Risperdal is a popular antipsychotic medication manufactured by the Janssen Pharmaceuticals division of Johnson & Johnson. After gaining FDA approval as a “safer alternative” to Haldol (haloperidol) and “next generation” treatment for bipolar and schizophrenia in December 1993, indications expanded to include pediatric conditions like autism irritability and bipolar mania.
J&J and Janssen are facing more than 13,500 Risperdal lawsuits across the U.S., alleging that the companies hid serious side effects of the drug, including male breast growth (gynecomastia). Additionally, the drug-maker agreed to pay the government over $2.2 billion over allegations that they illegally promoted the drug for off-label uses for more than a decade.
Sales of Risperdal peaked at $4.5 billion in 2007 before its patient expired. Now Risperdal is also sold under the generic name risperidone and a slightly different form known as Invega (paliperidone). All told, Risperdal has earned J&J over $40 billion in sales, with continuing revenues of about $3 billion per year.
Most people taking drugs understand that side effects are a fact of life. However, most people presume these side effects will be mild and clear up within a few weeks or that they can stop taking the drug and see the ill effects disappear. Common Risperdal side effects include nausea, vomiting, anxiety, restlessness, and fatigue.
However, other Risperdal and risperidone side effects have caused humiliation, emotional problems, the need for surgery, and an increased chance of death in some cases. Serious side effects cited in lawsuits include:
After initially allowing market approval for Risperdal for bipolar and schizophrenia treatment in 1993, the FDA expanded its use for autism irritability (2006), schizophrenia treatment in children (2007), and relapsing bipolar disorder (2008). They have approved new dosing amounts, new injection sites, and new therapeutic uses of Risperdal Consta in the treatment of schizophrenia and bipolar disorder as recently as 2009.
However, the FDA has expressed one major concern in using risperidone to treat the elderly. In 2005, they added a Black Box Warning – the strictest given – to warn that risperidone is not approved for elderly patients, as it can increase the risk of death from pneumonia, cardiac arrest, and stroke – particularly in those with dementia. Prior to the warning, Risperdal was prescribed off-label for elderly patients with dementia-induced psychosis. J&J paid criminal fines of $2.2 billion dollars for actively promoting this unapproved use.
Other FDA notifications over the years include:
The Risperdal label was changed again after placebo-controlled studies revealed a significantly higher risk of stroke and transient ischemic attack (including fatalities) among elderly patients with dementia-related psychosis. “Risperdal has not been shown to be safe or effective in the treatment of patients with dementia-related psychosis,” the FDA reported.
The FDA and Janssen revised the “warnings” section of the Risperdal label to include an increased risk of hyperglycemia and diabetes. All manufacturers of atypical antipsychotic medications were asked to update their labels.
The FDA notified healthcare providers of increased mortality risks in elderly patients treated with atypical antipsychotic drugs (like Risperdal, Abilify, Zyprexa, Seroquel, Clozaril, Geodon, and Symbyax) for dementia-related psychosis. A black box warning was added to Risperdal, and health care professionals were warned about writing “off-label” prescriptions.
Since their initial warning, the FDA has conceded that the risk is present with any type of conventional antipsychotic drug on the market.
OBGYNs were notified to be aware of symptoms of withdrawal in newborns whose mothers use antipsychotics like Haldol, Risperdal, FazaClo, Fanapt, Clozaril, Zyprexa, Seroquel, Abilify, Geodon, Invega, Loxitane, Moban, Navane, Orap, Saphris, Stelazine, Thorazine, and Symbyax. Agitation, abnormal muscle tone, tremors, sleepiness, difficulty feeding, and abnormal breathing were reported, but these symptoms typically subside within hours or days without treatment. Some newborns may require a longer stay in the hospital.
The FDA notified healthcare professionals and the public that patients were often given risperidone (Risperdal) instead of ropinirole (Requip) – a drug for Parkinson’s Disease, and vice-versa. In some cases, patients taking the wrong medication were hospitalized. The FDA attributed the errors due to poor handwriting and short-form used by doctors, poor patient communications, similarities in names, and carton packaging.
Specific lots of Risperdal 3mg and Risperidone 2mg tablets totaling approximately 40,000 bottles were due to an uncharacteristic odor thought to be caused by trace amounts of tribromoanisole, a chemical preservative from wood pallets used in storage and transportation. Though not toxic, a small number of patients reported gastrointestinal symptoms.
The manufacturers and marketers of Risperdal that have been named in lawsuits include:
Risperidone is the generic version of the drug. Other brand names for risperidone include:
As of November 2019, a multidistrict litigation (MDL) has not been created, although more than 6,500 cases were consolidated in a Philadelphia court, and cases continue to amass around the country.
Mass torts, also known as MDLs, generally work by consolidating hundreds or thousands of cases before the same judge for pre-trial rulings that remain consistent from case to case. A handful of cases are typically brought to trial to explore the strengths and weaknesses of the central arguments against the defendants. These are called bellwethers. A person is not necessarily bound by any of these decisions, but they do commonly set a precedent and may influence whether a defendant will offer to settle or not.
If the Risperdal litigation becomes an approved MDL, your individual filing will automatically be moved to the proceedings and resolved upon resolution of the MDL. You may be offered an individual settlement, with your case judged on its own merit – unlike class action proceedings, which apply to masses of people who were harmed relatively little and pay out the same across the board, regardless of individual suffering and expense.
If you have suffered or lost a loved one due to the routine use of Risperdal, you may be entitled to pursue compensation for medical expenses, lost wages, pain and suffering, and other related losses. Contact Bart Bernard for a free consultation.
So far, there have been several noteworthy verdicts related to Risperdal side effects:
This is just a small sampling of the many cases unfolding in U.S. courts over the years. Some of the cases resulted in confidential settlements under the threat of punitive damages.
If you have any questions about filing a Risperdal lawsuit, contact the law office of Bart Bernard to speak with “The People’s Trial Lawyer™” for a free consultation and contingency-based representation that costs you nothing upfront and no fees unless we recover a settlement or jury award on your behalf.