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compelling psychiatric examination even though plaintiff withdrew her claim of emotional distress, because where there was evidence her psychiatric condition could be the source of her physical symptoms, a psychiatric exam was warranted
Summary of this case from Beck v. Concord Ins. Co.Opinion
92-CV-0314 (LEK)(RWS)
August 16, 2001
MEMORANDUM — DECISION AND ORDER
Defendant seeks to exclude the testimony of Plaintiff's expert witnesses, Dr. Pierre Blais and Dr. Saul Puszkin, regarding the causation of systemic diseases by silicone breast implants. For the reasons stated herein, that testimony will be excluded.
I. BACKGROUND
Plaintiff Freda Gates Pozefsky underwent breast reconstruction surgery on February 16, 1973 and received silicone gel-filled breast implants allegedly manufactured by Heyer Schulte Corporation. Beginning in the 1980s, Plaintiff alleges that she began to suffer a number of symptoms with no known cause, including nausea, joint stiffness, chronic pain, and weakness. Her condition allegedly forced her early retirement from full-time employment and led to a finding of disability by the Social Security Administration.
Defendant is a successor in interest to Heyer Schulte.
In 1992, after having discovered through a routine mammogram that at least one of her breast implants had ruptured, Plaintiff had her implants removed. Upon removal, it was allegedly discovered that one implant had completely ruptured and the other one was leaking. Plaintiff now claims that she suffers from a variety of physiological diseases caused by her silicone gel breast implants. Plaintiff commenced this action by filing a complaint on March 5, 1992 alleging negligence, breach of implied warranties, negligent failure to warn, strict liability/design defect, and fraud/misrepresentation. The case was subsequently transferred to the Honorable Samuel C. Pointer, Jr., of the United States District Court for the Northern District of Alabama, for inclusion in multidistrict litigation for the purpose of consolidation of pre-trial proceedings. Judge Pointer remanded the case to this Court on December 13, 1995.
Defendant filed a motion for summary judgment on December 15, 1999. The Court issued an order on June 27, 2000 granting Defendant's motion in part and denying it in part.
The Court's order also denied Plaintiff's motion to extend time to conclude expert disclosure. This decision was relied on by the Court in its December 4, 2000 order, which held, among other things, that Plaintiff would not be allowed to use Dr. George Millowe, her treating physician, as an expert witness.
The Court's decision was based in part on the need for a Daubert hearing to test the reliability and relevance of Plaintiff's experts. That hearing was held on December 8, 2000.
II. ANALYSIS
A. Daubert Standard
The admission of expert scientific testimony in a federal trial is governed by Rule 702 of the Federal Rules of Evidence. See Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 588 (1993); Zuchowicz v. United States, 140 F.3d 381, 386 (2d Cir. 1998). Rule 702 states that:
If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise.
Fed.R.Evid. 702. In Daubert, the Supreme Court established a "gatekeeping" function for the courts, in which they are to determine the reliability and relevance of expert testimony. See id. at 597. The court is required to assess: (1) "whether the reasoning or methodology underlying the testimony is scientifically valid"; and (2) whether the "reasoning or methodology properly can be applied to the facts in issue." Id. at 592-94.
The Supreme Court identified a list of relevant factors for courts to consider when determining whether the evidence is scientifically valid under the first prong of the Daubert analysis. These include: "(1) whether the theory has been tested or is capable of being tested; (2) whether the theory has been subjected to peer review and publication; (3) the theory's potential rate of error; and (4) whether the theory has been generally accepted by the relevant scientific community." Id. at 593-94. This list is not meant to be comprehensive and the "court's inquiry should be a `flexible one.'" Zuchowicz, 140 F.3d at 387 (quoting Daubert, 509 U.S. at 594). Indeed, several courts have also considered whether the opinion has been put to any non-judicial uses and whether it was developed solely for the purposes of litigation. See Smelser v. Norfolk S. Ry. Co., 105 F.3d 299, 303 (6th Cir. 1997); Daubert v. Merrell Dow Pharm. Inc. ("Daubert II"), 43 F.3d 1311, 1317 (9th Cir. 1995); Grant v. Bristol-Myers Squibb, 97 F. Supp.2d 986, 987 (D.Ariz. 2000); Hall v. Baxter Healthcare Corp., 947 F. Supp. 1387, 1396 (D.Or. 1996). In making this determination, courts are to focus on the methodologies that the experts use to reach their conclusions rather than on the conclusions themselves. See Daubert, 509 U.S. at 595. On the other hand, the Supreme Court has stated that
conclusions and methodology are not entirely distinct from one another. Trained experts commonly extrapolate from existing data, but nothing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion testimony which is connected to existing data only by the ipse dixit of the expert. A court may conclude that there is simply too great of an analytical gap between the data and the opinion offered.
General Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997). The second prong of the analysis focuses on the relevancy or "fit" of the evidence. Courts look to "ensure that the proposed expert testimony is relevant to the task at hand, . . . i.e., that it logically advances a material aspect of the proposing party's case." Daubert II, 43 F.3d at 1315. "Scientific expert testimony introduces special dangers to the fact-finding process because it `can be both powerful and quite misleading because of the difficulty in evaluating it.'" In re Breast Implant Litig., 11 F. Supp.2d 1217, 1223 (D. Colo. 1998) (quoting Daubert, 509 U.S. at 595). Accordingly, courts must exclude expert testimony under Rule 702 "unless they are convinced that it speaks clearly and directly to an issue in dispute in the case, and that it will not mislead the jury." In re Breast Implant Litig., 11 F. Supp.2d at 1223 (citing Daubert II, 43 F.3d at 1321).
B. Causation
Plaintiffs in toxic tort cases are required to show both general and specific causation — that is, "that the allegedly toxic substance is capable of causing a particular injury in the general population, and that the substance caused the particular individual's injury." Grant, 97 F. Supp.2d at 988; see, e.g., Raynor v. Merrell Pharm., Inc., 104 F.3d 1371, 1376 (D.C. Cir. 1997); In re Breast Implant Litig., 11 F. Supp.2d at 1224 (citing cases). Therefore, in this case, Plaintiff must show that breast implants are capable of causing the systemic injuries she complains of and that her breast implants were the cause in fact of her injuries.
In the mass torts context, epidemiology is the best evidence of causation. See In re Breast Implant Litig., 11 F. Supp.2d at 1224 (citing cases) ("epidemiological studies are necessary to determine the cause and effect between breast implants and allegedly associated diseases"); Linda A. Bailey et al., Reference Guide on Epidemiology, in Reference Manual on Scientific Evidence 126 (1994) ("[i]n the absence of an understanding of the biological and pathological mechanisms by which disease develops, epidemiological evidence is the most valid type of scientific evidence of toxic causation"); Raynor, 104 F.3d at 1376 (non-epidemiological studies are "not capable of proving causation in human beings in the face of the overwhelming body of contradictory epidemiological evidence"); Hall, 947 F. Supp. at 1403 ("[t]he existence or nonexistence of relevant epidemiology can be a significant factor in proving general causation in toxic tort cases").
The general rule is that expert testimony put forth by a plaintiff must prove that it is more likely than not that the product caused the plaintiff's injuries. See In re Breast Implant Litig.,11 F. Supp.2d at 1225; Manucso v. Consolidated Edison Co. of New York, Inc., 967 F. Supp. 1437, 1466 (S.D.N.Y. 1997). This means that Plaintiff "must present expert testimony demonstrating that exposure to beast implants more than doubled the risk of [her] alleged injuries." In re Breast Implant Litig., 11 F. Supp.2d at 1226; Hall, 947 F. Supp. at 1403 (citing Daubert II, 43 F.3d at 1320-21).
In epidemiological terms, this means that Plaintiff must be able to show a relative risk of greater than 2.0. See Hall, 947 F. Supp. at 1403; In re Breast Implant Litig., 11 F. Supp.2d at 1226.
The threshold for concluding that an agent was more likely the cause of a disease than not is a relative risk greater than 2.0. Recall that a relative risk of 1.0 means that the agent has no effect on the incidence of disease. When the relative risk reaches 2.0, the agent is responsible for an equal number of cases of disease as all other background cases. Thus, a relative risk of 2.0 implies a 50% likelihood that an exposed individual's disease was caused by the agent.
Bailey et al., supra, at 168.
Defendants submit the reports of three panels of independent experts which have concluded that silicone breast implants are not associated with systemic illness. The first report was issued by the Rule 706 National Science Panel ("the Panel") appointed by Chief Judge Samuel C. Pointer as part of the Multidistrict Breast Implant Litigation. Judge Pointer appointed four members to the Panel with expertise in epidemiology, rheumatology, immunology, and toxicology. For more than two years, the Panel considered the causal relationship between systemic disease and silicone breast implants. In addition to its own research, the Panel was provided over 2,000 documents from both sides of the litigation and heard presentations from scientists and doctors. The Panel issued its report in November 1998. The executive summary of the report states the Panel's conclusion that "[n]o association was evident between breast implants and any of the individual connective tissue diseases, all definite connective tissue diseases combined, or the other autoimmune/rheumatic conditions." The Panel also found no association between breast implants and atypical connective tissue diseases or any distinctive constellation of symptoms observed in women with breast implants. The second report was commissioned by the United States Department of Health and Human Services upon instructions from Congress. The Institute of Medicine of the National Academy of Sciences ("the IOM") was instructed to create the Committee on the Safety of Silicone Breast Implants, which was made up of thirteen experts in rheumatology, epidemiology, immunology, neurology, silicone chemistry, toxicology, and other fields. The IOM considered over 3,000 studies and other writings, including over 2,000 peer-reviewed publications, and heard presentations from scientists and doctors as well as women with breast implants. Their work was reviewed by an additional panel of thirteen medical doctors and scientists.
In its July 1999 report, the IOM concluded that "there is insufficient evidence to support allegations that breast implants are associated with defined connective tissue disease, cancer, neurological diseases, or undefined, atypical syndromes." Grant, 97 F. Supp.2d at 990. Indeed, the "Committee asserted that `given repeated findings of no elevated risk, the evidence supports the conclusion that there is no association, and therefore no justification for the use of resources in further epidemiological exploration of such an association.'" Id.
Finally, Defendant submitted a report created by the Independent Review Group ("the IRG"), which was organized by the United Kingdom's Chief Medical Officer at the request of its Minister of Health to "review the evidence relating to the possible health risks associated with silicone gel breast implants." The IRG was constituted of a seven-member panel with expertise in rheumatology, immunology, epidemiology, internal medicine, plastic surgery, pathology, and law. The panel reviewed an extensive amount of evidence including scientific writings, both published and unpublished, submissions from plaintiffs and defendants, data from manufacturers, and oral and written evidence from patient groups, lawyers, scientists, doctors, industry, and other parties of interest.
The IRG's July 1997 report concluded that "[t]here is no epidemiological evidence for any link between silicone gel breast implants and any established connective tissue disease." Like the IOM, it stated that it could not "justify recommending further epidemiological studies to investigate this hypothesis."
In addition to these reports, Defendants point the Court to nearly thirty published epidemiological studies that conclude that breast implants do not cause any typical or atypical diseases. See In re Breast Implant Litig., 11 F. Supp.2d at 1227 (noting that "[e]very controlled epidemiological study concludes that silicone breast implants do not double the risk of any known disease," that none of the studies have revealed a relative risk of 2.0, and that "[n]one of these studies support the conclusion that breast implants cause rheumatic or connective tissue diseases, either classical or atypical in breast implanted women"). Defendants also submit public statements from numerous national and international medical and scientific organizations which have studied the alleged association between breast implants and disease and concluded that the implants do not cause disease. In addition to the multitude of scientific studies and reports, Defendant points the Court to many state and federal courts which have addressed the same issues currently before this Court. In each of these opinions, following extensive evidentiary hearings, the court disallowed expert testimony as to causation. See, e.g., Havard v. Baxter Int'l Inc., No. 1:92CV086396 (N.D.Ohio. filed July 21, 2000); Grant, 97 F. Supp.2d at 992 (holding that "[t]he evidence regarding systemic disease as proposed by Plaintiffs' experts is not scientifically valid and therefore will not assist the trier of fact," noting that there is "overwhelming evidence to the contrary," and finding that "Plaintiffs' experts [sic] conclusions about systemic disease have not gained acceptance in the relevant scientific community"); Bushore v. Dow Corning, No. 920-3440-Civ-T-26C, at 15 (M.D.Fla. Filed November 15, 1999) (finding that plaintiff's expert's "methodology in arriving at his conclusion fails to meet the reliability and relevance prongs of the Daubert analysis"); Allison v. McGhan Med. Corp., 184 F.3d 1300 (11th Cir. 1999) (upholding district court's exclusion of causation evidence as both irrelevant and scientifically unreliable); In re Breast implant Litig., 11 F. Supp.2d at 1244 (holding that the non- epidemiological methodologies of the plaintiffs' experts seeking to tie breast implants to auto-immune diseases had not been shown to be "based on valid, scientific principles and reliable scientific methods"); Anderson v. Bristol-Myers Squibb Co., No. H-95-0003 (S.D.Tex. Filed April 20, 1998); Kelley v. American Heyer-Schulte Corp., 957 F. Supp. 873 (W.D. Tex. 1997); In re Breast Implant Cases, 942 F. Supp. 958, 961 (E.D.N.Y. and S.D.N.Y. 1996) (holding with regard to the association between atypical diseases and silicone breast implants, that "[t]he hundreds of symptoms associated with this undifferentiated disease, the lack of any acceptable agreed upon definition, the inadequacy of any satisfactory supporting epidemiological or animal studies, the lack of a scientifically acceptable showing of medical plausibility, and the questionable nature of the clinical conclusions of treating doctors, all point to a failure of proof in making a prima facie case that silicone implants cause any of the syndromes claimed"); Hall, 947 F. Supp. at 1393, 1402 (following a report by a panel of four "totally unbiased and uncommitted experts" in epidemiology, rheumatology, immunology/toxicology, and polymer chemistry rejecting the theory that silicone implants caused an atypical connective tissue disease, noting that it "is at best an untested hypothesis" and that "there is no scientific basis for any expert testimony as to its causes and presence in plaintiffs").
These organizations include the American Medical Association, American Cancer Society, the American College of Rheumatology and the College of American Pathologists.
C. Plaintiff's Experts
Plaintiff alleges that she is suffering from a variety of physiological diseases as a result of her use of silicone breast implants. Plaintiff claims that these diseases are caused by an autoimmune response to the silicone gel which allegedly migrated throughout her body after one of her implants ruptured and the other leaked. In support of her theory, Plaintiff has only two remaining experts, Drs. Pierre Blais and Saul Puszkin. The Court will address the admissibility of their testimony regarding the causation of systemic disease by silicone breast implants in turn.
1. Dr. Blais
Dr. Blais holds a PhD in organic chemistry and is not a medical doctor. Although it is not clear what Dr. Blais is designated to testify to at trial, it appears from some of Plaintiff's submissions that his testimony would be limited to the alleged manufacturing defect in the implants and seepage of silicone gel from the defective seal in one of Plaintiff's implants and the rupture of the other one. Indeed, Dr. Blais' proposed testimony has been similarly limited in other cases. See, e.g., Grant, 97 F. Supp.2d at 991; In re Breast Implant litig., 11 F. Supp.2d at 1240. Perhaps this is so because, as an organic chemist, Dr. Blais is unqualified to testify as to the causes and mechanisms of disease.
In any event, any opinions he would offer as to disease causation would not be scientifically reliable. Not only would they be outside his area of expertise, but Plaintiff has not established that he has tested them, that they have been subjected to peer review, or that they have been generally accepted in the scientific community. To the contrary, as discussed above, the overwhelming weight of scientific authority holds that there is no connection between silicone breast implants and defined or atypical connective tissue disease. Moreover, it is important to note that Dr. Blais' theories have been created solely for the purpose of litigation.
A number of federal, state, and Canadian courts, presented with Dr. Blais' proposed testimony on these matters, have excluded or strictly limited it. See, e.g., Grant, 97 F. Supp.2d at 991 (finding his theories unsupported with testing, not developed independent of litigation, and not accepted in the general scientific community); In re Breast Implant Litig., 11 F. Supp.2d at 1242-43 (finding Dr. Blais unqualified by "knowledge, skill, experience, training, [and] education" and noting that his proposed testimony was untested, unpublished in peer reviewed literature, not supported by generally accepted scientific data, not created through the use of any definable sceintific methodology, and not developed independent of litigation); Cabrera v. Cordis Corp., 134 F.3d 1418, 1423 (9th Cir. 1998) (affirming district court's exclusion because testimony not tested or published in peer reviewed materials); Havard, No. 1:92CV086396 (holding that Dr. Blais does not publish his work and does not hold opinions that have been accepted by the scientific community). In light of Dr. Blais' lack of qualifications and his opinions' lack of scientific reliability, this Court will join those to come before it and exclude his testimony as to the causation of Plaintiff's alleged diseases by her silicone breast implants.
2. Dr. Puszkin
Dr. Puszkin has a PhD in Biochemistry and, like Dr. Blais, is not a medical doctor. However, he has worked in the fields of immunology and pathology. Again, it is not apparent what Dr. Puszkin would testify to at trial. At least one of Plaintiff's submissions to the Court suggests that he would testify only to the presence of silicone gel throughout Plaintiff's body. As with Dr. Blais, Dr. Puszkin's offered testimony has been so limited previously. See Grant, 97 F. Supp.2d at 991. However, in that case he had previously been prepared to testify that silicone "causes pathological complications and disease, and as to immunological reactions to silicone molecules when they migrate from a defective silicone breast implant." Id.
Any such theories that he would testify to at this trial would not be scientifically reliable. Again, Plaintiff has not established that he has tested his theories, that they have been subjected to peer review, or that they have been generally accepted in the scientific community. Also, like Dr. Blais, Dr. Puszkin's professional efforts regarding silicone breast implants have been aimed almost exclusively at litigation. Rather than provide the Court with support of her expert's theory or methods, Plaintiff spends the bulk of her efforts attempting to discredit the numerous experts and studies relied upon by Defendant. In doing so, Plaintiff has ignored her affirmative duty to establish the scientific reliability of her expert's proposed testimony.
As with Dr. Blais, a number of courts have excluded Dr. Puszkin's testimony on these issues. See, e.g., Cabrera v. Cordis Corp. et al., 945 F. Supp. 209, 213 (D.Nev. 1996); Havard, No. 1:92CV086396 (holding that Dr. Puszkin's methods have not been tested, that his opinions have not been accepted by the relevant scientific community and that his opinions have not been developed independent of litigation). Because Plaintiff has failed to establish the scientific reliability of his theories on causation and the overwhelming weight of scientific authority to the contrary, the Court will join these courts and exclude the testimony of Dr. Puszkin as to the causation of Plaintiff's alleged condition by her silicone breast implants.
Because the Court finds that the testimony of both Drs. Blais and Puszkin is unreliable under the first prong of the Daubert analysis, it does not address the second prong as to either expert.
III. CONCLUSION
Accordingly, it is herebyORDERED that the testimony of Drs. Pierre Blais and Saul Puszkin regarding causation is excluded; and it is
FURTHER ORDERED that the Clerk of the Court serve a copy of this Order on all parties by regular mail.
IT IS SO ORDERED.