Proving failure to diagnose breast cancer: breast cancer screening tests have improved dramatically, but they're only effective if they 're performed correctly. Understanding the state of the art in screening, diagnosis, and treatment will help you prove that your client's cancer should have been detected sooner.

Advances in screening mammography have led to earlier detection of breast cancer--and greater chances for survival among women diagnosed. A screening mammogram is an X-ray of the breast of an asymptomatic woman, designed to detect breast cancer before it becomes clinically detectable. A diagnostic mammogram is an X-ray performed on a patient who already has signs or symptoms of breast disease or who has had a possible abnormality detected on a screening mammogram. (1) These tests have helped save the lives of countess women. (2)

Despite the positive impact these advances have had, mistakes still occur. Typically, the plaintiff in a case arising from a misread mammogram is someone who was recently diagnosed with breast cancer, even though she had not been alerted to any suspicious findings on previous yearly screenings.

If you represent a client in this situation, you must determine not only whether a radiologist misread the mammogram films but also whether that mistake decreased the patient's chance for successful treatment and survival. To make this assessment, you need to obtain the client's full medical history, including all mammogram films and corresponding reports, medical records from all doctors who saw the client before the diagnosis, and the treatment records that followed the diagnosis.

You must then submit this information to a qualified radiologist for review. If the radiologist says the mammogram was misinterpreted, a qualified oncologist must review the materials and determine whether the delay in the diagnosis made a significant difference in the patient's outcome. If it did, your client has a case against the interpreting radiologist for misreading the film. (3)

Since the mammogram is generally a yearly screening test, the delay between when the cancer should have been diagnosed and when it was actually diagnosed is usually more than 12 months. This delay can allow the cancer to grow in the breast and perhaps spread, either locally (to the adjacent lymph nodes under the arm) or to other areas (to the bones, lungs, or brain). The chances of successfully treating breast cancer generally are tied to the extent and location of the disease at the time of diagnosis. (4)

The last 10 years have brought significant technological advances that help radiologists review patients' films. Today, medical professionals conducting mammography screening use either plain or digitized film, both of which meet the standard of care. (5)

Plain film is interpreted by a radiologist or, sometimes, two, which is known as a "double read." Digitized film is also interpreted by a radiologist, but he or she uses computer-assisted detection (CAD) as well. With CAD, the radiologist first reviews the mammogram and then uses the computer as a second pair of eyes.

CAD highlights suspicious areas--such as microcalcifications (build-ups of calcium) or a spiky or ill-defined mass--which alerts the radiologist to reevaluate those areas before issuing a report. Since the FDA approved the first CAD system in 1998, many different models have been approved, and more and more medical professionals have embraced the technology.

As CAD becomes increasingly prevalent as a diagnostic tool, lawyers must educate themselves about the technology so they understand how the interpreting radiologist examined the film. Re-creating the radiologist's analysis of the film in court, highlighting the suspicious areas that the computer flagged, and then explaining to a jury that the radiologist dismissed them is extremely compelling. But you cannot communicate this information unless you understand it.

Always bear in mind that the key factor in interpreting mammograms is to look for changes in the suspicious area from earlier films--to see if there have been any changes over time and whether the changes are calcifications, nodules, or masses.

When microcalcifications appear in patterns such as circles, lines, or tight clusters, they can indicate early cancer. If the microcalcifications themselves are round or oval, or they are scattered and not in tight clusters, they typically are benign. Therefore, if the screening mammogram shows tight clusters, for example, the radiologist should recommend a diagnostic mammogram, a spot compression, a magnification view, an ultrasound, or a biopsy, and the specific recommendation must be stated in the report. (6)

If the microcalcifications do not fit a suspicious pattern (as described above) but look questionable, the radiologist should recommend a follow-up mammogram in six months, with a comparison to the original film to identify any changes over time. The American College of Radiology guidelines state …