Two women suing Abbott Laboratories in a class-action lawsuit contend a faulty hormone test made by the company caused them to have unnecessary chemotherapy and, in one case, a hysterectomy, reports Correspondent Dr. Michael Breen of CBS station WBBM-TV in Chicago.
The lawsuit was filed Tuesday in federal court in Chicago on behalf of two women - a 24 year old from New York and a 38 year old from Michigan - who allegedly received incorrect results from a test known as Abbott B-hCG.
The lawsuit claim that "potentially hundreds if not thousands" of other women mistakenly received serious medical treatment.
The procedure often is used to test for pregnancy because pregnant women produce high levels of a hormone called human chorionic gonadotropin, or hCG, according to the lawsuit.
The test determined the women were not pregnant.
However, according to the lawsuit, doctors immediately put the women on chemotherapy because the test detected elevated hCG levels - a sign of trophoblast disease, a deadly cancer.
The lawsuit also alleges repeated tests during their treatment were inaccurate.
Eventually, doctors determined that neither woman, one of whom had a hysterectomy as part of her treatment, had cancer, according to the lawsuit.
Chicago-based Abbott denied the claims. The false positives are due to a phenomenon known as "phantom hCG," which company spokeswoman Rhonda Luniak said sometimes caused women to appear to have higher levels of hCG.
Doctors are not only well aware of the phenomenon but also would not treat a patient for cancer without performing a battery of other tests, Luniak said.
Earlier this month, Abbott the nation's largest maker of diagnostic tests, settled a complaint with the Food and Drug Administration for repeated violations of quality manufacturing rules. The company agreed to pay the government $100 million.
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