In Baird v Owczarek , No. 504, 2013 (Del. Sup. Ct. May 28, 2014), the plaintiff underwent LASIK surgery on both eyes, had a second procedure on the left eye, and developed postoperative complications that resulted in a significant injury. The ensuing lawsuit claimed that the surgeon was negligent, not in performing the procedure but in doing it at all. He also brought a claim for lack of informed consent that was later withdrawn.
After a verdict for the defendant, the plaintiff appealed on 2 grounds. The first related to a claim of juror misconduct, which I will not discuss. The second concerned the issue of informed consent being improperly admitted, and this issue forms the basis of this article. In short, the plaintiff sought to preclude any evidence or testimony regarding his granting of informed consent since that was not a cause of action claimed. Because the only action actually being litigated was that of negligence, the plaintiff argued that to include the evidence concerning informed consent would merely “prejudice, confuse and mislead the jury.” The trial court determined that the informed consent forms were relevant “as part of the work up by the defendant.” Therefore, evidence of such was admissible; however, it requested the plaintiff’s counsel to draft proposed jury instructions to mitigate this concern. The following instructions were proposed by the plaintiff’s counsel.
Informed consent is not a valid defense to a medical negligence action. Plaintiff-patient cannot consent to the negligence of a defendant-doctor. The fact that the defendant-doctor may have informed the plaintiff of certain known and accepted risks, does not excuse him of liability for any negligence.
When determining whether or not Dr. Owczarek committed medical negligence, you may not, and should not, consider any evidence of Mr. Baird’s consent or any warnings given by Dr. Owczarek, as evidence that Mr. Baird consented to Dr. Owczarek’s negligence, if any.
Although Delaware has never addressed this exact issue, the court noted that many other states have addressed it, and the court concluded that overwhelmingly most other states have held that “evidence of informed consent, such as consent forms, is both irrelevant and unduly prejudicial in medical malpractice cases without claims of lack of informed consent.” The underlying principle behind these decisions is that to be admissible, evidence must be relevant, and relevance is usually defined as evidence that has a tendency to make the existence of any fact material to the ultimate determination of the issue at hand more or less probable than it would be if the evidence were to be precluded. Relevance must contain aspects of both materiality and probative value. Finally, it was noted that assumption of the risk is not considered a valid defense to negligence; thus, any evidence that the plaintiff knew of the risks to be encountered is irrelevant regarding whether the treatment actually rendered was performed negligently.
The court noted that just because evidence might be relevant, it can still be excluded if its probative value “is substantially outweighed by the danger of unfair prejudice, confusion of the issues, or misleading the jury.”
Even though the judge granted the jury instructions as previously noted, the Supreme Court determined that the trial court’s decision to allow admission of the informed consent evidence was an abuse of discretion; it reversed the trial court’s ruling and remanded the case for a new trial.
We are taught to make sure that our patients complete an informed consent form. This is because we have determined as an enlightened society that patients have a right to be apprised of the risks inherent in any treatment proposed as well as the risks associated with the declination of treatment; only upon being so informed can they grant us elucidated consent to proceed. Risks are not limited to potential negative sequelae or poor outcomes: they include compromises and limitations as well. We deem this to be important because bad things can happen, and if we choose to undergo certain medical or dental interventions, we should know what those bad things may be to balance them against the good things to be achieved by undergoing the procedure. This exchange—the receipt of information, the balancing of the risk/benefit ratio, and the ultimate granting of one’s informed consent to proceed with what has been proposed—is the cornerstone of the ethical and legal principles associated with patient autonomy.
If you think about it, the above comments and sentiments have absolutely nothing to do with whether a doctor has breached the standard of care that ultimately resulted in an injury to the patient. That is the whole point of this case, and it is something we all need to be aware of. A claim of negligence and a claim for lack of informed consent are 2 totally different causes of action that plaintiffs can bring against us. One does not necessarily have anything to do with the other.
We have been trained to practice at a fairly high level of competence. We know pretty much how to do what we need to do. The problem is that our patients need to know some of what we know, and we must give them whatever that amount of information is. This is informed consent. Think of it this way. You are Joe Blow. You know squat about orthodontics. What do you need to know before you to say “Okay, doc, I’m all in, take good care of my kid”?
I’m not kidding—how much of all the bad stuff that can happen do you need to know? How many of the limitations do you need to know? How much of what can go wrong and what won’t we be able to accomplish do you need to know before you can give your informed consent? And now the kicker: regardless of what your answers are, we all expect the doctor to perform his or her ministrations in a competent manner and at an appropriate level. That’s why the 2 causes of action are different.
So, bottom line. Do the best that you can, but before going there, make sure that the patient is totally on board, and realize that one thing has nothing to do with the other.
Do not rely on the fact that because the patient was aware of x, y, or z, you don’t have to do the best that you can or that you can take risks with the patient’s treatment. Doing so can result in unexpected negative consequences—to you.