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Amarin responds to FDA claims
  • Weil Gotshal & Manges LLP
  • USA
  • July 3 2015

Just this week, I blogged about the FDA’s letter and opposition in response to Amarin Pharma, Inc.’s complaint challenging regulations that prohibit


No innovator liability: National Drug Code saves the day
  • Reed Smith LLP
  • USA
  • July 2 2015

This is a quick-hit post as we head into the Independence Day holiday weekend. The Southern District of West Virginia's order this week in McNair v


FTC refunds $3 million to consumers for cactus juice drink
  • Shook Hardy & Bacon LLP
  • USA
  • July 1 2015

Nearly 500,000 consumers will receive refunds totaling almost $3 million after the Federal Trade Commission (FTC) settled charges against dietary


No induced infringement where off-label use of a drug is not “inevitable”
  • McDermott Will & Emery
  • USA
  • June 30 2015

Finding that a drug label’s language did not rise to the level of “active encouragement” that would induce doctors to infringe, the U.S. Court of


FDA responds on claims regarding distribution of off-label information
  • Weil Gotshal & Manges LLP
  • USA
  • June 30 2015

Last month, I blogged on Amarin Pharma, Inc.’s complaint against the FDA challenging the agency’s regulations that prohibit the company from


FDA files brief regarding off-label promotion in Amarin Pharma lawsuit
  • Reed Smith LLP
  • USA
  • June 27 2015

As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of


No prescription for consumer protection
  • Reed Smith LLP
  • USA
  • June 25 2015

Allowing plaintiffs to pursue claims under consumer protection statutes in prescription medical product liability litigation is trying to pound a


A word to the wise from the garden state
  • Dechert LLP
  • USA
  • June 23 2015

A long time ago in a town not so far away, a teacher offered a piece of advice to his students: A word to the wise is sufficient. A word to the


Off-label promotion, state-level injury lawsuits, and preemption
  • Arnall Golden Gregory LLP
  • USA
  • June 23 2015

The issue of preemption in product liability cases involving medical device products continues to evolve. Recently, the U.S. Court of Appeals for the


The FDA sends Amarin a letter in their First Amendment court battle
  • Cozen O'Connor
  • USA
  • June 22 2015

Last month, Amarin Pharma, Inc. filed a complaint in the Southern District of New York asserting that the FDA could not apply its regulations to