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Pharmaceuticals and Healthcare
Experience
Antitrust
Cornerstone Research has experience addressing class certification, liability, and damages issues in pharmaceutical and healthcare antitrust cases. We have addressed such issues as mergers, life-cycle management strategies, predatory pricing, discriminatory pricing, exclusionary practices, and monopolization and collusion claims involving allegations of delayed generic entry. Our analyses in these cases have often focused on defining relevant antitrust markets and determining the competitive effects of the allegedly anticompetitive behavior. We work with some of the leading experts in the field to apply approaches based in sound economic theory and rigorously supported with empirical evidence.
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Class Certification
Cornerstone Research has a wide range of experience assisting counsel in class action lawsuits. Our class certification work in pharmaceuticals and healthcare includes antitrust, breach of fiduciary duties, off-label marketing, false advertising, and product liability matters. In these cases, we have used economic analysis to assess whether common evidence can be used to determine impact and damages on a class-wide basis and to evaluate whether there are potential conflicts of interest among the proposed class members.
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Pharmaceutical Patent Infringement
Cornerstone Research has worked on numerous pharmaceutical patent infringement cases assessing economic issues related to irreparable harm and commercial success. Branded drug manufacturers often bring patent infringement litigation after a generic drug manufacturer files an Abbreviated New Drug Application with a paragraph IV certification claiming that the branded drug’s patent is invalid or not infringed. Our experts use extensive knowledge of pharmaceutical markets to assess the impact of generic entry and analyze the factors affecting pharmaceutical sales in these cases.
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Patent Damages
Cornerstone Research has worked with experts on damages issues in patent infringement cases involving pharmaceuticals, medical devices, and biotechnology. We have analyzed lost profits, price erosion claims, accelerated market entry, and reasonable royalties. We have extensive experience in patent damages analysis such as cost and feasibility of design-arounds, existence of non-infringing substitutes, value of patented technologies, and industry licensing practices.
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Product Misrepresentation
Cornerstone Research has played an instrumental role in several cases involving product misrepresentation claims in the pharmaceutical and healthcare industries. These projects have ranged from damages analysis for false advertising claims to analysis of class certification issues in cases with allegations related to marketing and sales practices, product liability, and off-label marketing.
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Breach of Contract
Cornerstone Research has addressed issues of damages requiring specialized knowledge of the pharmaceutical, healthcare, and biotechnology industries arising from breach-of-contract disputes. In addition to assessing commercially reasonable efforts and damages, our experience includes analyzing the effects of generic entry, product life-cycle management techniques, and assessing the implications of competition among therapeutic alternatives.
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Reimbursement Disputes
Cornerstone Research has consulted on a variety of healthcare reimbursement-related cases, including out-of-network reimbursement, prescription drug reimbursement based on Average Wholesale Prices, healthcare provider–payor disputes, and cost shifting between payors by hospitals. Our work typically requires knowledge of claims databases and public healthcare databases as well as advanced modeling and statistical techniques.
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