David J. Ludlow

DAVID LUDLOW represents pharmaceutical, medical device, biotech, and other life sciences companies in high-stakes government enforcement actions, litigation, internal investigations, and compliance counseling matters.

He has successfully handled numerous Food & Drug Administration (FDA) and U.S. Department of Justice (DOJ) criminal and civil False Claims Act investigations, litigation matters, and internal investigations. The breadth of his experience spans the full life cycle of compliance issues life sciences companies face—from pre-clinical to manufacturing to post-marketing and commercial issues. David has extensive experience investigating good manufacturing practice (GMP), data integrity, scientific fraud, and related employee misconduct issues. David has achieved exceptional outcomes for his clients, including securing numerous enforcement declinations in matters he has handled.

David’s practice also includes counseling life sciences companies about their quality and corporate compliance programs, conducting program reviews, risk assessments, employee training, due diligence, and policy/procedure development.

Illustrative of the depth of David’s practice, his engagements include:

• Conducted dozens of GMP investigations involving potential data integrity and product quality issues involving the QC laboratory, microbiology, in-process controls, calibration, validation, cleaning, R&D, and application integrity.
• Represented numerous clients before the DOJ Consumer Protection Branch and various U.S. Attorneys’ Offices in investigations involving FDA 483 and warning letters referrals, product recalls, potential misbranding and adulteration charges, investigational device use, COVID Task Force issues, device design control validation and verification, and product diversion issues.
• Conducted an audit committee investigation for a public biotech company into allegations of scientific research fraud and manipulation.
• Conducted a board of directors’ investigation for a private equity firm into product quality complaint and potential misbranding issues.
• Conducted a quality and compliance investigation for a Fortune 500 company related to distribution and storage issues.
• Conducted an extensive product tampering investigation for a multinational company in coordination with local and federal authorities.
• Successfully obtained a DOJ declination for a multinational pharmaceutical company in a data integrity and GMP investigation conducted by the Southern District of New York.
• Successfully obtained a DOJ declination for a multinational pharmaceutical company in a criminal and civil data integrity and GMP investigation conducted by District of New Jersey.
• Led an independent investigation in response to European press allegations of misconduct against Monsanto and issuing a public findings report.

FDA/Good Clinical Practices

• Conducted an audit committee investigation for a public biotech company into allegations of scientific research fraud and manipulation.
• Conducted an investigation and leading a forensic assessment for a multinational pharmaceutical company into whistleblower claims alleging clinical trial fraud.
• Conducted an internal investigation into allegations of potential clinical research organization misconduct and clinical study fraud for a multinational pharmaceutical client.
• Conducted an internal investigation for a multinational pharmaceutical client into whistleblower allegations of R&D fraud and manipulation of testing results to support product applications.
• Conducted an internal investigation for a multinational pharmaceutical company into clinical data disclosures supporting FDA product applications.

FDA/Good Manufacturing Practices

• Conducted dozens of GMP investigations in the United States and abroad (e.g., China, India, Europe) involving potential data integrity and product quality issues involving the QC laboratory, microbiology, in-process controls, calibration, validation, cleaning, R&D, and application integrity.
• Successfully obtained a DOJ declination to prosecute for an Indian manufacturing company in a GMP investigation conducted by the U.S. Attorney’s Office for the District of New Jersey.
• Successfully obtained a DOJ declination to prosecute for a multinational pharmaceutical and combination product company in a criminal GMP investigation conducted by the U.S. Attorney’s Office for the Eastern District of Missouri.
• Represented a multinational pharmaceutical company in a multi-year investigation by the Consumer Protection Branch into alleged quality system regulation (QSR) issues involving combination products.
• Represented a Fortune 500 company in a COVID Task Force and U.S. Attorney’s Office investigation into alleged misbranding and marketing of medical devices.
• Conducted an investigation for a private equity firm into potential employee falsification of test and manufacturing data and handling voluntary self-disclosures to the Department of Justice and FDA.
• Conducted a board of directors’ investigation for a private equity firm into product quality complaint and potential misbranding issues.
• Conducted a quality and compliance investigation for a Fortune 500 company related to distribution and storage issues.

False Claims Act/Healthcare/Post-Marketing Issues

• Successfully obtained a DOJ declination to intervene for a multinational pharmaceutical company in a False Claims Act investigation into GMP and cleaning validation issues conducted by the Southern District of New York. The Second Circuit later affirmed dismissal with prejudice of qui tam relator’s “fraud on the FDA” claims.
• Successfully obtained a DOJ declination to intervene for a major pharmaceutical company in a qui tam matter alleging clinical trial and pediatric exclusivity application fraud. Case was dismissed with prejudice and affirmed on appeal.
• Successfully obtained a DOJ declination to intervene for a major pharmaceutical company in a qui tam matter related to pricing and reimbursement conducted by the U.S. Attorney’s Office for the Eastern District of Pennsylvania.
• Successfully obtained a DOJ declination to intervene for a major pharmaceutical company in a state Medicaid claims investigation conducted by the U.S. Attorney’s Office for the District of Massachusetts.
• Successfully obtained a DOJ declination to intervene for a major pharmaceutical company in a pharmacy benefit manager investigation conducted by the U.S. Attorney’s Office for the District of Rhode Island.
• Represented a multinational pharmaceutical company in a Civil Frauds investigation into Rx-OTC switching.
• Represented a multinational pharmaceutical company in False Claims Act investigation by the Southern District of New York into alleged quality system regulation (QSR) issues involving combination products.
• Represented a major pharmaceutical company in DOJ product diversion/fraud investigation conducted by the U.S. Attorney’s Office for the Southern District of Georgia.
• Represented a life sciences company in a DOJ product diversion/fraud investigation conducted by the U.S. Attorney’s Office for the District of New Jersey.
• Represented a major pharmaceutical company in DOJ qui tam investigation involving allegations off-label promotion and kickbacks.
• Conducted an extensive product tampering investigation for a multinational company in coordination with local and federal authorities.
• Led an independent investigation in response to European press allegations of misconduct against Monsanto and issuing a public findings report.

FCPA/Anti-bribery

• Successfully obtained DOJ and UK Serious Fraud Office declinations to prosecute for a multinational life sciences company in a matter involving anticorruption issues in China.
• Successfully obtained a DOJ declination to prosecute for a European life sciences company in a matter involving anticorruption issues in multiple countries.
• Successfully obtained a DOJ declination to prosecute for U.S. life sciences company in a matter involving anticorruption issues in multiple countries in Eastern Europe, Asia, the Middle East, and Latin America.
• Represented a former board member in a DOJ and U.S. Securities and Exchange Commission investigation of a multinational life sciences company.
• Conducted numerous internal FCPA investigations for major pharmaceutical and other companies involving activities in Eastern Europe, Asia, the Middle East, and Latin America (e.g., Argentina, Brazil, Belarus, Belgium, Bulgaria, China, Colombia Georgia, Germany, Greece, Indonesia, India, Iran, Libya, Malaysia, Poland, Russia, Saudi Arabia, Turkey, Ukraine, and Venezuela).
• Conducted internal investigations in Germany and China for a large manufacturing company related to potential anticorruption issues.
• Successfully represented an individual defendant in a criminal bribery prosecution (D.D.C. Case No. 1:06-cr-00249).

Compliance Counseling

• Conducted risk assessments for multinational life sciences company at affiliate sites, including in China, Colombia, Germany, India, Poland, Russia, Saudi Arabia, Singapore, and Taiwan.
• Conducted due diligence on acquisition target in China for multinational life sciences company.
• Conducted due diligence on U.S. acquisition target for multinational life sciences company.
• Compliance counseling on transactions and business practices for numerous life sciences and other companies.
• Developed corporate compliance policies and procedures and training employees for numerous life sciences companies.