(CNSNews.com) - The abortion clinic that administered the drug RU-486 to a Tennessee woman allegedly failed to diagnose a life-threatening medical condition, resulting in her death, according to a malpractice lawsuit filed by the deceased woman's estate.

Brenda A. Vise, a 38-year-old Hamilton County, Tenn. resident, died on Sept. 12, 2001, the lawsuit alleges, from a massive infection resulting from a ruptured ectopic (tubal) pregnancy, five days after she visited the Knoxville abortion clinic and began taking the RU-486 drug combination.

The Food and Drug Administration (FDA) warns that women with tubal pregnancies should not take RU-486. The drug combination will not abort a tubal pregnancy, which must be treated by medical therapy or surgery to prevent rupture, according to the American College of Obstetricians and Gynecologists (ACOG).

Ectopic pregnancy is a "major health problem for women" and, in the United States, is the leading cause of pregnancy-related death during the first trimester, ACOG states in its guideline pamphlet for obstetricians and gynecologists.

But in the case of Brenda Vise, the abortion clinic allegedly missed several opportunities to diagnose her condition and recommend appropriate medical care, according to the lawsuit filed in Hamilton County Circuit Court on Aug. 2. Vise was six weeks pregnant.

"The boyfriend who went with [Vise] said they (the abortion clinic) did the ultrasound and ... said, 'we don't see any fetus in the uterus, but that's not unusual. This is an early pregnancy,'" said plaintiff's attorney Hoyt O. Samples.

"The clinic should have properly performed an ultrasound, and if they had properly performed the ultrasound, they would have realized there was no fetus in the uterus," Samples alleged. Combined with a positive pregnancy test, the absence of a fetus in the uterus would have provided a near certain signal of a tubal pregnancy, Samples said, "and [the clinic] should have immediately referred her to appropriate medical care."

The clinic "never discussed the possibility of a tubal ectopic pregnancy at all, but that is a classic sign of [a] need to look further," said Samples. Instead, he said, "They went ahead and gave her the first pill, the RU-486 pill," Mifeprex.

After Vise was prescribed Mifeprex on Sept. 7, 2001 and returned home, she began to experience severe pain and bleeding, which worsened over several days, the complaint alleges. She placed "multiple" calls to the clinic as her condition worsened but "was advised that her symptoms were normal and routine," according to the lawsuit.

"Then when the symptoms got really bad, they said, 'well, bring her to Knoxville [where the clinic is located], don't take her to a place in Chattanooga [where Vise lived], because they don't know anything about these drugs there,'" said Samples. "All that's in contravention of the protocols from the manufacturer and FDA."

Two doctors, Edgar E. Perry, M.D. and Richard O. Manning, M.D, are also targeted in the lawsuit, because, according to the complaint, they "are responsible for attending to the medical needs of the clinic's patients and ensuring that appropriate care and advice are made available to the clinic's patients."

Perry was served the complaint on Aug. 22, according to a spokeswoman for the Hamilton County Circuit Court, but neither Manning nor the clinic had been served the complaint as of Friday, Aug. 30. The defendants have 30 days to file a response.

Officials at the Volunteer Women's Medical Clinic in Knoxville declined to comment on the pending lawsuit. But according to Samples, the clinic disputes the allegations made by Vise's boyfriend described in the complaint.

The clinic, Samples said, claims that it responded to Vise's call for medical advice by urging her to immediately go to a doctor in her hometown of Chatanooga.

Also, said Samples, the clinic claims the ultrasound did show a fetus in the uterus, which would indicate a normal pregnancy.

According to ACOG, ectopic pregnancies account for just two percent of pregnancies and nine percent of all pregnancy-related deaths. But the actual number is probably higher, ACOG believes, because ectopic conditions diagnosed and treated in physicians' offices are under-reported.

Dr. Steven Ory, a Florida obstetrician affiliated with ACOG, said that absent specific clues, doctors do not have a reason to check for ectopic pregnancies. "Often times there are no early signs for an ectopic," he said. "We usually direct [diagnostic efforts] to women we recognize are at risk for an ectopic pregnancy."

At highest risk are women who have had a previous ectopic pregnancy, anyone who's had a history of a tubal infection, an inflammatory disease, or other tubal surgery, Ory said. Infertility also puts women at a little higher risk of ectopic pregnancy, according to Ory.

"Other women who [report] abnormal bleeding in early pregnancy or pain would be at high risk," said Ory. "Those would be the two cardinal symptoms, bleeding and pain."

If a doctor performs an ultrasound and no fetus is visible, as the Vise lawsuit alleges, "the most probable diagnosis [is] that the patient has a pregnancy in the uterus that's not developing normally," said Ory. "There's placental tissue ... making the pregnancy hormones; it's growing to a certain point, but there's no baby associated with that."

Under those conditions, Ory said, his first guess would not be an ectopic pregnancy but, rather, some other abnormal form of pregnancy. However, if a subsequent hormone test showed pregnancy and an ultrasound failed to show a fetus within 35 days after the last menstrual period, "the absence of that would suggest an ectopic."

Dr. Beverly Winikoff, director of reproductive health for the Population Council, the group that spearheaded the effort to gain FDA approval of RU-486, said she knows of no problems experienced by doctors at abortion clinics in diagnosing ectopic pregnancies before administering RU-486.

Winikoff estimates that about 100,000 American women have used Mifepristone so far, and since ectopic pregnancies account for one to two percent of all pregnancies, "in theory you would say that would be between 100 and 200 ectopics" among women seeking chemical abortions. "So all the others were either caught or dealt with properly," she said.

"You can see that not much is going wrong because you would expect 100 to 200 such cases that came from Mifepristone, and you haven't heard of 100 to 200 disasters; you've heard of one," said Winikoff.

The effects of RU-486 are ordinarily felt very soon after taking the drug, Winikoff said, and it is not normal for pain and bleeding to begin several days after the drug is taken.

If that happens, "it's very easy to figure out that something is wrong," she said. "And then it depends on the diagnostic skill of the clinic. If you figure it out wrong, that's a problem; that means your competence is not very high."

As per FDA regulations, said Winikoff, physicians prescribing RU-486 must certify that they understand ectopic pregnancies and know how to diagnose them.

The suit against the Volunteer Women's Medical Clinic is seeking $5 million in compensatory damages and $10 million in punitive damages "to deter defendants from further acts of gross or wanton negligence."