Thursday's announcement of the $181 million settlement between Johnson & Johnson with 36 states and the District of Columbia over Risperdal marketing, was a fairly coordinated effort, with state attorneys general filing their own complaints in state courts and then issuing statements.
“Pharmaceutical corporations’ illegal promotion of drugs for off-label uses must stop," New York Attorney General Schneiderman said in a statement. "Consumers, including parents of children with serious mental disorders and vulnerable patients should be able to trust their doctor’s advice without fear that drug companies are manipulating their physician’s independent judgment.
"This landmark settlement holds the companies accountable for practices that put patients in danger, and serves as a warning to other pharmaceutical giants that they must play by one set of rules. It goes further by ensuring that the corporations stop rewarding doctors for prescribing certain drugs or presenting scientifically-suspect studies as sound.”
Pennsylvania, New Jersey and Delaware were among the states involved and a link to Friday's Inquirer story is here.
As Schneiderman suggested, this was the largest amount for a multi-state settlement, but J&J and its Janssen Pharmaceuticals subsidiary are fighting Risperdal litigation battles all over the country.
J&J will appeal, but the largest figure on the books at this stage is the $1.2 billion penalty imposed by a judge in Arkansas' individual case.
J&J also paid $158 million to stop the trial in the suit brought by the state of Texas, which joined the whistle-blower suit filed by Allen Jones. Jones uncovered wrongdoing as a investigator in the Pennsylvania Office of Inspector General, but he said that annoyed his superiors, who fired him after he went to the media.
J&J is also negotiating with the Justice Department over a separate investigation that might include criminal charges and a penalty around $2 billion.
But on Thursday, as in the past, Janssen said the settlement was "not an admission of wrongdoing or violation of any law or regulation."
Just to make the point further, the company statement said, "All parties have acknowledged that the payment is not a fine or penalty."
“We have chosen this path to achieve a prompt and full resolution of these state claims and to ensure we continue to focus on our mission of providing medicines to meet the significant unmet needs of many people who suffer from mental illness,” Michael Yang, president of Janssen Pharmaceuticals said in a statement.
From the New York Attorney General's office:
The settlement prohibits Janssen from:
- Making false, misleading or deceptive claims regarding Risperdal or Invega;
- Promoting Risperdal or Invega for off-label uses;
- Promoting Risperdal or Invega by highlighting use for selected symptoms instead of diagnoses;
- Misusing continuing medical education (“ CME”) programs to market Risperdal or Invega;
- Awarding grants to Health Care Professionals (“ HCPs”) based on their prescribing habits;
- Presenting information and conclusions from a study that is not scientifically sound, or presenting information and conclusions in a manner that is not supported by the underlying study;
- Disseminating reprints containing off-label usage information.
The settlement also requires Janssen to:
- Report clinical research results regarding Risperdal or Invega in an accurate, objective and balanced manner;
- Disclose on its website a searchable listing of all HCPs and related entities who or which received any payments directly or indirectly from Janssen;
- Provide clear and conspicuous disclosure of the risks associated with the use of Risperdal or Invega in all of its promotional materials;
- Provide accurate, objective and scientifically balanced responses to requests for off-label usage information by doctors.
From New Jersey, the link to the complaint filed by Attorney General Jeffrey Chiesa is here and the consent decree is here.