News & Insights

Press Release

June 5, 2017

FDA Associate Chief Counsel for Enforcement Joins King & Spalding

WASHINGTON, June 5, 2017 — King & Spalding announced today that Peter Leininger, Associate Chief Counsel for Enforcement with the U.S. Food & Drug Administration, joins King & Spalding’s Washington, D.C., office as counsel with the firm’s FDA & Life Sciences practice.

As a member of FDA’s Office of the Chief Counsel, Leininger represented the agency in numerous criminal investigations and prosecutions across the range of FDA-regulated products, including medical devices, drugs, food, dietary supplements and biologics. In that role, he regularly counseled and advised FDA’s Office of Criminal Investigations on evidence-gathering techniques and strategies, and he reviewed and evaluated evidence collected by FDA agents and investigators. Leininger developed referrals to the Department of Justice for criminal prosecutions of corporations and individuals, and participated in investigations that were prompted by whistleblower complaints and qui tam actions. During his five-year tenure with FDA, Leininger also served as a Special Assistant U.S. Attorney in criminal cases he helped develop and prosecute, including those involving the sale and distribution of counterfeit drugs, and the use of unapproved and misbranded drugs by physicians.

“While King & Spalding has enjoyed a tremendous relationship with the FDA for nearly 40 years, Pete’s arrival from the agency further strengthens an area of focus for us in FDA enforcement matters, especially criminal investigations, qui tam actions and government investigations,” said Mark Brown, chair of the firm’s FDA & Life Sciences practice. “Pete’s substantial experience with emerging enforcement priorities and insights gained from his work with FDA and the Department of Justice will be exceptionally valuable to both our current clients and our practice.”

Prior to joining FDA, Leininger worked in private practice for seven years, focusing on False Claims Act litigation in the healthcare and life science industries. Leininger received his B.B.A. from the College of William and Mary, and his J.D. from Case Western Reserve University Law School.

“I have long known that King & Spalding has a premier FDA regulatory and enforcement practice, and I am thrilled to join this great firm,” said Leininger. “I look forward to sharing insights from my experience at FDA and in private practice with clients and colleagues across the firm and helping to grow the FDA & Life Sciences practice even further.”

With more than 35 lawyers and professionals in the U.S. and Europe devoting their time exclusively to FDA matters, King & Spalding’s FDA & Life Sciences group provides sophisticated regulatory counseling to more than 200 large, mid-cap, and start-up medical device, drug, biotech, food, and tissue product manufacturers, as well as distributors, health care providers, and technology ventures. Law360 recently named King & Spalding’s team a Life Sciences Practice Group of the Year.

About King & Spalding
Celebrating more than 130 years of service, King & Spalding is an international law firm that represents a broad array of clients, including half of the Fortune Global 100, with 1,000 lawyers in 19 offices in the United States, Europe, the Middle East and Asia. The firm has handled matters in over 160 countries on six continents and is consistently recognized for the results it obtains, uncompromising commitment to quality, and dedication to understanding the business and culture of its clients. More information is available at