Podcast - Cybersecurity Roundup: Analyzing New and Proposed Rules for Contractors
AGG Talks: Women in Tech Law Podcast - Episode 3: Cybersecurity and FCA Compliance: Essential Insights for Tech Leaders
False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
False Claims Act Insights - If Everything Matters, Nothing Does: Parsing Materiality in FCA Disputes
False Claims Act Insights - Assessing the Fallout from a Thermonuclear FCA Verdict
False Claims Act Insights - Eureka! Government Investigators Seek Out Research Misconduct
Common Scenarios Triggering False Claims Act Violations, Part 3: Claims and Investigations
Common Scenarios Triggering False Claims Act Violations, Part 1: Gov. Contracts and Cybersecurity
False Claims Act Insights - Physician, Refer Thyself: How Stark Law and FCA Intersect
False Claims Act Insights - The Art and Science of Corporate Compliance in Managing FCA Risk
The Latest on Healthcare Enforcement
False Claims Act Insights - Railroaded! How to Approach the Twin Tracks of Parallel Proceedings
FCA Uncovered: Mitigating Risk in the Regulatory Spotlight — Regulatory Oversight Podcast
False Claims Act Insights - Are We Done Here? The Unique Dynamics of FCA Settlements
False Claims Act Insights - Help! I Got a Civil Investigative Demand from DOJ. What Do I Do?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 186: White Collar Crimes in Healthcare with Maynard Nexsen’s White Collar Team
False Claims Act Insights - Think You Know Whistleblowers? Think Again.
PilieroMazza Annual Review What DOJ’s Annual FCA Report Means for Government Contractors
Protecting Our Nation’s Data: Cybersecurity Compliance for Government Contractors
Medical Device Legal News with Sam Bernstein: Episode 19
The Fourth Circuit has clarified the standard for evaluating a nonparty’s attempt to access sealed summary judgment filings under the First Amendment. In United States ex rel. Oberg v. Nelnet, Inc., — F.4th –, No. 23-1808,...more
On Friday, January 13, the Supreme Court of the United States granted certiorari in eight cases: U.S. ex rel. Schutte v. SuperValu Inc.; U.S. ex rel. Proctor v. Safeway, Inc., Nos. 21-1326, 22-111: These consolidated...more
On August 2, 2021, the U.S. Food and Drug Administration (FDA) issued its final rule amending the intended use regulations codified at 21 CFR 801.4 and 21 CFR 201.128, marking the end of an effort FDA began in 2015. While the...more
Background - A Company received a grand jury subpoena under the Stored Communications Act (“SCA”) seeking information about an employee of one of the Company’s customers, who was the target of a criminal investigation. The...more
As the battle against COVID-19 intensifies, healthcare workers have become vocal about their perceptions of deficiencies surrounding patient care and safety within their workplaces and have expressed their views publicly on...more
CMS Regulation - District Court Strikes Down Rule Mandating Price Disclosure in DTC Pharmaceutical Advertisements - The U.S. Department of Health and Human Services (HHS), together with the Centers for Medicare &...more
On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....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
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
Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ) continues its...more
In this post, I will be focusing on the intersection of off-label communications with government enforcement of health care fraud through the False Claims Act. Over the past eight years, the U.S. Department of Justice (“DOJ”)...more
On Thursday of last week, the Supreme Court for the first time addressed the “implied certification” theory of liability under the False Claims Act. The Court ruled unanimously that the theory is valid in certain...more
For years, the U.S. Food and Drug Administration (FDA) has taken the position that a medical device (or drug) manufacturer that promotes an FDA-approved device (or drug) for an unapproved use violates the Federal Food, Drug,...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
The U.S. District Court for the Southern District of New York recently held that the FDA may not constitutionally bring a misbranding action based on truthful and non-misleading off-label promotion of an FDA-approved drug,...more
On August 7, 2015, the U.S. District Court for the Southern District of New York released its Amarin opinion addressing whether truthful, non-misleading off-label promotion of U.S. Food and Drug Administration (FDA)-approved...more
Employee's Inability To Work For A Particular Supervisor Does Not Constitute A "Disability" - Higgins-Williams v. Sutter Med. Found., 237 Cal. App. 4th 78 (2015) - Michaelin Higgins-Williams worked as a clinical...more