Representative Experience

Investigations and White Collar Defense

• Representation of multi-national medical device company in voluntary disclosure to the U.S. Department of Justice related to potential violations of the Foreign Corrupt Practices Act in Brazil and other Latin American markets, resulting in a declination.
• Representation of multi-national 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, resulting in no actions taken by prosecutors.
• Representation of multi-national pharmaceutical company in connection with a U.S. Department of Justice subpoena and investigation into rebate payments to pharmacy benefit managers, its patient support program, and government price reporting, resulting in no actions taken by prosecutors.
• Representation of a U.S. biopharmaceutical company in connection with U.S. Food and Drug Administration and U.S. Department of Justice investigations across multiple offices into its post-marketing approval study and sales and marketing practices with respect to a controlled substance, resulting in the sole civil-only opioid manufacturer resolution to date.
• 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 pharmaceutical company in connection with state attorney general investigation into patient support program benefits provided to employees of state employee healthcare plans.
• Conducted internal investigation on behalf of domestic pharmaceutical company into whistleblower allegations of potential Anti-Kickback Statute violations related to clinical trials and advisory boards.
• Conducted internal investigation on behalf of domestic pharmaceutical company into allegations of pre-approval promotion, off label promotion, and other sales and marketing practices.
• Conducted internal review on behalf of specialty pharmaceutical company’s patient access programs and conducted internal investigation into alleged pharmacy fraud and abuse.
• Conducted review on behalf of multi-national medical device company into whistleblower allegations related to distributor conduct and potential Foreign Corrupt Practices Act violations in Brazil.
• Conducted internal investigation on behalf of multi-national medical device company into allegations of corrupt payments related to building permits in Mexico.
• Conducted internal investigation and audit of third party contractors in Vietnam on behalf of a multi-national engineering and construction company in connection with a Foreign Corrupt Practices Act investigation before the U.S. Department of Justice and multi-lateral development banks.
• Conducted internal investigation and audit on behalf of multi-national medical device company in response to potential whistleblower allegations related to distributor conduct in Colombia.
• Conducted internal investigations on behalf of multi-national defense contractor into alleged improper sub-contractor gratuities in violation of the Anti-Kickback Act, alleged conflict of interests in violation of the Procurement Integrity Act, and whistleblower safety concerns related to the False Claims Act.
• Conducted internal investigation on behalf of multi-national defense contractor into alleged misappropriation of supplier trade secrets in anticipation of review by the U.S. Department of Defense’s largest Joint Program Office.
• Conducted internal investigations under Federal Acquisition Regulation mandatory disclosure rule on behalf of multi-national defense contractor, including overpayments on government contracts due to mischarging, violations of federal criminal law, fraud, conflicts of interest, and false claims.

Risk Assessments and Diligence

• Conducted product launch readiness assessment and compliance counseling related to patient-focused initiatives and support programs, including reimbursement/field support, data management, digital patient support platforms, free product, and bridge programs for various rare disease companies
• Designing and vetting diagnostic and genetic testing programs offered by companies, including rare disease companies, to patients, including the test assay design, physician and patient messaging and disclosures, and data usage
• Conducted comprehensive product launch readiness assessments for numerous pharmaceutical companies, tailoring control enhancements to evolving risk profiles associated with particular commercial, medical, and market access operational plans and strategies
• Conducted numerous global anti-bribery and anti-corruption risk assessment on behalf of pharmaceutical and medical device companies.
• Conducted numerous product launch readiness assessments on behalf of pharmaceutical companies.
• Conducted proactive compliance market reviews on behalf of multi-national rare disease company in Spain, Portugal, Middle East, and Brazilian markets.
• Conducted anti-bribery and anti-corruption due diligence associated with the multi-billion-dollar acquisition of a multi-national injectable drug and biosimilar company in the Brazilian market.
• Conducted anti-bribery and anti-corruption due diligence associated with the multi-billion-dollar acquisition of multi-national orphan drug company in the Brazilian market.
• Acted as regulatory advisor on behalf of private credit, direct lenders, finance companies, and alternative and specialty lenders in both cross-border and U.S. focused healthcare transactions.

Monitorships and Compliance Counseling

• Member of team appointed by the DOJ as an independent compliance monitor pursuant to a Deferred Prosecution Agreement related to alleged violations of the Foreign Corrupt Practices Act.
• Conducted internal review on behalf of multi-national medical device company into alleged misrepresentations made to the DOJ’s independent compliance monitor during the company’s Deferred Prosecution Agreement.
• Advised multi-national medical device company on obligations associated with the company’s Deferred Prosecution Agreement with the DOJ and the company’s Corporate Integrity Agreement with the OIG-HHS related to alleged violations of the Anti-Kickback Statute and False Claims Act and made presentations to federal monitors on the development of the company’s compliance and ethics program.
• Drafted and submitted U.S. Health and Human Services, Office of Inspector General advisory opinion request on behalf of multi-national oncology company.
• Developed and conducted anti-bribery and anti-corruption training in EMEA, LATAM, and APAC regions as well as targeted training to board of directors, corporate officers, finance, internal audit, and other risk managers.
• Developed and drafted numerous corporate policies and procedures addressing interactions with healthcare professionals, including company and third-party education and training events, sales and marketing practices, charitable donations and grants, consulting arrangements, as well as an internal fair market valuation process for hourly, clinical, and royalty-based consultant arrangements.
• Drafted and negotiated consulting agreements with domestic and international healthcare professionals, hospitals, and teaching institutions on behalf of multi-national medical device company. 
• Conducted product launch readiness assessment and compliance counseling related to patient-focused initiatives and support programs, including reimbursement/field support, data management, digital patient support platforms, free product, and bridge programs for various rare disease companies.
• Designing and vetting diagnostic and genetic testing programs offered by companies, including rare disease companies, to patients, including the test assay design, physician and patient messaging and disclosures, and data usage.
• Conducted comprehensive product launch readiness assessments for numerous pharmaceutical companies, tailoring control enhancements to evolving risk profiles associated with particular commercial, medical, and market access operational plans and strategies.

• Presenter, Compliance for Innovative Therapies: A Spotlight on Rare Disease Companies CBI West Coast Compliance Congress, October 22, 2019
• Lecturer, University of Florida Levin College of Law Global Corporate Compliance LAW 6090 course
• Program Faculty, Seton Hall Law School, Latin American Compliance Certification Program  

Publications

• Co-Author, Compliance Lessons from DOJ’s Merit Medical Settlement, Law360, November 3, 2020
• Co-Author, Telehealth Considerations for Medical Device Manufacturers During and After COVID-19, Medical Device & Diagnostics Industry, October 20, 2020
• Co-Author, 5 Compliance Lessons from Novartis’ FCPA Settlement, Law360, July 13, 2020
• Co-Author, 7 COVID-19 Compliance Areas for Life Sciences Companies, Law360, May 4, 2020
• Co-Author, Key Healthcare Compliance Governance Essentials for Small and Mid-Size Life Science Companies, Orange County Business Journal, October 14, 2019
• Co-Author, The Rise of Anti-Corruption Whistleblowers in Latin America Global Investigations Review, December 7, 2018
• Co-Author, Time to Clean Up: As Operation Car Wash Progresses, Are Medical Device and Pharmaceutical Companies Out of Time with Brazilian Authorities?  Paul Hastings Client Alert, May 18, 2017
• Co-Author, A Special Type of Government Scrutiny: Pharmaceutical Manufacturer Relationships with Specialty Pharmacies: Part I  Bloomberg Law, March 29, 2017
• Co-Author, A Special Type of Government Scrutiny: Pharmaceutical Manufacturer Relationships with Specialty Pharmacies: Part II  Bloomberg Law, April 7, 2017