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Results: 1-10 of 392

DOJ files FCA suit against PODs and physician-investors

  • Sidley Austin LLP
  • -
  • USA
  • -
  • September 26 2014

In recent years, the growing number of physician-owned distributors ("PODs")medical device distributors owned at least in part by physicians

OIG issues report on manufacturer-sponsored coupons and companion Special Advisory Bulletin

  • Sidley Austin LLP
  • -
  • USA
  • -
  • September 23 2014

On September 19, 2014, the U.S. Department of Health and Human Services' Office of Inspector General (OIG) issued a controversial report entitled

FDA affirms permissive comparative claim policies, while establishing foundation for restrictive guidance

  • Sidley Austin LLP
  • -
  • USA
  • -
  • September 22 2014

Food and Drug Administration (FDA) officials recently affirmed that prescription drug manufacturers may make comparative promotional claims regarding

EU Commission shifts responsibility for pharmaceuticals, medical devices, biotechnology and cosmetics

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • September 18 2014

On September 10, 2014, European Commission President-elect Juncker issued a press release unveiling his new EU executive team and announcing a

OIG issues alert regarding laboratory relationships with physicians

  • Sidley Austin LLP
  • -
  • USA
  • -
  • September 10 2014

On June 25 2014 the Department of Health and Human Services' Office of Inspector General (OIG) released a Special Fraud Alert addressing two

FDA moves forward with program for Medical Device Development Tools

  • Sidley Austin LLP
  • -
  • USA
  • -
  • September 8 2014

On August 15, 2014, FDA announced that it is soliciting proposals to participate in a pilot program for Medical Device Development Tools (MDDTs

Seventh Circuit limits “worthless services” theory, heightens the bar for public disclosure

  • Sidley Austin LLP
  • -
  • USA
  • -
  • September 4 2014

Several circuit courts have recognized the "worthless services" theory of FCA liability, which allows qui tam relators to assert FCA claims premised

Court allows second FCA suit alleging different fraudulent scheme in connection with the same underlying false claims as a previously-settled suit

  • Sidley Austin LLP
  • -
  • USA
  • -
  • August 29 2014

In United States ex. Rel. Lisitza v. Par Pharmaceutical Cos., Inc., No. 06 C 06131 (N.D. Ill. July 31, 2014), a federal district court in Illinois

Court rejects “swapping” claims, rejects claim that “below cost” discounting violates the Anti-Kickback Statute

  • Sidley Austin LLP
  • -
  • USA
  • -
  • August 26 2014

The Southern District of Ohio recently granted defendants' motion to dismiss in a FCA case based on alleged violations of the Anti-Kickback Statute

8th Circuit affirms dismissal of FCA claim, offering guidance on the application of the public disclosure bar

  • Sidley Austin LLP
  • -
  • USA
  • -
  • August 18 2014

On August 7, 2014, the Eighth Circuit affirmed the dismissal of a qui tam False Claims Act suit, and in doing so offered helpful guidance regarding