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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)."

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

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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.


Tony Klapper joined A2L Consulting after accumulating 20 years of litigation experience while a partner at both Reed Smith and Kirkland & Ellis. Today, he is the Managing Director of Litigation Consulting and General Counsel for A2L Consulting. Tony has significant litigation experience in products liability, toxic tort, employment, financial services, government contract, insurance, and other commercial disputes.  In those matters, he has almost always been the point person for demonstrative evidence and narrative development on his trial teams. Tony can be reached at klapper@a2lc.com.

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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.

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