Johnson & Johnson Settles Off-Label Use Charges
Johnson & Johnson recently settled a long-running case regarding the company’s marketing of certain drugs for off-label uses. The pharmaceutical company, along with its subsidiary, Janssen Pharmaceuticals, will pay $2.2 billion in an agreement that will end both civil and criminal investigations. Off-Label Use According to court documents, from 1999 through 2005, the company and its subsidiary promoted the off-label use of certain drugs, including Risperdal, Natrecor and Invega. The complaint claimed that representatives promoted Risperdal to control aggression and anxiety in elderly dementia patients and to treat behavioral disturbances in people with disabilities, including children. The drug is actually an anti-psychotic drug and is not approved by the FDA to treat any of those disorders. As a result of the settlement, Johnson & Johnson will plead guilty to a single misdemeanor charge related to its promotion of the drug. Ominicare Kickbacks In addition to the off-label use accusation, Johnson & Johnson paid millions in kickbacks to the nation’s largest nursing home pharmacy, Omnicare Inc. The kickbacks were made under labels such as “educational funding.” The purpose of the kickbacks, according to court documents, was to further promote the use of Risperdal and other drugs in nursing homes throughout the country. Reckless Actions U.S. Attorney General Eric Holder said that Johnson & Johnson “recklessly put at risk” the health of dementia patients and children by aggressively promoting Risperdal and other drugs to doctors who regularly treated elderly patients and children. The company even employed an “Eldercare Sales Force,” which targeted nursing home operators in an attempt to market the off-label use of the drugs. The FDA allows doctors to prescribe drugs for unapproved use, but pharmaceutical companies are forbidden from marketing the drugs for anything other than what they were FDA-approved to treat. When the actions of a drug company are suspected as the cause or a contributing factor that causes injury or death, a product liability claim may be in order. Contact Dallas-Fort Worth lawyers at Frenkel & Frenkel to schedule a free initial consultation regarding an incident where injuries may have been caused or worsened by the actions of a drug company.