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Off-label medicine: as bad as it sounds?
  • RPC
  • United Kingdom
  • June 13 2018

Consider this: the prescription your doctor wrote for you may not be "officially" approved for your illness. Before you panic, this may not be as

Two Enacted State Laws Permit Truthful Off-Label Promotion
  • Cooley LLP
  • USA
  • May 16 2018

Earlier this month, Tennessee House Bill 2220 (substituted for Senate Bill 2361) (Tennessee Law) was enacted, which provides, “A pharmaceutical

Boots on the Ground: PIL Task Force Targeting Opioid Providers in the War on Drugs
  • K&L Gates
  • USA
  • April 30 2018

Attorney General Jeff Sessions announced the creation of the Prescription Interdiction & Litigation (“PIL”) Task Force -- which Sessions described as

"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

Off-label use of medicines: the CJEU on "by object" infringement under EU competition law
  • Taylor Wessing
  • European Union
  • February 21 2018

In November 2017, we reported on Advocate General Saugmandsgaard Øe's Opinion in Case C-17916 F. Hoffman-La Roche Ltd and Others v Autorità Garante

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

Two DOJ Memos to Impact Health Care False Claims Act Litigation
  • Dinsmore & Shohl LLP
  • USA
  • February 14 2018

As the new year started, two Department of Justice memoranda began circulating that may bring a change in the way the United States focuses its

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