Andrew J. Hoffman IIPartner
Andrew Hoffman focuses his practice on defending pharmaceutical manufacturers and other life sciences companies in government investigations and related litigation.
He represents clients facing inquiries by Main Justice, the Securities and Exchange Commission, US Attorney's Offices, and State Attorneys General. And he has particular expertise defending against whistleblower lawsuits brought under the False Claims Act (FCA) and analogous state laws.
Andrew has extensive experience conducting internal investigations relating to potential violations of US health care laws, FDA regulations and corporate policies. His experience includes investigating potential GMP and GCP compliance issues both in the US and internationally.
He regularly conducts proactive risk assessments and provides clients with advice and analysis to help them mitigate the significant risks posed by the current enforcement and litigation environment.
- 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
- J.D., University of Texas School of Law
- B.A., Philosophy, University of Michigan
- 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
- 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
My latest insights
Fifth Circuit slashes damages because of government delay in bringing False Claims Act...
30 August 2023 .6 minute read
Appeals Court Ruling Deepens Circuit Split Surrounding Plaintiffs' Burden in False Claims...
14 August 2023 .1 minute read