Risperdal Lawsuit - Male Breast Growth Tied to Risperdone
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Risperdal Lawsuit

stethoscope and gavelRisperdal patients and their families continue to seek ways to cope with the serious injuries caused by the drug.  Although no sum can ever fully compensate for the harm, filing a Risperdal lawsuit may help victims obtain monetary relief for medical bills, lost income and other costs.

Consulting with a product liability attorney at the Sanders Firm gives a victim the chance to discuss what happened and determine whether bringing a personal injury lawsuit is the right step.  Such a consultation is always confidential, and involves no obligation of any kind, financial or otherwise.

Filing a Risperdal lawsuit 

When a patient is injured by a drug like Risperdal, the victim and his or her family may file a personal injury lawsuit to recover for a variety of losses.

Depending on an individual’s situation, compensation may include payment for:

  • medical bills– past, present and future
  • pain and suffering
  • lost income
  • reduced future earning capacity
  • emotional and psychological distress

In many Risperdal lawsuits, a parent or guardian may be required to bring the case for the victim.  If the patient is a minor, for example a teenage boy injured by Risperdal, a parent or guardian may bring the case on his behalf.  An elderly patient with dementia may also require a guardian to represent his or her interests.  Family members typically assert claims on behalf of Risperdal patients who died after suffering strokes.

Sanders Firm attorneys specialize in handling these and other issues that arise in Risperdal lawsuits.  Our legal team has been advising clients in personal injury actions arising from dangerous drugs for over four decades.  In the last five years alone, the firm has recovered over $100 million for clients across the country.

Our staff includes an in-house team of medical experts, veteran investigators and skilled paralegals. Sanders attorneys have handled hundreds of cases involving drugs like Risperdal that were marketed in misleading ways and injured vulnerable patients as a result.

Risperdal uses and side effects

The FDA first approved Risperdal in 1993 as a schizophrenia treatment.  The agency later authorized the drug to be used to treat bipolar disorder.  Not until 2006 did the FDA clear Risperdal for use in children with bipolar disorder, as well as irritability and aggression associated with certain types of autism.

Risperdal has been linked to very serious side effects, including:

  • Neuroleptic Malignant Syndrome, a life-threatening neurological disorder
  • Diabetes and high blood sugar
  • Tardive Dyskinesia (uncontrollable movements of face, tongue and other body parts), a condition with no known treatment that may not disappear even after the patient stops using Risperdal
  • Dysmenorrhea (cessation of menstruation)
  • Gynecomastia (abnormal male breast growth)
  • Low white blood cell count, which can be life-threatening
  • Persistent restlessness, tremors and muscle stiffness
  • Faintness or light-headedness
  • Painful, long-lasting erections

Misleading Risperdal marketing to children and elderly

Long before the FDA approved Risperdal for any use in children, its manufacturer promoted the drug extensively to treat children with symptoms of ADHD, obsessive-compulsive disorder and autism.  Company sales representatives were told to visit child-focused mental health facilities and physicians to market Risperdal as a safe and effective treatment.

The FDA has charged that the drug maker knew that Risperdal stimulated the production of prolactin in children, which can cause milk production and abnormal male breast growth. But Risperdal’s sales brochures either downplayed or omitted any mention of damaging side effects.

In another off-label marketing campaign, manufacturer Johnson & Johnson promoted Risperdal to control behavior problems in elderly non-schizophrenic patients with dementia.  But the company’s own studies revealed that Risperdal increased older patients’ risk of stroke and other life-threatening conditions.

The manufacturer even established ElderCare, a dedicated marketing team, to promote Risperdal to doctors who treated elderly patients.  Marketing materials emphasized Risperdal’s alleged effectiveness in reducing symptoms that made treating dementia patients difficult, especially in institutions such as nursing homes.

But the drug maker minimized the fact that Risperdal was approved only to treat schizophrenia.  Despite FDA warnings Johnson & Johnson continued its aggressive campaign.  

Risperdal settlements 

Patients injured by Risperdal began filing lawsuits as early as 2008 in courts across the country.  At least 350 Risperdal lawsuits have charged that boys and young men suffered gynecomastia (abnormal male breast growth) because they used the drug.  In some instances young men have asserted that they were required to undergo mastectomies to treat the abnormal breast growth.

Many of these claims have been consolidated in the Philadelphia Court of Common Pleas.  Several gynecomastia lawsuits have been settled before trial.  Former FDA Commissioner David A. Kessler, M.D. appeared as an expert witness in certain of these cases, in which boys as young as five when they began using Risperdal suffered abnormal breast growth as teens.

Dr. Kessler, a pediatrician who served for seven years as FDA Commissioner, stated that the drug maker’s “promotion of Risperdal, a powerful drug, for non-approved uses in the most vulnerable children is deeply troubling.”  Dr. Kessler concluded that the marketing campaign was unlawful under the federal Food, Drug and Cosmetic Act.

In November 2013, J&J paid $2.2 billion to settle a Risperdal lawsuit brought by the United States Department of Justice.  The case was one of the largest health-care fraud lawsuits in U.S. history.  The settlement included civil recoveries under the federal False Claims Act of $1.72 billion, as well as criminal penalties and forfeitures totaling $485 million.

Under the settlement, the drug makers pleaded guilty to one criminal charge involving the unlawful promotion of Risperdal as a means of controlling behavior in elderly patients with dementia.  But the companies did not admit any unlawful conduct as to the campaigns marketing Risperdal use in children or people with developmental disabilities.  In fact, company representatives continued to assert that the drug was safe and effective.

Consult with a leading Risperdal lawyer

As Risperdal victims continue to suffer serious and life-threatening injuries, patients and families are seeking compensation for their losses.  Risperdal attorneys at The Sanders Firm can advise such victims and, if circumstances warrant, file lawsuits on their behalf.  Drug manufacturers and their insurers may attempt to settle a claim quickly after it has been filed.  If the compensation offered is sufficient, patients and families can move forward without having to relive their suffering in a courtroom.

But if settlement negotiations fail, our attorneys will put their decades of trial experience to work to obtain full monetary recovery.  The Sanders Firm offers free, no-obligation consultations to Risperdal victims and their families.  To learn about your legal options contact us today at 1.800.FAIR.PLAY.


  1. Philly.com, “Former FDA chief David Kessler says J&J broke the law in promoting Risperdal,” October 4, 2012, http://www.philly.com/philly/blogs/phillypharma/Ex-FDA-chief-David-Kessler-says-JJ-broke-the-law-in-promoting-Risperdal.html#dWVp8LIR1zhF5aXC.99

  2. The Philadelphia Courts, First Judicial District of Pennsylvania, “In re Risperdal Litigation:  Expert Report of David A. Kessler, M.D.” http://freepdfhosting.com/e617b66c6d.pdf

  3. U.S. Department of Justice, “Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations,” November 4, 2013, http://www.justice.gov/opa/pr/2013/November/13-ag-1170.html

  4. FDA, Warning Letter to Janssen Pharmaceuticals, April 19, 2004, https://wayback.archive-it.org/7993/20170112064956/http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm055315.pdf