The attorneys at Chilivis Grubman represent individuals and companies of all types and sizes in connection with False Claims Act investigations and litigation. If you need assistance with such a matter please contact us.
May 11, 2025
On May 9, 2025, the United States Department of Justice (DOJ) announced that pharmaceutical manufacturer Assertio Therapeutics had agreed to pay $3.6 million to resolve allegations that it violated the False Claims Act (FCA) by causing the submission of false claims to federal healthcare programs for its immediate-release fentanyl drug Lazanda for patients who did not have breakthrough cancer pain.
Lazanda is a fentanyl nasal spray that is approved by the FDA solely for “break-through cancer pain in patients who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.” According to the DOJ, Assertio caused the submission of false claims to federal healthcare programs including Medicare and TRICARE by marketing to pain specialists who were prescribing high volumes of immediate-release fentanyl products, “including those who were flagged for diversion or who were later indicted.”
The government also alleged that Assertio placed these high-volume prescribers on its speakers’ bureau and advisory boards, and developed a “Signature Support Program” to ensure that these prescribers would be approved by insurance companies including Medicare Part D plans. According to the DOJ, this caused prescribers to write Lazanda prescriptions for beneficiaries who did not have breakthrough cancer pain.
The settlement resolves an FCA qui tam (whistleblower) case filed by two former Assertio sales representatives. The whistleblowers will receive over $650,000 as their share of the settlement.
This settlement continues to highlight the DOJ’s focus on the relationship between pharmaceutical representatives and prescribing providers. It follows on the heels of a $202 million settlement by Gilead related to its speaker program. While these programs are not per se illegal, it is essential that these arrangements are structured to fit within the personal services arrangement safe harbor of the Anti-Kickback Statute (AKS).
__________________
More News
Get in Touch With Us
For more information or to arrange a consultation, please contact us by telephone at (404) 233-4171 or online by submitting the form below. The use of the Internet or this form for communication with the firm or any individual member of the firm does not establish an attorney-client relationship nor create an expectancy of a potential attorney-client relationship. Do not submit information which is confidential or time sensitive, as it may not be treated as such.