We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results: 1-10 of 975

Non-Physician Learned Intermediaries
  • Reed Smith LLP
  • USA
  • February 20 2017

One of us was asked a question the other day that we couldn’t answer immediately. “Does the learned intermediary rule apply to a physician’s


FDA-Approved Labeling Medical Standard Of Care
  • Reed Smith LLP
  • USA
  • February 13 2017

We’ve been defending the ability of physicians to engage in off-label use ever since the Bone Screw litigation of the 1990s. Buckman Co. v


Nebraska Daubert Order Finds Expert a Mile Wide at the Mouth, But Only Six Inches Deep
  • Reed Smith LLP
  • USA
  • February 9 2017

A case from Douglas County, Nebraska, caught our eye this week for a couple of reasons. It’s a great Daubert order in an Accutane case in Nebraska


Unreliable Expert Causation Evidence Ends Birth Defect Case
  • Reed Smith LLP
  • USA
  • February 9 2017

We have posted several times in the last few years (like here, here, here, and here) about cases alleging birth defects from maternal SSRI use during


Reclast Plaintiff Experts Hobbled by Daubert
  • Reed Smith LLP
  • USA
  • February 7 2017

We have long suspected that the reason some judges are hostile to Daubert is because application of the doctrine involves so much work. Rather than


Gorsuch Looks Pretty Good On Preemption
  • Reed Smith LLP
  • USA
  • February 6 2017

When we heard about Judge Neil Gorsuch being nominated for the United States Supreme Court, our first move was to enter his name in Westlaw along


Just What the Doctor Ordered: Package Insert Does not Establish Standard of Medical Care
  • Reed Smith LLP
  • USA
  • February 3 2017

Like most Americans, we like our doctor. We like doctors in general. We are not looking to start another song battle with our friends over at the


Hip Case Breaks the Right Way in New York
  • Reed Smith LLP
  • USA
  • February 1 2017

A recent case in the Southern District of New York debunks two myths that we see all the time. Myth number one: A medical device is defective if it


FDA Off-Label Promotion Memo Should Affect 510k Preemption & Evidence
  • Reed Smith LLP
  • USA
  • January 30 2017

Remember how Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), dismissed the 510k “substantially equivalence” medical device clearance as non-preemptive


Midnight Madness The FDA Continues To Discount First Amendment Implications Of Restrictions On Off-Label Promotion
  • Reed Smith LLP
  • USA
  • January 27 2017

This guest post is from Liz Minerd, an associate at Reed Smith. She previously wrote the post on the FDA’s off-label promotion meeting last November