The passage of the Drug Price Competition and Patent Term Restoration Act in 1984 and its subsequent amendments (collectively the Hatch-Waxman Act) gave rise to more competition in the pharmaceutical industry and a new era of litigation. The act itself provides a mechanism for generic drug companies to quickly gain approval to sell a generic version of an existing brand name drug. The application that begins the FDA approval process for the generic firm is called an Abbreviated New Drug Application (ANDA). Brand name drug manufacturers have an understandable incentive to delay approval of the ANDA. Simply, if the ANDA approval is delayed, the brand name firm continues to enjoy the lawful ability to sell their brand name drug without a lower priced generic equivalent in the market. One lawful mechanism brand name manufacturers use that may have the effect of delaying the approval of an ANDA is the filing of a Citizen Petition with the FDA. The Citizen Petition filed by a brand name firm would typically allege that the proposed generic drug is not equivalent and thus should not be approved for sale. Should the Citizen Petition be deemed only a mechanism for delaying approval of the ANDA/generic drug rather than one filed with the public's health interest at heart, the brand name firm would be liable for antitrust violations. Such was the question our firm faced when working on behalf of a brand name pharmaceutical firm recently. A Citizen Petition had been filed and a jury was going to be asked whether it had been lawfully filed. Were the jury to find that the Citizen Petition had been unlawfully filed with the intent to simply delay approval of the generic drug, they could possibly award hundreds of millions of dollars in damages. One quirk in this case that proved advantageous was the fact that it was not the generic drug firm suing the brand name firm, but instead it was the middleman or drug wholesaler who was alleging antitrust violations. Our challenge in creating an effective trial presentation was to create trial exhibits that both taught the jury and persuaded the jury simultaneously. The trial exhibits shown below were part of an opening PowerPoint presentation that explained who was involved in the case (i.e. the typical parties/players trial exhibit) and who was not involved. We sought to emphasize that the brand name firm was being sued not by the generic drug manufacturer but instead the wholesaler who we painted as the delivery guys in these opening trial exhibits. The story told is this: Brand name firms seek approval for a new drug from the FDA; Brand name firms distribute their product through wholesalers who then sell them to pharmacies; Generic firms receive approval to sell through an ANDA; The brand name firm here is BrandName Pharma, generics will be mentioned and then there are the wholesalers. In this case HatchWax Wholesale Drug; One would think the generics are involved, but they are not. Only the wholesalers or the delivery guys are suing. What business do they have suing? Who is HatchWax Wholesale Drug? They are professional antitrust plaintiffs.
I have had the great pleasure of working closely with hundreds of world's best litigators since 1995. One common theme they communicate is that they see simplifying their case, prior to walking into the courtroom, as part of their job. Today, I am writing to share about a 'new' tool designed quite precisely for this purpose. The new tool is a modern software version of a decades-old technique modeled on centuries-old principles. In general this tool facilitates the visualization of complex and interrelated ideas. Specifically, I am talking about a process called mind mapping. Mind mapping is a 60s-era-sounding term for an activity that seems, at first glance, like it must have certainly been born on the left-coast. In a sense, both of those things are true. It was in fact developed in the era between the 50s and 70s, and it was born on a left coast of sorts. However, this 'left coast' is really the western suburbs of London. Regardless of mind mapping's nonconformist origins, I believe it has a place in the toolkit of the modern litigator. After all, many thought-leading litigation trends were born in California or places like it (e.g. demonstrative evidence, jury research, courtroom animation, etc.). A small version of a 30 inch x 90 inch litigation mind map is shown below. I encourage you to download a full-sized .pdf version of the actual chart to get a feel for how it is laid out. This sample mind map is based on a group of cases where we have used mind mapping as a system for quickly understanding a complex case in a short period of time, brainstorming a trial presentation approach and laying out specific exhibits. In this chart, green circles represent likely demonstrative exhibits, red boxes represent problems with our case that require additional strategic attention and the yellow boxes contain the background information on the case, trial team and strategy. The same approach we take for trial graphics development can easily be taken by a trial team organizing a complex case with many experts, theories and potential trial strategies. In addition to the obvious organizational benefits, the beauty of using this approach is just how easily one can pick up where one left off. I have gone a month or more between deeply complicated meetings and been able to start precisely where we left off without spending time trying to re-teach the team everything that was discussed weeks or months before. This is one of those benefits that I think one has to experience to believe. While litigation-specific tools do exist that offer a some of the features in today's mind mapping software, I prefer using a flexible tool that works very well. I have used two products: 1) Tony Buzan's iMindMap (he is considered the father of modern mind mapping); and 2) Mindjet's MindManager. I prefer the latter, as I find it to be a bit more business-oriented. When working with our firm on trial presentation strategy, we will likely be using mind mapping either internally or overtly. However, we are interested in testing this approach with a trial team at the front-end of a case rather than within the time period we are more typically consulting with the trial team (6 months prior to trial). If you would be interested in testing this technique with your trial team, we are willing to do so gratis for a limited number of trial teams working complicated cases with at least $10 million at stake. The output will be a wall chart for your team that you can refer to on an ongoing basis.
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