Ovarian Cancer Screening Test Lawsuit

Filing an ovarian cancer screening test lawsuit may be an option for victims of inaccurate results produced by the Risk of Ovarian Cancer Algorithm (ROCA) test or similar products. The U.S. Food & Drug Administration (FDA) recently warned against the use of such tests, as scientific data do not support claims that they aid in the early detection of ovarian cancer.

Free Legal Reviews

Bernstein Liebhard LLP is offering free legal reviews to women who underwent an ovarian cancer screening test such as the ROCA test and received inaccurate results, including a false-positive finding of ovarian cancer or a false-negative of no cancer. To learn more, please contact our office today, at (888) 994-5118.

Ovarian Cancer Screening Tests: What’s the Problem?

Most ovarian cancer screening tests currently on the market measure a blood protein called CA-125, which often appears at elevated levels in women with the disease. However, this is not always the case in women with early cancer. High CA-125 levels can also occur with other disorders, such as pelvic inflammatory disease and endometriosis.

The ROCA test marketed by Abcodia, Inc. uses CA-125 measurements, along with a woman’s age, menopausal status, and risk status to determine the likelihood of ovarian cancer. The company claims that the ROCA test is more accurate than a standard CA-125 test. Unfortunately, the FDA does not agree. In September 2016, it issued an alert recommending against the use of ANY ovarian cancer screening test, including the ROCA test.

“FDA is concerned that women and their physicians may be misled by such claims and rely on inaccurate results to make treatment decisions,” the agency said. “Based on the FDA’s review of available clinical data from ovarian cancer screening trials and recommendations from healthcare professional societies and the U.S. Preventive Services Task Force, available data do not demonstrate that currently available ovarian cancer screening tests are accurate and reliable in screening asymptomatic women for early ovarian cancer.”

While Abcodia continues to stand by the efficacy of the ROCA test, it did suspend U.S. sales of the product following release of the FDA alert.   Read More

How Can a Lawsuit Help?

Inaccurate results from an ovarian cancer screening test can have devastating consequences for a woman’s health:

  • A false-positive result may cause a patient to undergo additional medical tests and/or unnecessary surgery for cancer, exposing her to an unnecessary risk of complications.
  • A false-negative ovarian cancer result may lead a women to delay seeking surgery or other treatments, placing her life in serious jeopardy.
  • Women at increased risk for ovarian cancer may not take appropriate actions to reduce their future risk if they rely on a result that shows no cancer currently present.

Any of the above scenarios has the potential to result in considerable physical, financial and emotional damages for victims and their loved ones. Filing an ovarian cancer screening test lawsuit could allow such individuals to obtain compensation for their losses, including:

  • Medical bills
  • Lost wages
  • Emotional distress
  • Pain and suffering
  • Wrongful death

Arrange for Your Free Legal Review

Bernstein Liebhard LLP is offering free case reviews to women who may have suffered harm due to an inaccurate ROCA test or similar product. Please call (888) 994-5118 to learn more about filing an ovarian cancer screening test lawsuit.

  1. FDA (2016) “The FDA recommends against using screening tests for ovarian cancer screening: FDA Safety Communication” http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm519413.htm
Last Modified: November 4, 2016

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