Litigation-Generated Science: Why Should We Care?

Background In a 1994 Ninth Circuit decision on the remand of Daubert v. Merrell Dow Pharmaceuticals, Inc., Judge Alex Kosinski wrote that science done for the purpose of litigation should be subject to more stringent standards of admissibility than other science. Objectives We analyze this proposition by considering litigation-generated science as a subset of science involving conflict of interest. Discussion Judge Kosinski's formulation suggests there may be reasons to treat science involving conflict of interest differently but raises questions about whether litigation-generated science should be singled out. In particular we discuss the similar problems raised by strategically motivated science done in anticipation of possible future litigation or otherwise designed to benefit the sponsor and ask what special treatment, if any, should be given to science undertaken to support existing or potential future litigation. Conclusion The problems with litigation-generated science are not special. On the contrary, they are very general and apply to much or most science that is relevant and reliable in the courtroom setting.

[1]  Celeste Monforton,et al.  Manufacturing uncertainty: contested science and the protection of the public's health and environment. , 2005, American journal of public health.

[2]  Lloyd Dixon,et al.  Changes in the Standards for Admitting Expert Evidence in Federal Civil Cases Since the Daubert Decision , 2001 .

[3]  Henry T. Stelfox,et al.  Conflict of interest in the debate over calcium-channel antagonists. , 1998, The New England journal of medicine.

[4]  A. Wazana,et al.  Physicians and the pharmaceutical industry: is a gift ever just a gift? , 2000, JAMA.

[5]  Carol J. Henry,et al.  Scientific and Legal Perspectives on Science Generated for Regulatory Activities , 2007, Environmental health perspectives.

[6]  Susan Haack,et al.  What's Wrong with Litigation-Driven Science? An Essay in Legal Epistemology , 2008 .

[7]  P. Easterbrook,et al.  Publication bias in clinical research , 1991, The Lancet.

[8]  C. Gross,et al.  Scope and impact of financial conflicts of interest in biomedical research: a systematic review. , 2003, JAMA.

[9]  B. Djulbegovic,et al.  Pharmaceutical industry sponsorship and research outcome and quality: systematic review , 2003, BMJ : British Medical Journal.

[10]  Melissa S. Anderson,et al.  Withholding research results in academic life science. Evidence from a national survey of faculty. , 1997, JAMA.

[11]  Jeffrey M Drazen,et al.  Expression of concern reaffirmed. , 2006, The New England journal of medicine.

[12]  J. Cecil,et al.  Judge and Attorney Experiences, Practices, and Concerns Regarding Expert Testimony in Federal Civil Trials , 2002 .

[13]  Sheldon Krimsky.  THE FUNDING EFFECT IN SCIENCE AND ITS IMPLICATIONS FOR THE JUDICIARY , 2005 .

[14]  P. Rothwell,et al.  Reproducibility of peer review in clinical neuroscience. Is agreement between reviewers any greater than would be expected by chance alone? , 2000, Brain : a journal of neurology.

[15]  E. G. Eberle,et al.  How are the Mighty Fallen , 1920 .

[16]  S. Jasanoff,et al.  The Fifth Branch: Science Advisers as Policymakers. , 1991 .

[17]  A. Nierenberg,et al.  Industry sponsorship and financial conflict of interest in the reporting of clinical trials in psychiatry. , 2005, The American journal of psychiatry.

[18]  Stephen Hilgartner,et al.  Data Withholding in Genetics and the Other Life Sciences: Prevalences and Predictors , 2006, Academic medicine : journal of the Association of American Medical Colleges.

[19]  E. W. Morris.  No , 1923, The Hospital and health review.

[20]  E Ray Dorsey,et al.  Financial anatomy of biomedical research. , 2005, JAMA.

[21]  M. Kalichman.  Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical Research? , 2004 .

[22]  S. Jasanoff.  Representation and Re-Presentation in Litigation Science , 2007, Environmental health perspectives.

[23]  M. Berger.  What has a decade of Daubert wrought? , 2005, American journal of public health.

[24]  RATIONALITY , RESEARCH AND LEVIATHAN : LAW ENFORCEMENT-SPONSORED RESEARCH AND THE CRIMINAL PROCESS , 2004 .

[25]  K. Dickersin,et al.  Factors influencing publication of research results. Follow-up of applications submitted to two institutional review boards. , 1992, JAMA.

[26]  J. Gans,et al.  How Are the Mighty Fallen: Rejected Classic Articles by Leading Economists , 1994 .

[27]  Sheila Jasanoff,et al.  Just Evidence: The Limits of Science in the Legal Process , 2006, Journal of Law, Medicine & Ethics.

[28]  Christian Gluud,et al.  Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events? , 2003, JAMA.

[29]  W. Freudenburg.  Rethinking the Threats to Scientific Balance in Contexts of Litigation and Regulation , 2007, Environmental health perspectives.

[30]  Sheila Jasanoff,et al.  Law's knowledge: science for justice in legal settings. , 2005, American journal of public health.

[31]  John R. Bucher,et al.  Conflicting Views on Chemical Carcinogenesis Arising from the Design and Evaluation of Rodent Carcinogenicity Studies , 2007, Environmental health perspectives.

[32]  E. Richter,et al.  Relationship between conflicts of interest and research results , 2007, Journal of General Internal Medicine.

[33]  Richard Smith,et al.  Peer Review: A Flawed Process at the Heart of Science and Journals , 2006 .

[34]  R. Melnick,et al.  Implications for risk assessment of suggested nongenotoxic mechanisms of chemical carcinogenesis. , 1996, Environmental health perspectives.

[35]  Robert W. Matthews,et al.  Uniform requirements for manuscripts submitted to biomedical journals: Writing and editing for biomedical publication , 2010, Journal of pharmacology & pharmacotherapeutics.