The Dangers of Do-It-Yourself Enforcement

February 2, 2011

In his recent article appearing in FDLI Update, Hyman, Phelps & McNamara, P.C. Associate Peter M. Jaensch discusses the increasing use of the False Claims Act ("FCA") to privately prosecute what are actually violations of the FDC Act, and examines the allegations underlying the recent GlaxoSmithKline ("GSK") settlement, in which GSK agreed to pay $750 million to resolve claims based on violations of current good manufacturing practices ("cGMP"). He proposes that the GSK case represents a clear case of private enforcement of the FDC Act, and argues that the Government’s willingness to press the FCA suit on the basis of what were plainly cGMP violations was shortsighted and increases the likelihood of conflicting precedents.