Pete Leininger is a member of the firm’s FDA & Life Sciences Practice in Washington, D.C.  He represents medical device, pharmaceutical and biotech companies in FDA regulatory and enforcement matters, including civil and criminal government investigations.

From 2012-2017, Pete served as an Associate Chief Counsel for Enforcement in FDA’s Office of Chief Counsel.  Pete’s enforcement practice at FDA covered the range of FDA-regulated products, often focusing on product quality, GMP/QSR compliance, MDR reporting, and promotional activity.  He frequently handled criminal investigations arising out of qui tam lawsuits filed against drug and medical device manufacturers under the False Claims Act. 

During the course of his employment at FDA, he was admitted to serve as a Special Assistant United States Attorney (SAUSA) in several United States Attorney’s Offices.  As a SAUSA, Pete helped lead grand jury investigations and criminal prosecutions involving violations of the Food, Drug, and Cosmetic Act, as well as related Title 18 criminal offenses, including health care fraud and false statements.

In 2016, Pete received an Outstanding Service award from FDA’s Office of Commissioner for his representation of the agency in enforcement litigation.  He also received two special recognition awards from the Los Angeles Field Office of FDA’s Office of Criminal Investigations.  The first was awarded for his work as a SAUSA at trial in United States v. Kaplan.  The second was awarded in 2017 for his overall service to the agency.

Prior to joining FDA, Pete was an associate at an international law firm, where he specialized in government investigations and False Claims Act litigation in the health care and life sciences industries.

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