Saturday, December 20, 2008

Risperdal: The Eyes Of Texas Are Upon You

Here's Texas 2nd amended petition against the Risperdal Crowd. Looks like the Texas AG is demanding TWICE, Every penny they allege J&J/Janssen to have defrauded Texas State Medicaid out of, plus interest, penalties, and expenses pursuant to recovery of said monies.

pg. 22: 15.1

"Defendants' misconduct caused harm to and entitles Plaintiffs to remedies under the TMFPA. Under the TFMPA, each Defendant is liable to the State of Texas for the value of any payments or any monetary or in-kind benefits provided under the Medicaid program, directly or indirectly, as a result of its unlawful acts, two times the amount of those payments, plus prejudgment interest on the value of those payments, and a civil penalty for each unlawful act committed, in addition to the fees, expenses, and costs to the State of Texas and the Relator in investigating and obtaining civil remedies and injunctive relief in this matter."

This LINK (from psychdrugdangers) has Texas Medicaid paying out $436,601,024 (2000-2007) for Risperdal: so, ..... at Double that plus interest, penalties and expenses a win for Texas could cost J&J/Janssen roughly $1 Billion Dollars.

pg. 8: 8.1:

"Defendants pre launch marketing plans anticipated that up to 85% of Risperdal sales would be to Public Sector Payors, like Texas Medicaid. ..... (pg 9) Defendents developed a marketing plan based on misrepresentations and concealment of material facts to tout the superiority, cost effectiveness, appropriate use, safety and efficacy of Risperdal and to promote the drug to a wider patient population."

The following block quote - at 1st read - appears little different from the issues noted by other bloggers and sites. The key difference here, is that the State of Texas is saying "Now See Here You, ..... You, ..... ARE, ...... Going To Pay, Big Time."

Pg. 10: 9.2:

"Defendants used sophisticated strategies and tactics to disseminate misrepresentions about Risperdal to Texas Medicaid prescribers and decision makers about Risperdal's safety, superiority, appropriate use, efficacy and cost effectiveness. These strategies included control over speeches and publications by individuals deemed by Defendants to be "key opinion leaders" and advocacy group messages. Defendants used tactics such as initiating, controlling and producing scientifically insignificant-studies (small scale clinical trials, investigator initiated research, and pilot studies), ghost written publications, and/or letters to editors of professional journals, and seemingly independent articles related to non-FDA approved indications, some of which were ghost-written, for marketing and public relations purposes. Defendants engaged in such tactics to "seed the literature" and "increase the noise level" in the public and healthcare communities about Risperdal, thereby priming the market and influencing Texas Doctors to prescribe Risperdal to vulnerable populations for which Risperdal had no FDA approved indication. Also, Defendants compromised the objectivity of researchers, prescribers and public mental health decision makers by deeming them to be "key opinion leaders," "advisors," and "experts" and providing inducements including research funding, consulting fees, extravagant meals, and travel accommodations, honoraria, and enhanced professional reputation. This compromised objectivity led to the publication of biased research in favor of Risperdal, which was disseminated by the Defendants sales force, medical science liasons and public sector marketing representatives when they called on Texas prescribers and decision makers."

pg. 12: 10.2:

"Defendants did not limit their claims of safety or efficacy to the treatment of the very small adult population believed to suffer from schizophrenia and bipolar disorder."

Notice the Texas AG's use of the word Believed. We, are Not imputing Any motive to the Texas AG for choosing that particular word.

But, Our observation remains that:

We believe Bullwinkle J. Moose to have a better chance of reliably pulling rabbits out of his tophat than Psychiatry has of digging up any Bio Causative, Snarling Rhino justification for poisoning 1st Amendment Violations.

pg. 24: 17.4:

"As a result of Defendant's conduct, Plaintiffs (State of Texas) suffered harm and are entitled to recovery under common law fraud, including actual damages and prejudgment interest. Plaintiffs invoke in the broadest sense all relief possible at common law, whether specified in this pleading or not."

Black's Law Dictionary tells us that fraud is:

"All multifarious means which human ingenuity can devise, and which are resorted to by one individual to get an advantage over another by false suggestions or suppression of the truth. It includes all surprises, tricks, cunning or dissembling, and any unfair way which another is cheated."

Common Law? Isn't that Your 7th Amendment: the one FDA wants to pre-empt?

"In Suits at common law, where the value in controversy shall exceed twenty dollars, the right of trial by jury shall be preserved, and no fact tried by a jury shall be re-examined in any Court of the United States, than according to the rules of the common law."



As Genita Petralli noted in the 7th (0:44) CCHR video "Making A Killing" there is no such thing as a 'side effect'. There are only DIRECT EFFECTS.

If a drug produces effects other than those it is marketed to produce, calling those additional deleterious effects - from Bad Breath to Murder - "Side Effects", is sheer Hokum shielding their purveyors from the Legal Consequences of Inflicting those Direct Effects in the 1st place.

Back to Texas:

pg. 9: 8.1: (continued)

"The older prescription antipsychotics, typicals, have been available in generic form for many years, since before the atypicals came onto the market. The availability of the typicals in generic form means that patients and state health programs pay pennies per pill rather than the dollars per pill incurred for the purchase of newer, patented atypicals. Defendents viewed Government fiscal responsibility as a barrier to the overall success and tremendous profit potential of Risperdal. To overcome this barrier, defendents sought to distinguish their product, Risperdal, by improperly claiming that it was safer, more effective and more econmonical based upon patient outcomes."

The older prescription antipsychotics, typicals, include Stelazine, Thorazine and Haldol (another "humanitarian" leap forward from Janssen). The typical antipsychotics Stelazine and Thorazine are phenothiazine based, and Wiki has haloperidol/haldol exhibiting similar pharmacologic effects to phenothiazines.

In 1934 the USDA developed phenothiazines as insecticides, (backstory) and now Texas is petitioning J&J/Janssen for improperly claiming that Risperdal was safer and more effective than, ..... WHAT?

In Oct 2006 Risperdal was FDA approved to 'Treat' irritability in Children ages 5-17 with autism: and up to 85% of the Texas cost for Risperdal - in Dollars rather than typical antipsychotic Pennies - is alleged to have been Fraudulently targeted at Whose, ..... TAXES?

Mr. and Ms. America, Is This what you Really want Your Money spent on?

We have to wonder how J&J/Janssen will feel if, or when, the Remaining State AG's file similar $1 Billion Dollar petitions.



And just as abruptly as That, ..... America needs a rallying cry:

"Emory or Bust"

$9.3 Million of Tax Funded, NIH, Chemical Factory Advertising Grant, ..... WSJ 10/06/08.

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