Feds Worry Takeda Pharmaceutical Co. Ltd. Ruling Could Limit Whistleblower Lawsuits

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Concerned over the viability of the False Claims Act, the federal government has asked a federal appeals court to overturn a decision that Takeda Pharmaceutical was not liable for failing to inform the FDA of adverse event reports concerning several of its drugs. And the outcome is expected to be closely watched by the pharmaceutical industry, insurers and attorneys because of the policy implications. The move was sparked when a federal court judge last fall tossed a pair of whistleblower lawsuits that were filed by a former safety consultant, Helen Ge, who alleged Takeda misrepresented or altered descriptions of adverse events for the Uloric gout pill.

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