Life Sciences Disputes Compliance & Investigations
In the complex regulatory environment of today’s Pharmaceutical, Biotech, Medical Device and Diagnostics industries, companies and their counsel face an increasing number of dispute, compliance and investigation issues that have the potential for significant financial, economic and reputational impact. Companies need to secure oversight that represents an intimate knowledge of the laws and regulations of the industry and how each of the functional areas within a Pharmaceutical, Biotech, Medical Device and Diagnostic company operate.
Our professionals combine litigation and investigative experience with industry knowledge to assist clients with compliance and risk mitigation services; dispute resolution and litigation support; fraud and other special investigations; antitrust matters; class action services; breach of contract analysis; and data analysis and information systems consulting. Our collective industry experience provides our professionals with a cross-industry understanding of potential solutions that our clients regularly leverage.
Click here to view our expert perspectives in our Life Sciences Article series.
Our services include:
- Damages analysis
- Contract dispute/analysis
- Intellectual property
- Government pricing and rebates, and contract compliance
- Clinical data analysis
- Product liability
- Expert witness testimony
- Comprehensive compliance program assessment and support
- Government enforcement support: IROs, CIAs, DPAs and monitorships
- Board level compliance effectiveness certifications
- Discrete issue compliance assessment
- Contract/vendor compliance
- Technology solutions development
- Fraud and other special investigations
- Government shadow investigations
- False claims/qui tam investigations
- Fraudulent billing investigations
- Off-label pharmaceutical practices
- Sales and marketing practices
Managing Complex Risks in Life Sciences Organizations
Overview of Navigant's Life Sciences Disputes, Compliance and Investigations Services
Healthcare Disputes, Compliance and Investigations Service Overview
Navigating Complex Disputes Relating To Clinical Development
A major pharmaceutical company and their outside counsel required expert guidance in a case involving marketing practices, clinical development and data integrity. Navigant was engaged to evaluate clinical trial activity and related data management and advise outside counsel on potential case strategies, potential areas for further investigation and areas of risk to the case. Reviewing marketing practices in the industry, and related use of clinical data, our team further supported the case strategy development and provided insights into industry standards.
Department Of Justice Launches Anti-Kickback Investigation
A global medical device company received a subpoena related to their contractual arrangements with healthcare professionals. Outside counsel turned to Navigant to investigate the company’s arrangements and determine risk, support settlement activity and recommend actions to address risks. The Navigant team established a statistically relevant sample, analyzed extensive data sets and quantified the potential risk and related exposure. Working with outside counsel, our recommendations provided a road map to ensuring healthcare professional arrangements were established with the appropriate controls to manage risks associated with the Anti-Kickback Statute.