On behalf of Weisman, Kennedy & Berris Co., L.P.A. posted in Products Liability on Wednesday, November 13, 2013.

It has been termed as the largest monetary settlement ever reached between the government and a pharmaceutical manufacturer relating to a single drug offering.

The drug is Risperdal, a pharmaceutical approved by the Food and Drug Administration for the treatment of anti-psychotic conditions such as schizophrenia in patients across the country, including in Ohio. The settlement recently executed following a long product liability investigation and negotiations obligates mega-manufacturer Johnson & Johnson, based in New Jersey, to pay more than $2 billion in fines.

The money outlay satisfies both civil allegations and a criminal charge against the company, with the settlement also requiring J&J to plead guilty to a misdemeanor count of misbranding Risperdal for use in interstate commerce.

Although the FDA never approved Risperdal for use in non-schizophrenic patients, J&J’s guilty plea served as confirmation that the company pushed health care providers to market it to elderly dementia patients. The drug maker agreed to pay $400 million in fines and other costs to settle that criminal charge.

On the civil side of the ledger, J&J agreed to pay a staggering $1.7 billion for marketing Risperdal and a companion drug to patient groups for uses not approved by federal regulators.

Such uses are termed “off-label” and apply to drug applications for purposes other than what has been approved by the FDA. Under federal law, the license granted physicians to prescribe off-label uses of otherwise approved drugs does not extend to drug companies.

In a news conference last week, United States Attorney General Eric Holder said that J&J’s actions regarding Risperdal “constituted a clear abuse of the public trust, showing a blatant disregard for systems and laws designed to protect public health.”

Source: Modern Healthcare, “Johnson & Johnson to pay over $2 billion to settle Risperdal investigations,” Joe Carlson, Nov. 4, 2013