On February 24, 2015 a jury in Philadelphia, Pennsylvania concluded that Janssen Pharmaceuticals, a division of Johnson and Johnson, was negligent in their duty to warn prescribing doctors and patients of the potential side effects of the use of their 74 billion dollar drug, Risperdal. The family of the young man, now age 20, was awarded 2.5 million dollars by the jury. The patient was prescribed Risperdal at the age of twelve. After taking the drug, the boy developed a condition known as gynecomastia, which is the condition of abnormal female breast growth in boys. Austin’s breasts grew to a size of 46DD and had to be surgically removed.
What is Risperdal?
Risperdal is a drug produced by Janssen Pharmaceuticals, a division of drug giant Johnson and Johnson. It is an anti-psychotic drug approved by the FDA for treatment of Schizophrenia, Bipolar Disorder, Dementia, Autism, and Tourette Syndrome. In 1993, it was specifically approved for the use of treating schizophrenia and bipolar disorder in adults. In 2007, the drug was approved by the FDA for use in children with the same disorder. At that time, the FDA warned Johnson and Johnson not to market the drug for any other use, including ADHD because of safety concerns.
Risperdal is also marketed under the names Risperdone and Invega. Is is generically marketed as Paliperidone.
My son was prescribed Risperdal to help with the symptoms of ADHD, he isn’t bi-polar, autistic, schizophrenic, or has Tourette syndrome. Why was he given the drug?
After the drug was approved for use in adults, J&J started clinical trials in children with the same psychotic disorders. In those clinical trials, children with the psychotic disorders (Bipolar and Schizophrenia) experienced a 57% decrease in symptom manifestation. In other words, they were generally and calmer and had less frequent emotional outbursts.
This is where J&J got greedy. As of 2011, 11% of the country’s children had been diagnosed and treated for ADHD. This is compared to the nominal number of children diagnosed with bipolar disorder or schizophrenia.
Because the drug had shown to improve the behaviors of schizophrenic children and children with bipolar disorder, J & J began to market it for off-label use to help calm children with ADHD.
What is Off-Label Use?
Off-Label prescribing of drugs is actually very common and legal. The FDA merely approves certain drugs to be available for use by doctors to prescribe for patients, but they do not enforce standards that require drugs only be used for approved diseases. It is the position of the FDA that prescribing doctors should make that determination. There are of course risks to taking any drug and doctors have been instructed by the FDA to go over side effects with patients, especially for off-label drug use.
My son’s doctor prescribed the drug, what does Johnson and Johnson have to do with it?
Johnson and Johnson was told by the FDA NOT to market Risperdal for off-label use, especially for use in children. J & J completely disregarded that warning and did it anyway. They are accused off-label marketing of the drug with practices like:
- providing large amounts of free samples to doctors
- paying illegal kickbacks to pharmacies
- giving bonuses and other sales incentives to employees willing to market the drug to doctors for off-label use
- hosting consulting programs for doctors to educate them about the possibility of off-label use
Several trials have been held and in many of these cases, J & J has failed to prove that they made any effort to educate the doctors about off-label use of the drug or letting them know of the FDA’s warning.
But what does this have to do with my son?
If your child was prescribed Risperdal or Risperidone and has any of the side effects listed below, you should contact a medical malpractice lawyer in your area.
- Gynecomastia-development in breast tissue in males. This condition is very traumatic for adolescent young boys, who must deal with “locker room” embarrassment. The condition usually requires surgery to have the breasts removed.
- Pituitary Gland Abnormalities- Young girls who have been on the drug sometimes experience lactation and pituitary tumors.
- Diabetes- Dangerously elevated blood sugar levels.
- Neuroleptic Malignant Syndrome- muscle stiffness, fever, and irregularities in blood pressure. This can sometimes be fatal.
- Tardive Dyskinesia- A condition that causes facial movement often referred to as “ticks”. This condition is permanent in most patients even after they have stopped taking the drug.
- Rapid weight gain
- Lethargy
What Can A Lawyer Do To Help My Son Get His Life Back?
A medical malpractice lawyer will investigate your case and send a message to pharmaceutical giants like Johnson and Johnson that they are not allowed to put profits ahead of the safety of your child.. If your son has suffered the side effects from this potentially deadly drug, you may have a case. You may be entitled to lost wages compensation, payment for pain and suffering, and reimbursement for future and current medical treatment.
Call Paul Thomson, medical malpractice attorney in Roanoke, Va for a FREE case evaluation today. (540) 777-4900
