J&J/Risperdal Wants Jurisdiction Moved to Federal Court In Kentucky AG's Lawsuit

from Injury Lawyer News;

Kentucky Attorney General Files Risperdal Lawsuit

And here's Kentucky's filing:
http://freepdfhosting.com/f7231f6e46.pdf

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 knownclinical 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.

Thank You Ms. Klein and Injury Lawyer News.

And Thank You Kentucky AG Conway.

Hmmm, Why would the Risperdal gang want the case moved to Federal Court?

J&J/PhRMA Parented ObamaCare: The Administrative State v Property Rights

Kentucky Sues J&J/Risperdal

pharmalot has;
Kentucky Sues J&J

Posted Fri, 05/17/2013 - 8:40am by Ed Silverman 3

whac a mole.jpg

whac a mole.jpg

Like a game of whack-a-mole, no matter how many times Johnson & Johnson attempts to put to rest lawsuits over the marketing of its Risperdal antipsychotic, another claim pops up. The latest is a lawsuit filed this week by the Kentucky attorney general, who like others before him in federal and state governments, charge the health care giant with illegally promoting the widely prescribed pill.

The charges are familiar: J&J is accused of hiding and minimizing side effect data about diabetes and weight gain, and concealing evidence that Risperdal causes increased levels in children of a hormone that stimulates breast development and milk production. Last fall, J&J began settling lawsuits charging the pill causes gynecomastia, which is the abnormal development of large mammary glands in males (here is the lawsuit).

In the scheme of things, this is just one more lawsuit that, as noted, covers familiar ground, but underscores the extent to which Risperdal marketing practices continue to haunt the health care giant, which is struggling to overcome the negative impression caused by manufacturing gaffes that led to countless product recalls and a scandal over the safety of its hip replacement devices.

Continue reading pharmalot coverage here.

Thank You pharmalot and Mr Silverman.

AZ Settles With Kentucky for $5.5 Million Illegal Seroquel Promotion

Kentucky.gov has;
Attorney General Conway Announces $5.5 Million Settlement With Global Drug Maker AstraZeneca

Thursday, 02, 07, 2013

Shelley Catharine Johnson
Deputy Communications Director
502-696-5659 (office)

Attorney General Jack Conway and his Offices of Medicaid Fraud and Abuse Control and Consumer Protection today announced a $5.5 million settlement with AstraZeneca Pharmaceuticals LP to resolve allegations of off-label marketing of the atypical antipsychotic drug Seroquel. AstraZeneca, headquartered in London, England, is a global pharmaceutical manufacturer operating in more than 100 countries.

The settlement resolves allegations that AstraZeneca illegally marketed Seroquel for uses the Food and Drug Administration (FDA) had not approved as being safe and effective. The FDA has only approved Seroquel for the treatment of schizophrenia and various bipolar disorders in adults.

“I am pleased that we have reached this settlement and are recovering millions of dollars for a vital state program and for taxpayers,” General Conway said. “We’ve sent a clear message today that Kentucky will not tolerate drug companies that put profits ahead of patient care.”

Under the settlement, the Kentucky Medicaid program will receive more than $3.3 million.  The remainder of the proceeds will be distributed on a pro-rata basis to the Kentucky Department for Behavioral Health, Developmental and Intellectual Disabilities for certain treatment conducted at facilities across the Commonwealth, and to the Kentucky Department of Corrections, the Department for Juvenile Justice, the University of Kentucky Medical Center and the University of Louisville Hospital.  The pro-rata distribution is based on the off-label utilization at the respective agencies.

AstraZeneca illegally promoted Seroquel’s off-label uses in children and adolescents well before establishing that the drug was not safe or effective for any use by those that age.  AstraZeneca also promoted Seroquel for off-label uses for the elderly, without establishing its safety or effectiveness for elderly individuals. 

As a result of AstraZeneca’s unlawful marketing and promotion of Seroquel, utilization of the drug by Kentucky Medicaid recipients dramatically increased. By August, 2004 more than 25 percent of Seroquel users in Kentucky were under 18 years old and approximately 15 percent were older than 65.  As part of its marketing strategy, AstraZeneca sought to induce psychiatrists to switch from prescribing competing drugs for their patients to prescribing Seroquel.  AstraZeneca withheld or failed to disclose negative information concerning the effectiveness of Seroquel, and withheld or failed to adequately disclose the risks associated with using Seroquel.

Medicaid Fraud Recoveries

Since taking office in January, 2008, General Conway’s Office of Medicaid Fraud and Abuse Control has recovered or been awarded more than $292 million for the state and federal Medicaid programs.  These cases range from lawsuits and settlements against pharmaceutical companies to cases against individual providers.

The Attorney General’s Tip Line for reporting allegations of Medicaid fraud is 1-877-228-7384.

Thank You Kentucky.gov, AG Conway, and Ms. Johnson