Andrew J. Hoffman II

Partner

Emailandrew.hoffman@us.dlapiper.com

Call+1 310 595 3010

Los Angeles

About

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.

Areas of FocusLife Sciences Litigation, Arbitration and Investigations White Collar and Corporate Crime

Bar admissionsCaliforniaDistrict of Columbia

CourtsUnited States Court of Appeals for the First CircuitUnited States Court of Appeals for the Second CircuitUnited States Court of Appeals for the Third CircuitUnited States Court of Appeals for the Fifth CircuitUnited States Court of Appeals for the Sixth CircuitUnited States Court of Appeals for the Ninth CircuitUnited States Court of Appeals for the Tenth CircuitUnited States District Court for the Central District of CaliforniaUnited States District Court for the Eastern District of CaliforniaUnited States District Court for the Northern District of CaliforniaUnited States District Court for the Southern District of CaliforniaUnited States District Court for the Western District of Michigan

EXPERIENCE

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