William J. Cople, Attorney

Mr. Cople specializes in litigation involving pharmaceuticals, medical devices and highly regulated products, including class actions involving radiation claims and device implants. He has broad experience in FDA regulation and enforcement and advises manufacturers on drugs, biologics, devices and vaccines, including product approval applications, clinical trials, pharmacovigilance, inspections and warning letters, as well as off-label promotion and marketing exclusivity claims.

Mr. Cople works extensively on False Claims Act litigation, export control investigations, and the defense of federal fraud prosecutions. He handles international program investigations and Foreign Corrupt Practices Act matters. He represents government contractors and pharmaceutical and medical device manufacturers regarding Congressional investigations, committee hearings, and pending legislation, and represents companies in FDA investigations and enforcement proceedings before USDA.

Mr. Cople also handles government contracts and construction litigation. His experience includes contract claims, negotiations and litigation involving architect-engineers and construction, environmental remediation, telecommunications, computers, and defense contracting. He handles claims, bid protests, government audits, cost accounting standards, defective pricing, suspension and debarment, and international transactions (infrastructure projects, export controls, international joint ventures and technology transfers).

Mr. Cople lectures industry and government officials on government procurement and international contracting, and serves on the Legal Committee for the National Defense Industrial Association (NDIA).

Mr. Cople was principal advisor to the Corps of Engineers while serving on active duty as an Army officer in the Office of the Secretary of Defense (special assistant to the General Counsel). Mr. Cople also served as chief trial counsel for the U.S. Army Engineer Center at Fort Belvoir, and as federal prosecutor in the Eastern District of Virginia.

Mr. Cople was editor of the St. John's Law Review.