Cherokee Nation faces Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, in Oklahoma state court over Risperdal’s dangerous side effects. A judge ruled in April 2016 to keep the Cherokee Risperdal case in Oklahoma, despite Janssen’s federal court request. U.S. District Judge James H. Payne ruled the federal court lacked proper jurisdiction in this case. Now the Cherokee Risperdal case continues, as they seek restitution for damages caused by Janssen’s wrongful marketing of Risperdal.
Cherokee Nation says they purchased the drug believing it was safe for elderly patients with dementia. They seek financial restitution for money spent between March 3, 2002, and December 31, 2003. On the surface, there’s nothing remarkable about this case. It’s a fairly standard plaintiff-sues-corporation-for-negligence lawsuit. But when it comes to J&J’s off-label marketing of Risperdal to the elderly, the Cherokee Nation’s case is quite compelling.
Cherokee Risperdal Case Timeline
In 1994, Janssen submitted promotional materials to the FDA trying to widen Risperdal’s market. These materials encouraged doctors treating the elderly to prescribe Risperdal for off-label uses. If Risperdal treats schizophrenia, the marketing materials suggested, it could also help elderly patients with dementia and other “behavioral disorders.”
The FDA denied Janssen’s off-label campaign. FDA regulators said, “It would be misleading to suggest that the safety and efficacy of Risperdal has been established in the elderly.” When Janssen again proposed the FDA conduct elderly patient studies to expand Risperdal’s market in 1995, they refused.
After Janssen submitted their Risperdal-for-seniors marketing materials, Dr. Paul Leber of the FDA weighed in. Dr. Leber said they targeted “behavioral disturbances in demented patients would also encompass a range of other clinical findings”—including anxiety, depression, agitation, aggressiveness, wandering, etc.—“that would not necessarily be considered psychotic manifestations.” In other words, Janssen didn’t make a logical (or even medical) leap from Risperdal’s antipsychosis indication to behavioral treatment. Risperdal simply wasn’t intended to treat those types of conditions.
But there’s a loophole: While the FDA has jurisdiction over drug manufacturers, they cannot control which individual drugs doctors prescribe to patients. Knowing this, Janssen began to promote the drug for off-label use in the elderly directly to doctors.
That explains why the Cherokee Nation believed it was safe for treating patients with dementia.
How Off-Label Promotion Happens
If a drug is not approved by the FDA for a specific use, it cannot state anywhere on the label that it is safe or effective for that use. These regulations are put in place to protect patients from therapies when there is little or no evidence to support that use. However, doctors can prescribe drugs off-label, meaning for a use outside of the intended or approved by the FDA.
The Cherokee Nation cannot claim that Janssen explicitly states Risperdal was safe for dementia patients. But they can claim that Janssen promoted Risperdal off-label for this use. And according to substantial evidence, that is exactly what they did.
In 1998, Janssen launched a new sales campaign pitching directly to doctors with patients in the drug’s off-label market. Their primary market, according to Janssen’s internal budgets and sales plans, were geriatricians and pediatricians.
Notes from sales representatives who visited doctors say they discussed Risperdal’s use specifically for geriatric patients suffering from dementia.
The Dangers of Risperdal for the Elderly
The FDA specifically told Janssen marketing Risperdal as safe and effective for elderly patients was misleading. This is due in part to insufficient research conducted on that patient population. But by 2000, scientists published a study on how several antipsychotic drugs affect elderly patients. Further, the study specifically mentions Risperdal. The study states, “The results indicated that although risperidone is effective for treatment of agitation in elderly patients with dementia, adverse extrapyramidal or cognitive effects may occur even with low doses.”
Elderly patients are more sensitive to the drug’s effects and prone to age-related liver, kidney, or heart problems. The Mayo Clinic states, “This medicine should not be used for behavioral problems in older adults with dementia.”
In 2005, the FDA released a black box warning (the strongest statement they have) regarding Risperdal and its uses for the elderly. In it, they reveal a study they conducted, showing that those who took Risperdal for dementia-related behavioral disorders had a higher risk of death compared to those who took a placebo. “Although the causes of death were varied,” their report states, “Most of the deaths appeared to be either cardiovascular (e.g. heart failure, sudden death) or infectious (e.g. pneumonia) in nature.” The drug has also been linked to strokes and diabetes in elderly patients, another claim made against the drug giant in the Cherokee Risperdal case.
As part of their black box warning, the FDA ordered Janssen to include a package insert describing this risk. Additionally, they noted Risperdal isn’t approved for use in elderly patients with dementia.
Current Status of Cherokee Risperdal Case
While the Cherokee Nation case is ongoing, similar Risperdal allegations against Janssen were already settled. The most noteworthy settlement to date occurred in 2012. Janssen paid $181 million to resolve claims it improperly marketed Risperdal for uses not approved by the FDA.
“This landmark settlement holds the companies accountable for practices that put patients in danger,” New York Attorney General Eric Schneiderman said.
Filing Your Own Drug Injury Risperdal Case
If you or a loved one suffered severe side effects while taking Risperdal, you may be entitled to compensation. Risperdal lawsuits are being filed across the nation as thousands seek restitution for the damages Risperdal and Janssen’s illegal marketing practices have caused. Get a free case evaluation today to see if you may qualify.
Lori Polemenakos is Director of Consumer Content and SEO strategist for LeadingResponse, a legal marketing company. An award-winning journalist, writer and editor based in Dallas, Texas, she's produced articles for major brands such as Match.com, Yahoo!, MSN, AOL, Xfinity, Mail.com, and edited several published books. Since 2016, she's published hundreds of articles about Social Security disability, workers' compensation, veterans' benefits, personal injury, mass tort, auto accident claims, bankruptcy, employment law and other related legal issues.