J&J Battles $150M Verdict Over Alleged HIV Meds Marketing Breach

In 2012, a whistleblower lawsuit concluded with Johnson & Johnson being found guilty and ordered to pay $150 million. A New Jersey jury determined that the company violated the federal False Claims Act and similar laws in multiple states by promoting its HIV medications Prezista and Intelence in a misleading manner. Specifically, the jury found that J&J caused 159,574 false claims to be submitted to various governments.

J&J's Janssen division, now known as J&J Innovative Medicine, faced initial accusations of off-label marketing in a case involving multiple states and Washington, D.C. Over a decade later, the company has been instructed to pay $120 million for federal charges and an additional $30 million for violating state False Claims Acts. A spokesperson mentioned that the drugmaker plans to appeal, as stated in an email.

A spokesperson from Janssen said, “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.”

In a revised complaint spanning 122 pages filed in 2017, Janssen faced criticism for misleadingly advertising Prezista as "lipid-neutral" between 2006 and 2014. This claim directly conflicts with the FDA-approved label, which indicates a "significant negative effect" on lipids. Additionally, J&J's sales representatives allegedly promoted Prezista from 2007 onward, asserting its superior "binding affinity" based on a study that wasn't included in the FDA's labelling and was deemed to have "limited scientific value," according to the complaint.

During a similar timeframe, the company was accused of promoting Intelence off-label by suggesting it was safe and effective for once-daily dosing and for treatment-naïve patients. These claims contradicted the drug's approved usage as a twice-daily therapy specifically for patients with prior treatment experience.

Previously, Big Pharma has faced allegations under the False Claims Act. In 2013, the company settled a lawsuit by agreeing to pay over $2.2 billion. This resolved claims related to the improper promotion of its schizophrenia drugs Risperdal and Invega for unapproved uses, as well as the heart failure medication Natrecor. The settlement, which also addressed kickback allegations, was one of the largest healthcare fraud deals in U.S. history at the time, according to the Department of Justice.

Currently, Johnson & Johnson is embroiled in an extensive legal battle over allegations linking its talcum-based powders to cancer. Most recently, the company has been accused of employing deceptive tactics to avoid compensating cancer victims and their families.