By David Carnes, Staff Writer
Risperdal (known generically as Risperidone) is a powerful anti-psychotic drug produced by Johnson & Johnson, the largest pharmaceutical company in the world. This drug is commonly used to treat:
- bipolar disorder
- schizoaffective disorder
- irritability (in autistic patients)
Risperdal has been the subject of frequent complaints over adverse reactions to off-label uses (uses not approved by the FDA). Common off-label uses of Risperdal include treatment for severe depression, obsessive-compulsive disorder and Tourette’s syndrome. Although doctors are free to prescribe pharmaceuticals for off-label uses as long as the off-label use does not violate medical ethics or FDA regulations, the pharmaceutical company’s marketing and sales staff may be required to warn of off-label risks, and may be prohibited from promoting off-label uses altogether.
The risks of using Risperdal include:
- weight gain
- adult-onset diabetes
- tardive dyskinesia
- neuroleptic malignant syndrome
- increased risk of death (in elderly patients with dementia)
- hormonal problems (in children)
To mitigate the latter two of these risks, the U.S. Food & Drug Administration (FDA) prohibited the marketing of Risperdal to two off-label groups: children and elderly people with dementia (except for elderly patients with the most severe psychoses). The U.S. Department of Justice concluded that Johnson & Johnson systematically violated this prohibition over a period of several years, resulting in serious health problems for children and the elderly users, as well as billions of dollars in revenue for Johnson & Johnson. According to the Department of Justice, Johnson & Johnson marketed Risperdal for off-label uses so aggressively that at one point more than half its sales were attributable to use by children and the elderly. The Justice Department concluded that Johnson & Johnson sales staff knowingly promoted Risperdal even to pediatricians who had no adult patients.
On February 24, 2015, a Philadelphia jury awarded a $2.5 million dollar judgment (under appeal) to an autistic patent who began growing size 46DD breasts at age 12 after a Johnson & Johnson salesperson failed to warn the boy’s physician of the dangers of off-label uses. This award was just the tip of the Risperdal iceberg, however -- Johnson & Johnson has privately settled an avalanche of claims with both victims and the Department of Justice over the off-label use of Risperdal, including criminal claims brought by the Department of Justice. The story is far from over, however – even though Johnson & Johnson has paid out nearly $3 billion in fines and settlement funds, it is still facing over 4,000 pending Risperdal lawsuits.
The “Cost of Doing Business” Mentality
Most of Johnson & Johnson’s customers would blanch at $3 billion in legal expenses. But what’s a paltry $3 billion to a corporate behemoth that enjoyed sales of over $74 billion in 2014? According to some pharmaceutical industry executives, it’s just a cost of doing business in the same category as federal taxes and R&D expenses. The “cost of doing business” mentality among Big Pharma executives is exactly why companies like Johnson & Johnson lack the incentive to comply with FDA regulations – sometimes it’s simply more profitable to break the law, make billions of dollars, pay the legal bills, pocket the change and laugh all the way to the bank.
The Department of Justice should regularly seek long prison sentences for Big Pharma executives who knowingly flout FDA regulations at public expense. Perhaps the prospect of a few years behind bars would encourage these people to think twice before writing off the legal consequences of their reckless behavior as a mere “cost of doing business”.
If you or someone you know has suffered adverse effects from the off-label use of Risperdal, search our directory for a qualified Risperdal attorney for a consultation on your case.