Supervised criminal and civil litigation throughout the country under the Food, Drug, and Cosmetic Act (“FDCA”), including food safety, adulterated or misbranded drugs, medical devices, tobacco products, and supplements; directly engaged in significant matters and ensured uniform application and defense of the statute in all enforcement actions and suits filed against FDA.  Some recent examples include:

• Endo (May 2024) – Company was sentenced to pay $1.086 billion in criminal fines, $450 million in forfeiture for violations of the FDCA (second-largest criminal financial penalties ever against a pharma company), and $475.6 million in a civil False Claims Act settlement tied to opioid Opana ER. 

• McKinsey (Dec. 2024) – Resolved first-ever criminal case against a consulting firm for client advice (re: Purdue’s OxyContin), wherein McKinsey agreed to pay $650 million in penalties/forfeiture related to criminal FDCA and civil False Claims Act violations.  A former senior partner was also convicted for destroying records.

• Family Dollar (Feb. 2024) – Family Dollar pleaded guilty to violations of the FDCA for insanitary storage conditions from rodent infestation; fined $41.675 million, the largest-ever criminal food safety penalty.

• ENDS (Vaping) Matters (2023 and 2024) – Courts issued consent decrees against several companies and their owners prohibiting the defendants from continuing to sell illegal vaping products.

• Honey Smacks (Mar. 2023) – Two executives were sentenced after pleading guilty to distributing Kellogg’s Honey Smacks cereal manufactured under insanitary conditions, which caused a 2018 salmonellosis outbreak.  The company paid $19.2 million, the largest criminal food safety penalty at the time.

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Led multi-district teams in matters involving opioid manufacturers, distributors, and pharmacies, including:

• Walgreens (Apr. 2025) –$300 million resolution for violations of the Controlled Substances Act and False Claims Act related to allegations that Walgreens illegally filled millions of invalid prescriptions for opioids and other controlled substances.

• CVS (Dec. 2024) – Filed suit against CVS alleging that the company knowingly filled unlawful prescriptions for controlled substances, contributing to the opioid crisis for alleged violations of the Controlled Substances Act and False Claims Act.

• AmerisouceBergen (Dec. 2022) – Filed suit and managed litigation against AmerisouceBergen who is accused of ignoring red flags that suggested several pharmacies were diverting opioids to illicit markets.

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Oversaw the Branch’s role in enforcing FTC provisions, advancing dozens of civil-penalty actions and record resolutions that protect consumers from unfair and deceptive conduct.

• Williams-Sonoma (Apr. 2024) – Williams-Sonoma ordered to pay $3 million, a record civil penalty for violating an Administrative Order prohibiting its marketing of imported goods as Made in the USA.

• Microsoft (Jun. 2023) – Microsoft agreed to pay $20 million and injunctive relief to resolve alleged COPPA and FTC Act violations tied to its Xbox Live service for allegedly collecting children’s personal information.

• Amazon (July. 2023) – Amazon agreed to a permanent injunction and a $25 million civil penalty to resolve alleged violations of COPPA related to its Alexa service allegedly unlawfully retaining children’s voice recordings.

• Epic Games (Dec. 2022) – Ordered to pay $275 million, the largest COPPA penalty, for collecting children’s personal data in Fortnite without parental notice or consent.

 

Reinvigorated the Department’s enforcement of statutes administered by the Consumer Product Safety Commission and National Highway Traffic Safety Administration, including:

• Sunsetter (Apr. 2025) – Court ordered Sunsetter to pay $9.5 million in civil penalties in connection with alleged failure to timely report defective awning covers to the CPSC.

• Gree (May 2024) – Two corporate executives were sentenced to federal prison terms for failure to report information concerning a potential product safety hazard as required by the Consumer Product Safety Act.  In October 2021, a resolution was reached with the company in the first criminal corporate enforcement action for late reporting with criminal penalties of $91 million.

 

Launched an initiative to tackle fraud affecting older Americans, including through national case sweeps and enforcement focused on corporate facilitators of fraud, and created an Emerging Technology Initiative to target bad actors using AI to commit fraud schemes:

• Epsilon (May 2024) – Two executives were convicted and sentenced to federal prison terms for selling targeted consumer lists used in mail and wire fraud schemes. Epsilon, their employer, resolved its criminal liability in 2021, paying $150 million in penalties and victim compensation.

 

Created a Counterfeit Pill Initiative to address corporate bad actors allowing the manufacture and sale of counterfeit pills laced with narcotics, as well as the equipment used to make it:

• CapsulCN (May 2025) – a federal grand jury indicted the company and three nationals for smuggling, money laundering, and Controlled Substances Act offenses tied to the illegal import of pill presses and counterfeit molds.  The indictment also charged CapsulCN’s principal officer with leading a criminal enterprise, and authorities seized four domains used to market the illicit equipment.

• eBay (Jan. 2024) - $59 million settlement, the fourth-largest CSA settlement and first with an e-commerce company, for selling pill presses.

 

Built the Branch’s Corporate Compliance Program to standardize compliance terms in the Branch’s corporate resolutions.