Assertio (Depomed): Marketing to High-Volume Pain Prescribers

Assertio Therapeutics Inc., formerly Depomed Inc., agreed to pay $3.6 million in the Depomed Lazanda False Claims Act settlement over allegations that its marketing caused Medicare and TRICARE claims for patients who did not have breakthrough cancer pain. This pharmaceutical fraud case covered marketing and sales from August 1, 2013, through December 31, 2017.

The Justice Department announced the settlement on May 9, 2025. The government alleged that the company pursued high-volume pain prescribers, put them on its speakers’ bureau and advisory boards, and built an insurance-approval program around Lazanda. A spray approved only for cancer pain allegedly became a sale to patients without that pain, with taxpayers picking up the bill.

Lazanda’s Cancer-Pain Approval and the Patients Behind the Claims

Lazanda is a fentanyl nasal spray approved for breakthrough cancer pain in adults already receiving, and tolerant to, opioid therapy for underlying persistent cancer pain. The approved population matters at every step of this case: who the company marketed to, which patients received prescriptions, and which prescriptions reached a government health care program.

According to the settlement agreement, Depomed acquired the rights to manufacture and market Lazanda in July 2013, after FDA approval in June 2011. In setting out its allegations, the government said the FDA had never expanded Lazanda’s approved use and the drug-reference compendia recognized by Medicare supported no other indications.

Those drug-reference listings matter because Medicare Part D coverage depends on the use for which a drug is prescribed. Under the agreement’s coverage explanation, Medicare pays for FDA-approved uses or uses supported by those references. TRICARE requires medical evidence that an off-label use is necessary, safe and effective.

That is the reimbursement issue behind the off-label promotion allegations. The government said the marketing produced Lazanda prescriptions for beneficiaries without breakthrough cancer pain. Its account connects the sales effort to patients outside the approved population and then to the public programs billed for those prescriptions.

High-Volume Prescribers Became Speakers and Advisers

The government alleged that Assertio focused its marketing on pain specialists already prescribing high volumes of transmucosal immediate-release fentanyl products. Its target audience included prescribers flagged for diversion. The target was volume across this class of fentanyl products, while the alleged false claims concerned Lazanda.

According to the agreement, Assertio also placed high-volume prescribers of these fentanyl products on its speakers’ bureau and advisory boards. The same prescribers the company wanted to reach as customers could therefore become participants in its marketing and advisory activities.

For an employee running those programs, selection is a revealing business decision. We look at how prescribing volume figured in invitations, who selected the speakers and advisers, and what work the company expected from them. The records behind a speaker program and the work behind an advisory-board appointment help explain the purpose of the relationship. In the Lazanda case, the government’s stated allegation was that high-volume prescribing and those appointments went together.

A 2012 review, Corporate crime in the pharmaceutical industry is common, serious and repetitive, whose shorter version appeared in BMJ, describes an earlier version of that commercial pattern. Its account of Warner-Lambert’s Neurontin marketing says the company:

Prescribing volume can become the reason a doctor receives a speaking or consulting role, giving the sales relationship another purpose on paper. For a Lazanda insider, the question is how the company chose whom to invite.

Signature Support and the Insurance Approval

The government alleged that Assertio developed its Signature Support Program to ensure that insurers, including Medicare Part D plans, approved Lazanda prescriptions. That placed the manufacturer on both sides of the commercial effort: marketing to the prescriber and supporting approval by the payer.

That relationship gives reimbursement-support employees a distinct view of the business. Sales staff may know why a practice became a target. Support staff may know what the insurer was told about a prescription and how approval was pursued. We examine how those accounts fit the patients and claims at issue, including the company’s decisions about whom to promote Lazanda to and which prescriptions to help through insurance.

A separate civil case against Insys concerned alleged speaker bribes, medically unnecessary Subsys prescriptions and false reimbursement submissions. The useful parallel is the connection between generating prescriptions and obtaining payment.

How the Marketing Reached Medicare and TRICARE

The United States alleged that Assertio’s marketing caused false claims from thirteen high-volume prescribers. The agreement ties those claims to Lazanda prescriptions for Medicare and TRICARE beneficiaries without breakthrough cancer pain.

The payment route explains why a manufacturer’s sales decisions can become a case about bills submitted elsewhere. A pharmacy or physician can submit a claim to federal healthcare programs that a manufacturer’s conduct caused. Here, the government tied those claims to Assertio’s marketing of Lazanda.

The taxpayer-paid prescription is the financial consequence of the alleged marketing. For an insider, the useful detail is where those parts meet: a practice on a target list, its involvement in company programs, and the prescriptions for which the company pursued coverage.

The Sales Representatives Behind the Whistleblower Case

Two former Assertio sales representatives brought the qui tam case, and the United States joined the allegations concerning Lazanda reimbursement under Medicare Part D and TRICARE.

Their former sales roles matter because the allegations begin with commercial decisions inside the manufacturer. Sales representatives can explain how commercial priorities reached the field. In a case built around prescriber targeting, that knowledge can help connect the manufacturer’s decisions with prescriptions billed elsewhere.

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

You Know Why That Practice Was Targeted

If you saw how prescribing volume shaped sales targets, speaker invitations or reimbursement support, speak to one of our whistleblower experts about the decisions behind those prescriptions. We work with you to build your strongest pharmaceutical whistleblower case, bring in pharmaceutical fraud whistleblower lawyers who understand promotion and reimbursement, and stay beside you throughout the case.