If you had any reservations as to the length a giant pharmaceutical company will go to make a profit then this story may be the one that convinces you.

The Attorney General of Massachusetts, Martha Coakley’s office joined a federal lawsuit yesterday against Johnson & Johnson. The suit contends that, beginning as early as 1999, J&J paid tens of millions of dollars in kickbacks to national nursing home medical products provider Omnicare to get its drugs, especially the powerful antipsychotic Risperdal, prescribed in nursing homes.

This comes a year after the generic version of Risperdal was approved by the Food and Drug Administration (FDA). Officials J&J wrote in a business plan as recently as just a few months ago, “The geriatric market represents Risperdal’s second wave of growth. The aging population will continue to drive market growth well into the next century.”

This means that J&J intended to treat dementia patients with Risperdal even after learning about the side effects.

You see, the problem is that FDA specifically warned that Risperdal considerably raises a dementia patient’s chances of death. J&J might have intended to use early death of senior citizens with dementia as an engine for profit.

Risperdal

Risperdal is an antipsychotic drug that is used to treat schizophrenia. It quells symptoms of the mental disorder. In the mid 90’s it was also touted as a go-to drug for a myriad of mental disorders, but was severely reigned in by the FDA by the late 90’s because the side effects can be pretty severe. It is used for more mild conditions such as bi-polar disorder and over-aggression in autistic children.

The Risperdal side effects include:

• Severe allergic reactions
• Abnormal thoughts
• Confusion
• Drooling
• Fainting
• Irregular heartbeat
• Persistent Flu Symptoms – fever, chills, or sore throat
• Inability to control urination
• Increased sweating
• New or worsening mental or mood changes
• Seizures; Severe dizziness
• Stiff or rigid muscles
• Suicidal thoughts or attempts
• Trouble concentrating, speaking, or swallowing
• Pensiveness
• Unusual bruising
• Vision changes

The drug now competes with the likes of Seroquel, another antipsychotic that is currently facing thousands of lawsuits for misstating the side effects.

Currently 1.1 percent of the US population is thought to have schizophrenia, but the antipsychotic market in the US alone was $14.6 billion in 2008. This is opposed to $580 million in 1997 to 2004’s total US sales of just $1.4 billion. It sounded as if J&J needed to find something that would really catapult the sales figures. They found it in Nursing homes.

Anatomy of a Crime

Files full of more than 5,000 pages of official documents were made public by J&J, ordered by the judge in the case as requested by news agencies. The records give a detailed account of a decade-long campaign by Janssen (a subsidiary of J&J) to convince doctors, regulators and insurers that Risperdal was superior to older, cheaper antipsychotics.

It is illegal for drug companies to sell their products for off label uses.

The federal lawsuit details an elaborate program by J&J and Omnicare to allegedly convince resident physicians in nursing homes to prescribe Risperdal. Within the documents released, one was from 1999 in which Omnicare offered J & J’s sales team a list of nursing home physicians who had been resistant to prescribing the antipsychotic.

“These names were provided to the sales force in an effort to increase the call frequency on these resistant prescribers and to eventually influence them to use more Risperdal in the elderly demented patient,’’ the e-mail said.

Another J&J document, this one from 2003, showed that doctors accepted recommendations from Omnicare’s force of 900 consultant pharmacists more than 80 percent of the time.

Between 1999 and 2004 sales of J&J products to Omnicare nearly tripled from around $100 million to over $280 million. Annual purchases of Risperdal alone rose to over $100 million, the suit contends.

Omnicare then filed for reimbursement for these purchases, seeking payment from Medicaid, the joint federal and state health program for the poor, which pays for nursing home care for many seniors.

Protect Yourself and Loved Ones

Omnicare agreed in November of 2009 to pay $98 million to settle federal charges it took kickbacks. This may only be a fraction of what they actually received.

Johnson & Johnson is still fighting and are vowing to take this all the way.

J&J spokeswoman Carol Goodrich said yesterday that “airing the facts will confirm that our conduct, including rebating programs like those the government now challenges, was lawful and appropriate.” She added, “We look forward to the opportunity to present our evidence in court.”

Making a profit something that drug companies are very good at. Accountability on the other hand is perhaps their worst trait. This is why lawsuits are so important. Profit is the only thing that the large corporations see and the loss of profit is the only way they’ll learn that they have rules that they need to follow. The rules aren’t there to punish them. The rules are there to protect consumers.

If you or a loved one have been adversely affected by the conduct of Johnson & Johnson, Omnicare, your nursing home, or Risperdal call Phillips Webster today for a consultation on your legal options.

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