Andrew J. Hoffman II

Representative Experience

• Represents major pharmaceutical company in qui tam lawsuit alleging fraudulent procurement of regulatory drug approvals from the U.S. Food and Drug Administration (FDA)
• Represents life sciences innovator company in qui tam lawsuit alleging fraudulent procurement of patents from the U.S. Patent and Trademark Office (PTO)
• Represents multinational pharmaceutical company in Department of Justice (DOJ) and Securities and Exchange Commission (SEC) investigations under the Foreign Corrupt Practices Act (FCPA)
• Represents major pharmaceutical company in multidistrict litigation concerning public nuisance and consumer protection claims brought by cities, counties, and tribal governments
• Represents major pharmaceutical company in multidistrict litigation concerning antitrust and consumer protection claims brought by State Attorneys General and private parties
• Represents major pharmaceutical company in State Attorney General investigations involving copayment assistance programs
• Represented global hospitality company in lawsuit alleging hotel “resort fees” violated consumer protection laws
• 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 DOJ investigation 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 DOJ investigation relating to alleged kickbacks in the form of rebates paid to pharmacies; government declined to intervene in underlying whistleblower complaint and case voluntarily dismissed
• Represented major pharmaceutical company in US Attorney's Office investigation relating to alleged kickbacks paid to key opinion leaders (KOLs); government declined to intervene in underlying whistleblower complaint and case voluntarily dismissed
• 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, "Appeals Court Ruling Deepens Circuit Split Surrounding Plaintiffs’ Burden in False Claims Act Cases," Government Contracting Law Report, August 2023
• Co-author, "DOJ Should Weigh Dismissing Every Nonintervened FCA Suit," Law360, July 7, 2021
• Co-author, "HHS Working Group Could Take FCA Pressure Off Health Cos.," Law360, December 10, 2020
• 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

• IP Atty Fights To Revive Allergan FCA Suit At 9th Circ., Law360, November 21, 2024
• Pfizer Defeats Whistleblower Suit Over Covid-19 Clinical Trial, Bloomberg Law, April 4, 2023
• Allergan Wins Dismissal Of Alzheimer’s Drug Patent Fraud Case, Bloomberg Law, March 14, 2023
• Allergan, Adamas Keep Win In Whistleblower’s Patent Fraud Case, Bloomberg Law, November 4, 2022
• Allergan Wins Reversal In Whistleblower’s Patent Fraud Lawsuit, Bloomberg Law, August 25, 2022
• AbbVie Dodges Whistleblower’s Patent Fraud Suit Over Alzheimer’s Drugs, Reuters, August 25, 2022
• Pfizer, Hospira Beat FCA Suit Over Faulty Infusion Pumps, Law360, March 15, 2019
• Pfizer, Hospira Urge Nix Of Suit Over Faulty Pumps, Law360, October 8, 2018
• Pfizer Wins Interlocutory Review In Vfend Whistleblower Suit, Law360, June 22, 2017