[WEBINAR] Exploring the CPRA’s Investigatory Privilege
Podcast: Non-binding Guidance: SEC Disclosure Issues for Life Sciences Companies
[WEBINAR] Public Records Act - Taming the Email Tiger
Form 10s as Alternatives to Traditional IPOs – Interview with Bill Hicks, Member, Mintz Levin
Daily Reports: Tell Us Where The Money Is
Corporate Law Report: Cybersecurity, CEO Social Media, New Workplace Laws, Healthcare Reform in 2013
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 October 29, 2020, the US Departments of Health and Human Services, Labor and Treasury (collectively, the Departments) issued the Transparency in Coverage final rule (the Rule), along with a fact sheet, setting forth...more
Recently, the Securities and Exchange Commission (SEC) issued an order charging a publicly traded pharmaceutical company with violations of Regulation FD as a result of selectively disclosing material, nonpublic information....more
On August 20th, 2019, the SEC charged TherapeuticsMD Inc., a pharmaceutical company headquartered in Boca Raton, Florida, with violations of Regulation FD based on its sharing of material, nonpublic information with sell-side...more
In a rare act of bipartisanship, Senate Finance Committee Chairman Chuck Grassley, R-Iowa, and Ranking Member Ron Wyden, D-Ore., introduced on July 23rd a chairman’s mark, the Prescription Drug Pricing Reduction Act (PDPRA)...more
On June 18, the Third Circuit affirmed a District of Delaware decision dismissing a False Claims Act (FCA) case against Medco Health Solutions, Inc. because the relator was not an original source of the information underlying...more
Federal False Claims Act (FCA) recoveries in fiscal year 2018 amounted to $2.88 billion, down by roughly $600 million from the prior year and dropping below $3 billion for the first time in eight years. Healthcare cases,...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
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
Arnall Golden Gregory LLP's 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 Washington, DC...more
The Fourth Circuit recently held that a relator is prohibited from pursuing a False Claims Act (FCA) claim based on facts learned by relator’s counsel in a previous FCA suit. In United States ex rel. May v. Purdue Pharma...more
To dismiss a case based on the public disclosure bar, the defense will have to establish that the allegations of fraud already were exposed in the news media or certain federal sources of information. Pharmaceutical,...more
Since we last reported on the generic pricing investigations the investigations have expanded. Par Pharmaceutical Companies, Inc. disclosed in its March 13, 2015 Annual Report that it had received a December 5, 2014...more
On February 6, 2015, the U.S. Food and Drug Administration (FDA) issued a revised draft guidance titled Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and...more
To bring a valid qui tam action and overcome the so-called “public disclosure bar” under the False Claims Act (“FCA”), a whistleblower must have direct knowledge of the alleged fraudulent activity, independent of already...more
FTC Mows Down Astroturfing at Yahoo - The Federal Trade Commission has closed an investigation into “astroturfing” by Yahoo employees and declined to take enforcement action because of the limited number of workers...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