A Johnson & Johnson division has been slammed with a $1.64 billion penalty in a courtroom saga that cast a harsh spotlight on the pharmaceutical giant’s marketing of two HIV medications.
The ruling comes from a federal courtroom in Trenton, New Jersey, where U.S. District Judge Zahid Quraishi upheld a whistleblower suit that accused J&J’s Janssen unit of pushing its HIV drugs—Prezista and Intelence—beyond the scope of FDA approval. The judge ordered Janssen to cough up $360 million for violating the federal False Claims Act, and tacked on another $1.28 billion in civil fines—$8,000 for each of the 159,574 bogus claims funneled through government programs like Medicare, Medicaid, and the AIDS Drug Assistance Program.
The jury’s original $30 million award tied to state-level false claims violations? Tossed. The judge said the evidence just didn’t cut it.
Back in June 2024, a six-week trial ended with a jury siding—at least in part—with whistleblowers Jessica Penelow and Christine Brancaccio, former Janssen sales reps who claimed the company steered doctors toward off-label uses of the drugs. Among the questionable tactics? Marketing Prezista as “lipid-neutral,” implying it wouldn’t mess with cholesterol levels—something the FDA never backed. The duo also alleged that Janssen paid physicians through dinner programs and speaker gigs, which they said amounted to kickbacks. The jury, however, didn’t buy the kickback part.
Janssen tried to hit rewind, arguing that jury instructions were flawed and the case lacked proof. No dice.
In a lengthy opinion, Judge Quraishi wrote that Janssen’s off-label sales pitch “substantially influenced” doctors to bill federal programs—and that this outcome was “reasonably foreseeable” given how the drugs were pushed.
J&J, headquartered in New Brunswick, New Jersey, isn’t backing down. The company plans to appeal, insisting its drug promotions never strayed from what the FDA allowed. It claimed there was no solid evidence that its marketing misled doctors or led to false billing.
The $360 million in damages is triple the jury’s $120 million award, courtesy of the False Claims Act’s triple-damages clause. Under that law, whistleblowers who sue on behalf of the government can also pocket a share of the winnings—though just how much Penelow and Brancaccio will receive hasn’t been announced.
Their attorney praised the judge for factoring in what he called “years of egregious conduct” in determining the punishment.
The case—U.S. ex rel. Penelow et al v. Janssen Products LP—has become a landmark moment in the ongoing clash between Big Pharma and whistleblowers, with billions of taxpayer dollars and drug marketing ethics at stake.
