Patients try to tie ailments to Duke

A 35-year-old single mother from Wake Forest has gone through 20 doctors and can't regain the nearly 30 pounds she has lost, even though she eats protein shakes each day.

A retiree, also from Wake Forest, can't get rid of skin rashes, diarrhea and disorientation. And in Raleigh, a 34-year-old woman has stopped working because the autoimmune disease that it took doctors more than two years to diagnose has debilitated her.

All three say they were generally healthy before they underwent surgery at Duke Raleigh Hospital in late 2004. They were among the 3,648 patients exposed to surgical tools inadvertently washed in hydraulic fluid. All three blame that exposure for their illnesses.

The frustration with their illnesses was exacerbated recently with the release of a study claiming that patients weren't harmed by exposure to the tainted surgical tools.

Meanwhile, the three-year statute of limitations for potential litigation expires in a few months. Though hundreds of patients initially sought attorneys after Duke notified them of the fluid mishap, just one so far has sued Duke. Several patients did file suit against the elevator company and the medical supply distributor involved in the mix-up.

Duke health officials say the latest study -- conducted by an independent firm -- proves that patients exposed to the hydraulic fluid suffered no more health problems than would be expected in the general population.

A UNC scientist says the study is incomplete.

Steve Marshall, an epidemiologist and biostatistician with UNC-Chapel Hill's School of Public Health, questioned why the study didn't compare the Duke patients with a similar group not exposed to the hydraulic fluid.

The study, conducted by PharmaLinkFHI, evaluated the medical records of those 3,648 patients who had surgeries at Duke Raleigh and Durham Regional hospitals in November and December 2004, when the tainted surgical tools were in use. It also looked at those patients' medical records from subsequent visits to Duke's hospitals and clinics and determined that 89.5 percent of patients exposed to the fluid had no major clinical problems in the two years after the fluid mix-up.

The remaining 10.5 percent -- 383 patients -- reported problems such as infections, new malignancies, hospitalizations or autoimmune diseases. There were 67 reported deaths. Duke said that given the average age of the patients, those illness rates were within a normal range.

Marshall, the UNC-CH scientist, said the picture is incomplete without comparing Duke's patients to a separate, demographically similar group never exposed to the hydraulic fluid.

"What you have is half an answer," said Marshall, who tracked down the study after reading about it in the newspaper.

Study's limitations

Michael Cuffe, Duke University Health System's vice president for medical affairs, acknowledged that the PharmaLinkFHI study isn't as comprehensive as a formal research project. It was the best study Duke could produce given certain limitations, he said.

To do more exhaustive research, Duke would need consent and continuing participation from all patients who may have been exposed to the tainted surgical tools. That wasn't feasible, Cuffe said.

"Many people wanted to put this behind them," he said. "Others didn't trust Duke and wouldn't want to participate."

Duke commissioned the study -- which cost more than $1 million -- to track the medical records of all patients at the time of the exposure and the 81 percent of those who returned to Duke hospitals or clinics for more treatment, Cuffe said. He stands by the results.