Families are filing legal claims against Johnson & Johnson, alleging that antipsychotic drugs Risperdal and Invega cause male breast tissue enlargement. Known as gynecomastia, the emotionally damaging condition can lead to boys needing mastectomies (removal of the breasts).
The trouble with Risperdal
Risperdal, also known by its generic name risperidone, and Invega, also called paliperidone, are atypical antipsychotics that change the effect of brain chemicals.
The U.S. Department of Justice said Johnson & Johnson illegally marketed Risperdal and Invega. According to a former Johnson & Johnson sales manager, the company didn’t wait to obtain FDA approval before promoting its use for children.
- At a recent Risperdal trial in Pennsylvania, the manager claimed that Johnson & Johnson trained salespeople to promote Risperdal to children’s doctors as early 2003.
- The company issued this directive despite lacking approval for any use in children at the time.
- In addition, it is accused of paying doctors to speak favorably of the drug, sponsoring golf outings and offering other incentives encouraging physicians to prescribe Risperdal to children and adolescents.
- Allegations of illegal marketing activities between 1993 and 2004 eventually landed Johnson & Johnson and Janssen in hot water with consumer protection regulators in 36 states.
- In May 2012, the Kentucky attorney general announced a lawsuit alleging Johnson & Johnson concealed dangerous side effects of Risperdal and Invega, including diabetes, substantial weight gain, stroke and gynecomastia.
- In August 2012, the companies reached an agreement with those states to settle the claims of misconduct for $181 million. The companies also settled with Texas (for $159 million in 2012) and Montana ($5.9 million in 2014).