United States Of America Et Al V. Johnson & Johnson Et Al

Parties Involved

  • Plaintiff(s): Jessica Penelow | Christine Brancaccio | United States of America

 

  • Defendant(s): Johnson & Johnson | Janssen Products, L.P. | Johnson & Johnson
    • Counsel for Defendants: Melissa Anne Chuderewicz | Ronni E. Fuchs | Allison Brown | Brian M. Nichilo | Jason John Moreira | Logan Nicholas Anderson
    • Experts for Defendant(s): Jon Smollen |  Dr. Anupam Jena | Dr. Eric S. Rosenberg

Verdict Information

  • Verdict Date: June 13, 2024
  • Total damages awarded to Plaintiff: $150,206,380.00
    • False Claims Violations: $120,204,796.00
    • Violation of State False Claims Act: $30,001,584.00

About the Case

Cause

J&J and its subsidiary Janssen Products were accused of illegal off-label marketing of two antiretroviral drugs, Prezista (darunavir) and Intelence (etravirine), used in the treatment of HIV/AIDS. This case was particularly significant given J&J’s history of prior misconduct involving off-label promotion of other drugs like Risperdal, Topamax, and Natrecor.

The company allegedly delivered misleading messages about these drugs during sales calls, dinner programs, and speaker events nationwide. For Prezista, J&J’s sales representatives and managers routinely promoted the drug as “lipid-neutral” starting in 2006, directly contradicting its FDA-approved label, which warned of increased cholesterol and triglycerides as side effects.

Additionally, beginning around February 2007, J&J made unsupported claims about Prezista’s superiority, efficacy, and potency based on its purported “binding affinity.” These claims were based on a clinical study conducted by J&J’s subsidiary Tibotec, which the FDA had previously deemed inadequate and instructed J&J to remove from promotional materials.

Regarding Intelence, the defendants promoted once-daily dosing starting in 2008, despite the FDA-approved label explicitly requiring twice-daily administration. This off-label promotion continued through the time of the complaint.

J&J allegedly paid kickbacks to speakers at promotional events based on the market share of their drugs, violating anti-kickback laws. Speakers with a high market share received larger payments (up to $2,500 per program compared to $2,000), while those with low share risked dismissal from the speaker bureau.

The document cited Dr. Donald Kaminsky, a physician practicing in Manhattan, as an example. Dr. Kaminsky stated he relied on these payments for his mortgage and was willing to deliver J&J’s desired messages, even if off-label. This highlighted the material nature of these kickbacks to doctors involved in the scheme.

Injury

The off-label marketing practices potentially compromised patient health and safety in several ways. Promoting Prezista as “lipid-neutral” could have misled physicians about its side effects, posing a significant risk to HIV/AIDS patients who are already at higher risk for heart disease. This misinformation might have led to inappropriate prescribing decisions, potentially exacerbating cardiovascular risks in an already vulnerable patient population.

The improper promotion of Intelence’s dosing regimen (once-daily instead of the approved twice-daily) could have led to suboptimal drug levels in patients’ bloodstreams. This misuse could potentially result in increased viral load, weakened drug efficacy, and the development of drug-resistant HIV strains. Such outcomes could significantly compromise the long-term treatment success and overall health of HIV/AIDS patients.

The off-label marketing and kickback schemes allegedly caused physicians to prescribe the drugs inappropriately, leading to government reimbursement for uses not approved by the FDA. This violated both Federal and State False Claims Acts and the federal Anti-Kickback Statute. The practices misled doctors and increased J&J’s profits at the expense of government healthcare programs, as a significant percentage of HIV/AIDS patients rely on Medicare/Medicaid for their treatment.

The defendants’ actions resulted in numerous tainted claims being submitted for reimbursement, potentially causing substantial financial harm to government healthcare programs. This misuse of public funds could have far-reaching consequences, potentially limiting resources available for other necessary medical treatments and services.

Moreover, these practices compromised the integrity of medical decision-making in HIV/AIDS treatment. By influencing physicians through financial incentives and misleading information, J&J potentially interfered with the doctor-patient relationship and the principle of informed consent. Patients may have been prescribed treatments based on distorted information rather than purely on medical necessity and scientifically validated data.

Damages

The Relator demanded judgment in favor of the United States and Plaintiff States against the Defendants, seeking maximum damages and appropriate relief for each count. Under the Federal False Claims Act, they sought triple damages plus civil penalties ranging from $5,500 to $11,000 per false claim. The request also included maximum damages and penalties allowed under relevant state statutes and State False Claims Acts. Additionally, the Relator asked for the maximum permitted share of any proceeds or settlement from the action, along with reasonable expenses, attorneys’ fees, and costs. The Relator requested that their award be calculated based on the total value recovered, including amounts from parties not directly involved in the lawsuit.

Jury Verdict

The jury found Janssen violated the federal False Claims Act by unlawfully promoting Prezista and Intelence. They determined that Janssen’s actions resulted in 1,529,584 false claims being submitted. The jury awarded damages of $120,204,796.00 to the United States for these False Claims Act violations. Additionally, the jury found that the States sustained damages of $30,001,584.00 as a result of violations referenced in a previous question. The total damages awarded in this case amounted to $150,206,380.00, combining the damages to the United States and the States.

Court Documents:

Available upon Request