Life Sciences

Cornerstone Research’s staff and experts have conducted extensive research on pharmaceutical markets and have a deep understanding of the institutions and regulations that govern pharmaceutical competition. We have worked with life sciences clients to address:

• Price-fixing claims
• Reverse payment settlements
• Life-cycle management strategies or “product hopping”
• Monopolization and collusion claims involving allegations of delayed generic entry
• Mergers and acquisitions
• Predatory and discriminatory pricing
• Exclusionary practices
• Class certification

Life Sciences firms are often the target of False Claims Act allegations of unlawful marketing and sales practices, improper pricing, and violations of the Anti-Kickback Statute. During the investigation and litigation phases of these matters, we work with clients to identify and analyze the information needed to assess liability, damages, and penalties.

Breach of contract disputes often require detailed valuation analyses to assess damages. In addition to assessing commercially reasonable efforts and damages, we have helped clients evaluate such diverse issues as:

• Early stage uncertainty–risk in the R&D process
• Economic implications of generic entry
• Impact of changes in therapeutic alternatives space
• Effect of product life-cycle management techniques
• Reasonableness of commercial efforts

Our staff and experts draw on their extensive knowledge of pharmaceutical and medical device markets to estimate lost profits, reasonable royalties, and the value of innovative technologies in patent infringement and trade secret matters. Attorneys and companies also engage us in Hatch-Waxman litigation, litigation involving biosimilars, and inter partes reviews to assess commercial success and irreparable harm.

We work closely with clients to evaluate class certification, causation, injury, and damages in cases involving allegations of product misrepresentation and ERISA violations. Our experts have addressed improper marketing allegations such as overstated efficacy and failure to disclose safety risks as well as alleged ERISA violations such inadequate drug coverage by health plans.

In securities litigation, clients draw on our expertise in finance, accounting, economics, and biostatistics along with our knowledge of the competitive and regulatory environments that impact life sciences firms. Attorneys and corporations often retain us when facing government investigations or private litigation to address class certification, evaluate loss causation, and estimate damages. Our experience includes matters related to:

• Announcements of FDA approval decisions
• Publication of clinical trial results
• Accounting treatment of expected penalties for off-label marketing
• Withdrawal of a blockbuster drug from the market for safety reasons
• Value of Pharmacy Benefit Manager contracts in a pharmacy merger