Pharmaceuticals and medical devices

Overview
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In numerous matters on behalf of pharmaceutical and medical device manufacturers, Bates White has developed a deep knowledge of healthcare markets, government healthcare agencies, and third-party payor policies. Our team has developed a mastery of working with different sources of information and a variety of relevant databases. We also have built our own customized data tools that provide an infrastructure to respond quickly and efficiently to requests for support and analyses. Our rigorous approach offers significant detail, robust modeling of alternative scenarios, and clear results to evaluate the full range of possible outcomes and the potential financial and economic impacts to companies faced with product liability and related claims.

  • Birth control. On behalf of a major insurer, Bates White addressed an insurance dispute related to claims and settlement coverage associated with a birth control product line manufactured by a leading pharmaceutical company. We designed a claims file audit of Bermuda form policies that helped our client quickly gain a deep understanding of potential liabilities.  
  • Anti-inflammatory drug. We are working on behalf of an insurer involved in a dispute with a leading pharmaceutical company concerning losses related to a drug that allegedly caused personal injury to its users. The company seeks coverage for defense expenditures and indemnity payments. Case involves coverage based on Bermuda form policies.
  • Medical monitoring. Bates White has assessed the merits of medical monitoring in multiple settings—tobacco, various mixed dusts, and chemical pollutants—to determine whether it is reasonable for the population in question. Our analyses quantify the answers to questions like Does it make sense for the targeted group to receive medical monitoring? How many in the group are eligible? Of those eligible, how many would actually participate? Our quantitative analyses have provided clients with an understanding of potential costs and allowed for the effective rebuttal of opposing experts’ arguments.
  • Product marketing. On behalf of a leading pharmaceutical manufacturer, Bates White analyzed physician-level prescription data to estimate a statistical relationship between promotional support and demand for a leading anti-insomnia medication. Based on this analysis, we developed recommendations on the nature (e.g., physician detailing, product sampling) and magnitude of future marketing support.
  • Medical devices. One of Bates White’s experts testified on behalf of a medical device manufacturer facing allegations of fraudulently concealing product defects. The testimony included an analysis of liability, damages, and issues of causation.
  • Fraud and false claims. We provided consulting expertise on issues of liability, causation, and damages on behalf of a pharmaceutical manufacturer alleged to have engaged in off-label marketing. This work included:  (1) sizing the scope of off-label usage, (2) investigating issues such as the potential harm associated with the alleged off-label use and, (3) analyzing causation issues, such as the potential impact of the alleged off-label marketing itself.