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Fourth Circuit Affirms Duty to Defend Online Data Breach Allegations
  • Sidley Austin LLP
  • USA
  • April 25 2016

In Travelers Indemnity Company of America v. Portal Healthcare Solutions, LLC, No. 14-1944 (4th Cir. Apr. 11, 2016), the U.S. Court of Appeals for


Active Supreme Court Bench Probes Scope of “Fraudulent” Claims
  • Sidley Austin LLP
  • USA
  • April 20 2016

As we have discussed here and here, yesterday the Supreme Court heard oral arguments in Universal Health Services v. United States ex rel. Escobar


False Statements Regarding The Length Of Time A Patient Needs A Purchased Medical Device Are Not Material To The Government’s Payment Decision And Not Actionable Under The FCA
  • Sidley Austin LLP
  • USA
  • April 20 2016

If Medicare pays a flat rate for a patient to purchase a medical device regardless of how long the patient uses the item, any false statement to


FDA draft biologics guidance would rescind innovator exclusivities
  • Sidley Austin LLP
  • USA
  • April 13 2016

The Food and Drug Administration recently released a draft guidance regarding the implementation of the 'deemed to be a licence' provision of the


Federal Trade Commission Issues Guidance for mHealth App Developers
  • Sidley Austin LLP
  • USA
  • April 12 2016

The U.S. Federal Trade Commission (FTC) in coordination with the Food and Drug Administration (FDA), the Department of Health and Human Services’


New FDA Draft Guidance on Biosimilar Labeling Largely Follows Generic Drug Approach
  • Sidley Austin LLP
  • USA
  • April 7 2016

On March 31, the U.S. Food and Drug Administration (FDA) published its long-awaited draft guidance, "Labeling for Biosimilar Products." While the


Foreign Corrupt Practices Act enforcement refocuses on life sciences
  • Sidley Austin LLP
  • USA
  • April 6 2016

Life sciences companies should prepare for renewed Foreign Corrupt Practices Act enforcement by US authorities. This focus may be felt particularly


Universal Health Services Urges Court to Reject Implied Certification Theory of Liability
  • Sidley Austin LLP
  • USA
  • April 1 2016

On March 28, 2016, Petitioners in Universal Health Services v. United States ex rel. Escobar filed their reply brief reinforcing their argument that


Five Things To Know About The Amarin Settlement
  • Sidley Austin LLP
  • USA
  • March 31 2016

On March 8, 2016, Amarin Pharma, Inc., advised Judge Paul Engelmayer of the United States District Court for the Southern District of New York that


Trial Court Delivers Stunning Defeat to DOJ In AseraCare
  • Sidley Austin LLP
  • USA
  • March 31 2016

Today, the district court in the AseraCare case delivered the coup de grace to the Department of Justice, granting summary judgment for AseraCare