In recent years, the health care industry has experienced an increasing number of black box warnings and drug withdrawals, widely publicized litigation involving drug safety, and
government investigations of alleged off-label promotion of prescription drugs. Patent challenges and issues related to generic entry have also received considerable attention. In this environment, the strategies pursued by brand manufacturers may be vulnerable to a variety of legal challenges.
Our experience in health economics and outcomes research,
epidemiology, modeling and analytics, market access and commercial strategy, and health care policy has proven highly valuable in our expert litigation work. We have in-depth knowledge of health care data sources, access to proprietary data, and experience in analyzing data from clinical trials, FDA spontaneous reports, health insurance claims, third-party market research, and plaintiff medical records. Our academic and in-house experts have provided strategic assistance to counsel at key points in litigation, including pretrial discovery, settlement negotiations, and trial preparation.
We draw upon methodological tools and data sources, including those commonly used in
health economics and outcomes research, to analyze issues in litigation involving pharmaceuticals, biotechnology, and medical device products. We have provided economic consulting support in connection with class certification, liability, and damages in cases involving allegations of
antitrust violations, product failure, product fraud, and patent infringement.
From very high-stakes
class actions to cases involving allegations of
securities or product fraud, we apply fact-based expertise to help clients achieve successful outcomes in the courtroom. We have assessed claims of securities fraud related to the potential effect on stock price of the timely disclosure of information
concerning a product's underlying safety/efficacy profile and have assisted clients in multiple pharmaceutical 10b-5 matters, drawing on our economic expertise relating to class, liability, and damages, and in-depth knowledge of health care claims and clinical trial and adverse event data.
In government investigations of manufacturer promotion or pricing practices, we provide economic, epidemiologic, and statistical support to counsel, often in the context of settlement discussions. We have supported multiple academics who provided expertise in econometrics, pharmaceutical marketing, stock price
analysis, licensing practices, and historic mergers and acquisitions in the pharmaceutical industry in a long-running transfer pricing dispute involving
GlaxoSmithKline Holdings and the IRS.