Johnson & Johnson will have to pay fines totaling $1.2 billion after a judge refused to set aside an Arkansas jury's verdict that they had concealed risks associated with their drug Risperdal:
Judge Tim Fox ruled earlier this year that Janssen Pharmaceuticals Inc. and its parent company would have to pay $5,000 for each of the nearly 240,000 Risperdal prescriptions issued to state Medicaid patients over a 3 1/2-year period in addition to other fines.
Sources close to the negotiations say that Johnson & Johnson has agreed to pay $2.2 billion to end investigations into claims that it illegally marketed Risperdal and other drugs:
The settlement, which might be announced this week, will include a misdemeanor plea and criminal penalty of as much as $600 million, said the people, who didn’t want to be identified because they weren’t authorized to speak publicly about the agreement. The accord also would resolve civil claims that J&J paid kickbacks to Omnicare Inc. (OCR) (OCR), a company that dispenses drugs at nursing homes, the people said.
The agreement, which doesn’t end claims by some states, would be the government’s second-biggest settlement with a pharmaceutical company, behind a $2.3 billion pact Pfizer Inc. (PFE) (PFE) entered in 2009 to resolve U.S. investigations of improper marketing of its Bextra painkiller and other drugs.
“This is a gigantic settlement that reflects the seriousness of the criminal and civil allegations against J&J over Risperdal and the other drugs,” Carl Tobias, who teaches product-liability law at the University of Richmond law school, said in a phone interview.
Much more on Risperdal and autism here.
Maryanne Godboldo has filed a civil rights lawsuit after Child Protective Services removed her daughter Ariana forcibly and illegally from her care, allegedly because she took the girl off of Risperdal. Doctors put Ariana on the drug after she had what her mother calls "serious changes" after vaccinations.
Maryanne says that Risperdal made her daughter sick. She stopped giving Ariana the medication:
So CPS presented a petition – filled with mistakes – to court staff, who signed off it and issued a child removal order. The law requires that a judge review these petitions – but that never happened.
CPS then used the flawed order to get Detroit Police to take Ariana.
Attorney David Robinson says when police first came to Godboldo’s door, they didn’t show her the order or a warrant. According to the lawsuit, she refused to hand over her daughter, so police used a crowbar to break in the side door. That’s when the officers said Godboldo fired a shot.
“They had no authority,” said Southfield attorney, David Robinson. “She did what any mother is supposed to do… and that is protect her child. And that’s what she did – she did so legally, she did so responsibly.”
What happened next made international headlines -- tanks and SWAT teams surrounded the home and a 10 hour standoff began.
“The helicopters, the sharp shooters, that did not bother me. I was terrified they would get their hands on my child, and do exactly what they did,” said Godboldo.
Shain Neumeier's second report for the Autistic Self Advocacy Network on Cheryl McCollins' lawsuit against the Judge Rotenberg Center includes an interesting discussion of the use of medication, particularly Risperdal:
Mr. O’Connor also touched on one of JRC’s most famous defenses of its use of aversives – the fact that the alternative would be psychotropic medication, which, according to the program, is far more harmful than the use of aversives. In particular, he focused on the side effects of the antipsychotic Risperdal, the only medication that Andre had been on prior to attending JRC… side effects that can include permanent neurological problems related to movement in the form of a condition called tardive dyskinesia. He also used the fact that psychotropic drug manufacturing companies put out promotional materials in an attempt to show that JRC’s promotional video, which the plaintiff had argued had misled her in her decision to place Andre at the facility, was, if not acceptable, than at least not out of the ordinary. Finally, O’Connor used the discussion of psychotropic medication to call into question Dr. Whaley’s qualifications to speak about the use of aversives. Medications, argued the attorney through his questioning, were what a psychiatrist such as Dr. Whaley used in his practice, and Dr. Whaley was not trained or experienced in the use of aversives such as those at the JRC. Dr. Whaley rebutted this, stating that prescribing medication was only part of what he did as a psychiatrist (which included using behavioral methods in counseling and prescribing a medication that served as an aversive to people with alcoholism), while still insisting that taking Andre off Risperdal while he was at JRC had been a “terrible idea.”
I have been very clear about my concerns regarding Risperdal and autism, but I want to be equally clear about this: medication is a better choice than torture.
Yesterday, a jury found that Johnson & Johnson had dishonestly downplayed the risk of their drug Risperdal in Arkansas:
Jurors in Little Rock yesterday said the company's marketing campaign also violated consumer-protection laws. The panel deliberated about three hours before finding J&J and its Janssen unit engaged in "false or deceptive acts" by sending a 2003 letter touting Risperdal as safer than competing drugs to more than 6,000 doctors across the state.
The state was seeking more than $1.25 billion in penalties over the Risperdal marketing campaign. It's the third jury verdict against J&J, the second-biggest maker of health products, in cases where states alleged it hid Risperdal's risks and tricked Medicaid regulators into paying more than they should have for the medicine. Louisiana and South Carolina juries also found the company's Risperdal marketing violated consumer-protection laws.
Today, a judge ordered the company to pay nearly $1.2 billion in fines:
In a verbal ruling from the bench, Circuit Judge Tim Fox held that Johnson & Johnson and its subsidiary Janssen Pharmaceuticals Inc. committed nearly 240,000 violations of the state's Medicaid fraud law — one for each Risperdal prescription issued to state Medicaid patients over a 3 1/2-year period. Each violation carried a $5,000 fine.
He also fined the companies $11 million for more than 4,500 violations of the state’s deceptive practices laws.
Never, ever forget that Peter Bell of Autism Speaks was once a marketing executive for Johnson & Johnson.
Read more about Risperdal, Autism, and why the combination scares me to death.