Janssen: Risperdal Sales Targets and the Risks Behind the Pitch

In the Janssen Risperdal fraud settlement, Janssen and Johnson & Johnson agreed to $1.391 billion in civil payments over alleged off-label promotion and prescription kickbacks involving Risperdal and Invega. The government alleged that Janssen targeted elderly dementia patients while downplaying serious risks. Nursing home residents took the drug, and Medicaid programs paid for prescriptions the government said those programs should never have covered.

The Department of Justice announced the resolution on November 4, 2013. Janssen Pharmaceuticals was the Johnson & Johnson subsidiary selling the antipsychotic drugs.

This pharmaceutical fraud case connected the manufacturer’s sales targets, what it told prescribers and what Medicaid and other government health care programs paid for. The United States alleged that Johnson & Johnson and Janssen caused false claims through promotion of uses those programs did not cover, misleading safety and effectiveness claims, and payments to doctors to prescribe Risperdal.

What Is Considered Off-Label Promotion?

Off-label promotion means promoting a drug for a use outside the labeling approved by the Food and Drug Administration. In the civil complaint, the government alleged that Janssen’s ElderCare sales force targeted nursing homes and doctors treating the elderly from 1999 through 2005, promoting Risperdal to control behavioral disturbances in dementia patients.

Approval attaches to a particular use. The Food and Drug Administration evaluates whether a drug is safe and effective for the uses specified in its application. The civil complaint alleged that Janssen promoted Risperdal as effective and safe in geriatric patients despite the agency’s warnings and increased health risks.

Public Citizen’s 2018 report, Twenty-Seven Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991 Through 2017, puts the elderly market in perspective. Citing a government filing, it reports that 75 to 84% of Risperdal use among elderly patients was off-label in 2002 and 2003, with approximately half of that use involving elderly patients with dementia. The elderly prescribing figures help explain why a dedicated sales force mattered commercially.

Children Were Another Sales Target

The civil allegations also covered promotion to children and people with mental disabilities. According to the Justice Department’s account, Janssen directed representatives to child psychiatrists and facilities primarily treating children, marketing Risperdal for symptoms of attention deficit hyperactivity disorder, oppositional defiant disorder, obsessive-compulsive disorder and autism. Until late 2006, the drug had no approved use in children.

The government alleged that the companies knew of risks from elevated prolactin, a hormone that can stimulate breast development and milk production. The complaint described growing and protecting the child and adolescent market as a stated business goal. The sales instructions and the safety information again pointed in different directions.

Risperdal Business Plans Targeted the Elderly

The civil complaint described Janssen’s business objective: grow Risperdal’s position in geriatrics and long-term care. The ElderCare sales force allegedly pursued that market despite the Food and Drug Administration’s warnings about promoting the drug to elderly patients.

Those allegations describe a sales system. Management chose the market, assigned representatives to reach it and supplied claims about the drug’s safety and effectiveness. We examine how the business plans and clinical claims fit together, including the instructions that explain why prescribing changed.

The resolution also reached executive pay. Johnson & Johnson’s Corporate Integrity Agreement required changes allowing the company to recover annual bonuses and long-term incentives from covered executives if they or their subordinates engaged in significant misconduct. The provision applied to covered executives still at the company and those who had left.

The Safety-Data Allegations Behind the Sales Pitch

The government alleged that Johnson & Johnson and Janssen downplayed serious risks in elderly patients and that Janssen reshaped how study results reached prescribers. The Justice Department’s account of the civil complaint describes decisions about combining data, publishing findings and commissioning new analyses.

Stroke Findings Were Combined or Left Unpublished

The complaint alleged that a Johnson & Johnson study showed a significant risk of strokes and other adverse events in elderly dementia patients, and that Janssen combined its data with other studies to make the overall risk appear lower. The complaint also described a second study confirming increased safety risks whose results remained unpublished a year after Johnson & Johnson received them.

According to the complaint, a physician involved in that second study warned Janssen that the delay gave the appearance of deliberately withholding findings. For an employee who worked with those results, the dates and versions of the analyses can explain how the risk described internally became the risk described to a prescriber.

Outside Consultants Reworked the Diabetes Analysis

The government alleged that Janssen promoted Risperdal as not causing diabetes despite knowing patients faced an increased risk. The complaint described initial study results indicating a risk similar to that of other antipsychotics. Janssen allegedly retained outside consultants to reanalyze the results and ultimately published articles reporting a lower risk.

That account makes the consultant’s assignment, the original analysis and the published conclusion parts of the same sales story. A clinical employee may understand what changed between them. A sales employee may know how the final claim reached doctors.

The relationship between scientific articles and prescribing also appears in a whistleblower complaint against Amgen. The complaint alleged that tainted studies supported drug-reference listings used in government reimbursement decisions, and stated:

The alleged connection there ran from articles to drug-reference listings and reimbursement. In the Risperdal allegations, it ran through the safety claims used to promote prescriptions. In both accounts, someone who knew the underlying work could explain what the published conclusion concealed.

The FDA Questioned What the Drug Was Being Used to Control

According to the government’s complaint, the Food and Drug Administration repeatedly warned Janssen that marketing Risperdal as safe and effective for elderly patients would mislead prescribers. The complaint described a more uncomfortable point the agency raised: some behavioral disturbances could be responses to deplorable living conditions, raising an ethical question about using an antipsychotic for behavioral control.

That warning went to the purpose of the sales campaign. The government alleged that the company kept pursuing the elderly market despite it. The resident’s behavior was the sales opportunity even where the FDA had questioned whether the living conditions were the problem.

How Do Pharmaceutical Kickbacks Work?

In this case, the alleged pharmaceutical kickbacks paid for influence over prescriptions through doctors and a nursing-home pharmacy. The government’s complaint alleged that Janssen paid doctors speaker fees to induce Risperdal prescribing. Sales representatives allegedly told doctors that receiving speaking payments depended on increasing their prescriptions.

The payment’s stated purpose was speaking. The alleged condition for getting it was prescribing. An employee who handled speaker selection, payments or communications with the doctor may know how that condition operated.

Omnicare provided another route into the nursing home. Its consultant pharmacists regularly reviewed residents’ medical charts and recommended drugs to physicians. That placed them inside the prescribing decision, with recommendations presented as independent clinical judgment.

The government alleged that Johnson & Johnson paid Omnicare through market-share rebates, data-purchase agreements, grants and educational funding to encourage recommendations of Risperdal and other Johnson & Johnson drugs. It alleged that the manufacturer viewed those consultant pharmacists as an extension of its sales force. A payment recorded as purchasing data or supporting education allegedly bought access to the person recommending the medicine.

Johnson & Johnson and Janssen agreed to a separate $149 million civil settlement over that pharmacy-channel conduct. Omnicare had already paid $98 million in 2009 to resolve allegations that it accepted kickbacks from the companies, together with other conduct. Those resolutions addressed the paying and receiving sides of the relationship.

Where the Risperdal Civil Settlement Money Went

The Justice Department assigned $749 million of the newly announced Risperdal/Invega payment to the federal government and $524 million to the states. Medicaid’s joint federal-state funding meant the alleged false claims affected both.

The civil total included $118 million already paid in the Texas settlement in 2012.

Risperdal alone brought in $11.7 billion during its first 12 years after approval, according to Public Citizen’s report, far more than the civil payment for Risperdal and Invega.

Invega was a newer antipsychotic sold by Janssen. The settlement also resolved allegations that Johnson & Johnson and Janssen marketed it for unapproved uses and made false or misleading safety and effectiveness claims from 2006 through 2009. The civil payment covered both products’ promotion and kickback allegations.

The civil settlements resolved qui tam cases brought by whistleblowers under the False Claims Act. The Justice Department announced $112 million for the whistleblowers in the Eastern District of Pennsylvania from the federal share.

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

What Evidence Is Needed to Prove Fraud?

For the conduct alleged here, the evidence connects the company’s sales instructions and clinical representations to prescribing and government-funded healthcare. The useful connection may sit between departments: the person setting a sales target, the person analyzing a study and the person delivering the sales message each sees a different part.

That is where an insider’s knowledge can change the reading of an otherwise ordinary business record. We work with the person who knows what an instruction meant, why an analysis changed or what a payment was expected to buy, and connect that account to the documents supporting the case.

You Know What the Sales Plan Rewarded

If you saw safety findings reshaped for a sales pitch or payments tied to prescriptions, speak with our whistleblower experts about what you saw. We build the pharmaceutical fraud case with you and bring in pharmaceutical whistleblower lawyers who understand promotion, clinical evidence and government reimbursement. We stay beside you as your knowledge of the business becomes the case the company has to answer.