Debra E. Schreck | People | Arnold & Porter

A partner in the firm's White Collar Defense & Investigations group, Debra Schreck has significant experience representing clients in complex investigations and litigation matters across a wide range of industries.

A go-to advisor for life sciences clients, Debra represents pharmaceutical and medical device companies in connection with criminal and civil investigations by federal and state government agencies, including the U.S. Department of Justice (DOJ), U.S. Attorneys' Offices and state Attorneys General.

Debra defends clients in federal and state litigation, including actions brought under the qui tam provisions of the False Claims Act (FCA) and involving the Food, Drug & Cosmetic Act, the Anti-Kickback Statute (AKS) and other healthcare statutes and regulations. She also conducts and counsels clients in connection with large-scale internal investigations and internal training programs.

In addition to her expertise in healthcare, Debra leads internal investigations for corporations and institutions related to workplace issues, including allegations of harassment and other misconduct. She serves as co-chair of the firm's Privilege Committee, is a member of the firm's Recruiting Committee and is active in the firm's mentoring program.

Focus Areas

Experience

Eli Lilly and Company in qui tam suit brought by a relator in Eastern District of Texas, alleging kickback claims in connection with nurse education and reimbursement support programs.
Novartis Pharmaceuticals Corporation and Novartis Corporation in successful defense of a qui tam suit brought in District of Massachusetts by multiple relators, alleging off label and kickback claims in connection with the asthma medication, Xolair®. On a motion to dismiss, obtained dismissal with prejudice of all claims. United States ex rel. Garcia et al. v. Novartis Pharmaceuticals Corporation et al., 06 Civ. 10465 (WGY). Dismissal with prejudice of all federal claims was affirmed by the First Circuit. United States ex rel. Kelly et al. v. Novartis Pharmaceuticals Corporation et al., 827 F.3d 5 (1st Circuit 2016). Relators then filed suits in multiple state courts under state FCA statutes; those cases were also subsequently dismissed.
Mallinckrodt Pharmaceuticals in class action litigation alleging antitrust and marketing claims relating to one of its products.
Bayer Corporation, Bayer HealthCare Pharmaceuticals and Merck & Co., in federal and state product liability litigation involving two fluoroquinolone antibiotics, Avelox® and Cipro®.
Canon Business Process Services and General Electric, in data breach class action litigation in the Southern District of New York.

Major brand name prescription drug manufacturer in qui tam litigation brought in Southern District of New York by government and relator, alleging kickbacks to specialty pharmacies in connection with various medications.
Medical device manufacturer in multi-district federal investigation involving allegations of off-label promotion and kickbacks.
Medical device manufacturer in federal investigation involving allegations of kickbacks.
Pharmaceutical company in internal investigation of alleged violations of FDA regulations.
Biotech company in internal investigation involving alleged violations of healthcare regulations.
Pharmaceutical manufacturer in connection with U.S. Congressional inquiry regarding drug pricing.
Media company in connection with internal investigation of allegations of sexual misconduct by senior corporate executive.
Educational institution in connection with internal investigation of alleged sexual misconduct by faculty member.
International corporation in connection with pre-merger antitrust investigation by the DOJ, resulting in antitrust clearance.
Government agency/official in connection with ethics probe.