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 FDA 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 pharmacies improperly conspired with manufacturer Johnson & Johnson to switch vulnerable long-term care patients from similar anti-psycohotic medications (medications in the same “therapeutic class”) to the more costly Risperdal because of Johnson & Johnson’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. Kickback payments taint any claim submitted to the government. 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.

Levaquin ® (levofloxacin)

Levaquin® is an antibiotic, manufactured by Ortho McNeil, which is a wholly-owned subsidiary of Johnson & Johnson. All forms of this drug require a prescription. Levaquin is prescribed for serious infections common to long-term care facilities. Competing drugs include Cipro (ciprofloxacin) and Floxin (ofloxacin). Allegedly, Johnson & Johnson and Omnicare conspired to switch many antibiotic prescriptions for Omnicare-serviced patients to Levaquin. Omnicare’s long-term care pharmacies dispensed numerous Levaquin prescriptions annually.

Relator Lisitza’s complaint alleges that wholesale switching to Levaquin at Omnicare facilities was detrimental to patient care. While there are many medications within the same antibiotic drug class as Levaquin, only certain types of antibiotics are indicated for particular types of infections. Levaquin is not indicated for many types of infections that are very common in long-term care facilities. For example, nosocomial pneumonia is a common problem in long-term care facilities.

Allegedly, Johnson & Johnson improperly conspired with Omnicare to switch vulnerable long-term care patients from similar antibiotic medications (medications in the same “therapeutic class”) to Levaquin. Such switches can be dangerous to patient wellbeing. The complaints allege that Omnicare entered into a market share agreement with Johnson & Johnson where Johnson & Johnson paid Omnicare for switching, effectively en masse, all Omnicare patients who were taking similar medications to Levaquin.

Ultram ® (tramadol)

Ultram® is a pain reliever, manufactured by Ortho McNeil, which is a wholly-owned subsidiary of Johnson & Johnson. Ortho McNeil also manufactures tramadol in combination with acetaminophen – this combination is marketed as Ultracet (below “Ultram” will refer to both Ultram and Ultracet). All forms of this drug require a prescription. Ultram is prescribed to treat pain in long-term care facilities. Competing drugs include Tylenol #3, Tylenol #4, Darvocet, and vicodin. Allegedly, Johnson & Johnson and Omnicare conspired to switch may pain medication prescriptions for Omnicare-serviced patients to Ultram. Omnicare’s long-term care pharmacies dispensed numerous Ultram prescriptions annually.

Relator Lisitza’s complaint alleges that wholesale switching to Ultram at Omnicare facilities was detrimental to patient care. Although Ortho McNeil marketed Ultram as non-addictive, and thus ideal for patients with chronic pain, Ultram can cause psychic and physical dependence. Thus, treating Omnicare patients with Ultram instead of other pain medications may have led patients to addiction and potentially severe withdrawal symptoms.

Allegedly, Johnson & Johnson improperly conspired with Omnicare to switch its vulnerable long-term care patients from similar medications (medications in the same “therapeutic class”) to Ultram. Such switches of are dangerous to patient wellbeing. Omnicare entered into a market share agreement with Johnson & Johnson where Johnson & Johnson paid Omnicare for switching, effectively en masse, all Omnicare patients who were taking similar medications to Ultram. Payments under the market share agreement to switch patients to Johnson & Johnson’s drug were kickbacks. Payment and receipt of kickbacks used to induce business paid for by government payers is illegal under federal and state laws. Kickback payments taint any claim submitted to the government. Providers, such as Omnicare, must certify that they comply with kickback law to receive government payment.