Janssen Liable for Illegal Promotion of HIV Drugs in Berger Montague Case, Judgment May Top $1B

PHILADELPHIA, June 17, 2024 /PRNewswire/ -- In a landmark decision on June 13, 2024, a jury found Janssen Products, LP, a subsidiary of Johnson & Johnson, guilty of illegal off-label promotion of two HIV/AIDS-treatment drugs, Prezista and Intelence. The jury concluded that Janssen had violated both federal and state False Claims Acts by promoting these drugs for uses not approved by the Food and Drug Administration (FDA) and not medically necessary, thus defrauding Medicare, Medicaid, and the AIDS Drug Assistance Program.

The jury's unanimous decision indicated that Janssen was responsible for the submission of 159,574 false claims for reimbursement to the government, resulting in an award of $120,004,736 in single damages for violations of the federal False Claims Act and $30,001,184 for state False Claims Act violations. Given the False Claims Act's provision for mandatory trebling of damages and civil penalties ranging from $5,500 to $11,000 per false claim, the total judgment against Janssen is expected to exceed $1 billion after the court's final determination. This case is poised to be one of the largest False Claims Act jury verdicts in history.

The case was initially filed in 2012 by Berger Montague on behalf of whistleblowers Jessica Penelow and Christine Brancaccio. Known as United States ex rel. Penelow v. Janssen Products, LP, Civil A. No. 12-07758, the suit was filed in the District of New Jersey. The False Claims Act empowers private citizens, termed "Relators," to sue on behalf of the government in cases of fraud. Although the government chose not to intervene, the Relators and their legal team pursued the case independently.

Sherrie R. Savett, Chair of the False Claims Act, Qui Tam & Whistleblower Department at Berger Montague, stated, "We had confidence in our clients and their serious allegations of fraud. Despite the government’s decision not to intervene, we committed substantial resources over the years to this litigation and eventual trial." The case overcame significant legal hurdles, including a motion to dismiss in 2017 and a motion for summary judgment in 2021, before finally prevailing at trial.

The jury trial began on May 6th in the United States Court for the District of New Jersey in Trenton and was presided over by the Honorable Zahid N. Quraishi. The legal team from Berger Montague, including Sherrie Savett, Joy Clairmont, Michael Fantini, and William Ellerbe, collaborated with lead trial counsel Pete Marketos, Josh Russ, Andrew Wirmani, Adam Sanderson, and Whitney Wendel from Reese Marketos LLP of Dallas, Texas.

During the trial, the whistleblowers presented substantial evidence of a nationwide scheme by Janssen from 2006 through 2014 to promote Prezista and Intelence for unapproved uses to boost sales. Testimonies from the whistleblowers, who previously worked as sales representatives at Janssen, along with five other former employees, revealed that the company’s management orchestrated this off-label marketing scheme.

Joy Clairmont, a partner at Berger Montague, remarked, "It has been a long and arduous journey for our brave whistleblower clients, and we are elated to see their claims against Janssen validated in court."

Berger Montague, headquartered in Philadelphia, is known for handling complex civil litigation in federal and state courts across the United States. Over the past 50 years, the firm has been involved in precedent-setting cases and has recovered more than $60 billion for its clients. The firm also has offices in Chicago, Minneapolis, San Diego, San Francisco, Toronto, Wilmington, DE, and Washington, D.C.