Drug and Medical Device Manufacturers

Following a guilty plea last year by a major pharmaceutical company, Associate Attorney General Robert McCallum declared that “[t]he Department of Justice is committed to rooting out and prosecuting health care fraud. It is of paramount importance that the Department use every legal tool at its disposal to assure the health and safety of the consumers of America's health care system.” The tools — the variety of different criminal statutes and theories used to prosecute drug and device manufacturers — are so diverse as to defy easy summary. At one end are the general, long-established offenses, such as the Civil War-era statute criminalizing the submission of false claims to a department or agency of the United States, 18 U.S.C. ' 287 (the “criminal False Claims Act”) or the mail and wire fraud statutes. At the other are highly focused statutes, such as the federal health care “Antikickback Statute,” 42 U.S.C. ' 1320A-7b(b); see also 21 U.S.C. '' 331(t), 333(b) (drug importation and marketing violations), which prohibit, inter alia, “remuneration” to physicians to use drugs or devices that are reimbursable by a federal health care program. See also 68 Fed. Reg. 23,731, 23,734-38 (May 5, 2003) (identifying anti-kickback “risk areas”).