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Risperdal Lawsuits

RisperdalRisperdal side effects have triggered thousands of lawsuits and billions in fines and civil & criminal settlements for manufacturer Ortho-McNeil-Janssen, a subsidiary of Johnson & Johnson.

Risperidone, brand name Risperdal, is an anti-psychotic drug approved by the FDA for the treatment of schizophrenia in 1993. It has subsequently been approved to treat bipolar disorder and other psychiatric problems in minors.

Risperdal lawsuits have been filed on behalf of young men who developed gynecomastia, or increased male breast growth, as a result of taking risperidone to treat schizophrenia and other disorders. The plaintiffs in these cases point to medical studies showing that Risperdal use causes imbalances in reproductive hormones and increases levels of prolactin, the hormone that triggers milk production. Research, such as a 2012 study in the Journal of Child and Adolescent Psychiatry, showed that raised prolactin levels were 72% more likely in young men taking risperidone. Enlarged breasts and sexual dysfunction, including erectile dysfunction, are symptoms of high prolactin levels in men aged 10-20.

Million-dollar Risperdal verdicts

Approximately 1300 Risperdal gynecomastia lawsuits were pending, as of June 2015, as part of a mass tort in Pennsylvania state court. As is common in mass torts of this kind – which centralize cases based on similar allegations for the purpose of conserving financial resources and expediting pre-trial procedures – several individual cases where chosen for bellwether trials to serve as a litmus test for how jurors will be likely to react to the opposing parties’ arguments.

In May 2015, the third Risperdal bellwether trial ended only a few hours before it was set to begin with the announcement that defendant drug company Johnson & Johnson had agreed to a settlement with the plaintiff, Christopher Walker, who alleged that he had experienced abnormal breast growth caused by the drug. The terms of the settlement were not disclosed, and J&J admitted no liability, insisting that the plaintiff’s abnormally large breasts were the result either of obesity, puberty, or a combination of the two.

The first Risperdal gynecomastia bellwether trial took place in February 2015. The jury found in favor of 20-year-old plaintiff Austin Pledger, who claimed that he had developed size 44DD breasts as a result of faking Risperdal since he was 8 years old, for autism. Pledger was awarded $2.5 million in damages.

The second Risperdal trial in Pennsylvania resulted in a verdict for the defense.

In October 2012, Ortho-McNeil-Janssen agreed to an undisclosed settlement to cover 5 Pennsylvania cases alleging breast-tissue growth in young men taking Risperdal.  In one of the cases, the plaintiff claimed in his lawsuit complaint that he had started taking Risperdal when he was 5 years old, and had developed breasts by the time he was 12.

As part of the settlement agreement, J&J denied all liability for the plaintiffs’ injuries.

Who is eligible to file a Risperdal lawsuit?

Risperdal lawyers across the country continue to review cases of young men who developed gynecomastia during or after Risperdal use to determine if they are eligible to pursue legal damages. The best candidates for Risperdal product liability litigation are those who were free of other risk factors for gynecomastia, which can include obesity, or taking any other medications which may have breast growth as a side effect.

Plaintiffs will not only have to demonstrate that Risperdal was the direct and exclusive cause of their abnormal breast growth, but that the manufacturer Johnson & Johnson was aware of the risk and willfully withheld this information from the public.

During the Pledger bellwether trial in Pennsylvania, former FDA commissioner David Kessler testified that a 2001 study by J&J had revealed a “red flag” correlation between Risperdal and gynecomastia. Despite this link, according to Kessler, the drug behemoth refrained from updating the Risperdal label to reflect these male breast growth risks until 2006. As a result, from 2003 (when the FDA approved Risperdal for use in treating schizophrenia and bipolar disorder)  to 2006, parents and doctors trying to make the best treatment decisions for young men with psychiatric disorders did not have a complete picture of the cost-benefit profile of Risperdal.

Causes of action in Risperdal breast growth lawsuits include:

  • Failure to warn
  • Breach if implied warranty
  • Breach of warranty of fitness for ordinary use
  • Breach of express warranty
  • Redhibition
  • Strict Liability
  • Breach of federal regulations

Plaintiffs in these cases demand damages for all medical expenses related to gynecomastia, including costs of treatments and surgeries for the condition itself, as well as treatments for complications deriving from gynecomastia, such as major depression and other psychological and emotional side effects. They also demand compensation for lost wages (including those of a parent who must miss work to care for a child), pain & suffering, and loss of quality of life.

Risperdal has been linked to a number of serious side effects which may form the basis of a drug injury lawsuit:

  • Gynecomastia
  • Tardive dyskinesia (a Tourette’s-like movement disorder)
  • Diabetes
  • Neuroleptic Malignant Syndrome (NMS)
  • Stroke

Risperdal settlements

Johnson & Johnson has paid out billions of dollars in fines, settlements and damages awards because of its alleged negligence in regard to Risperdal side effects.

In 2012, J&J agreed to pay $181 million to 36 states to resolve allegations of marketing misconduct and improper advertising regarding Risperdal. This agreement comprised only one stage of a larger settlement agreement negotiated with the U.S. Justice Department, which was announced in late 2013, and which required J&J to pay $2.2 billion in total to resolve civil and criminal claims that it marketed Risperdal (as well as other drugs such as Invega and Natrecor) for unapproved “off-label” uses, and that it illegally paid millions in kickbacks to physicians, nursing home operators, and other healthcare practitioners.

In May 2015, Johnson & Johnson agreed to a $7.8 million settlement with the state of Arkansas over the illegal marketing of Risperdal, after the initial $1.2 billion fine was thrown out. In 2012, J&J agreed to a settlement over similar allegations with Texas to the amount of $158 million. The company still faces pending Risperdal lawsuits from Mississippi and Kentucky. Johnson & Johnson has not admitted any liability despite agreeing to the payouts, saying, for instance , that the Arkansas settlement “is a compromise reached in the interest of ending the litigation.”

Risperdal lawsuits continue to be filed

The physical and psychological consequences of gynecomastia can be devastating for young men, and most juries to date have responded dramatically in favor of plaintiffs in Risperdal male breast growth lawsuits. With 1300 Risperdal cases pending in Philadelphia alone, and more being filed weekly across the country, additional settlement negotiations may prove to be the most cost-effective and speedy way of resolving this sizable litigation. Young men who believe they may be eligible for damages for their Risperdal injuries are advised to contact a product liability attorney with experience going up against big pharmaceutical companies in drug side effect lawsuits.

  1. Philadelphia Court of Common Pleas,

  2. Bloomberg News, J&J Pays Millions to Settle Billion-Dollar Risperdal Case,

  3. Daily Beast, The ‘ADHD Drug’ That Gives Boys Breasts,

  4. Bloomberg News, Johnson & Johnson Agrees to Settle Five Risperdal Suits,

  5. FDA: Janssen Pharmaceuticals, Inc. to plead guilty and pay over $1.6 billion to resolve allegations of misbranding and filing false claims for its schizophrenia drug Risperdal,