The Litigation Consulting Report

Trial Exhibits: Antitrust, Pharmaceuticals & Hatch-Waxman Litigation

Posted by Ken Lopez on Tue, Apr 12, 2011 @ 07:30 AM


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. 

These trial exhibits shown in video format were part of a PowerPoint created for opening statements. Scroll below the movie for the impressive result.





Despite a serious threat with potential damages approaching half a billion dollars, our top five law firm client prevailed with the assistance of our trial exhibits.  We received a complete defense verdict and our client noted about Animators at Law:


"The whole team was incredibly thoughtful, creative and always willing to answer the call. We would not hesitate to recommend you to any of our colleagues, we had a far better experience with you than with others we have used in the past (who didn't quite "get" what we were trying to convey and were always three steps behind us - you guys were consistently one step ahead)."

Tags: Trial Graphics, Litigation Graphics, Trial Presentation, Animation, Patent Litigation, Pharmaceutical, Science, PowerPoint, Opening, Information Design, Antitrust Litigation

    Join 5,400 Subscribers and Get Notified of New Articles Every Week

    Watch Now: Using PowerPoint Litigation Graphics to Win - Webinar

    using powerpoint litigation graphics

    Free Litigation Webinars - Watch Now

    ryan flax a2l litigation consultants webinar recorded


    patent litigation webinar free litigation graphics demonstrative

    Featured E-Book: The Patent Litigator's Guide to Trial Presentation & Trial Preparation

    patent litigation ebook 3rd edition

    Featured Free Download: The Complex Civil Litigation Trial Guide

    a2l consultants complex civil litigation trial guide download

    Free Webinar - Integrating Expert Evidence & Winning Arguments - Watch Anytime.

    expert witness teach science complex subject courtroom webinar

    Nationally Acclaimed - Voted #1 Jury Research Firm and #1 Demonstrative Evidence Firm in the U.S.

    voted best demonstrative evidence consultants

    A2L best demonstrative trial graphics consultants
    best demonstrative evidence litigation graphics consultants

    Download the (Free) Storytelling for Litigators E-Book

    describe the image

    Considering Using a Trial Technician at Your Next Trial? Download this first.

    trial technicians trial technology atlanta houston new york boston virginia

    Featured Free Download: Using Science to Prevail in Your Next Case or Controversy

    using science to win at trial litigation jury

    Featured FREE A2L E-Book: Using Litigation Graphics Persuasively

    using litigation graphics trial graphics trial presentation consultants

    Free Jury Consulting & Trial Consulting Guidebook for Litigators

    jury consulting trial consultants guide

    Timelines Appear In Most Trials - Learn how to get the most out of using trial timelines in this ebook

    trial timelines graphics consultants litigators

    Featured Complimentary eBook - The 100-page Antitrust Litigation Guide

    antitrust ebook a2l litigation consultants

    Featured Complimentary eBook - Leadership Lessons for Litigators and Litigation Support

    leadership lessons litigation law firms litigation support

    Featured E-Book: The Environmental Litigator's Guide to Trial Presentation & Prep

    environmental litigation trial presentation trial prep ebook a2l

    Authors

    KenLopez resized 152

    Ken Lopez founded A2L Consulting in 1995. The firm has since worked with litigators from all major law firms on more than 10,000 cases with over $2 trillion cumulatively at stake.  The A2L team is comprised of psychologists, jury consultants, trial consultants, litigation consultants, attorneys and information designers who provide jury consulting, litigation graphics and trial technology.  Ken Lopez can be reached at lopez@A2LC.com.


    ryanflax blog litigation consultant 

    Ryan H. Flax, Esq., Managing Director, Litigation Consulting, joined A2L Consulting on the heels of practicing Intellectual Property (IP) law as part of the Intellectual Property team at Dickstein Shapiro LLP, a national law firm based in Washington, DC.  Over the course of his career, Ryan has obtained jury verdicts totaling well over $1 billion in damages on behalf of his clients and has helped clients navigate the turbulent waters of their competitors’ patents.  Ryan can be reached at flax@a2lc.com.


    dr laurie kuslansky jury consultant a2l consulting
    Laurie R. Kuslansky, Ph.D, Managing Director, Trial & Jury Consulting, has conducted over 400 mock trials in more than 1,000 litigation engagements over the past 20 years. Dr. Kuslansky's goal is to provide the highest level of personalized client service possible whether one's need involves a mock trial, witness preparation, jury selection or a mock exercise not involving a jury. Dr. Kuslansky can be reached at kuslansky@A2LC.com.

    Articles by Category

    Follow A2L Consulting

    Member Red Well Blog
    ABA Blawg 100 2013 7th annual

    • Letter from major law firm re: trial technician/hot-seat services.
      Letter from major law firm re: trial technician/hot-seat services.

    Follow Us on Google+

    A2L on Google+