doing business in the united states

LLCs May Be Right Unless They’re Wrong

Mike Burke Choice of Entity, Formation Issues , , , , , , , , , , , , , , ,

As I’ve posted before, I usually advise non-US companies to form a corporation when expanding to the United States. Every now and then, I get some pushback because the non-US company has heard about ‘limited liability companies’ (LLCs) in the US and wants to take advantage of the pass-through tax advantages of the LLC form. Before diving too deeply on this, let me get some definitional items out of the way. Corporate law in the US is predominately a creation of, and within the control of, the states. That’s why you hear about a ‘Delaware corporation’ or a ‘New York corporation’ and not a ‘United States corporation.’ That’s our Federal system at work (when it works). The corporation form in the US is similar to the limited company forms in Ireland and Northern Ireland, in that the shareholders/investors in each are only liable for the entity’s debts to the extent of their investment. Continue reading →

Expert Webinar on FDA Off-Label Communications Regulations

Mike Burke Uncategorized , , , , , , , , , , , ,

The US FDA’s regulation of ‘off-label communications’ (communications about the use of FDA-approved pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration) can be complex and confusing, especially for Irish and Northern Irish life sciences companies marketing/distributing their product in the US. Recent FDA actions have muddied the waters a bit more. Without clear guidance from the FDA , life sciences companies are struggling to decide how best to approach off-label communications, if at all. Continue reading →

A Holiday Gift: Making Lawsuits Speedier and Less Expensive

Mike Burke Litigation , , , , , , , , , , , ,

Even though it is the holiday season, nobody wants to get or give the ‘gift’ of civil litigation in a US Federal court. Not even a lawyer (I’m personally hoping for tickets to Bruce Springsteen’s new River tour, but I digress). I have spent a bit of virtual ink on this blog writing about how Irish and Northern Irish companies can avoid going to a US courthouse (I used a fancy phrase like ‘mitigate US litigation risk’), and I stand by that guidance. But if you do find yourself in a US Federal Court, some new amendments to the Federal Rules of Civil Procedure aim to make civil suits speedier and less expensive.  My colleague Ed Cadagin has written a client update on these amendments.  The takeaways: the revised rules (i) shorten the timelines for actions such as serving the defendant and issuing scheduling orders; and (ii) limit discovery to that which is “proportional to the needs of the case,” replacing the former discovery standard of “reasonably calculated to lead to the discovery of admissible evidence.” Ed’s full client alert can be read here. If you have to litigate here (and there will be times where US litigation is necessary), these rules should help make the experience more efficient for Irish and Northern Irish litigants.