On January 6, the Department of Justice (DOJ) announced that Athira Pharma Inc., a Washington-based biopharmaceutical company, agreed to pay over $4 million to settle allegations it violated the False Claims Act (FCA). The DOJ alleges Athira failed to report allegations of research misconduct in its grant applications, award progress reports, and assurances. The settlement serves as a reminder to companies performing on grants that the Department of Health and Human Services (HHS) takes allegations of research misconduct seriously and grantees must closely adhere to regulatory requirements related to disclosing such allegations.Continue Reading Athira Pharma Inc. Agrees to Settle False Claims Act Allegations
Join Us for a Pre-Conference Workshop at the Global Export Controls Forum
I’m excited to kick off the American Conference Institute’s 14th Annual Advanced Forum on Global Export Controls with a pre-conference workshop on February 24, 2025, from 1:30–5:00 PM. Together with Sarah York, Senior Counsel for International Trade Compliance at GE Aerospace, I’ll lead Workshop B – An Updated Roadmap on Making High Stakes, Time-Sensitive Decisions.
This interactive, small-group session will tackle critical compliance challenges, including:Continue Reading Join Us for a Pre-Conference Workshop at the Global Export Controls Forum
HHS-OIG Set To Intensify Scrutiny of Grants and Contract Compliance: How to Prepare
As we detailed in a previous blog, on October 3, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a strategic plan to “safeguard[] the integrity of HHS grants and contracts.” The plan comes after the HHS-OIG found “gaps in HHS oversight of grants and contracts—gaps that allow HHS funds to be misspent, programs to fall short of their promise, and people to be put at risk.”Continue Reading HHS-OIG Set To Intensify Scrutiny of Grants and Contract Compliance: How to Prepare
United States Files First Complaint Under the Civil Cyber-Fraud Initiative
On August 22, the United States filed its complaint-in-intervention (Complaint) against the Georgia Institute of Technology (Georgia Tech) and Georgia Tech Research Corp. (GTRC, collectively, defendants), asserting claims that the defendants knowingly failed to meet cybersecurity requirements in connection with certain Department of Defense (DoD) contracts in violation of the False Claims Act.
The government’s
The Tale of a Self-Disclosure
Last week, the Department of Justice (DOJ) announced a $12 million settlement with spinal device manufacturer, Innovasis Inc. (Innovasis), and senior executives Brent Felix and Garth Felix related to allegations that they violated the False Claims Act (FCA) by paying kickbacks to surgeons to induce their use of its spinal devices.Continue Reading The Tale of a Self-Disclosure
Recent False Claims Act Settlements in Government Contracts Cases
The government continues to prioritize fraud involving government contractors, as the Department of Justice’s (DOJ) most recent annual report on civil fraud recovery shows.
Although the majority of government recoveries are related to the healthcare industry, the government still recovered hundreds of millions of dollars in 2022 alone not related to the healthcare industry. Government
Buyer Beware: Settling FCA Allegations Costs Manufacturer $5.2 Million
Numet Machining Techniques, a Connecticut-based machined parts manufacturer for commercial and military aerospace engines, recently agreed to pay $5.2 million to settle alleged violations of the False Claims Act (FCA) for misrepresenting its size standard following an acquisition.
Continue Reading Buyer Beware: Settling FCA Allegations Costs Manufacturer $5.2 Million
Government Contractors Face False Claims Act Liability for Cybersecurity Non-Compliance
Last week, the District Court for the Eastern District of California denied the defendant’s motion for summary judgment of a False Claims Act (FCA) count against Aerojet Rocketdyne (Aerojet) for allegedly fraudulently inducing the government to enter into federal contracts when the company knew it was not compliant with cybersecurity requirements.
The order contains important lessons for government contractors in the emerging area of FCA liability based on noncompliance with cybersecurity obligations. While the litigation is ongoing and may ultimately be resolved in Aerojet’s favor, the order demonstrates the growing importance of cybersecurity compliance.Continue Reading Government Contractors Face False Claims Act Liability for Cybersecurity Non-Compliance
DOJ Expands False Claims Act Reach into Cybersecurity
There is a new weapon in the Department of Justice’s (DOJ’s) already powerful False Claims Act (FCA) arsenal. In October 2021, the DOJ announced a new Civil Cyber-Fraud Initiative, under which it will pursue FCA liability against government contractors in the cybersecurity space. According to the announcement from Deputy Attorney General Lisa O. Monaco, the
[WEBINAR] Procurement Fraud: Best Practices for Avoiding Risk During Heightened Government Scrutiny
This past January, the Department of Justice (DOJ) announced that procurement fraud recoveries comprised the second largest category of fraud recoveries in Fiscal Year (FY) 2020, a trend that continued from FY 2019. With last November’s announcement of DOJ’s intent to expand its Procurement Collusions Strike Force (PCSF), we expect to see a continued trend