Johnson & Johnson’s incoming CEO, Alex Gorsky, could be ordered to give sworn testimony in a Risperdal lawsuit, according to US government lawyers.

J&J has declined to make Gorsky available for a deposition in the case, which concerns the alleged payment of ‘kickbacks’ to health provider Omnicare.

The US government claims that millions of dollars paid by J&J to Omnicare as ‘market share rebates’ were inducements to buy and recommend Risperdal.

J&J claims that the rebates and the promotion of Risperdal were ‘common commercial practices’ that did not violate any law.

The case forms part of J&J's ongoing struggle to defend its marketing of the antipsychotic drug in the US against claims that it exaggerated the drug’s benefits and downplayed or concealed its risks.

Risperdal (risperidone) is approved as a treatment for schizophrenia and bipolar disorder in adults and behaviour problems in young people.

The company faces a cluster of lawsuits, both civil and criminal, based on allegations that it over-promoted the drug.

The US government has claimed that from 1999 to 2004, J&J gave Omnicare “market share rebate payments conditioned on Omnicare engaging in ‘active intervention’ programs for J&J drugs,” which it provided to nursing homes.

Gorsky succeeds Bill Weldon as CEO of J&J on April 26.

While with J&J subsidiary Janssen, Gorsky “was in a position to know why J&J chose not to inform Omnicare (or members of Janssen’s own sales staff) that, in January 1999, the FDA had warned J&J that marketing Risperdal as safe and effective in the elderly would be false and misleading,” the US filing stated.

Attorney Robert D. Keeling of Sidley & Austin, representing J&J, said that “Mr Gorsky has no reasonable connection to the subject matter of the government’s complaint,” and that the request for his testimony “unnecessarily targets – and thus would unduly harass – J&J’s top executive”.

Omnicare agreed in 2009 to pay $98m to settle civil claims by the US government and various states that it accepted kickbacks from J&J, but the company did not admit liability.

Johnson & Johnson has been fined $1.2bn by an Arkansas circuit court for fraudulent marketing of its antipsychotic drug Risperdal (risperidone).

The judge said the company and its US subsidiary Janssen Pharmaceuticals had lied about the drug’s benefits and risks in order to obtain Medicare reimbursement.

The fine is among the largest ever imposed in a US state fraud case involving a drug company.

J&J, which denies any improper conduct or actual harm, is calling for a retrial.

The judge, Tim Fox, fined the companies $1.19bn for nearly 240,000 violations of the state’s Medicaid fraud law and $11m for violations of its law on deceptive practices.

To date, 11 states have prosecuted J&J over its marketing of Risperdal, which is approved as a treatment for schizophrenia and bipolar disorder in adults and behaviour problems in young people.

Prosecutors have claimed that J&J inaccurately stated Risperdal to be more effective than generic alternatives, while concealing the increased risks of diabetes, stroke and weight gain associated with the drug.

Since reimbursement for Risperdal was available through the state-funded Medicaid system, J&J is accused of defrauding state authorities.

Arkansas attorney general Dustin McDaniel commented that the court’s verdict “sends a clear signal that big drug companies like Johnson & Johnson and Janssen Pharmaceuticals cannot lie to the FDA, patients and doctors in order to defraud Arkansas taxpayers”.

The fine was based on minimum penalties for each individual violation of state law through a prescription or marketing message – coming in this case to over 250,000 violations.

Janssen spokeswoman Teresa Mueller said the company would call for a retrial and, if that was denied, would appeal against the state verdict.

The court “did not show any Arkansas patient was ever harmed by using Risperdal” or “that any Arkansas physician or Arkansas Medicaid was ever misled by the drug’s label or package insert,” she asserted.

In the last year, J&J has reached a $158m settlement with Texas over the marketing of Risperdal and been fined $327m by South Carolina.

At the federal level, the company is in talks with the Justice Department to settle a misdemeanour criminal charge. However, the JoD has rejected a $1bn offer from J&J to settle all outstanding civil charges.

Johnson & Johnson has agreed to pay $158 million to settle a US lawsuit brought by the state of Texas, alleging that it promoted off-label use of its antipsychotic drug Risperdal (risperidone) and misled doctors about its risks.

Witnesses stated that J&J officials concealed data indicating the drug posed a high risk of weight gain and type 2 diabetes, and that it instructed its sales force to promote the drug’s off-label prescription for minors.

The settlement is the latest chapter in the ongoing dispute over J&J’s marketing of Risperdal in the USA (for more details, click here).

The state of Texas had originally sought $579 million in damages, but the company’s payment is reported to settle the dispute – though several other states, including most recently Massachusetts, intend similar lawsuits.

In the Texas court hearing, Harvard Medical School psychiatrist Joseph Glenmullen said that a clinical trial, Study 113, found that about half of people given Risperdal developed diabetes after a year of therapy. In 2000, when the FDA investigated potential links between antipsychotics and diabetes risk, J&J did not provide the results of Study 113 and two related studies.

Earlier in the trial, the court saw an internal memo instructing J&J’s sales representatives to “flood clinics with Risperdal stuff” as part of a 2004 campaign to increase off-label prescriptions for the drug in children and adolescents.

In his final ruling, Judge Roger Couch said of the Study 113 data: “It is apparent to this court that this information was not disclosed because it did not fit the marketing department’s vision for the promotion and marketing of this drug.”

Janssen-Cilag’s antipsychotic Xeplion (paliperidone palmitate) has received approval from the European Commission for the treatment of schizophrenia.

Xeplion is given as a once-monthly injection and has been proven to control symptoms and delay relapse in patients with schizophrenia in four controlled studies.

The drug is indicated as a maintenance treatment in adult patients stabilised with paliperidone or risperidone.

Prevention of future relapses is a crucial goal of schizophrenia therapy and patients who are non-adherent to medication are up to five times more likely to relapse than those patients who continue on medication.

It is hoped that as a long-acting, once-monthly treatment, Xeplion will help to improve medication adherence.

Professor Fernando Cañas, Head of Department of Psychiatry, Hospital Dr Rodríguez Lafora, Madrid, said: “Long-acting injectable antipsychotics such as Xeplion can help patients to maintain continual treatment, thereby reducing the likelihood of relapse. This is imperative not only to reduce the suffering and cost burden associated with relapse in schizophrenia, but to improve the future outlook and overall quality of life for these patients.”

In a longer-term, flexible-dose study involving 849 patients, just 10% of patients treated with Xeplion experienced a relapse compared to 34% of those taking a placebo.

“Xeplion provides healthcare professionals with the opportunity to rethink their overall approach to how they treat schizophrenia by using long-acting therapies,” said Dr Christophe Tessier, Medical Affairs Director, Psychiatry, Janssen EMEA.

“As a once-monthly injection, Xeplion can help healthcare professionals address the issue of non-adherence to medication thus ensuring symptom control and allowing patients to focus on shaping their lives.”