Recently we published a post, “One, Two, Three Strikes You’re Out,” about three recent (non-pelvic) mesh wins that occurred less than one week apart. We spent the most ink on Nowell v. Medtronic Inc., ___ F. Supp.3d ___, 2019 WL 1434971 (D.N.M. March 29, 2019), which also happened to be the longest
Have you ever left a deposition feeling confident that you obtained the testimony you hoped to receive, and it’s time to move for summary judgment? Then (whether within the time period permitted by the relevant rule – in federal court Fed. R. Civ. P. 30(e)(1) – or otherwise) you get back a so-called “errata sheet”
We just saw a commercial with the tag line, “Life is messy. Clean it up.” It’s true – life is messy, sometimes gloriously so. Rules get broken, scripts get torn up, best-laid plans are tossed aside by the winds of fortune. That’s why we like statutes of repose. They are bulwarks in a system in
With new grass on the field, the 2019 baseball season is underway and optimism springs eternal. Here in Philadelphia, the Phillies have actually around the top of the NL east for the first time since, umm…., last year actually. But this year, having added possibly the best player and best catcher in the league,
Every day our inbox overflows with legal news aggregation emails. Some of the items are useful. Some must have been authored by Captain Obvious. Some are irrelevant to our practice. We would have thought that comfortably residing in that last category are discussions of the burgeoning marijuana field. The “Week in Weed” and other such
This message is directed primarily to our overseas readers, and those who represent non-United States drug and medical device companies. Under FDA registration regulations, non-United States manufacturers (and other regulated companies) that import their regulated products into this country are required to appoint a domestic “agent” for regulatory purposes:
(i) Registration of foreign establishments
(1)
If the promise of adaptive artificial intelligence (sometimes called “Machine Learning”) is to be achieved in the medical area, FDA’s regulation of medical devices is going to have to graduate from geometry to calculus. By its nature, machine learning changes the details of its output constantly. The rigid regulatory model requiring FDA pre-approval of all
It’s Delaware week here at the DDL Blog. A couple of days ago we brought you a particularly clear-minded order rejecting innovator liability in the First State (so nicknamed because Delaware was the first of the original 13 colonies to ratify the Constitution in 1787), and yesterday we reported on a pair of Delaware orders
There will come a time when there is no such thing as the local radio station. Not only will transmission not occur via radio waves, but there will be nothing local about it. There also may be no banter from the DJ, short for “disc jockey”–a reference to placing flat, round pieces of plastic called
It’s tax week, so expect a lot of cases this week from that wonderful no-tax paradise, Delaware. With light traffic (iffy on I-95, to be sure), one can get from our office to Delaware in under a half hour. That’s a worthwhile trip for buying anything in triple or higher digits. It’s also a worthwhile