Eli Lilly: Selling Zyprexa by the Symptom

The Eli Lilly fraud settlement over Zyprexa included up to $800 million to resolve civil allegations of off-label promotion that caused false claims to government healthcare programs. The criminal information filed against Lilly charged that the company trained sales representatives to sell an antipsychotic by focusing on symptoms such as agitation and sleep problems, extending the pitch from nursing homes into primary care. Former sales representatives brought the whistleblower cases behind the civil settlement.

The Department of Justice announced the settlement on January 15, 2009. This pharmaceutical fraud case concerned how the company created demand for its drug and how the resulting prescriptions reached public health programs. For someone who worked in sales, training or medical education, the recognizable part is the instruction behind the prescription.

What Is the Eli Lilly Controversy?

The Zyprexa controversy concerned Lilly’s alleged promotion of its antipsychotic for unapproved uses, including dementia, and the claims submitted to government programs. According to the criminal information, the campaign encouraged doctors to treat behavioral and sleep complaints with a drug whose approved uses were much narrower.

Zyprexa, also called olanzapine, had FDA approval for schizophrenia and short-term treatment of acute manic episodes associated with Bipolar I Disorder.

The Justice Department’s account of those approvals stated that Zyprexa had never been approved to treat dementia or Alzheimer’s dementia. The distinction mattered because those symptoms became part of the alleged sales pitch.

The Nursing-Home Pitch Turned Sedation Into a Benefit

The criminal information charged that Lilly used its long-term-care sales force to promote Zyprexa in nursing homes and assisted-living facilities beginning in 1999. The proposed uses included dementia, depression, anxiety and sleep problems, along with agitation, aggression and hostility.

The Eastern District of Pennsylvania’s summary of the criminal information described the slogan “5 at 5”: five milligrams of Zyprexa at 5 p.m. would help patients sleep. According to the information, Lilly directed representatives to present sedation, a side effect, as a therapeutic benefit for patients with sleep problems, behavioral issues and dementia.

That pitch, as the criminal information described it, gave the representative something immediately recognizable to sell. A doctor seeing an agitated patient or a patient who could not sleep was being offered an answer to that symptom. The approved psychiatric condition no longer had to lead the conversation.

The criminal information also charged that Lilly promoted weight gain as a benefit for patients who had trouble maintaining their weight. Its account said Lilly knew significant weight gain and obesity were adverse effects and factors in hyperglycemia and diabetes, yet continued to promote those effects as benefits despite written FDA caution. The alleged sales strategy turned a safety concern into a reason to prescribe.

Viva Zyprexa Brought the Pitch Into Primary Care

The criminal information charged that Lilly expanded the symptom-based approach into primary care in October 2000, building on its promotion in long-term care. The information said the company knew there was virtually no approved use for Zyprexa in that market.

The district’s summary of the criminal information named the campaign “Viva Zyprexa” and described its goal as making the drug an “everyday agent in primary care.” Lilly allegedly added sales representatives and instructed them to recommend the drug for adults with behavioral symptoms, mood and sleep disturbances, and depression. The company recognized that primary-care physicians did not typically treat schizophrenia and bipolar disorder, the conditions on which the approvals rested.

This is the concrete mechanism behind the off-label promotion charged in the Zyprexa case. Change the conversation from the approved condition to a common symptom, and the audience for the product expands. The criminal information described that change as a deliberate sales instruction.

The district’s summary of the criminal information also described training for doctors’ objections. Management allegedly created the marketing materials, trained representatives to respond when physicians questioned off-label uses, and retained medical professionals to discuss those uses in peer-to-peer sessions. A physician’s objection became another part of the sales training.

The qui tam cases separately alleged that Lilly funded continuing medical education through millions of dollars in grants to promote off-label uses. The alleged message could therefore reach a doctor through a representative, another medical professional or an educational program. For an insider, who chose the topic and directed the message matters as much as who delivered it.

How Zyprexa Promotion Reached Government Claims

The government alleged that Lilly’s marketing caused claims for uses that government health care programs did not cover. Taxpayers were being asked to fund the prescriptions that the alleged campaign generated. The Justice Department identified Medicaid, TRICARE and the Federal Employee Health Benefits Program among the programs involved.

The civil settlement also covered alleged purchases for unapproved uses by federal agencies, including the Department of Veterans Affairs and the Department of Defense. The sales message reached both reimbursed prescriptions and direct government purchasing.

The pharmaceutical business separates the company selling the drug from the party billing for a patient’s prescription. A drug can move from a manufacturer through a wholesaler to a dispenser, while a pharmacy or physician can submit the claim for payment. That separation explains why the civil case followed Lilly’s influence on prescribing: the alleged chain ran from a company sales instruction to a prescription and then to a government bill.

In the government’s account of the whistleblower cases, the alleged promotion ran from September 1999 through the end of 2005. It reached patients of all ages and included anxiety, irritability, depression, nausea, Alzheimer’s and other mood disorders.

We examine that connection with the insider: the use the company promoted, the patients and prescribers it targeted, and the program asked to pay. A sales presentation explains the pitch. Prescription, coverage and payment records connect that pitch to the public money at issue.

Former Sales Representatives Saw the Instructions

Four qui tam cases brought by former Lilly sales representatives led to the civil settlement. Their role put the case’s sales practices within reach of employees who knew what management wanted doctors to hear.

The details show why a pharmaceutical whistleblower’s knowledge of the business matters. A training employee may recognize the instruction to sell by symptom. A representative may know the answer supplied for a doctor’s objection. Someone working on medical education may know how the company chose the subject and funded the program. We connect those accounts to the documents and the claims they help explain.

The wider settlement history gives that insider role some scale. Public Citizen’s 2018 report, Twenty-Seven Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991 Through 2017, found that whistleblower revelations contributed at least in part to 92 of the 170 federal pharmaceutical settlements in its inventory.

What the Civil Settlement and Whistleblower Reward Covered

The civil settlement allocated $438,171,544 to the federal government. The former sales representatives’ collective whistleblower reward was about $79 million from that federal share. The district’s announcement put their share at 18%.

The agreement also covered state Medicaid programs and the District of Columbia, with the state payment depending on how many states participated.

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

Lilly’s Corporate Integrity Agreement required annual compliance certifications from a board committee and certain managers, and public disclosure of payments to doctors.

What Other Promotion Cases Reveal

The Abbott Depakote case also involved a nursing-home sales force targeting agitation and aggression in elderly patients with dementia, as Abbott admitted in the agreed statement of facts filed in its criminal case. The criminal information against Lilly also reached a symptom-led primary-care campaign. The target market and the instruction given to representatives make each campaign recognizable.

A separate Abbott case over TriCor shows why the sales training and the written account of a sales call can tell different stories. The whistleblower’s complaint alleged:

That allegation makes the gap concrete: a representative could be required to record a call and told to leave out the very discussion that mattered. In a promotion case, we compare what employees were instructed to say with what they were instructed to write down.

You Know What the Sales Team Was Told

If you recognize a symptom-based pitch, an objection script or an education program built to expand prescribing, speak to one of our whistleblower experts about what the sales team was told. We build your strongest pharmaceutical whistleblower case with you, bring in pharmaceutical fraud whistleblower lawyers who understand promotion and government reimbursement, and stay beside you as the case develops.