On August 15, 2024, the NAM filed an amicus brief urging the 3rd Circuit to affirm a district court’s rejection of a qui tam relator’s fraud-on-the-FDA theory of False Claims Act liability. The relator brought this qui tam action in the District of New Jersey against defendants Bayer and Johnson & Johnson, arguing that they misled the FDA to obtain approval of FQs Cipro and Levaquin, so every reimbursement claim for the FQs is “false” under the False Claims Act. The relator claimed that the drugs are misbranded based on a variety of adverse events like mitochondrial toxicity and psychiatric events that are not included on the products’ warning labels. The district court rejected this theory of liability and twice granted the defendants’ motions to dismiss. The relator appealed to the 3rd Circuit.
We argue in our amicus brief that the relator cannot ask a jury to overrule FDA’s approval of the defendants’ drugs, which would violate Congress’s express grant to FDA of sole authority to exercise such regulatory judgments. In addition, the realtor cannot satisfy either the FCA’s materiality or causation elements based on a fraud-on-the-FDA theory where FDA has specifically considered the relator’s allegations and declined to remove the defendants’ drugs from the market.