Relators filed a civil action behalf of the United States, twenty-six states, and the District of Columbia, alleging fifty-six counts under the federal False Claims Act (“FCA”), the federal Anti-Kickback Statute, and the false claims act of various states (“state FCAs”). The claims arose from Janssen Products, LP’s (“Janssen”) purported kickback scheme and off-label (“OL”) promotions of two HIV/AIDS drugs: Prezista and Intelence. On May 6, 2024, a jury trial commenced on Relators’ claims against Janssen. The jury received stipulated facts, substantial documentary evidence, and testimony from 12 fact witnesses and 5 expert witnesses. After a six-week trial, on June 13, 2024, the jury found Janssen liable for unlawfully promoting Prezista or Intelence under the federal FCA, as well as under each of the state FCAs. The jury determined that Janssen submitted 159,574 claims in violation of the FCA and awarded $120,004,736 to the United States as a result of these violations. Separately, the jury determined that Janssen submitted false claims in violation of the state FCAs, and awarded a lumpsum of $30,001,184 to the States, collectively, as a result of these violations. Following the jury’s verdict in favor of Relators on the federal FCA and state FCA claims, Janssen filed its renewed Motion for Judgment as a Matter of Law pursuant to Rule 50(b) and Motion for a New Trial pursuant to Rule 59. Relators, in turn, filed a Motion for Entry of Judgment.
The United States District Court District of New Jersey stated in its unpublished Opinion filed on March 28, 2025:
Here, examining the record before it, the Court finds that Relators produced sufficient evidence from which the jury could reasonably adduce that Janssen’s OL marketing was a substantial factor in causing physicians to submit claims for reimbursement to Government payors, and that it was reasonably foreseeable that false claims would result from such conduct. Relators proffered detailed documentary evidence, as well as expert and fact testimony, that demonstrated claims for Prezista or Intelence were submitted to the Government as a result of Janssen’s OL marketing. Janssen raised challenges regarding the sufficiency, reliability and accuracy of Relators’ proffered evidence at trial. The jury evaluated both parties’ arguments and concluded that Relators had sufficiently proven causation. A reasonable jury could therefore have found that Janssen’s OL marketing caused the submission of claims to the Government, and judgment as a matter of law is inappropriate on this issue.
After reviewing the record in full, the Court is satisfied that there is ample evidence to support the jury’s verdict of liability under the FCA. It is not the Court’s role to second-guess the jury’s fact-finding and consideration of the evidence. Drawing all reasonable and logical inferences in Relators’ favor, the Court finds that Janssen has failed to carry its high burden of demonstrating that “any verdict other than the one directed would be erroneous under the governing law” and therefore denies Janssen’s Rule 50 Motion as to liability under the federal FCA.
[T]he Court agrees with Janssen that Relators failed to introduce sufficient evidence from which a reasonable juror could find Janssen liable on the state FCAs. During trial, Relators presented no evidence regarding the scope or elements of each state FCA, what type of fraudulent claims would lead to liability under these state FCAs, and what amount of damages each state suffered as a result of the statutory violations. Instead of introducing evidence specific to their state law claims, Relators premised their entire case on the legal argument that because Janssen’s conduct violated the federal False Claims Act, Janssen’s conduct also violated each of the analogous state statutes.
After consideration of the parties’ post-trial briefing and the trial evidence, the Court now finds that Relators failed to present sufficient evidence or analysis regarding the elements or scope of each state FCA at trial, despite the Court’s warning prior to closing arguments, and that it was error to accept Relator’s proposed jury instruction. As a result, the record is “critically deficient of that minimum quantity of evidence” from which a jury might find Janssen liable under the state FCAs … Accordingly, the Court will grant judgment as a matter of law to Janssen on Relators’ state law claims, and will vacate the jury’s award of $30,001,184 to the States under the state FCAs.
To be clear, whether or not Relators carried their burden of proof under the state law claims has no bearing on the jury’s finding of liability and damages under the federal FCA. In assessing Janssen’s liability under the federal FCA, the jury independently determined that Janssen had caused the submission of 159,574 claims to the Government, and that the United States suffered $120,004,736 as a result of these violations … Accordingly, the damages the jury awarded to the States under the state FCAs is wholly severable from the damages the jury independently awarded to the United States under the federal FCA.
Here, because the Government did not receive any tangible or measurable benefit from Janssen’s conduct, the Court finds that the proper measure of damages is the full amount the Government paid for the false claims, and that the Court did not err in instructing the jury on this measure of damages.
In light of the numerous challenges raised regarding Relators’ proffered evidence of damages, “it was within the jury’s realm, as the finder of the facts, to reject []the extreme figures proffered by the litigants as incredible and substitute an intermediate figure as a matter of its judgment from all of the evidence … Mindful of its role to be “deferential to a jury’s damages verdict,” the Court finds that there was a reasonable basis from which the jury could conclude that Janssen caused the submission of 159,574 false claims in violation of the federal FCA, and that the Government sustained $120,004,736 in damages as a result.
After reviewing the evidence in full, the Court cannot conclude that the jury’s verdict was against the great weight of the evidence on the FCA claim. On the state law claims in which the Court is overturning the jury’s verdict and finding that judgment as a matter of law should be granted in favor of Janssen, a new trial is not warranted because the Court’s decision effectively resolves these issues.
Under the FCA, a defendant is liable for “3 times the amount of damages which the Government sustains because of the [defendant’s] act.” 31 U.S.C. § 3729(a)(1) … The jury found that the Government suffered $120,004,736 in damages as a result of Janssen’s conduct. As such, the Court will enter judgment in the amount of $360,014,208 against Janssen.
In addition to compensatory damages, the FCA requires that the Court assess civil penalties against Janssen based on the number of false claims that they submitted. Under the FCA, the Court must assess a fine between $5,500 and $11,000 per false claim … The facts in the record support a civil penalty near the middle of the statutory range of $5,500 and $11,000. The Court is convinced that Janssen engaged in a deliberate and calculated scheme that spanned several years and involved the unlawful marketing of its products. The evidence at trial also demonstrated that Janssen was aware of the seriousness of its conduct, and entered into at least three agreements with the Government in the past to resolve allegations related to OL marketing of other drugs … While the need for deterrence, possible recidivism, Janssen’s evidenced pattern of misconduct, and its refusal to accept responsibility counsel in favor of the Court imposing a higher civil penalty, the lack of evidence regarding patient harm and general fairness principles counsel against the Court imposing the maximum penalty.
[T]he Court finds that a penalty near the middle of the statutory range both reflects the seriousness of the offense, and is not so grossly disproportionate to the jury’s finding of actual damages that it would constitute excessive punishment or a breach of due process under the U.S. Constitution … The Court thus imposes a fine of $8,000 for each false claim under the FCA. Such a penalty would amount to over ten times the actual damages suffered by the Government, which the Court finds adequately serves Relators’ interests and reflects the seriousness of the offense without being unfair to Janssen … The jury found 159,574 false claims. As such, the Court will award $1,276,592,000 in civil penalties.
Source United States of America, et al. v. Johnson & Johnson, et al., No. 3:2012cv07758.
If you have information regarding false claims having been submitted to Medicare, Medicaid, TRICARE, other federal health care programs, or to other federal agencies/programs by a drug company, and the information is not publicly known and no actions have been taken by the government with regard to recovering the false claims, you should promptly consult with a False Claims Act attorney (also known as qui tam attorneys) in your U.S. state who may investigate the basis of your False Claims Act allegations and who may also assist you in bringing a qui tam lawsuit on behalf of the United States, if appropriate, for which you may be entitled to receive a portion of the recovery received by the U.S. government.
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