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Summary

Ben Scher is an expert in providing data-driven insights to help solve complex problems. He has more than 15 years of experience performing empirical analyses of large data sets and conducting statistical and economic analysis. Mr. Scher’s work focuses on the healthcare and life sciences sectors. He has recently served as a testifying expert on several matters and as lead consulting expert for large healthcare providers, drug manufacturers, and medical device manufacturers on numerous engagements. Mr. Scher frequently presents analyses on behalf of clients to attorneys from the Department of Justice (DOJ) and the Office of Inspector General (OIG). These analyses often form the basis for resolutions of complex matters. He also provides consulting expertise based on his data analyses to senior executives of large healthcare and medical device companies contemplating potential regulatory actions (e.g., product recall, indication expansion, safety implications of manufacturing issues). Many of the matters Mr. Scher has worked on involve hundreds of millions of dollars or more in controversy. In addition, Mr. Scher is a Certified Health Data Analyst, a certification granted by the American Health Information Management Association, and has a Certificate in Data Analytics from the Cornell University SC Johnson College of Business.

Education

BS, Policy Analysis and Management, Cornell University

Practices

Selected Work

Selected Experience

Testifying retentions and experience

  • In United States ex rel. George v. Fresenius Medical Care Holdings, Inc., served as testifying expert on behalf of defendant Fresenius Medical Care in an alleged False Claims Act (FCA) matter.
  • In Andren et al. v. Alere Inc. et al., served as testifying expert on behalf of Alere at the class certification phase in a matter alleging deceptive and misleading practices relating to a product called INRatio.
  • In Commonwealth of Kentucky, ex rel. Andy Beshear, Attorney General v. Fresenius Medical Care Holdings, Inc., served as testifying expert on behalf of Fresenius Medical Care in a matter alleging misleading and deceptive practices relating to a product called GranuFlo. Analyzed numerous large databases and provided analyses of health-related data that formed the foundation of opinions of academic affiliate. 
  • Submitted an expert affidavit evaluating a proposed sampling protocol in an arbitration involving contractual disputes between a large healthcare provider and an insurer.
  • Retained as a testifying expert on behalf of a medical device supplier on issues of data analytics and statistics in the context of a dispute with the Centers for Medicare and Medicaid Services over the provision of and billing for certain services.
  • Retained as testifying expert for trial on data analytics and economic damages on behalf of one of the nation’s largest hospital systems.
  • Retained as testifying expert on behalf of a major nationwide healthcare provider facing allegations of FCA violations stemming from the frequency with which it provided certain services. Analyzed numerous large databases to evaluate empirical patterns, provided assessment of economic damages methodologies, and performed statistical analysis of certain patient health outcomes. 
  • Retained as testifying expert on behalf of a defendant medical device supplier in a putative class action lawsuit involving alleged misleading representations and omissions in advertising. Retained to provide opinions on data analytics and economic damages methodologies.
  • Retained as testifying expert on behalf of a major nationwide healthcare provider in a matter alleging misleading and deceptive practices.
  • Retained as testifying expert on behalf of a defendant cosmetic product supplier in a nationwide class action alleging misleading representations and omissions in advertising. Provided data analytics and economic analysis.

Consulting experience relating to government FCA investigations

  • Serving as lead consulting expert on behalf of a large physician chain relating to alleged FCA violations. Analyzed numerous databases and performed calculations of potential economic damages. Presented analyses to counsel for DOJ on multiple occasions.  
  • Serving as lead consulting expert on behalf of a provider of laboratory testing services facing government investigations into alleged FCA violations. Selected and evaluated statistical samples. Evaluating patterns in available data and potential economic damages.
  • Serving as lead consulting expert on behalf of a large home healthcare provider facing a lawsuit involving alleged FCA violations. Evaluated statistical sampling methodologies.
  • Served as lead consulting expert on behalf of a large hospital chain facing a government investigation relating to allegations of FCA violations. Analyzed sampling and extrapolation methods used by the government and determined appropriateness and statistical validity of the approach. Evaluated potential economic damages.  
  • Served as lead consulting expert on behalf of a medical device manufacturer facing a government investigation regarding allegations of FCA violations for several products. Utilized several large data sets pertaining to the products at issue and their clinical usage and performed statistical and empirical analyses of the allegations. Evaluated potential economic damages. 
  • Served as lead consulting expert on behalf of multiple pharmaceutical and biotechnology companies facing government investigations relating to interactions with patient assistance charities. Evaluated potential economic damages and liability theories using internal databases.
  • Served as lead consulting expert on behalf of numerous pharmaceutical and biotechnology companies facing investigations relating to alleged off-label promotion and kickbacks. Evaluated causation and potential economic damages using several large data sets pertaining to the sales and reimbursement of the products. 

Consulting experience relating to regulatory matters

  • Providing consulting expertise to a large medical implant manufacturer relating to the indications and performance of a product. Presenting analyses and reporting directly to senior executives.
  • Provided data analytics and meta-analysis of healthcare literature on behalf of a medical device manufacturer in support of its interactions with the Food and Drug Administration (FDA) regarding the performance of a product. Presented analyses and reported directly to senior executives.
  • Authored a report based on analyses of several data sets on behalf of a diagnostics manufacturer in support of its interactions with FDA regarding its manufacturing of a certain product.
  • Provided data analytics, cost-benefit analyses, and meta-analysis of healthcare literature on behalf of a medical device manufacturer in support of its interactions with the FDA regarding a potential expansion of the approved indications for a product. 

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