Don’t risk suit for failing to disclose surgery risks

Cover ‘quality of life’ risks

Ninety percent of informed consent disputes involve disagreements about who said what and when, according to an analysis of 481 malpractice claims and patient complaints from Australia involving allegations of deficiencies in the process of obtaining informed consent.1

Of the cases studied, 45 involved disagreements over whether a particular risk ought to have been disclosed before treatment.

“Many physicians express concern about the scope of their duty to disclose rare and remote risks,” says Marie Bismark, MD, one of the study’s authors and a senior research fellow at the University of Melbourne’s Centre for Health Policy in Australia. “These sorts of cases are legally interesting and have given rise to some high profile medico-legal court decisions.”

However, the study’s findings suggest it is actually rare for a dispute to involve a head-to-head disagreement over whether a particular risk ought to have been disclosed. “It is much more common for informed consent cases to involve a failure to get the basics right: spending enough time with patients, communicating clearly, and talking about common risks,” says Bismark. “This is where most disputes arise.”

The cases in which doctors did not disclose a risk, and the patients alleged that they should have, mostly involved failure to disclose the risk of chronic pain, potential need for reoperation, possibility of a poor cosmetic outcome, risk of sexual dysfunction, and the risk of visual or hearing loss. “Remember to discuss risks with significant ‘quality-of-life’ implications, rather than just focusing on conventional clinical risks such as bleeding and infection,” advises Bismark.

Document discussion

Anupam B. Jena, MD, PhD, an assistant professor of health care policy and medicine at Harvard Medical School and an assistant physician in the Department of Medicine at Massachusetts General Hospital, both in Boston, has analyzed claims in which patients were told about the risks of not agreeing to a procedure and ended up with a bad outcome after declining the procedure.

In one case, an elderly man presented to an emergency department (ED) with chest pain, and the ED physician and cardiologist recommended hospital admission. “The physicians were concerned that he was having an acute coronary syndrome and risked a heart attack in the near future,” says Jena. “The patient felt better and decided to go home.”

A week later the patient returned to the ED with a heart attack that he ultimately survived. He sued the ED physician and the cardiologist, and he claimed that he should not have been allowed to go home. “This example raises many issues about what should be expected for informed consent,” says Jena. “If a physician informs a patient of the risks and benefits of an intervention, there is an assumption that this eliminates all further risk of malpractice.”

That situation is not always the case, however, says Jena, who adds that even if no malpractice occurred and the claim ultimately is dismissed, the physician defendant would likely incur significant defense costs. “The challenge of the current medical liability system is that even though the physician may not be held liable, there are important downstream costs that have to be incurred to reach that conclusion,” he explains. He gives these risk-reducing practices.

  • Physicians should specify, verbally and in writing, that the patient was informed of the risks of declining a physician’s recommendation.
  • Physicians should take the time to explain to the patient exactly why the procedure is necessary and what harm could occur if the patient chooses not to have it.
  • To ensure that information is understood, physicians should ask patients to repeat the information back and document the conversation.

“At the end of the day, much of malpractice is about better communication between the physician and the patient,” says Jena.

If a patient later claims he or she was never told of the risks, the attorney has to verify this information and might investigate the matter by first exploring whether there is documentation of the conversation.

“If not, the matter may boil down to ‘he said, she said.’ In that case, it is impossible to predict how the claim will evolve,” says Jena. “Because defense costs are typically substantial, some insurers may choose to settle the case, rather than take it to court.” (See related story, below, on what physicians must disclose to obtain informed consent.)

Reference

  1. Bismark MM, Gogos AJ, Clark RB, et al. Legal disputes over duties to disclose treatment risks to patients: A review of negligence claims and complaints in Australia. PLoS Med 2012; 9(8):e1001283. Doi:10.1371/journal.pmed.1001283.

Sources

For more information on malpractice litigation, contact:

  • Roberta Carroll, RN, MBA, CPCU, Senior Vice President, Aon Risk Solutions — National Health Care Practice, Odessa, FL. Phone: (813) 926-8069. Email: roberta.carroll@aon.com.
  • Anupam B. Jena, MD, PhD, Assistant Professor, Department of Health Care Policy, Harvard Medical School, Boston. Phone: (617) 432-8322. Email: jena.anupam@mgh.harvard.edu.
  • Tammi J. Lees, Esq., Roetzel & Andress, Cleveland, OH. Phone: (216) 696-7562. Fax: (216) 623-0134. Email: TLees@ralaw.com.

Legally, what do you need to tell patients?

‘Material risks’ must be disclosed

Do you always document that you discussed the risks of treatment with the patient? This practice is a good one, but overly broad or highly detailed documentation of the discussion might work against you in a lawsuit, says Tammi J. Lees, Esq., an attorney with Roetzel & Andress in Cleveland, OH.

The general statement “I discussed all material risks with the patient” might not preclude a patient from claiming that he or she was not told about a particular risk that materialized, explains Lees.

“On the other hand, if the physician provides a detailed listing of the disclosed risks, it could be presumed that an omitted risk was never disclosed,” says Lees. She advises physicians to use language such as, “the risks discussed with the patient included, but were not limited to...”

To obtain informed consent, the physician does not need to disclose every conceivable risk to the patient but must disclose the “material risks” that are inherently and potentially involved with respect to the treatment, says Lees.

Know scope of disclosure

A physician could be sued successfully for failing to disclose a material risk if that risk materializes and directly causes injury, and the judge or jury determines that a reasonable person would have decided against the treatment had the risk been disclosed prior to the treatment, says Lees.

In addition to disclosing the material risks of the proposed treatment, the physician should also disclose the benefits to be expected from the proposed treatment, any alternatives to the treatment, the associated risks and benefits of the alternatives, and the results likely if the patient remains untreated, says Lees.

Many states have adopted a “reasonable patient” standard, which means that the scope of the physician’s disclosure is governed by the patient’s informational needs, notes Lees. “A risk is considered material if a reasonable person, while in the condition that the physician knew or should have known the patient was in, would be likely to consider important the risk in deciding whether or not to refuse the proposed treatment,” she says.

Roberta Carroll, RN, senior vice president at Aon Risk Solutions — National Health Care Practice in Odessa, FL, says that informed consent is “not a one-stop process. It doesn’t have to occur in the hospital setting. It can start much earlier, in the physician’s office.”

Informed consent requirements vary by state, but in general, should typically include what the procedure is, why the treatment is recommended, reasonable risks, and likely benefits, says Carroll. “One thing people often tend to forget is to talk about alternative treatments, as well as the alternative not to treat,” she adds.