Are you sure the patient is sick?

False positives can have devastating results. How can you protect your patients, and yourself, from an erroneous diagnosis?

By Mark Crane
Articles Editor

No diagnostic test is 100 percent accurate. Yet physicians must often rely on them to make recommendations that have life or death consequences. "You're fine; the test came back negative" sounds reassuring. But when it isn't true, that remark can delay urgently needed treatment.

"I'm sorry to tell you the tests confirm that you have . . ." has disastrous potential, too, if a false positive leads physicians to initiate unnecessary procedures or medication regimens, or when patients make life-altering decisions based on flawed information.

How liable are you for the chain of events you set in motion based on false test results? Although failure to diagnose a disease in a timely manner remains the most common allegation in malpractice trials, increasing numbers of lawsuits allege physical, emotional, and economic injury stemming from false positives.

While you might think patients would be overjoyed to learn that they don't actually have a dread disease, false positives have severe ramifications. People who've been told their days are numbered have given away life savings, quit jobs, had abortions, seen their marriages break up, and even had pets put to sleep.

"It's impractical to redo every test on the theory that it might be wrong, especially if there's no compelling clinical reason to doubt it," says Jeffrey Driver, chief risk officer for Beth Israel Deaconess Medical Center in Boston. "But there are times when a test should be done again. The key to a doctor's liability is whether he should have reasonably anticipated the danger created by a negligent act or omission."

In most jurisdictions, patients who haven't suffered a related physical injury won't prevail in a lawsuit for emotional distress. But there are exceptions. Like many aspects of the law, the answers are evolving and may vary from courtroom to courtroom. The following examples of recent litigation show how courts are wrestling with this issue.

False positives 44 times in a row

Last June, a Seattle jury awarded $15.5 million to a woman who underwent a hysterectomy and had a part of her lung removed after being misdiagnosed with a rare form of cancer. The now 25-year-old woman was given a pregnancy test at the University of Washington Medical Center, which showed abnormal HCG hormone levels indicative of either pregnancy or a gestational trophoblastic tumor. After doctors determined that the woman wasn't pregnant, the test was repeated 44 times. Each time, the results came back positive.

The woman began intensive chemotherapy and underwent three surgical procedures over the course of a year before doctors discovered that she'd never had cancer at all. The jury assigned equal liability to Abbott Laboratories (which manufactured the test) and to the university medical center and its doctors.

Both are considering appeals and are pointing fingers at the other. The medical center contends that the manufacturer didn't warn that false positives were a known problem with the test. The manufacturer's attorneys argued that the doctors provided substandard care, should have been aware of the possibility of wrong test results, and didn't seek a second opinion despite indications that the diagnosis might have been wrong.

A mistaken prognosis

Elvira Wyatt, 78, was visiting her granddaughter in El Paso in 1994 when she developed abdominal pain. After reviewing X-rays and CT scans of the abdomen and pelvis, gastroenterologist Rolando Longoria said that breast cancer had metastasized to her liver and peritoneum. He canceled a scheduled mammogram as academic, and told her she had three to six months to live.

Relying on that prognosis, Wyatt sold her townhouse and moved in with her granddaughter. She gave away most of her personal possessions, including several valuable paintings and a porcelain collection. She made funeral arrangements and had her dog put to sleep.

Her treatment with Longoria over the next 10 months involved mainly paracentesis, and she lost weight and became weak. Longoria finally ordered a biopsy, which revealed that Wyatt had a treatable lymphoma, not metastatic breast cancer.

Wyatt's lawsuit charged that the doctor was negligent for failing to obtain tissue biopsies earlier and in not referring her to an oncologist. She alleged that the misdiagnosis caused her to incur severe economic losses arising from property dispositions she made while believing her death was imminent.

A Texas appeals court ruled in 2000 that Wyatt's malpractice claim could go forward, but that she was not entitled to sue the doctor for her ill-advised economic decisions. "The possible responses to a diagnosis of terminal illness are as varied as the patients who receive them," the court held. "Dr. Longoria is not a financial planner or an estate planner. He has no control over how his patients choose to confront a life-threatening illness or how they decide to dispose of their property. . . . Predictions of life and death lack scientific certainty. . . . Those diagnosed with a terminal illness must bear the responsibility of not only planning for their death, but also planning for the possibility of continued life."

Did the wrong diagnosis lead to gunplay?

Philadelphia police officer Yvette Brown delivered her second child at the Philadelphia College of Osteopathic Medicine in 1991. A physician there told her that her daughter had been born with syphilis. When she confronted her husband, Gerald, with the news, he admitted that he'd been having an affair with a co-worker.

The baby and mother were both treated for syphilis. About two months later, the baby was retested. The first test was wrong; neither the baby nor the mother had the disease. But the damage had been done. The Browns' marriage deteriorated rapidly. According to court transcripts, Gerald became physically abusive and accused his wife of having an affair as well. After Gerald repeatedly struck her, Yvette chased him into the street and fired several shots at him with her service revolver. Both were arrested, but neither was prosecuted. Mrs. Brown was discharged from the police force, and the couple separated.

Litigation reunited what a false positive had torn asunder. The couple got back together to sue the hospital for the negligent misdiagnosis and the economic and emotional upheaval it caused. In 1998, a jury awarded the Browns $510,000. An appeals court overturned the award in 2000. While the hospital may have breached its duty to the couple and caused actual harm, the court held, the negligent act cannot be directly linked to the economic damages the couple claimed. The connection between the misdiagnosis and the Browns' marital and employment reversals was too remote.

"Mr. Brown conducted an extramarital affair and confessed this to his wife at a time when the affair was still ongoing," the decision read. "It is this affair and his confession to it, together with Mr. Brown's suspicions that his wife was having an affair herself, not the false diagnosis of syphilis, that had the greatest effect in bringing about the marital discord" and the subsequent loss of Mrs. Brown's job.

While the Browns may have suffered emotional distress due to the misdiagnosis, Pennsylvania law states there can be no recovery for negligent infliction of emotional distress without a corresponding physical injury.

Sometimes, emotional distress is enough

Most jurisdictions agree with Pennsylvania, but there are some exceptions. Several patients who've been mistakenly told they were HIV-positive have been allowed to sue for emotional distress even though they had no physical injury.

In a recent New York case, a city-owned lab informed a physician that a patient was HIV-positive. Nine months later, the lab recommended that the patient be retested because his blood had been examined on a "bad day." A new test showed opposite results.

The patient claimed he suffered severe depression as a result of the inaccurate report. New York courts generally require that a plaintiff be placed in physical danger before he can sue for negligent infliction of emotional distress. An appeals court, however, ruled the suit could go forward because it was an exceptional situation, and that mental anguish is a direct and predictable result of being falsely informed of an HIV-positive diagnosis.

An Alaska woman was told that she had tested HIV-positive, although a confirmatory assay hadn't been completed. The doctor informed the patient's husband, and asked him to break the news to her. Although a retest established that the wife was HIV-negative, the couple's marriage dissolved.

A trial judge initially threw out the woman's lawsuit, but the Alaska Supreme Court reinstated it. "The traditional rule is that emotional distress without physical injury is relatively trivial and easily feigned," the court held. But when emotional distress is severe, or the defendant's conduct is reckless, extreme, or outrageous, it can be grounds for damages. The court ruled that the doctor wasn't primarily responsible for the breakup of the couple's marriage, but the patient still had a legitimate claim for emotional distress.

When to let the patient know the test may be wrong

How can you minimize the injury, pain, and likelihood of litigation from false positives? Risk managers say many of these cases can be dismissed or won at trial if the physician manages them appropriately.

There's little legal protection in using a generic disclaimer, such as routinely telling patients, "With any test, there is a chance it could be inaccurate," says Beth Israel's Jeffrey Driver. "And such a pronouncement would needlessly undermine the doctor/patient relationship and the provision of health care."

But there are times when it's wise to disclose the possibility of erroneous test results. "If a positive result is inconsistent with the history, physical, and other collateral diagnostic tests, the doctor should repeat the test, obtain further information from the patient, and order other diagnostic tests as indicated," says Driver. "Tell the patient the initial test results are in question and ask for consent for further examinations."

The same risk management advice applies to negative test results. "If a test says the mole is benign, and it doesn't change for the next month, there's no need for second-guessing," says James Lewis Griffith Sr., a malpractice attorney in Philadelphia. "But if the mole turns blue and gets bigger, you obviously need to retest. Whenever a test result is incompatible with clinical observations, you need to do more."

Certain tests have such a high rate of inaccuracy that patients should be informed of the possible need for retesting. "A doctor should never tell a woman with a negative mammogram that she absolutely doesn't have cancer," says David Karp, a loss prevention consultant in Cloverdale, CA. "The test just says that it can't find an indication right now. But patients should be told that these tests aren't the definitive word."

Physicians should retest and tell patients about the chance of false results when the personal consequences are severe, such as a diagnosis of AIDS or a potentially fatal illness like cancer. "You can't pronounce a death sentence on a patient based on a scraping, a frozen section, a sputum test, or any single report," says Griffith. "You need a diagnosis based on a tissue biopsy. The patient should have the option of a second opinion as well."

What is a physician's liability if lab results are faulty? In general, a physician is liable only for his own actions. Relying on a reputable lab or consultant shouldn't result in liability, says Jeffrey Driver. The doctor isn't obligated to guarantee the lab's work.

But that legal protection won't hold if the doctor had reason to suspect that the lab does poor work. "A managed care plan required that physicians send dermatology slides to a certain lab," recalls David Karp from his days as a risk manager for a malpractice insurer. "One doctor told me the lab had done a lousy job and had recently missed three melanomas. He complained to the plan, but was told he still had to use that lab. This doctor could have been found liable for the lab's errors because he had reason to mistrust their work. He can't just shrug off what he knows. He must serve as the patient's advocate.

"We told the doctor to write a letter to the plan outlining the problems and requesting a legal opinion from the plan's attorneys about his and the lab's potential liability," says Karp. "Until things improved, the doctor didn't use that lab and told patients they might have to pay out of pocket for tests."

Advanced technology can create unique problems. In hospitals that allow patient access to online medical records, the patient may be able to see test results before the physician has had a chance to review them, says Driver. Patients can come to unwarranted conclusions or misinterpret results before speaking with their doctors. Where such a possibility exists, patients should be warned in advance of potential test variations and the need for confirmation or secondary testing to confirm a diagnosis.

 

Mark Crane. Are you sure the patient is sick?. Medical Economics 2002;8:24.