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Turning A Lemon Into Lemonade
  • Dechert LLP
  • USA
  • November 20 2017

Way back at the start of this year, we posted about a great preemption win on express warranty. Well, that case has worked its way through the

“Always a bridesmaid, never a bride” Might Work for Stark Liability but Not the Anti-Kickback Statute
  • Nossaman LLP
  • USA
  • November 16 2017

Last Thursday, a jury in federal district court in St. Louis handed down a verdict in a False Claims Act ("FCA") case that presents a laundry list of

FDA Finalizes Policy for Sharing Patient-Specific Data from Medical Devices
  • Reed Smith LLP
  • USA
  • November 15 2017

FDA recently released guidance ("Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request") finalizing its

MedTech Europe pushes for conformity post-Brexit
  • Baker McKenzie
  • European Union, United Kingdom
  • November 14 2017

MedTech Europe’s Position Paper on Article 50 Negotiations between the European Union and the United Kingdom (Brexit) outlines potential multiple

Recent FDA Steps To Advance Medical Device Access And Innovation
  • K&L Gates
  • USA
  • November 10 2017

On November 6, 2017, U.S. Food and Drug Administration (“FDA” or “the Agency”) Commissioner Dr. Scott Gottlieb reiterated the Agency’s commitment to

Anti-Corruption Quarterly - 3rd quarter 2017
  • Sidley Austin LLP
  • United Kingdom, USA
  • November 7 2017

The healthcare industry is no stranger to Department of Justice (DOJ) scrutiny. DOJ prosecutors have aggressively pursued improper billing practices

Ghosts in the OR: Assessing the Liability Risk of Medical Device Sales Reps Present During Surgeries
  • LeClairRyan
  • USA
  • November 7 2017

Despite being present in the operating room (OR) for many surgical procedures, medical device sales representatives have been fairly insulated from

Clinical trials Part II: Privacy, cybersecurity risks, and managing ePHI
  • Thompson Coburn LLP
  • USA
  • November 6 2017

The ongoing digitization of the drug and medical device industries continues, and, as a result, new considerations have come to the forefront for

New Trends: Reform to Drugs and Medical Devices in China
  • CMS, China
  • China
  • November 6 2017

On 8 October 2017, the General Office of the State Council issued the Opinions on Deepening the Reform of the Evaluation and Approval System and

Food, Drug and Device Law Alert - FDA’s Final Guidance Restricts Sharing Patient-Specific Information
  • Barnes & Thornburg LLP
  • USA
  • November 3 2017

The Food and Drug Administration (FDA) recently issued a brief final guidance titled "Manufacturers Sharing Patient-Specific Information from Medical