Government Investigations & Qui Tam Litigation
Pharmaceutical, biotechnology, and medical device companies are often under close government scrutiny regarding their marketing and pricing practices. The stakes in many government investigations and qui tam matters can be very high, and the impact can be multiplied by related private payer litigation.
Over the past decade, Analysis Group has provided expert support in numerous cases involving allegations of off-label promotion, kickbacks, and illegal pricing practices. Our extensive body of work in this context has spanned a range of therapeutic areas and specific disease states.
Our work often involves alleged violations of the False Claims Act; the Anti-Kickback Statute; the Food, Drug and Cosmetic Act; and/or the Foreign Corrupt Practices Act. We perform economic, statistical, and epidemiologic analyses to inform assessments of liability, causation, and damages under theories of government loss or corporate gain.
Our teams rely on numerous industry data sources ranging from company data (including product sales, marketing expenditures, and call note records) to market research data (including physician prescribing practices, formulary positioning, and competitor product trends). In addition, we draw on our expertise in health outcomes research in making use of administrative claims data, electronic medical records, and epidemiologic studies. We apply appropriate pharmacoeconomic methodologies to these data sources to help us understand the determinants of physician prescribing.