Risperdal Off-Label Prescriptions May Expose Johnson & Johnson to Punitive Damages

Plaintiffs in consolidated Risperdal lawsuits now pending in Pennsylvania have argued that a New Jersey statute barring punitive damages in lawsuits brought involving FDA-approved drugs does not apply when the injuries alleged result from off-label or uses unapproved by the FDA.

Janssen Pharmaceuticals, Inc., the division of Johnson & Johnson that manufactured and distributed Risperdal, had argued that insofar as the antipsychotic medication had been approved by the FDA, the plaintiffs in hundreds of lawsuits coordinated in Pennsylvania could not prevail on claims for punitive damages.

Plaintiffs in the Risperdal litigation stressed off-label marketing of the drug by the manufacturer including Janssen marketing Risperdal to children despite the FDA not approving the drug for children’s treatment prior to October 2006.  The plaintiffs further argued that even after the drug was approved by the FDA for children’s use, the manufacturer marketed the medication for uses beyond the scope of FDA approval.

Plaintiffs arguments are included in a pending Motion for Reconsideration asking the court and Judge Arnold New to reverse a granting of partial summary judgment on this issue in favor of Janssen Pharmaceuticals in May.

Most plaintiffs are alleging that administration of Risperdal to teenage boys led to abnormal growth of breast tissue in the boys, called gynecomastia.  This condition can be irreversible and lead to significant injuries and and remedial surgeries.  Given the serious nature of the gynecomastia condition, a ruling barring punitive damages is of significant import to many Risperdal plaintiffs.

If you, or a male to whom you are close, have been diagnosed with gynecomastia after having been administered Risperdal, you are urged to contact a Risperdal attorney at Audet & Partners, LLP by calling (800) 965-1461, or by completing and submitting out confidential inquiry form on the right side of this page.