Jessica Montes is an associate in the Litigation practice of Paul Hastings and is based in the firm's New York office. Her practice focuses on internal and government investigations, white collar defense, and compliance counseling, with an emphasis on the life sciences industry, fraud and abuse, and anti-bribery and anti-corruption.
Ms. Montes has extensive experience counseling life sciences companies across a variety of areas, including interactions and engagements with healthcare professionals and government officials, patient support and patient assistance programs, clinical trials, third party relationships, and domestic sales and marketing practices. Ms. Montes has also conducted risk assessments and proactive reviews and developed compliance programs for life sciences clients, including as a secondee at a multinational rare disease company.
Ms. Montes received her law degree from Columbia Law School, where she served on the Columbia Journal of Gender and Law. She earned Bachelor of Arts degrees in Political Science and International Studies from the University of California, Irvine, where she graduated with honors. Ms. Montes is admitted to practice law in New York.
Internal and Government Investigations
Representation of multi-national medical device manufacturer in connection with a voluntary disclosure to the U.S. Department of Justice related to potential violations of the Foreign Corrupt Practices Act in China and various other jurisdictions
Representation of multi-national rare disease pharmaceutical company in connection with an investigation into potential violations of the Foreign Corrupt Practices Act in Europe, Japan, and Latin America by the U.S. Department of Justice and Securities and Exchange Commission
Representation of pharmaceutical company in connection with a U.S. Department of Justice subpoena and investigation into its patient support program, drug pricing, and specialty pharmacy relationships
Representation of pharmaceutical company in connection with a U.S. Department of Justice subpoena and investigation into manufacturer rebates to pharmacy benefit managers
Representation of a senior executive of a biopharmaceutical company in connection with a U.S. Department of Justice subpoena and investigation into donations to copay assistance charities
Representation of an opioid manufacturer in connection with a multi-district federal investigation and a qui tam complaint focusing on promotional practices and alleging potential violations of the anti-kickback statute and False Claims Act, resulting in a $7.55 million civil-only settlement in the District of New Jersey
Conducted internal investigation on behalf of a pharmaceutical company into whistleblower allegations of potential Anti-Kickback Statute violations related to company-sponsored clinical trials, investigator-initiated studies, and advisory boards
Conducted internal investigation on behalf of a pharmaceutical company into allegations of pre-approval promotion, off label promotion, and other improper sales and marketing practices
Risk Assessments and Diligence
Conducted global anti-bribery and anti-corruption compliance program assessment on behalf of multi-national pharmaceutical company
Conducted proactive compliance market reviews on behalf of multinational pharmaceutical company in European markets
Conducted anti-bribery and anti-corruption diligence on high-risk distributors in the Middle East, Asia-Pacific, and Latin America
Conducted proactive compliance reviews of manufacturer patient support and assistance programs in view of U.S regulator guidance and enforcement on behalf of Fortune 100 pharmaceutical company
Enhanced and implemented global anti-bribery and anti-corruption compliance programs on behalf of multinational pharmaceutical and medical device companies
Developed and implemented numerous corporate policies and procedures addressing interactions with healthcare professionals in the U.S. and abroad and due diligence and risk management of third parties