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Risperdal Gynecomastia Lawsuit Filed in Louisiana District Court

Teenage boy with gynecomastiaThe powerful prescription medication Risperdal, which is classified as an “atypical antipsychotic,” was recently implicated in a federal personal injury lawsuit filed in United States District Court for the Middle District of Louisiana. At the heart of the plaintiff’s complaint is the assertion that her minor child was wrongfully exposed to the drug contrary to the approvals listed by the Food and Drug Administration (FDA), causing her male child to develop breast tissue – a condition known as gynecomastia.

The complaint was filed on November 25, 2014, and lists several causes of action against four defendants: Janssen Pharmaceuticals, Inc., Johnson & Johnson, Janssen Research & Development, LLC, and Mylan Pharmaceuticals.

Allegations of fraud, misrepresentation & negligence

The plaintiff in this Risperdal lawsuit, filing on behalf of her minor son, listed several causes of action against each defendant with regard to her son’s condition.

More specifically, the plaintiff is seeking redress for the following civil injuries:

  • Defective Construction or Composition: The drug Risperdal was defectively manufactured and is composed of an unreasonably dangerous combination of chemicals.
  • Defective Design: The drug Risperdal has been unreasonably dangerous to patients since it was designed, and these design defects should have been apparent to the defendants from the outset.
  • Failure to Warn: The defendants, who designed, manufactured and distributed the drug, were in the best position to warn patients of its tendency to cause the formation of male breast tissue – and failed to do.
  • Breach of Express Warranty: The defendants expressly stated that Risperdal was safe and effective for use in children, even though these statements were untrue.
  • Negligence: Defendants owed a duty to the plaintiff and her son to avoid causing harm, and failed to meet this standard.
  • Redhibition: At the time of purchase, the Risperdal product was redhibitory (i.e., useless) and, had plaintiff known of its defects, the product would have never been purchased.
  • Breach of Implied Warranties: The law imposes certain implied warranties on the sale of consumer goods, namely that the goods are fit for their intended use. Here, plaintiff alleges the defendants breached these implied warranties.
  • Strict liability: Defendants knew or should have known of the unreasonably dangerous nature of Risperdal – particularly when used to treat children.

In addition to the above-listed Louisiana law allegations, plaintiffs allege several federal counts against the defendants, including the failure to disclose known dangers of Risperdal and dangerous off-label marketing toward children.

Ongoing Risperdal litigation

The drug Risperdal, and its companion drug Invega, are approved for the treatment of adult schizophrenia and bi-polar mania. However, the makers of these drugs have allegedly engaged in widespread marketing campaigns touting the effectiveness of these powerful mood-altering medications for the treatment of pediatric behavioral disorders, ADHD, autism and aggression. This practice is known as off-label marketing, and is considered unlawful under federal and state laws as the FDA has not approved Risperdal for the treatment of these conditions.

Plaintiffs in several states have targeted the drug Risperdal, many specifically seeking redress for the pediatric development of male breast tissue. In Pennsylvania state court, nearly 1,000 Risperdal gynecomastia lawsuits are awaiting conclusion.