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The Shire Pharmaceutical settlement over off-label marketing of ADHD drugs Adderall and others announced last week brings a few new issues to mind. First, how was this matter different? There were no criminal charges nor penalties, attributed to Shire’s response to the U.S. Attorneys office when served with the first subpoena. See Tracy Staton’s take in Fierce Pharma, Hey Big Pharma: When the Feds Swoop In, Be Nice, It Worked For Shire.

See more after the video

Second, is the “first to file” whistleblower and their attorneys in the best position to successfully see a qui tam False Claims Act through? It depends. It’s always to the whistleblower’s advantage to be first to file, and the attorneys certainly are in a better position to present the case to the government from the beginning. But there are mitigating factors, and in some recent settlements, the whistleblower and attorneys who were technically first to file are said to have not adequately prepared the case and were therefore not able to be part of the settlement. It would not be a good thing to go through the process without the attention to detail on preparing the case to “tee it up” for the government.

Third, are there trends developing in the investigation and filing of qui tam False Claims Act cases? Yes. This topic is worthy of its own blog post, and will be posted in the near future along with a discussion of the issue on video from Stephen Sheller’s presentation to the Montgomery County Bench Bar Conference entitled¬†“An American Hustle: Whistleblowers & Prosecuting False Claims Cases” held at the Hyatt Regency Chesapeake Bay Golf Resort in Cambridge, Maryland on September 13, 2014. Steve was accompanied by former Assistant U.S. Attorney Joe Trautwein.

For more details on the Shire settlement, see the Department of Justice press release, the Sheller, P.C. news release, and The Legal Intelligencer article.

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