Topic
Preemption
1,725 published works
Drug & Device Law
New FDA Draft Guidance Helps Define the Scope of §510(k) Medical Device Preemption
By Bexis
Earlier this month the FDA issued a draft guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device.” It’s long, and anyone interested in reviewing…
Drug & Device Law
Two Favorable Tysabri Rulings Add Clarity to “Clear Evidence” Preemption Standard – and More
By Bexis
Anyone who has checked our post-Levine innovator drug & vaccine cheat sheet lately has no doubt noticed our two most recent entries, Gentile v. Biogen Idec, Inc., 2016 WL 4128159…
Drug & Device Law
California Court Clears The Way For Express Preemption
Not everyone sees eye to eye on federal preemption, including judges. Take for example the conflicting opinions from the California Court of Appeal applying the express preemption provision of the…
Drug & Device Law
Something Went Right In Brazil
By Bexis
Zika virus, Olympic unpreparedness, economic collapse, presidential impeachment − a lot of things have gone wrong in Brazil lately. But we’re not here to talk about any of that. Here’s…
Drug & Device Law
Post-Recall Negligence Claims Preempted
This post is from the non-Reed Smith side of the blog. We post a lot about preemption. We post a lot about PMA preemption. That’s because thanks to Riegel v.…
Drug & Device Law
Another Prescription Drug Warnings Preemption Decision
Not that our readers are dying for a glimpse behind the curtain into the making of the sausage (and mixed metaphors) of the blog, but we do try to first…
Drug & Device Law
Minnesota Gives Us Another Excellent Preemption Decision
This post comes from the non Reed Smith side of the blog. Minnesota is one of our most beautiful states and the setting for much of the terrific TV…
Drug & Device Law
Trimming Some Fat From Statin Litigation With Rule 702 and Preemption
One of the greatest spectacles on earth is the annual migration of wildebeest, zebras, and antelope in a loop around the Serengeti. The Blog will have its own migration shortly,…
Drug & Device Law
Failure to Train Preempted in California
This post is from the non-Reed Smith side of the blog. In Glennen v. Allergan, Inc., -- Cal. Rptr.3d --, 2016 WL 1732243 (Cal. Ct. App. Apr. 29, 2016), plaintiff…
The Energy Law Blog
Fracking Scores with Two Colorado Supreme Court Opinions
Hydraulic fracturing, or “fracking,” is a hotly debated topic in many states. In New York and Pennsylvania, anti-fracking groups have obtained a statewide ban on fracking and the allowance of…