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The top 5 corruption risks for pharmaceutical and medical device companies
  • LeClairRyan
  • USA
  • September 19 2012

Pharmaceutical and medical device companies are fast becoming the enforcement punching bag, eclipsing the long-suffering status of the oil and gas energy


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

Corporate executives have rarely been personal targets of FDA enforcement actions


FDA looks to boost criminal prosecutions
  • Sheppard Mullin Richter & Hampton LLP
  • USA
  • March 11 2010

In the wake of a scathing March 4th GAO Report, FDA has informed Congress that it will boost criminal prosecutions of pharmaceutical and food industry executives


GAO report calls for increase in FDA criminal prosecutions of company executives
  • Reed Smith LLP
  • USA
  • March 15 2010

The GAO recently issued a report entitled "Food and Drug Administration: Improved Monitoring and Development of Performance Measures Needed to Strengthen Oversight of Criminal and Misconduct Investigations," at the request of Senate Finance Committee Ranking Republican Charles Grassley


Matrixx Securities fraud case could affect product liability law
  • Squire Patton Boggs
  • USA
  • December 10 2010

Sometimes the most significant changes in the law come from unexpected places


U.S. Supreme Court: disclosing “statistically significant” incidents regarding a product’s potential adverse health effects is not enough
  • Kelley Drye & Warren LLP
  • USA
  • March 29 2011

The Supreme Court recently issued a unanimous decision in a securities fraud case, Matrixx Initiatives, Inc. v. Siracusano


The enforcement heat increases and Stryker is just the latest
  • Faegre Baker Daniels LLP
  • USA
  • October 30 2009

Recent statements by FDA and DOJ officials, including FDA Commissioner Hamburg, promised an increase in enforcement


Senate adopts food safety crime bill
  • Shook Hardy & Bacon LLP
  • USA
  • April 22 2011

The U.S. Senate has approved a bill (S. 216) designed to “strengthen criminal penalties for companies that knowingly violate food safety standards and place tainted food products on the market,” according to the legislation’s sponsor, Senator Patrick Leahy (D-Vt


GlaxoSmithKline LLC to pay the largest health care fraud settlement in U.S. history
  • Bricker & Eckler LLP
  • USA
  • July 3 2012

The United States Department of Justice (DOJ) announced on July 2, 2012, that drug maker GlaxoSmithKline LLC (GSK) has agreed to plead guilty and pay $3 billion the largest penalty ever paid by a pharmaceutical company to resolve its criminal and civil liability for off-label promotion of several drugs, failure to report safety data, and false price reporting practices


Boston Scientific prevails in securities fraud lawsuit
  • Winston & Strawn LLP
  • USA
  • August 22 2011

On August 15th, the First Circuit addressed what adverse events associated with medical devices an issuer must disclose, affirming the entry of summary judgment dismissing a Rule 10b-5 securities fraud lawsuit