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Results: 1-10 of 865

FDA Proposes to Delay Off-Label “Intended Use” Rule
  • Reed Smith LLP
  • USA
  • January 16 2018

Perhaps you have heard that elections have consequences. That is true not only for high-profile issues that hog the headlines on CNN and Fox News, but


Avandia Case Flunks Warning Causation
  • Reed Smith LLP
  • USA
  • January 3 2018

We're now into the New Year but aren't completely done with the old one. The name of the first month of the year, January, is conventionally


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


Inauspicious Debut for Depakote Plaintiffs’ First Amendment Argument
  • Reed Smith LLP
  • USA
  • December 27 2017

We've been aware of the other side attempting to construct a First Amendment counter-argument to our preemption defense for some time. It first


OIG Report Assesses Accuracy of Manufacturer-Reported Medicaid Rebate Program Data
  • Reed Smith LLP
  • USA
  • December 21 2017

The OIG recently issued a report evaluating the accuracy of pharmaceutical manufacturer-reported Medicaid drug rebate program data, including pricing


Breaking News: TH v. Novartis - California Supreme Court Recognizes New Tort Duties as Traditional Limits Slide into the Sea
  • Reed Smith LLP
  • USA
  • December 21 2017

We posted our 2017 "Worst 10 decisions" list a day too soon, because the California Supreme Court issued its anticipated decision in TH v. Novartis


The Lows Mourning the Worst Prescription DrugMedical Device Decisions of 2017
  • Reed Smith LLP
  • USA
  • December 21 2017

The second most successful college basketball coach of all time (in terms of NCAA Division 1 national championships) has said "All of life is peaks


Ninth Circuit Undoes Incretin Implied Preemption Ruling - For Now
  • Reed Smith LLP
  • USA
  • December 20 2017

We reported two weeks ago on an order favoring implied preemption in an innovator prescription drug case coming out of the Eliquis MDL in New York


Is Your Software a Medical Device? FDA Weighs-in with New Draft Guidances
  • Reed Smith LLP
  • USA
  • December 19 2017

On December 8, 2017 - nearly a year after President Obama signed into law the 21st Century Cures Act ("Cures Act") - the Food and Drug Administration


Michigan Strikes Back . . . In Pennsylvania
  • Reed Smith LLP
  • USA
  • December 15 2017

A (relatively) long time ago in a state not so far away, the Michigan Legislature enacted the Michigan Product Liability Act. It contained a