Two legal actions last week are focusing attention, once again, on pharmaceutical companies motivated by financial gain without regard for patient safety.
As reported by the New York Times, a court in Louisiana has ordered Takeda Pharmaceutical, a Japanese company, and its American partner to pay a combined $9 billion in punitive damages over Actos, a diabetes drug linked to bladder cancer.
In Arkansas, as explained on AboutLawsuits.com, the attorney general has asked the state’s Supreme Court to reconsider its ruling from last month overturning a $1.2 billion judgment against Johnson & Johnson concerning its antipsychotic drug, Risperdal.
The district court in Louisiana ordered Takeda to pay $6 billion in punitive damages after a jury found that the company had hidden the bladder cancer risks. The court also ordered Takeda’s U.S. partner, Eli Lilly, which marketed the drug in this country, to pay $3 billion. Takeda, of course, is planning to appeal.
In deliberating a lawsuit filed by a patient diagnosed with bladder cancer in 2011 after using Actos for seven years, the jury determined that Takeda became aware of links between Actos and bladder cancer more than a decade ago, but withheld that information from patients and doctors.
That was only one lawsuit of thousands filed against Takeda over Actos, which had been one of the company’s best-selling products, generating about $16 billion in U.S. sales since it was introduced in 1999.
Some European countries have banned Actos, and the FDA ordered that the drug’s labels include warnings about the increased risk of bladder cancer with long-term use of it.
J&J got into trouble over Risperdal for illegally marketing it. But in March, the Arkansas Supreme Court ruled that a state commission had incorrectly applied the Medical Fraud False Claims Act, and also that an FDA letter about the drug was improperly admitted as evidence at trial. So it overturned the judgment.
Now, the attorney general is requesting that the court reconsider because of breaches in legal procedure. He said the high court’s ruling was based on legal arguments that neither side had raised, and that one of the justices asked a key question during oral arguments. The court’s not allowed to raise an issue for the first time at that stage.
The procedural issues don’t absolve J&J, as indicated by the judgment of $1.2 billion in 2012 for marketing Risperdal for uses not approved by the FDA, and for minimizing the drug’s risks. Doctors may prescribe drugs for uses other than what the FDA approved, but the drug makers may not promote them for those “off-label” uses.
The illegal marketing led to the unwise use of Risperdal, for example, in nursing homes as chemical restraints. That’s not only abusive to residents, but can put dementia patients’ lives at risk.
As AboutLawsuits noted, the Risperdal damage award was only one of many state cases that resulted in verdicts of hundreds of millions of dollars against J&J over the drug.
Johnson & Johnson and its subsidiary, Janssen, have been sued in recent years because of other problems with the drug – namely, young males who were given the drug as children and who developed gynecomastia, which causes breast growth.
The complaints claim that the company did not warn consumers or practitioners about the risk of boys developing breasts, some of whom required breast removal surgery.