June 1st, 2010

Mass. joins lawsuit against Johnson & Johnson

Massachusetts is joining a U.S. Attorney-filed federal lawsuit against Johnson & Johnson. It alleges that the drug company paid kickbacks to boost the number of elderly nursing home patients taking anti-psychotic drugs like Risperdal. According to the complaint, the company’s actions during 1999 to 2004 violated the federal anti-kickback statute and False Claims Act. It alleges Johnson & Johnson paid its customer Omnicare, Inc., the nation’s largest long-term care pharmacy, tens of millions of dollars to have Omnicare pharmacists recommend Risperdal for nursing home patients with Alzheimer’s and dementia symptoms.

The payments, it alleges, were structured to subvert federal law and drug reimbursement was sought through Medicaid. During that period, Omnicare’s purchases of Johnson & Johnson drugs increased from approximately $100 million to more than $280 million. Risperdal purchases rose to $100 million plus. Omnicare paid $98 million to settle a federal civil complaint claiming that it, too, violated the False Claims Act.

The Massachusetts lawsuit will allege that Johnson & Johnson engaged in unlawful promotion of Risperdal for an off-label use. Although physicians are legally permitted to prescribe drugs for off-label uses, pharmaceutical companies are not allowed to market off-label uses. Risperdal is approved for treating patients with psychoses like schizophrenia.

Massachusetts Attorney General’s Office Deputy Press Secretary Jill Butterworth says, “the office remains concerned about the inappropriate off-label marketing of anti-psychotic drugs to nursing homes because it is a significant health and safety issue for seniors. In the past, we have taken a very strong action on this issue and we continue to monitor it. [However] the complaint won’t be limited just to off-label marketing.”

Federal law requires monthly reviews of nursing home patients’ medications by an independent pharmacist in order to help avoid overmedication. The lawsuit claims Omnicare employed more than 900 of these consultant pharmacists, who in turn were doing Omnicare and Johnson & Johnson’s bidding by encouraging physicians to prescribe these drugs rather than scrutinizing drug regimens with an independent eye.

The complaint says that the pharmacists’ recommendations were accepted 80 percent of the time.

The concern is that powerful drugs like Risperdal are used excessively to substitute for adequate nursing staff; the federal complaint referred to it as a “chemical restraint.” Patients overmedicated with anti-psychotics would likely receive less psychological treatment.

Carol Goodrich, Johnson & Johnson’s director of corporate media relations, states, “We will address the government’s lawsuit in court. We believe airing the facts will confirm that our conduct, including rebate programs like those the government now challenges, was lawful and appropriate.”

By Elinor Nelson

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