Oregon judge bars experts from testifying that breast implants cause disease.

Women suing breast implant manufacturers over illnesses allegedly caused by the devices have been barred by a federal judge in Oregon from presenting evidence of a connection between the implants and disease. The Portland judge said the research on which the experts would base their testimony was scientifically invalid.

Ruling in December after a four-day "science hearing," U.S. District Judge Robert Jones held that the plaintiffs could not present evidence that the implants cause atypical connective tissue disease or any other systemic illnesses. He also prohibited testimony supporting their claims of emotional distress from fear of becoming ill in the future. (Hall v. Baxter Healthcare Corp., No. 92-182-JO (D. Or. Dec. 18, 1996).)

Jones held that the testimony should be excluded because it did not show a probability that breast implants cause the diseases from which the women allegedly suffer. He said the plaintiffs' assertion that the implants cause new varieties of immune system disorders, as the experts had planned to testify, was "at best an untested hypothesis" and therefore could not be presented to a jury.

Jones is overseeing some 70 Oregon cases, which would largely be ended by his ruling if it is upheld on appeal. He acknowledged the effect of his order, saying he was "mindful that this opinion goes farther in evaluating and in eliminating plaintiffs' claims than any other opinion in breast implant litigation pending in this country."

The decision marked the first time a federal court has barred scientific testimony on implants because it found that the evidence could not satisfy the requirements of the U.S. Supreme Court's decision in Daubert v. Merrell Dow Pharmaceuticals, Inc. (113 S. Ct. 2786 (1993).) In that case, the Court held that federal judges must act as "gatekeepers," assessing which scientific evidence is reliable enough to be heard by a jury.

Fredric Ellis, a Boston attorney who has represented breast implant plaintiffs and participated in the Oregon hearing, said Jones "totally misconstrued" his role as judge as defined in Daubert.

"The judge totally blurred the distinction between the experts' methodology and the experts' conclusions," Ellis said. Under Daubert, courts must determine whether experts used scientifically valid methods to reach their conclusions, he said, but it is the jury's job to weigh the evidence and decide whether it proves causation.

"I think it's clear that this opinion will not stand," Ellis said.

He added that the Oregon ruling conflicts with decisions of other federal courts allowing causation evidence, notably a 1994 Ninth Circuit ruling that upheld the admissibility of expert testimony in breast implant litigation. (Hopkins v. Dow Corning Corp., 33 F.3d 1116 (9th Cir.1994).)

"The distinction between methodology and conclusions is difficult for some judges to comprehend," Ellis said. "That's the danger of the [Daubert] decision."

Jones stayed his order, saying he would wait for a decision on the admissibility of scientific evidence by Judge Sam Pointer Jr., who is overseeing the federal breast implant multidistrict litigation (MDL) in the Northern District of Alabama. Last spring, Pointer named a panel of experts to help him address scientific issues in the MDL. (Court Orders Search for Neutral Experts in Breast Implant Litigation, TRIAL, Aug. 1996, at 15.) A ruling from Pointer is not expected for at feast several months.

Ellis said that since Jones's order is not final, it does not appear that the plaintiffs can appeal it now, although they plan to do so in the future.

In the meantime, the court allowed the Oregon women to proceed with their claims for local injuries caused by ruptured implants, such as breast disfigurement and muscle damage.