Abbott Lab's Warning to Physicians Regarding Flawed Test Results ''Horribly Overdue'', Says Luvera Law Firm.

Business, Health & Medical Editors

SEATTLE--(BW HealthWire)--Nov. 12, 2001

False-Positive Can Lead to

Unnecessary Chemotherapy and Hysterectomies

In sharp contrast to earlier statements, Abbott Laboratories (NYSE:ABT) today released a strongly worded letter to thousands of medical professionals across the country warning that results from one of its most commonly used tests could produce flawed results, potentially causing women to undergo unnecessary procedures including chemotherapy and hysterectomies, attorneys said.

The letter comes on the heels of a recent court decision in which Jennifer Rufer, a 25-year-old Washington state woman was awarded $16.2 million after she needlessly underwent a hysterectomy, chemotherapy and had portions of her lung removed before it was discovered the Abbott test was wrong.

The Abbott B-hCG test is an immunoassay that medical professionals use to screen for a variety of medical conditions and diseases. Among other uses, it is commonly used to determine pregnancy.

Joel Cunningham, a partner with the Luvera Law Firm and one of the attorneys who tried the case with lead attorney Paul Luvera, said the declaration by Abbott was an appropriate step to take, but one that was "horribly overdue."

"When we filed our suit on behalf of Jennifer Rufer in 1999, Abbott's reaction was caustic and dismissive; they claimed that lawsuits against Abbott were 'frivolous and without merit' and went as far as to say that the suits were an 'attempt to profit at the expense of patients.'"

Cunningham said Abbott's public behavior began to shift as women began coming forward with claims. "In January of this year, Abbott Labs sent out a letter to a limited number of pathologists suggesting that results from the tests be cross-checked with other tests," he said. "Now, Abbott is pulling the fire alarm and sending warning letters to hundreds of thousands of physicians."

"Abbott is finally providing the warning to physicians that we implored them to issue years ago," he added. "Unfortunately for Jennifer Rufer -- and countless other women across the country -- the company's admission is a ticket for a train that has already left the station."

According to Luvera, it has been Abbott's position for more than a decade that it did not need to expand the warnings it had given doctors or labs, an assertion Abbott's attorneys used as a cornerstone of its defense in the Rufer case. "We argued the contrary, that Abbott had a legal, moral and ethical obligation to issue a broad alert about the danger of false positive results to a wide range of healthcare professionals."

Luvera noted that even after the jury found against Abbott, company attorney and spokesman Brad Keller continued to insist that additional warnings were unnecessary. "Now Abbott has done a complete about-face and provided the very information that its experts and attorneys claimed was unnecessary."

Abbott is currently facing numerous lawsuits based on similar claims, including at least one class action.

About the test

The Abbott test measures human chorionic gonadotropin, or hCG. Known as the "pregnancy hormone," elevated hCG is recognized throughout the medical community as a reliable way to determine pregnancy, including ectopic pregnancy.

However, elevated hCG levels in the absence of normal or ectopic pregnancy is routinely considered evidence of trophoblast disease, a deadly form of cancer. It is considered so deadly that if elevated hCG levels persist without any sign of pregnancy, physicians often immediately order chemotherapy. If elevated hCG levels still persist after chemotherapy, physicians often recommend hysterectomy to stem the spread of the cancer.

ED NOTE: Joel Cunningham is available for interview by contacting Mark Firmani at 206-849-9357 or [e-mail]. Background materials are also available to accredited media.