False Claims Act Insights - Eureka! Government Investigators Seek Out Research Misconduct
Common Scenarios Triggering False Claims Act Violations, Part 1: Gov. Contracts and Cybersecurity
FCA Uncovered: Mitigating Risk in the Regulatory Spotlight — Regulatory Oversight Podcast
False Claims Act Insights - Think You Know Whistleblowers? Think Again.
Fraud and Abuse Enforcement Priorities in the Wake of COVID-19 - Diagnosing Health Care Podcast
Health Care Continues to Drive False Claims Act Recoveries: Thought Leaders in Health Law Video Series
Ultragenyx to Pay $6 Million To Settle False Claims Act Case - Ultragenyx Pharmaceutical Inc. recently agreed to pay $6 million to settle a qui tam action filed under the False Claims Act (FCA). Ultragenyx manufactures a...more
We are pleased to bring you our 11th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more
On September 15, 2022, the Department of Justice (DOJ) announced a $7.9 million settlement with generic manufacturer Akorn Operating Company LLC (Akorn) to resolve allegations that Akorn caused the submission of...more
The following is a summary of the federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported are...more
Physician Partners of America Agrees To Pay $24.5 Million To Resolve False Claims Act Allegations - Physician Partners of America LLC (PPOA), its founder, and its former chief medical officer agreed to pay $24.5 million to...more
Kathryn Isted In Harbor Healthcare System, L.P. v. United States, 5 F.4th 593 (5th Cir. 2021), the court of appeals ruled that the district court abused its discretion in refusing to exercise its equitable jurisdiction over a...more
Three recent settlements demonstrate the U.S. Department of Justice’s (DOJ’s) continued scrutiny of product quality and manufacturing issues in the medical device industry. Using the civil False Claims Act (FCA) and the...more
DOJ’s 2020 False Claims Act Recoveries Lowest Since 2008 - On January 14, 2021, the Department of Justice (DOJ) announced that it obtained more than $2.2 billion in settlements and judgments from civil cases involving...more
The solicitor general filed an amicus brief in the U.S. Supreme Court last month supporting the relators’ opposition to certiorari in Gilead Sciences, Inc. v. United States ex rel. Campie, et al., No. 17-936. Yet the...more
On November 30, 2018, the Solicitor General of the United States filed an amicus curiae brief in the closely watched False Claims Act (FCA) lawsuit, Gilead Sciences Inc. v. U.S. ex rel. Campie. In what appears to be an...more
A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more
Deceptive Trade Practices - Meat Exporter Had No Duty Under FCA to Pay for Beef Inspection - In United States ex rel. Barrick v. Parker-Migliorini Int'l, LLC, 878 F. 3d 1224 (10th Cir. 2017), the court affirmed...more
• How have appellate courts applied the Supreme Court’s ruling in Escobar? • If the government is aware of the relator’s allegation, but does not undertake any administrative action to address the defendant’s alleged...more
In a recent False Act Claims (FCA) suit involving the blockbuster cancer drug Avastin, the Third Circuit barred a relator’s qui tam suit because his Complaint lacked sufficient factual allegations that, if true, would...more
OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more
Pharmaceutical industry and constitutional buffs have been closely watching Amarin Pharma Inc. v. U.S. Food and Drug Administration. The case presented the (not wholly novel) question whether the First Amendment protects...more
Latest Healthcare False Claims Act Roundup and Top 3 Best Practices to Reduce Exposure - As the legal landscape in healthcare becomes increasingly complex, healthcare companies that receive federal program funds face...more
Settlements - Pharmaceutical company Organon Inc. agreed to pay $31 million to settle federal and state allegations that it underpaid Medicaid drug rebates, provided kickbacks to nursing home pharmacy companies,...more
The first day of the Supreme Court term saw it decline, without comment, certiorari on two cases raising issues of liability and the sufficiency of pleading under the federal False Claims Act (FCA). ...more
Given the publicity generated by large settlements paid to whistleblowers, many individuals are regularly on the prowl for a qui tam lawsuit that will yield a large bounty. These eager whistleblowers may be likely to pursue a...more
Trends and Analysis - ..We have identified 24 health care-related qui tam cases unsealed since last month’s Qui Tam Update. Of those, only 2 were filed in 2013. Nearly half were filed before 2011. ..Among the 24...more
Trends and Analysis: ..We have identified 20 health care-related qui tam cases unsealed in July 2013. About a quarter of those were filed in 2013. ..Among the cases unsealed in July, the government has declined to...more
The U. S. Department of Justice (DOJ) has taken the unusual step of appealing a federal district court’s dismissal of a declined qui tam brought under the federal and multiple state false claims acts (FCA). Could the...more
On December 3, 2012, the United States Court of Appeals for the Second Circuit held that the First Amendment protects pharmaceutical companies who truthfully promote the lawful, off-label use of prescription drugs from...more