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Results: 1-10 of 381

9th Circuit affirms dismissal of FCA claim as “implausible” where defendant disclosed its disputed billing methodology to the government

  • Sidley Austin LLP
  • -
  • USA
  • -
  • July 25 2014

On July 22, 2014, the Ninth Circuit issued an important decision supporting the principle that good faith disputes about ambiguous or disputed

New FDA informed consent draft guidance broadens scope of sponsor disclosure obligations

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

On July 15, 2014, the U.S. Food and Drug Administration ("FDA" or the "Agency") issued a draft guidance document, entitled "Informed Consent

DOJ seeks aggressive enforcement of FCA overpayment provision

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

On June 27, 2014, the Department of Justice ("DOJ") elected to intervene in a FCA suit based solely on an alleged failure to timely refund

New MDDS guidance reduces regulatory hurdles for developers

  • Sidley Austin LLP
  • -
  • USA
  • -
  • July 9 2014

The Food and Drug Administration has issued draft guidance announcing that it does not intend to enforce compliance with the regulatory controls that

OIG issues Special Fraud Alert regarding laboratory relationships with physicians

  • Sidley Austin LLP
  • -
  • USA
  • -
  • June 30 2014

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

Court order compelling FCA defendant to produce documents previously produced to HHS OIG warns of limitations of confidentiality agreements

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

On May 29, 2014, the United States District Court for the Southern District of Illinois ordered K-Mart Corporation to produce documents to a relator

New FDA MDDS draft guidance reduces regulatory hurdles for software developers, signals continued intent to “regulate” software via policy

  • Sidley Austin LLP
  • -
  • USA
  • -
  • June 25 2014

On June 20, 2014, FDA issued a draft guidance titled "Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications

Decoding FDA: five things to know about the FDA’s June 6 response to the MIWG citizen petition concerning off-label promotion

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

On June 6, 2014, FDA sent a letter to counsel for the Medical Information Working Group (MIWG), a coalition of biopharmaceutical and medical

Fifth Circuit applies first-to-file bar in fraudulent billing suit

  • Sidley Austin LLP
  • -
  • USA
  • -
  • June 16 2014

On June 4, 2014, the Fifth Circuit affirmed the dismissal of a qui tam suit under the first to file bar, even though the later-filed complaint

Court holds that pharmacy cannot be liable under the FCA for filling “off-label” prescriptions

  • Sidley Austin LLP
  • -
  • USA
  • -
  • June 12 2014

A federal district court in Georgia recently granted summary judgment in favor of Omnicare, Inc. in a qui tam suit asserting FCA liability against