Misdiagnosis of Cancer

Months of debilitating chemotherapy continued, but Rufer's HCG levels on the Abbott test remained between 250 and 350, while a normal level is less than five. She was told she would have to have a hysterectomy.

"I didn't want to … not be able to have children," says Rufer, who has always wanted to be a mother. "But I just felt if I have the surgery, then I won't have to be sick anymore and I won't die."

Tissue samples after her hysterectomy showed no evidence of cancer. At first, her HCG levels dropped, but then went back up. Then, doctors saw two suspicious spots on her lung scan, so she had additional surgery. Doctors still found no cancer and yet her HCG levels remained elevated.

Then came a stunning relevation: "They ended up finding out that I have never had cancer," says Rufer. "That this test was faulty from the beginning, and that I had never had this disease. I had been treated for no reason at all."

False Positives

Laurence Cole, a Yale University researcher who published an article about women who are misdiagnosed with cancer based on incorrect pregnancy tests, found that Rufer is among the 10 percent of the population whose blood contains natural substances that can interfere with lab tests and cause results that are false positive.

No lab test is 100 percent perfect, and other companies that make pregnancy tests measuring HCG have also shown false positives. But Cole, who has become an expert witness in cases against Abbott, believes the company has a greater problem.

"We are still to this day hearing about false positive results in the Abbott Axsym test," says Cole, who saw 12 cases like Rufer's in the course of his 15-month study.

Since PrimeTime's report in April, Cole has confirmed 11 more cases of false positive pregnancy tests. He says he has now found 34 cases in all, 32 of which were measured exclusively or primarily on the Abbott test, though Abbott says that is because of a large market share.

Abbott's Response

In numerous statements to ABCNEWS, Abbott insists its test is no more prone to false positives than any other manufacturer's HCG test. The company says Cole's conclusions are seriously flawed, that Rufer's case is extremely rare, and that its test is approved by the Food and Drug Administration only as a pregnancy test — not to diagnose cancer.

Abbott also maintains that discussions about the problem of false positives with these kinds of tests have been in medical literature dating back 20 years. The company also says that information inserted in the test kits advises that if there are "consistently elevated" HCG levels, doctors should "confirm the results by an alternate method." The doctors, however, say it was not widely known about and say the inserts typically go to the labs rather than to the doctors.

Abbott has since added a line to the pregnancy test kit insert saying that the test should not be used to diagnose cancer, and in January, the company sent a letter reminding labs of this and asking them to share this with their customers.

But it is too late for Rufer. Her trial against the University of Washington Hospital and Abbott Laboratories lasted more than two months. Ultimately, the jury decided Abbott's test is not defective, but it did find Abbott negligent for failing to adequately warn doctors about false positives.

Rufer was awarded more than $16 million, half to come from the hospital and half from Abbott. She plans to use some of the settlement to try and harvest her eggs and use a surrogate mother to carry a child for her.

Abbott plans to appeal the decision, insisting that it was the doctors who failed to heed the company's warnings or read the medical literature about the problem of false positives.

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