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9/4/2012 4:22:00 AM
Wisconsin to receive $4.7 million in Risperdal case
Lawsuit says Janssen deceptively marketed drug for non-FDA approved uses

Richard Moore
Investigative Reporter


Wisconsin has joined 36 other states in settling a case with Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, for deceptively marketing the drug Risperdal.

According to the settlement, Janssen will pay the states a record $200 million. Wisconsin’s share will be $4,267,876.

Wisconsin attorney general J.B. Van Hollen said the record settlement was  part of the largest multi-state consumer protection settlement with a pharmaceutical company so far.  

The states alleged that Janssen improperly marketed the antipsychotic drugs Risperdal, Risperdal Consta, Risperdal M-Tab and Invega. Specifically, the complaint alleges that Janssen engaged in unfair and deceptive practices when it marketed the drugs for unapproved or so-called off-label uses.  Risperdal is among a class of drugs known as atypical or second generation antipsychotics.  

“This settlement sends a strong message that the state of Wisconsin will not tolerate the masking, withholding, or failure to disclose negative information contained in scientific studies concerning the safety and efficacy of a drug,” Van Hollen said. 

Federal law prohibits pharmaceutical companies from promoting their products for off-label uses, though physicians may prescribe drugs for those uses. The complaint alleged that Janssen promoted Risperdal for off-label uses to both geriatric and pediatric populations, targeting patients with Alzheimer’s disease, dementia, depression, and anxiety, when those uses were not FDA-approved and for which Janssen had not established that Risperdal was safe and effective.  

“Deceptive marketing in the sale of pharmaceuticals is unlawful,” Van Hollen said. “And this action and settlement make clear that Wisconsin will pursue pharmaceutical companies that misrepresent the risks and efficacy of the drugs they market.”

 

The history

The settlement grows out of lawsuits that had been filed as early as 2007. In particular, those lawsuits alleged, Janssen aggressively marketed the drug for a variety of non-FDA approved disorders, often with catastrophic results.

By 2007, Risperdal was the world’s 10th best-selling drug with $4.7 billion in sales, even though schizophrenia, bipolar disorder, and autism-related behavioral problems – the only approved treatment uses of the drug – affected less than 4 percent of the population combined, according to the National Institute of Mental Health.

By then, however, as The Lakeland Times reported in a series of stories in 2009, problems with the drug’s off-label use were gaining attention in a number of states, ranging from Pennsylvania to Texas to South Carolina

Officials in those states said few of the company claims were legitimate, that Janssen in particular rigged clinical trials to attain the results it wanted and subsequently misled the medical community as well as various state officials.

The drug itself was associated with increased risks of Parkinson’s-like symptoms and other movement disorders known as EPS, of cardiovascular disease and of the onset of diabetes. It was also linked to neuroleptic malignant syndrome, a potentially fatal condition involving muscle rigidity, and tardive dyskinesia, a disorder that induces repetitive, involuntary movements such as tongue pumping, lip smacking, and rapid blinking.

In addition, a 2002 study found an increased risk of stroke among the elderly taking Risperdal. In two of four clinical trials, a higher incidence of stroke was seen among participants taking Risperdal than in those groups taking a placebo, with a stroke rate among those taking Risperdal double that of the placebo groups for all four trials averaged. The four studies included 1,200 subjects.

Health Canada and Janssen-Ortho subsequently warned Canadian physicians of a possible link between Risperdal and stroke in 2002. The federal Food & Drug Administration issued a warning in 2003.

The FDA also issued a black-box warning for Risperdal and other atypicals in 2005 after 15 out of 17 clinical trials showed increased morbidity among elderly patients with dementia after being treated with antipsychotics.

Children, too, turned out to be a vulnerable population.

According to a November 2008 report in the New York Times, from 1993 through the first three months of 2008, 1,207 children given Risperdal suffered serious problems, and 31 died. The deaths included a nine-year-old with attention deficit troubles; the child had a fatal stroke 12 days after beginning Risperdal, the Times reported.

The pharmaceutical companies dismissed the claims and said any risks are well labeled.

Now, with this settlement, Van Hollen says Janssen has agreed to change how it promotes and markets its atypical antipsychotics, and it has agreed to refrain from any false, misleading or deceptive promotion of the drugs. In addition to the record-setting payment, the settlement targets specific concerns identified in the investigation.  

For example, the settlement agreement restricts Janssen from promoting its atypical antipsychotic drugs for “off-label” uses that the U.S. Food and Drug Administration has not approved. Additionally, for a five-year period, Janssen: 

• Must clearly and conspicuously disclose, in promotional materials for atypical antipsychotic products, the specific risks identified in the black-box warning on its product labels;

• Must present information about effectiveness and risk in a balanced manner in its promotional materials;

• Shall not promote its atypical antipsychotics using selected symptoms of the FDA-approved diagnoses unless certain disclosures are made regarding the approved diagnoses;

• Shall require its scientifically trained personnel, rather that its sales and marketing personnel, to develop the medical content of scientific communications to address requests for information from health care providers regarding Janssen’s atypical antipsychotics;

• Must refrain from providing samples of its atypical antipsychotics to health care providers whose clinical practices are inconsistent with the FDA-approved labeling of those atypical antipsychotics; 

• Must not use grants to promote its atypical antipsychotics nor condition medical education funding on Janssen’s approval of speakers or program content; 

• Must contractually require medical education providers to disclose Janssen’s financial support of their programs and any financial relationship with faculty and speakers; and 

• Must have policies in place to ensure that financial incentives are not given to marketing and sales personnel that encourage or reward off-label marketing. 

Richard Moore may be reached at richardmoore.gov@gmail.com





Reader Comments

Posted: Thursday, September 6, 2012
Article comment by: Lisa MaKarrall

I sent this article and my comments to CANHR (California Advocates for Nursing Home Reform) who I've been in constant contact with since this nightmare began. I was told that the Federal Dept of Justice is getting ready to announce a $2 billion settlement from Janssen.
So, may I suggest that when Mr. Van Hollen again announces Wisconsin's share that the Federal Government worked for, that the state use a few dollars of it to have the Wisconsin Medicaid Approved Drug List changed....I think that should cover the five minutes of time it would take an employee at the Dept of Medicare/Medicaid to change it.
May I also suggest what was discussed with Senator Kohl and at the hearing...that some of the money from that settlement be used to train nursing home staff to recognize the side effects of these drugs, which is still not a requirement in this state....again after almost four years and again when the Power's That Be have known this was a problem for all this time.
And may I suggest watching the hearing held in November and online under Senator Kohl's website. Lot's of great ideas from experts in this field who have been sending these warnings for years (years before my calls and letters to your office, and years before the Lakeland Times articles) but have been ignored...I know how they feel. I know the top dogs at the DHS watched it....and again obviously nothing has changed.
Don't worry about the Medication Consent Forms, at least in Wisconsin....I changed that with the help of the Lakeland Times, State Senator Jim Holperin and Representative Dan Meyer....we would have worked on the other issues except all hell broke loose at the Capital and my bipartisan team blew up.
But now, Mr Van Hollen, after 3, 1/2 years, you are sending a strong message that the state of Wisconsin will not tolerate the masking, withholding, or failure to disclose negative information contained in scientific studies concerning the safety and efficacy of a drug.
So would it be too much to ask that you take care of the training issues and preferred drug list? That would send a strong message to me that you care about the elderly in this state. Better late than never!!!


Posted: Tuesday, September 4, 2012
Article comment by: Lisa MaKarrall

J.B. Van Hollen's office has known the elderly in Wisconsin have been dying from Risperdal for over three years now and I have a letter from his office to prove it. I'm not impressed that they jumped on the band wagon with other states. Risperdal is on the Wisconsin Medicaid Preferred Drug List "without restrictions" to this day, just like it was four years ago.
The letter I received from his office dated June 18th, 2009, stated that they were aware of the Moore investigation ( Lakeland Times Articles) and were also aware that other states were looking into the improper use of the drug.
It also stated quote, "We have no control over the operational activities of the DHS and how it handles investigations, it is a separate state agency and responsible for the operations of the Medicaid Program. Of course we also have no control over press treatment of the issues you raise. Many of your comments, (which would be asking them what the hell they were doing about the murders in Wisconsin and getting the drug off the Medicaid list) would be characterized as editorial and we express no opinion on them."
Signed,
Thomas Storm, Assistant Attorney General, DIRECTOR, MEDICAID FRAUD CONTROL UNIT.
I guess Risperdal being on the Medicaid Preferred Drug List "without restrictions" doesn't count as fraud or worth the bother changing. At least adding the restrictions listed above would have been a step in the right direction, since they were well known at that time. That is out of the Attorney General's power?
Senator Kohl is currently working on medication consent forms legislation, similar to what we got passed in Wisconsin, for nationwide use. We hope to hear this month if it passes. He held hearings in Washington last November which raised many issues that after almost four years are still ALL issues in Wisconsin. And believe me, everyone that has the power to change things knows it.
It certainly would have been nice to have the help or even a little support from J.B. almost four years ago. I begged his office several times for help after my Dad was murdered at a local nursing home by Risperdal. (Which is what spurred Richard Moore's investigation in the first place). I wonder how many people in this state have died since.
If there is proof that his office started an investigation into this matter back in 2009, or before they jumped on the other state's bandwagon, I'd love to see it. Since it's still on the drug list, I'm thinking not.
“This settlement sends a strong message that the state of Wisconsin will not tolerate the masking, withholding, or failure to disclose negative information contained in scientific studies concerning the safety and efficacy of a drug,” Van Hollen said.
All I can say Mr. Van Hollen, is I wish I would have heard that 3, 1/2 years ago.
Here is the listing of drugs Mr. Van Hollen, dated this month. You will notice the big P next to Risperdone which stands for "Preferred". The same as it was May 19th, 2009, when you received my last coorespondence.
https://www.forwardhealth.wi.gov/WIPortal/Tab/42/icscontent/provider/medicaid/pharmacy/resources.htm.spage






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