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.

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. Professor Lakdawalla has extensive expertise in pharmaceutical industry policy, medical innovation, prescription drug pricing and drug competition, as well as health insurance coverage and drug reimbursement by private payors and Medicare Part D. In connection with his research, Professor Lakdawalla has testified before Congress a number of times on topics related to innovation, patient access, and government reimbursement of prescription drugs including most recently in connection with the Inflation Reduction Act’s anticipated economic impacts on the pharmaceutical industry.

Professor Lakdawalla has been retained as an expert witness in multiple life sciences and healthcare matters, in which he evaluated both liability and damages issues. He has provided economic testimony related to allegations of product liability, breach of contract, misappropriation of trade secrets, product hopping, and generic drug price fixing. He also served as an expert for the merging parties in the Federal Trade Commission’s (FTC’s) challenge of Amgen’s acquisition of Horizon Therapeutics, addressing the FTC’s allegation that the acquisition would allow Amgen to entrench Horizon’s dominant position through the use of bundled rebates. Professor Lakdawalla has testified both in deposition and at trial.

Professor Lakdawalla also has extensive experience providing business consulting services to major pharmaceutical companies, as well as 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 ReviewHealth 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 EconomicsThe 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 the Journal of Health Economics. He was previously an associate editor for the American Journal of Health Economics and the Review of Economics and Statistics. He has also served 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. Before 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.

Celeste C. Saravia

Vice President,
Cornerstone Research;
Lecturer,
University of California, Berkeley

Celeste Saravia coheads Cornerstone Research’s antitrust and competition practice. Dr. Saravia provides economic and statistical consulting, analysis, and expert testimony in complex business litigation. She addresses class certification, liability, and damages issues in antitrust litigation matters involving allegations of collusion, vertical restraints, and other allegedly anticompetitive behavior, as well as assessing the competitive effects of mergers.

Dr. Saravia works on matters in many industries, including life sciences (pharmaceuticals and medical devices), finance, information technology, energy, telecommunications, and media. Who’s Who Legal has recognized her multiple times as a Global Leader among competition economists. Dr. Saravia teaches economics courses at the University of California, Berkeley.

Antitrust and competition

Dr. Saravia has served as an expert in more than a dozen cases dealing with a variety of antitrust issues, including no-poach agreements, non-compete agreements, price fixing, monopolization, bundling, exclusive dealing, predatory pricing, price discrimination, and product hopping. These cases include Inline Packaging LLC v. Graphic Packaging International Inc. and Fresenius Kabi USA LLC v. Par Sterile Products LLC et al. Dr. Saravia offered trial testimony in In re HIV Antitrust Litigation, a case involving an allegedly anticompetitive reverse payment in a pharmaceutical patent settlement; and in J & M Distributing Inc. v. Hearth & Home Technologies Inc. et al., an alleged monopolization case.

Dr. Saravia has provided government agencies and parties support in all phases of merger review. She has analyzed competitive effects in prominent proposed mergers, such as Sysco/US Foods and Thoratec/Heartware. The Department of Justice (DOJ) retained Dr. Saravia to assess the competitive effects of the proposed merger between China International Marine Containers Group and Maersk Container Industry.

As a consultant, Dr. Saravia leads teams working on high-profile matters, including FTC v. Qualcomm, In re Flash Memory Antitrust Litigation, American Express Travel Related Services Company Inc. v. Visa USA Inc. et al., and Thales Avionics Inc. v. Matsushita Avionics Systems Corporation.

Energy and commodities

Dr. Saravia has developed analytical and statistical models to examine the competitiveness of deregulated electricity markets and modeled the competitive effects of a proposed merger of two electricity firms. In a matter related to an alleged monopsony by the largest purchaser of a natural resource, she provided a preliminary injunction analysis and addressed class certification, liability, and damages issues.

Intellectual property

Dr. Saravia has addressed general damages and intellectual property issues in a variety of matters. In Verizon Services Corp. et al. v. Cox Fibernet Virginia Inc. et al., she analyzed reasonable royalty rates, lost profits, and price erosion due to patent infringement. She also addressed reasonable royalty rates due to patent infringement in Brandeis University and GFA Brands Inc. v. Keebler Co. et al. Dr. Saravia analyzed class certification, liability, and damages related to a breach of contract dispute in the hospitality industry.

Dr. Saravia speaks and publishes frequently on competition issues. She won a Concurrences Antitrust Writing Award for her coauthored article, “Analyzing Incentives and Liability in ‘Hub-and-Spoke’ Conspiracies.” She has published research in Global Competition Review, including “Horizontal Merger Guidelines and Market Definition in Monopolization Cases” and “Standards for Assessing Bundled Discounts.”

Before joining Cornerstone Research, Dr. Saravia worked at the University of California Energy Institute.

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 to 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.

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 conduct extensive research and have a deep understanding of the institutions and regulations that govern biopharmaceutical competition. We have addressed class certification, liability, and damages issues in a wide range of matters.  Our experience includes economic analysis of the following allegations, among others:

  • Price fixing and market allocation
  • Delayed generic entry, by means of reverse payments, sham patent litigation, improper patent listings, and misuse of REMS programs
  • Life-cycle management strategies or “product hopping”
  • Market foreclosure by means of exclusive contracts with suppliers, distributors, or insurers
  • Monopolization through “killer” acquisitions
  • Anticompetitive rebate bundling

In recent years, regulators have expanded their theories of potential anticompetitive harm from mergers in the life sciences industry. Antitrust regulators are now assessing the potential for:

  • Reduced future competition among drugs that are currently at early stages of development
  • Foreclosure of competition through bundled rebates
  • Foreclosure of competition by limiting access to licensable technology and R&D
  • Reduction in R&D effort—e.g., killer acquisitions
  • Monopsony power in the labor market for highly specialized R&D personnel

Cornerstone Research and its affiliated experts have a deep understanding of the relevant market structure and the competitive interaction between market participants. Our staff and academic affiliates have been retained to present to antitrust regulators as they assess proposed mergers. We have also been retained as testifying experts in litigation brought by antitrust regulators to enjoin proposed mergers.

In breach of contract disputes clients call on us to construct valuation models, review financial records, and assess lost sales and avoided costs. We have helped clients evaluate a diverse set of issues, including:

  • Early-stage uncertainty and risk in the R&D process
  • Economic implications of generic entry
  • Effect of product life-cycle management techniques
  • Impact of marketplace changes
  • Reasonableness of commercialization efforts

 

Life Sciences firms are often the target of private class actions and government investigations under the False Claims Act and Anti-Kickback Statute.  Cornerstone Research consulted and supported economic, marketing, biostatistics, sampling, and industry experts to assess allegations of:

  • Kickbacks, in the form of speaker programs, advisory boards, and patient assistance programs
  • Off-label, fraudulent, or misleading marketing
  • Misrepresentations of a product’s safety and/or efficacy
  • Product design defects
  • Fraudulent list prices
  • Creation of a public nuisance requiring abatement

The Inflation Reduction Act (IRA) is expected to affect the biopharmaceutical industry across multiple dimensions, including pricing, insurance coverage, innovation, and competition. Our experts are actively analyzing the IRA’s regulatory framework. They have published and testified before Congress on its likely effects and proposed updates to the law to mitigate its potential adverse effects.

Our staff and experts draw on their extensive knowledge of biopharmaceutical 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.

In securities litigation, clients draw on our expertise in finance, accounting, economics, marketing, and biostatistics, along with our knowledge of the complex institutional, regulatory, and market forces that shape the life sciences industry. In addition to supporting experts addressing class certification, loss causation, and damages, we have supported experts retained to educate finders of fact on such topics as:

  •  Clinical trial protocols and data analysis
  • Drug development and the FDA approval process
  • Payment flows in pharmaceutical markets
  • The role of intermediaries such as drug wholesalers, pharmacies, hospitals, and PBMs
  • Brand and generic drug pricing and reimbursement
  • Pharmaceutical marketing and its regulation

 

Featured Cases

Featured Publications

20 February 2024

Brussels Team Expands with Experienced Competition Hire

Dr. Norbert Maier joins Cornerstone Research, with deep antitrust law and competition expertise from the EU Commission DG COMP team.

30 January 2024

5 Questions with Sayeh Nikpay: The 340B Drug Pricing Program

Professor Sayeh Nikpay of the University of Minnesota discusses the role and implementation challenges of the 340B Drug Pricing Program.

4 January 2024

Most-Favored Entry Clauses in Drug-Patent Litigation Settlements

The authors examine the competitive impacts of such clauses taking into account the regulatory structure and economics of the pharmaceutical indust...

19 September 2023

Cornerstone Research Staff and Affiliated Experts Submit Comments on the Joint FTC-DOJ Draft Merger Guidelines

The Federal Trade Commission and the Department of Justice’s Antitrust Division launched a joint public inquiry to solicit comments from the public...

1 September 2023

The Economics of New Product Launches and Access to Pharmaceutical Products in the EU

The authors provide an economic perspective on the European Commission’s proposed reform of the EU’s pharmaceutical legislation.

29 June 2023

The Inflation Reduction Act Could Have Unintended Consequences

This article analyzes the potential unintended economic impacts of the Inflation Reduction Act on the pharmaceutical industry.

23 June 2023

Expert Network for Women in Healthcare and Life Sciences

This network connects women economists and academics working on healthcare and life sciences topics and offers an opportunity to learn about expert...

7 October 2022

Life Sciences Capabilities

From initial strategy through deposition and trial, clients have used our findings in hundreds of matters involving the life sciences industry.

19 May 2022

Intersection of Intellectual Property and Competition Policy in Recent Cases

The authors discuss high-profile cases in the EU and US that concern IP rights and competition policy.

23 August 2021

Why Curve-Fitting Cannot Be Used to Show Causation or Estimate Impact

Iain Cockburn discusses the problems with curve-fitting methodology in economic analysis in this Westlaw article.

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