The notion of informed consent is actually quite old, dating back to medieval times. Italian, French, and Middle Eastern archives from as early as the 14th century describe pro corpore mortuoto, or “hold harmless documents,” aimed at absolving doctors from responsibility for untoward events in the course of treatment. This concept has evolved to the modern day concept of informed consent, in which physicians discuss the risks of procedures with patients and obtain signed consent forms.
Informed consent has become such a commonplace event that few physicians consider this a potential generator of malpractice claims. However, the process of obtaining informed consent is a potential pitfall for malpractice liability for three reasons.
First, patients do not feel as informed as we think they are. Second, an informed consent claim is easier to successfully prosecute than a traditional medical malpractice claim. Third, the modern practice of medicine introduces several twists that can generate more potential informed consent claims.
“I never knew that was a risk”
Patients are not as informed as physicians think. A recent study showed that actually only 40 percent of patients think the informed consent they signed reflects their actual understanding of the procedure and its risks and benefits.
This generates both ethical and legal problems. Ethically, this violates the concept of patient autonomy, which, in an ideal case, enables patients to determine the course of their treatment in an informed way. Legally, this can translate to lawsuits grounded not in negligence, but in assault.
The classic case reflecting this approach occurred in 1914. The patient consented to have an abdominal exploration, during which the physician found a deadly tumor. The physician, believing he was saving the patient’s life, removed the tumor. The patient subsequently sued, and prevailed on the ground that she had not given consent for the tumor removal.
The case—Schoendorff v. Society of New York Hospital—gave rise to the following opinion by Justice Benjamin Cardozo: “Every human being of adult years and sound mind has a right to determine what shall be done with his own body, and a surgeon who performs an operation without the patient’s consent commits an assault for which he is liable in damages.”
More recently, the idea of informed consent has been articulated as a duty owed by the physician to the patient. In a 1988 decision, for example, the judge wrote: “A physician owes to his patient the duty to disclose in a reasonable manner all significant medical information that the physician possesses or reasonably should possess that is material to an intelligent decision by the patient whether to undergo a proposed procedure.”
An informed consent claim then is properly alleged when a patient states the following:
- A material risk of the procedure was not disclosed by the physician.
- The patient would not have gone forward with the procedure if he or she had known about the risk.
The risk of informed consent claims
The problem with informed consent claims is that they are insidious, retrospective, and likely easier to prosecute than traditional medical liability claims. Any surgical procedure carries risk, and surgeons surely discuss these risks with patients beforehand.
In hindsight, however, patients who are unhappy with their results may then turn around and say they don’t remember discussing the risk, and thereby generate an informed consent claim. And an informed consent claim cannot be defended as simply as a negligence case.
In negligence cases, physicians are, for the most part, safe if they practice good medicine. The defendant has to prove that the physician deviated from the normal standard of care and that this deviation resulted in the alleged harm.
Informed consent claims, however, are not grounded in negligence. The plaintiff does not have to prove negligence at all. In fact, the physician can have made the right diagnosis, rendered the correct treatment, and performed the most flawless surgery … and still be successfully sued.
Furthermore, the burden of proof shifts from the patient to the physician in informed consent cases. In negligence cases, the defendant has to prove which damages resulted from the negligent act. In informed consent cases, the physician must prove which damages were based on the unauthorized act, rather than on the surgery itself. Otherwise, the physician is liable for all damages flowing from the surgery.
A recent case is illustrative. A patient with back pain consented to “lumbar diskectomy and fusion with iliac crest bone graft + ‘steffe plates,’” according to the court records. The surgery was indicated and technically performed correctly. The fusion did not take, however, and the patient sued after he learned that cadaver bone was also used.
The patient claimed that the allograft was against his wishes. The physician said that no such restrictions against allograft were discussed and there was no such documentation.
Although the trial court found for the defendant, the appellate court remanded the decision. In its decision, the court stated that if the patient did, in fact, place stipulations against allograft, and the physician ignored those stipulations, the entire surgery was a battery. Consequently, unless the physician could prove otherwise, he would be liable for damages from the entire surgery (not just the portion attributed to allograft).
Research and financial interests are increasingly being viewed as pertinent information that should be disclosed during the informed consent process. In Darke v. Isner, a man sought an experimental gene therapy for occluded vessels. The therapy did not work, and the patient died.
The estate raised an informed consent claim, not because the deceased did not understand the risky and experimental nature of the treatment, but because the physician had not disclosed his financial interest in the treatment company. The expert witness testified that a reasonable physician would disclose any financial interests in such a situation, and the court denied summary judgment for the defendant.
Researchers may also consider including the following additional information as safeguards in their informed consent process:
- The patient is part of a study.
- The effects of the treatment are unknown.
- The patient can withdraw from study.
- A data and safety monitoring board will terminate the study if adverse effects are found.
- Patient rights are a priority and may not be waived.
Substitution of one physician for another may also constitute battery without appropriate consent. In Tom v. Lennox Hill Hospital, a patient consented for an attending physician to perform a colonoscopy. A fellow assisting the attending performed the procedure and accidentally perforated the bowel. Both were subsequently sued for battery.
The defendants requested a summary dismissal because Lennox Hill is a teaching hospital and fellows and residents routinely assist in procedures. Indeed, the signed consent form included wording to this effect. The court, however, denied the motion, stating “this consent form only raises a factual issue as to whether there was consensual contact.” Thus, it is clear that informed consent is a process, not just a piece of paper, and a signed piece of paper is not automatically protective.
Similar suits may be raised even in Good Samaritan cases. When a physician is called in intra-operatively to help another physician who is struggling, it is perhaps advisable to first obtain consent from the patient’s family. If an adverse event results, a potential informed consent claim could be filed for the unauthorized substitution of one physician for another.
Most physicians feel they are safe if they ultimately practice good medicine. Performing procedures correctively and prescribing the correct medicine, however, are not a defense in an informed consent malpractice claim. For this reason, informed consent should be taken seriously and viewed as a process that covers disclosure of all relevant surgical risks, as well as the physician’s financial interests, research risks, and potential collaborators.
Preferably, informed consent should be obtained some time prior to the procedure, so that the patient does not feel rushed or pressured to sign. In the end, respecting a patient’s autonomy is the best defense against potential informed consent, remembering that part of good medicine is good communication.
David H. Sohn, JD, MD, is a member of the AAOS Medical Liability Committee and editor of Orthopaedic Risk Manager. He can be reached at firstname.lastname@example.org
Editor’s Note: Articles labeled Orthopaedic Risk Manager (ORM) are presented by the Medical Liability Committee under the direction of David H. Sohn, JD, MD, ORM editor.
Articles are provided for general information and are not legal advice; for legal advice, consult a qualified professional.
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- Leclercq WK, Keulers BJ, Scheltinga MR et al. A review of surgical informed consent: past, present, and future. A quest to help patients make better decisions. World J Surg 2010; 34: 1406-15.
- Akkad A, Jackson C, Kenyon S et al. Patients' perceptions of written consent: questionnaire study. BMJ 2006; 333: 528.
- Schoendorff v. Society of New York Hospital. NE: N.Y. 1914:93.
- Martin v. Lowney. Mass: Mass. 1988:1006.
- Kern SI. More Ways to be Sued: New Informed Consent Forms Required for Physician Protection. N.J. http://www.drlaw.com/uploadedfiles/70/70c30c47-4790-49c3-9bea-45f8685f6166.pdf (Accessed 3-12-13)
- Darke v. Isner. Mass L Rep 2004:689.
- Raab EL. The parameters of informed consent. Trans Am Ophthalmol Soc 2004; 102: 225-30; discussion 30-2.
- Tom v Lenox Hill Hosp. NYS2d: NY App Div 1995:874.