Risperdal was approved to help people suffering from schizophrenia, bipolar disorder and autism. It was supposed to help patients cope with mood changes and be able to feel better. But the pharmaceutical company Janssen and its parent company, Johnson & Johnson marketed the drug for off label use and downplayed the dangerous side effects of Risperdal. If you or somebody you love was hurt by taking Risperdal you may be entitled to compensation. Call the Risperdal lawyers at Isaacs & Isaacs now for your free case evaluation. Our experienced team of Risperdal Lawsuit attorneys are standing by day and night to assist you. We serve clients in Kentucky, Ohio & Indiana at 800-800-888.
FDA Approved Risperdal Uses
Risperdal was approved by the United States Food and Drug Administration (FDA) for treating schizophrenia in adults in 1993. In 2003 it was also approved for treating bipolar disorder in adults. In 2006 and 2007 the FDA approved the drug for additional uses.
In 2006 it was approved to treat irritability in autistic children (aggression; deliberate self-injury; tantrums). In 2007 it was the first antipsychotic drug the FDA approved to treat schizophrenia in adolescents aged 13-17, and was also approved for short term treatment of bipolar disorder in children ages 10-17. It was also approved for treating bipolar disorder in adults.
Company Bribes Doctors to Prescribe Risperdal as an Off-Label Medication
The FDA regulates drug safety standards and sets the requirements for a drug to be approved to market in the U.S. Off-label drug use means to prescribe or take a drug for another purpose, or in another amount or strength than the one the FDA approved. While doctors are allowed to prescribe medications off-label, what they are doing is prescribing a drug in a way that has not been tested to meet FDA standards for safety for that particular illness, dosage or group of patients.
Prescribing drugs off-label is a common practice. Hopefully in most cases when the prescribing doctor uses her/ his own judgment without FDA backing, they are trying to help the patient, and there may not be an alternative drug to treat the particular patient/ illness, for numerous reasons. The prescribing doctor should weigh the benefits and the risks, and use caution in prescribing off-label.
It is not illegal for physicians to use their specialized training and professional judgment as healers to prescribe a drug off-label. But it is illegal and also unethical for the pharmaceutical company to promote off-label use. It is also illegal and unethical for the pharmaceutical company to bribe doctors and healthcare providers to prescribe a drug for unapproved uses, so that financial gain, rather than the health of a patient, becomes a factor in the patient’s treatment. Especially for patients who are vulnerable, such as mentally ill or handicapped people, children, elderly patients, or those with a combination of the above characteristics, and who in their vulnerable state may be powerless to articulate negative side effects they are experiencing or do anything else to protect themselves against the unethical behavior of those who, as their health care givers, exercise power over their lives.
Side Effects of Risperdal in Elderly Can Be Catastrophic
In 2005 the FDA required Johnson & Johnson (J&J) and its subsidiary Janssen to issue a black box warning that use of Risperdal to treat dementia in the elderly carried a serious risk of strokes and of premature death. The warning said Risperdal was not safe to treat elderly patients with dementia.
However J&J / Janssen continued to market the drug aggressively to eldercare health providers such as nursing homes and physicians to prescribe to their patients as an effective way to treat specific symptoms of senile dementia (forgetfulness, hostility).
Our Risperdal Law Firm Uncovers Harmful Realities
One of the tactics J & J/ Janssen used to market this dangerous drug was to reward sales employees for aggressively promoting Risperdal to treat senile dementia with hefty bonuses. One whistleblower said these bonuses amounted to 70% of all bonuses to J&J’s ElderCare Division sales force. The ElderCare Division targeted our aging baby boomer population for pharmaceutical sales.
Use of Risperdal (Risperidone)as Off-Label Medication
Other off-label uses of Risperdal include:
- Attention Deficit Hyperactivity Disorder (ADHD)
- Sleep disorder
- Obsessive-compulsive disorder
- Personality disorder
- Post Traumatic Stress Disorder (PTSD)
- Substance Abuse
- Tourette’s Syndrome
J&J / Janssen aggressively marketed Risperdal to treat many disorders when the benefits were marginal and serious side effects included:
- Movement disorders;
- Risperdal Diabetes;
- Gynecomastia (developing large breasts in boys and adolescent males) and abnormal early breast development in prepubescent girls.
Risperdal Lawsuit: Whistleblowers File Lawsuits Under False Claims Act
Former employees filed suit against J&J under the False Claims Act and ultimately, after a federal investigation which lasted for a decade, these employees were awarded a portion of the $ 2.2 billion settlement amount when the company settled with the United States Department of Justice to avoid prosecution for the federal crime of Misbranding. Each of five employees was awarded just under $30 million dollars for their role in helping the feds amass evidence of the company’s illegal and aggressive promotion of their toxic product to disabled children and the elderly.
A November 4, 2013 news release from the United States Department Of Justice Office of Public Affairs announcing the guilty plea and settlement with State and Federal Government said:
“The United States alleges that Janssen marketed Risperdal to control the behaviors and conduct of the nation’s most vulnerable patients: elderly nursing home residents, children and individuals with mental disabilities. The government alleges that J&J and Janssen caused false claims to be submitted to federal health care programs by promoting Risperdal for off-label uses that federal health care programs did not cover, making false and misleading statements about the safety and efficacy of Risperdal and paying kickbacks to physicians to prescribe Risperdal.”
The announcement condemned corrupt pharmaceutical companies like Johnson & Johnson/ Janssen for betraying the public trust while causing grave injury or death to thousands or millions of patients.
When somebody pleads guilty to committing a crime, it is easier to sue that person or entity in civil court because you don’t have to prove they did something if they admitted to doing it. This may be why J&J / Janssen settled with the federal government before the case went to court, but they did plead guilty and agree to pay a hefty amount in fines, though perhaps $2.2 billion dollars is minimal compared to the profits they made from their illegal Risperdal marketing campaigns.
Risperdal Lawyers Isaacs & Isaacs Can Help You to Recover Damages
Hundreds of Risperdal victims continue to file lawsuits across the United States for the damages they suffered, alleging failure to warn of harmful side effects, including the hormonal changes in boys which resulted in gynecomastia (enlarged, sometimes lactating breasts) and delayed adolescent development such as a deepening voice and growing whiskers. The drug also caused early breast development in pre-adolescent girls which could be equally damaging.
Especially in children and adolescents who want to fit in, a horrific development such as growing breasts for boys or growing breasts too early for girls could cause irreparable emotional and developmental damage along with pain and suffering and the high cost of, for instance, having to have a mastectomy to remove the breasts. The fact that the children the company preyed on were already vulnerable only makes the behavior more heinous.
We all have to go to the doctor, and have family members who go to the doctor, maybe for one of the issues J&J/ Janssen has marketed Risperdal so aggressively for. At Isaacs & Isaacs our dangerous drug lawyers are implacably opposed to greedy, unethical companies who prey on the most vulnerable members of our communities. These predatory companies seem to have no bottom besides their bottom line. Perhaps the only way to stop these dangerous drug companies from preying on our communities and our loved ones is through civil litigation.
If you or somebody you love were prescribed Risperdal and have suffered any of the above side effects, or if you are not sure whether the drug Risperdal has harmed you, you should talk to a Risperdal lawsuit attorney immediately. You may be entitled to compensation for your:
- Pain and suffering;
- Mental and emotional trauma;
- Medical costs;
- Lost wages;
- Any other discomfort / harm / financial loss which the drug caused you.
At Isaacs & Isaacs our Risperdal lawyers have decades of experience in winning settlements for our clients who have been hurt by bad drug companies. We understand that these cases can be costly and time consuming, and frequently the victims are people who are not rich enough to win a legal battle against a big pharmaceutical company alone.
We will represent you on a contingency fee basis. We don’t get paid until you do. If we do not win your case you don’t owe us a nickel. Our 99% success rate is due to our passion for justice and our determination to recover the maximum amount of money for each and every client we represent.
There’s a statute of limitations for filing a civil lawsuit which varies from state to state. However sometimes the statute of limitations can be tolled (the clock doesn’t start running until later) in cases where a victim is suffering from mental illness and doesn’t understand what’s happening or who is responsible for his/ her suffering.
It is crucial that you speak to an attorney immediately if you or somebody you love has taken the prescription drug Risperdal and you aren’t sure if the drug hurt you. You must act before the statute of limitations to file your case expires and bars you from recovering any compensation for your ordeal.
Our experienced and compassionate Risperdal lawsuit attorneys are on call day and night to help you. Call Isaacs & Isaacs at 800-800-888for your free case evaluation.