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Law Firm Files Risperdal Lawsuit Against FDA


A Philadelphia law firm has filed a Risperdal lawsuit against the Department of Health and Human Services and the Food and Drug Administration. The firm represents hundreds of children who have been allegedly injured as a result of ingesting Risperdal.

The antipsychotic drug is used to treat a variety of mental/mood disorders such as schizophrenia, bipolar disorder and irritability associated with autistic disorder. Risperdal is designed to help patients think clearly and function in everyday life.

Risperdal lawsuit

The lawsuit is based on the FDA’s decision to deny a citizen petition filed by the law firm, requesting that the Agency require a change in the labeling for Risperdal and remove the drug’s pediatric indication. The petition also asked the FDA to review certain confidential documents that highlight the dangers of the antipsychotic drug.

The law firm obtained these documents while representing clients in other litigation, but is not able to provide them to the FDA, due to confidentiality and protective orders in the cases. The firm’s citizen petition requested that the FDA seek these documents from Johnson & Johnson and its subsidiary Janssen — the manufacturer of Risperdal — or release the confidentiality order so they can submit the confidential documents to the Agency.

However, the FDA denied the firm’s citizen petition without so much as a hearing or meeting — or even taking the time to review all the evidence presented.

“The FDA’s denial of the citizen petition was arbitrary, capricious, and an abuse of discretion,” states the complaint.

Particularly speaking, the FDA refused to review the confidential documents cited by the law firm, although the Agency allowed Janssen to make an ex parte submission of documents that the law firm only learned about through discovery in other litigation.

In its denial of the petition, the FDA “expressly refused” to consider certain facts the law firm had submitted concerning the inadequate labeling of Risperdal drugs. The Agency gave no reason for its decision to deny the law firm’s request for a hearing and its denial of the request suggests the FDA completely misunderstood the nature of relief sought by the law firm.

“The FDA’s decision puts at risk numerous pediatric patients who are prescribed the Risperdal drugs,” states the claim. “The Risperdal drugs cause increased levels of prolactin, which leads to a variety of side effects including abnormal development of breasts in male patients and a variety of adverse effects on sexual development in patients of both sexes. These adverse effects are severe and long-lasting.”

Claim states that Risperdal is dangerous for pediatric uses

The FDA has granted approval to at least 10 generic manufacturers of Risperdal. However, the law firm claims the Risperdal drugs are mislabeled and their pediatric indication should be withdrawn.

The drug received FDA approval for adults in 1993 as an anti-psychotic therapy for schizophrenia. In 2003, its uses were expanded to include the short-term treatment of acute manic or mixed episodes linked to bipolar I disorder in adults.

In 2006, Risperdal was approved to treat irritability associated with autistic disorder in children between the ages of 5 and 17. In 2007, its uses were expanded to include the treatment of schizophrenia and acute manic or mixed episodes associated with bipolar I disorder in children as young as 13 and 10 years of age, respectively.

  1. U.S. District Court for the Eastern District of Pennsylvania, Sheller, P.C. vs. the United States Department of Health and Human Services
  2. WebMD, Risperdal