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 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 email@example.com