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ITC Institutes Investigation Based on Allegation of Drug Sales Without FDA Approval
  • Jones Day
  • USA
  • May 17 2018

Normally, it is the FDA that monitors the improper distribution of drugs. But, as it turns out, the International Trade Commission ("ITC") might be


Snack Bar Class Action is KIND-ly Stayed Pending USDA Regulation on Bioengineered Food
  • Proskauer Rose LLP
  • USA
  • March 26 2018

Earlier this month, Judge William H. Pauley III in the Southern District of New York stayed a lawsuit against the snack bar maker KIND LLC, styled as


Third Circuit Issues Precedential Ruling on Express Preemption for Hybrid Medical Devices
  • Cozen O'Connor
  • USA
  • March 20 2018

The Third Circuit has become the first U.S. Court of Appeals to address the application of the express preemption provision in the Medical Device


Third Circuit Grants Express Preemption in “Hybrid” Medical Device Case
  • Bradley Arant Boult Cummings LLP
  • USA
  • March 6 2018

On March 1, the U.S. Court of Appeals for the Third Circuit, in Shuker et al. V. Smith & Nephew PLC, affirmed a District Court’s ruling that claims


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


The Bank Rejects Fosamax Folly
  • Reed Smith LLP
  • USA
  • October 11 2017

Look what just fell into our lap. Our blogging about the favorable California Risperdal preemption decision last week shook loose from that same case


Supreme Court Biosimilar Patent Dance Decision Largely Favors Biosimilars
  • Foley & Lardner LLP
  • USA
  • June 13 2017

On June 12, 2017, the Supreme Court issued a unanimous decision in Sandoz Inc. v. Amgen Inc. (No. 15-1039), deciding that 42 U.S.C. 262(l)(9)(C


Supreme Court Issues Highly Anticipated Decision Interpreting the Biologics Price Competition and Innovation Act
  • Kramer Levin Naftalis & Frankel LLP
  • USA
  • June 12 2017

On June 12, the Supreme Court decided Sandoz Inc. v. Amgen Inc., the first case under the Biologics Price Competition and Innovation Act of 2009


Picking Up the Post-Preemption Pieces
  • Reed Smith LLP
  • USA
  • May 25 2017

Parties often file motions in limine on fairly case-specific issues, building on the history of discovery and motions practice in the case. Applying


No Ifs, Ands Or Butts - Preemption Gutts, Rebutts, and Shutts Down Utts
  • Reed Smith LLP
  • USA
  • May 17 2017

Late last year we happily blogged about Utts v. Bristol-Myers Squibb Co., ___ F. Supp.3d ___, 2016 WL 7429449 (S.D.N.Y. Dec. 23, 2016), chiefly