Tag Archive > Risperdal

Montana reaches $5.9M settlement in pharmaceutical case

admin » 12 March 2014 » In Legal News, Mass Tort » No Comments

HELENA – Montana Attorney General Tim Fox announced Thursday that a $5.9 settlement has been reached in a lawsuit filed against a large pharmaceutical company, and money will be used to pay for a new prescription drug abuse prevention program, mental health services and ongoing consumer protection services.

The Attorney General’s Office filed a lawsuit in 2008 against Janssen Ortho LLC and Janssen Pharmaceuticals, Inc. The lawsuit alleged the company employed illegal, unfair and deceptive practices in the marketing of Risperdal, an antipsychotic drug used to treat certain psychological disorders in adults.

The lawsuit alleged Janssen deceived Montana physicians and consumers when it promoted Risperdal as safe and effective for a variety of conditions, but was aware that research showed dangers associated with its use and hid that research from the public.

Janssen’s own studies of Risperdal demonstrated it had the potential to cause weight gain and diabetes, cerebrovascular complications in the elderly, as well as other severe adverse side effects.

Janssen agreed to settle the lawsuit for $5.9 million last month. The settlement also restricts Janssen from making misleading claims in the promotion of its drugs, and present information about the benefits and risks of its product in promotional materials.

Janssen did not admit wrongdoing through the settlement.

Fox said about $1.5 million of the settlement will be used to bolster the state’s Prescription Drug Abuse Prevention Program. A public education specialist will be hired to create a student education program, look for ways to expand prescription drug drop box locations across the state, and create a public awareness campaign about the dangers of prescription drug addiction.

Continue

Continue reading...

Tags: , ,

J&J agrees to pay more than $2.2 billion in Risperdal accord

admin » 04 November 2013 » In Defective Products, FDA, Legal News, Mass Tort » 2 Comments

J&J EARNS

Johnson & Johnson agreed to pay more than $2.2 billion to resolve criminal and civil probes into the marketing of the antipsychotic drug Risperdal and other medicines in one of the largest U.S. health-care fraud cases.

J&J’s Janssen unit will plead guilty to a misdemeanor criminal charge over misbranding Risperdal for uses not approved by the Food and Drug Administration, including for elderly patients with dementia. Under the plea deal announced Monday, Janssen will pay a $334 million fine and forfeit $66 million.

Janssen also settled civil claims that it marketed Risperdal without approval for the elderly, children and mentally disabled, and that it paid kickbacks to physicians and to Omnicare Inc., the largest pharmacy for nursing homes. The civil accord covered off-label marketing of Risperdal, another antipsychotic, and Natrecor, a heart failure drug.

“These companies lined their pockets at the expense of the American taxpayers, patients and the private insurance industry,” Att. Gen.l Eric Holder said. J&J “recklessly put at risk the health of some of the most vulnerable members of our society — including young children, the elderly, and the disabled.”

“Today we reached closure on complex legal matters spanning almost a decade,” Michael Ullmann, J&J’s general counsel, said in a statement. “This resolution allows us to move forward and continue to focus on delivering innovative solutions that improve and enhance the health and well-being of patients around the world.”

J&J said the company had previously accrued the settlement amounts, and no other charge to earnings will be recorded.

The agreement is the government’s third-biggest with a pharmaceutical company, behind a $3 billion settlement that GlaxoSmithKline Plc reached last year over marketing of medicines, including Paxil, Avandia and Wellbutrin, and the $2.3 billion accord that Pfizer Inc. entered in 2009 over marketing of the painkiller Bextra and other drugs.

J&J’s settlement doesn’t end Risperdal claims brought by several U.S. states, including Louisiana and South Carolina.

The civil settlement, which involves the Justice Department and 45 states, resolves several lawsuits filed by whistleblowers under the False Claims, which lets citizens sue on behalf of the government and join in any settlement. The Justice Department joined those cases.

The U.S. government has been probing Risperdal sales practices since 2004, including allegations the company marketed the drug for unapproved uses.

U.S. and state investigators examined whether J&J improperly promoted the drug for treating elderly patients with dementia, a use never approved by regulators, and for children before the Food and Drug Administration first approved pediatric uses in 2006.

While doctors may prescribe an approved drug for any reason, companies can market them only for purposes authorized by the FDA.

Risperdal has been linked to excessive weight gain and diabetes. The drug, once J&J’s biggest seller, generated worldwide sales of $24.2 billion from 2003 to 2010, reaching $4.5 billion in 2007. After that, J&J lost patent protection and sales declined.

The FDA approved Risperdal in 1993 for psychotic disorders including schizophrenia. That market is limited, and J&J’s Janssen unit sought to sell Risperdal for bipolar disorder, dementia, mood and anxiety disorders and other unapproved uses, according to court filings. The drug was later approved for other uses.

Continue

Continue reading...

Tags: , ,