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 patient 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 regularly 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 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, and licensing practices. We have also worked on a number of government investigations related to historic mergers and acquisitions in the pharmaceutical industry.
We have worked on numerous payer-provider disputes. These range from disputes over the medical necessity of care to appropriate billing to determining the reasonable value of medical services provided. Our clients include both government entities and commercial payers and our work has resulted in some of the largest settlements ever reached, including US Department of Justice v. Tenet Healthcare Corporation. A number of state and federal courts have cited our analyses in their decisions on reasonable value cases, such as Sanjiv Goel MD, Inc. v. Blue Shield of California.
When clients seek assistance with matters involving employer, union, or government health insurance, they receive our unique combination of expertise with ERISA and insurance litigation, health care matters, and claims-based data analysis.
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