J&J to seek appeal of $150M verdict in long-spanning HIV meds off-label marketing case

A whistleblower case dating back to 2012 culminated in a $150 million guilty verdict for Johnson & Johnson after a New Jersey jury determined that the company stepped on the federal False Claims Act as well as that of many states with misleading promotions of its HIV meds Prezista and Intelence.

More specifically, the jury decided that J&J caused submissions of a grand total of 159,574 false claims across the governments involved.

J&J’s Janssen arm, which has recently been rebranded as J&J Innovative Medicine, was initially accused of engaging in off-label marketing in a case that expanded to include several states and Washington, D.C.

Twelve years later, the company has now been ordered to pay $120 million for federal allegations and $30 million for violating the state’s respective False Claims Acts.

The drugmaker will now seek an appeal, a spokesperson said in an emailed statement.

“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 Janssen spokesperson said. “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 122-page amended complaint filed in 2017, Janssen was slammed for misleadingly promoting Prezista as “lipid-neutral” from 2006 to 2014. That makes for a potentially dangerous contradiction from the drug’s FDA-approved label, which points to a “significant negative effect” on lipids.

J&J’s sales reps also made claims starting in 2007 regarding Prezista’s purported superior “binding affinity,” a statement backed by a study that wasn’t included in the FDA’s labeling and is of “limited scientific value,” the complaint alleged.

The company was further accused of off-label promotion in a similar timeframe by claiming its Intelence was safe and effective for once-daily dosing and in treatment-naïve patients, both of which directly contradict with the drug’s approval as a twice-daily therapy for treatment-experienced patients.

While the case also included illegal kickback allegations, the jury ultimately decided that Janssen was not guilty in that vein.

The Big Pharma has been accused of other False Claims Act violations before. In 2013, the company agreed to pay more than $2.2 billion to settle litigation tied to off-label promotion of its schizophrenia treatments Risperdal and Invega plus heart failure med Natrecor. That case also included kickback damages and was at the time one of the largest healthcare fraud settlements in U.S. history, the Department of Justice said at the time.

These days, J&J is busy with a long-spanning legal saga relating to alleged cancer links to its talcum-based powders. Most recently, the drugmaker was accused of using a series of “fraudulent maneuvers” to avoid paying compensation to cancer victims and their families.