WOMEN, CANCER AND COMMUNITY
But the money is of scant comfort to the LaMonica family: After a mastectomy, chemotherapy and radiation treatments, Phyllis LaMonica died in 1994, at age 45.
Of all the medical mistakes that occur every year in the vast U.S. health system, delayed diagnosis of malignant breast tumors is the single most frequent reason for malpractice lawsuits, according to the Physician Insurers Association of America (PIAA) in Rockville, Maryland. These lawsuits have resulted in average settlements of $307,000 for the women who sued successfully, second in size only to payouts for mistakes leading to neurological impairment in newborn babies, PIAA statistics show.
Physicians, however, win most breast cancer lawsuits. The PIAA's ongoing Breast Cancer Study reveals that nationally, from 1985 to 1998, patients won only 12 percent of the suits that went to trial. (Physicians' insurers paid to settle 44 percent of claims before they went to trial.) As these statistics suggest, proving that a doctor is liable for failing to correctly diagnose a breast tumor is not easy. "One of our biggest problems is convincing a jury that a woman would just go home after a doctor says, 'It's a cyst, don't worry'," says Boston attorney Andrew C. Meyer, Jr., who represented La Monica. "But you'd be astounded at how many women do just that." Meyer, whose law firm, Lubin & Meyer, is one of the largest malpractice firms in the Northeast, adds that jurors also find it hard to believe any doctor would actually send home a patient who has a lump without evaluating it further.
Why do these mistakes happen? Responding to a massive public information initiative that tells them early detection offers the best hope of surviving breast cancer, women are undergoing about 30 million mammograms a year. The situation thus raises questions about the reliability of mammography equipment and interpretation, and about the manner in which physicians like LaMonica's respond when women themselves find a suspicious lump.
WHOSE FAULT IS A MISDIAGNOSIS?
From 1985 to 1995, 2,448 claims and lawsuits involving breast cancer were reported to the PIAA by member companies that insure more than 90,000 doctors--about 12 percent of the doctors in the United States. (A claim is typically a filing with an insurance company asserting that someone has been damaged by the insured doctor.) In interviews with malpractice attorneys, surgeons, breast cancer patients and other experts, three basic errors are consistently cited as causes of missed diagnoses: A physician's failure to take a patient's complaint seriously and carefully examine her, particularly if she is young; a radiologist's misreading of a mammogram; and a specialist's assessment of a patient's lump by feel alone and failure to order further tests.
In nearly 80 percent of the lawsuits PIAA examined in its Breast Cancer Study, mammogram results were reported as "negative or equivocal when, in fact, a lesion was present." (A lesion is any pathological change in the tissue, including a lump.) In 60 percent of the lawsuits, the woman herself had found the lesion; only 10.7 percent had been identified by a screening mammogram. It is not surprising that radiologists are most often named in the lawsuits examined by the PIAA.
The United States has no nationwide cancer registry, so it is impossible to say exactly how most of the breast cancers diagnosed each year are discovered. However, some small studies and anecdotal information suggest that despite the prevalence of mammograms, they are responsible for only about half the diagnoses. For example, a national survey of 250 women who had undergone breast biopsy (and were willing to answer questions about it) showed that 56 percent of their abnormalities were discovered by a screening mammogram, while 12 percent were found during routine checkups by physicians, and 28 percent were found by the woman herself (or a partner). The study was sponsored by the National Association of Breast Cancer Organizations and Johnson-& Johnson.
THE TROUBLE WITH MAMMOGRAMS
Concern about the quality of mammography has prompted the American College of Radiology (ACR) in Reston, Virginia, to look for ways to improve the accuracy of readings by its 30,000 members. Leonard Lucey, ACR's associate counsel, says the organization expects the federal Mammography Quality Standards Act, which went into effect in 1994, to increase accuracy. The law specifies qualifications for physicians, technologists and equipment at any certified, accredited mammography facility. "It's too soon to measure results," he says, but "early indicators show it's raised the level of care, which should increase detection."
The ACR also recently implemented new guidelines for radiologists to use when reporting their results. However, when researchers at the University of California, San Francisco asked two expert radiologists to independently review 2,616 mammograms, 25 percent of the cancers were missed--a rate similar to what had been found in studies predating the new guidelines. The two radiologists agreed on a diagnosis 54 percent of the time when cancer was present; when it wasn't, they agreed 62 percent of the time.
Accuracy may also be affected by a more mundane problem brought about when patients switch HMOs, or the HMOs change their approved list of diagnostic centers and doctors. "Radiologists may not have the old X-rays to compare," says Henry Ferstenberg, MD, a New York City surgeon. "The percent of error would drop if they did."
Reading mammograms of younger women is particularly difficult. False negatives and ambiguous results are most frequent in women under 40, due to their denser tissue. In PIAA's study of settled lawsuits, over 60 percent were filed by patients under 50, especially pre- and perimenopausal women. Breast cancer is "thought to be less common among younger women, which often causes a physician to be less impressed by a patient's complaints, according to the study.
"I do think the public has very high expectations for mammography," says Marie Zinninger, ACR's associate executive director. Citing human error, she warns: "You can't expect more from radiologists than from others. The important message is, even with an annual mammogram, you should follow up on any lump you find with a physician. A lump takes precedence over any other kind of report."
Zinninger says she believes many claims are filed simply because "we five in a litigious society. If you look at the total number of mammograms--about 30 million--the number of lawsuits is still small."
SHOW AND TELL
According to malpractice attorneys, juries are sympathetic to the argument that radiologists are simply human and unavoidably make errors. That is why, they say, they take on cases only when the evidence is strong. In the easiest type of case, "the trial becomes almost show-and-tell," explains Joseph Miklos of Silberstein Awad & Miklos, a Garden City, New York law firm. "We blow up the mammogram and present it to the jury. An expert testifies, making a circle around the tumor. The jury can see it--tumors are easy to spot once they're pointed out. In egregious cases, you don't even need to point it out, it's so discernible."
Contrary to the popular stereotype, jurors are not easily swayed by a victim's pain, and are not biased in favor of plaintiffs because doctors are usually well-heeled. "In reality, sympathy more often falls on the side of the doctor--who can't cure the disease, didn't cause it and shouldn't be held accountable," Meyer says. "The jury listens to medical and factual debates about what happened. The burden is very heavy on the part of the patient." In Massachusetts, he says, 94 percent of malpractice cases that go to trial are won by physicians.
The jury who heard the sad story of Phyllis LaMonica, a resident of Reading, Massachusetts, found in her favor because they were convinced by evidence that she repeatedly tried to get her HMO doctor to take her complaint seriously. Her efforts began in March 1988, when she found a lump in her breast. Her daughters were 9 and 12 at the time. She brought the lump to the attention of her primary care doctor, who examined her, looked at the mammogram he ordered and told her it was a benign cyst she need not worry about. Because of her concern, he said he'd see her every three months, if she wished.
By July, the lump still present, LaMonica requested another mammogram and aspiration, or a referral to a physician who would aspirate. Her physician said these procedures were unnecessary. In October, LaMonica finally went outside her HMO for a second opinion and learned she had stage III breast cancer. During the trial, the primary physician denied that LaMonica had had any breast lump or abnormality on her last visit to him--in July--and claimed she requested no mammogram or aspiration. The defense further contended that only after that last visit did she develop the cancer.
LaMonica's repeat visits to her doctor helped persuade the jury to find in her favor, according to Meyer. While her doctor repeatedly told her not to worry, and that her breasts were normal, his records noted an area of "fibrocystic breast disease." When Meyer asked him during the trial how frequently he schedules visits for patients with normal breasts, the doctor replied "Once a year." To jurors, his seeing LaMonica every three months further suggested he felt something was wrong.
BETTER MEDICINE THROUGH LAWSUITS?
Do malpractice lawsuits serve any purpose besides compensating the patients or their families and earning their attorneys handsome fees?
Adriane Fugh-Berman, MD, chair of the National Women's Health Network, doesn't think so. "For dealing with misdiagnosis, the legal system does both patients and doctors a disservice," she contends. "You can always hire experts to testify one way or another, I've always thought an independent scientific board should review medical malpractice and misdiagnosis claims before they get to a jury." Such a system would avoid the "rent-an-expert type of testimony that trials feature she says.
Dr. Ferstenberg says he has noticed a trend: His colleagues are practicing defensive medicine by referring more and more women to him for biopsies. "In a year, I do some biopsies that I don't feel are absolutely needed," he says. The doctors are motivated by nonmedical concerns, including the fear of a possible lawsuit that might blight their professional record, and possibly cause an HMO to drop them.
Naturally, malpractice lawyers regard the effects of lawsuits as positive. Miklos believes lawsuits raise the level and quality of care. "Doctors are very worried that ' t they may be sued," he says, "so they practice better medicine when it comes to diagnosis of breast cancer, having realized that earlier diagnosis means a better prognosis." Miklos says doctors now have a heightened awareness of the link between lawsuits and insurance rates. "They're in a position to directly affect their insurance costs by practicing better medicine. With earlier diagnosis, their malpractice insurance would go down," he maintains.
Meyer agrees. "Litigation causes doctors to think twice about advice they give their patients. They may be motivated by fear of what will happen-like a lawsuit-if they don't do the right tests. If a doctor changes his practice because he's been sued, that's OK with us. Fear is as good a motivator as any to improve the way doctors practice." Meyer believes doctors who dismiss women's complaints too easily will continue that harmful pattern until they're held responsible and penalized financially.
TOWARD BETTER DIAGNOSTIC TOOLS
The chances of delayed diagnoses, of course, would be greatly reduced if mammography were more accurate. Mammography's goal, says the ACR's Zinninger, is finding "nonpalpable lumps that cannot yet be felt: tiny calcifications, small as a pencil dot. Ten to 15 percent of lesions do not record on X-ray film--no one knows why. We have no exam that is 100 percent perfect; this is the best tool we have."
New diagnostic techniques under development may soon offer greater accuracy. Digital mammography uses a computer to show images of a breast in a wide scale of gray tones. Still in the research phase, digital mammography may lower the radiation dose. It makes dense tissue more readable and allows for computer-aided diagnosis.
The National Cancer Institute (NCI) has been funding research into Magnetic Resonance Imaging (MRI), which can help show the difference between benign and malignant lesions. However, MRI cannot detect microcalcifications. NCI-funded projects are also exploring the potential for using another form of imaging that is breast-specific, called positron emission tomography (PET).
Researchers at the University of Chicago Medical Center spent a decade developing a computer program to doublecheck mammograms for human error. "Tested on small tumors missed by radiologists, the computer detected more than half of them," says medical center spokesman John Easton. The technology is now being marketed as the Image Checker, a spinoff machine produced by R2 Technology of Los Altos, California, which has won FDA approval for the product and installed it in several locations. (See Resources on page 79 for R2 Technology contact information.)
The PIAA views the findings of its widely publicized survey of breast cancer litigation as consciousness-raising for physicians that will lead to "decreasing the frequency and severity of patient injury resulting from these errors in diagnosis," according to the report. But, given that claims against doctors take years to make it through the courts, it's too soon to judge whether the effort is succeeding. "With many more mammograms and better preventive care, more cancer is being found, but the bigger pool of women being tested allows more opportunity to miss one lesion," says PIAA research director Lori Bartholomew. "If a doctor misses one now, there's potential for a lawsuit. There's no really good news until we find a cure."
WHEN IN DOUBT, BIOPSY
When a mammogram and sonogram fail to give a definitive answer about a breast lump or abnormality, a biopsy should resolve any doubts.
The simplest and quickest type is done by a surgeon using a fine needle to aspirate, or suck out, a few cells from a lump that can be felt. The procedure is done with local anesthesia and leaves no scar. If the lump is actually a cyst, the needle will pull out fluid. If it is solid, the cells are sent to a specialist called a cytologist. The accuracy of this procedure in diagnosing breast cancer ranges from 70 percent to 100 percent, according to Robert Smith, PhD, director of cancer screening at the American Cancer Society.
With a lump that cannot be felt, a stereotactic biopsy is necessary. In this procedure, the woman lies down on a special table with her breast hanging through an opening. The surgeon can be guided to the lump by ultrasound or other imaging equipment. Cells are removed and read by a cytologist.
At this point, writes breast surgeon Susan M. Love, MD, in Dr. Susan Love's Breast Book (Addison Wesley, 1995), a woman can relax as long as results of the mammograrn and sonogram of her breast show that the lump is not malignant, and the surgeon agrees with the diagnosis based on her own exam.
If, however, there is any disagreement over the diagnosis, a surgical biopsy may be called for. With this procedure, either the entire lump or a piece of it is removed. Examination by a pathologist will give a definitive diagnosis. A surgical biopsy can cause soreness and leaves a scar.
After any of these procedures, Dr. Love advises, get a copy
of the report and keep it.
SHOULD YOU COMPLAIN? SHOULD YOU SUE? DON'T SWEEP ERRORS UNDER THE RUG!
If you get bad advice from a doctor, such as not to worry about a lump that she has diagnosed by feel alone. Should you sue if the lump later turns out to be malignant? That depends on what you did after you saw the doctor.
"If you got a second opinion the next day, and had the lump removed," says attorney Andrew C. Meyer Jr., then "you have no damage to base a claim on. But if you trusted the doctor and later found out that your cancer had progressed during the time you delayed, then your additional pain and suffering, your inability to work or care for your family would translate into monetary damages that might be recovered by a lawsuit."
However, don't pursue a malpractice claim. You may wish to write to the doctor pointing out the mistake and also send a copy to the institution where the doctor works, and to the local medical society. "For your own and othcrs' sake, don't sweep error under the rug," urges Meyer. "Money is only the secondary reason for action aginst a doctor," he says. "Getting the doctor to stop the behavior is the social goal."
Given the imperfection of the diagnostic tools now available, women concerned about the possibility of breast cancer or its recurrence need to take an active role in the diagnostic process to lessen the chances of error.
Hillary Rutter, director of the Breast Cancer Center at Adelphi University in Garden City, New York, cautions: "When a doctor says, 'Let's wait and watch,' it may be a warning that he or she is responding too slowly. When your gut tells you something is not right, get a third or fourth opinion, for peace of mind."
Don't allow your doctor to rush you or brush off your questions, says New York City surgeon Henry Ferstenberg. "A doctor should take the time and make the effort to answer all your questions. If not, that's the wrong surgeon or gynecologist." Furthermore, he says, trust your doctor, but bear in mind that "their recommendations are dictated by experience, insecurity and finaincial need, as well as by patient findings."
Women with a lump they can feel should not rest until it is thoroughly evaluated. After 25 years of working with medical misdiagnoses, Attorney Meyer advises: "Do not be content with a doctor who says, 'It feels like a cyst. Don't worry.' That's the biggest mistake we see in our practice. No one can tell by feel whether a lump is a cyst or is cancerous. Make sure the next step is taken. Be aggressive. Painless, simple procedures exist today."
Ask to see the written report after a mammogram. If the results are ambiguous, request a sonogram; combined with a mammogram, a sonogram is about 95 percent accurate when properly done.
You should check the credentials of the sonographer. "An ultrasound image is only as good as the person administering it," stresses Marie De Lange, chair of the American Registry of Diagnostic Medical Sonographers (ARDMS) in Rockville, Maryland. "To help protect against needless tests, misdiagnosis or unnecessary surgery, such as biopsy, to remove a tumor that isn't there, I urge consumers to see a sonographer's credentials before an exam." ARDMS certification is the only available assurance that a sonographer actually has the needed skill, education and experience, she says.
At any mammography center, look for FDA certification. A facility also needs approval from a state accrediting agency or the American College of Radiology (ACR), and must provide adequate means to resolve consumer complaints. (For the nearest certified mammographer or status of your own imaging center, call the National Cancer Institute 800-4-CANCER.)
"From the patient's point of view, there's no such thing as a minor misdiagnosis," says attorney Joseph Miklos. "Doctors should take all reasonable steps to ensure an accurate diagnosis: Her life is in their hands."
by Carol Milano