Then 43, Fubini had received similar reports after three other mammograms over the previous five years. Her latest, she thought, was yet another clean bill of health.
Several months later, however, her confidence was shattered: while doing a routine exam of her left breast, Fubini found a lump. A biopsy was performed. It showed that Fubini had cancer -- specifically, a ductal adenocarcinoma that eventually was determined to have spread to her lymph nodes.
"I had started wondering afterward how I could have fairly advanced cancer -- they said I was stage three -- when I had had a mammogram six months before I felt this lump," she said. "I really started to think about whether something had been overlooked."
A Major Case That Sent Shock Waves
Last May, after just three hours of deliberation, a Massachusetts jury awarded Fubini $5.5 million, one of the largest malpractice awards in state history.
The jury agreed with the testimony of expert witnesses who claimed that her radiologist should have discovered Fubini's cancer on mammograms done in 1989 and 1992.
Fubini, whose cancer recurred and has now spread to her ribs, said she was "relieved" by the jury's decision.
"If I could have advanced breast cancer -- just six months after my clean mammogram --then everything they tell women about mammograms, and self-examination, and testing is all a sham," she says.
The Truth About Mammograms: They're Not Perfect
Fubini's case illustrates a growing awareness that mammograms aren't perfect. Indeed, according to the Food and Drug administration, studies show they reveal about 80 of every 100 cancers. At the same time, more and more patients are filing lawsuits when lesions are found after earlier mammograms failed to detect them.
Last year alone:
- A Florida jury awarded a 56-year-old woman $3.35 million after she claimed her breast cancer diagnosis was delayed six months because her cancer was missed on a mammogram.
- A Hawaii jury awarded a 57-year-old woman $1.32 million after she said her breast cancer diagnosis was delayed 17 months because her radiologist erred in reading her mammogram.
- And in Houston, the estate of a 60-year-old woman was awarded $3.9 million because she was not diagnosed with breast cancer until 1996, despite mammograms in 1994 and 1995 that indicated that she had the disease.
Radiologists are well aware of such cases. "The number of medical malpractice lawsuits alleging injury due to missing or delayed diagnoses of breast cancer has increased so rapidly that such lawsuits have now reached epidemic proportions," wrote Leonard Berlin, MD, chairman of radiology at Rush-Presbyterian-St. Luke's Medical Center in Chicago, in the November 1999 issue of the American Journal of Roentgenology.
A Simple Mistake, or Negligence?
Given what mammography can and can't do (see Why A Mammogram May Miss a Tumor), when does a patient have the right to sue?
The answer, experts say, depends on whether or not there's evidence that the radiologist or someone else involved in administering the test -- such as a technician -- acted negligently and that this act caused or contributed to a delay in diagnosis.
"Anybody can sue. The question is will they win. Most will lose. The point is that there has to be a departure from the standard of care that is followed or there has to be negligence," said Harvey F. Wachsman, M.D., J.D., a neurosurgeon, attorney, and president of the American Board of Professional Liability Attorneys.
He cautions that women, and their lawyers, must prove that an error by a radiologist caused a delay in their diagnosis and that the delay harmed their health.
"If somebody does something wrong, but it does not cause any harm, then there is no case," Wachsman said. "Most cases are fought not on the negligence issue -- but on the approximate cause issue. If a woman finds she is has cancer just six months after a clear mammogram, and it is shown that the cancer was visible on that mammogram, then that is a case."
Among Radiologists, Fear and Changes
Meanwhile, some radiologists are already taking steps to protect themselves from malpractice suits.
Phan Huynh, M.D., a breast imaging specialist at the University of Texas Health Science Center in Houston, says he knows of radiologists who are trying to get out of the breast imaging business altogether for fear of being sued over a misread or unclear mammogram. Physicians are also more likely to order a biopsy of a suspicious mass instead of following it over time using mammograms and other tests.
"Today, doctors are more likely to biopsy anything that shows up just because we are worried about lawsuits," says Huynh. "It's defensive medicine."
Putting Mammograms in Their Place
Given the legal fears, some women's health advocates are pushing for clearer public health messages that warn women not to depend exclusively on mammograms.
Groups such as the National Association of Breast Cancer Organizations say mammograms should only be done as part of a three-part strategy that includes monthly breast self-exams and annual clinical breast exams by a doctor or other medical professional.
Fubini says women need to ask more questions or even seek a second opinion if they have any concerns about the quality of their mammogram.
"If they have any reason to feel uneasy about the results, they should act on that," she says. "They should have someone else screen their mammogram. Women need to learn not to rely too heavily on mammograms."
Michael D. Towle is a regular contributor to WebMD; his last article was about breast implants.