1. Medtech Insight
  2. >>Business

Unlocking Legalities: Overseas Practices, Park Doctrine Could Drive More Fraud Cases

 
• By Elizabeth Orr

The US Department of Justice recently announced the largest-ever civil settlement in a device-related False Claims Act case. But otherwise it was a textbook FCA case, attorneys say, and many device companies still have a lot of work to do to ensure compliance and that their executives stay out of trouble. This is the first article in an occasional series in which Medtech Insight talks to attorneys to get the best takes on hot legal topics.

MT1701_Investigation_1200x675

The US Department of Justice’s recent announcement of a $350m settlement by Shire PLC resolving allegations that the company illegally enticed physicians to prescribe the company’s Dermagraft artificial skin product brought fresh attention to the ongoing issue of False Claims Act enforcement. The settlement, DOJ said, was the largest ever paid in a device enforcement action. (Also see "Shire To Pay Record-Setting Device FCA Settlement" - Medtech Insight, 12 January, 2017.)

However, attorneys urged caution in making too much of the settlement. While $350m is a large amount for a device...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Business

Aneira Health Launches New Precision Medicine Platform Exclusively For Women

 
• By Natasha Barrow

Cecilia Lindgren, Aneira Health’s co-founder and chief science officer, said that the company has “redesigned the diagnostic model.” The subscription-based platform offers clinical-grade and AI diagnostics alongside clinical consultation.

Thermo Fisher Cuts Annual Profit Outlook Amid Estimated $400M Tariff Hit

 
• By Shubham Singh

Thermo Fisher is aggressively managing its supply chain and cost base using its Practical Process Improvement (PPI) Business System. The company is also increasing investments in US-based manufacturing and R&D, with around $2bn allocated to bolster domestic operations.

‘Small Business’ Applications For Waiver Of Device User Fees To Be Streamlined By US FDA

 
• By Brian Bossetta

FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.

Ultrahuman Launches Home Health Monitoring

 
• By Natasha Barrow

Ultrahuman seeks to “create an environment that aligns with our bodies" by linking environmental parameters collected by Ultrahuman Home to health physiology, measured by the Ultrahuman Ring Air.

More from Medtech Insight

Ultrahuman Launches Home Health Monitoring

 
• By Natasha Barrow

Ultrahuman seeks to “create an environment that aligns with our bodies" by linking environmental parameters collected by Ultrahuman Home to health physiology, measured by the Ultrahuman Ring Air.

FDA Outlines Responsibilities For Owners Of Transferred 510(k)s

 
• By Elizabeth Orr

The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.

US House Budget Sets FDA FY26 Funding At $3.2B

 
• By Sue Sutter and Derrick Gingery

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.