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Unlocking Legalities: False-Claim Standards Continue To Evolve

 
• By Elizabeth Orr

The finer points of when exactly the US government can collect from a device company for selling it a bill of goods are under reconsideration, even as the fast pace of False Claims Act suits continues, attorneys with law firm Gibson Dunn concluded during a series of recent webinars.

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Can a manufacturer be held liable for violating the US False Claims Act if it never directly lied to the government? Some recent court cases suggest it’s possible, attorneys say.

The question was raised by the US Supreme Court’s 2016 Escobar decision, which held that a company could be held liable for FCA violation in some situations if it submitted a claim that falsely implied that the company complied with an important statutory, regulatory, or contractual requirement. In addition, the claim must make specific representations about the goods or services provided and the defendant’s failure to disclose non-compliance must make those representations “misleading half-truths

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• By Elizabeth Orr

States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.

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• By Elizabeth Orr

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• By Ashley Yeo

Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.

Debate On FDA User Fee Reauthorization Begins To Take Shape

 
• By Elizabeth Orr

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• By Elizabeth Orr

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