Johnson & Johnson has agreed to pay more than $2.2 billion to resolve criminal and civil liability arising from allegations that the company and its subsidiaries encouraged doctors to prescribe Risperdal, Invega, and Natrecor for uses not approved as safe and effective by the Food and Drug Administration (FDA). The FDA has approved Risperdal to treat schizophrenia and symptoms of bipolar disorder, but Johnson & Johnson allegedly encouraged doctors to prescribe the drug for other uses. Johnson & Johnson is currently facing numerous lawsuits throughout the country alleging that the antipsychotic medication Risperdal can cause male patients to develop gynecomastia, a medical condition associated with the enlargement of breast tissue.
Johnson & Johnson is no stranger to government lawsuits involving sales and marketing activities.
According to the Department of Justice, an unspecified number of whistleblowers who provided the government with information about Johnson & Johnson’s misbranding activities will share a $168 million reward from the federal government. CNN has reported that Joe Strom, a former Johnson & Johnson employee who filed a whistleblower lawsuit against the company in 2005, will receive a reward of $28 million. Mr. Strom provided information that helped the government’s attorneys build their case against the pharmaceutical company.
The whistleblower lawsuits alleged that Johnson & Johnson and its subsidiary Janssen were aware that Risperdal posed serious health risks for the elderly, including an increased risk of strokes, but the companies downplayed these risks. The lawsuits also alleged that Johnson & Johnson knew that patients taking Risperdal had an increased risk of developing diabetes, but nonetheless marketed Risperdal as “uncompromised by safety concerns (does not cause diabetes).”
Despite FDA warnings and increased health risks, from 1999 through 2005, Johnson & Johnson aggressively marketed Risperdal to control behavioral disturbances in dementia patients through an “ElderCare sales force” designed to target nursing homes and doctors that treated the elderly.
Furthermore, from 1999 through 2005, Johnson & Johnson allegedly encouraged doctors to prescribe Risperdal to children and individuals with mental disabilities. The lawsuits allege that Johnson & Johnson was aware that Risperdal posed certain health risks to children, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development and milk production. Notwithstanding these known risks, one of Johnson &Johnson’s business goals was to grow and protect the drug’s market share among children and adolescents.
As alleged in the lawsuits, Johnson & Johnson instructed its sales representatives to visit child psychiatrists, as well as mental health facilities that primarily treated children, and to market Risperdal as safe and effective for symptoms of various childhood disorders, such as attention deficit hyperactivity disorder, oppositional defiant disorder, obsessive compulsive disorder, and autism. Until late 2006, Risperdal was not approved for use in children for any purpose, and the FDA repeatedly warned the company against promoting it for use in children.
Johnson & Johnson is no stranger to government lawsuits involving its Risperdal sales and marketing activities. Previous payments made by Johnson & Johnson to state governments regarding Risperdal misbranding allegations include:
Johnson & Johnson has also entered into a five year “corporate integrity agreement” with the Department of Health and Human Services Office of Inspector General. As such, the company is now allowed to recover compensation incentives, including bonuses, from workers who took part in ‘significant misconduct’.
Has the company learned its lesson? Hard to say – but it will certainly be more careful about overstepping its boundaries with drugs’ approved uses in the future.
James Magazine is a partner at the law firm Lucas, Green & Magazine. In addition to handling complex litigation involving defective medical devices and dangerous prescription drugs, Mr. Magazine represents individuals in personal injury, wrongful death, and bad-faith insurance claims. Recognizing his many achievements in the courtroom, Mr. Magazine has been named one of the “Top 100 Trial Lawyers in the State of Florida.”
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