Diagnosed with cancer at 22, Jennifer Rufer underwent debilitating chemotherapy and a hysterectomy.
"I can't have kids," she says, "and I desperately want to have a family."
Compounding the physical and emotional pain that haunts her every day, doctors have discovered Rufer never had cancer at all.
Rufer has brought a lawsuit against Abbott Laboratories, one of the world's largest diagnostic and pharmaceutical companies, claiming that flawed results from their Axsym BHCG pregnancy test led to unnecessary cancer treatments, including chemotherapy and a hysterectomy. Rufer is also suing her doctor, the hospital and its lab. The hospital and Abbott are also suing each other.
High HCG Level
Three years ago, soon after Rufer was married, she went to the doctor because of irregular bleeding. The doctor took a blood sample for the Axsym BHCG routine pregnancy test, one of the most common blood pregnancy tests in the country.
The test results came back positive, showing Rufer was pregnant. But her doctor could find no baby. Additional Axsym pregnancy tests came back positive for Rufer, and still, there was no indication of a pregancy.
When a woman is pregnant, she produces high levels of a hormone called beta human chorionic gonadotropin (HCG). But if there is no baby, the elevated HCG levels can be a sign of a rare form of cancer called a gestational trophoblastic tumor. If untreated, it can spread rapidly and kill. If treated early with chemotherapy, it is highly curable. In fact, early treatment is so important that doctors sometimes order chemotherapy even if there is no evidence of a tumor.
Rufer was referred to a cancer specialist at the University of Washington Medical Center in Seattle for more extensive tests. Though scans showed no sign of a tumor, her HCG level continued to be alarmingly high. Doctors diagnosed her with cancer, and she began chemotherapy immediately.
"I looked like a completely different person," says Rufer. "I was grey in color … I had a lot of people call me sir because they thought I was a man … I was sick all the time."
Chemotherapy continued for four months, 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."
Rufer is not the first to have blood pregnancy test results indicate a false positive.
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," he says.
In numerous statements to ABCNEWS, Abbott insists its test is no more prone to false positives than any other test on the market. The company says Cole's conclusions are seriously flawed, that the problem is extremely rare and its test is FDA approved only as a pregnancy test.
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 and that Rufer's doctors should have known about it. Abbott points out that the test kit insert describes the potential problem as well.
The doctors, however, say it was not widely known about and say the inserts typically go to the labs rather than to the doctors. Just who is responsible for Rufer's tragedy will be sorted out next week as her case goes to trial.
But Rufer still wonders how many other women have suffered like she has. "I just don't want this to happen to anyone," she says.