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coding and describing these documents. This work was performed by attorneys across the country. In providing this work product to plaintiffs’ counsel at large, it was critical to provide structure for the documents, or they would be lost in a sea of data. This was done using the theme grid. In many ways, this searchable data- base functioned as the framework for the story of liability. It imposed, if not a nar- rative structure, then certainly a coher- ence that enabled users to access the story of the Vioxx case. While all coded documents were
available in the complete trial package, approximately 1,500 of the “hottest” and most relevant were organized and search- able using the theme grid. All of these documents were subjectively coded, and short descriptions of each were provided, with links to complementary documents. But perhaps most important, all docu- ments on the theme grid were catego- rized by themes and subthemes. For example, a key point in the plaintiff ’s case was Merck’s motive to sell Vioxx aggressively even in the face of early con- cerns about the drug’s safety. Documents relevant to this contention were organ- ized under the general theme “Merck desperate for a blockbuster.” Beneath this general theme were more focused subthemes such as: “Vioxx has to succeed against tough Celebrex competition”; “Products going off patent”; “Pipeline is thin”; and “Analysts are gloomy about Merck future.” This organizational struc- ture enabled litigators to quickly and eas- ily assemble documents to prove an ele- ment of the case, or to interrogate a Merck defense. • Deposition Designations In previous iterations of MDL trial
packages, videotaped depositions of key witnesses were provided, some with trial designations, but often these were of lim- ited value. In Vioxx, we were able to go a step further because of the comparatively large number of trials that were complet- ed before the trial package was dissemi- nated. For all key liability witnesses (not just company employees, but third-party witnesses and experts – retained and independent), deposition and trial
transcripts were provided, with exhibits. In addition, deposition designations from all trials were provided – together with the committee’s recommended des- ignation – and Merck’s counter-designa- tions, with previous rulings on admissibil- ity from various courts. When used with the master order of proof, these “witness folders” enabled practitioners to assem- ble the majority of the general liability case pretrial, mapping out beforehand a large portion of the evidence to be offered at trial, with a well-developed plan for how and when it would be offered into evidence. • Cross Examination Modules Of course, there is a limit to the
number of variables in trial which can be controlled with pretrial preparation. While significant portions of the plain- tiff ’s case-in-chief can be presented using videotaped deposition testimony, every pharmaceutical trial involves live cross examination of critical defense witnesses. These witnesses are almost always highly educated scientists and physicians, with broad experience in their respective fields, who are generally very well pre- pared for trial. Witnesses of this type consistently offer remarkably sophisticat- ed defenses to liability, based on analyses of scientific data and convoluted phar- maceutical regulations. To better enable attorneys to engage these witnesses and defenses, at deposition and trial, the trial package contained witness folders for defendant employees and retained wit- nesses who could reasonably be expected to testify live at trial, complete with all depositions, transcripts of previous trial testimony, cross examination outlines and, where applicable, expert reports. In addition to these, folders were also pro- vided for critical witnesses whose identi- ties would change from case to case; such as case-specific experts, sales representa- tives, treating cardiologists (in heart attack cases) and prescribing physicians. Similar to the witness folders, which
were designed to help practitioners pre- pare for a live witness, the committee also supplied defense modules, to help counsel rebut common Merck defenses. These provided strategies for responses
to defense claims pertaining to liability – e.g.: “We gave all relevant information to the FDA”; “Vioxx was no more dangerous than any other drug in the class”; or “Hypotheses demonstrating the risks of Vioxx had been disproved.” The modules contained narrative explanations of the Merck defense, explained the evidence relied upon by the company, and cata- logued the evidence available to rebut the claims, including cites to deposition testimony, liability documents, medical literature, and other material.
Conclusion Every Vioxx case presented signifi-
cant plaintiff-specific issues. The signa- ture injury – heart attack – has a host of co-morbid conditions, most of which were in play in every case. Merck’s attor- neys defended their client relentlessly, contesting every issue throughout the liti- gation. And yet, by consistently pushing individual cases to trial, the plaintiffs negotiated a settlement of nearly $5 bil- lion. In large measure, this was made possible by the development of a portable liability package. This is an example of one of the ways which plain- tiffs’ leadership cases can fulfill their obligations to claimants who – of necessi- ty – rely on common-benefit work prod- uct. In fulfilling this obligation, these attorneys can keep the focus of these often unwieldy cases where it should be: on individual trials of strong cases. The more this approach is given precedence over indiscriminate mass settlements, the better the rights of all claimants can be protected.
Pete Kaufman is an attorney at Panish,
Shea & Boyle, LLP. He specializes in phar- maceutical and medical device litigation, and has practiced for ten years. He is a graduate of the University of Wisconsin-Madison and the University of Florida Levin College of Law. He served as co-chair with Gerald Meunier of the Vioxx MDL Trial Package Committee.
JANUARY 2012 The Advocate Magazine — 39
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