On Friday, I used the phrase “Uber Settlement” as (maybe) click-bait to introduce an important, but hidden, issue facing Irish and Northern Irish companies operating in the US. As I noted in that post, many Irish and Northern...more
5/11/2016
/ Department of Labor (DOL) ,
Economic Realities Test ,
Employer Liability Issues ,
Independent Contractors ,
Ireland ,
IRS ,
Misclassification ,
Northern Ireland ,
Penalties ,
Uber ,
Wage and Hour
Uber recently settled—for US$100 million—two class-action cases involving some of its drivers, and one of the issue points in the litigation was whether Uber drivers are independent contractors or employees under relevant US...more
Bottom line up front: as of last Friday, new changes to the US’s Visa Waiver program restrict the use of that program by persons who have visited Iran, Iraq, Syria, or the Sudan at any time after March 1, 2011....more
Lawyers are often of two minds about providing ‘free stuff.’ Some look at it as a straight economic loss; others look at it as a service that can build to something even bigger. One of my good friends was, as he has said, ‘in...more
Once a month, AGG’s terrific FDA team publishes a newsletter updating readers on the latest regulatory news affecting food/drug companies–including those from Ireland and Northern Ireland. The August newsletter is here and...more
8/27/2015
/ 510(k) RTA ,
Bifurcation ,
Commercial Speech ,
Data Security ,
Evidence ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Free Speech ,
Litigation Hold ,
Medical Devices ,
Off-Label Promotion ,
Pharmaceutical Industry ,
Privacy Policy ,
Sanctions
Irish and NI life sciences companies operating in the US likely are familiar with the concept of “off-label” promotion–providing information about drug/device uses that have not been cleared by the FDA (even where the FDA has...more
Businesses operating in or expanding to the US, including those from Ireland and Northern Ireland, use independent contractors to avoid some of the baggage associated with the employer/employee relationship under US law. The...more
8/7/2015
/ Administrative Interpretation ,
Control Test ,
Cross-Border ,
Department of Labor (DOL) ,
Economic Realities Test ,
Foreign Entities ,
Independent Contractors ,
International Labor Laws ,
Ireland ,
Misclassification ,
Northern Ireland
Officers and directors of Irish and Northern Irish companies whose products would be regulated by the US Food and Drug Administration (life sciences companies, specifically) should be aware of developments on the issue of...more
7/10/2015
/ Board of Directors ,
Corporate Officers ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Indictments ,
Ireland ,
Medical Devices ,
Misbranding ,
Northern Ireland ,
Off-Label Promotion ,
Off-Label Use ,
Personal Liability
AGG produces a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from our Washington, DC office. The June 2015 update is now available....more
Foreign investors increasingly complain that US arbitration is morphing in to a process closer to full-blown litigation. I’ve always found it interesting that ‘full-blown’ is used to describe ‘all-in’ litigation and ‘all-in’...more