Unlocking Legalities: Overseas Practices, Park Doctrine Could Drive More Fraud Cases
Executive Summary
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.
You may also be interested in...
FDA Memo Reiterates Off-Label Enforcement Policy
Pre-Trump agency memo on manufacturer communications about unapproved uses says new court rulings and studies on off-label uses and adverse reactions support restrictions; whether agency’s new leadership has the same view remains to be seen.
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.
Vascular Solutions Case (Partially) Points Way Forward For Off-Label Marketing
Attorneys involved with a recent court ruling favoring Vascular Solutions believe the verdict might give manufacturers more latitude to engage in truthful, non-misleading, off-label speech. But caution is necessary.