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 Supreme Court issued a number of headline-grabbing decisions this term on topics like religious accommodation, LGBTQ protections, and consideration of race in college admissions. These decisions are wide-reaching and...more
On June 1, 2023, the U.S. Supreme Court issued a unanimous opinion in United States ex rel. Schutte v. SuperValu Inc. reversing a pair of False Claims Act (FCA) cases on review from the Seventh Circuit Court of Appeals. In...more
The Situation: The Supreme Court's ruling in Universal Health Services, Inc. v. U.S. ex rel. Escobar, 136 S. Ct. 1989 (2016), opened the door to more materiality defenses under the False Claims Act ("FCA"), but without making...more
With more than 34.8 billion recovered by the government since 2010 under the federal False Claims Act, it has never been more crucial for private practitioners and corporate in-house counsel to keep abreast of the changes and...more
This latest installment of the Health Care Enforcement Quarterly Roundup reflects on trends that persisted in 2018 and those emerging trends that will carry us into 2019 and beyond. Leading off with the US Department of...more
Perhaps the single most appropriate word to describe the current state of the civil and criminal healthcare fraud enforcement environment is uncertainty. From changes in personnel and policy at the highest levels of...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
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
We expect 2018 to be another year of rapid change within the health care industry. In this episode, Mary Beth Johnston highlights some of the key topics that the health care practice group will monitor in the coming year,...more
Hospitals and Health Systems Prepare for a Value-Based Future - Editor’s Note: Hospitals and health systems are actively working to service their communities in numerous ways, including through the adoption of initiatives...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
Last year in Universal Health Services, Inc. v. United States ex rel. Escobar et al. the Supreme Court reminded litigants that the False Claims Act “is not an all-purpose antifraud statute.” In that case, the Court expanded...more
On July 7, 2017, the Ninth Circuit Court of Appeals issued an opinion in United States ex rel. Campie v. Gilead Sciences, Inc., holding that violations of Food and Drug Administration (FDA) regulations could create liability...more
On July 7, 2017, the U.S. Court of Appeals for the Ninth Circuit reversed a federal district court’s dismissal of a False Claims Act (FCA) whistleblower suit in United States ex rel. Campie v. Gilead Sciences, explaining that...more
One year after the Supreme Court changed the False Claims Act landscape, FCA litigants continue to grapple with the “demanding” materiality standard set forth in Universal Health Services v. United States ex rel Escobar. Now...more
In May 2017, the U.S. Court of Appeals for the Third Circuit relied on the “heightened materiality standard” endorsed by the U.S. Supreme Court in its 2016 Escobar decision in dismissing a False Claims Act (FCA) whistleblower...more
In the recent Third Circuit decision United States of America, ex rel. Gerasimos Petratos, et al. v. Genentech Inc; et al., No. 15-3805, 2017 WL 1541919 (3d Cir. May 1, 2017), the Third Circuit addressed a “false...more
A recent circuit court decision will be a welcome development for False Claims Act defendants because it reinforces a significant pleading hurdle for claims to proceed, with the court citing lack of government intervention as...more
Bass, Berry & Sims is pleased to announce the release of its fifth annual Healthcare Fraud and Abuse Review 2016. The Review, compiled by the firm’s Healthcare Fraud Task Force, is an industry-leading guide to healthcare...more
Activist investor Carl Icahn has taken a sizeable stake in Bristol-Myers Squibb, a move that reportedly caught execs at the drugmaker unawares and sets the stage for a potential sale....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
Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more