There is no 

scientific evidence

to show that 

women with 

silicone implants 

have a signifi-

cantly elevated 

probability of 

suffering from 

classical diseases.



Judge Jones Recent Ruling in the Silicon Breast Implant Case
 By Laura Graser 

Laura Graser is an O4R member and attorney specializing in appeals. She also teaches law classes at Portland Community College and Lewis and Clark Law School.

There was recently an interesting ruling by a local judge in the breast- implant litigation: The Honorable Robert E. Jones, a federal trial judge in the District of Oregon sitting in Portland, ruled in December of 1996. His ruling has since received a good deal of national press. This is a summary of the case, written by a lawyer with no special expertise or opinions in the area, with light editorializing which should be apparent.

     Many women with silicone breast implants have sued many breast implant manufacturers, in both state and federal courts. The federal cases have been loosely consolidated and are being coordinated by a federal judge elsewhere. He has sent groups of cases back for trial to the places where they were first filed. Judge Jones was assigned the cases filed in the District of Oregon (all of Oregon is in one federal district). Some Oregon women have also filed in Oregon state court, and those cases are not directly affected by Judge Jones's ruling, but I expect his ruling will be very influential to the state judges. Judge Jones grouped his cases together under the name Hall v. Baxter Healthcare Corp, 92-182-JO-LEAD (D. Or. 1996).

     The plaintiffs include two groups: those who claim their implants ruptured, and those who claim their implants are intact but the silicone got into their bloodstreams and caused "atypical connective tissue disease" (ACTD) with symptoms including headaches, fatigue, joint pain, and confusion. The women claiming their implants ruptured are not a part of this ruling. (They may have good cases; implants are not supposed to rupture.)

     Women get breast implants for two reasons: reconstructive surgery and cosmetic surgery. The reason for the implant is not legally relevant.

     To win their case, the plaintiffs must prove, by a preponderance of the evidence, that the implants are defective and caused their symptoms. They must present experts to explain the causation.

     The federal rules of evidence require that a judge, alone, decide if evidence is legally appropriate for the jury to hear. A 1993 US Supreme Court case, Daubert v. Merrell Dow [Daubert I, 509 US 579 (1993)] and its Ninth Circuit offspring [Daubert II, 43 F3d 1311 (9th Cir 1995)] lay out the rules for the judge in these non-jury hearings. The judge must act as a "gatekeeper" - keeping out evidence that is not admissible. In these cases Judge Jones ordered all the plaintiffs and all the defendants to submit transcripts and reports to show that silicone implants do - or do not - cause the described injuries. He appointed independent, neutral advisors to evaluate the evidence, and he chose experts in the fields of epidemiology, immunology, toxicology, rheumatology and polymer chemistry. The parties submitted questions to the experts, and there was a four-day hearing with witnesses and legal argument, all of which was videotaped.

     Pre-trial rulings are very common, and independent experts are used from time to time, but Judge Jones's elaborate process is very unusual; it may be unprecedented in this form.

     Meanwhile in federal court in New York City, two judges are using a somewhat different procedure to evaluate the evidence. This will take some time, and Judge Jones's December 1996 ruling will be provisional until the hearing in New York is over. "My decision will only be changed in the unlikely event that new scientific research would require such modification" he wrote, adding that he is not in any way bound by the court in New York.

     The federal rules of evidence permit an expert to testify about "scientific, technical or other specialized knowledge" if it will help the jury understand the case. The judge determines the qualifications of the proposed expert, to determine if the proposed testimony is "scientific knowledge" and if it is sufficiently reliable to be used. "Proposed testimony must be supported by appropriate validation" and must be "trustworthy." It also must be relevant to the case at hand, that is, it must "logically advance a material aspect of the case."

     Judge Jones ruled that the breast implant plaintiffs flunked both tests: Their proposed evidence was not "trustworthy" (scientifically valid) nor was it "relevant."

     To determine trustworthiness, the court applied a multi-factor test (lawyers love multi-factor tests). The court considered:

     1. Whether the theory is generally accepted in the scientific community, or whether a significant minority has accepted it, with good reasons.

     2. Whether it has been subjected to peer review.

     3. Whether it is testable, and has been tested.

     4. What is the potential rate of error.

     5. Whether the information came from pure research, or for the purposes of testifying. (This last factor seems slippery to me, as a great deal of good research is sponsored by commercial ventures).

     To determine if evidence is relevant, that is, whether it fits the case at hand, the court is not so factor-based. Judge Jones explained by means of an example: If a certain chemical causes a certain disease in rats, that does not automatically mean that information is relevant or "fits" the question of whether it causes disease in people. There must be good ground to extrapolate.

     The court also noted that an expert must be able to state the causal connection in terms of probability or certainty. The court must scrutinize the validity of the reasoning leading to the expert's conclusions before the expert's testimony can be heard by a jury.

     In the implant cases, the plaintiffs' theory of causation they call "bioplausibility." They claim silicone is released through "gel bleed" and migrates throughout the body, causing a dangerous autoimmune response and systemic disease (ACTD). The most the plaintiffs' expert could say about ACTD is that, "we are back at the beginning of formulating suitable hypotheses to test." In sum, ACTD is not a disease, it is an alleged disease. There is no "signature" disorder in ACTD. Thus, there is no scientific basis for expert testimony about ACTD, and no witness will be permitted to testify about it.

     Also, there is no scientific evidence to show that women with silicone implants have a significantly elevated probability of suffering from classical diseases. No epidemiological evidence will be permitted. As to plaintiffs' epidemiology expert, Judge Jones all but called him names. It is noteworthy to me that some of the plaintiffs' experts have very impressive credentials. Judge Jones also discussed and discarded plaintiff's immunology and chemistry witnesses, finding there was insufficient proof that silicone degrades into silica in the body and thus no proof that silica causes a reaction in the body. He concluded that plaintiffs cannot show that silicone generally causes disease, so necessarily they cannot show it caused disease in a specific person. Thus, the plaintiffs are out of court. I assume they will appeal. There are a good many people, lawyers and clients, who really believe in these cases.

     Judge Jones was on the state trial bench in Multnomah County for many years, and then was on the Oregon Supreme Court. He was appointed to the federal trial bench about five years ago. He has taught "Evidence" at Lewis and Clark Law School for years, to hundreds of now-lawyers, including myself. He is considered an evidence law expert. He is one of the most energetic people I've ever met; he is a man who loves his job. He says what he is thinking, has lots of ideas, and implements them. These are unusual traits in any judge, particularly in a federal judge, as federal judges are appointed for life and tend to get grey over the years.

     As a middle-aged woman without breast implants, but with headaches, fatigue, joint pain, and confusion on a regular basis, the plaintiffs' "ACTD" theory seems pretty bogus to me. However, we should not get carried away by the "anti-junk science" bandwagon. The tobacco companies have been saying for years that smoking does not cause cancer, but smoking and cancer is not, I venture, a "junk science" correlation.

     We are learning things all the time - some judge somewhere had to be the first to accept DNA evidence. Also, there is information being developed that may prove to be significant after further research. For example, in studies I've read, some 80% of people on death row probably have documentable frontal lobe (brain) abnormalities. What does that mean? My answer: I don't know what it means, but that doesn't make that "junk science" (and we should keep trying to determine if it means anything).

     The topic of "junk science" is very politically charged, as the plaintiff in a defective-product case is typically a "little guy/gal" and the defendant is typically a "big corporation." And we should not dismiss novel theories out of hand.

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 2001 Oregonians for Rationality