JUNE 9, 1997
Malee Shay: the woman who wouldn't go away
by Deborah Stone
Woodinville resident Malee Shay's personal horror story of medical negligence made news last fall (Nov. 4, 1996 issue)when several newspapers and TV stations reported on her experience and subsequent testimony in front of the Food and Drug Administration.
Readers may remember that this 45-year-old woman's nightmare began three and a half years ago with a routine mammogram which led to what she claimed was an unnecessary stereotactic core breast biopsy at an Eastside radiology clinic. In addition to being misled regarding the nature and need for the procedure, Shay was used as a guinea pig for experimental data, denied access to her medical records, and traumatized by the fear she had breast cancer.
She began waging a one-woman battle researching and consulting with experts nationwide and eventually presented her case to the FDA, the American College of Radiology (ACR), the King County Medical Society, and the Washington State Medical Quality Assurance Commisssion, all of which dismissed her case. Only the FDA was responsive.
"They invited me to speak before the National Mammography Quality Assurance Advisory Committee last October where I told them of my experiences and the research I had done. I urged them to regulate this procedure to prevent overuse and also to ensure women are fully advised of their options. They need to do this because over 700,000 women have biopsies in one year in the U.S." Shay was told that her testimony changed the course of the meeting and brought the focus back to the patient.
After speaking before the FDA, she filed suit against the Eastside radiology clinic and the radiologist who performed the procedure for medical negligence, violation of the right to informed consent, fraud, misrepresentation, misdiagnosis, excessive radiation, and for breaking state law and not allowing her access to her medical records. Since then, the radiologist has left the area, and the clinic has undergone a name change.
Shay has also given the State Medical Quality Assurance Commission notice of her intent to appeal their ruling. She said, "I am very disappointed and angry with our State Board. It is supposed to be the medical disciplinary board for our state and is supposed to help protect the consumer. I perceive their mission as one of protecting the medical profession at all cost. They don't want to take action against physicians because they don't want a black mark against the medical system so as to keep up public confidence. Doctors dominate the licensing boards. They are there to protect doctors, really, more than consumers, no matter what they tell you publicly."
More notoriety came Shay's way recently in the form of an invitation to appear on an Oprah Winfrey Show that dealt with the topic "Medical Errors and the Risks Patients Can Encounter When Entering the Medical System." Shay was contacted a few weeks ago by the show's producer who received her name from Charles Inlander. Early in her research, Shay had contacted the People's Medical Society, and Inlander had offered support and guidance, as well as being interested in following the developments of her case. Inlander encouraged Oprah's producer to have Shay on the show. After being interviewed on the phone and sending numerous articles and documents, Shay went to Chicago to tape the show.
"People might think this would be exciting, but for me, it was a very scary thing. I hate flying, cameras, and speaking in public," Shay said. "This was not fun, but after giving up the last three and a half years of my life and thousands of dollars, I'm compelled to follow through and do this kind of thing."
According to Shay, the show's guests included several doctors, authors, attorneys, and patients, each with their own horror stories. It was very consumer-oriented and provided advice on safeguards for the patient. Several statistics were provided. The most shocking was that "180,000 people die each year from medically related negligence."
Even though Shay felt her contribution to the show was small, she said, "To be a part of the show with all these experts was the ultimate honor, and it's all part of helping improve consumer awareness."
Her next step has been to prepare a document to send to key legislators in Washington and Governor Locke and other organizations. It will include a timeline of events from 1993-1997, her FDA statement, articles, statistics, cases, and selected excerpts from medical consumer books and consumer advocacy groups that indicate what the consumer in the medical realm might face.
"The document is in response to the nonresponsiveness I encountered in my own experience. My hope is that a State Board can be constructed that actually does their job, but most importantly I will be arming consumers with information," said Shay.
What will eventually satisfy her? In response, she says, "My lawsuit has nothing to do with money," Shay said. "It has to do with accountability and showing the medical community that patients will stand up and challenge them. I am the woman who wouldn't go away."
The Oprah Winfrey Show that Shay appeared on will air in June.