Andrew O’Connor represents clients in high-stakes government investigations and complex civil litigation. Andrew has represented numerous well-known healthcare and life sciences companies facing major federal investigations, class actions, and false claims act litigation.
Andrew’s practice spans civil and criminal matters involving fraud statutes, anti-kickback laws, FDA regulations, the Controlled Substances Act, insurance billing rules, the Foreign Corrupt Practices Act, and federal securities laws. Andrew has led internal investigations and represented clients in resolving potential enforcement actions by the U.S. Department of Justice, numerous state attorneys general and federal regulatory agencies. He has also successfully litigated complex civil cases on behalf of clients in state and federal court, at both the district and appellate levels.
Andrew is a graduate of Yale University and Harvard Law School, where he served as an editor of the Harvard Law Review. He maintains an active pro bono practice, representing individuals in federal Immigration Court and state law matters.
Civil & Criminal Investigations
- Negotiated first-of-its-kind resolution of allegations regarding potential violations of the Controlled Substances Act and DEA regulations by a pharmaceutical manufacturer in connection with the sale and distribution of prescription opioid products.
- Defended major pharmaceutical and medical products company in civil and criminal investigation by United States Attorney's Office and the Office of Consumer Protection Litigation of the U.S. Department of Justice into alleged off-label promotion and kickback arrangements, leading to favorable civil-only resolution.
- Represented large multinational pharmaceutical company in consumer protection investigations by state Attorneys General into allegedly misleading direct-to-consumer advertising.
- Represented international medical device manufacturer in multi-year criminal investigation into alleged kickbacks and Medicare fraud. Reached favorable settlement with the U.S. Department of Justice, HHS Office of Inspector General and other government agencies.
- Represented large multinational pharmaceutical company in high-profile, wide-ranging investigation of foreign bribery allegations.
- Represents international medical device company in wide-ranging government investigation regarding alleged provision of in kind services to healthcare providers.
- Represents major national organization in connection with investigation of patient assistance programs.
- Successfully represented surgical implant manufacturer in connection with civil and criminal investigation into allegedly improper consulting relationships with physicians.
- Represented Chief Compliance Officer of medical device company in connection with federal grand jury investigation of healthcare fraud.
- Represented drug manufacturer in connection with municipal false claims investigation involving allegedly misleading promotion of branded and generic prescription drugs.
False Claims Act & Class Action Litigation
- Secured dismissal with prejudice of False Claims Act qui tam complaint against major healthcare provider regarding external patient referral practices.
- Secured favorable resolution of qui am alleging improper billing for laboratory testing by major national healthcare provider.
- Secured dismissal with prejudice of class action complaint alleging improper Medicare billing practices.
- Successfully represented medical device manufacturer in multiple qui tam actions under the federal False Claims Act involving alleged kickbacks and over-billing.
- Secured zero-dollar resolution for medical products and pharmaceutical company in action under California state qui tam statute alleging the submission of false claims to private insurers.
- Successfully represented pharmaceutical manufacturer in federal false claims action alleging improper conduct during contract bidding process.
- Successfully argued motion to dismiss complaint against biotechnology and medical device company in securities fraud action involving allegedly misleading statements to investors.
- Represented biotechnology firm in securing dismissal of a securities class action involving allegedly false statements concerning FDA approval of the company’s flagship medical product. Successfully represented company in a challenge to the dismissal before the U.S. Court of Appeals.
- Represented executive officers in multi-billion dollar securities fraud class actions involving alleged accounting misstatements concerning exposure to subprime and other nontraditional mortgage-related securities.
- Successfully represented biotechnology company in defending against shareholder action threatening strategic merger with medical device company.
Corporate Compliance Counseling
- Advised corporate board of directors regarding compliance oversight responsibilities under securities laws and federal sentencing guidelines.
- Conducted compliance audit to identify potential regulatory vulnerabilities at mid-size pharmaceutical company.
- Co-author, “Five Questions Companies That Handle Controlled Substances Should Ask,” Bloomberg BNA’s Health Care Fraud Report (August 16, 2017)
- Co-author, “Corruption and the Greater Good: NGOs and International Compliance Risk,” The FCPA Report (June 7, 2017)