The Litigation Consulting Report

Pharmaceutical companies can be embroiled in many types of litigation. Very often, because of the length of time and the tremendous investment of money that it takes to develop a new drug and bring it to market, these cases can be crucial to the company’s continuing financial health.

One of the most important jobs of the trial lawyer and of the litigation consultant is to make highly complex and technical issues understandable to the average juror who does not have a scientific, engineering or technical background. In technology cases, especially patent cases, using demonstrative evidence is normally a good tactic. Here's why. The trial lawyer has spent months or probably years delving into every aspect of the case, and by the time it gets to trial, even the most arcane subjects can appear simple to him or her. Of course, that doesn’t mean they are easily understood by the general population of which the men and women in the jury box are a representative sample. Think of the challenge as needing to explain a complicated subject to a kid or to your grandparent; it takes creativity (and visual presentations - e.g. demonstrative evidence) to make the concept digestible to all audiences.

Demonstratives can frequently be used very effectively in product liability litigation, in which the issue is whether a product was manufactured negligently, causing harm – or in some cases, whether a product that was manufactured and used properly still caused harm to a consumer that leads to liability on the part of the manufacturer or seller.

by Ken Lopez Very often, trial attorneys in complex cases need to explain extremely difficult and elusive scientific concepts to jurors who are not well versed in science. The lawyer’s job is to convey the science correctly to the jury so that they can make a rational decision – yet not to bury the jury under a blizzard of scientific terms and concepts that they will never understand. The answer is to use visuals in the form of photographs, schematic diagrams, animation, timelines, demonstrative evidence, document call outs or whatever is suited to the situation, and to explain them in terms that jurors who are not specialists in the scientific subject can understand.

Although checklists are not as dramatic as other types of litigation graphics such as three-dimensional animations or interactive PowerPoint timelines, they can be very effective in persuading juries on key issues and in making it easier for them to recall the important elements of a case.

In a trial in which harm to the environment is at issue, the major challenge for any litigator is to present complex scientific information in a way that is easy for an average person to understand. For our litigation graphics consultants, this is true whether we are helping to represent an alleged polluter against a landowner or other person who alleges environmental damage, or whether it’s an insurance coverage case in which our client is asking an insurer to cover a claim under a business insurance policy. In many cases, the task is further complicated by the fact that environmental harm occurs over a period of years or even decades. In such situations, it is crucial to show not only how the damage occurred initially but how it became more serious, or less serious, over a period of time.

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.

Still think PowerPoint is a trial presentation tool primarily for bullet points and text? Allow me to show you otherwise! Like a good salad, PowerPoint is all about the ingredients you put into it. Bad ingredients (e.g. text only, bullet points, clip art, poor color choice, etc.) equal bad PowerPoint trial graphics. Good ingredients (e.g. technical illustration, well-designed backgrounds, quality transitions between slides, animation, etc.) equal winning trial graphics. Since the introduction of the 2003 version, PowerPoint has been a go-to tool for patent litigators in claim construction hearings, tutorials, at the ITC and in patent infringement trials. Out of the box, PowerPoint is simply a blank canvas that allows text, clip art and basic shapes to be combined on a slide. However, in the hands of an information designer at a trial consulting firm, it is a powerful tool indeed. Like a master painter with high quality paints, skill and experience, the blank canvas of PowerPoint can be filled with true works of information art in the hands of a skilled information designer. The movie below contains four examples of patent infringement trial graphics created by Animators at Law. Three of the four examples were created for jury trials or Markman hearings. One example was built for a §337 ITC hearing. All examples combine technical illustration and PowerPoint animation in a clever way. The examples are: