J&J Announces Settlement Payments for US Probes into Risperdal Personal Injury
Reportedly, the blockbuster pharmaceutical manufacturer will also plead one misdemeanor.
The plea deal would preserve the New Brunswick, NJ company’s ability to sell its products to Medicare and other government health programs, while ending prosecutors’ investigations into J&J’s marketing practices around Risperdal, along with Invega, another schizophrenia drug, and Natrecor, a heart-failure drug. It would also cease an investigation into potential kickbacks paid by J&J to nursing home operator Omnicare, which may have amounted to tens of millions of dollars, specifically to boost the sale of certain J&J medications to nursing home patients.
According to the original lawsuit, Johnson & Johnson and their subsidiary Janssen promoted Risperdal for off-label and unapproved uses between 1999 and 2005, such as controlling aggression in elderly dementia patients, as well as behavioral disturbances in children. Risperdal was approved in 1993, launched in 1994, and lost patent protection in 2008; the FDA did not approve pediatric use of the drug until 2006.
This settlement will be among the largest between pharmaceutical manufacturers and the US government. Others include the settlement with GlaxoSmithKline PLC, which agreed to pay $3 billion and plead guilty to criminal charges involving antidepressants Paxil and Wellbutrin, along with the diabetes drug Avandia; and in 2009, Pfizer Inc. agreed to pay $2.3 billion to resolve an investigation into the painkiller Bextra, which has been recalled, along with some other drugs.
The settlement with the US government does not end more specific personal injury cases involving Risperdal, which have been filed in several state courts, particularly Louisiana and South Carolina. In those personal injury cases, off-label use of Risperdal has been linked to personal injury such as excessive weight gain leading to Type 2 diabetes.
South Carolina Personal Injury Cases Against Risperdal and J&J
In a state that currently ranks 8th in the nation for obesity rates, with between three and four people dying each day from diabetes-related complications, additional risk of developing diabetes is a very serious side effect. South Carolina lawyers argued that Risperdal’s label downplayed the risk of diabetes and heart disease. A 2003 letter from Janssen to South Carolina doctors further violated consumer protection laws in the state by suggesting that Risperdal was superior to other anti-psychotic drugs, encouraging doctors to prescribe the name brand over alternatives.
The drugmaker’s executives “allowed the profit-at-all- costs mentality to cloud” their judgment in connection with the drug’s marketing campaign and its labeling, Judge Roger Couch said in his 17-page ruling. Couch stated that the letter was “a clever effort” to “manipulate the message” about the dangerous drug.
Couch awarded South Carolina $4,000 per violation. The state won $174.2 million in penalties for the letter, and $152.8 million for misrepresentation on the label.
According to Janssen’s lawyers, the FDA approved the marketing tactics and the label, and since they are a federal agency, a state court cannot penalize the manufacturer.
The Strom Law Firm Can Help with Dangerous Drug Cases
Strom Law Firm, L.L.C. is a leader in the consumer protection battle against dangerous prescription drugs and medical devices, like Risperdal. We represent individuals who have been killed or injured by dangerous or defective pharmaceuticals. If you or a family member have been injured or killed after using a dangerous drugs or medical products such as Risperdal, contact our dangerous drug lawyers as soon as possible so that we can begin taking steps to preserve evidence and your claim immediately. We offer free consultations to discuss the facts of your case. 803.252.4800