The Bendectin Litigation: a Case Study in the Life Cycle of Mass Torts Joseph Sanders

Hastings Law Journal Volume 43 | Issue 2 Article 2 1-1992 The Bendectin Litigation: A Case Study in the Life Cycle of Mass Torts Joseph Sanders Follow this and additional works at: https://repository.uchastings.edu/hastings_law_journal Part of the Law Commons Recommended Citation Joseph Sanders, The Bendectin Litigation: A Case Study in the Life Cycle of Mass Torts, 43 Hastings L.J. 301 (1992). Available at: https://repository.uchastings.edu/hastings_law_journal/vol43/iss2/2 This Article is brought to you for free and open access by the Law Journals at UC Hastings Scholarship Repository. It has been accepted for inclusion in Hastings Law Journal by an authorized editor of UC Hastings Scholarship Repository. For more information, please contact [email protected]. The Bendectin Litigation: A Case Study in the Life Cycle of Mass Torts by JOSEPH SANDERS* Table of Contents I. Introduction ............................................ 303 II. Case Congregations ..................................... 305 A. Beyond the Individual Case ......................... 305 B. Case Congregations and Mass Torts ................. 307 C. A Note on Case Studies ............................. 310 III. Bendectin Background .................................. 311 A. The Firm .......................................... 311 B. The Drug .......................................... 312 (1) Thalidomide ................................... 313 (2) M ER/29 ....................................... 315 (3) Bendectin ...................................... 317 IV. The Science ............................................. 321 A. Background ........................................ 321 (1) In Vitro Studies ................................ 322 (2) In Vivo Studies ................................. 322 (3) Epidemiological Studies ........................ 326 a. The Primacy of Epidemiology? ... 328 b. Causal Inference ............................. 329 B. The Bendectin Studies .............................. 331 * Professor of Law, University of Houston Law Center; B.A. 1966; J.D. 1969; Ph.D. 1974, Northwestern University. This Article is a revised version of a paper originally given at the Law and Society Meetings in Berkeley, California in June 1990. The research for the Article was supported by the University of Houston Environmental Liability Law Program. The Article would not have been possible without the assistance of the following University of Houston law students who work for the Environmental Law Liability Program: Michael Brown, Bill Robbins, Michael Rose, Lisa Salzman, and especially Terry Salem and Randall Terrell. The Environmental Law Liability Program is indebted to Marion Merrell Dow for its willingness to provide transcripts and other materials from the Bendectin cases. Herbert Kritzer and Michael Rustad also provided valuable materials. I wish to thank W. Glenn For- rester, Marc Galanter, Richard Lempert, Barry Nace, Al Schretter, the student editors of the Hastings Law Journal, and especially Michael Green for helpful comments on earlier drafts. [3011 302 HASTINGS LAW JOURNAL [Vol. 43 (1) In Vitro Studies ................................ 331 (2) In Vivo Studies ................................. 333 (3) Epidemiological Studies ........................ 339 a. Background ................................. 339 b. The Evolution of Bendectin's Epidemiological Research .................................... 341 c. The Increase in Statistical Sophistication and Power ....................................... 342 d. The End of Research ........................ 345 (4) The Life Cycle of the Bendectin Science ........ 347 V. The Law ................................................ 348 A. M obilization ........................................ 349 (1) The "First Plaintiff" Problem .................. 349 (2) Merrell's Preventive Efforts ..................... 354 B. The Caseload and Trial Load ..... ............. 359 C. Rationing Law ..................................... 362 (1) Procedural Rationing ........................... 362 (2) Substantive Rationing .......................... 372 a. Trial Court Opinions ........................ 372 b. Appellate Court Opinions .................... 375 (i) Oxendine .............................. 379 (ii) Richardson ............................ 380 (iii) Brock ................................. 382 (iv) Ealy ................................... 383 c. A Defense Bias? ....... 384 VI. The Larger Context ..................................... 386 A. Substantive Rationing and the Judge-Jury Relationship ........................................ 386 B. Substantive Rationing in the School Desegregation Cases ............................................... 390 VII. Conclusion: Case Congregations and the Interaction of Macro and Micro Processes ............................. 391 VIII. Appendices ............................................. 394 January 1992] MASS TORTS One precedent creates another. They soon accumulate and constitute law. What yesterday was fact, today is doctrine. Junius1 I. Introduction In an important recent article on prodefendant developments in products liability during the late 1980s, James Henderson and Theodore Eisenberg discuss areas of products liability law in which, during the early 1980s, new plaintiff breakthroughs had seemed imminent.2 One of these areas involved "[t]he imposition of liability on manufacturers of prescription drugs and other toxic substances based solely on epidemiological evidence of causal links between those products and plaintiffs' in- juries... ." -3 Among the products believed most likely to lead to such a breakthrough was the drug Bendectin, a widely prescribed morning sick- ness remedy alleged to cause birth defects in the children of mothers who had taken it. Given the sympathetic early reaction of several courts to plaintiffs' presentation of epidemiological proof of causation 4 the expec- tation that Bendectin cases would produce the next breakthrough for plaintiffs was more than reasonable.5 Yet, as Henderson and Eisenberg note, by the end of the decade early plaintiff victories were replaced by general defeat, "now mak[ing] it unlikely that Bendectin-related claims have a promising future."'6 What occurred in the intervening years to lead to this altered assess- ment? This Article addresses the question through an in-depth examina- tion of the legal and scientific history of Bendectin. While Henderson and Eisenberg use the Bendectin litigation as an example of general trends in products liability law, the cases can be understood at a micro level as well. The failure of the Bendectin cases to usher in a new era of causal proof based solely on statistical data is due as much to factors specific to the drug as it is to large-scale changes in tort law. The Bendectin cases are not simply a random group of otherwise independent 1. DEDICATION TO THE ENGLISH NATION, THE LETTFs OF JUNIUS [1769-1771], re- printed in FAMILIAR QUOTATIONS 1001 (John Bartlett ed., 13th ed. 1955). 2. James A. Henderson, Jr. & Theodore Eisenberg, The Quiet Revolution in Products Liability: An Empirical Study of Legal Change, 37 UCLA L. REv. 479 (1990). 3. Id at 486. 4. See, ag., Oxendine v. Merrell Dow Pharmaceuticals, 506 A.2d 1100, 1107-14 (D.C. 1986) (testimony of expert witness that drug used during pregnancy caused child's birth defects sufficient to carry case to jury where testimony was based on four different types of scientific studies). 5. Henderson & Eisenberg, supra note 2, at 491. 6. Id. HASTINGS LAW JOURNAL [Vol. 43 products liability cases that happen to involve the same drug. Rather, they are a collection of cases that, over time, have interacted in varied ways. Robert Emerson 7 and, more recently, Marc Galanter 8 have dis- cussed the nature of these interactions. Like other mass torts, the cases concerned with Bendectin are usefully thought of as a unit-the Bendec- tin Cases. This "congregation" of cases, to use Galanter's term,9 has a beginning, a middle, and apparently a rapidly approaching end. The topic of this Article is the life cycle of the Bendectin Cases. In Part II, I review Emerson's and Galanter's thoughts as to how the exist- ence of a congregation affects the way individual cases are processed and resolved. Part III provides some background on Bendectin and its man- ufacturer, Merrell Dow. The Bendectin litigation, like that of most mass torts, revolves around a body of scientific evidence employed to demon- strate that the product does or does not cause the harm alleged. Part IV surveys the science on Bendectin, examining it from a congregation per- spective as well. In Part V the attention turns to the law and legal pro- cess surrounding Bendectin. I examine plaintiff and defense efforts to mobilize resources and fight for position in the early stages of the congregation. After presenting an overview of the Bendectin litigation's life cycle, this Part concludes by discussing how the judiciary procedurally and substantively rations adjudicatory resources to large congregations such as the Bendectin Cases. The Article concludes with some general thoughts about the relationship between judicial rationing and case congregations and the ways in which case studies such as this one help us understand the larger trends in tort law uncovered by Henderson and Eisenberg. In the Bendectin Cases, the judiciary has played a much more active role in rationing its resources than anticipated by Galanter. I discuss the factors that compel the judiciary in this direction when it is

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