Life Sciences Litigation

CRA’s life sciences litigation support services are grounded in a comprehensive understanding of pharmaceutical, biotechnology, medical device, and diagnostic markets. For more than 30 years, our experts have consulted with major life science companies, law firms, and regulatory agencies around the globe. We provide clients with the industry and analytical expertise needed to solve our clients’ most complex issues.

CRA leverages its deep industry knowledge and familiarity with healthcare data analytics to help our clients navigate government investigations involving civil, criminal, and regulatory enforcement issues. We have expertise in pharmaceutical pricing and reimbursement and the intersection of these areas with government regulations. Our team has experience working with complex data, including Medicare, Medicaid, and private insurance claims data, pharmaceutical sales data, and market research to investigate questions of wrongful conduct, causation and damages.

CRA has assisted clients in intellectual property (IP) matters concerning products and services in the life sciences sector, including Hatch-Waxman and BPCIA matters. We have also addressed patent, trademark, and copyright infringement, trade secret misappropriation, and IP licensing. Our experts have quantified damages based on lost profit and reasonable royalty methods and provided opinions on irreparable harm. In addition, we have experience addressing other forms of relief, such as rescission and disgorgement.

Our understanding of the unique dynamics of different therapeutic areas informs assessments of commercial success as a secondary indicator of non-obviousness and the claimed nexus between patented technologies and product success.

Product development in the life sciences sector is frequently complex, costly, and time-consuming, and collaborations between companies are common. Disputes may arise at all stages of development and commercialization. Our experience helps clients navigate disputes involving drug development and commercialization and identify relevant commercial factors (size of the opportunity, therapeutic area, business risks, etc.). CRA has provided expert reports and testimony evaluating development and commercialization efforts and assessing damages associated with alleged contractual breaches.

CRA has extensive experience in pharmaceutical arbitrations across a wide range of disputes, including those involving licensing, product development, commercialization, supply, and investor-state proceedings. CRA has provided expertise in evaluating the merits of claims in dispute as well as damages and valuation. Our experts have presented expert reports and testimony at major commercial arbitral institutions, including JAMS, AAA, ICC, and ICDR.

CRA has a broad range of experience in complex shareholder lawsuits and appraisal disputes involving life sciences and healthcare companies. We assist clients across all phases of the securities litigation process, including responding to pre-litigation SEC investigations, class certification, discovery, materiality, loss causation, damages, and settlement negotiations. CRA assists clients in disputes arising from mergers and acquisition. Our experts have provided valuation opinions related to appraisal lawsuits brought by dissenter or minority shareholders, and estimated damages related to shareholder disputes for breach of contingent valuation rights agreements.

CRA has experience evaluating product liability claims, including Lanham Act matters, for prescription drugs, over-the-counter products, medical devices, and other consumer goods. Our understanding of the industry’s complexity provides a basis for evaluating consumer theories of damages with a focus on understanding the link between marketing claims (or the lack of warnings) and product sales.

Our experience also includes the evaluation of wellness and health claims (e.g. “all-natural”) for consumer products. In such matters, we have evaluated plaintiff methods in determining the “value” or “price impact” of specific product claims. In addition, we have experience in working with various data sources to analyze price impacts and in conducting surveys to evaluate consumer valuation of product claims.