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John M. Hillebrecht

DLA Piper

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The writing’s on the wall: wise pharma companies will heed FDA warning in new draft guidance on data integrity cGMPs

USA - May 2 2016 FDA is again shining a spotlight on data integrity violations, announcing in a new draft Guidance for Industry: Data Integrity and Compliance with...

James N. Czaban, Matthew A. Holian, Rebecca Jones McKnight.

Second Circuit affirms employers’ right to terminate employees who fail to cooperate with internal investigations

USA - July 1 2016 A recent decision from the Second Circuit affirmed an employers’ right to terminate an employee who refused to participate in an internal...

Brett Ingerman, Michael D. Hynes, Brian H. Benjet.

First Circuit affirms Pfizer victory in False Claims Act case

USA - February 1 2017 The First Circuit has rejected an appeal in United States ex rel. Booker v. Pfizer, a False Claims Act (FCA) case alleging that Pfizer engaged in...

Courtney Gilligan Saleski, George M. Karavetsos, Andrew J. Hoffman.

False Claims Act year in review: 2017

USA - February 28 2018 In 2017, False Claims Act (FCA) recoveries totaled more than $3.7 billion, down from more than $4.7 billion in total recoveries in 2016. More than $3...

Courtney Gilligan Saleski, Andrew J. Hoffman, Christopher George Oprison.

Middle District of Florida reverses $350 million verdict and joins other courts in enforcing Escobar's strict materiality standard

USA - January 17 2018 A recent decision from a judge in the Middle District of Florida reversed a $350 million jury FCA verdict and joined other courts throughout the...

Courtney Gilligan Saleski, Asha M. Natarajan, Andrew J. Hoffman, Christopher George Oprison.