Lab Is Charged in Deaths; Pap Test Errors Are Cited

A suburban Milwaukee laboratory was charged on Wednesday with reckless homicide in the deaths of two women whose Pap smears were allegedly misread at a time when each had cervical cancer.

It is extremely unusual for medical professionals to be prosecuted as criminals when they are accused of negligence. Such cases are more commonly decided by civil lawsuits--the families of the two women have already agreed to multimillion-dollar settlements--or by regulators.

“We went through the malpractice crisis. Now are we on the edge of the criminal prosecution crisis?” asked Arthur Caplan, director for the Center of Bioethics at the University of Pennsylvania. “If hospitals and doctors were fearful before, now they’re going to be on the edge of complete paranoia.”

With Wednesday’s criminal charges against Chem-Bio Corp., Milwaukee County Atty. E. Michael McCann carried out the last request of Karin Smith, a 29-year-old certified public accountant from Nashotah, Wis., who died March 8. She had testified before the U.S. Senate Labor and Human Resources subcommittee the previous month, describing what happened after three Pap smears were characterized by Chem-Bio as normal.

Dolores Geary, a mother of three who died in 1993 at age 40, also had two Pap smears reported by Chem-Bio as normal. During a hysterectomy in 1991, she was found to have advanced cancer of the cervix. Geary was from Oak Creek, the suburb where Chem-Bio also is located.

Experts testified during a three-day inquest last week that the slides of both women’s Pap smears showed obvious signs of cancer. When detected early, cervical cancer is curable.

Each of the two charges carries a maximum penalty upon conviction of a $10,000 fine and 10 years’ imprisonment.

On Monday, the six-member inquest jury also recommended homicide charges against the laboratory director, Robert Lipo, and the technician, June Fricano, who read the Pap smears in both women’s cases.

But McCann decided to defer prosecution against the two for six years if they abide by agreements negotiated on Wednesday.

Lipo is prohibited from acting as a medical director at any lab and from supervising technicians who test tissue. “He is very pleased,” said his attorney, Patrick J. Knight.

Fricano will not accept employment as a cytotechnologist where she is paid for each slide, as she was by Chem-Bio, and she will obtain continuing education. Fricano, who has 30 years’ experience, is currently working as a cytotechnologist for another lab, said her attorney, Dennis Coffey.

“Obviously, she’s distraught about what happened with the ladies,” Coffey said. “She made errors, which we all make. . . . She’s also helped save a lot of people. I don’t think that stigmatizing people as criminals is the answer.”

Martin Kohler, the lawyer for Chem-Bio, said the decision to prosecute the company is “unfortunate.”

“Everyone knows that this is a tragic situation, but it does not belong in criminal court,” Kohler said. He added: “Every health care provider in America . . . will be put on trial. . . . The end result is that the health care delivery system is being sent a chilling and negative message.”

Several experts in medical ethics were not surprised, nor were they critical.

“The existence of the (civil) law doesn’t supersede the interest society has in deterring such conduct,” said Alexander M. Capron, director of the Pacific Center for Health Policy and Ethics at USC. “The message is not only is your insurer going to pay damages, but you may go to jail.”

Caplan, noting several recent cases of criminal prosecutions of physicians, said: “It’s a change in attitude--that medicine is less a profession that can be trusted to regulate itself and more as just another business. . . . “

Smith and Geary belonged to the same health maintenance organization, Family Health Plan, which contracted with Chem-Bio for analysis of Pap smears. Lipo, the company director, was also a board member of Family Health Plan. He no longer sits on the HMO board, Knight said.

A 1987 Pap smear from Geary was reported as normal, as was another one later. Billy J. Bauman, medical director of the Dane County Cytology Center, testified at the inquest that there were a large number of malignant cells on the 1987 slide.

The results of 1988 and 1989 Pap smears from Smith also showed “unequivocal” indicators of cancer, Bauman testified. Biopsies also were misread, Coffey said.

Smith’s cancer was diagnosed in 1991 when she saw a physician outside Family Health Plan.

“I’m married to a wonderful man, but I’ll never bear his children,” Smith said tearfully in a Washington hearing room in February. “My parents will outlive their youngest child.”

Researcher John Beckham from Chicago contributed to this story.