David Ludlow

Background

About David Ludlow

I am a partner in Sidley Austin’s globally-recognized Life Sciences, FDA, and Healthcare Law practices. My practice focuses on high-stakes investigation, enforcement, and litigation issues impacting the Life Sciences industry, and I represent numerous multinational pharmaceutical, biologics, vaccine, device, therapeutic, and agricultural companies. My industry focus, paired with my litigation background, allow me to successfully serve clients across the spectrum of life cycle issues. I have deep experience conducting whistleblower investigations and litigation matters involving pre-clinical, R&D, clinical trial, and good manufacturing practices (cGMP)/ QSR-related issues, including issues surrounding data integrity and research fraud. I likewise have significant experience assisting companies in the post-approval / post-marketing issues they face, including litigation and investigation matters involving fraud, kickbacks and corruption, lobbying, promotional and marketing practices, pricing and reimbursement, product tampering and diversion, post-market reporting, and data privacy. I have handled dozens of cross-border matters in Europe, India, China, Asia, the Middle East and South America and have represented clients in various enforcement matters before the U.S. Department of Justice, Health and Human Services Office of Inspector General, Department of Commerce, and Department of Defense. I have obtained numerous declinations and non-prosecution decisions for my clients. Specialties: Life Sciences Industry, Government and Internal Investigations, White Collar Criminal Defense, Qui Tam Litigation, FDA Enforcement Defense, Healthcare Enforcement Defense, Foreign Corrupt Practices Act Defense, Data Integrity, Clinical Trials, Cell & Gene Therapy, Good Manufacturing Practices (cGMP). Attorney Advertising. Prior results do not guarantee a similar outcome.