Charles Biro

Senior Counsel

Charles BiroCharles Biro is a seasoned litigator with extensive experience handling complex civil, criminal, and administrative matters. He has developed a strong focus in health care law, particularly in cases involving the False Claims Act and the Food, Drug, and Cosmetic Act. His background includes conducting in-depth investigations and delivering strategic litigation solutions across a broad spectrum of regulatory and enforcement actions.

Prior to joining Esbrook, Charles served 16 years at the U.S. Department of Justice, working in the Civil Fraud Section, Consumer Protection Branch, and the Office of the Inspector General. During his time there, he led multiple interagency teams in investigating corporate violations of the False Claims Act; the Food, Drug, and Cosmetic Act; and the Anti-Kickback Statute. Charles also brings substantial courtroom experience, having litigated cases at both the trial and appellate levels.

Charles started his legal career at Sidley Austin LLP where he represented clients in all stages of complex civil litigation in state and federal court, including at trial.

Selected Experience
  • Investigated several multinational drug companies for off-label marketing of prescription drugs, resulting in convictions and criminal fines in excess of $3 billion.
  • Participated in an eight-member interagency prosecution team during a five-week jury trial of a publicly traded medical device firm and its CEO for selling devices without FDA approval and conspiring to defraud the United States.
  • Investigated and sued a publicly traded medical device company for off-label marketing, resulting in a settlement that erased all income from the product at issue.
  • Assisted in investigation of an opioid manufacturer and executives for false statements regarding the safety of opioids. Resulted in DOJ’s largest opioid resolution of over $2 billion, a corporate felony plea, and misdemeanor pleas for two executives with a six-month jail sentence.
  • Defended Food and Drug Administration’s denial of a drug company’s petition for pediatric exclusivity. Successfully opposed motions for a temporary restraining order and for summary judgment. Drafted and argued appeal.
  • Investigated and negotiated settlements in multiple qui tam cases relating to Medicare fraud.
Professional Awards
  • Council of the Inspectors General on Integrity and Efficiency, Award for Excellence (2021)
  • Department of Health and Human Services Office of the Inspector General Award for Excellence (2020, 2021)
  • Department of Justice Special Commendation for Outstanding Service (2019)
  • Attorney General’s Distinguished Service Award (2013)
  • Department of Health and Human Services Inspector General’s Cooperative Achievement Award (2013)