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Results: 1-10 of 773

"Off-label" Cases Aren't Going Away - DOJ Sheds Light on Direction of Enforcement of Misbranding Rules Governing Medical Products
  • Venable LLP
  • USA
  • March 6 2018

On February 28, Ethan Davis, the U.S. Department of Justice's (DOJ) deputy assistant attorney general responsible for consumer protection, gave a


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


PMA Preemption & Fraud by OmissionConcealment
  • Reed Smith LLP
  • USA
  • November 29 2017

As our PMA preemption scorecard makes clear, warning claims are preempted under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), because the


Off-Label Marketing Case Tossed
  • Reed Smith LLP
  • USA
  • September 29 2017

Implied Preemption. Off-label promotion. TwIqbal. They make up a core of our posts, yet we never seem to tire of them. Maybe our readers, especially


How Companies Should Prep for Enforcement Shift to State AGs
  • Foley & Lardner LLP
  • USA
  • August 23 2017

“Top Cop” is how every state Attorney General wants to be known. In reality, state AGs have far more authority for civil enforcement than they do for


The Past, Present, and Future of Government Regulation of Off-Label Communications - Part 4
  • Mintz Levin
  • USA
  • August 14 2017

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent


PhRMA Comment on the FDA’s Proposed Off-label Rule: The Rule of Law is the Best Medicine
  • Reed Smith LLP
  • USA
  • July 25 2017

The FDA cannot get out of its own way on the issue of off-label communications. Its power to punish off-label promotion comes from an odd regulatory


Off-Label Use Gets Congressional Hearing
  • Cooley LLP
  • USA
  • July 11 2017

Tomorrow, the House Energy and Commerce Committee will hold a hearing tilted “Examining Medical Product Manufacturer Communications.” According to the


Law Review Article on Off-label is On Target
  • Reed Smith LLP
  • USA
  • June 27 2017

More than once we've said that we read law review articles so you don't have to. We separate the wheat from the chaff. The wheat is scarce. That is


Fifth Circuit Affirms Defense Verdict and Dismissals of Off-Label FCA Claims
  • Sidley Austin LLP
  • USA
  • June 13 2017

Last week, the Fifth Circuit affirmed a defense verdict and the earlier dismissal of several False Claims Act claims related to the alleged off-label