Pharmaceutical giant Johnson & Johnson finalized a $2.2 billion settlement with the U.S. Department of Justice (DOJ) for misleading doctors about the safety of its antipsychotic Risperdal; which in some cases led to boys developing lactating breasts.
"Today we reached closure on complex legal matters spanning almost a decade. This resolution allows us to move forward and continue to focus on delivering innovative solutions that improve and enhance the health and well-being of patients around the world," said Michael Ullmann, Vice President and General Counsel, Johnson & Johnson, in a press release Monday.
United States prosecutors have been investigating the company’s Risperdal sales practices since 2004, including accusations that from 1999 through 2005 it marketed the drug for unapproved uses, Johnson & Johnson said in the press release.
"J&J's promotion of Risperdal for unapproved uses threatened the most vulnerable populations of our society - children, the elderly and those with developmental disabilities," said Zane Memeger, U.S. Attorney for the Eastern District of Pennsylvania.
Hostile outside, fragile inside
Janssen Pharmaceuticals, a division of Johnson & Johnson, admits that it promoted Risperdal marketed for geriatric patients using a theme of “hostile outside, fragile inside.”
In other words, it "promoted Risperdal to health care providers for the treatment of psychotic symptoms and associated behaviors exhibited by elderly, non-schizophrenic patients who suffered from dementia – even though the drug was approved only to treat schizophrenia," United States Attorney General Eric H. Holder Jr. said in a news conference announcing the settlement.
The government alleged that the company paid kickbacks to physicians and pharmacies to recommend and prescribe the drug for off-labeled use while minimizing side effects of strokes, diabetes and other potentially fatal complications.
Lactating breasts in boys
From 1999 through 2005, one of Janssen’s Key Base Business Goals was to grow and protect share in the child/adolescent market. The problem: Risperdal was not FDA approved for this patient population.
But that didn't stop the company, the government alleges.
The government claims it did so although "J&J and Janssen knew 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."
First reported in the Miami Herald in the summer of 2004:
"The drug, Risperdal, has been commonly prescribed to Florida children in state care, including to a handful of boys who developed lactating breasts after taking it."
In 2001, The Herald published a series of stories about the common use of Risperdal among children in state care. Child-welfare advocates said the drug routinely was being used by foster care providers as a ''chemical restraint'' on children whose unruly behavior was a frustration to caretakers.
As a result, J&J subsidiary Janssen Pharmaceuticals will plead guilty to a single misdemeanor violation of the Food, Drug and Cosmetic Act for past promotional practices of Risperdal, subject to approval by the U.S. District Court.
Other drugs included in the settlement included Invega, another antipsychotic, and Natrecor, a drug used to treat heart failure.
Johnson and Johnson not alone
Johnson and Johnson is just the latest pharmaceutical company that has agree to pay big bucks to settle allegations of improper marketing and other charges.
Last year, the British drug maker GlaxoSmithKline agreed to pay a record-setting $3 billion in to resolve criminal charges that it improperly targeted its Paxil depression treatment to children, sold its Wellbutrin antidepressant for unapproved uses and failed to inform U.S. regulators of safety risks seen with its Avandia diabetes drug, according to the New York Times.
In 2009, Pfizer settled with the government for $2.3 billion to settle allegations it improperly marketed 13 drugs, including the painkiller Bextra, which is no longer on the market. It was also alleged that the company paid kickbacks to healthcare providers.
Under scrutiny in China
Drugmakers have also come under scrutiny in China. Glaxo, for example, is now under the microscope of Chinese police, who in recent months alleged it has participated in a widespread bribery and corruption scheme in which the company used travel agencies to funnel illegal payments to doctors and government officials to bolster drug sales, Reuters reported.
As a result, many Chinese doctors have shunned its sale representatives. The company also found its drug sales in China taking a 61 percent plunge in the third quarter.