| Clients draw on our deep knowledge of the life sciences industry—its institutional structure, its competitive environment, and its regulatory framework. Our experience spans a spectrum of cases, including antitrust, intellectual property, reimbursement disputes, product misrepresentation, securities, and breach of contract. | Our staff and experts provide strategic advice, rigorous analysis, and persuasive testimony. From initial strategy through deposition and trial, clients have used our findings in hundreds of matters involving the life sciences industry. |
Our extensive network includes top experts from academia and industry.
Our extensive network includes top experts from academia and industry.
Margaret K. Kyle
Chair in Intellectual Property and Markets for Technology,
MINES ParisTech
Margaret Kyle is a noted authority on competition, intellectual property (IP), and innovation, with extensive multinational experience with life sciences and healthcare topics.
Professor Kyle has been retained as an expert witness in multiple matters and has significant testifying experience, including at trial. She has provided testimony on a range of issues, including damages related to alleged product misrepresentation, pricing of pharmaceutical products, and nascent competition. The global Women@Competition platform named Professor Kyle among forty notable women competition professionals in their forties. Global Competition Review recognized her in its inaugural list of the world’s most important antitrust academics.
In her academic work, Professor Kyle has examined the impact of antitrust, trade, and IP policies on R&D investment, innovation, and competition. In particular, Professor Kyle has substantive experience with issues related to pricing of pharmaceutical products, R&D productivity, new product distribution, and competition between branded and generic pharmaceutical products. In addition, she has written about antitrust merger enforcement issues in pharmaceutical markets, with applications to other dynamic markets characterized by innovation. In the context of COVID-19, she has analyzed how incentives can promote the development of new medical technologies and advance the rapid manufacture of tests and treatments.
Professor Kyle’s previous positions include visiting professor of strategy at Northwestern University’s Kellogg School of Management; visiting scholar at the Center for the Study of Income and Productivity at the U.S. Federal Reserve Bank of San Francisco; professor at the Toulouse School of Economics; assistant professor at the London Business School, Duke University, and Carnegie Mellon University; and visiting professor at the University of Hong Kong.
Professor Kyle consults to policy entities in the United States, Europe, and the UK on competition, economics, and innovation topics. She is a member of DG Competition’s Economic Advisory Group on Competition Policy. At France’s Conseil National de Productivité, which advises the French Prime Minister and the Minister of Economic Affairs, she is one of eleven independent academic economists analyzing the country’s productivity and competitiveness, particularly issues linked to the Euro Zone. She coauthored a note on policies to encourage pharmaceutical innovation for France’s Conseil d’Analyse Économique. In the UK, Professor Kyle serves on the Research Committee for the Office of Health Economics.
Professor Kyle has coauthored chapters in the Handbook of Health Economics, the Oxford Handbook of the Economics of the Biopharmaceutical Industry, and Elsevier’s Encyclopedia of Health Economics. Her academic papers have been published in leading economics, strategy, and health policy journals. She is associate editor of the International Journal of Industrial Organization. Professor Kyle has been invited to speak at numerous conferences on issues such as nascent competition, reverse payment patent settlements, and excessive pricing.
Our extensive network includes top experts from academia and industry.
Iain M. Cockburn
Richard C. Shipley Professor in Management,
Questrom School of Business,
Boston University
Iain Cockburn specializes in competition and innovation in the life sciences, software, and information technology industries. He has provided expert testimony in intellectual property, breach of contract, product misrepresentation, and antitrust matters, addressing class certification, merits, and damages issues. Professor Cockburn’s expert testimony has covered a range of industries, including robotics, smartphones, medical devices, diagnostic testing, online auctions, cloud computing services, and oil well equipment. He has particular expertise in pharmaceuticals and biotechnology.
On pharmaceutical matters, Professor Cockburn’s expert work has covered topics that include pricing, the impact of marketing on prescribing, off-label promotion, Medicare and Medicaid reimbursement, competition between brand and generic products, reasonable royalties, and valuation issues associated with licensing and collaboration agreements.
The author or co-author of multiple book chapters, Professor Cockburn has also published articles in leading journals, including the American Economic Review, the RAND Journal of Economics, and Health Affairs. A frequent speaker on intellectual property and business strategy topics, he has presented his research at numerous academic conferences, and in policy briefings to government agencies in Canada, the United Kingdom, and the United States. Professor Cockburn is a research associate at the National Bureau of Economic Research.
Professor Cockburn has been honored with several awards for teaching and research excellence. He is the chair of the Strategy & Innovation Department at Boston University. Prior to joining the faculty of Boston University, he served as the VanDusen Professor of Business Administration in the Faculty of Commerce at the University of British Columbia. He has also been a visiting scholar at Harvard University and the MIT Sloan School of Management.
Our extensive network includes top experts from academia and industry.
Darius Lakdawalla
Quintiles Chair in Pharmaceutical Development and Regulatory Innovation, School of Pharmacy,
Professor, Sol Price School of Public Policy,
Director of Research, Leonard D. Schaeffer Center for Health Policy and Economics,
University of Southern California
Darius Lakdawalla is a leading authority on health economics and health policy. He has particular expertise in pharmaceutical industry policy, medical innovation, prescription drug pricing, health insurance coverage, and reimbursement, including for private payors and Medicare Part D. Professor Lakdawalla also analyzes the industrial organization of healthcare markets.
Professor Lakdawalla has been retained as an expert witness in multiple life sciences and healthcare matters and has both deposition and trial testimony experience. He has provided economic testimony related to allegations of product liability, breach of contract, misappropriation of trade secrets, and generic drug price fixing. His expert work has addressed both liability and damages issues. Professor Lakdawalla also has extensive experience providing business consulting services to major pharmaceutical companies, as well as experience analyzing drug clinical trial data.
An award-winning researcher, Professor Lakdawalla has published articles in leading economics, medical, and health policy journals, including the American Economic Review, Health Affairs, the Quarterly Journal of Economics, the New England Journal of Medicine, and the Journal of the American Medical Association. His article “Economics of the Pharmaceutical Industry” was published in the Journal of Economic Literature. He has also coauthored chapters in the Handbook of Health Economics, The Oxford Handbook of the Economics of the Biopharmaceutical Industry, and The Elgar Companion to Health Economics (2nd edition), among others.
Professor Lakdawalla currently serves as an associate editor for Journal of Health Economics. He previously served as associate editor for the Review of Economics and Statistics and the American Journal of Health Economics. He has also served as as an expert panelist for the National Academy of Medicine. Professor Lakdawalla is a research associate at the National Bureau of Economic Research (NBER).
For more than a decade, Professor Lakdawalla has taught courses on health economics and policy, risk analysis, and health management. Prior to joining USC, he served as senior economist and director of research at the RAND Corporation’s Bing Center for Health Economics.
Our extensive network includes top experts from academia and industry.
Sean Nicholson
Professor, Department of Economics,
Professor, Brooks School of Public Policy,
Director, Sloan Program in Health Administration,
Cornell University;
Senior Advisor, Cornerstone Research
Sean Nicholson is an expert in the analysis of pharmaceutical competition, innovation, and pricing. In pharmaceutical and healthcare matters, Professor Nicholson has provided expert testimony in antitrust and competition, product misrepresentation, fraudulent pricing, kickback, patent infringement, trade secrets, and breach of contract matters. He has testified at trial in federal and state courts and before the International Trade Commission.
Professor Nicholson conducts research on innovation in the pharmaceutical and biotechnology industries and the value of new medical technologies. He is a research associate at the National Bureau of Economic Research and has served as a research director of the Upstate Health Research Network.
Widely published, Professor Nicholson’s research has appeared in the New England Journal of Medicine, the Journal of Health Economics, and the Handbook of Health Economics, among others. He is a former associate editor of Health Economics.
Professor Nicholson teaches in the department of economics and the Brooks School of Public Policy at Cornell University. Before joining the Cornell faculty, he taught courses on healthcare systems at the Wharton School, University of Pennsylvania. Professor Nicholson has received several awards for excellence in teaching.
Life Sciences Capabilities
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
Featured Cases
Selected Professionals
Our staff consultants contribute expertise in economics, finance, accounting, and marketing, as well as business acumen, familiarity with the litigation process, and a commitment to provide outstanding support.
Featured Publications
How can we help you?
For more information or assistance with a specific matter, please contact us.
