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A plaintiff whose silicone breast implants ruptured will not be able to present expert testimony that her alleged chest-wall and breast pain was caused by silicone gel, a Pennsylvania common pleas judge has ruled. “Testimony that silicone gel causes disease or pain is novel scientific evidence, the validity of which is not generally accepted in the scientific community,” wrote Allegheny County Common Pleas Court Judge R. Stanton Wettick, writing for the coordinating court for silicone-implant litigation. Accordingly, Wettick concluded, the testimony did not satisfy the test for scientific evidence set forth in U.S. v. Frye, and such testimony should be excluded. The impact of Wettick’s decision in Toledo v. Medical Engineering — on this case and others like it filed in state court — is unclear. That’s because there is an apparent discrepancy between the scope of the Frye motion filed by the defendants and the scope of the decision issued by Wettick. In the beginning of the 60-page opinion, the judge stated: “The issue raised by the Frye motion is whether plaintiffs may offer testimony that silicone gel causes localized pain.” However, as noted above, the judge concluded the opinion by stating that the connection between silicone gel and disease or pain is not generally accepted in the scientific community. “We have a status conference scheduled for Jan. 16,” said defense attorney Cynthia L. Brennan of O’Brien & Ryan. Brennan represented Dr. Amithaba Mitra, the surgeon who placed the implants in Jacqueline Toledo in 1986. “We’re hoping to get some clarity on the opinion then,” she said. Peter J. Hoffman and Elizabeth Howard of McKissock & Hoffman are co-counsel representing Mitra. Defendant Medical Engineering Corp., the manufacturer of the implant, is represented by Therese M. Keeley of McCarter & English. Toledo’s is represented by John P. Kopesky of Sheller Ludwig & Badey. His colleague, Stephen A. Sheller, said he likewise thought the court opinion was inconsistent. “This is a splitting of hairs that makes no sense to me,” Sheller said. “[Wettick] is saying you can have localized pain from everything but the [silicone] gel, and yet [a breast-implant recipient] can have inflammation from the gel which causes pain. “So I guess experts cannot testify that you get pain from the [silicone] gel, but that you can have gel implants that cause pain,” Sheller said. “I don’t understand it.” Sheller did not say what the firm’s plans were in response to the order but did say that Kopesky would be at the Jan. 16 status conference. CHEST, BREAST PAIN Toledo claimed she suffered from 11 conditions as a result of her silicone implants, including implant rupture; chest wall skeletal changes; loss of, or changes in, sensation of the breast or nipple; gel migration; and formation of a fibrous, hardened “capsule” of tissue, which formed around the implants. But the defendants only raised a Frye objection to two of the claims: “swelling of the breasts” and “acute and chronic chest wall pain.” Wettick noted the defendants did not object in the nature of a Frye motion to the other nine claims, and none of them were included in the opinion’s later discussion. That would seem to indicate that expert testimony would be allowed on these claims because they were not the subject of the Frye motion. However, the last sentence of Wettick’s opinion delivered a surprise. After discussing the scope of the defendants’ Frye motion, the scientific expert reports that the plaintiff presented, and three other recent independent reports, Wettick concluded the opinion by saying, ” … I am granting defendants’ Frye objections to expert testimony that any of plaintiff’s injuries or pain are the result of the body’s response to silicone gel.” And in the attached order on the following page, the judge reiterated, ” … defendants’ motion to bar plaintiffs’ expert witnesses from offering testimony that any of plaintiff’s injuries and pain are the result of the body’s response to silicone gel is granted.” Thus, if the word “injuries” encompasses Toledo’s other claims, Wettick’s order would seemingly prevent any of the plaintiff’s expert testimony. Defense attorney Brennan said she is happy with the decision either way, although she is anxious to find out exactly what it means for her client. “I’ve been waiting for this decision for 2-1/2 years,” she said. “It’s a great ruling that has the potential to impact many other [silicone breast-implant] cases in Pennsylvania.” According to Wettick, this case has been identified as the first case in state court scheduled to go to trial. ‘FRYE’ AND ‘BLUM’ The law in Pennsylvania on admissibility of expert scientific testimony is still governed by Frye, which bars the admissibility of expert scientific evidence until it has achieved “general acceptance” in the relevant scientific community. This stands in contrast to the later, more relaxed U.S. Supreme Court ruling in Daubert v. Merrell Dow, which substitutes a judicial determination of scientific reliability for the general-acceptance standard. The state supreme court’s Dec. 22 opinion in Blum v. Merrell Dow, a case which also involved a Frye motion challenging the admissibility of causation testimony, left the Frye rule in place. However, the court never addressed whether there must be general acceptance of scientific methodology, or of the scientific conclusion reached, in order to satisfy Frye. “In the present case, I will reach the same result,” Wettick said, regardless of whether the focus is on methodology or conclusions, or both. Toledo intended to use expert testimony for the following issues: � There was gel migration either from gel bleed or rupture. � Gel will migrate outside the implant and capsule to other parts of the body, including the chest. � There is a foreign body reaction to this gel that can result in severe, persistent inflammatory responses characterized by chronic granulomatous inflammation. � This bodily reaction results in adverse clinical and immunological manifestations, including persistent pain. “The dispute is over whether bodily reactions to the silicone gel produce adverse clinical and immunological manifestations, including persistent pain,” wrote Wettick. The defendants’ Frye motion did not challenge the testimony with regard to the first three statements, he said. SCIENCE AND STUDIES According to the opinion, the defendants did not argue that pain was out of the ordinary in a breast-implant case. To the contrary, the defendants said, pain was to be expected in implantation and explantation of a breast implant. They argued, however, that the cause of that pain was attributable to inflammation from a very normal “foreign body reaction,” which causes the immune system to form a “capsule” of thicker scar tissue around the implant. The defendants claimed that resulting pressure from a thickening of tissue, called “capsular contracture,” can cause pain as a result. At a status conference in September, the defendants claimed that none of the studies Toledo presented would support her claim linking silicone directly to pain. “When asked if it is defendant’s position that the ‘body does not react to silicone causing pain,’ counsel responded as follows: ‘That’s correct; it doesn’t react any more than it reacts to any other foreign material put in the body,’ ” Wettick wrote. Wettick said he reviewed the three major studies cited by the defendants: the Report of the Institute of Medicine, the report of the Independent Review Group, and the report of the National Science Panel, also known as the 706 Group. The IOM report was completed at the request of Congress in early 2000. The findings supported expert testimony of pain associated with capsular contracture, as well as gel migration. “However, the IOM report finds no support for the proposition that there is any relationship between silicone breast implants and any immune-related human health conditions, either local or systemic,” wrote Wettick. He noted the plaintiff’s counsel had also relied on the report. The IRG was organized in the United Kingdom by the Chief Medical Officer at the request of the Minister of Health. Its scope of review was similar to that of the IOM: to review the evidence relating to the possible health risks associated with silicone gel breast implants. The project, which “addressed the full array of associations between breast implants and various diseases and health conditions,” reached the same conclusions as the IOM report, Wettick said. That report concluded that, among other things, the overall biological response to silicone is “consistent with conventional forms of response to foreign materials, rather than an unusual toxic reaction.” The National Science Panel was appointed by Federal District Judge Sam C. Pointer, the coordinating judge for the federal MDL breast implant litigation. The panel’s task was to provide an independent assessment of the science involved in the litigation. This panel was asked not only to look at local complications such as disfigurement and capsular contracture, but also to identify a scientific basis for any claimed link between silicone breast implants and a disease, symptom or condition. “The findings of the 706 Panel are not inconsistent with the findings of the IOM report and the IRG report,” said Wettick. “None of plaintiff’s studies other than the IOM report addresses chest and breast pain unrelated to capsular contracture.” And the IOM report did not support Toledo’s position, he said. “The only pain that it attributes to silicone gel implants is that caused by capsule contracture and that which the surgeries may have caused.” Because the judge said he was “not required to accept” the findings of these three studies, he said he also reviewed the plaintiff’s 167 exhibits, plus her brief and appendices, “to determine what studies may support the expert testimony that … plaintiff’s chest and breast pain is related to a localized response to the silicone gel.” “Plaintiff’s brief identifies several studies as supporting plaintiff’s position that there is an immune response to silicone gel that causes pain and other injuries,” Wettick said. “However, none of the studies do so.” Wettick cited other documents presented in Toledo’s brief as being unsupportive of her claim, or inconclusive. One of the documents the plaintiff cited, he said, even said that “incidence of immunological sensitization and autoimmune disease in association with silicone breast implants is not known, nor is the exact relationship between the two clearly established.” In the end, the judge appeared to conclude that, just because silicone implants can cause inflammation and inflammation can cause pain, it doesn’t follow that silicone causes pain. CASE MANAGEMENT Litigation of breast-implant cases at the state level is being managed by a three-judge panel appointed in 1993 by the Pennsylvania Supreme Court, on which Wettick sits. The coordinating court stayed case-specific discovery in state cases pending the resolution of the high-profile, federal multi-district litigation against the manufacturers of silicone breast implants. After completion of the MDL, in 1998, the panel began to selectively lift the stay on certain cases to proceed forward to manage them more effectively. Currently, there are about eight active cases in the state, said defense lawyer Brennan. The cases come to the coordinating court with the assistance of attorneys who sit on a plaintiffs’ steering committee and defendants’ steering committee. These attorneys oversee the status of the ongoing cases and update other attorneys across the state on an ongoing basis. They also keep the coordinating court informed about which cases are ready to go. Currently sitting on the defendants’ steering committee are attorneys from White & Williams, O’Brien & Ryan and McKissock & Hoffman, who primarily represent hospitals and health-care providers. The plaintiffs’ steering committee includes Sheller Ludwig & Badey and James R. Ronca, a senior partner with Schmidt Ronca & Kramer in Harrisburg. “Since the court originally planned on lifting the stay on four cases per month, we could potentially have 50 or 60 active cases at this point,” Brennan said. “I think the fact that there are so few is because [plaintiffs] are waiting to see what happens with the first few, like this one.”

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