Risperdal (Risperidone)
Omnicare® 2009 Case

Risperdal is the trade name version of generic Risperidone, an atypical antipsychotic medicine. Risperdal is manufactured by Janssen (a wholly-owned subsidiary of Johnson & Johnson). All forms of this drug require a prescription. Risperidone is used to treat schizophrenia, bipolar mania, and irritability in autistic children. Omnicare’s long-term care pharmacies dispensed numerous Risperdal prescriptions annually

In April 2003, Janssen sent out a “Dear Healthcare Provider” letter indicating that: (1) Risperdal enhanced the risk of cerebrovascular events such as strokes, and (2) Risperdal was neither safe nor effective when prescribed for dementia-related psychosis. Risperdal is not approved for dementia-related psychosis and is associated with an increased risk of death for such patients. Risperdal is also associated with an increased risk of hypotension for elderly patients. Additionally, Janssen’s Ridperdal package insert states that treatment of schizophrenic patients did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently to Risperdal than younger patients. Lastly, interactions of Risperdal and other drugs have not been fully studied.

Allegedly, Omnicare improperly conspired with manufacturer Janssen to switch its vulnerable long-term care patients from similar anti-psycohotic medications (medications in the same “therapeutic class”) to the more costly Risperdal because of Janssen’s payment of kickbacks to Omnicare. Payment and receipt of kickbacks used to induce business paid for by government payers is illegal under federal and state laws. The taint of the kickback payment makes any claim submitted to the government for switched-to drug improper. Providers, such as pharmacies, must certify that they comply with anti-kickback laws to receive government payment. If they take kickbacks, the certifications are false and both parties to the kickback must pay damages to the government.