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FDA Announces Plans to Improve Safety and Advance Innovation of Medical Devices
  • Reed Smith LLP
  • USA
  • April 18 2018

On April 17, 2018, FDA announced its plan to launch the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health (Action Plan


Materiality Part III: It Is Not Enough That The Government Could Refuse PaymentThe Question Is Whether The Government Would Refuse Payment
  • Sheppard Mullin Richter & Hampton LLP
  • USA
  • April 16 2018

In Part II of our series, we discussed government knowledge. When the government knows of a claim’s falsity, but nevertheless pays the claim, the


Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar
  • Skadden Arps Slate Meagher & Flom LLP
  • USA
  • March 29 2018

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused


New DOJ Task Force to Take on Opioid Crisis Using the FCA and Other Enforcement Tools
  • McDermott Will & Emery
  • USA
  • March 2 2018

Earlier this week, the US Department of Justice (DOJ) launched a new front in its effort to combat the opioid crisis and explicitly stated that it


Top 7 Legal Challenges Facing Physicians and Hospitals
  • Jackson Lewis PC
  • USA
  • February 21 2018

The American Health Lawyers Association’s 2018 Physicians and Hospitals Law Institute in New Orleans focused on the legal challenges faced by


False Claims Act's "Rigorous" Materiality Standard Enforced by Second Circuit
  • Jones Day
  • USA
  • January 11 2018

A decision by the U.S. Court of Appeals for the Second Circuit reinforces the growing body of case law regarding the strict materiality requirements


Materiality Part II: Government Knowledge
  • Sheppard Mullin Richter & Hampton LLP
  • USA
  • January 3 2018

This is the second in a five-part series on how U.S. district courts and courts of appeal have applied the materiality standard set forth in Universal


Second Circuit Finds That The Government’s Continued Payment In The Face of Fraud Allegations Undercuts Materiality
  • Sidley Austin LLP
  • USA
  • January 2 2018

The Supreme Court emphasized in Escobar that questions of materiality are not "too fact intensive for courts" to decide through a motion to dismiss


Another State Alleges False Claims Act Violation to Combat Opioid Crisis
  • McDermott Will & Emery
  • USA
  • October 26 2017

On October 5, 2017, the State of New Jersey sued Insys Therapeutics, Inc. (Insys), alleging that the company improperly marketed and promoted the


Litigation Update: Ninth Circuit Stays Mandate to allow Gilead to Seek Cert on Key Post-Escobar Issues
  • Vinson & Elkins LLP
  • USA
  • October 6 2017

We reported previously on yet another implied certification case raising significant questions about materiality and falsity in the post-Escobar world