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FDA De Novo Device Classification Process & Preemption
  • Reed Smith LLP
  • USA
  • December 10 2018

The FDA has recently released a proposed rule “to establish requirements for the medical device De Novo classification process” provided in 21 U.S.C


A Couple of MDL Ideas from the Recent ACI DrugDevice Conference
  • Reed Smith LLP
  • USA
  • December 6 2018

Late last month Bexis attended the annual ACI Drug and Medical Device Conference in New York. In between helping to lead the discussion in the


Personal Jurisdiction Wins Cases
  • Reed Smith LLP
  • USA
  • November 29 2018

We’ve discussed personal jurisdiction a lot on the Blog lately, and not so lately, and for good reason. The Supreme Court’s reining in of both general


Biomaterials Access for the 21st Century
  • Reed Smith LLP
  • USA
  • November 12 2018

We’ve blogged several times about the Biomaterials Access Assurance Act of 1998, 21 U.S.C. 1601-06. In a nutshell, the BAAA provides suppliers of


IVC Inconsistent Verdict Created
  • Reed Smith LLP
  • USA
  • April 3 2018

We don’t normally comment on verdicts, whether they favor our side or the plaintiffs, because the bare fact of a verdict doesn’t give us much to


Another Comparative Book Review
  • Reed Smith LLP
  • USA
  • January 24 2018

What follows is a guest post from Mark Herrmann, the co-founder and former co-host of this blog. While he hasn't litigated since going in house, he


Where To Find Our Research 3.0
  • Reed Smith LLP
  • USA
  • January 2 2018

Happy New Year! It’s been 3 years since we last updated our index to our online research resources. That’s almost of the total life of the blog


The Highs Celebrating the Ten Best Prescription DrugMedical Device Decisions of 2017
  • Reed Smith LLP
  • USA
  • December 28 2017

Ending the year on a high note is one thing that the blog tries to do - with the top ten drugdevice product liability decisions of the year


Guest Post - Protecting Reasonable Physician Choice in Medical Product Cases
  • Reed Smith LLP
  • USA
  • December 12 2017

We have a guest post today, from Luther Munford of Butler Snow. He's been doing some thinking about how something analogous to the "two schools of


Guest post - Observations on FDA 3D Printing Guidance
  • Reed Smith LLP
  • USA
  • December 7 2017

This guest post is by Reed Smith‘s Matthew Jacobson. It discusses the FDA’s recent guidance on the hot topic of 3D printing as a manufacturing