Episode 335 -- The New DOJ Whistleblower Program
#WorkforceWednesday®: New DOJ Whistleblower Program - What Employers Must Know - Employment Law This Week®
DOJ’s New Self-Disclosure Policy and Corporate Whistleblower Awards Pilot Program
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The Presumption of Innocence Podcast: Episode 37 - Vintage or Trendsetting? The SDNY's Whistleblower Pilot Program
Episode 321 -- Review of the EU Whistleblowing Directive wih Alex Cotoia and Daniela Melendez
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Corruption, Crime and Compliance: NAVEX’s 2024 Whistleblower Report — More Reports, Higher Substantiation Rates
False Claims Act Insights - Are We Done Here? The Unique Dynamics of FCA Settlements
Understanding the Whistleblower Pilot Program in the Southern District of New York
Corruption, Crime & Compliance: DOJ Adopts New Whistleblower Bounty Program and Encourages Voluntary Self-Disclosure
False Claims Act Insights - Think You Know Whistleblowers? Think Again.
FCPA Compliance Report: Mary Inman on DOJ Whistleblower Bounty Program
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How One Hospice Owner Got Convicted of Healthcare Fraud and How You Can Avoid That Fate
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The EU Whistleblowing Directive
#WorkforceWednesday: SEC Cracks Down on Private Companies for Violating Whistleblower Protections - Employment Law This Week®
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
Pharmacies and Healthcare Providers May Be Impacted - A June 1st U.S. Supreme Court (SCOTUS) decision on two whistleblower cases may have far reaching consequences for pharmacies or healthcare providers that charge a discount...more
Oral arguments are scheduled for April 18, 2023, in the Supreme Court case combining two Seventh Circuit Court of Appeals cases U.S. ex rel. Schutte v. SuperValu, Inc. (“SuperValu”) and U.S. ex rel. Thomas Proctor v. Safeway,...more
DOJ Files Complaint in AWP False Claims Act Suit Against Pharmaceutical Ingredient Seller - On November 8, 2021, the Department of Justice (DOJ) announced that it intervened in a qui tam suit and filed a False Claims Act...more
St. Jude Medical agreed to pay $27 million to settle False Claims Act charges that it knowingly sold a defective heart device to health care facilities. St. Jude was acquired by Abbott Laboratories in early 2017....more
In United States ex rel. Silver v. Omnicare, Inc., et al. (D.N.J. No. 11-cv-01326), a whistleblower relator consistently alleged that certain pharmaceutical service providers have engaged in an illegal kickback arrangement...more
This week the Department of Justice reported it recovered $3 billion from False Claims Act cases in 2019. Of that recovery amount, $2.1 billion resulted from whistleblower, or qui tam, actions. In addition, 633 new qui tam...more
On September 4, 2019 the Department of Justice (DOJ) announced a $15.4 million settlement with pharmaceutical company Mallinckrodt ARD LLC (Mallinckrodt) to resolve alleged violations of the Anti-Kickback Statute (AKS) in two...more
One of the reasons compliance officers and health care attorneys read fraud settlements is to identify issues the government is focused on. The cases the government decides to pursue are very indicative of the areas of fraud...more
On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more
Prompt Payment Discounts Not an Anti-Kickback Statute Violation - In United States of Am. et al. ex rel. Ruscher v. Omnicare, No. 15-20629, 2016 WL 6407128 (5th Cir. Oct. 28, 2016), the court of appeals affirmed summary...more
Charitable organizations can easily become enmeshed in Justice Department enforcement issues. We have seen charities used in FCPA cases as a means to funnel bribes to government officials, spouses or family members....more
Abbott Laboratories recently won a jury verdict in a high profile qui tam lawsuit alleging that Abbott “caused” health providers to submit false Medicare payment claims for off-label use of biliary stents. U.S. ex rel....more
The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more
The U.S. Department of Justice (DOJ) obtained a record $5.69 billion in settlements and judgments from civil cases involving fraud and false claims against the government in fiscal year 2014. This marks the first time the DOJ...more
Over the last decade, it has often felt as though the pharmaceutical industry has been the government’s and whistleblowers’ main, and at times only, target for False Claims Act (“FCA”) investigations. While manufacturers are...more
The common industry practice of compensating independent contractor sales representatives on a "percentage of sales" commission basis may be creating an enhanced risk of False Claims Act liability for illegal kickbacks in...more
On March 31, 2014, in U.S. ex rel. Nathan v. Takeda Pharmaceuticals North America, the Supreme Court of the United States declined to review a decision by the U.S. Court of Appeals for the Fourth Circuit upholding a district...more
Last year continued the trend of robust False Claims Act (FCA) enforcement by the U.S. Department of Justice (DOJ) and proliferating qui tam lawsuits brought by whistleblowers on behalf of the United States. In 2012, DOJ...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
Last year was another busy year in health care fraud enforcement. In 2012, the Office of Inspector General for the Department of Health and Human Services (HHS-OIG) reported total expected recoveries of $6.9 billion from all...more
In yet another large recovery for the DOJ, on December 6, 2012, DFB Pharmaceuticals, and its subsidiary, Healthpoint Ltd., agreed as part of a settlement to pay up to $48 million to resolve allegations that Healthpoint caused...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