Newsletter - March 2015

Newsletter - March 2015

Introduction

Risperdal Litigation

The antipsychotic drug Risperdal is causing a whirlwind of lawsuits in courtrooms around the country as victims of this drug, mostly male, are getting what they haven't signed up for. Men and boys who take the antipsychotic drug to treat bipolar disorder and schizophrenia are developing gynecomastia, male breast growth. More recently, however, Risperdal is being used to treat patients with Attention Deficit Hyperactivity Disorder, off-label use of which hasn't been approved by the FDA. Although Johnson & Johnson, the maker of the drug, had settled countless claims, much more arise to take their place.

Many Risperdal cases involve children, especially young boys who have developed male breasts as a result of the drug's use.

As of February 2015, nearly 1,300 cases involving Risperdal have been reported in Pennsylvania alone. Johnson & Johnson and its pharmaceutical arm have been accused of promoting the off-label use and, as a result, they agreed to pay $2.2 billion to resolve similar charges involving Risperdal and a number of other drugs in a settlement with the U.S. Department of Justice.

Originally approved in the U.S. By the FDA in 1993 in the treatment of schizophrenia and the temporary treatment of dangerous manic or mixed episodes associated with bipolar I disorder. 
Risperdal is used to treat schizophrenia in adults and adolescents aged 13-17; in the temporary treatment of dangerous manic or mixed episodes associated with Bipolar I Disorder in adults, and only in children and adolescents aged 10-17 years; in the treatment of dementia associated with autistic disorders in children and adolescents aged 5-16 years. Risperdal has also been marketed as a non-label treatment option for people with Attention Deficit Disorder (ADD).

Risperidone, offered underneath the emblem name risperdal among others, is an ordinary antipsychotic used to treat schizophrenia and bipolar disorder. It's far taken both with the aid of mouth or by injection into a muscle. The injectable model is lengthy-performing and lasts for about  weeks.

Common side consequences encompass motion problems, sleepiness, dizziness, trouble seeing, constipation, and extended weight. Severe facet consequences might also encompass the doubtlessly permanent movement ailment tardive dyskinesia, in addition to neuroleptic malignant syndrome, an improved hazard of suicide, and excessive blood sugar degrees. In older people with psychosis as a result of dementia, it is able to boom the chance of loss of life. It's far unknown if it's miles safe to be used in being pregnant. Its mechanism of action isn't absolutely clear, but is thought to be related to its action as a dopamine antagonist and serotonin antagonist.

Study of risperidone started out inside the overdue Nineteen Eighties and it became permitted on the market inside the u.S. In 1993. It is on the sector health organization's listing of vital drug treatments. It is to be had as a universal medication. In 2018, it turned into the 159th maximum commonly prescribed medicine in the america, with more than 3 million prescriptions.

Risperidone is mainly used for the treatment of schizophrenia, bipolar ailment, and irritability related to autism.

Risperidone is effective in treating the psychogenic polydipsia and the extreme exacerbations of schizophrenia.

Research comparing the software of risperidone by way of mouth for maintenance therapy have reached varying conclusions. A 2012 systematic overview concluded that proof is powerful that risperidone is more effective than all first-technology antipsychotics apart from haloperidol, but that evidence directly helping its superiority to placebo is equivocal. A 2011 assessment concluded that risperidone is greater effective in relapse prevention than different first- and second-technology antipsychotics excluding olanzapine and clozapine. A 2016 cochrane assessment indicates that risperidone reduces the general signs of schizophrenia, however company conclusions are tough to make due to very low-excellent evidence. Facts and data are scarce, poorly mentioned, and possibly biased in favour of risperidone, with approximately half of of the included trials evolved by drug agencies. The item increases worries concerning the critical facet outcomes of risperidone, which includes parkinsonism. A 2011 cochrane evaluation in comparison risperidone with different unusual antipsychotics which include olanzapine for schizophrenia.

Risperidone seems to produce rather extra extrapyramidal facet effects and sincerely more prolactin increase than maximum different bizarre antipsychotics. It could also differ from different compounds inside the incidence of other unfavourable effects inclusive of weight gain, metabolic problems, cardiac outcomes, sedation, and seizures. Though, the huge share of individuals leaving studies early and incomplete reporting of effects makes drawing firm conclusions tough.

Long-acting injectable formulations of antipsychotic tablets provide progressed compliance with therapy and decrease relapse costs relative to oral formulations. The efficacy of risperidone lengthy-appearing injection seems to be similar to that of lengthy performing injectable kinds of first technology antipsychotics.

2nd-technology antipsychotics, which includes risperidone, are effective within the remedy of manic signs in acute manic or blended exacerbations of bipolar disease. In kids and youth, risperidone can be greater powerful than lithium or divalproex, but has more metabolic aspect consequences. As renovation remedy, long-appearing injectable risperidone is effective for the prevention of manic episodes however no longer depressive episodes. The lengthy-appearing injectable shape of risperidone may be tremendous over long acting first generation antipsychotics, as it's far better tolerated (fewer extrapyramidal outcomes) and due to the fact long acting injectable formulations of first technology antipsychotics can also increase the hazard of depression.

As compared to placebo, risperidone treatment reduces positive complex behaviors in autistic youngsters, including aggression closer to others, self-harm, difficult behaviour, and rapid temper modifications. The evidence for its efficacy seems to be greater than that for alternative pharmacological treatments. Weight gain is an critical unfavourable impact. Some authors advise restricting the use of risperidone and aripiprazole to people with the most difficult behavioral disturbances so that it will reduce the threat of drug-brought about destructive effects. Proof for the efficacy of risperidone in autistic children and young adults is less persuasive.

Risperidone has shown promise in treating therapy-resistant obsessive–compulsive disorder, whilst serotonin reuptake inhibitors aren't sufficient.
Risperidone has not established a benefit inside the treatment of eating issues or character problems. Whilst antipsychotic medications consisting of risperidone have a mild benefit in people with dementia, they have been connected to higher incidences of dying and stroke. Because of this increased chance of dying, remedy of dementia-associated psychosis with risperidone is not fda accepted.

SUSPECTED INJURIES POSSIBLE INCLUDING:
Gynaecomastia
Weight Loss
Hyperprolactinemia

FDA SAFETY WARNINGS:
2005: After receiving information that older patients with dementia-related psychosis were treated with anti-psychotic drugs (second generation) are at a higher risk of death compared to placebo, the Food and Drug Administration (FDA) requested that the package include Risperdal to include a black box warning describing the danger and note that this drug is not approved for this indication, giving September 2006 as the last day to be reviewed.

Allegations: Allegations are being made against Johnson & Johnson regarding Risperdal gynecomastia-related complications and a significant impact on quality of life often requiring surgery, which is even more dangerous. 
The allegations further allege that Janssen encouraged Risperdal in the use of the label, such as the treatment of young chizophrenia.

Defendant's Lead Tip:
William Hanssen, Biddle Drinker & Reath, LLP
Defendant Liaison Advisor:
Rodney Hudson - Beverage Biddle & Reath, LLP
Sarah Trankiem- Beverage Biddle & Reath, LLP
Complainant's Steering Committee
Amy Carter - Simon Greenstone Panatier, PC
Denman H. Heard - Heard Robins Cloud LLP
Ellen A. Presby - Nemeroff Legal Company
Brian J. McCormick - Jr., Ross Feller Casey
Michael K. Johnson - Johnson Becker, PLLC.
Laura V. Yaeger - Morgan and Morgan
Perry R. Sanders Jr. - Sanders Law Firm
Fletch Trammell, Laminack - Pirtle and Martines LLP
Willard J. Mody, Jr. - I Moody Law Firm
Aimee H. Wagstaff -, and Andrus Wagstaff, PC.
Trevor B. Rockstad - Davis & Crump, PC
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 And Lack
Thomas J. Preuss - Wagstaff & Cartmell
Tony Buzbee - Buzbee Legal Company

Court Status:
2010: Risperdal docket complex of cases established in Philadelphia Common Pleas Court.
As compiled proceedings before the Judicial Justice Council (Risperdal and Invega Product Liability Cases, JCCP 4775): in the Supreme Court of Los Angeles, California, led by the Honorable William Highberger.
Thousands of lawsuits are filed in state courts in Pennsylvania, Missouri, and other courts throughout the country.
According to Johnson & Johnson's SEC submission, as of August 2018, at least 13,500 cases in Risperdal are pending in state and federal courts.

Important sentences and human settlements
January 2012: J&J resolves Texas Medicaid fraud case for $ 158 million.
September, 2012 - J&J has settled an undisclosed amount of money lawsuit filed by Aaron Banks alleging that Risperdal caused her gynecomastia early in the morning trial.
October 2012: J&J agrees to pay 5 gynecological cases for undisclosed amounts.
November 2013: J&J has agreed to pay more than $ 2.2 billion to resolve a lawsuit filed by the U.S. Department of Justice. For various criminal and civil cases.
February 2014: A Philadelphia County Common Court judge awarded $ 2.5 million to the family of an Alabama child, 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).
November 2015: The Philadelphia County Court of Common Pleas jury has filed a lawsuit against plaintiff Nicholas Murray of Maryland plaintiff Nicholas Murray of Maryland alleging that Janssen failed to warn health care providers and patients about the dangers of gynecomastia.
(Nicholas Murray v. Janssen Pharmaceuticals Inc., case number 130401990)