Assertio Therapeutics, Inc., the pharmaceutical manufacturer previously known as Depomed, Inc., has agreed to a $3.6 million settlement over claims it violated the False Claims Act. Announced by the Justice Department on May 5, the company faced allegations of causing the submission of false claims tied to its marketing of the fentanyl product Lazanda. The settlement also resolves a whistleblower lawsuit, further detailing the company's dealings with prescribing practices relevant to high-volume prescribers of transmucosal immediate-release fentanyl (TIRF).
According to a press release by the U.S. Attorney's Office for the District of Columbia, the company directed its marketing towards pain specialists who prescribed significant amounts of TIRF drugs. Some of these are even after being flagged for diversion or following indictments. The marketing approach included allegedly placing these high-prescribing individuals onto its speakers’ bureau and advisory boards, and implementing a "Signature Support Program" tailored to ensure that insurance plans, including Medicare Part D, would cover Lazanda prescriptions.
The allegations brought forward claim that Assertio's marketing tactics resulted in prescriptions written for beneficiaries of Medicare and TRICARE, who did not require the drug, as it was approved by the FDA solely for breakthrough cancer pain in patients who were already on an opioid regimen for persistent cancer pain. "This company took steps to boost its profits despite the risk of boosting the deadly opioid epidemic," U.S. Attorney Edward R. Martin stated, emphasizing a commitment to combat such violations that display a disregard for public safety.
Further emphasizing the government's stance, Acting Assistant Attorney General Yaakov Roth mentioned in a statement, “The Department is committed to pursuing companies that contributed to the tragic opioid epidemic." The resolution, as outlined by the FBI's Assistant Director in Charge Steven J. Jensen of the Washington Field Office, "demonstrates that companies that recklessly marketed powerful opioids, like fentanyl, will be held accountable for their role in the opioid crisis."
The suit arose from the qui tam provisions of the False Claims Act, which allows private parties to sue on behalf of the government for false claims and share in any recovery. The case, filed by former Assertio sales representatives Noelle Webb and Nicole Novellino, has not yet resulted in a determined share of the settlement for the relators. The Justice Department’s efforts underscore an ongoing commitment to cracking down on healthcare fraud and those actions that have fueled an ever-lingering opioid crisis.
This case was processed by Assistant U.S. Attorney Darrell Valdez for the District of Columbia, alongside Senior Trial Counsel Sarah Arni, Trial Attorney Matthew Arrow, and Assistant Director Natalie Waites from the Civil Division's Fraud Section. Investigations drew substantial assistance from the FBI led by the Washington Field Office, the FDA’s Office of Criminal Investigations, and the Department of Health and Human Services Office of Inspector General.
The claims resolved by this settlement stand as allegations, with no determination of liability formally made. The Justice Department remains steadfast: health care providers and corporations engaged in schemes threatening patient safety will be held to account.
