New Hampshire to receive $3.8 million in Johnson & Johnson Risperdal settlement
New Hampshire will receive $3.8 million in a multistate settlement with pharmaceutical manufacturer Johnson & Johnson after allegations of unlawful marketing practices to promote the sales of antipsychotic drugs Risperdal and Invega, according to an announcement yesterday from Attorney General Joe Foster.
The settlement is part of a $2.2 billion agreement in which a unit of the company will plead guilty to a misdemeanor criminal charge of misbranding Risperdal for uses not approved by the Food and Drug Administration, including treating elderly patients who have dementia.
Risperdal is one of a second generation of anti-psychotic medications initially approved for use in the early 1990s. Once the FDA approves a drug as safe and effective, a manufacturer cannot market or promote a drug for an “off-label” use, that is, any use not specified in the FDA-approved product label.
The states contend in the suit that from Jan. 1, 1999, through Dec. 31, 2005, Johnson & Johnson and a subsidiary promoted Risperdal for off-label uses, made false and misleading statements about the drug’s safety and efficacy, and paid illegal kickbacks to health care professionals and long-term care pharmacy providers to induce them to promote or prescribe Risperdal to children, adolescents and the elderly when there was no FDA approval for Risperdal use in those patient populations.
Risperdal has been linked to excessive weight gain and diabetes. The drug generated worldwide sales of $24.2 billion from 2003 to 2010, reaching $4.5 billion in 2007, according to Bloomberg News.
In September, a former company manager testified in Pennsylvania state court that Johnson & Johnson promoted Risperdal by paying physicians to give favorable speeches, subsidizing golf trips and even having sales staff “butter up doctors” with bags of “Risperdal Popcorn,” according to a Bloomberg News report from the trial of a separate suit, filed by more than 400 people alleging they were harmed by off-label use of the drug.
The states also claim that from Jan. 1, 2007, through Dec. 31, 2009, the companies promoted Invega for off-label uses and made false and misleading statements about the safety and efficacy of Invega.
The alleged illegal marketing caused false and possibly fraudulent claims to be submitted to or caused purchases by government-funded health care programs, including the state Medicaid programs, according to the suit.
(Sarah Palermo can be reached at 369-3322 or email@example.com or on Twitter @SPalermoNews.)