Posted on Sunday 25 March 2012

Texas, Johnson & Johnson heading back to court
By Corrie MacLaggan
March 25, 2012

Representatives of Johnson & Johnson and the state of Texas will head back to court on Tuesday over a $158 million settlement agreement announced in January involving the drug Risperdal, a spokesman for Texas Attorney General Greg Abbott said on Sunday. "As far as we knew, we had a solid settlement," said Tom Kelley, Abbott’s spokesman. "We’ll have more information on Tuesday about what has caused (Johnson & Johnson) some concerns."

A spokesman for Johnson & Johnson did not immediately respond to questions about the hearing before state District Judge John Dietz in Austin. Johnson & Johnson said in January that it would pay $158 million to settle a Texas lawsuit that accused the drugmaker of improperly marketing its Risperdal anti-psychotic drug to state residents on the Medicaid health program for the poor.

The settlement would fully resolve all Risperdal-related claims in Texas, the company said at the time. The agreement – the largest Medicaid fraud recovery ever in Texas – was specific to the Lone Star State and did not involve other state or federal Risperdal litigation. The deal marked the first Risperdal settlement with any U.S. state. It settled claims brought by Texas in 2004 involving alleged Medicaid overpayments during the years 1994 to 2008. The settlement was to be paid to the original plaintiff, his attorneys, the state of Texas and the federal government, which provides Medicaid reimbursements, the company said in January.

Tom Melsheimer, a lawyer for plaintiff Allen Jones, said on Sunday that the hearing on Tuesday is "just to finalize the settlement." But Jones, a whistleblower on J&J’s marketing practices, said the sticking point is that Johnson & Johnson wants to reduce the amount of the settlement that he and his attorneys receive. Johnson & Johnson "has reneged on the agreement and it’s back in court," Jones said. "They are trying to produce a chilling effect on the ability of whistleblowers to come forward."

What is it about the word "settlement" that Johnson & Johnson doesn’t understand? I have no idea what this is about, but I’m not surprised. Johnson & Johnson’s behavior throughout this whole affair has been maddening, and this is no exception. But having seen Judge Dietz in action, I doubt he will tolerate much in the way of sheenanigans.

On overnight reflection, I think Allen Jones’ analysis must be correct ["They are trying to produce a chilling effect on the ability of whistleblowers to come forward"]. From their point of view, their problem was a whistle-blower, and that’s the mentality that is the tragic piece of this story from its beginning. The problem in this story is certainly not that they got exposed, it’s what they actually did that’s the problem. I wonder if the powers that be at J&J have taken a break from their damage control stance, and actually pondered their corporate climate and how really sick it had become? or are they still so corrupted by it that it still has them in its grip? or perhaps they’re frightened by what’s lies ahead [Trial set for Ark. suit over anti-psychotic drugs]? It’s going to take a lot more than a BAND-AID® to get J&J on a reasonable path…
    Joel Hassman, MD
    March 26, 2012 | 12:31 PM

    These ongoing lawsuits over second generation antipsychotics really has made me start to wonder if at some point a physician does assume some culpability for writing for these drugs outside any legitimate indication, note I did not just use the simple term “FDA approved indication”, because the latter is not truly legitimate just because some people in Washington were either bought off or just clueless in reviewing the claims for an indication by a drug.

    Part of me would like that, to get these unqualified physicians and other non mental health providers who are writing for psychotropics like Pez these past 10 or so years, but also part of me is genuinely concerned that even when prescribing a medication with a clear documented efficacy for the problem in front of me, the litigation-hungry crowd will scream for blood WHEN the random chance 5% of negative outcomes come to pass.

    I am not interested in debating with the commenters who are eager to see all psychotropics tossed in the garbage heap, but those who have had positive experiences with responsible prescribing providers who give the full Risk/Benefit profiles when giving prescriptions but had a less than desireable experience with the trial medication.

    What defines culpability and just being unlucky taking a legitimate medication? And is there really just one answer, or once again we see the world of gray being doused with 55 gallon drums of black or white by narrow minded combatants?

    March 27, 2012 | 3:08 PM

    As the mom of a teen son who does take these types of meds for Bipolar 1, the biggest problems I see are how casually the doctors take prescribing psych meds. I also see a problem in how the doctors always want to increase the dose when you don’t get the desired effect from a low dose.. They never seem to think that maybe it’s just the wrong med and the undesired effect at a low dose is the primary indicator of that. Also, you almost never see a psychiatrist wanting to lower a dose or wean from a med unless the patient insists on it. Those are all problems.

    My son has had what I would consider to be great and highly trained (Stanford, Johns Hopkins) and experienced psychiatrists over the years and yet when they prescribe meds they rarely mention possible side effects or possible drug interaction issues (ex. Lithium and Advil – which we had to learn the hard way). Then when there are side effects they always seem a bit shocked. Why? I have no idea. Selective ignorance, I guess, because these meds are chock full of potential side effects and they know it. These meds aren’t candy and although they can help and be real life savers they can also cause serious long term health problems which no one ever seems to mention. The meds given to help problems can also make immediate symptoms worse, which then inevitably gets attributed to the suspected mental illness and not the meds themselves – therefore causing even more problems.

    We used to live in Texas and my son had a grand mal seizure from being on a combo of Adderall and Risperdal. At the time the psychiatrist’s answer to the craziness the Adderall (prescribed for ADHD) was causing was to just add Risperdal on top of it. And then he kept upping the Riserpdal when it didn’t help. Like idiots, we as parents followed his suggestions until my son went completely psychotic, started hallucinating, and then dropped to the floor in a grand mal seizure. That was the end of us using psych meds for about 6 years until my son got to where he really needed them again to function. And that psychiatrist never did apologize or even mention that his suggestions may have been ‘off’ (we, of course, dropped him).

    So yes, I do think the doctors should share in some of the blame. They should take these meds more seriously and care more for the negative impact they can potentially have on their patients lives.

    Conversely, the patients and parents of patients need to buck up and be more assertive with their psychiatrist. Patients need to do research, know what they will take and won’t take and why and make that clear to your doctor. Pharm companies do push and pull ad campaigns targeting the general consumer and the general public needs to use this model with doctor/patient relationships as well to decide what we won’t take in addition to what we will. If ‘death’ is a top 10 listed side effect of a med advertised on TV, people probably need to say no to using it unless death without it is a higher possibility.

    March 28, 2012 | 9:10 PM

    Dr. Hassman, psychiatry’s crap science is a minefield for clinicians, isn’t it?

    April 2, 2012 | 7:18 PM

    Allen Jones’ analysis …”They are trying to produce a chilling effect on the ability of whistleblowers to come forward”.

    One small quibble: they are attempting to maintain and heighten a chilling effect…

    Believe me, the temperature is already below freezing.

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