Ex-FDA Chief Testified in Risperdal Trial that J&J Knew About Dangerous Side Effects
According to testimony in the current Risperdal trial, Johnson & Johnson knew as early as 2001 that it’s antipsychotic drug had serious, dangerous side effects, including that it could cause gynecomastia (female breast tissue growth) in young boys.
Former FDA Chief Richard Kessler testified in the latest Risperdal trial in Philadelphia that a 2001 study conducted on Risperdal showed that 3.8% of boys using the drug grew breasts. That was five years before J&J put a warning label on Risperdal that the drug could have psychologically and physically damaging side effects like gynecomastia.
“A manufacturer can always warn about a safety issue and should warn about a safety issue,” Kessler said during his Risperdal testimony. “There is nothing in the federal register that prevents a manufacturer from warning about a safety problem and there are many different ways. If somebody is sending a sales rep into a doctor’s office, into a pediatric neurologist’s office and doing it multiple times, you have an obligation to provide adequate direction. If you have information on a safety issue, you have to communicate that. Tell the good. Tell the bad.”
Kessler added that the study “certainly was a red flag to me” during the Risperdal trial brought forward by a 20 year old Alabama man who blames his 100-pound weight gain and female breasts on his Risperdal prescription, which he took for 5 years of his childhood. This victim was reportedly prescribed Risperdal for off-label use to treat psychoses associated with his autism. Risperdal was not approved for pediatric use until 2006.
The plaintiff’s pediatric neurologist also testified about J&J’s behavior, stating that the pharmaceutical giant’s subsidiary, Janssen Pharmaceuticals, dropped off samples of Risperdal in his office 20 times between 2002 and 2004, well before the drug was approved for any use in children.
In a separate federal level act, the Justice Department settled an off-label Risperdal lawsuit with J&J for $2.2 billion, which resolved all criminal and civil allegations that the company promoted the powerful antipsychotic for inappropriate use, included in elderly dementia patients and young children. 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 company and its subsidiary Janssen face more than 1,000 personal injury cases that have been consolidated in Philadelphia.
Risperdal “has improved the lives of countless children and adults throughout the world who suffer from debilitating mental illnesses, and it continues to improve patients’ quality of life today,” a Janssen spokeswoman said in an e-mailed statement. Both pharmaceutical companies continue to deny that Risperdal was inherently dangerous, and that they properly warned patients and their doctors about the risks of taking Risperdal, whether the use was approved by the FDA, or it was off-label.
The Strom Law Firm Can Help with Dangerous Drug Cases
The 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