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“Dueling Counsel Views on Off-label Marketing Ruling”

Claire M. Sylvia, a partner with Phillips & Cohen LLP, was featured in Bloomberg BNA in a story about “dueling” views over an opinion out of the Sixth Circuit Court of Appeals.

Claire M. Sylvia, a partner with Phillips & Cohen LLP in San Francisco who represents whistle-blowers, told me that the dissenting opinion “correctly summarizes the trend” in FCA pleading standards, and agreed with the dissent that requiring direct knowledge of a defendant’s billing procedures shouldn’t be necessary.

Sylvia said the decision likely wouldn’t affect pharmaceutical marketing, however, as “[t]he FCA has been extremely effective at enforcing off-label restrictions and calling attention to abuses and the associated harms to public health.” Sylvia said the effect of the decision would be limited because it only applies to cases in the Sixth Circuit, and that drugmakers would be unwise to “ignore past substantial penalties that have been paid for violating the False Claims Act.” Drugmaker Celgene agreed to a $280 million off-label FCA settlement in June of this year.

The full article can be read on Bloomberg BNA.

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