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EU Court ruling on how off-label use is to be analysed under competition law
  • White & Case LLP
  • European Union
  • February 14 2018

The highest EU court has held that an agreement to disseminate misleading information about the safety of a medicine being used off-label may restrict

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

News Update EU - Life Sciences Special December 2017
  • Houthoff
  • United Kingdom, European Union, France
  • December 7 2017

On 20 November 2017, the EU Council announced that Amsterdam will be the new location for the European Medicines Agency (EMA) after the UK will

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

Sixth Circuit Affirms Dismissal of FCA Complaint for Lack of Rule 9(b) Particularity
  • Bass, Berry & Sims PLC
  • USA
  • November 10 2017

Recently, in United States ex. rel. Ibanez v. Bristol-Meyers Squibb Co., No. 16-3154 (Oct. 27, 2017), the Sixth Circuit Court of Appeals affirmed a

Here Is Why The False Claims Act Is An “Awkward Vehicle” In Pharma Cases
  • Reed Smith LLP
  • USA
  • November 9 2017

We have always thought that the False Claims Act resides in some sort of alternate universe when it comes to pharmaceutical products. The central

The Past, Present, and Future of Government Regulation of Off-Label Communications - Part 5
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • October 26 2017

In this post, I will be focusing on the intersection of off-label communications with government enforcement of health care fraud through the False

Time to Take Your Medicine: Fifth Circuit Decision Diagnoses Problems with Causation Arguments
  • Vinson & Elkins LLP
  • USA
  • October 10 2017

Last month, we covered United States ex rel. King v. Solvay Pharmaceuticals, Inc. on the issue of the FCA’s public disclosure bar pre-Affordable Care

A Reminder Of The Dangers In Green Marketing & Organic Labeling
  • GB&A
  • USA
  • October 6 2017

"100 organic", "all natural", "biodegradable", "green certified"...what do all of these statements have in common aside from the fact that they're

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