Posted On: April 26, 2010

Massachusetts Nursing Home Kickback Scheme Lands Johnson & Johnson In Federal Court - PAa 2 of 2

In my previous post, I reported on the fact that Johnson & Johnson has been dragged into court by the United States Attorney in Boston, accused of hatching an elaborate scheme to press nursing home doctors to prescribe J&J’s anti-psychotic drugs, including Risperdal, to Massachusetts nursing home residents who were not suffering from mental illness or psychosis, but only dementia. Critically, it is widely known in the medical and geriatric care communities that the use of anti-psychotic medications in patients suffering from dementia, doubles the risk of death. The “marketing” scheme was a twisted effort by J&J to increase sales of their anti-psychosis drugs even higher than the $100 million in annual sales they were previously enjoying.

Antipsychotics were approved by the U.S. Food and Drug Administration (FDA) to treat people with severe mental illness – such as schizophrenia. While many of these medications have brought relief to severely mentally ill patients, and while they have their valid place in medical practice, in general they produce horrible side-effects. These unavoidable side effects include:

Dystonia - A neurological movement disorder in which sustained muscle contractions cause twisting and repetitive movements or abnormal postures. Essentially, this condition can reduce someone to an involuntary mass of body spasms, or twist you into distorted postures.
Parkinsonism – Muscle rigidity and muscle tremors; Essentially, this can reduce the body or parts of it, to being as stiff as a board.
Akathisia - A syndrome characterized by unpleasant sensations of "inner" restlessness that manifests itself with an inability to sit still or remain motionless. This condition can produce symptoms ranging from anxiety, to a complete inability to still or stand still.
Tardive dyskinesia, A condition in which the sufferer may show repetitive, involuntary, purposeless movements often of the lips, face, legs, or torso. These involuntary, purposeless movements usually occur in the face and lips, reducing someone’s expression to a mass of jerking tics.
Pancreatitis – An extremely painful and emiserating condition, leaving one’s midsection enflamed, swollen, and producing severe fevers.
Seizures – Causing patients to be constantly exposed to horrid and frightening neurological attacks, never knowing when the next one is to come – not to mention the brain damage that can result from seizures.
Diabetes – Placing patients at risk of losing their limbs due to amputations often necessitated by the disease.
Neuroleptic malignant syndrome, in which the body’s temperature regulation centers fail, resulting in a medical emergency, as the patient's temperature suddenly increases to dangerous levels. Essentially, the patient is subjected to sudden, high-grade fevers that are usually witnessed in the worst if influenza infections.

The list of these well-known side effects goes on and on. Now you know why it’s widely estimated that approximately two-thirds of mentally ill patients who are prescribed many anti-psychotics, stop taking them: They’re known as the “Treatment that’s worse than the disease.” And all of the above side-effects, and more, pale in comparison to the most widely-known side-effect of these drugs: That when given to patients suffering from dementia, they double the risk of premature death.

So how were J&J, and their criminal co-conspirator OmniCare, able to do this? Because as with many drugs approved by the FDA to treat specific illnesses and conditions, it is nonetheless legal for doctors to prescribe drugs, including anti-psychotics, “off-label” for other purposes. While that practice may be strictly legal when engaged in by individual doctors with individual patients, J&J engaged in a widespread, full-blown campaign to aggressively market their drugs to nursing homes as being appropriate, even desirable, for use with patients not suffering from mental illness, but merely dementia. Under J&J’s and OmniCare’s scheme, J&J quietly (and illegally) paid OmniCare millions in kickbacks to push these drugs to nursing home doctors. Once OmniCare sold these antipsychotics to nursing homes, it actually then filed for reimbursement from Medicaid for purchasing these drugs from J&J. Medicaid is the joint federal-state health care program for the poor – which pays for nursing home care for many poor seniors.

I trust you see the added hook here for OmniCare – not only did this scheme allow them to grossly increase their sales of these anti-psychotic drugs to nursing homes, but the fact that they were selling to nursing homes that cared for many poor elderly patients, allowed OmniCare to then bill Medicaid for the cost of buying these drugs from J&J in the first place, (who also paid OmniCare kickbacks for purchasing the drugs from them.) End result: J&J, the drug manufacturer, massively increased sales of their anti-psychotic drugs to their distributor, OmniCare (from $100 million to $280 million.) OmniCare received millions of dollars in kickbacks from J&J on the front end, for buying higher amounts of these drugs from J&J, and then OmniCare illegally billed Medicaid on the back end for reimbursement of the cost of purchasing the drugs from J&J, since the drugs were administered to low-income or indigent nursing home residents.

And the thousands of powerless Massachusetts nursing home residents who were needlessly pumped full of these mind-altering anti-psychotic drugs? There were less than nothing; an afterthought in this twisted scheme. As to just how many Massachusetts nursing home residents were victimized in the process of bloating both J&J and OmniCare’s profits, consider this: The Massachusetts Attorney General reported that a whopping 28 per cent of Massachusetts nursing home residents were given these anti-psychotic drugs, last year alone. Of that figure, 22 per cent were not mentally ill or did not have a medical condition that warranted such extreme treatment. This rate was the 12th highest in the nation.

Pretty sick, isn’t it? Yet nothing new for huge corporations like this.

This sad and sick story illustrates two key points: 1) Massachusetts nursing home abuse and neglect is rampant – far more common than most people can imagine – and it’s not always committed by a cruel or thoughtless health aide, acting alone. In this case, the abuse was actually aided and abetted by nursing home doctors who didn’t question either J&J’s or their distributor’s (OmniCare’s) claims about the use of these anti-psychotic drugs with patients who were not suffering from mental illness or psychosis. 2) This twisted story illustrates how Massachusetts and the rest of this country must remain vigilantly opposed to big business and corporate efforts to enact “tort reform”. As I’ve said before, “tort reform” is nothing more or less than an effort to re-write liability laws, to allow big business and others to commit wrongdoing, and be shielded from the lawsuits that would hold them accountable. Thankfully, we haven’t reached that stage yet in Massachusetts, which is one reason why nursing homes and their doctors will think twice about engaging in such irresponsible and unethical conduct in the future: Because they’ll pay in court if they don’t.

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Posted On: April 22, 2010

Massachusetts Joins U.S. Attorney In Accusing Johnson& Johnson of Kickback Scheme With Nursing Homes – Part 1 of 2

This case is filed under “Nursing Home Abuse and Neglect” on this blog for a good reason: That’s exactly what it is – except that the abuse wasn’t committed by a lone employee of a single nursing home, who ended up abusing patients. It was committed by a conspiracy among a multi-billion dollar pharmaceutical firm, dozens of separate nursing homes, and doctors and nurses also. If true (and to date, I see little evidentiary reason not to believe the allegations) it is a sickening story of corporate and individual greed, compounded by some of the worst examples of human cruelty to the most frail and forgotten members of society – nursing home residents.

By all credible accounts, the story seems to have unfolded as follows: Pharmaceutical giant Johnson & Johnson apparently paid tens of millions of dollars to a firm called OmniCare, which although most people have never heard of, happens to be the nation’s largest provider of pharmaceutical drugs to nursing homes. The illicit payments were designed specifically to entice and assure that the company (OmniCare) aggressively and intensively pushed several of its drugs, particularly the powerful antipsychotic drug Risperdal, to nursing home doctors, using aggressive rebate programs and other financial incentives. The scheme is alleged to have lasted from 1999 to 2004. What’s the problem with that, one might ask – don’t some nursing homes need antipsychotic medications? Yes, but the twisted cruelty and malignancy here, is that Johnson & Johnson and OmniCare aggressively waged a campaign with nursing homes and their doctors to prescribe antipsychotics such as Risperdal, to patients suffering from dementianot psychosis. J&J marketed their antipsychotics as a legitimate, valid medication to “sedate and control” patients suffering from dementia, when it was originally designed and approved to treat severe mental illness.

That twisted marketing campaign resulted in J&J nearly tripling sales of its antipsychotic drugs to OmniCare, from approximately $100 million just before the scheme began, to in excess of $280 million when the operation was discovered by government investigators in 2004. Imagine - - $100 million in sales (of these drugs alone) was not enough for J&J: They concocted this twisted scheme to fatten their profits even more, all the while risking the health and lives of tens of thousands of helpless nursing home patients. It is well- known in the medical profession that prescribing antipsychotics to patients suffering from dementia more than doubles their risk of death due to these medications. But that didn't phase J&J, nor OmniCare, in their insatiable quest for more profits.

Before anyone thinks that dementia and psychosis are similar, let me assure readers of this blog, as someone who is very familiar with nursing home practices and medical issues related to dementia, that dementia and psychosis are completely, totally different illnesses, and to deliberately try to lump them together and push these mind-altering drugs into a population that is least capable of defending themselves, and doubling their risk of death, is beyond sick. It is among the most disgusting stories of corporate greed I have encountered in my legal career. Yet, it is nothing new for corporate America: The crazed drive for greed and financial gain at any cost to human life and human dignity, controls so much of corporate America. It has, for so long. If anyone doubts this, think of these names: Ford Pinto, The Dalkon Shield, Philip Morris, W.R. Grace, Lehman Brothers, AIG, Goldman Sachs, the banking industry, the insurance industry, Toyota, on and on. It never seems to end. I’ll provide more details on this elaborate corporate scheme, in my next post.