Dallas commercial litigation boutique Reese Marketos has obtained a $150 million jury verdict against Janssen Products over its off-label marketing of HIV drugs.
The federal jury in New Jersey found Janssen Products violated the federal False Claims Act by unlawfully promoting Prezista or Intelence.
The jury of eight people heard five and a half weeks of testimony and deliberated two days before delivering its verdict Thursday. The trial began May 6 before U.S. District Judge Zahid N. Quraishi.
Under federal FCA law, the judgment could be trebled, firm partner Pete Marketos said. Jurors also found that Janssen submitted 159,574 false federal claims to Medicare and Medicaid. Each claim has a statutory penalty of at least $5,500 per claim, Marketos said, which adds up to $877,657,000 in penalties.
In total, the company could be on the hook for more than $1 billion.
But the jury found Janssen did not violate the Anti-Kickback Statute. Plaintiffs had accused Janssen of using a nationwide speaker program as an unlawful kickback scheme in which the company would pay doctors to promote the drugs.
The company issued a statement Friday morning vowing to appeal:
“The jury has correctly rejected the claims relating to Janssen’s speaker bureau for PREZISTA® and INTELENCE® and the majority of the claims related to the marketing of PREZISTA® and INTELENCE®. We continue to believe that Janssen’s marketing and promotion of these life-saving medications has always been consistent with the FDA approved labels. The decision on the promotional claims is predicated on a clearly erroneous jury instruction that is contrary to the law and we are confident will be reversed on appeal.”
The lawsuit was first filed in 2012 by Philadelphia firm Berger & Montague, which brought in Reese Marketos two years ago.
Plaintiffs accused Janssen, whose parent company is Johnson & Johnson, of falsely advertising from 2006 through 2014 that its Prezista drug would not affect a user’s cholesterol or triglyceride levels, according to the lawsuit. The drug’s FDA-approved label, however, listed high cholesterol and triglycerides as well as increased “bad” cholesterol as adverse drug effects, the lawsuit states.
“The misleading promotion … is significant because heart disease caused by high cholesterol and triglycerides is a real safety threat and concern for HIV/AIDS patients,” the lawsuit states. “Heart disease is one of the leading causes of death for HIV/AIDS patients.”
The company also provided false and misleading promotions of Intelence between 2008 and 2014, the lawsuit contends. Janssen marketed Intelence as safe and effective for once-a-day use and for patients who had not previously consumed ARV medications, but the FDA-approved label instructed twice-daily dosage and for patients who had previously taken ARV medications, according to the lawsuit.
The plaintiffs’ team included Marketos, Josh Russ, Andrew Wirmani, Adam Sanderson and Whitney Wendel.
Janssen was represented by Allison Brown of Skadden, Arps, Slate, Meagher & Flom. The case is 3:12-cv-07758 U.S.A. ex rel v. Johnson & Johnson et al.