Johnson & Johnson|Sued Over Risperdal

LOUISVILLE (CN) - Janssen Pharmaceuticals and Johnson & Johnson concealed the harmful side effects of their antipsychotic drug Risperdal, which include stroke, diabetes and weight gain, Kentucky's attorney general claims in court.

The Commonwealth of Kentucky sued Janssen Pharmaceuticals fka Ortho-McNeil-Janssen Pharmaceuticals and Janssen Research & Development fka Johnson & Johnson Pharmaceutical Research, in Jefferson County Court.

The state sued Tuesday. On Wednesday, three mass tort claims involving Risperdal were filed in Philadelphia state court.

All citations in this article are from the Kentucky attorney general's complaint.

The state claims the defendants knew of the dangerous side effects of Risperdal "Before and since Risperdal's launch in 1994," but concealed them from doctors and patients, and misrepresented the drug as safe.

Kentucky claims that Risperdal is "the most widely used atypical antipsychotic in the world," with $4.5 billion in sales in 2007.

"Crucial to this success was defendants' marketing/promotion and labeling of Risperdal, which willfully, and unfairly, falsely, misleadingly, or deceptively minimized, misrepresented or concealed the drug's true safety profile from the public, including Kentucky healthcare providers and patients," the complaint states.

It continues: "Defendants' own clinical studies and other safety information in defendants' possession demonstrated that taking Risperdal seriously7 increases a patient's risk of diabetes, hyperglycemia, clinically significant weight gain, hyperprolactinemia, cerebrovascular adverse events including stroke in the elderly with dementia, and other serious diseases and health conditions. That knowledge made defendants aware of such risks. However, defendants never warned doctors and patients about the serious risk of cerebrovascular adverse in the elderly with dementia until mid-2003. Defendants also never warned doctors and patients of the increased risk of diabetes and hyperglycemia until late 2003. Defendants have also never warned doctors and patients of the serious risk of increased weight gain, and only warned patients about the hyperporlactinemia risk associated with Risperdal beginning in mid-2007. Furthermore, defendants in varying ways have obfuscated, downplayed, misrepresented, hid, and lied about vital safety information they knew concerning those deadly risks associated with Risperdal use."

The state seeks $2,000 for each violation of the Kentucky Consumer Protection Act, $10,000 for each violation concerning a person 65 or older, plus costs and an injunction.

Kentucky seeks the damages for violations of state laws. It makes no federal claims.

Also Wednesday, Dow Jones Newswires reported that Johnson & Johnson has set aside an unstated amount of money to settle complaints of illegally promoting Risperdal for off-label uses. That allegation was not one of Kentucky's claims.

"The health-care company, in a filing with the Securities and Exchange Commission Tuesday, didn't specify the size of the reserve it booked in the first quarter for a potential Risperdal settlement," Dow Jones reported.

Johnson & Johnson paid $78 million in April to settle kickback allegations in the United States and United Kingdom, and reported $271 million in first-quarter litigation expenses, but did not explicitly tie those expenses to Risperdal litigation, according to Dow Jones.

Johnson & Johnson said on Tuesday it had not set aside a reserve to cover civil claims under the False Claims Act involving Risperdal because it had not been served with such a lawsuit. Such lawsuits, if and when they come, would be separate from Kentucky's which raises only state claims. The federal government, however, could intervene in state whistleblower suits and file superseding complaints in Federal Court.

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