Abbott attorney responds to UWMC's allegations

When jurors in the King County Superior Court ruled on June 29 that both the UW Medical Center (UWMC) and Chicago-based Abbott Laboratories were responsible for the misdiagnosis that led to Jennifer Rufer's unnecessary hysterectomy, both defendants in the case maintained the other was a fault.

Rufer, who now cannot bear children, plans to have a family via a surrogate mother, a medical procedure that can cost thousands of dollars. Both Abbott and the UWMC were ordered to pay Rufer and her husband $8.1 million each, but Abbott plans to appeal the decision. According to Bradley Keller, a Seattle-based attorney defending Abbott, that process could take at least two to three years.

Officials at the medical center hoped to settle the case as soon as possible, so that Rufer could begin undergoing treatment for having a child. The medical center claimed it may get dragged along in the appeal process, and that this could delay when Rufer begins starting her family.

"The UW doesn't have to appeal if it doesn't want to," said Keller. "It can write a check to the Rufers tomorrow so that they could go on and have their family."

The majority of the debate in court revolved around which party was responsible for the misdiagnosis. The medical center claims a device manufactured by Abbott (known as the AxSym BHCG pregnancy test) that was used to diagnose Rufer was defective.

According to Dr. David Eschenbach, acting chair of the department of obstetrics and gynecology, the UWMC never received any information from Abbott Laboratories about the possibilities of false-positive readings from the Axsym BHCG test. When the medical center contacted the company asking about the possibility of false positive readings, the company never responded, according to Eschenbach.

Keller said there was "an enormous amount" of literature available for doctors concerning the possibilities of false positive readings with the device, and that a pamphlet insert accompanying the device also notes the potential risk. He added that Abbott has no record confirming that someone from the UWMC called about the device.

According to Keller, internal e-mails from the laboratory at the medical center show lab technicians were aware of the inconsistent test results in October 1998, but these e-mails were not forwarded to Rufer's physician, Dr. Hisham Tamimi, a gynecological oncologist.

"All of this could have come to a screeching halt in October of that year," said Keller. The UWMC laboratory "did not take the time to pick up the phone and let the treating physician know what it was learning in its own lab."

Keller said Tamimi had a file in his desk that illustrated the possibilities of false positive readings with the test. This evidence was brought up in court, according to Keller.

Although the court did rule that Abbott was partially responsible, the pregnancy test was not found by the jury to be faulty.

"The safety and the efficacy of the BHCG diagnostic test has been affirmed. Criticisms (that the test was faulty) were rejected by 12 fair-minded people who listened to all the evidence from both sides," said Keller.

Eschenbach said the UWMC will no longer be using the AxSym BHCG test.

According to Keller, since the case began in 1998, the company has taken additional steps to warn the medical community about the possibility of false positive readings. Abbott educated customer-service representatives about the possibility of false positive readings in order to assist those who call the company, and has sent out warning notices to doctors across the country. Keller said all of this is supplemental information already available to the UWMC.

"Not withstanding all the medical literature, not withstanding its package insert, there are some people that claimed they didn't know about it," he said.