Laura Lester represents both individual and corporate clients in federal and state government criminal and civil investigations throughout the United States and leads large defense teams through all phases of an investigation—from internal investigations, subpoena compliance and grand jury proceedings to criminal defense at trial. Ms. Lester has particular experience in US Food and Drug Administration (FDA) criminal matters, healthcare fraud, false claims/qui tam actions, corruption, terrorism-related crimes, immigration fraud, government contracts fraud, and criminal antitrust matters. She has deep experience representing medical device and pharmaceutical manufacturers and individual employees in antitrust, FCPA, misbranding, kickback, adverse event reporting, and Medicaid pricing criminal and civil investigations. In addition, she has experience with First Amendment challenges to FDA's authority and has dealt extensively with the Department of Health and Human Services Office of Inspector General related to negotiating and implementing Corporate Integrity Agreement (CIA)s. Ms. Lester also has experience investigating and negotiating employment issues and claims, including whistleblower claims of harassment, retaliation, and wrongful termination, many of which arise during internal and criminal investigations.
- Par Pharmaceutical Companies, Inc. and Par Pharmaceutical, Inc. in multi-year investigation of the company's promotional practices by the US Department of Justice (DOJ), US Food and Drug Administration (FDA), and New Jersey US Attorney's Office that concluded with a favorable global settlement. Ms. Lester was lead counsel in defending Par's promotional practices, which included filing a First Amendment challenge to the FDA's intended use regulations in US District Court in Washington, DC and a Third Circuit appeal related to the grand jury investigation. Ms. Lester also led the Corporate Integrity Agreement (CIA) negotiations with the US Department of Health & Human Services Office (HHS) Office Inspector General (OIG).
- Global pharmaceutical manufacturer in a multi-year investigation of the company's adverse event reporting practices by the DOJ, FDA, and Massachusetts US Attorney's Office. Ms. Lester was lead counsel in defending the company's practices, which led to a declination by the DOJ.
- Global pharmaceutical and device manufacturer in a kickback investigation by the DOJ, FDA, and New Jersey US Attorney's Office, which resulted in a declination by the DOJ.
- Par Pharmaceutical, Inc. in the implementation and ongoing administration of its 5-year CIA.
- Global pharmaceutical manufacturer in a state Attorney General investigation of the company's Medicaid price reporting.
- Executive of a medical device manufacturer in a multi-year investigation of the manufacturer's promotional practices by the DOJ and New Jersey US Attorney's Office.
- Ophthalmic surgery provider in an internal investigation and in a later investigation by the US Attorney's Office for the Northern District of Georgia.
- Ambulance service provider in a multi-year federal investigation into alleged violations of the Anti-Kickback Statute.
- Government contractor in a False Claims Act investigation by HHS OIG.
- Multiple employees of pharmaceutical and medical device manufacturers in various federal probes of the companies' promotional practices.
- Multiple individual healthcare providers, including physicians and physician practice groups, as well as healthcare executives in various federal probes involving allegations of Medicare and/or Medicaid fraud and violations of the Anti-Kickback Statute.
- Executive of a global pharmaceutical manufacturer in an FCPA investigation by the DOJ and Securities and Exchange Commission (SEC).
- Sales executive of a global airplane manufacturer in an FCPA investigation by the DOJ and SEC.
- Qatari government official in an FCPA investigation by the DOJ and SEC.
- Jacques Dessange, Inc. in multi-defendant immigration fraud conspiracy trial in the Southern District of New York ending with a small corporate fine and community service and no employee convictions.
- Japanese executive of a multinational corporation in an antitrust cartel probe by the United States Department of Justice.
- Individual indicted on terrorism-related charges, including conspiracy to levy war against the United States.
Professional and Community Activities
- Member, American Bar Association
- Member/Anti-Racism Working Group, Women's White Collar Defense Association