Published: March 28, 2015

In Brief

  • Government files a Statement of Interest in Cestra case to argue that free speech is not an issue in FCA off-label drug promotion cases.
  • If the court rejects the Government’s argument, pharmaceutical producers and medical device manufacturers may gain more freedom to promote their products off-label so long as they are truthful.

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Published: February 23, 2015

In Brief:

  • A federal District Court judge in the Eastern District of Pennsylvania has addressed the corporate knowledge requirement for claims brought under the whistleblower protection provisions of the Sarbanes-Oxley Act.
  • The court ruled whistleblowers need only allege their supervisor knew about their protected reporting activity and need not allege the person who decided to terminate the employee also knew.

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Published: January 9, 2015

OtisMed Corporation and its former CEO, Charlie Chi, agreed to pay $80 million to resolve criminal and civil allegations that the company intentionally distributed knee replacement surgery cutting guides after its application for marketing clearance had been rejected by the Food and Drug Administration).

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Published: December 9, 2014

A former Sanofi paralegal filed a lawsuit claiming that she was fired after complaining the pharmaceutical company paid $34 million in kickbacks to induce physicians, hospitals and pharmacies to use its diabetes drugs.

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Published: June 3, 2014

In Brief

  • When an alleged scheme to market drugs for unapproved “off-label” uses had already been identified by an earlier complaint, a later complaint providing additional details, but alleging the same “essential facts,” was barred by the statute.
  • The Court of Appeals rejected the argument that later complaints were only barred if they alleged identical facts.

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Published: February 3, 2014

In Brief

  • Case alleges that a whistleblower’s former employer processed drugs in violation of safety regulations and, therefore, caused those drugs to be ineligible for reimbursement by Medicare and Medicaid.
  • The decision closes a potentially lucrative avenue for False Claims Act cases against pharmaceutical companies and others based solely on regulatory non-compliance.

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