Lawsuit questions use of informed consent waiver
Physicians still may be exposed to risk
Informed consent has become an ingrained part of health care in the United States, and risk managers depend on clinicians to follow the proper procedures when informing a patient of the risks of a procedure. But what if the patient says he or she does not want to hear about the risks, choosing instead to just trust the doctor?
The law in some states specifically allows patients to make such a request, even though it does not happen very often. But if the patient chooses to invoke that right, risk managers say providers can be challenged by this topsy-turvy situation. If you don’t handle it properly, they say, you can put yourself at significant risk if the patient later sues for malpractice. A jury may decide that the doctor used the waiver because he or she was trying to keep the risks of the procedure secret from the patient, practically guaranteeing a huge award.
Consent waiver is rarely used
An informed consent waiver is used rarely even in states where the law specifically allows it, says Steve Johnson, director of risk management for Wellstar Health System in Marietta, GA. A malpractice lawsuit in Georgia has drawn attention to the matter, with some risk managers wondering if their providers are familiar with how to use the waiver. Johnson says he suspects that most physicians are unfamiliar with the waiver because it is so seldom used. That could increase the likelihood that it is misused, he says.
"We’ve drummed into these doctors the need for informed consent and how to document that, but I doubt anybody tells them how to handle a waiver to receive information," Johnson says. "That’s not good, because if the need arises, you’d better hope they do it correctly. Otherwise, you’re going to have a problem on your hands if the patient takes you to court."
Patient alleges she was tricked
Without solid documentation that the patient insisted on using the waiver, a plaintiff’s attorney could argue that the doctor used the waiver because he or she did not want to reveal the true risks of the procedure to the patient. That is the situation with the Georgia case involving Camran Nezhat, MD, FACOG, a renowned gynecological surgeon operating at Northside Hospital in Atlanta. He is being sued by a former patient, Stacey Mullen, who alleges that Nezhat botched an operation to treat her endometriosis by removing tissue from her bowel laparoscopically. The facts are in dispute, but in court documents the two parties agree that Mullen signed a Waiver of Right to Receive Information instead of a standard informed consent form.
Mullen says she never asked for the waiver and expected to be told of all the risks. The attorney for the doctor says Nezhat accidentally handed Mullen a waiver form instead of the standard consent form. But when she sued the doctor, alleging failure to provide informed consent along with a host of physical and mental injuries from the operation, the defense cited the waiver form. The judge agreed that the waiver form prevented Mullen from including the consent charge in her lawsuit.
Henry Green, JD, the Atlanta attorney representing Nezhat, tells Healthcare Risk Management that there is no conflict with relying on the waiver form in court even though the doctor says he used it by mistake. Though the form may imply otherwise, Green says the doctor actually did discuss the risks and benefits of the procedure with the patient just as you would expect with any procedure. When it came time for Mullen to sign the informed consent document, Green says the doctor mistakenly grabbed the waiver form and Mullen signed it. No one noticed the error until Mullen or her attorney discovered it after the procedure, he says.
The waiver form and the standard informed consent form both were provided by the hospital, Green says. They were kept in stacks next to each other, and that’s how the mistake was made, the attorney says. Nezhat does not use the waiver forms any more than any other physician and had no intention of using it in this case, Green says.
"This was an unfortunate mistake," Green says. "The testimony was that she was given informed consent, but even if she hadn’t been, she signed this form. The form complies with the law, so we relied on that document in court."
Difficult to prohibit use of a waiver form
Though the Nezhat case involves much more than just the waiver issue, it shows some of the difficulty in using the waiver forms. Johnson says he would be uncomfortable with any provider in his organization using a waiver form instead of providing informed consent, but he also says he cannot totally prohibit its use.
"The law specifically provides that this is an option for patients in Georgia, so we have to make it available if they insist on it," he says. "We have to follow the law regarding informed consent, and even though I may not like it, this is part of the law."
Johnson says he always would encourage the physician to provide informed consent rather than use the waiver form. Furthermore, he says the physician never should suggest to a patient that he or she sign a waiver form instead of receiving information about the risks. That would be a breach of the provider’s obligation to inform the patient, he says. And if the doctor suggests use of the form, it might be easier for a plaintiff’s attorney to argue that the doctor pursued that course as a way to avoid disclosing the risks.
Taking a cue from the Nezhat case, Johnson provides this advice: Advise physicians not to keep the waiver forms next to the informed consent forms. In fact, he says, it could be a good idea not to provide the waiver forms to physicians at all, requiring instead that doctors obtain them from the risk manager on the rare occasions when they are needed. That can help eliminate accidental use and gives the risk manager a chance to remind the doctor about proper use of the waiver.
Johnson theorizes that the patients suggesting a waiver on their own are likely to be older, very trusting of their doctors, and reluctant to face a host of bad outcomes when they know there is really no alternative.
"If the patient asks to use the waiver, I would want the doctor to make sure that the patient really understands he is waiving his rights," Johnson says. "I want to see that this idea originated with the patient, and the progress notes should very clearly reflect that the patient requested it and understands what it means."
The documen tation is key to avoiding risks from the waiver form, Johnson says. While it is not possible to just prohibit its use, he says, the liability risks may justify requiring physicians to consult with the risk manager before using a waiver form. That gives the risk manager an opportunity to make sure the patient’s intentions are thoroughly documented. Once it is clear that the patient understands what the waiver means, Johnson says he would not hesitate to use it in the defense of a malpractice case.
The way a waiver is used is all-important. In particular, Johnson says he would be wary of a physician using the waiver for any procedure that is experimental or borderline experimental. A truly experimental procedure will require a number of other consent safeguards, but it is possible that a waiver could be used for a procedure considered cutting edge but not experimental. That could raise even more questions about whether the doctor really wanted to tell the patient about the risks.
"Don’t leave any room for the jury to doubt the doctor’s intentions," Johnson says. "The more it looks like maybe this was the doctor’s idea to use [a waiver] form instead of providing information, the more trouble you’re going to have with a jury."
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