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Advice of counsel defense in US v. Lauren Stevens: dismissal of indictment is not necessarily good news for companies
  • Hogan Lovells
  • USA
  • March 25 2011

The indictment last November of former GlaxoSmithKline (GSK) in-house counsel, Lauren Stevens, for purportedly obstructing a U.S. Food and Drug Administration (FDA) investigation into whether GSK marketed Wellbutrin, an anti-depressant drug, off-label, falsifying and concealing documents, and making false statements sent shockwaves through the legal community


How to respond to a search warrant - ten practical steps
  • Ober Kaler
  • USA
  • December 31 2013

Presented by Gina L. Simms and James P. Holloway of OberKaler's Government Investigations and White Collar Defense Group, this podcast provides


Responding to a government subpoena or other document demand - six helpful hints
  • Ober Kaler
  • USA
  • December 31 2013

Presented by Gina L. Simms and James P. Holloway of OberKaler's Government Investigations and White Collar Defense Group, this podcast provides


Employee charged with theft of company trade secrets
  • Epstein Becker Green
  • USA
  • February 9 2010

The importance of corporate security and vigilance with regard to trade secrets was demonstrated by recent events in Syracuse, New York


FDA to increase enforcement actions against corporate officials
  • Faegre Baker Daniels
  • USA
  • March 5 2010

Corporate executives have rarely been personal targets of FDA enforcement actions


Eli Lilly & Co
  • Dorsey & Whitney LLP
  • USA
  • June 24 2011

In an effort to solicit members for a class action, two law firms that represent shareholders in class actions against publicly traded companies are investigating certain officers and directors of Eli Lilly


Recent prison sentences demonstrate government intent to increase criminal prosecutions of liable corporate officials
  • Arnall Golden Gregory LLP
  • USA
  • December 5 2011

In late November, two former senior executives of Synthes Inc. were sentenced to nine months in prison and a third sentenced to five months in prison for their management roles in a company that marketed a medical device for an unauthorized use and conducted unauthorized clinical trials


Government puts in-house counsel in its cross-hairs
  • Venable LLP
  • USA
  • November 12 2010

Confirming recent statements by Department of Justice ("DOJ") and Food & Drug Administration ("FDA") officials that the government will increasingly target individual executives for criminal prosecution, DOJ has indicted a former Associate General Counsel for pharmaceutical giant GlaxoSmithKline ("GSK") on two counts of obstruction of justice and four counts of making false statements during an FDA investigation


New indictment of in-house counsel indicates enhanced efforts to hold corporate executives accountable for food and drug law violations
  • Fish & Richardson PC
  • USA
  • November 15 2010

This year, both the Food and Drug Administration (FDA) and Department of Justice have repeatedly signaled to the pharmaceutical and medical device industries that they should expect an increase in the criminal prosecution of individuals for alleged violations of the food and drug laws, with the stated goals of increasing deterrence and greater compliance


OIG Advisory Opinion 12-05 approves consumer rewards program
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • May 2 2012

In OIG Advisory Opinion 12-05, the OIG found that a consumer rewards program (the “Program”) offered by a supermarket chain with in-store and independent pharmacies (the “Requestor”) would not be subject to enforcement under the Anti-Kickback Statute (the “Kickback Statute”) or the beneficiary inducement prohibition found in the civil monetary penalties law (the “CMP Law”