For decades, our lawyers have skillfully represented public and private corporations, boards of directors, and individuals in high-stakes white collar cases and government investigations. We handle a broad range of matters, including internal investigations, enforcement inquiries and litigations, compliance advice and counseling, and corporate governance. Within this arena, Arnold & Porter has a tremendous track record and has become a "go to" firm for clients in the life sciences arena.
The Federal Food, Drug, and Cosmetic Act is enforceable through criminal prosecution, injunction proceedings, civil money penalties, and a variety of administrative actions, as well as through the False Claims Act and general federal criminal statutes. We have significant experience, both in the courtroom and in helping avoid the courtroom altogether through effective early intervention, to prevent inappropriate or unnecessary enforcement actions. Our attorneys are experienced advocates before the FDA, the DOJ, and other federal agencies with related jurisdiction, including the Drug Enforcement Administration, the Inspector General of Health and Human Services (HHS), and the CPSC, as well as state regulatory agencies. The firm also has advised clients during intensive government investigations and audits. We have, for example, successfully defended several manufacturers of medical devices in so-called Section 305 hearings that resulted either in no criminal referral by the FDA or in no subsequent action by the DOJ.
Our team is recognized for our experience in complex healthcare fraud and abuse matters, including off-label promotion matters and False Claims Act litigation. Additionally, we have extensive experience representing clients in FCPA, UK Bribery Act, and other anti-bribery investigations and compliance matters in more than 85 countries. We have built a strong reputation in dealings with the U.S. DOJ, the SEC, the UK's SFO, and other U.S. and international government authorities. Many of our partners joined the practice from former high-ranking government positions. Together, our lawyers bring in-depth knowledge and insights to potential criminal issues and build long-standing credibility with prosecutors to resolve matters effectively for our clients.
Areas of Focus
- Government Investigations and Enforcement Actions
- Qui Tam Litigation
- Securities and Accounting Fraud Investigations and SEC Enforcement
- Internal Investigations
- Compliance Advice and Counseling
- Corporate Governance