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Results: 1-10 of 879

Another Reason Why Medical Device Class Actions Don’t Work
  • Reed Smith LLP
  • USA
  • August 26 2016

The Ninth Circuit filed a preemption opinion the other day that should help prevent the “foodification” of medical device litigation. That made-up


New FDA Draft Guidance Helps Define the Scope of 510(k) Medical Device Preemption
  • Reed Smith LLP
  • USA
  • August 22 2016

Earlier this month the FDA issued a draft guidance entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device."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


Guest Post - Through the Dictionary, and What One Court Found There: Adventures in the BAAA
  • Reed Smith LLP
  • USA
  • August 19 2016

It's August and several your valiant bloggers are on vacation, so the skeleton crew manning the fort is even more grateful for reinforcements than


Guest Post Marion Even with a Road Map, Only One Dubious Claim Navigates Preemption
  • Reed Smith LLP
  • USA
  • August 17 2016

Here's another guest post, this time from Reed Smith's Elizabeth Graham Minerd. This post concerns PMA preemption, and a second opinion largely


Two Favorable Tysabri Rulings Add Clarity to “Clear Evidence” Preemption Standard - and More
  • Reed Smith LLP
  • USA
  • August 15 2016

Anyone who has checked our post-Levine innovator drug & vaccine cheat sheet lately has no doubt noticed our two most recent entries, Gentile v


New York Decision Not Good For Asbestos, But Not Bad For DrugDevice
  • Reed Smith LLP
  • USA
  • August 12 2016

The recent decision of the New York Court of Appeals in In re New York City Asbestos Litigation, ___ N.E.3d ___, 2016 WL 3495191 (N.Y. June 28, 2016


California Court Clears The Way For Express Preemption
  • Reed Smith LLP
  • USA
  • August 11 2016

Not everyone sees eye to eye on federal preemption, including judges. Take for example the conflicting opinions from the California Court of Appeal


CMS Still Finding Its Way Through Significant Medicare Appeals Backlog - Proposes New Rule in an Effort to Catch Up
  • Reed Smith LLP
  • USA
  • August 9 2016

In the proposed rule, CMS focuses on taking administrative actions to alleviate the backlog, including introducing the concept of precedential


Guest Post - Benicar MDL Court: An Unconventional, but Relatively Simple, Remand Decision
  • Reed Smith LLP
  • USA
  • August 9 2016

This is a guest post, by Jaimee Farrer, an associate at Reed Smith. We're always looking for new twists that can help in efforts to remove cases to


Off-Label Marketing - Industry Groups Step into the Breach
  • Reed Smith LLP
  • USA
  • August 8 2016

We have been waiting, literally for years, for the FDA to revise, clarify, update, or simply pay attention to, its off-label promotion regulatory