Clearing away the junk: Court-appointed experts, scientifically marginal evidence, and the silicone gel breast implant litigation

Food and Drug Law Journal

Volumn 56, Issue 2, 2001, Pages 227-240

  Goss, Peter J ^a   Worthington, Debra L ^b   Stallard, Merrie Jo ^c   Price, Joseph M ^a  

^a LLP   (United States)

^b AUBURN UNIVERSITY   (United States)

^c Litigation Insights   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

SILICONE GEL;

BREAST AUGMENTATION; CONFERENCE PAPER; EXPERT WITNESS; FOOD AND DRUG ADMINISTRATION; LAW; MEDICOLEGAL ASPECT; SAFETY;

BREAST IMPLANTS; EXPERT TESTIMONY; HUMANS; JURISPRUDENCE; SCIENCE; SILICONE GELS; UNITED STATES;

EID: 0034884324     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (103)

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2. Daubert v. Merrell Dow Pharm., 509 U.S. 579 (1993).
3. PETER HUBER, GALILEO'S REVENGE: JUNK SCIENCE IN THE COURTROOM 2-3 (1991).
4. Id. at 3.
5. Suzanne E. Riley, The End of an Era: Junk Science Departs Products Liability, 63(4) DEF. COUNS. J. 502 (1996).
6. EDWARD J. IMWINKELREID, Evidence Law and Tactics for the Proponents of Scientific Evidence, in SCIENTIFIC AND EXPERT EVIDENCE 37 (1981).
7. Id.
8. See MICHAEL T. NIETZEL ET AL., Juries: The Current State of the Empirical Literature, in PSYCHOLOGY AND LAW: THE STATE OF THE DISCIPLINE 23, 39 (Ronald Roesch et al. eds. (1999)) (Nietzel et al., in their review of the literature, found only 22 studies concerning the effects of psychology experts on juror decisionmaking, and these were all limited to testimony in matters of psychology and psychiatry.).
9. At the same time, however, the results do not support claims that such testimony makes "no difference." Id.
10. The authors note that they found few studies using conclusionary expert testimony. Of those they reviewed, however, they found the research findings "[left] opportunity for both foes and fans of ultimate opinion testimony to find support for their positions." Id. at 41.
11. Frye v. United States, 293 F. 1013 (1923).
12. 293 F. at 1014.
13. Note, Improving Judicial Gatekeeping: Technical Advisors and Scientific Evidence, 110 HARV. L. REV. 941 (1997).
14. See Bert Black, A Unified Theory of Scientific Evidence, 56(4) FORDHAM L. REV. 595, 628, 637 (1988).
15. Patricia E. Lin, Opening the Gates to Scientific Evidence in Toxic Exposure Cases: Medical Monitoring and Daubert, 17 REV. OF LITIG. 551, 569 (1998).
16. J. Michael Veron, The Trial of Toxic Torts: Scientific Evidence in the Wake of Daubert, 57 LA. L. REV. 647, 657 (1997).
17. Id. at 657.
18. See M. Neil Browne et al., The Epistemological Role of Expert Witnesses and Toxic Torts, 36 AM. BUS. L.J. 1, 27-28 (1998).
19. Daubert v. Merrell Dow Pharm., 509 U.S. 579, 592-93 (1993).
20. Daubert, 509 U.S. at 593-94.
21. Id. at 589.
22. Hon. Harvey Brown, Procedural Issues Under Daubert, 36 HOUS. L. REV. 1133, 1175-76 (1999).
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25. Molly T. Johnson et al., Expert Testimony in Federal Civil Trials: A Preliminary Analysis, at 1 (Federal Judicial Center, Washington, D.C., 2000).
26. Id. at 5.
27. General Electric Co. v. Joiner, 522 U.S. 136 (1997).
28. Hon. Harvey Brown, Eight Gates for Expert Witnesses, 36 HOUS. L. REV. 743 (1999).
29. Kumho Tire Co., Ltd. V. Carmichael, 526 U.S. 137 (1999).
30. Bert Black, Expert Evidence in the Wake of the Daubert-Joiner-Kumho Tire Trilogy, in SCIENTIFIC EVIDENCE REVIEW 4 (Cynthia H. Cwik & John L. North eds. (1999)).
31. Nietzel et al., supra note 8, at 38.
32. Daniel W. Shuman et al., An Empirical Examination of the Use of Expert Witnesses in the Courts - Part II: A Three City Study, 34 JURIMETRICS J. 193, 194 (1994).
33. MARCIA ANGELL, SCIENCE ON TRIAL: THE CLASH OF MEDICAL EVIDENCE AND THE LAW IN THE BREAST IMPLANT CASE, at 205 (1996); see also Browne et al., supra note 18, at 70-71; Joseph M. Price & Ellen S. Rosenberg, The War Against Junk Science: The Use of Expert Panels in Complex Medical-Legal Scientific Litigation, 19 BIOMATERIALS 1425 (1998); Joseph M. Price & Ellen S. Rosenberg, The Silicone Gel Breast Implant Controversy: The Rise of Expert Panels and the Fall of Junk Science, 93 J. ROYAL SOC'Y MED. 31 (2000); Jane F. Thorpe et al., Court-Appointed Experts and Technical Advisors, 26(4) LITIG. 31, 66 (2000); Note, supra note 13.
34. MARCIA ANGELL, SCIENCE ON TRIAL: THE CLASH OF MEDICAL EVIDENCE AND THE LAW IN THE BREAST IMPLANT CASE, at 205 (1996); see also Browne et al., supra note 18, at 70-71; Joseph M. Price & Ellen S. Rosenberg, The War Against Junk Science: The Use of Expert Panels in Complex Medical-Legal Scientific Litigation, 19 BIOMATERIALS 1425 (1998); Joseph M. Price & Ellen S. Rosenberg, The Silicone Gel Breast Implant Controversy: The Rise of Expert Panels and the Fall of Junk Science, 93 J. ROYAL SOC'Y MED. 31 (2000); Jane F. Thorpe et al., Court-Appointed Experts and Technical Advisors, 26(4) LITIG. 31, 66 (2000); Note, supra note 13.
35. MARCIA ANGELL, SCIENCE ON TRIAL: THE CLASH OF MEDICAL EVIDENCE AND THE LAW IN THE BREAST IMPLANT CASE, at 205 (1996); see also Browne et al., supra note 18, at 70-71; Joseph M. Price & Ellen S. Rosenberg, The War Against Junk Science: The Use of Expert Panels in Complex Medical-Legal Scientific Litigation, 19 BIOMATERIALS 1425 (1998); Joseph M. Price & Ellen S. Rosenberg, The Silicone Gel Breast Implant Controversy: The Rise of Expert Panels and the Fall of Junk Science, 93 J. ROYAL SOC'Y MED. 31 (2000); Jane F. Thorpe et al., Court-Appointed Experts and Technical Advisors, 26(4) LITIG. 31, 66 (2000); Note, supra note 13.
36. MARCIA ANGELL, SCIENCE ON TRIAL: THE CLASH OF MEDICAL EVIDENCE AND THE LAW IN THE BREAST IMPLANT CASE, at 205 (1996); see also Browne et al., supra note 18, at 70-71; Joseph M. Price & Ellen S. Rosenberg, The War Against Junk Science: The Use of Expert Panels in Complex Medical-Legal Scientific Litigation, 19 BIOMATERIALS 1425 (1998); Joseph M. Price & Ellen S. Rosenberg, The Silicone Gel Breast Implant Controversy: The Rise of Expert Panels and the Fall of Junk Science, 93 J. ROYAL SOC'Y MED. 31 (2000); Jane F. Thorpe et al., Court-Appointed Experts and Technical Advisors, 26(4) LITIG. 31, 66 (2000); Note, supra note 13.
37. MARCIA ANGELL, SCIENCE ON TRIAL: THE CLASH OF MEDICAL EVIDENCE AND THE LAW IN THE BREAST IMPLANT CASE, at 205 (1996); see also Browne et al., supra note 18, at 70-71; Joseph M. Price & Ellen S. Rosenberg, The War Against Junk Science: The Use of Expert Panels in Complex Medical-Legal Scientific Litigation, 19 BIOMATERIALS 1425 (1998); Joseph M. Price & Ellen S. Rosenberg, The Silicone Gel Breast Implant Controversy: The Rise of Expert Panels and the Fall of Junk Science, 93 J. ROYAL SOC'Y MED. 31 (2000); Jane F. Thorpe et al., Court-Appointed Experts and Technical Advisors, 26(4) LITIG. 31, 66 (2000); Note, supra note 13.
38. MARCIA ANGELL, SCIENCE ON TRIAL: THE CLASH OF MEDICAL EVIDENCE AND THE LAW IN THE BREAST IMPLANT CASE, at 205 (1996); see also Browne et al., supra note 18, at 70-71; Joseph M. Price & Ellen S. Rosenberg, The War Against Junk Science: The Use of Expert Panels in Complex Medical-Legal Scientific Litigation, 19 BIOMATERIALS 1425 (1998); Joseph M. Price & Ellen S. Rosenberg, The Silicone Gel Breast Implant Controversy: The Rise of Expert Panels and the Fall of Junk Science, 93 J. ROYAL SOC'Y MED. 31 (2000); Jane F. Thorpe et al., Court-Appointed Experts and Technical Advisors, 26(4) LITIG. 31, 66 (2000); Note, supra note 13.
39. Melvin M. Mark, Social Science Evidence in the Courtroom: Daubert and Beyond?, 5 PSYCHOL., PUB. POL'Y & L. 175, 188-89 (1999); Shuman & Sales, supra note 24, at 3-15.
40. Melvin M. Mark, Social Science Evidence in the Courtroom: Daubert and Beyond?, 5 PSYCHOL., PUB. POL'Y & L. 175, 188-89 (1999); Shuman & Sales, supra note 24, at 3-15.
41. Developments in the Law - Confronting the New Challenges of Scientific Evidence: Addressing the Problems of Complex and Scientific Evidence, 108 HARV. L. REV. 1583, 1595 (1995).
42. JOE S. CECIL & THOMAS E. WILLGING, MOORE'S FEDERAL PRACTICE: REFERENCE MANUAL ON SCIENTIFIC EVIDENCE 547, 554 (Matthew Bender & Co. Inc. (1994)) ("Judges who appoint an expert indicated that the final outcome on the disputed issue was almost always consistent with the testimony of the appointed expert.").
43. Nancy J. Brekke et al., Of Juries and Court-Appointed Experts: The Effect of Non-Adversarial vs. Adversarial Testimony, 15 LAW & HUM. BEHAV. 451 (1991).
44. The decision is left to the court. See FED. R. EVID. 706(c).
45. Margaret A. Berger et al., Court-Appointed Experts: Their Rules and Roles, DRI: Drug and Medical Device Litigation Seminar KI-K14 1590, Defense Research Institute, Chicago, IL (1997) (on file with authors); FED. R. EVID. 104, 706.
46. Lisa Gelhaus, A Case Against CASE, 35(8) TRIAL 11 (1999).
47. Id.
48. See Thorpe et al., supra note 33, at 66.
49. Joe S. Cecil & Thomas E. Willging, Accepting Daubert's Invitation: Defining the Role for Court-Appointed Experts In Assessing Scientific Validity, 43 EMORY L.J. 995, 1004, 1008 (1994).
50. Angell, supra note 33, at 36.
51. Id. at 23, 51, 62.
52. Id. at 23, 51-52; see also John P. Heggers et al., Psiocompatibility of Silicone Implants, 11 ANNALS OF PLASTIC SURGERY 38 (1983); Yasuo Kumagai et al., Scleroderma After Cosmetic Surgery: Four Cases of Human Adjuvant Disease, 22 ARTHRITIS & RHEUMATISM 532-537 (1979); Sheryl A. Van Nunen et al., Post-Mammoplasty Connective Tissue Disease, 25 ARTHRITIS & RHEUMATISM 694 (1982).
53. Id. at 23, 51-52; see also John P. Heggers et al., Psiocompatibility of Silicone Implants, 11 ANNALS OF PLASTIC SURGERY 38 (1983); Yasuo Kumagai et al., Scleroderma After Cosmetic Surgery: Four Cases of Human Adjuvant Disease, 22 ARTHRITIS & RHEUMATISM 532-537 (1979); Sheryl A. Van Nunen et al., Post-Mammoplasty Connective Tissue Disease, 25 ARTHRITIS & RHEUMATISM 694 (1982).
54. Id. at 23, 51-52; see also John P. Heggers et al., Psiocompatibility of Silicone Implants, 11 ANNALS OF PLASTIC SURGERY 38 (1983); Yasuo Kumagai et al., Scleroderma After Cosmetic Surgery: Four Cases of Human Adjuvant Disease, 22 ARTHRITIS & RHEUMATISM 532-537 (1979); Sheryl A. Van Nunen et al., Post-Mammoplasty Connective Tissue Disease, 25 ARTHRITIS & RHEUMATISM 694 (1982).
55. Id. at 23, 51-52; see also John P. Heggers et al., Psiocompatibility of Silicone Implants, 11 ANNALS OF PLASTIC SURGERY 38 (1983); Yasuo Kumagai et al., Scleroderma After Cosmetic Surgery: Four Cases of Human Adjuvant Disease, 22 ARTHRITIS & RHEUMATISM 532-537 (1979); Sheryl A. Van Nunen et al., Post-Mammoplasty Connective Tissue Disease, 25 ARTHRITIS & RHEUMATISM 694 (1982).
56. Angell, supra note 33, at 104.
57. Id. at 51.
58. Id. at 52-54.
59. The plaintiff was awarded $211,000 in compensatory damages and $1.5 million in punitive damages. Stern v. Dow Corning Corp., Case No. C-83-2348-MMP (N.D. Cal. 1985).
60. Angell, supra note 33, at 56.
61. Id. at 52-56, 62.
62. Id. at 154.
63. Id. at 52-56.
64. Id. at 160.
65. Id. at 160-161.
66. Id. at 53-54, 158; Terence Corcoran, While Science Burns, the Media Fiddle, NAT'L. POST, July 3, 1999, at D6.
67. Anna Vondrak, Junk Science Finally Gets Slammed, WASH. TIMES, Oct. 18, 1998, at B5.
68. Id.
69. Affidavit of Stephan Penrod, Ph.D., Feuer v. McGhan Medical Corp., No. 92 CIV 9496, (S.D.N.Y. 1996) (on file with authors).
70. Id.
71. See Doss v. McGhan Med. Corp., CN 92-14155 Jud. Dist. 189 (Tex. Dist. Ct. 1994); Hopkins v. Dow Corning Corp., 33 F.3d 1116 (9th Cir. 1994); Johnson v. Bristol-Myers Squibb Corp., CN 91-21770 Jud. Dist. 125 (Tex. Dist. Ct. 1992).
72. James T. Rosenbaum, Lessons From Litigation Over Silicone Breast Implants: A Call for Activism by Scientists, 276 SCI. 1524, 1525 (1997).
73. Steven M. Edworthy et al., A Clinical Study of the Relationship Between Silicone Breast Implants and Connective Tissue Disease, 25 J. RHEUMATOLOGY 254 (1998); Sherine E. Gabriel et al., Risk of Connective Tissue Disease and Other Disorders After Breast Implantation, 330 NEW ENG. J. MED. 1697 (1994); Jorge Sanchez-Guerrero et al., Silicone Breast Implants and the Risk of Connective Tissue Diseases and Symptoms, 332 NEW ENG. J. MED. 1666 (1995); David Schottenfeld et al., The Design of a Population-Based Case Control Study of Systemic Sclerosis (Scleroderma: Commentary of the University of Michigan Study), 48 J. CLINICAL EPIDEMIOLOGY 583 (1994).
74. Steven M. Edworthy et al., A Clinical Study of the Relationship Between Silicone Breast Implants and Connective Tissue Disease, 25 J. RHEUMATOLOGY 254 (1998); Sherine E. Gabriel et al., Risk of Connective Tissue Disease and Other Disorders After Breast Implantation, 330 NEW ENG. J. MED. 1697 (1994); Jorge Sanchez-Guerrero et al., Silicone Breast Implants and the Risk of Connective Tissue Diseases and Symptoms, 332 NEW ENG. J. MED. 1666 (1995); David Schottenfeld et al., The Design of a Population-Based Case Control Study of Systemic Sclerosis (Scleroderma: Commentary of the University of Michigan Study), 48 J. CLINICAL EPIDEMIOLOGY 583 (1994).
75. Steven M. Edworthy et al., A Clinical Study of the Relationship Between Silicone Breast Implants and Connective Tissue Disease, 25 J. RHEUMATOLOGY 254 (1998); Sherine E. Gabriel et al., Risk of Connective Tissue Disease and Other Disorders After Breast Implantation, 330 NEW ENG. J. MED. 1697 (1994); Jorge Sanchez-Guerrero et al., Silicone Breast Implants and the Risk of Connective Tissue Diseases and Symptoms, 332 NEW ENG. J. MED. 1666 (1995); David Schottenfeld et al., The Design of a Population-Based Case Control Study of Systemic Sclerosis (Scleroderma: Commentary of the University of Michigan Study), 48 J. CLINICAL EPIDEMIOLOGY 583 (1994).
76. Steven M. Edworthy et al., A Clinical Study of the Relationship Between Silicone Breast Implants and Connective Tissue Disease, 25 J. RHEUMATOLOGY 254 (1998); Sherine E. Gabriel et al., Risk of Connective Tissue Disease and Other Disorders After Breast Implantation, 330 NEW ENG. J. MED. 1697 (1994); Jorge Sanchez-Guerrero et al., Silicone Breast Implants and the Risk of Connective Tissue Diseases and Symptoms, 332 NEW ENG. J. MED. 1666 (1995); David Schottenfeld et al., The Design of a Population-Based Case Control Study of Systemic Sclerosis (Scleroderma: Commentary of the University of Michigan Study), 48 J. CLINICAL EPIDEMIOLOGY 583 (1994).
77. Rosenbaum, supra note 63, at 1524.
78. M.E. Reed, Daubert and the Breast Implant Litigation: How is the Judiciary Addressing the Science?, 100 PLASTIC & RECONSTRUCTIVE SURGERY 1322-1326 (1997); William W. Schwarzer & Joe S. Cecil, Management of Expert Evidence, in REFERENCE MANUAL ON SCIENTIFIC EVIDENCE 39 (2d ed. 2000) available at (last visited June 1, 2001) air.fjc.gov/public/fjcweb.nsf/pages/16.
79. M.E. Reed, Daubert and the Breast Implant Litigation: How is the Judiciary Addressing the Science?, 100 PLASTIC & RECONSTRUCTIVE SURGERY 1322-1326 (1997); William W. Schwarzer & Joe S. Cecil, Management of Expert Evidence, in REFERENCE MANUAL ON SCIENTIFIC EVIDENCE 39 (2d ed. 2000) available at (last visited June 1, 2001) air.fjc.gov/public/fjcweb.nsf/pages/16.
80. Jocelyn Kaiser, Breast Implant Ruling Sends a Message, 275 SCI. 21 (Jan. 3, 1997).
81. Hall v. Baxter Healthcare Corp., 947 F. Supp. 1387 (Or. 1996).
82. Judge Pointer's National Science Panel advisors and their fields of expertise: Betty Diamond, Ph.D., immunology; Barbara Hulka, epidemiology; Nancy Kerkvliet, Ph.D., toxicology; and Peter Tugwell, rheumatology.
83. In re: Silicone Gel Breast Implant Prod. Liab. Litig. (MDL 926), Order No. 31E: Directions to National Science Panel Under FRE 706 (1996) (on file with authors).
84. See Schwarzer & Cecil, supra note 66, at 60.
85. Barbara S. Hulka et al., Experience of a Scientific Panel Formed to Advise the Federal Judiciary on Silicone Breast Implants, 342 NEW ENG. J. MED. 812, 813 (2000).
86. Id.
87. Id.
88. B.A. Diamond et al., Silicone Breast Implants in Relation to Connective Tissue Diseases and Immunologic Dysfunction: A Report by a National Science Panel to the Honorable Sam C. Pointer Jr., Coordinating Judge for the Federal Breast Implant Multi-District Litigation (1998), available at (last visited June 1, 2001) earth.fjc.gov/BREIMLIT/SCIENCE/report.htm.
89. Id.
90. Independent Review Group's Report on Silicone Gel Breast Implants (1998), available at (last visited June 1, 2001) www.silicone-review.gov.uk/silicone/index.htm;
91. Institute of Medicine - National Academy of Sciences, Safety of Silicone Breast Implants (1999) available at, (last visited June 1, 2001) www.nap.edu/books/0309065321/html/.
92. Allison v. Minnesota Mining & Mfg. Co., 184 F.3d 1300 (11th Cir. 1999); Grant v. Bristol-Myers Squibb, No. 93-1275 (Ariz. 2000); Harvard v. Baxter Int'l, Inc., No. 1:92CV0863 (S.D. Ohio 2000); Toledo v. Med. Eng'g Corp., No. 136 (Philadelphia County, Pa. 2000).
93. Meister v. Surgitek, Inc., No. 92-2660 (D.D.C. 1999) (J.N.O.V. Order on file with authors).
94. Id.
95. In re: Silicone Gel Breast Implant Prod. Liab. Litig. (MDL 926), Order No. 31L: Denying Plaintiffs' "Motion for Relief from Prejudicial Bias" (N.D. Ala. 1999) (on file with authors).
96. Id.
97. Id.
98. See Price & Rosenberg, supra note 33, at 1432.
99. Rosenbaum, supra note 63, at 1525.
100. Kaiser, supra note 67, at 21; Price & Rosenberg, supra note 33, at 33-34; Thorpe et al., supra note 33, at 33.
101. Rosenbaum, supra note 63, at 1525-26.
102. Hulka et al., supra note 72, at 812.
103. Id. at 815.