Patients Say Risperdal Warnings Didn’t Go Far Enough
Risperdal has been named in hundreds of different lawsuits filed in particular by young men and boys who developed gynecomastia. Other side effects have also been reported by patients alleging that Risperdal warnings should have been placed clearly on the medication to allow them to make an informed decision about using the drug to begin with.
The anti-psychotic medication was initially developed to treat schizophrenics. However, it has been prescribed for off label uses across numerous different demographics and age groups.
Many of the plaintiffs who have come forward to file a lawsuit, allege that the company is responsible for a lack of Risperdal warnings, which would have helped the plaintiffs and their treating physicians determine whether or not Risperdal was the right medication.
The development of severe side effects may come as a surprise to patients who went over the drug’s risks with their doctors. If the information about a serious side effect is not included with the medication or given to doctors, this can later lead to a lawsuit based on lack of proper Risperdal warnings.
This drug was initially approved by the FDA in 1994 for use with schizophrenic adults and not for use with the elderly or children. Despite the fact that Johnson & Johnson tried numerous times over the course of the 1990s to get approval for these different age groups, they continued to market efforts for these off label uses.
Furthermore, Risperdal warnings were not placed on the exterior of the medication or in the documentation provided with the drug that would have allowed patients to understand the risks. Johnson & Johnson is accused of encouraging the use of Risperdal with geriatric patients with dementia, children with autism and children who have ADD and other behavioral disorders.
Many of the Risperdal lawsuits filed as a result of a lack of Risperdal warnings, also allege that the physicians who prescribed the drug received kickbacks from the company in order to encourage its use.
More than one-fifth of Risperdal users by the year 2000 were adolescents and children.
The FDA repeatedly reached out to Johnson & Johnson about marketing the drug to children and the drug finally became FDA approved in 2006 for use with children and adolescents who had autism.
This led to a number of different Risperdal lawsuits alleging lack of Risperdal warnings about the problems associated with gynecomastia or the development of breast tissue. Many young men and boys have come forward to file Risperdal lawsuits, accusing the company of inappropriate or no Risperdal warnings about these dangers. In many of these cases, gynecomastia could only be reversed with surgery.
In 2005, a Risperdal warning from the FDA required a black box label about the high risk of death from cardiovascular events for use with elderly patients.
If you’ve been harmed because of a lack of Risperdal warnings, schedule a consultation with the lawyers at McDonald Worley today.