Post-Trial Missteps
The DOJ also flagged errors in the judge’s post-trial opinion, which cemented the judgment in favor of whistleblowers Jessica Penelow and Christine Brancaccio, former Janssen sales representatives. The court wrongly suggested that off-label marketing alone rendered reimbursement claims false under the FCA, the DOJ said.
“Misbranding rules govern marketing, not federal reimbursement,” the brief stressed, adding that the judgment should be vacated and remanded for reassessment under the correct law.
Constitutional Flashpoints
Janssen’s appeal has attracted national attention because it challenges not only the staggering verdict but also the very framework of qui tam whistleblower suits. The DOJ defended the mechanism, emphasizing that private relators act under government authority, not as rogue enforcers.
The DOJ also rebuffed J&J’s claim that the $1.6 billion penalty violates the Eighth Amendment’s ban on excessive fines. Penalties, it argued, are unconstitutional only if they bear “no relationship to the gravity of the misconduct.” Given that the award nearly mirrors Janssen’s $1.7 billion in annual HIV drug revenue, the DOJ said the fine clearly reflects the scale of wrongdoing.
