Off-label drugs have been extensively prescribed by doctors for years now. “Off-label” refers to medication used for alternative purposes not indicated or authorized by the FDA. Doctors are permitted to prescribe off-label prescriptions if they feel it is medically necessary, and they are not required to inform a patient when doing so. As a result, a myriad of doctors have prescribed drugs labeled specifically for adults, to children.
This occurs commonly, especially when prescribing medication to children with psychotic disorders. A study conducted by the Journal of the American Medical Association found that 418,000 children under the age of 12 were prescribed at least one anti-psychotic each year, which does not necessarily reflect the number of children who actually have these disorders. These medications are frequently given to those who actually have ADHD, but are mistakenly diagnosed with psychotic disorders. A large quantity of children on the receiving end of these medications are toddlers. The FDA has not yet approved any drugs for children under the age of 5. The story of Frankie Perry, a Chicago boy who was a toddler at the time he received anti-psychotic drugs, has stirred up conversation involving doctors and the risks associated with off-label prescriptions.
Lori Perry, mother of three, did not know how what was going on with her eldest son. When Frankie was two years old, he would habitually escape from his crib at night and get into everything. She blamed the episodes on the developing curiosity and adventurous spirit her son exhibited, claiming that at the time his escapades were “adorable.” It wasn't until Frankie turned 3 that Perry became concerned with his behavior. He had began throwing intense tantrums aimed at his younger brother Michael. More alarmingly, he had not uttered a single word at an age where he was supposed to be talking. Perry didn't think he understood what she was saying when she scolded him.
After speaking with several language and developmental specialists to no avail, Perry called the Children's Memorial Hospital to meet with a child psychologist by the name of Karen Pierce. She conducted thorough observations and monitored Frankie for several hours for 10 days. At the end of the program Perry was given a prescription for a strong atypical anti-psychotic named Risperdal. Pierce claimed it would help him sleep more soundly, but had failed to mention that the drug was only indicated to be administered to adults. Worrisome symptoms such as “drooling, stumbling” and moving “almost like a drunk person” emerged. Perry's complaints to Pierce only garnered the response of upping the dosage.
By the time he turned five, Frankie was taking 3 milligrams of the drug a day, more than quadruple the minimum dose recommended for children ages 5 to 17. Frankie had developed large breasts, gained a considerable amount of weight and suffered episodes where his legs gave out. After seeing her son's debilitating condition, she decided to take legal action and pry her son off the Risperdal. Perry filed a lawsuit against Children's Memorial Hospital claiming medical negligence and for failing to monitor the child properly. She received a settlement neither party is allowed to discuss. Shortly after the lawsuit was filed, it was revealed that Pierce was a paid speaker for Johnson & Johnson subsidiary Ortho-McNeil. She was being paid to promote off-label uses to fellow colleagues and medical students.
If you have been harmed by a medical professional, you may be entitled to compensation. Call the law office of Charles Gilman and Briggs Bedigian at (800) 529-6162 or contact them online. The firm handles cases in Maryland, Pennsylvania, and Washington, D.C.