n December 26, 1996, when the Hon. Robert E. Jones of the U.S. District Court in Portland threw out all testimony provided by expert witnesses on both sides of Hall v. Baxter Healthcare Corporation, heads turned. It was the first time new rules governing the admissibility of scientific testimony as evidence established by the United States Supreme Court decision in Daubert v. Merrell Dow Pharmaceuticals had been applied.* A ripple effect is expected in courtrooms across the country. |
Ronald McClard, Arthur F. Scott Professor of Chemistry at Reed, left his print on this precedent-setting trial, as did the three other expert panelists selected to serve the court. McClard--along with Merwyn R. Greenlick, an epidemiologist at Oregon Health Sciences University (OHSU); Robert F. Willkens, a rheumatologist with a private practice in Seattle; and Mary Stenzel-Poore, an immunotoxicologist at OHSU--were brought together by Richard Jones, a biochemist at OHSU who assisted Judge Robert Jones in the evidentiary aspects of the trial. The biochemist's charge was to hand-pick an ensemble of objective expert panelists from relevant areas of science who could take the scientific testimony of expert witnesses and determine whether or not it was reliable. From this determination, the judge would rule on the admissibility of the testimony.
This unprecedented procedure brought Hall v. Baxter Healthcare Corporation into a national spotlight. The complaint was not unlike scores of others that have been leveled against manufacturers of silicone-gel breast implants for women in an attempt to link leakage of the polymer in human tissue to autoimmune disorders. But the new mandate for providing the court documented methodology, along with research conclusions in matters of science and technology, was now to be exercised.
McClard says he welcomed the opportunity to see the courts at work from an objective vantage point. The toxicology of silicone-gel breast implants was, however, not something he had previously considered. "I'd never given this matter any thought--I had no predisposition, other than my usual suspicions of large corporations. I was interested in the evidence and its intrinsic merit."
In 1992 David Kessler, commissioner of the U.S. Food and Drug Administration, banned silicone-gel-filled breast implants on the grounds that manufacturers had not fulfilled their responsibility to demonstrate the safety of the implants. Dow Corning, Bristol-Meyers Squibb, Baxter International, Bioplasty, Inc., Mentor Corporation, and Inamed (once owned by 3M) have spent millions of dollars in legal fees defending the honor of their product in suits brought to the courts by women who attribute disorders of virtually every description to silicone leakage in their systems. The complaints, which range from aches and fatigue to serious, chronic conditions, are well documented. Unfortunately for these women, there is no proof to date that will withstand scientific scrutiny.
Presented with a staggering amount of written and videotaped testimony, closing arguments, transcripts, and scientific papers for this as well as prior implant cases, the panelists were asked to evaluate the scientific literature and testimony, together. "That, I think, was the real strength of this method--we were able to see what they had actually written," says McClard. In the beginning, McClard admits to being somewhat overwhelmed. "The first thing I did was perform triage. Anything that wasn't actually dying, I didn't touch. If it was rheumatology, immunology or some other 'ology,' I ignored it."