years prior to returning for a second residency in Radiology. I always got my own consent. I purposefully avoided the “consent” obtained for me that amazingly always was on the chart signed by the patient. Now I work in a place that is a “stroke center” and as such does not feel the patient requires consent prior to TPA administration. This is justified by the claim the the state’s teaching hospital as well as one of the other “centers” does not get one. I think this is going to be costly both to the administering physician as well as the facility. What say you?
Wow. I had no idea that practicing medicine was so fraught with potential adverse outcomes.
I don’t recall having to sign an informed consent prior to matriculating medical school. I should have been warned about the dangers and possible injury to my well being!
Who can I sue about that?
I agree with Dr. Coleman that NOT getting a consent prior to administering tPA is a mistake. By the time the patient has gotten to the stage of possibly getting tPA, it is assumed that the type of stroke has already been ascertained: hemorrhagic vs ischemic.
Then there is the time limit (4.5 hours) from which the “best” possible benefits can be derived. This can cause a real tizzy in the ER. Often, elderly patients who are diagnosed properly (with the required scans) are demented and non-communicative. They and you have no idea when the stroke occurred. It is at best a guess.
So, Dr. Coleman has a “decision” whether or not to go ahead and give it. The patient (and their family) may have unrealistic perceptions of the value of tPA. There should be some way of re-allocating expectations. The executed consent form (also with the family involved) is a good way to temper expectations and “inject” reality into a stressful situation.
Ultimately you will have no real idea on the value of the drug until a period of time has elapsed, and that time is usually well beyond the timeline exposure of an ER physician. The last thing you need is to see is the lawsuit from a patient you don’t remember arrive from the courier, about a drug that is associated with unrealistic, heightened expectations.
You will feel a hell of a lot better if you had written proof that you explained this to the family.
Michael M. Rosenblatt, DPM
I read Dr. JD comments on informed consent and to me it seems it is quite clear to most physicians how the process of informed consent should be. I follow it to the letter. One thing that is still a big question is: suppose you, as the treating physician or surgeon have followed the informed consent process exactly as it should be but in a malpractice lawsuit, the patient still alleges that he or she was not appropriately advised about possible risks or complications or outcomes or anything else (of course the patient here has an economic incentive to lie). How can the physician prove that the informed consent was performed appropriately since by what Dr.JD describes the legal document that describes every potential problem is not proof of the actual consent process as stated by Dr JD as follows :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.
So, in reality, during a malpractice case the physician is doomed if he was stupid enough to perform a procedure without the legal consent signed but is still not protected by having performed the consent process perfectly well since the patient can still allege ignorance about the facts he or she signed in the written consent document. How can this doctor “prove” he talked to the patient about risks, benefits and alternatives ?
It seems to me that only proving the patient is lying would confirm that informed consent was done appropriately.
Even doing everything right we are still at the mercy of unscrupulous trial lawyers and greedy patients.
I COMPLETELY AGREE WITH DR ZAVALA ABOVE. AFTER READING THE JD ARTICLE ON HOW TO OBTAIN AND DOCUMENT INFORMED CONSENT PROPERLY, I FELT THAT THE OBVIOUS WAS MISSING. MOST OF US KNOW HOW TO NAVIGATE THE INFORMED CONSENT PROCESS, BUT THE ARTICLE DOESNT ADDRESS OUR DAY TO DAY PLIGHT OF THE FACT THAT THE TRUTH IS IRRELEVANT IN A MALPRACTICE LAWSUIT. WHAT LAWYER IS GOING TO SAY, ” that was a wonderful informed consent, ill drop this action”?–PERHAPS THE ANSWER PARTIALLY LIES IN VIDEOTAPING THE PROCESS. DOES ANYONE HAVE ANY EXPERIENCE WITH VIDEO OF THE INFORMED CONSENT PROCESS?-BUT THEN, OF COARSE, THERE ARE MANY OTHER THEORIES UPON WHICH TO BASE A MALPRACTICE ACTION OTHER THAN CONSENT.
IH, suggests that videotaping might help cement a consent visit. While that is true, it will probably strike most patients as “artificial” and self-serving of the doctor. Many consent visits form a standard part of a physicians’ hospital rounds. Video taping would be impractical under those circumstances.
Superb chart notes are still the best defense against MP suits. Listening to patients’ questions are another. You can chart the fact that the patient asked about specific issues of the consent, and list your answers to them on the chart note as well.
That is a powerful shock to plaintiffs’ attorneys. Anything you do that thoroughly describes that you care about the patient does not help them either.
Your chart notes form the “skeleton” of your patient care history. The time you spent on them repays you back thousand fold in the event of a patient care disaster. Superb chart notes are a little like travel insurance: You never think about how much the insurance cost when you need the coverage for an actual incident.
It’s a pity that physicians must actually create these records themselves. There would probably be an excellent market for specialized associates who traveled along with you to create them, as you go through your day…
Michael M. Rosenblatt, DPM