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Where is the CIA? Recent pharmaceutical and hospital False Claims Act settlements raise the question of whether a presumption against corporate integrity agreements exists for certain categories of conduct

  • Faegre Baker Daniels
  • -
  • USA
  • -
  • February 14 2012

In the most recent of a long line of False Claims Act (FCA) whistleblower settlements involving allegations of shenanigans with government price reporting metrics, late last week Dava Pharmaceuticals, Inc. agreed to pay the United States $11 million to settle claims that it misreported prices in order to reduce its Medicaid Drug Rebate liability

Judge rules for indicted GlaxoSmithKline attorney and the protection of attorney-client privilege

  • Faegre Baker Daniels
  • -
  • USA
  • -
  • May 11 2011

After the initial indictment of former GlaxoSmithKline (GSK) vice-president and associate general counsel Lauren Stevens for her role in responding to the government's investigation of off-label promotion of Wellbutrin was dismissed due to legal errors by the prosecution, the prosecution obtained a new indictment against Stevens

Supreme Court decides Matrixx Initiatives, Inc. v. Siracusano

  • Faegre Baker Daniels
  • -
  • USA
  • -
  • March 22 2011

On March 22, 2011, the U.S. Supreme Court decided Matrixx Initiatives, Inc. v. Siracusano, No. 09-1156, holding that a plaintiff may state a claim against a pharmaceutical company for securities fraud under 10(b) of the Securities Exchange Act of 1934, 48 Stat. 891, as amended, 15 U. S. C. 78j(b), and Securities and Exchange Commission (SEC) Rule 10b5, 17 CFR 240.10b5 (2010), based on the company's failure to disclose reports of adverse events associated with a product even if the reports do not disclose a statistically significant number of adverse events

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

The enforcement heat increases and Stryker is just the latest

  • Faegre Baker Daniels
  • -
  • USA
  • -
  • October 30 2009

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