$8 billion Risperdal verdict? It’s not the money, it’s the message, Big Pharma

Risperdal-300x150When regular citizens get together in the civil justice system to deliberate difficult claims about complex matters, they may not get everything just right to the satisfaction of the disputing parties. But jurors’ wisdom and findings should not be taken lightly, especially by Big Pharma.

That’s why Johnson & Johnson — and other drug makers — may want to heed the message in a just-announced $8-billion verdict in a Philadelphia courtroom in a case involving a young Baltimore patient and Risperdal, a prescription antipsychotic medication.

It’s true that the whopping award to Nicholas Murray, now 26, likely will be reduced, probably substantially for J&J, a company that has built its brand on being “family friendly.”

What can’t be tamped down, though, is the outrage that jurors are unleashing on Big Pharma and its conduct, practices that lead them to believe that drug makers put profits far ahead of patients. And to declare, Enough is enough.

In the Pennsylvania case, the court originally found that J&J should compensate Murray a lesser amount — $680,000 — for actual damage he suffered when, at age 9, he was given Risperdal to help him sleep. That was not the use for the drug approved by the federal Food and Drug Administration after required testing.

But J&J, as other cases have shown, long had promoted without scientific evidence that Risperdal should be given “off label” to an array of patients, including youngsters with autism diagnoses and seniors who were “difficult” to control due to advancing dementia and Alzheimer’s.

The drug maker also knew, evidence has shown, that Risperdal potentially had an unhappy and even humiliating side effect when given to already appearance-wary young men: It caused them to grow breasts, a condition known as gynecomastia. These did not disappear if the drug was discontinued, instead, often requiring surgery as a remedy.

J&J declined before to settle with Murray, who earlier had won a $1.75 million negligence claim against the firm — an award later slashed to $680,000 on the company’s appeal. And, while J&J got reduced the compensation it owed, it fast found itself in a different wrangle with the young patient. That’s because courts changed their mind, reversing a decision that had barred claimants from seeking punitive damages. Those had been foreclosed to them because they were not allowed in J&J’s home state of New Jersey. Suddenly, J&J was subject to Pennsylvania jurors’ decision-making about potential dollar-amount punishment for its products and actions.

The company already might have known what was coming. That’s because no less than the U.S. Department of Justice had breathed the legal equivalent of dragon fire on the J&J subsidiary that was making billions off Risperdal, forcing the company into a $2.2 billion legal settlement on charges it improperly hustled the drug and harmed patients in doing so.

The U.S. Attorney General found the firm, without evidence, had paid doctors speaker fees and used other inducements to aggressively promote Risperdal, FDA approved for schizophrenia care, to treat autism and dementia. Nursing homes, with J&J largess, pumped thousands of seniors with the drug and others of its kind into residents, arguing the vulnerable and often frail elderly were noncompliant. They, instead, were turned into zombies with medication restraints.

Youngsters, like Murray, also became victims of off-label prescribing of antipsychotics — long one of the scandals of pediatric care. These drugs, which pack a giant wallop, especially for kids, had not undergone testing for the uses for which doctors prescribed them: The evidence was lacking that they wouldn’t harm children, and makers never showed how the drugs benefited youngsters. Still, in jaw-dropping fashion, doctors and institutions keep pushing the drugs on patients, some of whom are babies and infants.

J&J has adopted a hardline legal stance, battling lawsuits on multiple fronts and over several of its products. The company insists it abides by federal laws and has done no wrong. This includes with Risperdal. J&J lawyers have denounced the Pennsylvania verdict, saying it was far out of proportion to any harms shown. The company says Risperdal was an FDA-approved drug, and its labels carried due warnings about side-effects.

As the Washington Post reported, J&J is taking big hits in court with its take-no-prisoners approach to claims against it. Significant losses the firm has racked up this way include: a half-billion-dollar loss in Oklahoma in a state opioid damages suit; and a $4.7 billion defeat to 22 women in St. Louis who asserted that J&J baby powder caused their reproductive cancers. And now the Risperdal decision.

To be sure, J&J has backed down a bit in recent days, settling, for example, for $20.4 million its part of opioid suits in a big case in Ohio.

But legal experts quoted by the newspaper said Big Pharma is facing a wave of suits and public anger, which may be reversing a period in which drug maker litigation had lessened:

“The nonprofit watchdog group Public Citizen has tracked the number of criminal and civil settlements and court judgments against pharmaceutical companies for the past three decades, through 2017. Its figures show a strongly increasing trend until 2013, when they reached a peak of 60 in 2013. The number dropped off sharply in the next four years. In terms of dollars paid in penalties or damages over those decades, Johnson & Johnson ranked third at $2.9 billion in 20 settlements, behind GlaxoSmithKline ($8 billion in 32 settlements) and Pfizer ($4.7 billion in 34 settlements).”

The Philadelphia case may speak to increased peril for J&J, which has reported it has more than 13,000 Risperdal suits pending, with “hundreds” dismissed but others blackening the once respected J&J brand. Drug makers often have sought to bundle big numbers of suits like these and seek “global settlements,” as J&J reluctantly decided to do in opioid cases outside Oklahoma.

The twist in the Risperdal lawsuits, of course, traces to J&J’s top echelon, as the New York Times reported when the company settled with the Justice Department:

 “Much of the conduct highlighted in the case, which for Risperdal extends from 1999 through 2005, occurred while Alex Gorsky was vice president for sales and marketing and later president of the company’s pharmaceutical unit, Janssen. Mr. Gorsky became chief executive of Johnson & Johnson last year. Risperdal, which has lost its patent protection, was once one of the company’s best-selling drugs.”

Indeed, the antipsychotic has made by some estimates $40 billion for Janssen and J&J, a pharma titan with annual income of $71 billion. Cynics might regard J&J’s not insignificant legal expenses with Risperdal to be a sad cost of business.

In my practice, I see not only the harms that patients suffer while seeking medical services but also the damages that can be inflicted on them by dangerous drugs. It is bad enough when prescription medications prove to be confounding and bankrupting for the uncertain treatments for which they undergo FDA approval. It is unacceptable when Big Pharma uses sketchy tactics to promote meds for damaging off-label uses.

Though they spend decades of their lives in arduous study and labor to acquire medical expertise in hopes of helping patients, doctors have been shown to be sad, gullible marks for drug-peddling sharks. It isn’t just the speaker fees and conferences that can boost MDs earning. It’s the underhanded money flow and outright kickbacks. It’s the tawdry offerings like lap dances or the pizza, beer, and cheery chat that seems a petty way to get highly trained professionals to whip out their pads, dash off scripts — and put at peril patients, young and old, who may be most vulnerable and at risk. When will ethical professionals slap down the abuses in their ranks, and when will regulators step up, yet again, to put down Big Pharma profiteering at the expense of the public’s safety and well-being? We’ve got a lot of work to do on prescription drugs.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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