Kathryn Luker specializes in economic analyses and leading teams that analyze large, complex data sets. Her work focuses on False Claims Act (FCA) and related engagements involving drug manufacturers, medical device manufacturers, and healthcare providers. These cases often require analysis of medical claims data and large internal company databases, such as prescription, sales, product performance, and billing data. She has experience working with counsel through all stages of litigation—during government investigations and settlement discussions—as well as supporting testifying experts.
- BS, Economics, The George Washington University
- In RTI Surgical, Inc. v. LifeNet Health, supported the expert in a declaration regarding commercial success as an objective indicator of patent non-obviousness on behalf of the patent owner LifeNet Health in an Inter Partes Review challenge to the validity of certain LifeNet Health patents.
- Providing consulting support for a large medical care provider alleged to have violated the FCA by failing to comply with Medicare guidance regarding the provision of certain services.
- Providing consulting support on behalf of a mail order pharmacy in response to fraud allegations. Analyzing and maintaining large prescription order, dispensing, and claim adjudication databases to demonstrate pharmacy valuation.
- Providing consulting support for a large provider of healthcare services facing a government investigation. Analyzing several large internal compliance-related data sets to gather insights on issues relating to potential FCA violations.
- On behalf of Alere, in Andren et al. v. Alere Inc. et al., supported expert analyses of Ben Scher on issues relating to data analytics and economic damages methodologies.
- In United States ex rel. George v. Fresenius Medical Care Holdings, Inc., supported expert analyses of Dr. David Bradford and Ben Scher on behalf of Fresenius Medical Care. Analyzed and maintained large databases, including inventory, prescription order, and claims data.
- Provided consulting support for pharmaceutical manufacturers in several price reporting cases and demands brought by the State of Texas on behalf of its Vendor Drug Program. Analyzed price reporting practices related to and reimbursements paid by the Medicaid Vendor Drug Program to Texas-based retail pharmacies.
- Executed meta-analysis of healthcare literature on behalf of a medical device manufacturer in support of its interactions with the Food and Drug Administration regarding the performance of certain products.
- In United States ex rel. Kevin N. Colquitt v. Abbott Labs., Inc., supported expert analyses of Dr. Eric M. Gaier in connection with alleged off-label promotion of certain medical devices that violated the FCA.