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Results: 1-10 of 4,406

Due Diligence: Calculating the Regulatory Review Period for Patent Term Extension
  • Pepper Hamilton LLP
  • USA
  • May 25 2017

When applying for a patent term extension (PTE), due diligence matters. If an applicant did not act with due diligence during the testing phase or


Similar Claims but Opposite Results
  • Dechert LLP
  • USA
  • May 23 2017

A federal judge in Texas recently ruled that Texas law does not allow a claim for negligence per se based solely on alleged violations of the FDCA or


Defibrillator Device Suit Dismissed On Federal Preemption
  • Weil Gotshal & Manges LLP
  • USA
  • May 22 2017

A District Court in New Jersey recently dismissed a products liability action against Boston Scientific Corp., Guidant Corp., and two related medical


Speaking of the First Amendment. . . .
  • Reed Smith LLP
  • USA
  • May 22 2017

Now that Dr. Scott Gottlieb is safely installed as FDA Commissioner, we at DDLaw can end our moratorium on blogposts about First Amendment issues


Federal Judge Clobbers Claims in a Class III Medical Device Case
  • Baker Sterchi Cowden & Rice LLC
  • USA
  • May 22 2017

Talk about a one-two punch. First, federal question jurisdiction kept a medical device case in federal court. And then came the knock-out blow: a


Summary Judgment for Concentric Medical on Design Defect and Warnings Claims Related to Fracture of Merci Retriever Device
  • Reed Smith LLP
  • USA
  • May 18 2017

When last we wrote, we were about to embark on a journey to Budapest and Vienna to visit the Drug and Device Law Rock Climber. We mentioned that we


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


N.D. Alabama Issues Mixed Bag of Branded Preemption Rulings
  • Reed Smith LLP
  • USA
  • May 16 2017

We like bright lines in the law. They streamline arguments for lawyers and, more important, they make it easier for non-lawyers to conduct their


Indiana Judge Relies on Bausch to Bounce Preemption Motion
  • Baker Sterchi Cowden & Rice LLC
  • USA
  • May 15 2017

The old adage “location, location, location” applies as much for medical device preemption as it does for real estate. Despite acknowledging that the


Food and Beverage News and Trends 15 May 2017
  • DLA Piper LLP
  • USA
  • May 15 2017

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. How FDA