Michael S. Heesters Counsel 202-737-7557

Overview

Michael Heesters is a trial attorney, former Assistant United States Attorney and pharmacist.  Mr. Heesters has served as a first-chair litigator and has direct experience with government investigations involving agencies, such as FDA, DEA and HHS.  He leverages his experience to represent pharmaceutical companies, pharmacies, distributors, healthcare professionals and other healthcare/life science entities with litigation, government investigations, internal investigations and other compliance issues.

As a federal prosecutor, Mr. Heesters investigated and prosecuted healthcare fraud, FDA regulatory violations, illegal kickbacks, money laundering, controlled drug diversion and organized crime cases.  In particular, Mr. Heesters has prosecuted healthcare professionals (including doctors, pharmacists and dentists), recovered millions of dollars for Medicare, private insurance companies and the United Auto Workers and shut down several large-scale crime syndicates using the RICO Act.  Mr. Heesters has specific, demonstrable experience investigating individuals and corporations with federal investigatory entities, such as the FBI, DEA, FDA and HHS.

Prior to joining Hyman, Phelps & McNamara, Mr. Heesters worked for a large international law firm where he represented pharmaceutical, medical device and other healthcare/life science companies with litigation, internal and governmental investigations, regulatory and intellectual property issues and corporate transactions.

Mr. Heesters is also a licensed pharmacist that has worked in both the hospital and retail sectors.  Mr. Heesters routinely uses his pharmacy and science background to understand legal issues.

Education & Admissions

Education

J.D., University of Pennsylvania Law School, 2009

PharmD, University of Pittsburgh School of Pharmacy, 2004

Admissions

American Society for Pharmacy Law (ASPL)

Experience

Litigation / Internal Investigations

  • Led an investigation and prosecution (with FDA and HHS) of a physician and her co-conspirators related to healthcare fraud, illegal kickbacks and money laundering involving compounded pain creams.
  • Investigated and prosecuted (with FDA) a pharmacist and her co-conspirator for misbranding and healthcare fraud.
  • Investigated and prosecuted (with FDA) a conspiracy involving a wire fraud and adulterated medical devices.
  • Investigated and prosecuted a doctor and his co-conspirators (with FBI and HHS) for a healthcare fraud and controlled drug distribution conspiracy.
  • Investigated and prosecuted (with DEA) a doctor for controlled drug distribution and a death resulting from such illegal distribution.
  • Investigated and prosecuted two large-scale RICO conspiracy cases.  Each conspiracy involved more than 12 defendants and each trial was approximately 4 weeks in length.
  • Represented a large pharmaceutical company in a patent litigation from pre-suit due diligence through trial and appeal.
  • Defended a large pharmaceutical company in a litigation involving an OTC product and obtained a favorable settlement immediately prior to trial.
  • Represented a care facility in a state attorney general investigation and obtained a favorable settlement regarding Medicaid overpayments.

Corporate Transactions / Regulatory Submissions

  • Drafted, submitted and obtained a successful OIG opinion on behalf of a large pharmaceutical manufacturer regarding a multi-dose vaccine.
  • Organized and conducted the due diligence for a merger between two health systems.
  • Led the corporate formation and drafting of incorporation documents and related contracts for a newly formed healthcare firm (g., articles of incorporation, bylaws, board resolutions and a shareholder agreement).

Speaking Engagements

What’s New in Prescription Drugs?, Institute of Continuing Legal Education, March 2017

Education

J.D., University of Pennsylvania Law School, 2009

PharmD, University of Pittsburgh School of Pharmacy, 2004

Admissions

American Society for Pharmacy Law (ASPL)

Practice Areas
Industries
FDA Regulatory Categories