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June 17, 2024 News

In Berger Montague Whistleblower Case, Janssen Found Liable for Illegal Off-Label Promotion and Marketing of Two HIV/AIDS-Treatment Drugs – Judgment Could Exceed $1B

Philadelphia, PA. – Berger Montague PC is pleased to announce that on June 13, 2024, a jury unanimously found Johnson & Johnson subsidiary Janssen Products, LP liable for illegal off-label promotion and marketing of two of its HIV/AIDS-treatment drugs, in violation of the federal False Claims Act and state False Claims Acts. The jury of eight unanimously agreed that Janssen was responsible for defrauding Medicare, Medicaid and the AIDS Drug Assistance Program. The jury found that Janssen caused 159,574 false claims for reimbursement to be submitted to the government for its drugs, Prezista and Intelence, and awarded single damages of $120,004,736 on the federal False Claims Act violations and $30,001,184 on the state False Claims Act violations. The False Claims Acts provide for mandatory trebling of damages and the imposition of civil penalties ranging from $5,500-$11,000 per false claim. Once finalized, the total judgment against Janssen will likely exceed $1 billion, after a final determination by the Court. This judgment will represent one of the largest False Claims Act jury verdicts in history.

The historic jury verdict is the culmination of over a decade’s long battle against the billion-dollar pharmaceutical company Janssen. In 2012, Berger Montague, on behalf of its two whistleblower-clients, Jessica Penelow and Christine Brancaccio, filed the case United States ex rel. Penelow v. Janssen Products, LP, Civil A. No. 12-07758 in the District of New Jersey. The False Claims Act allows private citizen whistleblowers (known as “Relators” under the law) to bring claims on behalf of the government when the government is defrauded. The government declined to intervene in the case. However, as is permitted under the law, Relators and their attorneys decided to litigate on their own.

According to Sherrie R. Savett, Chair of the False Claims Act, Qui Tam & Whistleblower Department at Berger Montague, “We believed in our clients and their serious allegations of fraud, and we were willing to devote significant resources over the years to the litigation of this case and eventual trial, even without the direct involvement of the government. We defeated Janssen’s motion to dismiss the case in 2017, defeated its motion for summary judgment in 2021, and ultimately prevailed at trial.”

The jury trial commenced on May 6th in the United States Court for the District of New Jersey in Trenton before the Honorable Zahid N. Quraishi. Berger Montague’s Sherrie Savett, Joy Clairmont, Michael Fantini and William Ellerbe partnered with lead trial counsel Pete Marketos, Josh Russ, Andrew Wirmani, Adam Sanderson and Whitney Wendel from Reese Marketos LLP of Dallas, Texas.

During trial, Relators presented substantial evidence of a nationwide scheme carried out by Janssen from 2006 through 2014 to market and promote Prezista and Intelence off-label, for uses not approved as safe and effective by the Food and Drug Administration (FDA) and for uses not medically reasonable and necessary. Relators, who worked as sales representatives at Janssen, as well as five other former Janssen employees, testified that the management of the company orchestrated the scheme to promote the drugs off-label in order to increase sales of the two drugs that had limited FDA-approved indications. 

Berger Montague partner, Joy Clairmont, commented, “It has been a long and difficult process for our courageous whistleblower clients, and we are thrilled to finally see their claims against Janssen vindicated at trial.” 

If you are a whistleblower seeking representation concerning a potential qui tam / whistleblower / False Claims Act case, please contact Berger Montague.

About Berger Montague

Berger Montague is a national law firm focusing on complex civil litigation in federal and state courts throughout the United States. For over half a century, Berger Montague has played lead roles in consequential, precedent-setting cases and has recovered over $60 billion for its clients and the classes they have represented. Berger Montague is headquartered in Philadelphia and has offices in Chicago, Minneapolis, San Diego, San Francisco, Toronto, Wilmington, Del., and Washington, D.C.

Contact: Sherrie R. Savett, 267-979-8995, [email protected].

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