Risperdal

  • Risperdal Medical Record Review & Outsourcing Services

Risperdal (risperidone) is a class of drugs called atypical antipsychotic, developed and manufactured by Janssen Pharmaceuticals, a division of Johnson & Johnson. It was initially approved in the U.S. by the FDA in 1993 for the treatment of schizophrenia and for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder. In 2008, Janssen announced the launch of an authorized generic version of Risperdal (R) and added that it would continue to make available branded Risperdal.

Due to its antiadrenergic, antiserotonergic and anti-histaminergic properties and being a dopamine antagonist, Risperdal is used in the treatment of schizophrenia in adults and adolescents aged 13-17 years; for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults, and alone in children and adolescents aged 10-17 years; for the treatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years. Risperdal has also been marketed as an off-label treatment option for people with Attention Deficit Disorder (ADD).

It works by helping to restore the balance of certain natural substances in the brain.

Serious Alleged Injuries may include:

  • Gynaecomastia
  • Weight gain
  • Hyperprolactinemia

FDA Safety Warnings:

In 2005: After receiving data that elderly patients with dementia-related psychosis treated with atypical (second generation) antipsychotic medications are at an increased risk of death compared to placebo, the Food and Drug Administration (FDA) requested that the package insert for Risperdal to include a black box warning describing this risk and noting that this drug is not approved for this indication, giving September 2006 as the deadline to update.

Legal Updates:

Defendants: Janssen Pharmaceuticals, Inc.; Johnson & Johnson; Janssen Research & Development, LLC; Patriot Pharmaceuticals, LLC

Defendant Law Firm:

Janssen is represented by Morgan Lewis & Bockius LLP, Patterson Belknap Webb & Tyler LLP and Drinker Biddle & Reath LLP, & McCarter & English

Allegations: Claims against Johnson & Johnson are filed over Risperdal gynecomastia problems having devastating psychological damage and impact on the overall quality of life often requiring the need for surgery, which carries additional risks. Allegations include failure to adequately warn families or the medical community about the risk of gynecomastia.

The lawsuits further allege that Janssen promoted Risperdal for off-label uses, such as the treatment of schizophrenia in adolescents.

Defendants' Lead Counsel:

  • William Hanssen, Drinker Biddle & Reath, LLP

Defendants' Liaison Counsel:

  • Rodney Hudson - Drinker Biddle & Reath, LLP

  • Sarah Trankiem- Drinker Biddle & Reath, LLP

Plaintiff Steering Committee

  • Amy Carter - Simon Greenstone Panatier, PC

  • Denman H. Heard - Heard Robins Cloud LLP

  • Ellen A. Presby - The Nemeroff Law Firm

  • Brian J. McCormick - Jr., Ross Feller Casey

  • Michael K. Johnson - Johnson Becker, PLLC.

  • Laura V. Yaeger - Morgan & Morgan       

  • Perry R. Sanders Jr. - Sanders Law Firm

  • Fletch Trammell, Laminack - Pirtle & Martines LLP

  • Willard J. Mody, Jr.​ - The Moody Law Firm

  • Aimee H. Wagstaff -, Andrus Wagstaff, PC.

  • Trevor B. Rockstad - Davis & Crump, P.C

  • Todd Hilton - Stueve Siegel Hanson LLP

  • Michael K. Johnson - Johnson Becker, PLLC

  • Rick Meadow - The Lanier Law Firm

  • James O'Callaghan - Girardi and Keese

  • Brian Depew, Engstrom - Lipscomb & Lack

  • Thomas J. Preuss - Wagstaff & Cartmell

  • Tony Buzbee - The Buzbee Law Firm

Lawsuit Status:

  • 2010: Risperdal complex litigation docket established in the Philadelphia Common Pleas Court.

  • 2014: Philadelphia Court of Common Pleas: March 2010 Term No.296 established  in the Court of Common Pleas of Philadelphia County, Pennsylvania before Judge Arnold New. Over 7,000 lawsuits are pending in this docket as of October 2018.

  • As coordinated proceedings before the Judicial Council of Coordinated Proceedings (Risperdal and Invega Product Liability Cases, JCCP 4775): in the Los Angeles Superior Court, California, presided by Honorable William Highberger.

  • Thousands of cases are filed in the state courts of Pennsylvania, Missouri, and other courts across the country.

According to Johnson & Johnson’s SEC filings, as of August 2018, at least 13,500 Risperdal lawsuits were pending in state and federal courts.

Important Verdicts & Settlements

January 2012: J&J settled Texas Medicaid fraud lawsuit for $158 million.

September, 2012 - J&J settled a case for an undisclosed amount over claims filed by  Aaron Banks that Risperdal caused his gynecomastia on the morning the trial was to begin.

October 2012: J&J agreed to settle 5 gynaecomastia lawsuits for undisclosed amounts.

November 2013: J&J agreed to pay more than $2.2 billion to settle a lawsuit brought by the U.S. Department of Justice over a variety of criminal and civil charges.

February 2014: Philadelphia County Common Pleas Court jury awarded $2.5 million to the family of a minor from Alabama, Austin Pledger, represented by Benita Pledger.

(P.P., et al. v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., et al., No. 120401997, Pa. Comm. Pls., Philadelphia Co.).

March 2015: A Philadelphia County Court of Common Pleas jury found Risperdal did not cause plaintiff William Cirba’s injuries. Although the jury found that Janssen failed to warn about the male breast growth risk, but it awarded no damages after finding no direct link to his condition.

(Cirba et al v. Janssen Pharmaceuticals Inc., case number 130301803)

November 2015: A Philadelphia County Court of Common Pleas jury awarded $1.75 million to plaintiff Nicholas Murray of Maryland stating Janssen failed to warn health care providers and patients of gynecomastia risks.

(Nicholas Murray v. Janssen Pharmaceuticals Inc., case number 130401990)

December 2015: A Philadelphia County Court of Common Pleas jury awarded the plaintiff, Timothy Stange, compensatory damages of $500,000, stating J&J failed to warn about gynecomastia risks.

(Timothy Stange v. Janssen Pharmaceuticals, Inc., et al., No. 130401984, Pa. Comm. Pls., Philadelphia Co.).

March 2016: J&J Ordered to Pay $124M to South Carolina to settle claims of illegally promoting Risperdal prescription drug for unapproved or “off-label” uses.

July 2016: A Philadelphia jury awarded a Tennessee boy, Andrew Yount, $70 million over gynaecomastia; Judge Paula Patrick later added almost $7 million in delay damages in August 2016.

(Andrew Yount, et. al., vs. Janssen Pharmaceuticals, Inc. et. al., Case No. 130402094).

October 2016: J&J agreed to pay an undisclosed settlement in order to avoid a trial that was slated to begin in Pennsylvania state court

N.F. et al. v. Janssen Pharmaceuticals Inc. et al., case number 13500998

October, 2017: A jury in US District Court, Northern District of New York awarded Shaquil Byrd from Troy $1 million in compensation. (Byrd v. Janssen Pharmaceuticals, Inc. et al, Case No. 1:14-cv-00820)

November 2017: The Superior Court reversed the 2015 defense verdict citing erroneous evidentiary as their reasoning in a case filed by William Cirba. A new trial was also granted to Cirba to solely focus on causation and damages.

January 8, 2018: The three-judge Superior Court panel (Superior Court Judges Jack A. Panella, Alice Beck Dubow and Kate Ford Elliott) allowed plaintiffs in the Philadelphia cases to apply the law of their home state to seek punitive damages. (Punitive damages had previously been barred by a 2014 trial court judge in accordance to New Jersey state law.) This ruling applies across-the-board, as even plaintiffs who have previously received jury verdicts in Risperdal litigation, can now petition the court for new trials or request hearings to enhance verdict awards by adding punitive damages.

September 2018:

  • Massachusetts court District Judge Denise J. Casper ruled in favor of defense granting a summary judgment over claims filed by a Bay State man, Emmanuel Jackson and his parents, stating the case lacked the backing of a medical expert to support their claim.

  • Chief Judge Glenn T. Suddaby for the Northern District of New York, overturned a $1 million Risperdal verdict awarded to Shaquil Byrd in October 2017 as  compensation stating that ‘the failure-to-warn claims made against Janssen stays preempted since the federal law bars the company from adding a gynecomastia warning label.’

  • Judge Donald Cabell of the U.S. District Court for the District of Massachusetts, allowed plaintiff Jessie Acevedo to replead his negligent failure-to-warn claims linked to Risperdal side-effects. However, claims of consumer law violations, fraudulent concealment, and design defect against defendants Janssen Research & Development and Johnson & Johnson were dismissed.

October 2018: J&J agreed to settle a Mississippi plaintiff's case involving Risperdal side-effects, days before going to trial.

Evidence:

  • Indication of Usage in Medical and Pharmacy Records
  • Duration of Usage
  • Complication and treatment after usage

Medical Record Review and claim validation of Risperdal case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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