Thursday, August 11, 2011

J&J, Feds Reach Deal On One Risperdal Charge

Fierce Pharma has;

August 10, 2011 — 10:32am ET | By

Johnson & Johnson ($JNJ) has come to terms with the Justice Department on one Risperdal marketing charge. It's a single misdemeanor, stemming from a long-running investigation of allegations that the company promoted its antipsychotic drug Risperdal for off-label uses. But that doesn't mean the company's DoJ negotiations are at an end--far from it, Bloomberg reports.

The feds are "continuing to pursue both criminal and civil actions," J&J said in a quarterly filing. "Discussions have been ongoing in an effort to resolve criminal penalties...Certain issues remain open before a settlement can be finalized." The government has also decided to join "multiple" whistleblower lawsuits against J&J's Janssen Pharmaceuticals unit, all of which deal with Risperdal marketing practices.

Meanwhile, there are the feds' civil investigations; J&J says it's in negotiations to settle those, too. The probes involve sales of Risperdal and Invega, a follow-up antipsychotic drug. Almost a dozen state attorneys general have sued for deceptive marketing or misleading claims about the drug. And AGs in 40 more states are considering joining the fray. The company disclosed that the state lawyers "have indicated a potential interest in pursuing similar litigation."

The good news for J&J is that settling the federal probes isn't expected to hurt the company's financial position. J&J in May set aside some unspecified amount to cover Risperdal-related legal costs, and now says it's adding to that fund to cover criminal penalties.

Without a dollar amount attached to the misdemeanor charge, it's tough to put this potential settlement in context. Other antipsychotic marketing probes have resulted in no criminal charges, but a big payment--AstraZeneca agreed to pay more than $500 million to resolve Seroquel-related claims, for instance. Eli Lilly's Zyprexa settlement included a $515 million criminal fine on a misdemeanor charge, and another $800 million in civil claims. But it's probably safe to say that we're not looking at a Pfizer-type deal: The settlement covering Bextra marketing included a felony plea--and a total of $2.3 billion in payments.

- read the Bloomberg story

Related Articles:
Another AG sues J&J over Risperdal marketing
WSJ: Feds want $1B settlement in J&J Risperdal probe
J&J earmarks funds to settle Risperdal probe

Thank You Fierce Pharma and Ms Staton

IF you read the filing from the Massachusetts Attorney General, Massachusetts Sues J&J Over Risperdal Marketing (Thank You Pharmalot) you'd find This on page 21:
“95. The Company also understood that Risperdal had unique disadvantages, including, “more likely to cause extrapyramidal symptoms (EPS), including tremor and stiffness; higher long-term risk of tardive dyskinesia (TD); more likely to cause increased prolactin levels, gynecomastia, lactation; 4 [and] causes significant weight gain (which can be advantageous in children with ADD who are often too thin).” Id. at JJRE07998951.”
Which raises the bar Considerably regarding culpability in the area of Intent from J&J.

The Company KNEW Risperdal was MORE Likely to CAUSE EPS?

So Who told them? Might it have been the FRAUDS who sold/prescribed $29 Billion worth of Risperdal for them down at street level?


And what Else have J&J "Known"?

You gotta wonder if J&J also "Knew" that their Risperdal was Useless for Vets who've been slimed with a PTSD label too? Maybe J&J ought to have the New York Times do their Clinical Studies for them from now on, because the NYT seems to be able to figure out stuff that Psychiatrists with their all knowing, all seeing, all Insurance Company Compliant DSM Telephone Book of Billing Codes can't seem to figure out.

But then you really can't blame the Psychic Fraudsters, when they're not even bright enough, after All these years, to realize that if the Veterans Administration can't even make Risperdal or any Other antipsychotic produce a Single 'Positive Outcome' ...... YET, ..... for the Psychiatric Opinion it was primarily developed and marketed for - Schizophrenia - they're not likely to Ever, "Know" ..... "Something, ..... from Shineola."

"Though a positive outcome has not been observed with the NJ Algorithm to date,researchers suspect that a larger sample size might generate significant findings in the future."

No matter which drugs singly or in which combination, no matter Which idiot Why Psychotherapies Never Get Better 'Bait & Switch' Brain Washing Mind Control, It AIN'T Healthcare Theories they offer our Vets, there has been "No Positive Outcome", ...... except of course for Russia & Communist China.
We've posted this next block of screed as a comment, and with all of the "Who knew What and who Didn't know What from When from a 97% profit of $28.90 Billion - - on Risperdal:

it bears repeating.
With 2 posts, just 2, these Doktors are left with only 1 Courtroom excuse.

They're too stupid to be Doctors. If they admitted that they Do know what they're doing, any jury in the land would throw the book at them in a 12 to nothing heartbeat.

These people make 6 figures. They work with these drugs 40 hours a week, for Decades. It's their Job & their Responsibility to know what these drugs are.

But they're 'Off The Hook' because the manufacturer wrote them a false and misleading Dear Healthcare Provider Letter.

It's intentional. It's wink and a nod, because a private Citizen has a Snowball's chance in Hell of suing a Drug Company, so the Drug Company takes the heat by pretending to deceive their pseudo-Doctors who peddle their drugs at street level.

But then what can you expect from an industry which reveres an extra-marital affair peddling, horoscope casting Gasbag who claimed that Hitler was a Demi-Deity? (since their Freud Fraud has Already been pretty much yanked out from under them)

So, ....... America; How much longer are you going to let this Psychiatric Punch & Judy Charade continue?

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