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.
- Managed support of expert analyses on behalf of a pharmaceutical manufacturer in a price reporting case brought by the State of Texas. Analyzed price reporting practices and reimbursements paid by the Medicaid Vendor Drug Program (VDP) to Texas-based retail pharmacies in response to allegations that false prices were submitted to the VDP.
- In United States and State of New York ex rel. Lacey v. Visiting Nurse Service of New York (VNSNY), served as lead manager supporting expert analyses of Dr. Frederic Selck on behalf of VNSNY. Developed database utilizing patient medical records and several large company data sets to gather insights on issues relating to alleged FCA violations.
- Provided consulting support for a large mail-order medical supplies company alleged to have violated the FCA and Anti-Kickback Statute. Constructed and analyzed database based on internal company data pertaining to accounts receivable, claim adjudication, and patient demographics.
- Provided consulting support for medical device manufacturer in a government investigation of device performance. Analyzed potential exposure using internal sales data and clinical trial event studies.
- 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. Analyzed performance data and oversaw team in executing analyses at expert’s request.
- Provided 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. Evaluated causation and potential exposure by analyzing variation in service patterns observed in large company databases and Medicare claims data sets.
- 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 on behalf of a mail-order pharmacy in response to fraud allegations. Analyzed and maintained large prescription order, dispensing, and claim adjudication databases to demonstrate pharmacy valuation.
- 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.