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Kentucky Attorney General Files Risperdal Lawsuit

The Kentucky attorney general filed a Risperdal lawsuit in Jefferson County Court, on June 14, 2013, against Janssen Pharmaceuticals and Johnson & Johnson, claiming the companies concealed the harmful side effects of the drug. An antipsychotic medication intended for use of the treatment of schizophrenia, symptoms of bipolar disorder, and irritability in autistic children, doctors also commonly prescribe the drug for patients with obsessive-compulsive disorders, stuttering, Tourette syndrome, and severe dementia.

The claim states that Risperdal is “the most widely used atypical antipsychotic in the world,” with $4.5 billion in sales in 2007.

Risperdal side effects litigation

The lawsuit alleges that patients have suffered serious Risperdal side effects after ingesting the drug. The claim states that “through their labeling and their promotion of Risperdal, Defendants concealed, downplayed, and misrepresented serious health risks caused by the drug for the purpose of increasing sales.” Plaintiffs allege that before and since the launch of the drug in 1994, the defendant has known clinical studies have proven results showing that Risperdal carried an increased risk of dangerous side effects including:

  • Tardive dyskinesia: An incurable movement disorder, causing uncontrollable muscle movements.
  • Diabetes: Studies have suggested the drug causes an increased risk of high blood sugar, which is an early indicator of type 2 diabetes.
  • Neuroleptic malignant syndrome (NMS): A potentially life-threatening neurological disorder causing rigidity, fever, autonomic instability, delirium, paranoia, changes in blood pressure, and excessive sweating.
  • Sexual dysfunction: Some patients have reported a decreased libido and impaired performance.
  • Gynecomastia: A condition causing abnormal male breast growth, gynecomastia is the topic of mounting Risperdal side effects litigation
  • Cardiovascular problems: Symptoms including high blood pressure, heart attack, and palpitations have been connected to the drug.
  • Stroke: Some cases of strokes have been traced to Risperdal, especially in the elderly.
  • Death: Death due to heart failure in elderly patients using the drug have been reported.

Other minor side effects patients have experienced include sensitivity to temperature, impaired thinking, dizziness, hyperactivity, sudden involuntary muscle movements, abdominal pain, fatigue, fever, and nausea.

Arguments for the Risperdal lawsuit

Defendants argue that the Risperdal lawsuit should be taken to federal instead of state court, due to the following reasons:

  • The Commonwealth’s Label Claim Necessarily Raises a Disputed Federal Issue: The Commonwealth’s label claim is based on allegations that certain risk information should have been placed in the warnings section of the label and that it was inappropriate to disclose the risk information in other sections of the label.
  • The Federal Interest in the Issue of the Placement of Risk Information in FDA-Approved Package Inserts Is Substantial: In Empire Healthchoice Assurance, Inc. v. McVeigh, 547 U.S. 677 (2006), the Supreme Court “identified four aspects of a case or an issue that affect the substantiality of the federal interest in that case or issue. The first and third factors are objective, and the second and fourth are subjective, and no single factor is dispositive of the issue of substantiality.
  • The Exercise of Federal Jurisdiction Over this Action Will Not Disturb Any Congressionally Approved Balance of Federal and State Judicial Responsibilities: Exercising federal jurisdiction over this case will not disturb the congressionally approved balance between federal and state judicial responsibilities.

In the lawsuit, the state of Kentucky seeks $2,000 for each violation of the Kentucky Consumer Protection Act, in addition to $10,000 for each violation involving a person aged 65 or older, plus costs, and an injunction.