Aug 23 2013

Assumption of risk versus informed consent

Published by at 5:00 pm under Healthcare Reform

We continue with our series of articles penned by one attorney, an MD, JD, giving you a view of the world through a malpractice plaintiff attorney’s eyes. In this article, the author addresses “Assumption of risk versus informed consent..” This attorney is a seasoned veteran.  The series includes a number of pearls on how to stay out of harm’s way. While I do not necessarily agree with 100% of the details of every article, I think the messages are salient, on target, and fully relevant.  Please give us your feedback – and let us know if you find the series helpful.

“The patient signed a consent.  He understood the risks. Why can he sue me now??? Why can’t my lawyer just present the signed consent and get this case dismissed?”

You have probably heard it from colleagues.  You may have even asked it yourself.

The subtext is a reference to an affirmative defense (a defense the defendant must plead and prove) called “assumption of risk.”

What is assumption of risk as a legal defense?

A person who is aware of the dangers involved in a situation but still agrees, either by an express agreement or as implied by their conduct, to proceed anyway should then be barred from suing, (or have their award reduced), when one of those dangers comes to pass. On first blush, this seems to fit a typical medical malpractice setting.  After all, patients are informed of the cons as well as the pros of a treatment and then agree to proceed either expressly by signing a consent form or impliedly by accepting the treatment.

Doctors often do not understand why having a valid signed consent from the patient (or a provable course of conduct by the patient that demonstrates consent) fails to knock the lawsuit right out of the box.

This bewilderment is not surprising because assumption of risk superficially does look like the informed consent doctrine. As with informed consent, a patient must be informed of specific risks and agree to proceed anyway. And, like informed consent, assumption of risk does not cover reckless or intentional conduct by the defendant.

However, a closer look at assumption of risk tells us why it is rarely applicable in the medical malpractice setting.

Express assumption of risk is a defense asserted in cases involving injuries that occur during inherently dangerous recreational activities – like bungee jumping. It is usually based on a release the participant signs with the operator.

This release can vary in what it covers.  It can permit an action for negligence if there is an injury but will more likely restrict any future claims to an operator’s reckless or intentional conduct (eg: the bungee operator was drunk and used a cord that was too long). If so, it eliminates the duty of care that runs from the defendant to the plaintiff. Hence, there can be no claim of negligence. Such an agreement bars a claim for a subsequent injury unless the operator actually was reckless or intended to cause the harm.

Implied assumption of risk is a defense asserted in cases involving injuries that occur when the plaintiff was voluntarily in a place where an activity with dangerous aspects was going on, like attending a baseball game.

There is obviously no document stating that the individual consented to the risk of being beaned by an errant ball, but their choice to sit in a place where such events are known to happen is held as evidence of their consent to assume that risk.

When these principles are applied to medical care, however, they fit poorly.

The idea that the physician could owe no duty to protect the patient from the risk of the medical harm that caused the injury, is antithetical to the very practice of medicine. Public policy would never condone any level of medical conduct short of utter recklessness or actual assault to be acceptable simply because the patient agreed to try a treatment the doctor recommended.

If that were the case, the consent form would make the lay-patient solely responsible for any harm he suffered. The trained physician who recommended and performed that treatment would owe no responsibility to the patient as long as he wasn’t completely reckless and didn’t try to hurt the patient intentionally.

That dog won’t hunt.

This brings us back to the heart of the informed consent doctrine: Consent is being given to medical care rendered correctly.

The patient, by agreeing to the recommended treatment after being informed of its risks, is only acknowledging negative consequences of treatment can still occur even if the treatment is carried out properly.  He is not agreeing to treatment performed negligently which then produce the harm found in the consent form.

The patient consents to the risk that chemotherapy, properly prescribed to cure his cancer, might cause severe nausea or that surgery properly performed to reduce spinal cord compression could result in arachnoiditis. But he does not consent to being a victim of negligence in the prescribing of the chemotherapy or the performance of the surgery even though negligence may result in severe nausea or in arachnoiditis.

Now, can a patient, by his consent, expressly relieve their doctor of the responsibility to make good medical choices on his behalf, literally immunizing the doctor if the doctor does what the patient demands? An example that often comes to mind is Michael Jackson, who persuaded doctor after doctor to perform increasingly destructive cosmetic procedures. A more conventional example is the patient demanding a vaginal birth after C-section (VBAC) in a setting that does not meet typical guidelines, but willing to sign a consent form detailing its potentially severe complications.

The answer to the question is generally no – the patient cannot pre-emptively excuse you from any harm from what he convinces you to do against your better judgment. The reason for this: as a physician you are bound by a duty to assess the reasonability of what is being requested of you and to refuse to comply if such is medically incorrect. [Medical Justice note: this is not a hard and fast rule. If the patient is informed and sophisticated, and really informed, there is some latitude. One case comes to mind. Lance Armstrong chose a riskier form of treatment for his cancer, one less likely to be curative. But, his choice made lung scarring less likely, allowing him to continue as a cyclist. He definitely understood and assumed the risks.]

In medical ethics, “beneficence” requires you to act on your patient’s behalf even if that is against your patient’s preference. More broadly, the general duty of care requires a physician refuse to rubber stamp a poor decision by their patient.

The informed consent doctrine notes a patient’s willingness to proceed with or refrain from a treatment is not informed if his doctor lets him steer the medical ship and never pointed out the unreasonability of his choice.

This may apply even if the patient is very knowledgeable medically or is a medical professional.  The patient is seen as being in a dependent role in the doctor-patient relationship because he is the one seeking the physician’s expertise, an expertise that clearly exceeds his own – and the reason he is consulting with the physician. [Medical Justice note: A medical professional, aware of the choices, will likely be allowed to assume more risk than a less sophisticated lay-person].

If the patient wants you do to what you feel is inappropriate, do not rely on the most densely worded consent or even a “hold harmless” letter as actual immunization.  Instead, just say “No.”

Of course, none of any of this means that the patient is entirely without responsibility. He can be partially (or fully) liable for the medical harm he suffers.

That principle is, in fact, the other side of the medical ethical coin -  patient autonomy. A patient is free to make a poor choice, but he must share in the responsibility for having done so.

A well-known case from New York (Schneider v. Revici) illustrates this.

A woman with breast cancer rejected recommendations to have the mass removed and instead went to a quack who claimed he could cure it with concoctions of lipids, caffeine and selenium.  His treatments (not surprisingly) failed and the patient’s cancer spread. She sued for malpractice and won, although the jury, applying comparative negligence, found her 50% liable for her own injuries. Her award was significantly reduced. The doctor then appealed the case arguing the plaintiff should have been barred from bringing the suit under express assumption of risk. She had signed a consent form that said that she knew the treatment was unconventional and that there were no guarantees.

The case was decided on technical grounds. The appellate court ruled it was appropriate to consider the plaintiff’s “awareness of the risk of refusing conventional treatment” under the assumption of risk doctrine.

In any event, the nature of the case matters.

This was a case of a patient who stepped outside of normative medical care.  It therefore lines up well with classic assumption of risk law in which staying on the ground where it is known to be safe is the norm and choosing to go on the rollercoaster is the assumption of risk.

Applying the assumption of risk doctrine to situations where a patient who has been informed of the dangers of refusing proper treatment – and still chooses to proceed- is reasonable. But extending the doctrine to bar patients’ claims who agree to exactly what their doctor suggested and were harmed is not reasonable.

This brings us to the practical utility of the assumption of risk doctrine in medical malpractice litigation.

Since most medical malpractice cases are about bad results from recommended standard treatment, the assumption of risk doctrine has little place in a doctor’s defense.

Assumption of risk adds little substantively to what the comparative and contributory negligence doctrines already allow. There, the defendant describes the plaintiff’s own culpable conduct.

The next time you take a consent, remember that, rather than it being a permission slip from the patient, it signifies that you and the patient are agreeing to jointly enter the treatment process.  The patient must bear responsibility for any conduct of his own that undercuts that process but you retain your full duty of care

In summary: The assumption of risk doctrine does have a place in cases in which a patient rejected proper treatment despite appropriate warning but it does not apply, through informed consent, to cases in which the patient agreed to a recommended treatment after having been warned of its risks.

6 responses so far

6 Responses to “Assumption of risk versus informed consent”

  1. Scott Kasdenon 23 Aug 2013 at 11:41 pm

    “Since most medical malpractice cases are about bad results from recommended standard treatment, the assumption of risk doctrine has little place in a doctor’s defense.”

    Bottom line, if you have a valid informed consent, plaintiff’s attorney will argue that it is invalid. If you don’t have a consent, he will argue it was assault. His expert “whore” will argue that any bad results are due to the doctor being a bad doctor, doing a bad job, making a bad decision, or not acting timely, etc.

    Bottom line, if you get sued, the informed consent is almost irrelevant, and you are in for years of being slammed. Patients tend to sue because they are angry and/or don’t like the doctor anymore.

    sek

  2. Michael M. Rosenblatt, DPMon 24 Aug 2013 at 11:09 am

    I think it is necessary to connect any discussion of informed consent and assumption of risk with contributory negligence. I think it also helps to understand some of the history of informed consent doctrine. It originates out of the concept of patients having civil rights and the ability to control their own destiny. Because medical treatment is complex and not always easy to comprehend, it was thought that doctors have a responsibility to break treatment choices/risks down into understandable patterns.

    Eventually that got mixed into the concept of assault, in that treatment without informed consent could be viewed as a form of criminal assault. Ultimately, the purpose of informed consent therefore is to assure the patient of their civil rights in a society that wishes to grant individuals those privileges.

    The practicality of informed consent is as much aural as written. I have always believed that real informed consent occurs when a doctor and patient thoroughly discuss the history of their disease process, the various therapeutic choices and risks, and lastly, their relationship as doctor and patient. This is a partnership, not a written document, although that is what is usually discussed in court.

    Patients want to know that their doctor not only heard what they said, but actually listened to it. Naturally, much of this disappears in the case of a real emergency, but the attempt should still be made to form that partnership, if time and circumstances allow.

    Contributory negligence occurs when a patient abrogates that partnership for whatever reason they choose to do so. Despite your best efforts to fulfill your part of that partnership, such incidents still occur. All you can do is do your own part, and try to educate them as to why they should seriously consider your advice. The advantage of this is that even if you do have a sub-optimal result, your patient will not doubt your motives. That has far more power than the words on the informed consent document. Legal discussions tend to be pedantic. But there is nothing pedantic about a relationship between human beings.

    Michael M. Rosenblatt, DPM

  3. Eric M. Joseph, M.D.on 24 Aug 2013 at 11:59 am

    During a pre-op visit for revision facelift surgery, your patient is informed there is a 5% chance of experiencing temporary or permanent facial paralysis. Your patient then signs their name next to the words “facial paralysis” on the consent form.

    If FNP occurs as a complication during revision surgery since there was excessive bleeding, scar tissue, and difficulty in the surgical dissection, how can you be accused of negligence and sued? Informed consent may take 20 minutes or longer. If this affords little protection, why bother?

  4. Medical Justiceon 24 Aug 2013 at 3:28 pm

    The point about “contributory negligence” is important.

    Historically, if a patient “contributed” through his or her own negligence, then even 1% negligence on their part wiped out a claim for negligence on the doctor’s part. Contributory negligence still exists as a defense to med mal in a handful of states.

    Most other states have replaced it with “comparative negligence.” There, an award is reduced by percent reflecting the patient’s negligence. So, if the patient is 10% negligent, a $1M award becomes 900k. Comparative negligence has evolved so that payout is reduced only to the point that the patient is 51% negligent, in which case there is no award.

    Finally, it is still important to explain to the patient the likely risks and the serious risks. The more detailed and substantive the dialogue, the more informed the patient, and the more likely a lawsuit will not be filed – at least based on informed consent. Sure there are exceptions. I have seen a system where the patient watches a 20 minute video discussing the intended procedure and that patient takes a short quiz at the end. The patient is free to watch this video as often as desired. This process is automatically documented. That system essentially bulletproofs the doctor against any allegation there was no substantive informed consent – particularly if the patient passed the quiz.

  5. Peter J Polack MD FACSon 25 Aug 2013 at 5:34 pm

    In our ophthalmology practice, we use a tool called emmi which is an online interactive patient education system that goes through the entire procedure, has pauses along the way to allow the patient to ask questions, and then these are answered at the time of informed consent with the doctor. Then in the office, while the patient is waiting on the surgeon, they watch a video that describes the procedure with animations.

    This is followed by the consent form that is signed by the patient in the office and includes the standard risks associated with the procedure but also has sections to add information specific to the patient – additional risks based on their specific comorbidity. Overkill? I would submit that it is not, because the patient cannot say that the procedure was not explained to him properly.

  6. Michael M. Rosenblatt, DPMon 26 Aug 2013 at 2:09 pm

    I agree completely with Dr. Polack and Medical Justice. Anything that streamlines your ability to explain complex procedures, their associated risks and benefits is helpful. Technology stands out as one of the first places to look for that new form of communication. (Many) patients are used to the Internet and looking at monitor screens.

    Since MP is very much a war-game, any technology you can use to defend your position should be considered.

    The only thing I would watch for myself, is if that technology tends to “separate” you from your patients. Yes, you will be able to demonstrate that they had very effective informed consent.

    But that may not humanize you in their eyes. It’s that lack of “humanness” which is one of the first causes of MP claims, especially in cases with a sub-optimal result.

    The interview with the surgeon (after) viewing the informed consent video is a must. During that time you will be able to communicate your own personal approach to the surgery and have eye contact with them. Technology will never be an adequate substitute for that.

    Michael M. Rosenblatt, DPM