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Results: 1-10 of 13

U.S. v. Stevens: former GSK attorney acquitted on all counts

  • Ropes & Gray LLP
  • -
  • USA
  • -
  • May 16 2011

On May 10, 2011, Judge Roger Titus of the District of Maryland dismissed the case United States v. Stevens

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

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

“The elephant in the room”: indictment of former GlaxoSmithKline in-house attorney dismissed due to prosecutors’ misstatement of advice of counsel defense to grand jurors

  • Jenner & Block
  • -
  • USA
  • -
  • March 24 2011

A federal district court has dismissed the indictment of a former in-house counsel at pharmaceutical company GlaxoSmithKline ("GSK"), Lauren Stevens, who was charged in November 2010 with obstruction of a proceeding, false statements, and falsifying or concealing documents, for her role in responding to a document request from the Food and Drug Administration ("FDA"

Former GSK in-house counsel Lauren Stevens acquitted

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • May 10 2011

Earlier today, Honorable Roger W. Titus, who is the judge presiding over the Lauren Stevens trial, granted the defendant's motion for a judgment of acquittal, bringing the case to an end

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

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

Ten steps global life sciences companies should take in 2011

  • Sidley Austin LLP
  • -
  • USA
  • -
  • February 16 2011

Focus on potential kickback, Foreign Corrupt Practices Act, and Good Clinical Practice liability, especially in developing countries

D.C. Circuit decision in Friedman v. Sebelius overturns exclusions of three Purdue pharma executives

  • Sidley Austin LLP
  • -
  • USA
  • -
  • August 6 2012

In the pharmaceutical industry, government investigations initiated by whistleblower qui tam complaints canand often doresult in both civil and criminal charges against the company