Maker of flawed AIDS test should have warned public



NEWARK, N.J. (AP)—The maker of a flawed blood test once used by most hospitals and blood banks had an obligation to warn the public it might not always detect the AIDS virus, a state judge has found.

The ruling allows an infected Bergen County woman to continue her lawsuit against North Chicago, Ill.-based Abbott Laboratories. Abbott’s test was revised after the woman received tainted blood during hip surgery in September 1986.

Abbott’s new test, approved in January 1987, is used by about three-fourths of the nation’s hospitals and blood banks, including the American Red Cross, according to the company.

The 42-year-old Ridgewood woman now suffers from AIDS-related complex, but has not developed ‘‘full-blown AIDS,’‘ said George T. Baxter, her lawyer, who asked that her name not be used.

Her husband and two children have not contracted HIV, the virus that causes AIDS, he said Thursday.

The woman contends Abbott knew of questions about the test’s ‘‘sensitivity’‘ at least five months before her operation and was negligent in not alerting the public. She is suing Abbott and the Bergen County Blood Center.

Abbott representatives and attorneys did not return repeated telephone messages seeking comment.

Other lawsuits from infected people also are pending against Abbott, and one lawsuit names the Red Cross.

In the Bergen County case, Abbott asked a state court to dismiss the complaint, contending the lawsuit is pre-empted by federal regulations governing medical devices.

In a Nov. 30 ruling, state Superior Court Judge Anthony J. Sciuto found that Abbott did not adequately explain ‘‘false negatives’‘ on the information it provided with the tests.

In a ‘‘false negative,’‘ a test fails to detect HIV infection. The woman had a blood test after it was learned that her transfusion was tainted. A second test after the donor returned to the Bergen blood bank was positive for HIV.

Correspondence between Abbott and the U.S. Food and Drug Administration, which licensed the test, ‘‘conclusively’‘ shows the company knew about the test’s deficiencies five months before the woman’s surgery, the judge said.

‘‘While Abbott investigated the problem and sent the FDA a proposed statement to be included in the package insert, they cannot escape liability. Abbott continued to manufacture, market and distribute the screening test without warning against the sensitivity problem,’‘ the judge wrote in a 10-page ruling.

The Abbott test was approved in March 1985, the first license granted in the United States to determine the presence of the AIDS virus.

A Chicago Tribune investigation determined Abbott, the FDA and the Red Cross learned of problems with the test in spring 1986 from researchers at the California Department of Health Services in Berkeley.

The California data was turned over to Abbott and researchers began working with the company to correct the test. Another researcher at the National Institutes of Health also discovered the problem and presented his findings to the FDA in May 1986.

The Red Cross debated whether to drop the test, a congressional probe found, but eventually decided it would create more errors by switching tests.