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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.

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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 manufacturer, it pales in comparison to settlements from other makers...

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• By Elizabeth Orr

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Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.

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FDLI: Clinical Labs Face Uncertainty After Texas Court’s LDT Ruling

 
• By Elizabeth Orr

A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.