Informed Consent Misinterpretations Are Common
“If only the doctor had warned me of this terrible complication, I never would have agreed to his treatment.”
When a patient has a poor outcome, that statement is typically the basis for a malpractice lawsuit claiming that the physician didn’t provide adequate informed consent before a procedure or treatment.
For most operations and many other treatments, including those in a primary care setting, informed consent means that the physician must disclose the risks, benefits, and alternatives of the planned treatment. The patient is requested to sign a form acknowledging that he was told of these risks, understands them, and consents to the treatment.
“Too many doctors are far too casual about how they inform patients and therefore expose themselves to lawsuits that could be easily avoided,” warns Michael J. Schoppmann, a healthcare attorney with Kern Augustine Conroy & Schoppmann of Bridgewater, New Jersey.
Physicians are typically well meaning about informed consent, but they still make critical mistakes.
‘Sign This So We Can Get Started’
Informed consent isn’t just a piece of paper that the patient needs to sign. It’s the discussion—the give-and-take—between the doctor and patient. “Doctors need to disclose the material risks. That means the most common likely potential risks and the most severe ones, including death, paralysis, or brain damage,” says Schoppmann. “You don’t have to disclose every esoteric complication that could occur. It needn’t be a lengthy document.”
“The manner in which you disclose risks is important,” says Lee J. Johnson, a healthcare attorney in Mount Kisco, New York. “If you gloss over them like a fast-talking announcer in a radio commercial, the patient could claim that he didn’t understand you or that you didn’t allow for a serious discussion of the side effects.”
“Doctors need to explain that any time there’s a procedure that’s invasive or involves anesthesia, there is a risk of harm, including death,” said Schoppmann. “The law requires this discussion. It’s also good practice. Many physicians worry that disclosing risks will scare the patient away from a treatment he needs, but studies have shown the opposite. The discussion helps build rapport. Patients who feel that their doctor has been candid with them are less likely to sue even if there’s a poor outcome. Informed consent should be seen as a risk-management tool, not an oppressive burden for the doctor.”
How Informed Consent Can Create Malpractice Risk
Don’t Get the Small Details Wrong
Too many physicians are almost flippant about the details of the informed-consent process. They fail to secure witness signatures or conduct the discussion in the presence of a witness. The witness should be a healthcare professional such as a nurse or physician assistant, not a receptionist. “Doctors don’t always sign the paper as the treating physician. They don’t properly date the form or complete the patient information. They don’t make sure that their signatures and the witness’ are legible,” Schoppmann said.
“The physician must follow the protocols of his hospital, employer, or group practice. They usually have standard forms that shouldn’t be modified,” Schoppmann said. “Doctors shouldn’t shorten it or just pull something off the Internet to use. If something goes wrong and the patient has a poor result, the hospital or employer may be sued as well. They could be in an adversarial position with the doctor and may jettison him for failing to follow protocols.
“A physician can be fired for this kind of sloppiness. That damages his credibility to testify in court as a discharged former employee. That can be legal suicide on the witness stand.”
Don’t Ask a Sedated Patient to Sign a Form
Sometimes patients are given a mild sedative such as diazepam before the doctor asks them to sign the form. “We’ve seen a number of lawsuits where that happens,” Schoppmann said. “The plaintiff’s attorney can argue that this isn’t legitimate informed consent because the patient isn’t of coherent mind to give consent.”
Warn Patients They May Need a Second Operation.
The doctor may have a signed consent for a lumpectomy but not a mastectomy. He may have consent to remove fibroids but not for a hysterectomy. “If you don’t have specific consent for the more serious operation, the procedure has to end,” said Schoppmann. “The patient needs time to recover from the anesthesia and then you need to have a second discussion where she gives consent again.
“That’s why the consent discussion and form should include giving the doctor the discretion to go further than initially planned if it’s medically appropriate,” he said. “Tell the patient of the more serious possibilities and get consent for it. If you don’t, the patient could come out with a result he or she never expected.
“We’ve seen cases where the allegation isn’t just for medical malpractice but for assault because the doctor didn’t get consent for the more serious procedure,” Schoppmann added. “That carries serious implications. The doctor’s insurance may not cover him for assault. The doctor can expose himself to more serious legal risks.”
Even ‘Minor’ Issues May Require Informed Consent
Informed consent isn’t only for surgeons. The type of care and treatment rendered in an office setting continues to expand and informed consent may be required. Physicians could have claims filed against them for not disclosing risks of even small things such as mole removal, blood pressure medication, colonoscopy, CT scans, stitches, flu shots, etc.
“A parent brings a young child into an FP’s office because of a laceration,” said Schoppmann. “You should discuss with the parent that she may want to get a consultation from a plastic surgeon. The parent declines and asks the FP to close the wound. Then there’s a residual scar. The family may claim that you never mentioned the option of having a plastic surgeon close the wound. You need to adequately document that you offered the option and the family declined.”
Don’t Forget to Document Informed Refusal
In addition to the risks, benefits, and alternatives regarding procedures, a physician must include discussion of the potential consequences of doing nothing, including the progress of the disease if no treatment is rendered. If the patient still refuses treatment, the physician must properly document that and ask a patient to sign the form stating that the risks were explained.
“In many cases, documenting informed refusal may be more important than informed consent,” said Schoppmann.
Take an ob/gyn who recommends amniocentesis. “He informed the patient of all the risks but didn’t tell her what could happen if she declines it,” said healthcare attorney Lee Johnson. “The patient refused the procedure and gave birth to an infant with Down syndrome. The patient then sued the physician and won.”
In another case, a physician asked the patient to get a Pap smear. “The patient refused and ended up dying of cancer,” she said. “The doctor had put in his notes that she refused but didn’t write that she was aware of the consequences of not getting it done, including death. The family sued. Because the doctor didn’t clearly document that the patient was aware of the risks of not getting the Pap smear, he lost the case.”
The good news about informed consent is that physicians win the vast majority of these cases, said Schoppmann. Most malpractice insurers and hospitals have suggested templates and forms on how to secure informed consent. “These cases are avoidable when you have a full and candid discussion and you document it properly.”