Shire To Pay Record-Setting Device FCA Settlement

The $350m settlement resolves False Claims Act allegations Shire and its subsidiaries used tactics including lavish meals, free medical equipment, unearned speaker payments and cash to encourage doctors to prescribe the company’s Dermagraft human skin substitute.

Gavel_1200x675

Shire PLC and its subsidiaries will pay $350m to settle state and federal allegations the manufacturer paid kickbacks and used other illegal means to encourage providers to use its Dermagraft human skin substitute. The product was FDA-approved to treat diabetic foot ulcers.

This is the largest civil settlement to date in a device-related False Claims Act case, the Department of Justice said...

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

More from Legal & IP

Former Top OIG Attorney Gives Inside Look At Fraud Prevention

 
• By 

Former HHS-OIG attorney Rob DeConti emphasized the significance of data analytics and compliance in combating healthcare fraud, urging medical tech companies to adopt robust measures to prevent potential risks.

DME And Diagnostics In Crosshairs As DOJ ‘Follows The Money’

 
• By 

The DOJ has launched nearly 70 enforcement actions in 2025, targeting diagnostics, durable medical equipment, and telehealth fraud. Key cases involve significant fraudulent claims against Medicare, with individuals facing severe penalties.

Mexico’s New Procurement Rules Aim To Increase Healthcare Investment, But May Face Legal Trouble

 

Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.

Innovative Wants Injunction Against J&J Subsidiary After $442M Antitrust Verdict

 
• By 

Innovative Healthcare is asking for a permanent injunction against Johnson & Johnson subsidiary Biosense Webster after winning a $442 million antitrust verdict. The injunction aims to prevent continued anticompetitive practices in the electrophysiology catheter market.

More from Policy & Regulation