Johnson and Johnson’s Second-Generation Antipsychotic drug, Risperdal has been marketed off label and now the company is facing hundreds of lawsuits for extensively promoting the unapproved usages of the drug.
Type 2 diabetes, breast development in boys and eating disorder – those are just a few of the horrible side effects of Risperdal. Risperdal’s “son” named Invega (generic, paliperidone) is no exception as it could bring the same side effects.
Janssen and its parent company, Johnson and Johnson, the big names behind Risperdal and Invega, have been aggressively marketing the drug even under the FDA’s hood. Originally, Risperdal was created to treat schizophrenia and a limited classification of autism disorder. Risperdal was allegedly illegally promoted to treat conditions like ADHD and PTSD.
Since early 2000’s Johnson and Johnson have already been facing accusations. The charges are for allegedly giving bonuses to sales companies, including Big Pharma, who extensively marketed the Risperdal. J&J is also accused of paying the get-aways of doctors who agreed to prescribe the drug to their patients. According to investigators, Johnson and Johnson was also paying incentives to physicians who give favorable speeches about the drug. The off-label uses of Risperdal are reported to generate billions of revenue for these companies.
On November 2013, J&J agreed to pay over $2 billion to settle criminal and civil claims surrounding Risperdal. Since the drug’s creation, the manufacturer have been constantly requesting to the Food and Drug Administration to permit its usage for elders and children but that request had been denied. According to whistle blowers, J&J had already promoted Risperdal to treat conditions in children and elder lies throughout those years since the drug’s availability in the market. The drug had already promoted to treat almost all Autism Spectrum Disorders and ADHD in children even without the authorities’ official approval. Moreover, there has only been a little clinical evidence that second-generation antipsychotics are successful. According to a statistical study, Risperdal was mostly prescribed for children younger than 13 years old.
The U.S Attorney General, Eric Holder called Johnson & Johnson’s off-label marketing as “recklessly put at risk the health of some of the most vulnerable members of our society.” Overtime, the numbers of families of whom children experienced side effects of the drug are growing and so are the cases filed against J&J.
Illegal Marketing of Risperdal to Children and Young Adults
Although Risperdal is approved to treat irritability on children who are diagnosed with autism, the drug was not approved to treat entire classifications of Autism Spectrum Disorders. It’s off-label Risperdal marketing strategy also included selling the drug to patients who have anxiety, Post Traumatic Stress Disorder (PSTD), Attention Deficit Hyperactivity Disorder (ADHD), depression and even to those who have insomnia J&J did not wait for the Food and Drug Administration’s approval. The result led to more sales for J&J as there was a growth of consumers who bought the drug.
Technically, it means that more people out there are prospective victims of Risperdal adverse effects.
Looking back, J&J asked the Food and Drug Administration to approve Risperdal for children’s use but failed as the FDA quoted; “vague reference to the safety and effectiveness in pediatric patients…would serve only to promote the use of the drug in pediatric patients without any justification.”
Now, states and federal officials and those people who were injured by Risperdal’s side effects filed complaints against J&J.
Marketing Risperdal under the Hood
Johnson and Johnson nailed at least 50% of the markets when it comes to selling antipsychotics. J&J have also been allegedly hiding the drug’s possible side effects which include breast development in males, weight gain, diabetes, movement disorders and cardiovascular problems According to whistle blowers the marketing plans for selling Risperdal involved;
- Thousands of free Risperdal samples to be given to doctors
- High incentives for sales people who nail their sales’ goal for selling the drug to children with mental disabilities and elder-lies who have dementia
- Lucrative consulting agreements to physicians who agree to promote Risperdal and make it their major prescription
Federal and State Settlements
State and federal investigators stated that Johnson and Johnson have been ignoring FDA’s warning to not promote Risperdal to children and elder-lies. These warnings were thrown to J&J since 1999 until 2005. In November 2013, the largest health care fraud settlement in the United States was recorded when the Department of Justice announced J&J’s $2.2.billion settlement with the government. This settlement was also participated by 45 states.
The November 2013 settlement included a $485-million criminal charges and a $172-million civil claim settlement. Things were a bit smooth for J&J after the settlement but there was an unresolved case filed by the Arkansas attorney general, a lawsuit that targeted the company for marketing Risperdal to elderly dementia patients. The case was filed for J&J’s misleading claims about the drug’s efficacy while putting older patients to higher risk of diabetes and other serious illnesses.
At some point, dating back in 2011, a $327 million verdict against Johnson and Johnson for deceptive marketing but the appeal is still pending. In 2012, a jury returned a $1.2 billion verdict against J&J when the company successfully appealed. There is also an overturned $258 million verdict from the Louisiana Supreme Court because there wasn’t enough medical fact to support the state’s Medical Law’s accusations against Johnson and Johnson. There may be this few unsettled Risperdal lawsuits but the number of successful claim is higher.
Hundreds of Risperdal lawsuits are already filed and everyone who is hit by the drug’s life-threatening side effects are encouraged to come out. If you or your loved one is one of them, contact us at Drugwatch for immediate help.