John Fuson, Partner Washington, D.C.
jfuson@crowell.com
Phone: +1 202.624.2910
1001 Pennsylvania Avenue NW
Washington, DC 20004-2595

John Fuson is a partner in the firm's Health Care, Advertising & Product Risk Management (APRM), and White Collar and Regulatory Enforcement groups, focusing on U.S. Food and Drug Administration (FDA) enforcement and counseling matters. He is also a member of the Steering Committee for the firm's APRM Group. Before joining Crowell & Moring, John served as associate chief counsel at the FDA, with broad law enforcement responsibilities, from 2007-2012. John has experience handling all types of major enforcement actions brought by the FDA, including seizure actions, injunction actions, actions for civil money penalties, and contempt actions. His cases have involved drugs, devices, food, and veterinary drugs.

In the medical device field, he oversaw litigation seeking civil monetary penalties for unlawful distribution of unapproved devices, worked on recall issues, and developed enforcement strategies against device manufactures, including the manufacturer of faulty test strips for infectious disease screening. In the drug arena, he oversaw injunction actions to prevent the manufacture of unapproved new drugs, developed agency enforcement strategies against distributors who compound bulk ingredients into unapproved new drugs, and oversaw suits against companies that failed to comply with good manufacturing practice regulations. He also defended litigation challenging the scope of warning labels for a class of drugs and the approval of generic drugs under the Hatch-Waxman Act.

In the food sector, he oversaw a seizure of contaminated cheese linked to an e. coli outbreak and a subsequent injunction against the manufacturer, oversaw an injunction against a produce grower for failure to control harmful bacteria in its manufacturing facility, oversaw injunction actions against seafood distributors for failure to implement appropriate food safety plans, worked with agency experts to develop an enforcement strategy against a beverage manufacturer that failed to control for lead and other unlawful food additives in its products, and assisted in defense of a Federal Tort Claims Act case brought by tomato growers after the agency cited tomatoes as a potential source of a nationwide salmonella outbreak.

John also has experience with animal food and veterinary drug matters. He oversaw various injunction actions against dairy farms for improper use of new animal drugs and failure to control medicated livestock, oversaw a mass seizure of adulterated pet food from a dirty warehouse, and worked with agency experts to develop an enforcement strategy against distributors of unlawfully compounded new animal drugs.

Prior to joining the FDA in 2007, John was an associate for six years at Covington & Burling LLP. After graduating from law school, John clerked for the United States Court of Appeals for the Ninth Circuit.



Affiliations

Admitted to practice: District of Columbia, California (inactive)



Highlights, News & Knowledge


Speeches & Presentations

  • "Under the Watchful Eye of the FDA: What Do FDA Warning Letters Tell Us?" Third Annual ABA Life Sciences Legal Summit, San Francisco, CA (September 21, 2016). Presenter: John Fuson.
  • "UDI Update," FDLI - Hot Topics in Medical Device Law, Washington, D.C. (March 31, 2016). Presenter: John Fuson.
  • "Food & Beverage Industry: What Will 2016 Bring?" Webinar (February 10, 2016). Presenters: John Fuson, Michelle Gillette, Andrew Kaplan, and Chalana N. Williams.
  • "Regulatory Considerations in the Medical Device Litigation Discovery Process," Exponent Webinar (November 12, 2013). Presenter: John Fuson.
  • "How Internal Policies & Practices Can Prevent - or Fuel - a Crisis: Managing a Product Recall Crisis," Crowell & Moring Advertising Product Risk Management Seminar (March 19, 2013). Moderator: Laura Jastrem Walther; Panelists: Daniel T. Campbell, John Fuson, and Steve Edwards (Stericycle).
  • "Navigating High-Profile Litigation and Administrative Enforcement," Crowell & Moring Advertising and Product Risk Management Seminar (March 19, 2013). Moderator: Andrew Kaplan; Panelists: Kevin C. Mayer, Keith J. Harrison, and John Fuson.
  • "Consumer Protection and What Obama's 2nd Term Means to Your Business (Including Advertising; Data/Privacy Protection; Product Safety & More)," Association of Corporate Counsel San Francisco Bay Area Chapter, San Francisco and Palo Alto, CA (February 12-13, 2013). Presenters: Bridget E. Calhoun; Christopher A. Cole; Cheryl A. Falvey; John Fuson.
  • "Failure Analysis, Product Recalls, and Liability Preventative Measures to Help Prevent the FDA from Knocking on Your Door," Exponent and Crowell & Morning, Menlo Park, CA (January 29, 2013). Presenters: Kevin C. Mayer and John Fuson.


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Firm News & Announcements

Jan.13.2015 Crowell & Moring Releases Third Annual Litigation Forecast Report and Inaugural Regulatory Forecast
May.30.2012 Former FDA Official John Fuson Joins Crowell & Moring
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