Andrew J. Hoffman

Representative Experience

• Represents life sciences innovator company in qui tam lawsuit alleging fraud on the U.S. Patent and Trademark Office and subsequent pricing issues involving federal health care programs
• Represents multinational pharmaceutical company in Department of Justice and Securities and Exchange Commission investigations under the Foreign Corrupt Practices Act
• Represents major pharmaceutical company in State Attorney General investigations involving patient assistance programs 
• Represented major pharmaceutical company in Department of Justice inquiry relating to alleged kickbacks in the form of patient support programs; government declined to intervene in underlying whistleblower complaint and moved to dismiss the complaint over the relator’s objection
• Represented major pharmaceutical company in Department of Justice inquiry relating to alleged kickbacks paid to long-term care pharmacies; government declined to intervene in underlying whistleblower complaint
• Represented major pharmaceutical company in US Attorney's Office investigation relating to alleged kickbacks paid to KOLs and prescribers; government declined to intervene in underlying whistleblower complaint
• Represented medical device distributor in qui tam lawsuit alleging violations of FDA regulations and whistleblower retaliation; all claims dismissed under Rules 12(b)(6) and 9(b)
• Represented major pharmaceutical company in qui tam litigation alleging underpayment of Medicaid rebates; all claims dismissed following close of discovery
• Represented major pharmaceutical company in qui tam lawsuit alleging concealment of adverse clinical trial results, off-label promotion and kickbacks
• Represented major pharmaceutical company in State Attorney General inquiries into patent litigation settlement raising potential pay for delay issues
• Conducted internal investigations into potential violations of Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) guidelines
• Conducted internal investigation into potential violations of regulations and corporate policies governing adverse event reporting
• Conducted internal investigations into alleged failure to disclose safety risks allegedly associated with prescription medications 
• Conducted proactive assessments of litigation and compliance risks presented by the promotion of various prescription medications and other critical business functions

• Co-author, "DOJ Should Weigh Dismissing Every Nonintervened FCA Suit," Law360, July 7, 2021
• Co-author, "INSIGHT: Consequences of DOJ’s Granston Memo—Dismissals Are Up, Circuits Split," Bloomberg Law, November 25, 2019
• Featured, "Attys Reflect On Escobar's FCA Impact 2 Years Later," Law360, June 15, 2018
• Co-author, "On FCA Enforcement, Sessions DOJ Might Be More Friendly Than It First Appears," Westlaw Journal, April 2017
• Co-author, "Post-Escobar Courts Reaching Consensus On FCA Materiality," Law360, March 27, 2017