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Chem-Bio
MISTAKES IN interpreting pap smears at this Wisconsin laboratory cost two lives, resulting in the first case of criminal prosecution for lab errors. In 1996, the lab was fined $20,000 for missing signs of the cervical cancer that killed Dolores Geary and Karin Smith. Family Health Plan, a regional health maintenance organization (HMO) contracted with Chem-Bio for processing of medical samples.
Questions would later be asked about the influence of one Chem-Bio co-owner, Dr. Robert Lipo, who also sat on the board of Family Health Plan. The tests processed by Chem-Bio included routine Pap smears: testing of cells scraped from the cervix for signs of cervical cancer. With early detection, cervical cancer is virtually always curable, according to the National Cervical Cancer Coalition.
Chem-Bio's labs, also supervised by Lipo, seemed to meet the HMO's needs for speed, efficiency, and low cost. One source of Chem-Bio's efficiency may have been a policy of paying cytotechnologists, such as June Fricano, on a piecework basis, with pay depending on the number of slides processed. Fricano, who had more than 25 years of experience, claimed to be able to read between 180 and 200 slides per day, well above the number suggested by professional guidelines. It was Fricano who misread Geary's 1987 and 1990 Pap smears, Smith's 1988 and 1989 pap smears, and Smith's 1989 and 1990 biopsies. Both women had cervical cancer that was not diagnosed until it was too far advanced for effective treatment. “There is strong evidence she [Fricano] never read any of the slides from Dolores Geary or Karin Smith,” declared Circuit Judge David Hansher in sentencing the Chem-Bio for reckless homicide.
Charges Filed
Criminal charges against Chem-Bio were the last step in the long road of litigation. In 1991, Geary, Smith, and their families filed civil charges for medical malpractice against Chem-Bio, Family Health Plan, and other defendants. Each family settled out of court: the Gearys for $3.5 million and the Smiths for $6.3 million. Only after the 1993 death of Geary, a 40-year-old mother of three, and the 1995 death of Smith, a 29-year-old accountant, did the Milwaukee County District Attorney consider criminal charges against Chem-Bio.
At an inquest hearing in April 1995, experts testified that the disputed slides showed clear evidence of cervical cancer. The six-person jury recommended pressing reckless homicide charges against the company and, separately, against Lipo and Fricano. Chem-Bio pled no-contest in December 1995. The state appeals court refused to hear Chembio's request for dismissal on the grounds that a corporation could not be charged with homicide. In February 1996, Judge Hansher exacted the harshest financial penalty allowed by statute: $10,000 per victim. Hansher characterized the penalty as “absolutely inadequate.”
Milwaukee County District Attorney E. Michael McCann boasted that he had been officially censured by the Medical Society of the State of Illinois. Lipo and Fricano avoided prosecution by negotiating agreements with McCann. Lipo promised that he would not supervise tissue testing or act as a lab medical director for six years. By 1997, he was teaching in the Department of Pathology at the Medical College of Wisconsin. Fricano, who had already found employment at another lab, promised to take additional training and to refuse any position that involved payment by the slide.
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