A massive settlement of a federal probe into Johnson & Johnson’s Risperdal sales practices has been put on hold.
The hold concerns wording in the agreement that might leave the health care giant vulnerable to private lawsuits, say people familiar with the talks, according to The Wall Street Journal.
In 2012, Johnson & Johnson agreed to pay nearly $2.2 billion to settle a Justice Department investigation into allegations that it had illegally promoted medications, such as antipsychotic Risperdal. The deal has not been announced over Johnson & Johnson seeking to avoid admitting to conduct that could potentially have an impact on how pending personal injury lawsuits might be concluded and that involve allegations Risperdal caused serious side effects in children, those close to the matter told The Wall Street Journal.
Those people also said the primary issue concerns side effect information that Johnson & Johnson provided to the United States regulators when it sought approval to market Risperdal for use in children and adolescents, according to The Wall Street Journal. The data involved if Risperdal, and other drugs in its class, increased hormone levels in children that stimulate breast development and milk production in women.
Prosecutors are seeking to have the drug maker admit that the data it submitted minimized risks of the hormone increase; Johnson & Johnson want prosecutors to agree to cease pursuing the allegations, according to one of the people familiar with the negotiations, The Wall Street Journal reported. The wording, it seems, could have an impact on dozens of lawsuits that allege Risperdal caused side effects that include breast development in boys who were treated with the drug.
Janssen, a Johnson & Johnson unit, challenged the lawsuits in court fillies and said it sufficiently warned about the drug’s potential side effects. A spokesman for the drug maker said that FDA-approved prescribing information for Risperdal “clearly stated” that the drug increases levels of the hormone prolactin, and that side effects seen in a small number of patients did include male breast development, according to The Wall Street Journal.
In 2012, an Arkansas state judge ordered Johnson & Johnson to pay $1.2 billion after a jury found its prior marketing of Risperdal violated state consumer-protection and Medicaid-fraud laws. That case was brought by the Arkansas attorney general, said The Wall Street Journal previously. The drug maker was also mandated to pay large penalties in other lawsuits brought by attorneys general in South Carolina and Louisiana, and last year agreed to pay $158 million to settle a Texas Risperdal lawsuit.
Johnson & Johnson was previously accused of marketing Risperdal as a safe and effective treatment for some symptoms of dementia among the elderly. Risperdal is only approved to treat schizophrenia and symptoms of bipolar disorder and actually increases the risk of death in the elderly who suffer from dementia. The drug was being marketed illegally to treat symptoms including irritability and aggression among dementia sufferers and was also illegally marketed to treat symptoms of Alzheimer’s disease, which also increased patient risks of death and serious injuries.
While it is not illegal for a physician to prescribe a drug for an off-label treatment, it is a violation of U.S. Food and Drug Administration (FDA) regulations for the manufacturer of the drug to do so. Any new indications for a prescription drug must first receive FDA approval and requires extensive clinical safety trials to determine that the drug provides a benefit to a new class of patients.