New Brunswick, NJ — [Date] – Following a historic $1.6 billion verdict under the False Claims Act (FCA), Johnson & Johnson (J&J) has filed a constitutional challenge to the law’s core provisions, igniting major legal and industry-wide debate.
The pharmaceutical giant, through its Janssen Products LP division, is appealing the decision to the U.S. Court of Appeals for the Third Circuit after a federal jury in New Jersey found it liable for promoting HIV drugs for unapproved uses, triggering massive FCA penalties.
J&J argues the FCA’s qui tam provisions — which allow private whistleblowers to sue on the government’s behalf — violate the U.S. Constitution by delegating executive powers to private individuals. The case follows growing scrutiny of the FCA’s structure and comes in the wake of rising legal and financial risks for corporations in whistleblower-driven litigation.
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“The qui tam system is spiraling out of control,” said the National Association of Manufacturers in an amicus brief filed in support of J&J’s appeal. The group cited the $1.6B J&J verdict as evidence of “systemic breakdown.”
J&J’s brief claims the verdict is excessive and unconstitutional under the Eighth Amendment, especially since the case involved no proven patient harm and concerned life-saving medications. The company also contends that its commercial speech is protected by the First Amendment, raising broader questions about the...
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