Andrew J. HoffmanPartner
Andrew Hoffman focuses his practice on representing pharmaceutical manufacturers and other life sciences companies in government investigations and related litigation.
He defends clients facing inquiries by Main Justice, the Securities and Exchange Commission, US Attorney's Offices, State Attorneys General and municipal entities. He also represents clients facing whistleblower lawsuits brought under federal and state false claims 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 data integrity concerns and other GMP issues at U.S. and international manufacturing sites.
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 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
- J.D., University of Texas School of Law 2008
- B.A., Philosophy, University of Michigan 2005
- 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
My latest insights
Split Seventh Circuit lowers the bar for pleading a False Claims Act violation
13 September 2021 .5 minute read
Silver linings for FCA defendants in new HHS Working Group
11 December 2020 .6 minute read