Assertio Therapeutics Pays $3.6 Million to Settle False Claims Act Allegations Over Fentanyl Marketing

Key Takeaways

• $3.6 Million Settlement: Assertio Therapeutics, formerly Depomed, agrees to pay $3.6 million to resolve allegations it violated the False Claims Act by submitting false claims for its fentanyl product, Lazanda.
• False Claims for Non-Qualifying Patients: Between 2013 and 2017, Assertio allegedly marketed Lazanda to prescribers who wrote prescriptions for patients who did not have breakthrough cancer pain, leading to false claims submitted to Medicare and TRICARE.
• Whistleblower Lawsuit: The case stems from a 2017 qui tam lawsuit filed by two former sales representatives, Noelle Webb and Nicole Novellino, who are entitled to a share of the settlement proceeds.
• Ongoing Accountability for Opioid Crisis: The settlement is part of a broader effort by the DOJ, FBI, and HHS-OIG to hold pharmaceutical companies accountable for contributing to the opioid epidemic.
• No Liability Determined: The settlement resolves the claims, but no formal determination of liability has been made regarding the alleged violations.

Deep Dive

Assertio Therapeutics has agreed to pay $3.6 million to resolve allegations tied to misleading marketing practices involving its fentanyl nasal spray, Lazanda. The settlement was announced by the Department of Justice on May 5, 2025, addressing claims that Assertio’s marketing led to false billing for prescriptions that were not medically justified.

Lazanda is approved by the FDA solely for the treatment of breakthrough cancer pain in patients who are already tolerant to opioid therapy. But according to federal authorities, between 2013 and 2017, Assertio pushed this powerful drug to doctors who prescribed it to patients who did not meet the necessary criteria. This resulted in false claims submitted to both Medicare and TRICARE for individuals who weren’t suffering from breakthrough cancer pain.

A Reckless Marketing Campaign?

The details of the case are concerning. Assertio allegedly directed its marketing efforts at pain specialists, including some with questionable practices, such as high-volume prescribers flagged for possible drug diversion. It’s claimed that the company even placed some of these prescribers on its speakers’ bureau and advisory boards, strengthening ties and ensuring the continued prescription of Lazanda. A program called the “Signature Support Program” was also developed, allegedly to streamline the approval process for insurance, including Medicare Part D plans, to ensure prescriptions were written for patients who didn’t qualify.

This is a violation that played into the larger opioid epidemic, with the company accused of prioritizing profit over patient safety.

U.S. Attorney Edward R. Martin, Jr. said, “This company took steps to boost its profits despite the risk of boosting the deadly opioid epidemic.” He made it clear that his office is committed to pursuing cases like this one that demonstrate a complete disregard for public health.

The claims stem from a lawsuit filed in 2017 by two former Depomed sales reps, Noelle Webb and Nicole Novellino. Under the qui tam provisions of the False Claims Act, they brought the case forward on behalf of the government, and they will be entitled to a portion of the recovery. Their courage has brought to light practices that could have gone unnoticed, allowing the government to pursue justice.

Holding Companies Accountable

This case is part of a broader effort by federal authorities to hold companies accountable for their role in fueling the opioid crisis. Acting Assistant Attorney General Yaakov Roth of the Justice Department reaffirmed the commitment to bringing companies to justice for their reckless actions. “This resolution demonstrates that companies that recklessly marketed powerful opioids, like fentanyl, will be held accountable,” Roth said.

The FBI, along with partners like the Department of Health and Human Services Office of Inspector General (HHS-OIG), provided substantial assistance in the investigation. The case shows that there’s still ongoing scrutiny on the pharmaceutical industry and its role in perpetuating the opioid epidemic.

The Justice Department's vigilance in these cases is not just about financial settlements, it’s about ensuring that public safety comes first and that the people behind the opioid crisis are held accountable.

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