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Results: 1-10 of 888

Still No Causation, Still No “Parallel Claim”
  • Reed Smith LLP
  • USA
  • May 31 2018

We have made it no secret that we think the Ninth Circuit wrongly decided Stengel v. Medtronic. That is the case where the Ninth Circuit reversed


Breaking News - Solicitor General Recommends Grant and Reversal in Fosamax Appeal
  • Reed Smith LLP
  • USA
  • May 23 2018

We immediately called for the further appeal and reversal of the hideous decision in In re Fosamax (Alendronate Sodium) Products Liability Litigation


This Is How It is Supposed to Work: Summary Judgment On Claims About The Adequacy Of Extensive, FDA-Approved Warnings
  • Reed Smith LLP
  • USA
  • May 11 2018

Prescription drug manufacturers are not insurers of injuries sustained while taking their products. Even in the most plaintiff-friendly jurisdictions


Citing Lack of Standing, D.D.C. Tosses Challenge to FDA Denial of Citizen Petition
  • Reed Smith LLP
  • USA
  • May 9 2018

If clients get sued by someone where physical or financial injury seems remote, unclear, or speculative, consider raising the defense of lack of


FDA Issues Two Guidances on Next Generation Sequencing
  • Reed Smith LLP
  • USA
  • April 24 2018

This guest post is from Reed Smith‘s Matt Jacobson, who is keeping us up to date with the FDA’s initiatives concerning pharmacogenomics and


FDA Announces Plans to Improve Safety and Advance Innovation of Medical Devices
  • Reed Smith LLP
  • USA
  • April 18 2018

On April 17, 2018, FDA announced its plan to launch the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health (Action Plan


New CMS Guidance for ADLT Lab Tests and ADLT Application Released
  • Reed Smith LLP
  • USA
  • April 6 2018

CMS is still rolling out policies and procedures to fully implement the major clinical laboratory payment reforms mandated by the Protecting Access to


When Parallel Claims Are Neither Claims Nor Parallel
  • Reed Smith LLP
  • USA
  • April 5 2018

This is not new. PMA devices should have broad preemption against product liability claims. Not just from the express preemption provisions of the MDA


S.D. Fla. Dismisses Supplements Case for Lack of Standing
  • Reed Smith LLP
  • USA
  • April 4 2018

We recently read an editorial in The New York Times advocating lawsuits as a means of regulating an industry. Politicians are gripped by paralysis -


“No Newly Acquired Evidence” Argument On Implied Preemption Gaining Traction
  • Reed Smith LLP
  • USA
  • March 27 2018

It took a while for courts to catch on that implied preemption in drug cases depends on whether the plaintiffs can present “newly acquired evidence”